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BIOATLA REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PROGRESS

BIOATLA REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PROGRESS

– Mecbotamab vedotin (BA3011) Phase 2 preliminary observations in Non-Small Cell Lung Carcinoma (NSCLC) supports advancing to the registrational stage of the study; anticipate full interim data set in 4Q22
– Mecbotamab vedotin (BA3011) Undifferentiated Pleomorphic Sarcoma (UPS) and osteosarcoma Phase 2 part 2 enrollment anticipated to begin 4Q22 following requested written feedback from FDA; continuing to enroll additional cohorts
– Mecbotamab vedotin (BA3011) sarcoma Phase 2 top-line interim data support advancing with liposarcoma and synovial sarcoma; next steps under evaluation
– Ozuriftamab vedotin (BA3021) NSCLC and Squamous Cell Carcinoma of the Head and Neck (SCCHN) Phase 2 studies ongoing as planned; NSCLC preliminary cohort interim update on track for 2H22, SCCHN trial ongoing with first patient dosed now anticipated in 3Q22; melanoma enrollment ongoing with status update using new validated Circulating Tumor Cell (CTC) assay anticipated Q422
– CAB-CTLA-4 (BA3071) Phase 1 study ongoing with first patient dosed
– Cash balance of $202.3 million at quarter-end expected to provide funding into 2H24
– Management to host conference call and webcast today at 4:30 PM Eastern Time

SAN DIEGO, August 9, 2022 – BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced its financial results for the second quarter ended June 30, 2022, and provided an interim topline data update from the mecbotamab vedotin (BA3011) Phase 2 study in NSCLC as well as an operational update on its ongoing clinical programs, including BA3011, ozuriftamab vedotin (BA3021) and CAB-CTLA-4 (BA3071) addressing multiple tumor types.
“BioAtla continues to progress our CAB-ADC programs, most recently with important signals observed this quarter in our Phase 2 BA3011 NSCLC study. In parallel, we continue to advance with our Phase 2 studies for BA3011 in multiple sarcoma subtypes, with positive signals identified in liposarcoma and synovial sarcoma and official enrollments into part 2 for UPS and osteosarcoma expected to begin this year. We also are progressing with our additional clinical assets, ozuriftamab vedotin (BA3021) in Phase 2 NSCLC, melanoma and head & neck cancer, as well as with our Phase 1/2 naked immuno-oncology antibody CAB-CTLA-4 (BA3071) across multiple tumor types, and anticipate several updates later this year,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc.
“We are very encouraged by our Phase 2 NSCLC preliminary observations, which are consistent with results from our Phase 1 NSCLC and Phase 2 sarcoma studies. Collectively, these data further strengthen the potential opportunity of BA3011 as a best-in-class therapeutic across multiple solid tumor types,” said Scott Smith, President of BioAtla. He continued, “We are also very excited with the continued execution across all the other important programs in our pipeline, including BA3021, BA3071, and BA3182. BioAtla
has a strong cash position to support our robust clinical and preclinical programs into the second half of 2024, and we will remain acutely focused on prioritizing the indications we view have the highest probability of success to maximize value for patients and our shareholders.”
Key Developments, Operational Updates and Upcoming Milestones • Phase 2 Trial of Mecbotamab Vedotin (BA3011, NCT03425279) in Patients with: o AXL-positive NSCLC ▪ Trial ongoing in patients who have previously experienced failure of PD-1/L1, EGFR, or ALK inhibitor therapy (average failure 2.5 lines of therapy; 2 prior lines for non-squamous, 4 prior lines for squamous) ▪ 15 patients enrolled to date, with 9 efficacy-evaluable patients • 4 patients currently on treatment did not yet have the opportunity to be followed for 3 months and 2 patients were not deemed efficacy-evaluable. Of the 9 evaluable patients (7 in the non-squamous adenocarcinoma group and 2 in the squamous cell carcinoma group), a total of 1 complete response (CR) and 2 partial responses (PRs) were observed for a combined objective response rate (ORR) of 33% o In the non-squamous group, 4 of 7 had monotherapy and 3 of 7 had combination therapy o All CR / PRs observed were in the non-squamous group, representing an ORR of 43%, or 3 out of 7 patients (2 PRs were in monotherapy, ORR 50%; and 1 CR in combination therapy, ORR 33%)

• The observations in non-squamous cohort are consistent with the signal observed in the Phase 1 study
• Initiating preparations for discussions with the FDA about part 2 of the registrational study in AXL-positive NSCLC patients
▪ No clinical responses (ORR, PR) observed to date in the squamous cohort in either monotherapy (n=1) or combination therapy (n=1)
▪ BA3011 is generally safe and well-tolerated in both monotherapy and combination with nivolumab in advanced NSCLC patients with no new safety signals observed
▪ Full interim data set of approximately 20 patients anticipated this year o AXL-positive Soft Tissue and Primary Bone Sarcomas
▪ Interim Phase 2 analysis after a minimum of 3 months demonstrates antitumor activity following BA3011 treatment in:
• UPS and osteosarcoma; advancing as separate cohorts into part 2 of the Phase 2 study; additional detail for part 2 will become available following FDA written feedback
• Liposarcoma; PFS rate 60% (n=6); next steps under evaluation
• Synovial sarcoma; PFS rate 50% (n=5); next steps under evaluation
▪ Continuing to enroll across cohorts, awaiting data and will provide an update when available
• Phase 2 Trial of Ozuriftamab Vedotin (BA3021, NCT03504488) in Patients with:
o ROR2-positive NSCLC
▪ Trial enrolling in patients who have previously experienced failure of PD-1/L1, EGFR or ALK inhibitor therapy
▪ Interim update on track for second half of 2022
o ROR2-positive Melanoma
▪ Trial ongoing in patients who have previously experienced failure of PD-1 therapy ▪ Completed successful validation of non-invasive liquid biopsy; implementation as part of study protocol is underway
▪ Enrollment ongoing and actively dosing; anticipate trial enrollment status update in Q422
o ROR2-positive SCCHN
▪ Trial ongoing in patients who have previously experienced failure of PD-1 therapy alone or in combination with platinum therapy
▪ Anticipate first patient dosed in third quarter of this year
• Phase 1/2 Dose-Escalation Trial of CAB-CTLA-4 (BA3071) Across Multiple Solid Tumor Types
o Trial ongoing with first patient dosed and actively screening additional patients across multiple centers with advanced solid tumors
• On track for IND filing for CAB EpCAM x CAB-CD3 bispecific antibody (BA3182) in 4Q22
• Anticipate potential IND filings for a pre-clinical next generation CAB-ADC candidate and a second CAB bispecific in 2023

Second Quarter Financial Results

Cash and cash equivalents as of June 30, 2022 were $202.3 million, compared to $245.0 million as of December 31, 2021. We expect current cash and cash equivalents will be sufficient to fund planned operations including all ongoing CAB product development programs into second half 2024.
Research and development (R&D) expenses were $20.7 million for the quarter ended June 30, 2022 compared to $14.9 million for the same quarter in 2021. The increase of $5.8 million was primarily driven by expansion of our product development efforts including clinical development for CAB-CTLA-4 (BA3071) and pre-clinical development of additional CAB candidates. We expect our R&D expenses to remain variable from quarter to quarter and generally increase as we continue to invest in R&D activities to advance our product candidates and our clinical programs. General and administrative (G&A) expenses were $8.3 million for the quarter ended June 30, 2022 compared to $15.9 million for the same quarter in 2021. The $7.6 million change was attributle to a decrease in stock-based compensation for the 2022 period. We expect our G&A expenses to moderately increase to support development of our product candidates, advance our intellectual property portfolio, support focused pre-commercialization activities for our product candidate mecbotamab vedotin (BA3011) and satisfy requirements as a public company. Net loss for the quarter ended June 30, 2022 was $28.9 million compared to a net loss of $30.4 million for the same quarter in 2021.
Net cash used in operating activities for the six months ended June 30, 2022 was $42.1 million compared to net cash used in operating activities of $28.5 million for the same period in 2021. The increase in net cash used in operating activities for the first six months of 2022 is primarily due to an increase in research and development expense related to our program development efforts as compared to the first six months of 2021.
Second Quarter 2022 Conference Call and Webcast Details The management of BioAtla, Inc. will host a conference call and webcast for the investment community today, August 9, 2022, at 4:30 pm Eastern Time. A live webcast may be accessed here: https://edge.media-server.com/mmc/p/czrtgcet. The conference call can be accessed by dialing toll-free (844) 826-3035. The passcode for the conference call is 10169204.
A replay of the webcast and slides with topline interim clinical data referenced on the call will be available through “Events & Presentations” in the Investors section of the company’s website after the conclusion of the presentation and will be archived on the BioAtla website for one year.
About Mecbotamab Vedotin (BA3011)
Mecbotamab vedotin (BA3011), CAB-AXL-ADC, is a conditionally and reversibly active antibody drug conjugate targeting the receptor tyrosine kinase AXL. This Phase 2 stage clinical asset is targeting multiple solid tumor types, including soft tissue and bone sarcoma, non-small cell lung cancer (NSCLC) that have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapies. We are also supporting a multi-center investigator-initiated clinical trial in combination with a PD-1 inhibitor in patients with platinum-resistant ovarian cancer, with other potential indications in the future. The Office of Orphan Drug Products (OODP) at FDA granted Orphan Drug Designation to mecbotamab vedotin for the treatment of soft tissue sarcoma. In the Phase 1 clinical study in sarcoma patients mecbotamab vedotin was generally well-tolerated, few patients discontinued due to an adverse event, and no clinically meaningful on-target toxicity to healthy AXL-expressing tissue was observed. Of the seven sarcoma patients who had an AXL tumor membrane percent score (TmPS) of greater than or equal to 70, four of these obtained a confirmed partial response, including patients with leiomyosarcoma, UPS, and Ewing sarcoma. Multiple subtypes of sarcoma present a significant unmet medical need. For example, UPS is one of the most aggressive sarcoma subtypes with the highest recurrence rate and has approximately 4,000 new cases annually in the U.S. There is no FDA approved treatment for UPS and current first and second line therapies are typically limited to doxorubicin, gemcitabine and docetaxel.
About Ozuriftamab Vedotin (BA3021)
Ozuriftamab vedotin, CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck, melanoma and breast. We are advancing this Phase 2 stage clinical asset for multiple solid tumor types, including NSCLC that have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapies, melanoma, SCCHN that have previously progressed on a PD-1 inhibitor and ovarian cancers that have previously progressed on platinum therapy.
About BA3071
BA3071, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy comparable to the approved anti-CTLA-4 antibody, ipilimumab, but with lower toxicities due to the CAB's tumor microenvironment-restricted activity. This may enable safer anti-CTLA-
4 antibody combination therapies, such as with anti-PD-1 antibody checkpoint inhibitors, and potentially broaden the patient population tolerant to combination therapy and deliver greater efficacy. Like mecbotamab vedotin, ozuriftimab vedotin and our other CAB candidates, BA3071 is designed to be conditionally and reversibly active in the tumor microenvironment. BA3071 is being developed as a potential therapeutic for multiple solid tumor indications, including renal cell carcinoma, NSCLC, small cell lung cancer, hepatocellular carcinoma, melanoma, bladder cancer, gastric cancer and cervical cancer.
About BioAtla®, Inc.
BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 600 patents, more than 350 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The Phase 1 stage CAB-CTLA-4 antibody, BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.
Forward-looking statements
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, including potential selective licensing and collaborations, expectations about the sufficiency of our cash and cash equivalents, expected R&D and G&A expenses, the timing and expectations with respect to enrollment in our clinical trials, the timing and success of our clinical trials and related data, plans to advance development of several bispecific CAB candidates, including the timing of potential IND submissions and our market opportunity. Forward-looking statements are based on BioAtla's current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials due to the global COVID-19 pandemic; other potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the success of our current and future collaborations with third parties; our reliance on third parties for the manufacture and supply of our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K filed
with the Securities and Exchange Commission (SEC) on February 28, 2022 and in our Quarterly Reports on Form 10-Q filed with the SEC on May 4, 2022 and August 9, 2022 and our other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable law.

Internal Contact:
Richard Waldron
Chief Financial Officer
BioAtla, Inc.
rwaldron@bioatla.com
858.356.8945

External Contact: Bruce Mackle
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
BioAtla, Inc.

BioAtla to Participate in 2022 Jefferies Global Healthcare Conference

SAN DIEGO, June 01, 2022 -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced that Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder, and Scott Smith, President, will provide a corporate update and participate in one-on-one investor meetings at the Jefferies Global Healthcare Conference, to be held in-person in New York, NY June 8-10, 2022.

 

Jefferies Global Healthcare Conference

Format: In-person presentation (formal remarks with slides) and scheduled one-on-one investor meetings

Date: Wednesday, June 8, 2022

Time: 10:00 a.m. ET

Webcast: https://wsw.com/webcast/jeff240/bcab/1789800

 

Please contact your Jefferies sales representative to register for a meeting with the Company.

A webcast of the session will be available on the “Events and Presentations” section of the Company’s website at https://ir.bioatla.com. An archived replay of the webcast will be available on the Company’s website for 60 days following the event.

 

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 500 patents, including over 250 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). In addition, the company is advancing a Phase 1/2 CAB-CTLA-4 antibody, BA3071, which is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.

 

Internal Contact:

Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945

 

External Contact:
Bruce Mackle

LifeSci Advisors, LLC

bmackle@lifesciadvisors.com

FIRST PATIENTS DOSED IN PHASE 2 PLATFORM CLINICAL TRIAL TESTING NOVEL IMMUNOTHERAPY COMBINATIONS IN HIGHLY MALIGNANT OVARIAN CANCER

  • Patients with ovarian cancer of the high-grade serous carcinoma subtype and that no longer respond to treatment with platinum-based therapy will receive a PD-L1-blocking antibody along with one of two antibody-drug conjugates targeting overexpressed receptor tyrosine kinases in the first two cohorts of this study
  • Multiple sites across Canada and the U.S. open in 2022
  • Combination immunotherapy may offer hope to the 80 percent of patients with this type of ovarian cancer who relapse and eventually succumb to the disease
  • Cohorts A and B of this platform study are enrolling patients

 

NEW YORK, May 11, 2022 — The Cancer Research Institute (CRI) and Ovarian Cancer Research Alliance (OCRA) announced today that the first patients have been dosed in a new muti-center platform clinical trial testing novel cancer immunotherapy combinations in patients with a common and highly aggressive form of ovarian cancer that has become resistant to treatment with platinum-based chemotherapy.

Currently, the majority of ovarian cancers – upwards of 75 percent – are of the subtype “high grade serous carcinoma,” which is the type being treated in this phase 2 study. While most patients with this malignant ovarian cancer subtype initially respond to standard cytotoxic therapies, more than 80 percent will relapse and succumb to the disease within five years. New treatments are urgently needed for this deadliest of gynecological cancers, which is diagnosed in more than a quarter-million women worldwide each year according to World Health Organization estimates.

This phase 2 trial titled, “Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (IPROC)” (NCT04918186), is sponsored by CRI clinical partner the Canadian Cancer Trials Group (CCTG), and is open and actively recruiting patients to sites in Canada and, in the second half of 2022, will open sites in the United States. Overall, up to 60 patients are planned to be enrolled in this platform study with up to 40 patients in these two initial cohorts.

This clinical trial is using an adaptive platform study design that utilizes a single master protocol that allows for multiple treatments to be evaluated in different groups of patients, or cohorts, from the same patient population. Such a study design offers flexibility in that different treatments can be evaluated in different cohorts, treatment regimens can be modified between cohorts, and treatment selection criteria can be customized for a specific cohort.

Immunotherapy as monotherapy in treating patients with this aggressive type of ovarian cancer has not resulted in improvement in patient outcomes. In contrast, a recent randomized Phase 2 trial led by Dmitriy Zamarin, M.D., Ph.D., a member of the Cancer Research Institute Drug Selection Committee and study chair on the IPROC platform trial, demonstrated a three-fold improvement in overall response rates among ovarian cancer patients treated with a combination of immunotherapies compared to patients treated with a single immunotherapy.

“The IPROC trial builds upon the results seen in positive immunotherapy combination studies in ovarian cancer, and was designed in collaboration with our partners to explore each patient’s immunological response to determine which combinations result in the greatest patient benefit and why they are more effective than other combinations,” said Jay Campbell, managing director of the Anna-Maria Kellen Clinical Accelerator and Venture Fund at the Cancer Research Institute.

Patients with high grade serous ovarian cancer that is refractory or resistant to platinum-based cytotoxic therapy will be assigned to one of two cohorts testing novel immunotherapy combinations with drugs supplied by AstraZeneca and BioAtla, Inc.: Cohort A will receive AstraZeneca’s PD-L1-blocking antibody durvalumab (IMFINZI®) in combination with BioAtla’s BA3011 (mecbotamab vedotin), a conditionally active antibody-drug conjugate targeting AXL, a receptor tyrosine kinase that is overexpressed across many solid tumor types, while Cohort B will receive durvalumab in combination with BioAtla’s BA3021 (ozuriftamab vedotin), a conditionally active antibody-drug conjugate targeting ROR2, another receptor tyrosine kinase that is overexpressed in solid tumors. As part of the eligibility evaluation process, patients will be screened for expression levels of AXL or ROR2 and eligible patients will be assigned to the appropriate cohort accordingly.

“Ovarian cancer patients are in dire need of additional treatment options, and partnering with the Cancer Research Institute on this innovative platform trial is a crucial step in our efforts to hasten drug development,” said Audra Moran, president and CEO of Ovarian Cancer Research Alliance. “This collaboration allows OCRA to have a direct impact on future outcomes for our patients as well as add to the collective understanding of this disease.”

“We are excited to move forward in partnership with CRI, OCRA, and our collaborators with this important study. IPROC’s innovative trial design means that we can accelerate the pace of discovery in understanding how to optimize immunotherapy for the treatment of patients diagnosed with ovarian cancer,” said CCTG study lead Helen MacKay, MBChB, B.Sc., MRCP, M.D.

“Our hope is that the immunotherapy combinations we are studying in this clinical trial will do better than current standard-of-care treatments, providing ovarian cancer patients with much-needed therapeutic options and better odds of survival,” said Kunle Odunsi, M.D., Ph.D., FRCOG, FACOG, director of the University of Chicago Comprehensive Cancer Center and a study co-chair.

Key industry and academic partners

This clinical trial is the third to result from the collaboration formed in 2018 between CRI and CCTG, a Canada-based cooperative oncology group that is sponsoring the study. AstraZeneca is collaborating to support this study. BioAtla, Inc., is supplying BA3011 and BA3021 as well as co-funding to support this study.

About the Trial

Title: Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (IPROC) (NCT04918186)

Study Chairs:

  • Helen MacKay, MBChB, B.Sc., MRCP, M.D., Head, Division of Medical Oncology and Hematology, Odette Cancer Center, Sunnybrook Health Sciences Centre, Toronto, ON Canada
  • Kunle Odunsi, M.D., Ph.D., FRCOG, FACOG, Director, University of Chicago Comprehensive Cancer Center, Chicago, IL USA
  • Anna Tinker, M.D., FRCPC, Medical Oncologist, British Columbia Cancer, Vancouver Centre, BC Canada
  • Dmitriy Zamarin, M.D., Ph.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center, New York, NY USA

Study Contact:

Media Contacts:

Cancer Research Institute: Brian Brewer, Chief Communications Officer
bbrewer@cancerresearch.org or +212-688-7515 x242

Ovarian Cancer Research Alliance: Deb Levy, Vice President, Marketing & Communications
dlevy@ocrahope.org or +212-268-1002

Canadian Cancer Trials Group: Lisa Callahan, Communications Leader, lcallahan@ctg.queensu.ca or +613-533-6430

About IMFINZI® (durvalumab)
AstraZeneca’s IMFINZI is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

About Mecbotamab Vedotin (BA3011)
BioAtla’s BA3011, CAB-AXL-ADC, is a conditionally and reversibly active antibody-drug conjugate targeting the receptor tyrosine kinase AXL that is overexpressed across multiple different solid tumors.

About Ozuriftamab Vedotin (BA3021)
BioAtla’s BA3021, CAB-ROR2-ADC, is a conditionally and reversibly active antibody-drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors.

About the Cancer Research Institute
The Cancer Research Institute (CRI), established in 1953, is a highly rated U.S. nonprofit organization dedicated exclusively to saving more lives by fueling the discovery and development of powerful immunotherapies for all cancers. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 27 members of the National Academy of Sciences, CRI has invested $474 million in support of research conducted by immunologists and tumor immunologists at the world’s leading medical centers and universities and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to cancerresearch.org and follow CRI on Twitter @CancerResearch.

About the CRI Anna-Maria Kellen Clinical Accelerator
CRI’s clinical program, the Anna-Maria Kellen Clinical Accelerator is a unique academic-nonprofit-industry collaboration model that serves an as “incubator” that delivers multicenter clinical trials of promising new immunotherapy combinations. CRI’s venture philanthropy fund supports clinical trials within the program, which fosters a collaborative environment that enables scientists to advance their most ambitious research ideas by accelerating studies that one group or company could not do alone. To learn more, go to cancerresearch.org/clinical-accelerator.

About Ovarian Cancer Research Alliance
Ovarian Cancer Research Alliance (OCRA) is the largest non-government funder of ovarian cancer research and has invested $110 million in research since its founding. OCRA fights ovarian cancer from all fronts, including in the lab and on Capitol Hill, and through innovative programs to support patients and their families.

OCRA’s ongoing investments in the most promising scientific research is funding discoveries, creating new treatments, and hastening desperately needed breakthroughs. OCRA is the voice for the ovarian cancer community, working with legislators to ensure federal ovarian cancer research and education, patient safety, and access to high-quality care are protected on Capitol Hill. OCRA’s programs help people navigate their diagnosis and support patients and their families when and where they need it most. Visit ocrahope.org to learn more

About Canadian Cancer Trials Group
The Canadian Cancer Trials Group (CCTG) is a cancer clinical trials research cooperative that runs phase I-III trials to test anti-cancer and supportive therapies at over 85 hospitals and cancer centers across Canada. From the operations center at Queen's University, CCTG has supported more than 600 trials enrolling 100,000 patients from 40 countries on 6 continents through a global network of 20,000 investigators and clinical trial staff. CCTG is a national program of the Canadian Cancer Society and their aim is to improve survival and quality of life for all people with cancer.

BIOATLA REPORTS FIRST QUARTER 2022 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PROGRESS

  • Mecbotamab vedotin (BA3011) sarcoma Phase 2 top-line interim data support advancing with UPS and osteosarcoma –

 

  • Mecbotamab vedotin (BA3011) Phase 2 interim analysis in NSCLC anticipated in first half 2022; interim update projected on 2Q22 earnings call –

 

  • Ozuriftamab vedotin (BA3021) NSCLC Phase 2 preliminary cohort enrollment completion and interim update anticipated in second half of 2022 –

 

  • Ozuriftamab vedotin (BA3021) SCCHN Phase 2 and BA3071 Phase 1 studies anticipate first patients dosed in second quarter of 2022 –

 

  • Cash balance of $219.4 million at quarter-end expected to provide funding into the second half of 2024

 

  • Management to host conference call and webcast today at 4:30 PM Eastern Time –

 

SAN DIEGO, May 4, 2022 -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for treatment of solid tumors, today announced its financial results for the first quarter ended March 31, 2022, and provided an interim topline data update from the mecbotamab vedotin (BA3011) Phase 2 study in sarcoma as well as an operational update on its ongoing clinical programs, including BA3011, ozuriftamab vedotin (BA3021) and CAB-CTLA-4 (BA3071) addressing multiple tumor types.

 

“BioAtla has achieved several important clinical milestones in our CAB-ADC programs, most recently with encouraging interim clinical data this quarter in our Phase 2 BA3011 sarcoma study that support a path forward for multiple sarcoma subtypes.  In parallel, we continue to progress additional Phase 2 studies for BA3011 in Non-Small Cell Lung Cancer and with our second lead asset, ozuriftamab vedotin (BA3021) in multiple indications, and anticipate several updates later this year,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc.

 

“We are very excited by the interim Phase 2 sarcoma data, which confirm our Phase 1 results. We achieved, and even exceeded, pre-defined criteria in UPS and osteosarcoma subtypes, and plan to begin enrolling patients in part 2 of the study following upcoming discussions with the FDA. Given the significant unmet medical need and commercial opportunity in sarcoma, we are thrilled to move one step closer towards a potential accelerated regulatory approval pathway of BA3011 in multiple sarcoma subtypes. As BioAtla continues to build our medical affairs and commercial capabilities, coupled with our already robust clinical and preclinical pipeline, we are hopeful to bring innovative and differentiated treatments to cancer patients worldwide, while creating long-term sustainable value for our shareholders,” said Scott Smith, President of BioAtla.

 

 

Key Developments, Operational Updates and Upcoming Milestones

  • Phase 2 Trial of Mecbotamab Vedotin (BA3011, NCT03425279) in Patients with:
    • AXL-positive Soft Tissue and Primary Bone Sarcomas
      • Interim Phase 2 analysis at 3 months demonstrates antitumor activity following BA3011 treatment
        • In undifferentiated pleomorphic sarcoma (UPS), partial responses (PR) were observed in two of six patients (ORR 33%) – one of five in monotherapy and one of one in the combination cohort
          • Combining Phase 1 and Phase 2 data at 1.8 mg/kg, PRs were observed in four of eight UPS patients (ORR 50%)
        • In osteosarcoma, the PFS rate at 3 months was 67% (n = 6)
          • Combining Phase 1 and Phase 2 data at 1.8 mg/kg, the PFS rate at 3 months was 57% (n = 7)
        • Enrollment is ongoing in synovial sarcoma, liposarcoma, Ewing sarcoma and other bone cohorts as present sample size is not sufficient to determine advancement into Part 2
        • Leiomyosarcoma cohort did not achieve pre-defined criteria, with a PFS rate at 3 months of 27% (pending confirmation; n = 17); thus, this subtype was not selected to move forward into part two of the trial
      • Interim data in UPS and osteosarcoma cohorts meet or exceed pre-defined criteria (e., one PR or complete response [CR], or PFS at 3 months ≥40%), which support moving forward into the second part of our Phase 2 study and working towards a meeting with the FDA anticipated by July 2022, with enrollment into second part of Phase 2 study expected shortly thereafter.
      • With regards to safety, there were no treatment-related deaths, and few treatment-related serious adverse events (9%, n = 6). Treatment-related AEs were generally consistent with monomethyl auristatin E (MMAE) toxicity. Two patients out of 68 (3%) discontinued treatment due to treatment related AEs (both were grade 2 peripheral neuropathy).
    • AXL-positive Non-Small Cell Lung Carcinoma (NSCLC)
      • Trial ongoing in patients who have previously experienced failure of PD-1/L1, EGFR, or ALK inhibitor therapy
      • Anticipate preliminary cohort enrolled by end of second quarter 2022
      • Interim update anticipated on or around 2Q22 earnings call

 

  • Phase 2 Trial of Ozuriftamab Vedotin (BA3021, NCT03504488) in Patients with:
    • ROR2-positive NSCLC
      • Trial ongoing in patients who have previously experienced failure of PD-1/L1, EGFR or ALK inhibitor therapy
      • Anticipate preliminary cohort enrolled and interim update in second half of 2022
    • ROR2-positive Melanoma
      • Trial ongoing in patients who have previously experienced failure of PD-1 therapy
      • Enrollment ongoing and actively dosing
      • Anticipate transitioning to a non-invasive liquid biopsy in second quarter of 2022
      • Anticipate full trial enrollment update on the 2Q22 earnings call
    • ROR2-positive Squamous Cell Carcinoma of the Head and Neck (SCCHN)
      • Trial ongoing in patients who have previously experienced failure of PD-1 therapy alone or in combination with platinum therapy
      • Anticipate first patient dosed in second quarter of 2022

 

  • Phase 2 Investigator-Initiated Trial in Patients with Platinum-Resistant Ovarian Cancer (NCT04918186)
    • Mecbotamab vedotin (BA3011) or ozuriftamab vedotin (BA3021) in combination with a PD-1 inhibitor
      • Initiated and currently screening patients in a multi-center, investigator-initiated Phase 2 clinical trial in Canadaand in the US

 

  • Phase 1/2 Dose-Escalation Trial of CAB-CTLA-4 (BA3071) Across Multiple Solid Tumor Types
    • Trial ongoing in patients with advanced solid tumors
    • Anticipate first patient dosed in second quarter of 2022

 

  • Anticipate IND filing for CAB EpCAM x CAB-CD3 bispecific antibody in 2022

 

  • Anticipate IND filings for multiple pre-clinical CAB bispecific and next generation CAB-ADC candidates in 2023

 

  • Entered into a clinical collaboration with Bristol Myers Squibb (NYSE: BMY) to investigate mecbotamab vedotin (BA3011) and ozuriftamab vedotin (BA3021), in combination with Bristol Myers Squibb’s anti-PD-1 therapy Opdivo® (nivolumab).

 

First Quarter Financial Results

Cash and cash equivalents as of March 31, 2022 were $219.4 million, compared to $245.0 million as of December 31, 2021. We expect current cash and cash equivalents will be sufficient to fund planned operations including all ongoing CAB product development programs into second half 2024. 

 

Research and development (R&D) expenses were $16.9 million for the quarter ended March 31, 2022 compared to $10.4 million for the same quarter in 2021. The increase was primarily driven by expansion of our product development efforts including clinical development for CAB-CTLA-4 (BA3071) and pre-clinical development of additional CAB candidates. We expect our R&D expenses to increase as we continue to invest in R&D activities to advance our product candidates and our clinical programs, and to expand our product candidate pipeline.

General and administrative (G&A) expenses were $7.4 million for the quarter ended March 31, 2022 compared to $8.4 million for the same quarter in 2021. The change was primarily attributable to a decrease in stock-based compensation related to awards issued under our equity incentive plan. We expect our G&A expenses to increase to support development of our product candidates, expand our intellectual property portfolio, support pre-commercialization activities for our lead product candidate mecbotamab vedotin (BA3011) and meet all requirements as a public company.

Net loss for the quarter ended March 31, 2022 was $24.3 million compared to a net loss of $18.7 million for the same quarter in 2021. 

Net cash used in operating activities for the three months ended March 31, 2022 was $25.1 million compared to net cash used in operating activities of $15.0 million for the same period in 2021.

 

First Quarter 2022 Conference Call and Webcast Details

The management of BioAtla, Inc. will host a conference call and webcast for the investment community today, May 4, 2022, at 4:30 pm Eastern Time. A live webcast may be accessed here: https://edge.media-server.com/mmc/p/vhg5myi4. The conference call can be accessed by dialing toll-free (844) 419-8639. The passcode for the conference call is 2695713.

A replay of the webcast and slides with topline interim clinical data referenced on the call will be available through “Events & Presentations” in the Investors section of the company’s website after the conclusion of the presentation and will be archived on the BioAtla website for one year.

 

 

About Mecbotamab Vedotin (BA3011)

Mecbotamab vedotin (BA3011), CAB-AXL-ADC, is a conditionally and reversibly active antibody drug conjugate targeting the receptor tyrosine kinase AXL, as a potential therapeutic for multiple solid tumor types, including soft tissue and bone sarcoma, non-small cell lung cancer (NSCLC) and ovarian cancer, with other potential indications in the future. The Office of Orphan Drug Products (OODP) at FDA granted Orphan Drug Designation to mecbotamab vedotin for the treatment of soft tissue sarcoma. In the Phase 1 clinical study in sarcoma patients mecbotamab vedotin was generally well-tolerated, few patients discontinued due to an adverse event, and no clinically meaningful on-target toxicity to healthy AXL-expressing tissue was observed. Of the seven sarcoma patients who had an AXL tumor membrane percent score (TmPS) of greater than or equal to 70, four of these obtained a confirmed partial response, including patients with leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), and Ewing sarcoma. The several subtypes of sarcoma present a significant unmet medical need. For example, UPS is one of the most aggressive sarcoma subtypes with the highest recurrence rate and has approximately 4,000 new cases annually in the U.S. There is no FDA approved treatment for UPS and current first and second line therapies are typically limited to doxorubicin, gemcitabine and docetaxel.

 

About Ozuriftamab Vedotin (BA3021)

Ozuriftamab vedotin, CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck, melanoma and breast. We are developing ozuriftamab vedotin as a potential therapeutic for multiple solid tumor types, including NSCLC, melanoma, SCCHN and ovarian cancer. Based on encouraging Phase 1 data we believe ozuriftamab vedotin has broad potential as a cancer therapy for patients with advanced solid tumors that have previously progressed on a PD-1 inhibitor.

 

About BA3071

BA3071, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy comparable to the approved anti-CTLA-4 antibody, ipilimumab, but with lower toxicities due to the CAB's tumor microenvironment-restricted activity. Like mecbotamab vedotin, ozuriftimab vedotin and our other CAB candidates, BA3071 is designed to be conditionally and reversibly active in the tumor microenvironment via the Protein-associated Chemical SwitchTM or PaCSTM mechanism discovered by BioAtla scientists. This proprietary system is expected to enable reduction of systemic toxicity and potentially enable safer combination therapies, such as with anti-PD-1 antibody checkpoint inhibitors in the case of BA3071. BA3071 is being developed as a potential therapeutic for multiple solid tumor indications, including renal cell carcinoma, NSCLC, small cell lung cancer, hepatocellular carcinoma, melanoma, bladder cancer, gastric cancer and cervical cancer.

 

About BioAtla®, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 600 patents, more than 350 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The Phase 1 stage CAB-CTLA-4 antibody, BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.

 

Forward-looking statements

 

Internal Contact:

Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945

 

External Contact:
Bruce Mackle

LifeSci Advisors, LLC

bmackle@lifesciadvisors.com





BioAtla to Announce First Quarter 2022 Financial Results and Provide Business Highlights on May 4, 2022

SAN DIEGO, April 8, 2022 -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody and other protein therapeutics, today announced that it plans to host a conference call and webcast on Wednesday, May 4, 2022 at 4:30 p.m. Eastern Time to discuss its financial results for the quarter ended March 31, 2022, and provide an interim topline data update from the mecbotamab vedotin (BA3011) Phase 2 study in sarcoma as well as an operational update on our ongoing clinical programs, including BA3011, ozuriftamab vedotin (BA3021) and CAB-CTLA-4 (BA3071).

 Conference Call and Webcast Information

Date: May 4, 2022
Time: 4:30 p.m. ET
Webcast Link: BioAtla First Quarter 2022 Earnings Conference Call
Dial-in Numbers: (844) 419-8639 (domestic) or (631) 259-7541 (international)

The press release with the financial results will be accessible prior to the conference call through “News Releases” in the News & Events section of the company’s website.  A replay of the call will also be available through “Events & Presentations” in the Investors section of the company’s website.

 

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 600 patents, more than 350 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The investigational CAB-CTLA-4 antibody, BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.

 

Internal Contact:
Richard Waldron
Chief Financial Officer
BioAtla, Inc.
rwaldron@bioatla.com
858.356.8945

External Contact:
Bruce Mackle
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com

BIOATLA ANNOUNCES FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS

  • Mecbotamab vedotin (BA3011) sarcoma Phase 2 top-line interim update expected in first quarter results conference call. NSCLC Phase 2 interim update expected in first half 2022.
  • Ozuriftamab vedotin (BA3021) continues with enrollment of patients in Phase 2 clinical studies in NSCLC and melanoma. Expect mid-year initial interim update for NSCLC and melanoma.  Phase 2 study in Head and Neck cancer has been initiated.
  • CAB-CTLA-4 Phase 1/2 clinical trial (BA3071) addressing multiple solid tumor indications has been initiated.
  • IND filings for four CAB bispecific and antibody drug conjugate product candidates expected in 2022 through end of 2023.
  • Cash balance of $245 million at year end 2021 will fund planned operations including all current product development programs into first half of 2024.

 

SAN DIEGO, CA – March 1, 2022 - BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announces its financial results for the fourth quarter and full year December 31, 2021, and provides an update on product pipeline developments.

 

“BioAtla made significant progress in 2021 by advancing the potentially registration-enabling Phase 2 clinical trials for our two lead CAB product candidates as well as our other preclinical and pipeline programs. Our cash resources at year end by themselves are sufficient to provide the funding for all of our clinical, pre-clinical and development stage product candidates and corporate operations into the first half of 2024, without including upside opportunities to further extend our cash runway through regional licensing and partnering deals for select candidates,” stated Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “We expect to provide interim updates on our Phase 2 clinical programs by mid-year for both mecbotamab vedotin and ozuriftamab vedotin.  We have aggressive development plans for these clinical assets, and have initiated a Phase 1/2 trial for CAB-CTLA-4. In addition, we have several CAB bispecific and CAB next generation ADC product candidates in our near term IND strategy,” stated Scott Smith, President of BioAtla.

 

Mecbotamab Vedotin (BA3011)

We are developing mecbotamab vedotin (BA3011), CAB-AXL-ADC, a conditionally and reversibly active antibody drug conjugate targeting the receptor tyrosine kinase AXL, as a potential therapeutic for multiple solid tumor types, including soft tissue and bone sarcoma, non-small cell lung cancer (NSCLC) and ovarian cancer, with other potential indications in the future.  The Office of Orphan Drug Products (OODP) at FDA granted Orphan Drug Designation to mecbotamab vedotin for the treatment of soft tissue sarcoma. In the Phase 1 clinical study in sarcoma patients mecbotamab vedotin was generally well-tolerated, few patients discontinued due to an adverse event, and no clinically meaningful on-target toxicity to normal AXL-expressing tissue was observed. Of the seven sarcoma patients who had an AXL tumor membrane percent score (TmPS) of greater than or equal to 70, four of these obtained a confirmed partial response, including patients with leiomyosarcoma, undifferentiated pleiomorphic sarcoma (UPS), and Ewing sarcoma. The several subtypes of sarcoma present a significant unmet medical need.  For example, UPS is one of the most aggressive sarcoma subtypes with the highest recurrence rate and has approximately 4,000 new cases annually in the U.S. There is no FDA approved treatment for UPS and current first and second line therapy are typically limited to doxorubicin, gemcitabine and docetaxel. In the overall Phase 2 sarcoma trial, over 70 patients are currently enrolled, and we plan to provide an interim update in the second quarter of 2022. We also are conducting a Phase 2 study (BA3011-002) in AXL-expressing NSCLC patients who previously progressed on PD-1/L1, EGFR, or ALK inhibitor therapy. An interim clinical update of this trial is projected in the first half of 2022.  In addition, a multi-center investigator-initiated Phase 2 clinical trial of mecbotamab vedotin in combination with a PD-1 inhibitor in patients with platinum-resistant ovarian cancer has been initiated.

 

Ozuriftamab Vedotin (BA3021)

Ozuriftamab vedotin, CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck, melanoma and breast. We are developing ozuriftamab vedotin as a potential therapeutic for multiple solid tumor types, including NSCLC, melanoma, squamous cell cancer of the head and neck (SCCHN) and ovarian cancer. Based on encouraging Phase 1 data we believe ozuriftamab vedotin has broad potential as a cancer therapy for patients with advanced solid tumors that have previously progressed on a PD-1 inhibitor. We are enrolling a Phase 2 trial of ozuriftamab vedotin monotherapy or in combination with a PD-1 inhibitor in ROR2-expressing melanoma patients who had previously progressed on PD-1/L1 inhibitor and in ROR2-expressing NSCLC patients who had progressed on previous PD-1/L1, EGFR or ALK inhibitor therapy. A Phase 2 study in ROR2-expressing SCCHN patients has been initiated. In addition, a multi-center investigator-initiated Phase 2 clinical trial of ozuriftamab vedotin in combination with a PD-1 inhibitor in patients with platinum-resistant ovarian cancer has been initiated.

 

BA3071

BA3071, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy comparable to the approved anti-CTLA-4 antibody,  ipilimumab, but with lower toxicities due to the CAB’s tumor microenvironment-restricted activity.  Like mecbotamab vedotin, ozuriftimab vedotin and our other CAB candidates, BA3071 is designed to be conditionally and reversibly active in the tumor microenvironment via the Protein-associated Chemical SwitchTM or PaCSTM mechanism discovered by BioAtla scientists. This proprietary system is expected to enable reduction of systemic toxicity and potentially enable safer combination therapies, such as with anti-PD-1 antibody checkpoint inhibitors in the case of BA3071. BA3071 is being developed as a potential therapeutic for multiple solid tumor indications, including renal cell carcinoma, NSCLC, small cell lung cancer, hepatocellular carcinoma, melanoma, bladder cancer, gastric cancer and cervical cancer. We have initiated a Phase 1/2 clinical trial for BA3071 and plan to commence patient enrollment in the first half of 2022.

 

Advancing several pre-clinical CAB bispecific and next generation CAB ADC candidates

We have also leveraged our CAB technology to develop bispecific antibodies, which bind both a tumor-specific antigen and a T cell receptor (CD3) using CAB antigen-binding domains. With this design, bispecific antibodies can induce potent T cell responses against tumors expressing the tumor target antigen. We have shown in preclinical experiments that our CAB bispecific molecules meet or exceed the activity of conventional bispecifics and reduce systemic activation of potentially severe immune responses. We are conducting IND-enabling studies for two CAB bispecific antibody product candidates.  We are on track to file an IND for CAB EpCAM x CAB CD3 in 2022, and an IND for CAB B7-H3 x CAB CD3 is targeted in the first half of 2023. Nectin-4 and B7-H4 CAB next generation ADC candidates are progressing along with the CAB EGFR x CD3 bispecific candidate for a total of up to three IND filings in 2023. In addition, we have several CAB bispecific and CAB ADC in earlier development stages.

 

Fourth quarter and full year 2021 financial results

Cash and cash equivalents as of December 31, 2021 were $245.0 million. We expect current cash and cash equivalents will be sufficient to fund planned operations into the first half of 2024.

Research and development (R&D) expenses were $16.4 million for the quarter ended December 31, 2021 compared to $10.5 million for the same quarter in 2020.   R&D expenses were $58.3 million for the full year 2021 as compared to $19.9 million in 2020.  We expect our R&D expenses to continue to increase for the foreseeable future as we continue to invest in R&D activities to advance our product candidates and our clinical programs, and expand our product candidate pipeline.

General and administrative (G&A) expenses were $7.0 million for the quarter ended December 31, 2021 compared to $6.0 million for the same quarter in 2020.  G&A expenses were $38.4 million for the full year 2021 as compared to $10.6 million in 2020.  We expect our G&A expenses to increase to support development of our product candidates, expand our intellectual property portfolio and meet all requirements as a public company.

Net loss for the fourth quarter ended December 31, 2021 was $23.4 million compared to a net loss of $16.4 million for the same quarter in 2020.  Net loss for the full year 2021 was $95.4 million as compared to a net loss of $35.9 million in 2020.

Net cash used in operating activities for the twelve months ended December 31, 2021 was $62.2 million compared to net cash used in operating activities of $36.3 million for the same period in 2020.

 

 

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 500 patents, more than 250 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The investigational CAB-CTLA-4 antibody, BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.

 

Forward-looking statements

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, expectations about the sufficiency of our cash and cash equivalents, expected R&D and G&A expenses, the timing and expections with respect to enrollment in our clinical trials, the timing and success of our clinical trials and related data, and plans to advance development of several bispecific CAB candidates, including the timing of potential IND submissions. Forward-looking statements are based on BioAtla’s current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials due to the global COVID-19 pandemic; other potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the success of our current and future collaborations with third parties; our reliance on third parties for the manufacture and supply our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 28, 2022 and in our other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable law.

 

Contact:
Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945


BioAtla Announces Clinical Collaboration with Bristol Myers Squibb to Study Mecbotamab Vedotin (BA3011) and Ozuriftamab Vedotin (BA3021) in Combination with Opdivo® (nivolumab) for Treatment of Solid Tumors

SAN DIEGO, CA – January 10, 2022 - BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that it has entered into a clinical collaboration with Bristol Myers Squibb (NYSE: BMY) to investigate BioAtla’s two lead CAB-ADC candidates, BA3011 and BA3021, in combination with Bristol Myers Squibb’s anti-PD-1 therapy Opdivo® (nivolumab).

Under the terms of the agreement, BioAtla and Bristol Myers Squibb will collaborate on clinical trials of separate combination therapies using two of BioAtla’s Conditionally Active Biologic Antibody Drug Conjugates, BA3011 and BA3021, each in combination with Opdvio. BioAtla will serve as the study sponsor and will be responsible for costs associated with the trial execution. Bristol Myers Squibb will provide Opdivo clinical drug supply for the study.   

BA3011 (CAB-AXL-ADC) and BA3021 (CAB-ROR2-ADC) are CAB antibody drug conjugates that target receptor tyrosine kinase AXL and ROR2, respectively. AXL and ROR2 are important targets as they are expressed in many solid tumors with higher frequency of expression observed in tumors previously treated with anti-PD-1 therapy. This, coupled with the therapeutic index advantages provided by BioAtla’s proprietary CAB technology, lends strong rationale for investigating BA3011 and BA3021 in combination with Opdivo.

“BioAtla is very pleased to enter into this collaboration with Bristol Myers Squibb. Identification of optimal combination regimens holds significant promise for cancer patients, and we look forward to expanding investigation of our CAB-ADCs in combination with Opdivo,” stated Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc.

“This collaboration supports our strategy to aggressively drive development of therapeutics in areas of high unmet medical need and underscores the potential broad applicability of our CAB-ADCs to provide benefit to many patients across a wide range of tumor types,” added Scott Smith, President of BioAtla.

Opdivo® is a trademark of Bristol-Myers Squibb Company.

 

About Mecbotamab Vedotin (BA3011)

BA3011, CAB-AXL-ADC, is a CAB antibody drug conjugate targeting the receptor tyrosine kinase AXL that is overexpressed across multiple different solid tumors. We are developing BA3011 as a potential therapeutic for multiple solid tumor types, including soft tissue and bone sarcoma, non-small cell lung cancer (NSCLC) and ovarian cancer, with other potential indications in the future. We are enrolling a potentially registration-enabling Phase 2 clinical trial (NCT03425279) of BA3011 given as monotherapy or in combination with a PD-1 inhibitor in soft tissue and primary bone sarcoma patients 12 years and older that are high AXL tumor membrane expressors (AXL high).  We also are conducting a Phase 2 study (NCT04681131) in AXL high NSCLC patients who have previously progressed on PD-1/L1, EGFR, or ALK inhibitor therapy. In addition, a multi-center investigator-initiated Phase 2 clinical trial of BA3011 in combination with a PD-1 inhibitor in patients with platinum-resistant ovarian cancer has been initiated in Canada and in the US (NCT04918186).

 

About Ozuriftamab Vedotin (BA3021)

BA3021, CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck, melanoma, and breast. We are developing BA3021 as a potential therapeutic for multiple solid tumor types, including NSCLC, melanoma, squamous cell cancer of the head and neck (SCCHN) and ovarian cancer. We are enrolling a Phase 2 trial (NCT03504488) of BA3021 monotherapy or in combination with a PD-1 inhibitor in patients with ROR2 high melanoma who have previously progressed on PD-1/L1 inhibitor and patients with ROR2 high NSCLC who have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapy. A Phase 2 study in patients with ROR2 high SCCHN will be initiated in early 2022. In addition, a multi-center investigator-initiated Phase 2 clinical trial of BA3021 in combination with a PD-1 inhibitor in patients with platinum-resistant ovarian cancer has been initiated in Canada and in the US (NCT04918186).

 

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 500 patents, more than 250 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). To learn more about BioAtla, Inc. visit www.bioatla.com.

 

Forward-looking statements

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, expectations about the sufficiency of our cash and cash equivalents, expected R&D and G&A expenses, the timing and success of our clinical trials and related data, and plans to advance development of several bispecific CAB candidates, including the timing of potential IND submissions. Forward-looking statements are based on BioAtla’s current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials due to the global COVID-19 pandemic; other potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the success of our current and future collaborations with third parties; our reliance on third parties for the manufacture and supply of our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2021 and in our Quarterly Reports on Form 10-Q filed with the SEC on May 12, 2021, August 13, 2021, and November 15, 2021 and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable law.

 

Contact:
Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945

BIOATLA APPOINTS EDWARD L. WILLIAMS TO BOARD OF DIRECTORS


SAN DIEGO, CA
– December 21, 2021 - BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that Edward L. (Eddie) Williams has been appointed to the BioAtla Board of Directors and has agreed to serve on the Audit Committee of the Board.  Mr. Williams has extensive executive experience in the biopharmaceutical industry and as a member of the board of directors of a biotechnology company in late-stage clinical development. Jay M. Short, Ph.D., Chairman of the Board and Chief Executive Officer, stated, “Eddie’s career of demonstrated success and knowledge in growing biopharmaceutical businesses complements the notable skills and experience of our current directors, and thereby makes an especially valuable contribution to our board’s capabilities as BioAtla advances into late-stage clinical trials and develops commercialization plans and strategies.”

At Novo Nordisk, Inc. Mr. Williams held positions of increasing responsibility from 2006 when he joined to his retirement in 2017. As Senior Vice President, Biopharmaceuticals, he was responsible for general management of all aspects of Novo Nordisk’s biotechnology business and increased that sector’s revenue by three-fold by achieving market leadership in all three of its therapeutic areas including orphan biotech drugs and devices. He was recognized as Global General Manager of the Year, and he served on the global boards of strategy, commercial, marketing, management, and business development.

From 2003-2006, Mr. Williams served as Vice President, Sales of the Respiratory and Dermatology business unit of Novartis Pharmaceuticals.  Mr. Williams began his career in biopharmaceuticals in 1980 with The Upjohn Company (Pharmacia, now Pfizer) in marketing and sales roles rising to Regional Vice President – Sales for the Northeast Region in 2001-2003.

Since March 2020, Mr. Williams has served as special advisor to the CEO of Ascendis Pharma, Inc., a clinical stage and commercial biopharmaceutical company. From August 2020 to May 2021 he served as its interim US Chief Commercial Officer in preparation for its first commercial launch. Since 2018, Mr. Williams has served as a member of the Board of Directors of Catalyst Biosciences, Inc., a clinical-stage biopharmaceutical company, and has served on that board’s audit committee, compensation committee and currently serves on the governance and nominating committee. Mr. Williams’ contribution and service to the biotechnology industry is exemplified by his service from 2015-2017 on the Board of Directors, and several of its committees, of the Biotechnology Innovation Organization (BIO).  Mr. Williams holds a Bachelor of Science degree from Marshall University.   

 

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 500 patents, more than 250 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The investigational CAB-CTLA-4 antibody, BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.

 

# # #

Contact:


Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945

 

BIOATLA TO PRESENT AT 40TH ANNUAL J.P. MORGAN VIRTUAL HEALTHCARE CONFERENCE

Phase 2 Clinical Trial Update Will Be Provided

 

SAN DIEGO, CA – December 20, 2021 - BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that Jay M. Short, Ph.D., Chief Executive Officer, and Scott Smith, President, with participation by other BioAtla executives, will present at the 40th Annual J.P. Morgan Virtual Healthcare Conference on Tuesday, January 11, 2022, at 3:00 PM Eastern Time. An audio webcast link, when available, will be posted to BioAtla’s website in the Investors-Events and Presentations section.

 

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 500 patents, more than 250 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The investigational CAB-CTLA-4 antibody, BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.

 

# # #

Contact:


Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945

BIOATLA ANNOUNCES THIRD QUARTER 2021 FINANCIAL RESULTS AND PROVIDES CLINICAL AND BUSINESS UPDATE

 

  • Mecbotamab vedotin (BA3011 ) sarcoma Phase 2 interim data read-out on-schedule for year end. Phase 1 sarcoma data presented at recent CTOS 2021 annual meeting
  • Mecbotamab vedotin (BA3011) and ozuriftamab vedotin (BA3021) continue to advance through Phase 2 in multiple indications
  • CAB-CTLA-4 Phase 1/2 clinical trial planned to be initiated by year end
  • Advancing several CAB bispecific and antibody drug conjugate (“ADC”) product candidates in preclinical development
  • Sheri Lydick, Celgene/BMS veteran, joins BioAtla to lead commercial strategy
  • $75 million institutional private placement of common equity brings quarter ended cash balance to $270 million; expected to provide funding for operations into first half of 2024

 

 

SAN DIEGO, CA – November 15, 2021 - BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced financial results for the third quarter of 2021 and provided an update on its clinical progress and business.

 

“BioAtla continues to advance the progress of the potentially registration-enabling Phase 2 clinical trials for our two lead CAB product candidates as well as our other preclinical and pipeline programs. The increase in our financial resources in the third quarter through our equity placement provides the funding into the first half of 2024 to develop these key assets and the several additional ADC and bispecific CAB candidates in our development pipeline,” stated Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “We are aggressively advancing all of our clinical programs and are on track for a sarcoma Phase 2 interim data read out by year-end for BA3011, CAB-AXL-ADC. Additionally,  a clinical trial for CAB-CTLA-4 is expected to be initiated by the end of the year,” added Scott Smith, President of BioAtla.

 

Advancing clinical trials for lead candidates

Mecbotamab Vedotin (BA3011)

We are developing BA3011, CAB-AXL-ADC, a conditionally and reversibly active antibody drug conjugate targeting the receptor tyrosine kinase AXL, as a potential therapeutic for multiple solid tumor types, including soft tissue and bone sarcoma, non-small cell lung cancer (NSCLC) and ovarian cancer, with other potential indications in the future.  The Office of Orphan Drug Products (OODP) at FDA granted Orphan Drug Designation to BA3011 for the treatment of soft tissue sarcoma, and  Phase 1 results in sarcoma patients were presented  at the recent Connective Tissue Oncology Society (CTOS) 2021 Annual Meeting. BA3011 was generally well tolerated in this refractory sarcoma population. Few patients discontinued due to an adverse event (2 patients out of 26 or 7.7%).  No clinically meaningful on-target toxicity to normal AXL-expressing tissue was observed. Dose-limiting toxicities were limited to monomethyl auristatin E (MMAE) conjugate-associated toxicity at the highest dose tested, including reversible neutropenia.The degree of AXL tumor membrane expression correlated with response to treatment. Of the seven sarcoma patients who had an AXL tumor membrane percent score of greater than or equal to 70, four of these obtained a confirmed partial response, including patients with leiomyosarcoma, undifferentiated pleomorphic sarcoma, and Ewing sarcoma. Prolonged response to therapy was observed in this ongoing study with the duration of response ranging from 33 to more than 60 weeks. Overall, mecbotamab vedotin may have a favorable benefit-risk profile, and importantly this is one of the few studies with a putative biomarker which is not only highly expressed in sarcomas, but also may help select patients across multiple sarcoma subtypes who may benefit from therapy. In the ongoing potentially registration-enabling sarcoma Phase 2 study, patients are enrolled for therapy by prescreening for AXL expression. We also are conducting a Phase 2 study (BA3011-002) in AXL high NSCLC patients who have previously progressed on PD-1/L1, EGFR, or ALK inhibitor therapy. We currently expect to have enrolled more than 70 patients by year end in our sarcoma Phase 2 trial in the U.S.  Interim analyses in the sarcoma and NSCLC trials are anticipated this year and in early 2022, respectively. In addition, a multi-center investigator-initiated Phase 2 clinical trial of BA3011 in combination with a PD-1 inhibitor in patients with platinum-resistant ovarian cancer is expected to begin enrollment by year end.

 

BA3021 (Ozuriftamab Vedotin)

BA3021, CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck, melanoma and breast. We are developing BA3021 as a potential therapeutic for multiple solid tumor types, including NSCLC, melanoma, squamous cell cancer of the head and neck (SCCHN) and ovarian cancer. Based on Phase 1 data we believe BA3021 has broad potential as a cancer therapy for patients with advanced solid tumors that have previously progressed on a PD-1 inhibitor. We are enrolling a Phase 2 trial of BA3021 monotherapy or in combination with a PD-1 inhibitor in patients with ROR2 high melanoma who have previously progressed on PD-1/L1 inhibitor and patients with ROR2 high NSCLC who have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapy. A Phase 2 study in patients with ROR2 high SCCHN is anticipated to enroll in early 2022. In addition, a multi-center investigator-initiated Phase 2 clinical trial of BA3021 in combination with a PD-1 inhibitor in patients with platinum-resistant ovarian cancer is expected to begin enrollment by year end.

 

BA3071

BA3071, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy comparable to the approved anti-CTLA-4 antibody,  ipilimumab, but with lower toxicities due to the CAB’s tumor microenvironment-restricted activation. The development of BA3071 is the subject of a 2019 Global Co-Development and Collaboration Agreement between BioAtla and BeiGene, Ltd.  Like BA3011, BA3021 and our other CAB candidates, BA3071 is designed to be conditionally and reversibly activated in the tumor microenvironment via the Protein-associated Chemical SwitchTM or PaCSTM mechanism discovered by BioAtla scientists. This proprietary system enables reduction of systemic toxicity and potentially enables safer combination therapies, such as with anti-PD-1 antibody checkpoint inhibitors in the case of BA3071. BA3071 is being developed as a potential therapeutic for multiple solid tumor indications, including renal cell carcinoma, NSCLC, small cell lung cancer, hepatocellular carcinoma, melanoma, bladder cancer, gastric cancer and cervical cancer. We are currently in advanced discussions with BeiGene regarding the allocation of roles and responsibilities for global development and commercialization of BA3071 under our Global Co-Development and Collaboration Agreement with BeiGene.  As part of these ongoing discussions, BeiGene is planning to initiate the transfer of the IND for BA3071 to BioAtla and BioAtla anticipates initiating the Phase I trial for BA3071 during 2021, with dosing commencing in the first half of 2022.

 

Plans to advance development of several bispecific CAB candidates

We have also leveraged our CAB technology to develop bispecific antibodies, which bind both a tumor-specific antigen and a T cell receptor (CD3) using CAB antigen-binding domains. With this design, bispecific antibodies can induce potent T cell responses against tumors expressing the tumor target antigen. We have shown in preclinical experiments that our CAB bispecific molecules meet or exceed the activity of conventional bispecifics and reduce systemic activation of potentially severe immune responses. We are conducting IND-enabling studies for two CAB bispecific antibody product candidates, EpCAM/CD3 and B7-H3/CD3, and presently plan to file INDs in mid-2022 and by year end 2022, respectively. We also are evaluating additional candidates including EGFR and Nectin-4 for CAB CD3 bispecific modalities. Nectin-4 is also progressing as a CAB ADC candidate. Overall, we are advancing multiple pre-clinical assets with the potential to submit up to four US INDs over the next 18 months for our CAB bispecific or ADC molecules. 

 

Sheri Lydick joins to lead commercial strategy

BioAtla is building its capabilities to plan for and execute the commercial launches of its CAB portfolio of product candidates. A key element of this strategy is the recent hiring of Sheri Lydick as the company’s Senior Vice President, Commercial Strategy.  Ms. Lydick will be leading commercial strategy, which includes long-range portfolio planning, assessing strategic business opportunities and delivering on these plans. Ms. Lydick has more than 20 years of leadership and commercialization experience in the biotechnology and pharmaceutical industry. In her most recent role at Bristol-Meyers Squibb Company, Ms. Lydick was responsible for building the sales and marketing teams and leading the commercial launch of Zeposia® across multiple therapeutic areas (multiple sclerosis and ulcerative colitis). In her twelve years (2007-2019) at Celgene her leadership role expanded from Director of Global Marketing for the Inflammation and Immunology (I&I) Franchise to Executive Director, US Rheumatology Lead, to Vice President, US Commercial Lead for Zeposia®. Among her accomplishments, she was instrumental in building Celgene’s Inflammation and Immunology franchise and led the planning and launch of the multi-billion dollar drug Otezlaâ.  BioAtla president Scott Smith commented, “Sheri has deep experience and success in global commercial marketing and sales and in building and leading multidisciplinary teams. We are excited for her to bring that expertise to BioAtla.”

 

 

Third quarter 2021 financial results

Cash and cash equivalents as of September 30, 2021 were $269.9 million. We expect current cash and cash equivalents will be sufficient to fund planned operations into the first half of 2024.  In September 2021, we executed a private placement of common stock yielding gross proceeds of $75.0 million before deducting placement agent fees and other offering expenses. The investors included both current and new institutional investors.

 

Research and development (R&D) expenses were $16.6 million for the quarter ended September 30, 2021 compared to $4.9 million for the same quarter in 2020. We expect our R&D expenses to increase substantially for the foreseeable future as we continue to invest in R&D activities to advance our product candidates, and our clinical programs and expand our product candidate pipeline.

 

General and administrative (G&A) expenses were $7.1 million for the quarter ended September 30, 2021 compared to $3.3 million for the same quarter in 2020. We expect our G&A expenses to increase as a result of operating as a public company. In addition, we expect our intellectual property expenses to increase as we expand our intellectual property portfolio.

 

Net loss for the third quarter ended September 30, 2021 was $22.9 million compared to a net loss of $11.6 million for the same quarter in 2020.  Net cash used in operating activities for the first nine months of 2021 was $41.3 million compared to net cash used in operating activities of $22.3 million for the same period in 2020.

 

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 500 patents, more than 250 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The investigational CAB-CTLA-4 antibody, BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.

 

 

Forward-looking statements

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, expectations about the sufficiency of our cash and cash equivalents, expected R&D and G&A expenses, the timing and success of our clinical trials and related data, and plans to advance development of several bispecific CAB candidates, including the timing of potential IND submissions. Forward-looking statements are based on BioAtla’s current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials due to the global COVID-19 pandemic; other potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the success of our current and future collaborations with third parties; our reliance on third parties for the manufacture and supply our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2021 and in our Quarterly Reports on Form 10-Q filed with the SEC on May 12, 2021, August 13, 2021, and November 15, 2021 and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable law.

 

Contact:
Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945

BIOATLA ANNOUNCES PRIVATE PLACEMENT OF 2.7 MILLION SHARES

Proceeds to advance CAB-AXL and CAB-ROR2 through potentially registration enabling Phase 2 clinical trials, and additional CAB development programs

 

SAN DIEGO, CA – September 29, 2021 - BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that it has entered into stock purchase agreements with a group of institutional investors in connection with a private placement of its common stock. The Company will issue 2.7 million shares of common stock for a purchase price of $28 per share. The transaction is expected to result in gross proceeds to the Company of $75.0 million, before deducting placement agent fees and other offering expenses. The Company plans to use the net proceeds from the private placement primarily to advance clinical development, medical affairs and commercial preparation, and for general corporate purposes.

 

Investors in the offering included Great Point Partners, Deerfield Management Company, Cormorant Asset Management, Soleus Capital, Sphera Healthcare, Ikarian Capital, LLC, HBM Healthcare Investments, Monashee Investment Management, LLC, funds managed by Hudson Bay Capital Management, and Pappas Capital.

The closing of the private placement is subject to certain conditions and is expected to occur on or about Thursday, September 30, 2021.

J.P. Morgan acted as lead placement agent and Jefferies acted as co-placement agent for the private placement.

The common stock being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the common stock, nor shall there be any sale of the common stock in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the common stock under the resale registration statement will only be by means of a prospectus.

 

About BioAtla, Inc.

 

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through its contractual relationship with BioDuro, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 500 patents, more than 250 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). BioAtla’s investigational CAB CTLA-4 antibody, BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.

 

Forward-Looking Statements

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, without limitation, statements regarding use of proceeds and the completion and timing of the closing of the private placement. Forward-looking statements are based on BioAtla’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties related the satisfaction of customary closing conditions related to, and the completion of, the private placement and other risks and uncertainties that are described in the section titled “Risk Factors” in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the Securities and Exchange Commission on August 13, 2021. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable law.

 

# # #

Contact:


Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945

BIOATLA ANNOUNCES SECOND QUARTER 2021 FINANCIAL RESULTS AND PROVIDES CLINICAL UPDATE

  • $207.6 million cash balance expected to provide funding for operations into 2023
  • Continue to advance potentially registration enabling Phase 2 studies for mecbotamab vedotin (BA3011) and ozuriftamab vedotin (BA3021) in several indications in the U.S. and in Asia with first patient dosed in Taiwan
  • Advancing several CAB bispecific and antibody drug conjugate (“ADC”) product candidates in preclinical development

 

 

SAN DIEGO, CA – August 13, 2021 - BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced financial results for the second quarter of 2021 and provided an update on its business.

 

“BioAtla is advancing potentially registration-enabling Phase 2 clinical trials for our two lead CAB product candidates. With strong financial resources, we are also broadening our development pipeline to include several additional ADC and bispecific CAB candidates,” stated Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “Our clinical objectives in 2021 include providing Phase 2 interim data readouts by year-end for CAB-AXL-ADC and CAB-ROR2-ADC. Our Phase 1 trials for these product candidates demonstrated encouraging results in difficult to treat cancer indications, particularly in patients with late-stage disease refractory to other lines of therapy,” added Scott Smith, President of BioAtla.

 

Advancing clinical trials for lead candidates

 

BA3011           (Mecbotamab Vedotin)

We are developing BA3011, CAB-AXL-ADC, a conditionally activated antibody drug conjugate targeting the receptor tyrosine kinase AXL, as a potential therapeutic for multiple solid tumor types, including soft tissue and bone sarcoma, non-small cell lung cancer (NSCLC) and ovarian cancer, with other potential indications in the future. On March 1, 2021 the Office of Orphan Drug Products (OODP) at FDA granted Orphan Drug Designation to BA3011 for the treatment of soft tissue sarcoma. Phase 1 results in sarcoma patients have been submitted for presentation at the Connective Tissue Oncology Society (CTOS) 2021 Annual Meeting in November. As previously indicated, we have initiated a potentially registration-enabling Phase 2 clinical trial (BA3011-001) of BA3011 given as monotherapy or in combination with a PD-1 inhibitor in soft tissue and primary bone sarcoma patients 12 years and older that are high AXL tumor membrane expressors (AXL high), and a Phase 2 study (BA3011-002) in AXL high NSCLC patients that have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapy. Enrollment continues in our sarcoma Phase 2 trial in the U.S. and initiated in Asia this quarter with first patient dosing in Taiwan. A pre-planned Independent Data Monitoring Committee (IDMC) was held and the IDMC recommended BioAtla continue the BA3011-001 study without modifications. Additional Interim analyses in the sarcoma and NSCLC trials are anticipated this year and early 2022. In addition, the commencement of a multi-center investigator-initiated Phase 2 clinical trial for BA3011 in platinum-resistant ovarian cancer in combination with a PD-1 inhibitor has been approved by Health Canada and is expected to begin enrollment in the second half of this year in Canada and the United States.

 

BA3021 (Ozuriftamab Vedotin)

BA3021, CAB-ROR2-ADC, is a CAB antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck, melanoma and breast. We are developing BA3021 as a potential therapeutic for multiple solid tumor types, including NSCLC, melanoma, squamous cell cancer of the head and neck (SSCHN) and ovarian cancer. Based on phase 1 data we believe BA3021 has broad potential as a cancer therapy for patients with advanced solid tumors that have previously progressed on a PD-1 inhibitor. We are enrolling a Phase 2 trial of BA3021 monotherapy or in combination with a PD-1 inhibitor in ROR2 high melanoma patients that have previously progressed on PD-1/L1 inhibitor and ROR2 high NSCLC patients that have previously on PD-1/L1, EGFR or ALK inhibitor therapy. A Phase 2 study in ROR2 high SSCHN patients is anticipated to initiate in second half of 2021. A BA3021 in combination with a PD-1 inhibitor Phase 2 clinical trial for platinum-resistant ovarian cancer has been approved by Health Canada and is expected to begin enrollment in the second half of this year in Canada and the United States.

 

BA3071

BA3071, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy comparable to the approved anti-CTLA-4 antibody,  ipilimumab, but with lower toxicities due to the CAB’s tumor microenvironment-restricted activation. Like BA3011, BA3021 and our other CAB candidates, BA3071 is designed to be conditionally and reversibly activated in the tumor microenvironment via the Protein-associated Chemical SwitchTM or PaCSTM mechanism discovered by BioAtla scientists. This proprietary system enables reduction of systemic toxicity and potentially enables safer combination therapies, such as with anti-PD-1 antibody checkpoint inhibitors in the case of BA3071. We are currently in a global collaboration with BeiGene, and are developing BA3071 as a potential therapeutic for multiple solid tumor indications, including renal cell carcinoma, NSCLC, small cell lung cancer, hepatocellular carcinoma, melanoma, bladder cancer, gastric cancer and cervical cancer. Our goal is to initiate a Phase 1/2 study for BA3071 in 2021. 

 

Plans to advance development of several bispecific CAB candidates

We have also leveraged our CAB technology to develop bispecific antibodies, which bind both a tumor-specific antigen and a T cell receptor (CD3) using CAB antigen-binding domains. With this design, bispecific antibodies can induce potent T cell responses against tumors expressing the tumor target antigen. We have shown in preclinical experiments that our CAB bispecific molecules meet or exceed the activity of conventional bispecifics and reduce systemic activation of potentially fatal immune responses. We advanced two CAB bispecific antibody product candidates, EpCAM/CD3 and B7-H3/CD3, into IND-enabling studies in the second half of 2020. We also are evaluating additional candidates including EGFR and Nectin-4 for CAB CD3 bispecific modalities. Nectin-4 is also progressing as a CAB ADC candidate. Overall, we are advancing multiple pre-clinical assets with the potential to submit up to four US INDs by the end of 2022 for our CAB bispecific or ADC molecules. 

 

Second quarter 2021 financial results

Cash and cash equivalents as of June 30, 2021 were $207.6 million. We expect current cash and cash equivalents will be sufficient to fund planned operations into 2023.

 

Research and development (R&D) expenses were $14.9 million for the quarter ended June 30, 2021 compared to $2.9 million for the same quarter in 2020. We expect our R&D expenses to increase substantially for the foreseeable future as we continue to invest in R&D activities to advance our product candidates, and our clinical programs and expand our product candidate pipeline.

 

General and administrative (G&A) expenses were $15.9 million for the quarter ended June 30, 2021 compared to $1.8 million for the same quarter in 2020. We expect our G&A expenses to increase as a result of operating as a public company. In addition, we expect our intellectual property expenses to increase as we expand our intellectual property portfolio.

 

Net loss for the second quarter ended June 30, 2021 was $30.4 million compared to a net loss of $6.2 million for the same quarter in 2020.  Net cash used in operating activities for the first six months of 2021 was $28.5 million compared to net cash used in operating activities of $6.9 million for the same period in 2020.

 

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 500 patents, more than 250 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). BioAtla’s investigational CAB CTLA-4 antibody, BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.

 

Forward-looking statements

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, expectations about the sufficiency of our cash and cash equivalents, expected R&D and G&A expenses, the timing and success of our clinical trials and related data, and plans to advance development of several bispecific CAB candidates, including the timing of potential IND submissions. Forward-looking statements are based on BioAtla’s current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials due to the global COVID-19 pandemic; other potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the success of our current and future collaborations with third parties; our reliance on third parties for the manufacture and supply our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2021 and in our Quarterly Report on Form 10-Q filed with the SEC on May 12, 2021, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable law.

 

Contact:
Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945


10Q Data

BIOATLA ANNOUNCES FIRST QUARTER 2021 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE


  • Initiated potentially registration-enabling Phase 2 studies for our CAB-AXL-ADC in refractory sarcoma patients and NSCLC patients refractory to EGFR or PD-1/L1 inhibitors
  • Initiated potentially registration-enabling Phase 2 studies for our CAB-ROR2-ADC in NSCLC and melanoma patients refractory to PD-1/L1 inhibitors
  • Advanced several CAB bispecific product candidates in preclinical development
  • $221 million cash balance expected to provide funding for operations into 2023

 

SAN DIEGO, CA - May 12, 2021 - BioAtla, Inc. (NASDAQ: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced financial results for the first quarter of 2021 and provided an update on its business.

 

"BioAtla is rapidly advancing potentially registration-enabling Phase 2 clinical trials for our two lead CAB product candidates. With strong financial resources, we are also broadening our development pipeline to include several additional ADC and bispecific CAB candidates," stated Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. "Our clinical objectives in 2021 include providing Phase 2 interim data readouts by year-end for CAB-AXL-ADC and CAB-ROR2-ADC. Our Phase 1 trials for these product candidates demonstrated encouraging results in hard to treat cancer indications, particularly in patients with late-stage disease refractory to other lines of therapy," added Scott Smith, President of BioAtla.

 

Advancing clinical trials for lead candidates 

BA3011   

We are developing BA3011, CAB-AXL-ADC, a conditionally activated antibody drug conjugate targeting the receptor tyrosine kinase AXL, as a potential therapeutic for multiple solid tumor types, including soft tissue and bone sarcoma, non-small cell lung cancer (NSCLC) and ovarian cancer, with other potential indications in the future. On March 1, 2021 the Office of Orphan Drug Products (OOPD) at FDA granted Orphan Drug Designation to BA3011 for the treatment of soft tissue sarcoma. In Phase 1, five partial responses (PR) were observed, four in sarcoma patients and one in a PD-1 refractory NSCLC patient. These responses occured in stage IV refractory patients with high AXL tumor membrane expression and at our recommended phase 2 dose (RP2D). We have initiated a potentially registration-enabling Phase 2 clinical trial of BA3011 given as monotherapy or in combination with a PD-1 inhibitor in soft tissue and primary bone sarcoma patients 12 years and older that are high AXL tumor membrane expressors (AXL high), and a Phase 2 study in AXL high NSCLC patients that have previously progressed on PD-1/L1 or EGFR inhibitor therapy. We expect to submit Phase 1 results in sarcoma patients for presentation at the Connective Tissue Oncology Society (CTOS) 2021 Annual Meeting in November. Interim analyses in the sarcoma and NSCLC trials are anticipated this year. In addition, a multi-center investigator-initiated Phase 2 clinical trial for BA3011 in platinum-resistant ovarian cancer in combination with a PD-1 inhibitor is currently under review by Health Canada and is expected to commence in the first half of this year in Canada and the United States.

 

BA3021

BA3021, CAB-ROR2-ADC, is a CAB antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck, melanoma and breast. We are developing BA3021 as a potential therapeutic for multiple solid tumor types, including NSCLC, melanoma, squamous cell cancer of the head and neck (SSCHN), and ovarian cancer. We completed a Phase 1 dose-escalation trial with BA3021 in which we observed one complete response (CR) and 3 PRs. The CR was observed in the only ROR2-positive melanoma patient enrolled in the trial. This stage IV melanoma patient had experienced prior therapy failures with nivolumab (PD-1 inhibitor), and with nivolumab in combination with ipilimumab (CTLA-4 inhibitor). A PR was observed in the only SSCHN patient enrolled in the study. This patient was ROR2 positive and was refractory to four lines of prior therapy including with cetuximab and with pembrolizumab. Additionally, PRs were observed in two stage IV ROR2-positive NSCLC patients, both of whom had failed prior PD-1 therapy. All responses occurred at exposure levels equivalent to the BA3021 RP2D. We believe BA3021 has broad potential as a cancer therapy for patients with advanced solid tumors that have previously progressed on a PD-1 inhibitor. We are presently enrolling a Phase 2 trial of BA3021 monotherapy or in combination with a PD-1 inhibitor in ROR2 high NSCLC and melanoma patients that have previously progressed on PD-1/L1 inhibitor. A Phase 2 study in ROR2 high SSCHN patients that have previously progressed on a PD-1/L1 inhibitor is anticipated to initiate in second half of 2021. A BA3021 in combination with a PD-1 inhibitor Phase 2 clinical trial for platinum-resistant ovarian cancer is also under review by Health Canada.

 

BA3071

BA3071, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy comparable to the approved anti-CTLA-4 antibody,  ipilimumab, but with lower toxicities due to the CAB's tumor microenvironment-restricted activation. In a global collaboration with BeiGene, we are developing BA3071 as a potential therapeutic for multiple solid tumor indications, including renal cell carcinoma, NSCLC, small cell lung cancer, hepatocellular carcinoma, melanoma, bladder cancer, gastric cancer and cervical cancer. BeiGene is responsible for all costs of development, manufacturing and commercialization globally. BioAtla is eligible to receive milestone payments and royalties on product sales upon regulatory approvals and commercialization by BeiGene. A Phase 1 dose-escalation trial of BA3071 as monotherapy and in combination with BeiGene's anti-PD-1 antibody, tislelizumab, are planned to commence in 2021.

 


Plans to advance development of several bispecific CAB candidates

We have also leveraged our CAB technology to develop bispecific antibodies, which bind both a tumor-specific antigen and a T cell receptor (CD3) using CAB antigen-binding domains. With this design, bispecific antibodies can induce potent T cell responses against tumors expressing the tumor target antigen. We have shown in preclinical experiments that our CAB bispecific molecules meet or exceed the activity of conventional bispecifics and reduce systemic activation of potentially fatal immune responses. We advanced two CAB bispecific antibody product candidates, EpCAM/CD3 and B7-H3/CD3, into IND-enabling studies in the second half of 2020. We also are evaluating additional candidates including EGFR and Nectin-4 for CAB CD3 bispecific modalities. Nectin-4 is also progressing as a CAB ADC candidate. Overall, we are advancing multiple pre-clinical assets with the potential to submit up to four US INDs by the end of 2022 for our CAB bispecific or ADC molecules. 

 

First quarter 2021 financial results

Cash and cash equivalents as of March 31, 2021 were $221.2 million. In July 2020, BioAtla completed a successful private placement offering with institutional investors, for net proceeds of approximately $68.2 million. In December 2020, we received net proceeds of approximately $198.4 million from our initial public offering. We expect current cash and cash equivalents will be sufficient to fund planned operations into 2023.

Research and development (R&D) expenses were $10.4 million for the quarter ended March 31, 2021 compared to $1.7 million for the same quarter in 2020. We expect our R&D expenses to increase substantially for the foreseeable future as we continue to invest in R&D activities to advance our product candidates, and our clinical programs and expand our product candidate pipeline.

General and administrative (G&A) expenses were $8.4 million for the quarter ended March 31, 2021 compared to $(0.5) million for the same quarter in 2020. We expect our G&A expenses to increase as a result of operating as a public company. In addition, we expect our intellectual property expenses to increase as we expand our intellectual property portfolio.

Net loss for the first quarter ended March 31, 2021 was $18.7 million compared to a net loss of $1.6 million for the same quarter in 2020.


About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 500 patents, more than 250 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). BioAtla's investigational CAB CTLA-4 antibody, BA3071, is subject of a global co-development and collaboration agreement with BeiGene Ltd. for its development, manufacturing and commercialization. BA3071 is a novel CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.


Forward-looking statements

Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, expectations about the sufficiency of our cash and cash equivalents, expected R&D and G&A expenses, the timing and success of our clinical trials and related data, the and plans to advance development of several bispecific CAB candidates, including the timing of potential IND submissions.. Forward-looking statements are based on BioAtla's current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials due to the global COVID-19 pandemic; other potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the success of our current and future collaborations with third parties; our reliance on third parties for the manufacture and supply our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2021 and in our Quarterly Report on Form 10-Q filed with the SEC on May 12, 2021, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable law.

 

Contact:
Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945



BioAtla Quarterly Results


BIOATLA ANNOUNCES FULL YEAR 2020 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

  • Year end $239 million cash balance, primarily generated from net proceeds from December IPO and July private placement, and is expected to provide funding at least through end of 2022
  • Conducting Phase 2 clinical trials for CAB-AXL-ADC and CAB-ROR2-ADC and with BeiGene initiating CAB-CTLA4 Phase 1 trial
  • Potentially registration-enabling Phase 2 clinical trials for CAB-AXL-ADC, in treatment for refractory sarcoma and PD-1 refractory NSCLC, and for CAB-ROR2-ADC, in treatment for PD-1 refractory NSCLC and melanoma
  •  Recent PNAS peer-reviewed paper describes design and functionality of BioAtla's proprietary CAB technology to provide potent anti-tumor activity with reduced toxicity

 

SAN DIEGO, CA - March 25, 2021 - BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced financial results for the full year 2020 and provided an update on its business.

 

"BioAtla made several achievements in 2020 that significantly enhance the company's ability to advance our CAB clinical programs, expand our development portfolio, and further exploit the opportunities of our CAB technology," stated Jay M. Short, Ph.D., chairman, chief executive officer and co-founder of BioAtla, Inc. "The encouraging clinical trial data that allows us to proceed into potentially registration-enabling Phase 2 clinical trials along with prospects of developing several CAB bispecific candidates underscore the potentially broad applicability of CAB technology to address a wide range of tumor types and other indications," added Scott Smith, president of BioAtla.

 

Advancing clinical trials for lead candidates BA3011, BA3021 and BA3071

We are developing BA3011, CAB-AXL-ADC, as a potential therapeutic for multiple solid tumors, including soft tissue and bone sarcoma, non-small cell lung cancer (NSCLC) and ovarian cancer with other potential indications in the future. We have completed a Phase 1 trial in patients with refractory solid tumors, established a recommended Phase 2 dose, and continue to dose patients that are responding to therapy. We recently initiated dosing in a potentially registration-enabling Phase 2 clinical trial in soft tissue and bone sarcoma. We have also initiated a Phase 2 clinical trial in PD-1 refractory NSCLC patients. Additionally, we expect a multi-center investigator-initiated trial in platinum- resistant ovarian cancer will likely commence in the first half of 2021.

 

We are developing our second product candidate BA3021, CAB-ROR2-ADC, a CAB antibody directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including breast, lung, pancreatic, renal, colorectal, head and neck and melanoma. We are developing BA3021 as a potential therapeutic for multiple solid tumors, including NSCLC, ovarian cancer and melanoma. We have completed a Phase 1 all-comers dose-escalation trial with BA3021 where we observed two partial responses in advanced, treatment refractory NSCLC and one partial response in melanoma which represents all ROR2 positive patients at a Phase 2 relevant dose and ROR2 expression level. We believe BA3021 has broad potential as a cancer therapy for patients with advanced solid tumors. We recently initiated Phase 2 enrollment in patients with PD-1 refractory NSCLC and melanoma.

 

BA3071, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering the efficacy of approved CTLA-4 antibodies, such as ipilimumab, but with lower toxicities due to the CAB's tumor microenvironment-restricted activation. In a global collaboration with Beigene, we are developing BA3071 as a potential therapeutic for multiple solid tumor indications, including renal cell carcinoma, NSCLC, small cell lung cancer, hepatocellular carcinoma, melanoma, bladder cancer, gastric cancer and cervical cancer. BeiGene is responsible for all costs of development, manufacturing and commercialization globally. BioAtla is eligible to receive milestone payments and royalties on product sales upon regulatory approvals and commercialization by BeiGene. A Phase 1 dose-escalation trial of BA3071 as monotherapy and in combination with tislelizumab, an anti-PD-1 antibody in late stage development by BeiGene, are planned to commence in 2021.

 

Plans to advance development of several bispecific CAB candidates

We have also leveraged our CAB technology to develop bispecific antibodies, which bind both a tumor- specific antigen and a T cell receptor using CAB antigen-binding domains. With this design, bispecific antibodies can induce potent T cell responses against tumors expressing the tumor target antigen in a simplified manner relative to even off-the-shelf or allogeneic CAR-T therapies. We have shown in preclinical experiments that our CAB bispecific molecules meet or exceed the activity of conventional bispecifics and reduce systemic activation of potentially fatal immune responses. We advanced two CAB bispecific antibody product candidates, EpCAM/CD3 and B7-H3/CD3, into IND-enabling studies in the second half of 2020. We are also evaluating ADC modalities for each of our CAB bispecific molecules, including EGFR/CD3 and Nectin-4/CD3. Our goal is to submit up to four US INDs in 2022 for our CAB bispecific or ADC molecules.

 

Recent peer-reviewed publication in Proceedings of the National Academy of Sciences (PNAS) indicates potentially broad application of BioAtla's CAB technology

The paper describes the design and functionality of therapeutic antibody candidates utilizing BioAtla's proprietary CAB technology making them active only in the acidic tumor microenvironment while binding is reversibly inhibited in healthy tissue. This improved tumor targeting utilizes a newly discovered chemical switch system and is shown in animal models to provide for potent anti-tumor activity with markedly reduced toxicity to normal tissue, indicating a widened therapeutic index. BioAtla scientists discovered this novel chemical switch mechanism that involves physiological- occurring chemicals, such as bicarbonate and hydrogen sulfide. These molecules are negatively charged at physiological conditions and interact with positive charged areas on the protein surface. Under acidic conditions of the tumor microenvironment they are neutralized and released from the protein surface, uniquely allowing CAB antibodies to bind to their target and attack the tumor cell. BioAtla refers to this novel physiological mechanism, used for generating CABs, as Protein-associated Chemical Switch(es) or PaCS mechanism.

 

It is expected from the studies described in the paper that there is a potential for other yet to be identified PaCS molecules in disease related microenvironments, whether controlled through pH, concentration, or other molecular characteristics (intra- or intermolecularly) for enhancing a drug's therapeutic index. Potential new therapeutic candidates addressing these opportunities are not limited to antibodies, but also include small molecules, encompassing lipids, sugars and nucleic acid-based agents or drugs. Further, it is expected that PaCS protein-chemical systems are important naturally occurring regulatory systems linked to a range of disease-related microenvironments, including cancer, inflammation and cellular senescence.

 

Full year 2020 financial results

Cash and cash equivalents as of December 31, 2020 were $238.6 million compared to $3.7 million as of December 31, 2019. In July 2020, BioAtla completed a successful private placement offering with institutional investors, for net proceeds of approximately $68.2 million. In December 2020, we received net proceeds of approximately $198.4 million from our initial public offering. We expect current cash and cash equivalents will be sufficient to fund planned operations at least through end of 2022.

Research and development (R&D) expenses were $19.9 million for the full year ended December 31, 2020 compared to $25.9 million for the year 2019. We expect our R&D expenses to increase substantially for the foreseeable future as we continue to invest in R&D activities to advance our product candidates, and our clinical programs and expand our product candidate pipeline.

General and administrative (G&A) expenses were $10.6 million for the full year ended December 31, 2020 compared to $7.5 million for the year 2019. We expect our G&A expenses to increase as a result of operating as a public company. In addition, we expect our intellectual property expenses to increase as we expand our intellectual property portfolio.

Net loss for the full year ended December 31, 2020 was $35.9 million compared to a net loss of $29.8 million for the year 2019.

 

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 250 issued patents and more than 200 pending patent applications worldwide. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two CAB programs currently in Phase 2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). BioAtla's investigational CAB CTLA-4 antibody, BA3071, is subject of a global co-development and collaboration agreement with BeiGene Ltd. for its development, manufacturing and commercialization. BA3071 is a novel, CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.


 

 

Forward-looking statements

Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, expectations about the sufficiency of our cash and cash equivalents, expected R&D and G&A expenses, the timing and success of our clinical trials and related data, plans to advance development of several bispecific CAB candidates, potential for other yet to be identified PaCS molecules and potential applicability of our CAB technology in other disease related microenvironments. Forward-looking statements are based on BioAtla's current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials due to the global COVID-19 pandemic; other potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the success of our current and future collaborations with third parties; our reliance on third parties for the manufacture and supply our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2021, and other reports as filed with the SEC. Forward- looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable law.

 

Contact: Richard Waldron

Chief Financial Officer BioAtla, Inc. rwaldron@bioatla.com 858.356.8945


 

BioAtla, Inc.

Consolidated balance sheets

(in thousands, except unit/share amounts)

December 31,

 

 

2020

2019

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

 

$ 238,605

$ 3,704

Prepaid expenses and other current assets

 

2,076

803

Total current assets

 

240,681

4,507

Property and equipment, net

 

4,102

4,675

Other assets

 

154

154

Total assets

 

$ 244,937

$ 9,336

Liabilities and Stockholders'/ Members' Equity (Deficit)

 

 

 

Current liabilities:

 

 

 

Accounts payable and accrued expenses

 

$    12,068

$    11,972

Accrued interest

 

—

3,253

Current portion of deferred rent

 

387

367

Current portion of deferred revenue

 

19,806

1,420

Current portion of convertible debt, less debt discount

 

—

9,706

Total current liabilities

 

32,261

26,718

Profits interest liability

 

—

8,592

Long-term accrued interest

 

5

623

Deferred rent, less current portion

 

2,015

2,185

Deferred revenue, less current portion

 

—

18,815

Convertible debt, less current portion and debt discount

 

—

8,414

Other debt

 

682

—

Total liabilities

 

34,963

65,347

Commitments and contingencies

 

 

 

Stockholders'/Members' equity (deficit):

 

 

 

Class C preferred units — 0 units and 23,968,178 units issued and outstanding at

December 31, 2020 and 2019, respectively

 

 

—

 

89,345

Class A units — 0 units and 54,600,000 units issued and outstanding at December 31,

2020 and 2019, respectively

 

 

—

 

750

Preferred stock, $0.0001 par value; 200,000,000 shares and 0 shares authorized at December 31, 2020 and 2019, respectively; 0 shares issued and outstanding at

December 31, 2020 and 2019

 

 

 

—

 

 

—

Common stock, $0.0001 par value; 350,000,000 shares and 0 shares authorized at December 31, 2020 and 2019, respectively; 32,171,560 shares and 0 shares issued

and outstanding at December 31, 2020 and 2019, respectively

 

 

 

3

 

 

—

Class B common stock, $0.0001 par value; 15,368,569 shares and 0 shares authorized

at December 31, 2020 and 2019, respectively; 1,492,059 shares and 0 shares issued and outstanding at December 31, 2020 and 2019, respectively

 

 

 

—

 

 

—

Additional paid-in capital

 

300,888

2,295

Accumulated deficit

 

(90,917)

(148,354)

Total stockholders'/members' equity (deficit)—BioAtla, Inc. / BioAtla LLC

 

209,974

(55,964)

Noncontrolling interest

 

—

(47)

Total stockholders'/members' equity (deficit)

 

209,974

(56,011)

Total liabilities and stockholders'/members' equity (deficit)

 

$ 244,937

$ 9,336


 

BioAtla, Inc.

Consolidated statements of operations and comprehensive loss (in thousands)

 

  Years ended December 31,   

 

2020

2019

 

Collaboration revenue

 

$ 429

 

$ 5,200

Operating expenses:

 

 

Research and development expense

19,933

25,919

General and administrative expense

10,595

7,549

Total operating expenses

30,528

33,468

Loss from operations

(30,099)

(28,268)

Other income (expense):

 

 

Interest income

100

128

Interest expense

(1,389)

(1,630)

Change in fair value of derivative liability

(1,581)

(63)

Extinguishment of convertible debt

(2,883)

—

Other income (expense)

(1)

(22)

Total other income (expense)

(5,754)

(1,587)

Consolidated net loss and comprehensive loss

(35,853)

(29,855)

Net loss attributable to noncontrolling interests

—

61

Net loss attributable to BioAtla, Inc./ BioAtla LLC

$ (35,853)

$ (29,794)

 

BIOATLA CONDITIONALLY ACTIVE BIOLOGIC ANTIBODY DESIGN AND FUNCTIONALITY FOR CANCER TREATMENT DESCRIBED IN LEADING SCIENTIFIC JOURNAL PEER-REVIEWED PAPER

BioAtla Scientists Discover Novel pH Mechanism Published in Proceedings of the National Academy of Sciences

 

 

SAN DIEGO, CA - February 22, 2021 - BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced the publication by Proceedings of the National Academy of Sciences (PNAS) that describes the design and functionality of therapeutic antibody candidates utilizing BioAtla's proprietary CAB technology making them active only in the acidic tumor microenvironment while binding is reversibly inhibited in healthy tissue. This improved tumor targeting utilizes a newly discovered chemical switch system and is shown in animal models to provide for potent anti-tumor activity with markedly reduced toxicity to normal tissue, indicating a widened therapeutic index. 

 

The peer reviewed paper, "Generating Tumor-selective Conditionally Active Biologic Anti-CTLA4 Antibodies Via Protein-associated Chemical Switches" by Hwai Wen Chang, Ph.D., Gerhard Frey, Ph.D., Haizhen Liu, Ph.D., Charles Xing, M.S., Lawrence Steinman, M.D., William J. Boyle, Ph.D., and Jay M. Short, Ph.D., describes the application of CAB technology in the context of the preclinical development of BioAtla's immuno-oncology based CAB-CTLA4 antibody candidates, as well as several CAB antibodies directed against other important oncology targets. "CAB antibodies utilize a newly discovered switch mechanism that allows them to be active only in the tumor microenvironment and not active under normal physiological conditions. CAB antibodies demonstrate reduced peripheral toxicity and therefore are expected to provide a wider therapeutic window compared to traditional antibodies currently available for cancer therapy, potentially enabling higher dosing and longer treatments for improved efficacy," stated co-inventor Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc.

The CAB technology capitalizes on the well-established Warburg Effect that through a glycolytic process leads to an acidic external tumor microenvironment. Extracellular pH levels in tumors have been measured to be as low as pH5.8 compared to the tightly controlled, alkaline, pH7.4 of blood, with even higher pH in healthy tissues. Glycolytic metabolism is also the basis of the established PET scanning technology for cancer detection for tumor types. CAB proteins have increased binding activity as the pH in the microenvironment becomes acidic, while being inactive in normal physiological environments. BioAtla scientists discovered a novel chemical switch mechanism involving physiological-occurring chemicals, such as bicarbonate and hydrogen sulfide. These molecules are negatively charged at physiological conditions and interact with positive charged areas on the protein surface. Under acidic conditions of the tumor microenvironment they are neutralized and released from the protein surface, uniquely allowing CAB antibodies to bind to their target and attack the tumor cell. BioAtla refers to this novel physiological mechanism, used for generating CABs, as Protein-associated Chemical Switch(es) or PaCS mechanism.

CAB antibodies belong to a novel class of tumor-selective therapeutics that do not require the addition of a protective group and irreversible enzymatic activation in the tumor that is used with prodrug designs. The CAB-CTLA4 candidates described in the paper showed substantially reduced binding at pH7.4 compared to binding at pH6.0, while the comparable Ipilimumab analogue (IpA) binding showed no dependence on pH, thereby leading IpA to bind and attack normal cells, which results in dangerous on-target off-tumor toxicity. In comparison, multiple CAB candidates demonstrated substantial binding differentials between pH6.0 and pH7.4 conditions ranging from 9-fold to over 175-fold by ELISA, which is expected to lead to an improved therapeutic index and the potential improved clinical risk benefit in future therapies. The ability to design CAB tumor target binding for a specific range of pH conditions demonstrates the flexibility provided by the PaCS mechanism and the CAB technologies. Selection of a CAB antibody candidate is based upon strong differential pH binding between tumor and normal cells that can lead to increased anti-tumor potency with reduced toxicity, while maintaining a low immunogenicity risk and efficient manufacturing characteristics.

In addition to the development of CAB-CTLA4 discussed in the paper, BioAtla has successfully generated several CAB antibodies against multiple targets including EpCAM, Her2, Nectin-4, and CD73. The proprietary technology has also successfully been used for the development of ADCs and T-cell engaging bispecific antibodies. The ability to design conditionally active therapeutics with stronger selectivity over narrower pH ranges using the PaCS mechanism offers the opportunity to greatly enhance both the safety and potency of future therapies for solid tumors. 

 

Potential for additional therapeutic modalities and disease targets

It is expected from the studies described in the paper that there is a potential for other yet to be identified PaCS molecules in disease related microenvironments, whether controlled through pH, concentration, or other molecular characteristics (intra- or intermolecularly) for enhancing a drug's therapeutic index. Potential new therapeutic candidates addressing these opportunities are not limited to antibodies, but also include small molecules, encompassing lipids, sugars and nucleic acid-based agents or drugs. Further, it is expected that PaCS protein-chemical systems are important naturally occurring regulatory systems linked to a range of disease-related microenvironments, including cancer, inflammation and cellular senescence.

 

About BioAtla, Inc.

 

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 250 issued patents and more than 200 pending patent applications worldwide.  Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products.   BioAtla has two CAB programs currently in Phase 2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). BioAtla's investigational CAB CTLA-4 antibody, BA3071, is subject of a global co-development and collaboration agreement with BeiGene Ltd. for its development, manufacturing and commercialization. BA3071 is a novel, CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors such as anti-PD-1 antibody.

 

 

Learn more at www.bioatla.com.

# # #

Contact:


Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945

 

BIOATLA TO PRESENT AT 39TH ANNUAL J.P. MORGAN VIRTUAL HEALTHCARE CONFERENCE

SAN DIEGO, CA - January 8, 2021 - BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that Jay M. Short, Ph.D., Chief Executive Officer, and Scott Smith, President, with participation by other BioAtla executives, will present at the 39th Annual J.P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021, at 2:50 PM Eastern Time. 

While the conference on the whole is invitation-only, public listeners can listen to our virtual presentation via this link.
https://jpmorgan.metameetings.net/events/healthcare21/sessions/35735-bioatla/webcast?gpu_only=true&kiosk=true

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has two programs currently in Phase 1/2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). BioAtla's investigational CAB CTLA-4 antibody, BA3071, is subject of a global co-development and collaboration agreement with BeiGene Ltd. for its development, manufacturing and commercialization. BA3071 is a novel, CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors such as BeiGene's anti-PD-1 antibody, tislelizumab.

 

 

Learn more at www.bioatla.com

Contact:
Richard Waldron
Chief Financial Officer
BioAtla, Inc.
rwaldron@bioatla.com
858.356.8945

BioAtla Announces Closing of Initial Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

December 18, 2020

SAN DIEGO, Calif., December 18, 2020 -- BioAtla, Inc. (Nasdaq: BCAB), a clinical-stage biopharmaceutical company developing a novel class of highly specific and selective antibody-based therapeutics for the treatment of solid tumor cancer, today announced the closing of its initial public offering of 12,075,000 shares of common stock at a public offering price of $18.00 per share, which includes 1,575,000 shares sold upon full exercise of the underwriters' option to purchase additional shares of common stock. All of the shares of common stock were offered by BioAtla. The shares of common stock began trading on the Nasdaq Global Market on December 16, 2020 under the ticker symbol "BCAB." The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by BioAtla, were approximately $217.4 million.

J.P. Morgan, Jefferies and Credit Suisse acted as joint book-running managers for the offering. BTIG acted as co-manager for the offering.

Registration statements relating to these securities became effective on December 15, 2020. Copies of the registration statements can be accessed by visiting the Securities and Exchange Commission website at www.sec.gov. The securities referred to in this release were offered only by means of a prospectus. A copy of the final prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, by telephone at (800) 221-1037, or by e-mail at usa.prospectus@credit-suisse.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About BioAtla

BioAtla is a clinical-stage biopharmaceutical company developing a novel class of highly specific and selective antibody-based therapeutics for the treatment of solid tumor cancer.

Media Contact:

Richard A. Waldron, CFO
BioAtla, Inc.

info@bioatla.com

Investor Contact:

Richard A. Waldron, CFO
BioAtla, Inc.

rwaldron@bioatla.com

BIOATLA ANNOUNCES PRICING OF INITIAL PUBLIC OFFERING

December 15, 2020

SAN DIEGO, Calif., December 15, 2020 -- BioAtla, Inc. (Nasdaq: BCAB), a clinical-stage biopharmaceutical company developing a novel class of highly specific and selective antibody-based therapeutics for the treatment of solid tumor cancer, today announced the pricing of its initial public offering of 10,500,000 shares of common stock at a public offering price of $18.00 per share. All of the shares of common stock are being offered by BioAtla. The shares of common stock are expected to begin trading on the Nasdaq Global Market on December 16, 2020 under the ticker symbol "BCAB." The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by BioAtla, are expected to be approximately $189.0 million. The offering is expected to close on December 18, 2020, subject to the satisfaction of customary closing conditions. In addition, BioAtla has granted the underwriters a 30-day option to purchase up to an additional 1,575,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

J.P. Morgan, Jefferies and Credit Suisse are acting as joint book-running managers for the offering.

Registration statements relating to these securities became effective on December 15, 2020. The offering is being made only by means of a prospectus, copies of which may be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, by telephone at (800) 221-1037, or by e-mail at usa.prospectus@credit-suisse.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About BioAtla

BioAtla is a clinical-stage biopharmaceutical company developing a novel class of highly specific and selective antibody-based therapeutics for the treatment of solid tumor cancer.

Media Contact:

Richard A. Waldron
BioAtla, Inc.

rwaldron@bioatla.com

Investor Contact:

Richard A. Waldron
BioAtla, Inc.

rwaldron@bioatla.com

BIOATLA AND BEIGENE REVISE GLOBAL DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

San Diego, CA; Beijing, China and Cambridge, MA - October 6, 2020 - BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biotechnology company, today announced that the two companies have revised their previous global co-development and commercialization agreement for BioAtla's investigational CAB CTLA-4 antibody, BA3071. The previous agreement from April 2019 now becomes a global licensing agreement for BA3071, which was designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors, such as BeiGene's anti-PD-1 antibody, tislelizumab.

 

Under the amended terms of the agreement, BeiGene will hold an exclusive global license to BA3071 and will be solely responsible for its global clinical development and commercialization and have the right to receive all profits on any future sales net of royalty payments to BioAtla. In addition to the upfront payment BioAtla received upon execution of the original agreement, BioAtla is eligible to receive near-term development and regulatory milestone payments together with increased tiered royalties on worldwide sales. Additional terms of the amended agreement were not disclosed.

 

"BeiGene is a recognized leader in global clinical development, with broad oncology clinical programs, including tislelizumab, its anti-PD-1 antibody which is approved in China," said Scott Smith, President of BioAtla. "This amended agreement reflects both BeiGene's commitment to BA3071 and BioAtla's strategy of rapidly and broadly building our pipeline of innovative CAB oncology candidates. This amended agreement enhances BioAtla's strategic execution capabilities to support the development of our product pipeline, advance compelling combination therapies, and address markets with strong growth potential and high unmet medical need.  BA3071 is expected to become BioAtla's third CAB candidate in clinical trials along with CAB-AXL-ADC and CAB-ROR2-ADC."

 

"BioAtla has developed a differentiated proprietary protein discovery and expression platform to generate CABs, which in turn have been applied to BA3071, a novel, investigational CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment," commented Lai Wang, Ph.D., Senior Vice President, Head of Global Research, Clinical Operations & Biometrics and  APAC Clinical Development at BeiGene. "The unique nature of BA3071 provides us with an exciting scientific rationale to investigate the combination of this investigational CTLA-4 antibody with our anti-PD-1 antibody, tislelizumab. We look forward to advancing the global development and commercialization of this potentially unique cancer therapy as a single agent or in combination with other therapies."

 

"We believe that our amended agreement with BeiGene will align and potentially accelerate the global development and potential commercialization of BA3071. BeiGene's management of the global clinical trials of BA3071 in combination with BeiGene's tislelizumab may advance the prospects of new combination therapies for the treatment of several cancer indications," stated Jay M. Short, Ph.D., Chairman, CEO and co-founder of BioAtla. "The expanded royalty rates also recognize the exceptional opportunity that CAB technology can provide for novel combination therapies."

 

About BA3071

BA3071 is a novel, investigational conditionally active CTLA-4 inhibitor. A Phase 1/2 multi-center, open-label study is planned to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of BA3071 alone and in combination with BeiGene's tislelizumab, an anti-PD-1 antibody. The Investigational New Drug application for BA3071 has been cleared by the U.S. Food and Drug Administration. 

 

Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) is an inhibitory receptor expressed on T cells. The CTLA-4 pathway is a key immune checkpoint pathway that provides a downregulating signal to T cells. The blockade of CTLA-4 is intended to induce an antitumor immune response by promoting the activation and proliferation of tumor-specific T cells. Although inhibition of CTLA-4 has been shown to significantly improve antitumor response, it may also lead to immune attack of healthy cells. To minimize on-target off-tumor toxicity, BioAtla has applied its proprietary CAB technology with the intent to activate binding to the CTLA-4 receptor only on T cells in the tumor microenvironment.

 

Inhibition of immune checkpoints using anti-programmed cell death-1 (PD-1) or anti-CTLA-4 monoclonal antibodies has revolutionized the management of patients with advanced-stage melanoma and are among the most promising components of treatment approaches for many other cancers. Employing BioAtla's proprietary CAB technology, BA3071 is designed to improve the efficacy and safety of anti-CTLA-4 therapy, as a monotherapy and in combination with other therapies, by restricting its activation and that of tumor specific T cells to the tumor microenvironment.

 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologics are proteins generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

About Tislelizumab

 

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene's immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

 

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin's lymphoma who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

 

In addition, three supplemental new drug applications (sNDAs) for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review, for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

 

Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials.

 

Tislelizumab is not approved for use outside of China.

 

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has two programs currently in Phase 1/2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC).

 

About BeiGene

 

BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 4,200+ employees in China, the United States, Australia, Europe, and elsewhere are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology products: BTK inhibitor BRUKINSA© (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.

 

BeiGene Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding future research, development and potential commercialization activities under the agreement with BioAtla, potential payments payable to BioAtla, the speed and outcome of drug development plans, the advancement of and anticipated clinical development, regulatory milestones and commercialization of BA3071 and tislelizumab, potential advantages and differentiation of BA3071 and tislelizumab, plans for a Phase 1/2 clinical trial of BA3071 alone and in combination with tislelizumab, BeiGene's  other development and commercial plans, and other information that is not historical information.  Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene's limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on BeiGene's clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled "Risk Factors" in BeiGene's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission.  All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

 


BeiGene Contacts:

Investors

Craig West

(857) 302-5189

ir@beigene.com

 

Media

Liza Heapes or Vivian Ni

(857) 302-5663 or (857) 302-7596

media@beigene.com

 

BioAtla Contact:

Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858-356-8945

BIOATLA RAISES $72.5 MILLION IN SERIES D FINANCING

Proceeds will advance CAB-AXL and CAB-ROR2 clinical programs into Phase 2 trials, CAB-CTLA-4 Phase 1 trial, and additional CAB development programs

 
SAN DIEGO, CA
- July 15, 2020 - BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced closing of a Series D financing round raising $72.5 million. The financing was led by Soleus Capital and joined by several new investors including HBM Healthcare Investments as co-lead, Cormorant Asset Management, Farallon Capital, Pappas Capital, funds managed by Janus Henderson, Boxer Capital, and one other institutional investor. Current investor Pfizer Ventures, the venture capital arm of Pfizer Inc. (NYSE: PFE), also participated in the financing.

"The funding provided by this group of highly respected investors strongly supports the execution of BioAtla's current and future product and strategic plans. The proceeds of this financing greatly enhance our ability to design, implement, and execute clinical programs evolving from our CAB platform that uniquely yields tumor-targeting antibodies with the potential for an enhanced benefit risk profile" said Jay M. Short, Ph.D., chairman and chief executive officer of BioAtla. "We look forward to driving Phase 2 trials addressing high unmet medical needs in oncology for our innovative CAB-AXL-ADC (BA3011) and CAB-ROR2-ADC (BA3021) product programs, as well as advancing clinical studies for CAB-CTLA-4 (BA3071)," stated Scott Smith, president of BioAtla. "In addition, we are pursuing development of several T cell-recruiting CAB-bispecific candidates."

 About Conditionally Active Biologics (CABs)

Conditionally Active Biologics are proteins generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has two programs currently in Phase 1/2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). BioAtla's investigational CAB CTLA-4 antibody, BA3071, is subject of a global co-development and collaboration agreement with BeiGene Ltd. for its development, manufacturing and commercialization. BA3071 is a novel, CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors such as BeiGene's anti-PD-1 antibody, tislelizumab.

 

 

 

# # #

Contact:

Richard Waldron

Chief Financial Officer

BioAtla, Inc

rwaldron@bioatla.com

858.356.8945

BIOATLA APPOINTS ERIC SIEVERS, M.D., AS CHIEF MEDICAL OFFICER

Experienced leader of oncology clinical trial approvals to head BioAtla's clinical development programs


SAN DIEGO, CA
- June 28, 2019 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced the appointment of Eric L. Sievers, M.D., as chief medical officer.  Dr. Sievers, an experienced biotechnology drug developer in oncology, joins the Company bringing clinical development and management experience directly relevant to BioAtla's oncology focus and pipeline of Conditionally Active Biologic (CAB) candidates including in immuno-oncology and antibody drug conjugates (ADCs). His clinical development leadership, design and execution resulted in several successful oncology registration trials and approvals including, for Seattle Genetics, approvals of ADCETRIS in Hodgkin lymphoma, in peripheral T-cell lymphoma, and in cutaneous T-cell lymphoma. 

 

"Dr. Sievers' experience and proven capabilities in leading the clinical development of innovative oncology products greatly enhances BioAtla's ability to design, implement, and execute clinical programs evolving from our CAB platform that uniquely yields tumor-targeting antibodies with high safety" said Jay M. Short, Ph.D., chairman and chief executive officer of BioAtla. "Dr. Sievers' knowledge of and background in developing advanced biologics including ADC's, and his experience in leading partnership interactions with pharmaceutical company partners is directly applicable to our current and future product and strategic plans," stated Scott Smith, president of BioAtla.

 

About Dr. Sievers

Dr. Sievers joins BioAtla with over 25 years of clinical and translational biomedical research experience in multiple settings, including biotechnology industry, hospital- and clinic-based clinical practice and academics. During his nine years at Seattle Genetics, he was closely involved with the development and regulatory approval of ADCETRIS (brentuximab vedotin), an ADC.  Serving in multiple roles of increasing leadership responsibility, he led the Seattle Genetics clinical team and Takeda (Millennium) development partner to design, initiate and enroll four randomized Phase 3 registration trials for ADCETRIS that each ultimately resulted in new indications approved by the FDA. Dr. Sievers has managed clinical development efforts from Phase 1 to Phase 3 clinical trials, from strategy planning to study execution and BLA/NDA submissions. Prior to his career at Seattle Genetics, Dr. Sievers was Medical Director at ZymoGenetics where he designed and supervised clinical trials of recombinant human interleukin 21 and TACI-Fc5 for patients with cancer and evaluated new oncology opportunities.  Before then, he was with the Fred Hutchinson Cancer Research Center for 12 years where he attained the position of Assistant Member and was Assistant Professor of Pediatrics at the University of Washington. During this time, he served as the lead investigator of Phase 1 and pivotal trials that resulted in the approval of an antibody drug conjugate MYLOTARG© indicated for patients with acute myeloid leukemia. Dr. Sievers' most recent position was Chief Medical Officer at Trillium Therapeutics where he developed clinical trial strategies and oversaw all clinical development employing a decoy receptor to block the CD47 "do not eat" signal overexpressed by cancer cells.  Dr. Sievers received both his medical degree and his B.A. degree from Brown University.

 

 

 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologics are proteins generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

About BioAtla, LLC

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has two programs currently in Phase 1/2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC).

 

Learn more at www.bioatla.com.

 

# # #

Contact:


Richard Waldron

Chief Financial Officer

BioAtla, LLC

rwaldron@bioatla.com

858.356.8945

BIOATLA SUBSIDIARY, HIMALAYA THERAPEUTICS, WILL DEVELOP AND COMMERCIALIZE CAB PRODUCTS IN GREATER CHINA MARKET

First Conditionally Active Biologics licensing participation in Greater China territory

San Diego, CA
- April 16, 2019 - BioAtla©, LLC, a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics for the oncology market, today announced that Himalaya Therapeutics SEZC, a Cayman Island corporation and majority owned subsidiary of BioAtla, has the exclusive license from BioAtla to develop and commercialize several specific, differentiated product candidates for the Greater China market of the PRC, Hong Kong, Macau and Taiwan. The Himalaya Therapeutics portfolio includes two CAB candidates, CAB-AXL-ADC and CAB-ROR2-ADC, each currently in Phase 1/2 clinical trials conducted by BioAtla at sites in the United States. In addition, Himalaya Therapeutics will participate in BioAtla's potential Greater China derived returns from the recently announced BioAtla and BeiGene, Ltd. global co-development and collaboration agreement for the development, manufacture and commercialization of CAB-CTLA-4 (BA3071).  Himalaya will also support Bioatla's global clinical trials effort in Greater China.  

"We believe that Himalaya's product development and business related activities directly addressing Greater China will maximize the strategic opportunities for both BioAtla and Himalaya in the world's second largest pharmaceutical market," stated Carolyn Short, General Manager of Himalaya Therapeutics. "The access to clinical development capabilities in China can accelerate the global development and potential commercialization of the BioAtla product portfolio and effectively address markets with strong growth potential and high unmet medical need," added Scott Smith, President of BioAtla.

Recent sweeping changes to the China regulatory processes for the development of pharmaceutical products now closely align them with those in the United States and broadens the use of clinical data for regulatory purposes between the two nations.  Consequently, close coordination of clinical development in the U.S. and China of a pharmaceutical candidate is highly desireable and more efficient.  Furthermore, the access to capital markets for early-stage biotechnology companies in China has recently been greatly enhanced especially with the revision to the stock listing requirements on the Hong Kong Stock Exchange. Himalaya Therapeutics is expected to fund its operations independent from BioAtla.  These were primary motivating factors for Beijing Sinobioway Group Company and its related investor groups to contribute all of their rights to certain and any future CAB candidates that were part of their 2015 collaboration agreement with BioAtla in exchange for a minority equity position in Himalaya Therapeutics.   

About Conditionally Active Biologics (CABs)

Conditionally Active Biologics are proteins generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells. Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

About BioAtla, LLC

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has two programs currently in Phase 1/2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC).

 

Contact:

Richard Waldron

Chief Financial Officer BioAtla, LLC rwaldron@bioatla.com 858.356.8945

BIOATLA AND BEIGENE FORM WORLDWIDE COLLABORATION TO DEVELOP AND COMMERCIALIZE NOVEL CONDITIONALLY ACTIVE BIOLOGIC CTLA-4 THERAPY


Plan to pursue development as a monotherapy and in combination with BeiGene's investigational anti-PD-1 antibody, tislelizumab

 

San Diego, CA; Beijing, China and Cambridge, MA,  - April 8, 2019 - BioAtla ©, LLC, a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the two companies have entered into a global co-development and collaboration agreement for the development, manufacturing and commercialization of BioAtla's investigational CAB CTLA-4 antibody (BA3071). BA3071 is a novel, CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors such as BeiGene's investigational anti-PD-1 antibody, tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages.

 

Under the terms of the collaboration, BioAtla will co-develop the CAB-CTLA-4 antibody to defined early clinical objectives and BeiGene will then lead the parties' joint efforts to develop the product candidate and be responsible for global regulatory filings and commercialization. Subject to the terms of the agreement, BeiGene will hold a co-exclusive license with BioAtla to develop and manufacture the product candidate globally and an exclusive license to commercialize the product candidate globally. BeiGene will be responsible for all costs of development, manufacturing and commercialization in Asia (ex-Japan), Australia and New Zealand, and the parties will share development and manufacturing costs and commercial profits and losses upon specified terms in the rest of the world. BioAtla will receive an upfront payment of $20 million and a milestone payment upon reaching the defined early clinical objectives. BioAtla is also eligible to receive up to $249 million in subsequent development and regulatory milestones globally and commercial milestones in the BeiGene territory, together with tiered royalties on sales in the BeiGene territory. Additional terms of the agreement were not disclosed.

 

"BeiGene is a recognized leader in China-inclusive global clinical development, with broad oncology clinical programs, which include tislelizumab," said Scott Smith, President of BioAtla. "This collaboration complements our strategy of building our pipeline of innovative CAB oncology candidates, advancing combination product therapies, and effectively addressing markets with strong growth potential and high unmet medical need."

 

 

"BioAtla has developed an exciting proprietary protein discovery and expression platform to generate CABs, which in turn have been applied to BA3071, a novel, investigational CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment," commented Dr. Lai Wang, Senior Vice President, Asia Pacific Clinical Development, Global Research, Clinical Operations and Biometrics, for BeiGene. "The unique nature of BA3071 provides an exciting opportunity to combine this CTLA-4 antibody with our anti-PD-1 antibody, tislelizumab. We look forward to working with BioAtla through proof-of-concept, followed by global development of this potentially unique cancer therapy as a single agent or in combination with other therapies."

 

"We believe that our collaboration with BeiGene will accelerate the global development and potential commercialization of BA3071 and advance the prospects and potential of safer and more effective combination therapies for the treatment of several cancer indications," stated Jay M. Short, Ph.D., Chairman, CEO and co-founder of BioAtla. "The application of BioAtla's CAB technology to CTLA-4 inhibition may offer greater potency and safety, thereby improving this important cancer therapy and expanding its potential applications."

 

About BA3071

 

BA3071 is a novel, investigational conditionally active CTLA-4 inhibitor. The first investigational new drug (IND) filing is currently planned for mid-2019. Subject to regulatory clearance of the IND, a Phase 1/2 multi-center, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of BA3071 alone and in combination with BeiGene's tislelizumab, an investigational anti-PD-1 inhibitor, is anticipated to start in the second half of 2019.

 

The cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) is an inhibitory receptor expressed on T cells. The CTLA-4 pathway is a key immune checkpoint pathway that provides a downregulating signal to T cells. The blockade of CTLA-4 is intended to induce an antitumor immune response by promoting the activation and proliferation of tumor-specific T cells. Although inhibition of CTLA-4 has been shown to significantly improve antitumor response, it may also lead to immune attack of healthy cells. To minimize on-target off-tumor toxicity, BioAtla has applied its proprietary CAB technology with the intent to activate binding to the CTLA-4 receptor only on T cells in the tumor microenvironment.

 

Inhibition of immune checkpoints using anti-programmed cell death-1 (PD-1) or anti-CTLA-4 monoclonal antibodies has revolutionized the management of patients with advanced-stage melanoma and are among the most promising components of treatment approaches for many other cancers. Employing BioAtla's proprietary CAB technology, BA3071 is designed to improve the efficacy and safety of anti-CTLA-4 therapy, as a monotherapy and in combination with other therapies, by restricting its activation and that of tumor specific T cells to the tumor microenvironment.

 

About Conditionally Active Biologics (CABs)

 

Conditionally Active Biologics are proteins generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

 

About Tislelizumab

 

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene's immuno-oncology biologic program, and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

 

Clinical trials of tislelizumab include a global Phase 3 clinical trial in patients with second-line non-small cell lung cancer (NSCLC); a global Phase 3 clinical trial in first-line patients with hepatocellular carcinoma (HCC); a global Phase 3 clinical trial in second-line patients with esophageal squamous carcinoma (ESCC); a global Phase 3 clinical trial in first-line patients with gastric cancer (GC); a global Phase 3 clinical trial in first-line patients with ESCC; a global Phase 3 trial in patients with Stage III NSCLC; a global Phase 2 clinical trial in second- or third-line patients with HCC; a global Phase 1 clinical trial in patients with relapsed/refractory (R/R) NK/T-cell lymphomas; and a global Phase 1 clinical trial in patients with solid tumors. In China, BeiGene has completed a pivotal Phase 2 clinical trial in patients with R/R classical Hodgkin's lymphoma (cHL), and is conducting a Phase 3 clinical trial in first-line patients with non-squamous NSCLC; a Phase 3 clinical trial in first-line patients with squamous NSCLC; a Phase 2 clinical trial in second-line urothelial cancers (UC); and a Phase 2 clinical trial in patients with MSI-H or dMMR solid tumors.

 

The new drug application (NDA) in China for R/R cHL has been accepted by the China National Medical Products Administration (NMPA) and granted priority review.

BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

 

About BioAtla, LLC

 

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has two programs currently in Phase 1/2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC).

 

About BeiGene

 

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 2,200 employees in China, the United States, Australia and Europe, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. BeiGene markets ABRAXANE© (nanoparticle albumin-bound paclitaxel), REVLIMID© (lenalidomide), and VIDAZA (azacitidine) © in China under a license from Celgene Corporation.1 

 

BeiGene Cautionary Note Regarding BeiGene's Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding future research, development and potential commercialization activities under the agreement with BioAtla, potential payments payable to BioAtla, the speed and outcome of drug development plans, the advancement of and anticipated clinical development, regulatory milestones and commercialization of BA3071 and tislelizumab, potential advantages and differentiation of BA3071 and tislelizumab, BioAtla's and BeiGene's development and commercial plans, and other information that is not historical information.  Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene's limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled "Risk Factors" in BeiGene's most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission.  All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

 


BeiGene Investor Contact
Craig West
+1 857-302-5189
ir@beigene.com 

 

BeiGene Media Contact
Liza Heapes
+1 857-302-5663 
media@beigene.com


 

BioAtla Contact:

Richard Waldron

Chief Financial Officer

BioAtla, LLC

rwaldron@bioatla.com

858-356-8945

 

1 ABRAXANE©, REVLIMID©, and VIDAZA© are registered trademarks of Celgene Corporation.

 

BIOATLA PRESENTS CAB-CTLA-4 AND CAB-EpCAM-ADC DATA AT THE AMERICAN ASSOCIATION FOR CANCER RESEARCH ANNUAL MEETING

Oral presentation highlights CAB-CTLA-4 pre-clinical data demonstrating expected efficacy and reduced immune side effects and toxicities as monotherapy or in combination with PD-1 inhibitors

 

Poster presentation of CAB-EpCAM-ADC demonstrating anti-tumor efficacy in vivo

 

San Diego, CA - February 27, 2019 - BioAtla ©, LLC, a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, will present pre-clinical data on BA3071 and BA3181, the company's novel CAB-CTLA-4 and CAB-EpCAM-ADC programs, at the 2019 American Association For Cancer Research (AACR) annual meeting in Atlanta, Georgia on March 29-April 3, 2019.

"These new data showcase the capabilities of our proprietary CAB technology, which we believe will expand the number of druggable protein targets and maximize both potency and safety in combination therapies, antibody drug conjugate (ADC) medicines, bispecifics and other targeted therapy formats for cancer treatments," stated Jay M. Short, Ph.D., Chairman, CEO and co-founder of BioAtla.

"We are particularly excited by these new preclinical data for our novel CAB-CTLA-4 program as a single-agent or in combination with checkpoint inhibitors. This novel CAB has the potential for an improved safety margin and therapeutic index thereby improving this important cancer therapy," said Scott Smith, President of BioAtla.

"These preclinical data suggest that our CAB technology may effectively address the issue of on-target off-tumor toxicity and allow leveraging the widely expressed and promising EpCAM target for cancer therapy," added Scott Smith.

BA3071 is a novel conditionally active CTLA-4 inhibitor. The CTLA-4 pathway is a key immune checkpoint pathway that provides a downregulating signal to T cells. Although inhibition of CTLA-4 has been shown to significantly improve the antitumor response, it may also lead to immune attack of healthy cells. To minimize on-target off-tumor toxicity, BioAtla applies its proprietary CAB technology with the intent to activate binding to the CTLA-4 receptor preferentially on T cells in the tumor microenvironment. The data to be presented at AACR indicate that our CAB-CTLA-4 molecule may have a superior safety profile when used in combination with PD-1 inhibitors and allow increased dosing levels to achieve superior efficacy to current anti-CTLA-4 therapy as a single agent or in combination with other anti-cancer therapies including immuno-oncology agents. The BA3071 IND filing is planned for mid-2019. A Phase 1/2 multi-center, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of BA3071 alone and in combination with a PD-1 inhibitor is anticipated to start in H2 2019.

BA3181 is a novel conditionally active EpCAM targeted antibody drug conjugate (CAB-EpCAM-ADC). EpCAM is expressed at high levels exclusively in epithelia and epithelial-derived neoplasms, making it a suitable target for many important solid tumor types and cancer stem cells. EpCAM expression on normal tissues limits its utility as a target for therapeutic antibodies and ADCs due to the potential effects on normal epithelial throughout the body. Using our CAB technology, BioAtla has developed CAB antibodies to EpCAM that reversibly bind to recombinant EpCAM and EpCAM expressing cells under select conditions that are present in the tumor microenvironment but not in normal tissues. In vitro and in vivo efficacy data for several anti-EpCAM antibodies and ADCs will be presented and suggest that conditionally active EpCAM ADCs generated using the CAB technology provided drug candidates, including BA3181, that have the potential to have an increased safety margin and therapeutic index in the clinic. 

Abstract Selected for Oral Presentation:

19-A-6330-AACR:  Potent CAB CTLA-4 antibody to reduce immune side effects and toxicities associated with single agent and combination cancer immuno therapies

Abstract Control Number: 6215

Session Title:  Rational Combinations of Immunotherapy

Session Date and Time: 4/1/2019 3:00PM - 5:00 PM

Presenter:  William Boyle, Ph.D., Chief of Translational Medicine, BioAtla LLC

Abstract Selected for Poster Presentation

Novel conditionally active biologic (CAB) antibody targeting EpCAM demonstrates anti-tumor efficacy in vivo

Session Title:  New Anticancer Agents

Session Date and Time:   Sunday Mar 31, 2019 1:00 PM - 5:00 PM

Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 14

Poster Board Number:  17

Permanent Abstract Number: 356 

Session information is available online via the Annual Meeting Itinerary Planner through the AACR website at www.aacr.org.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These tumor microenvironments (TMEs) are primarily influenced by the characteristic glycolytic metabolism associated with cancer cells, including for those cells under aerobic conditions referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible, to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa, thereby widening the therapeutic index. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

About BioAtla , LLC

BioAtla is a global clinical-stage biotechnology company headquartered in San Diego, California, and with operations in Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has two programs currently in Phase 1/2 clinical testing in the US, BA3011 a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC) and BA3021 a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC), in addition to two licensed, royalty-bearing clinical stage CAB programs.

 

Contact:

Richard Waldron

Chief Financial Officer

BioAtla, LLC

rwaldron@bioatla.com

858.356.8945

 

BIOATLA CONGRATULATES JAMES ALLISON, PH.D. FOR RECEIVING NOBEL PRIZE

Drs. Allison and Sharma advising BioAtla on its CAB-CTLA4 antibody drug candidate and other proprietary CAB programs and the design of combination therapies

 

SAN DIEGO, CA - October 4, 2018 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, congratulates James Allison, Ph.D., for receiving the 2018 Nobel Prize in Physiology or Medicine recognizing his leading role in launching an effective new way to attack cancer by treating the immune system. Dr. Allison and Padmanee Sharma, M.D., Ph.D., both at MD Anderson and leading researchers in the field of immuno-oncology, are scientific advisors to BioAtla. Dr. Allison's pioneering research in the regulation of T cell responses and strategies for cancer immunotherapy led to the development of the ipilimumab antibody to CTLA-4, the first immune checkpoint blockade therapy approved by the U.S. Food and Drug Administration. 

 

"We congratulate Jim for receiving the world's preeminent award for outstanding discoveries in the field of life sciences and medicine," said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla. "As scientific advisors to BioAtla, he and Dr. Sharma provide valuable contributions to the direction and prioritization of our CAB development programs, including our CAB-CTLA4 antibody candidate, and to enhance our decisions and design of combination CAB immunotherapies and CAB bispecifics,"

 

About Dr. Allison

James Allison, Ph.D., is Chair of the Department of Immunology, the Vivian L. Smith Distinguished Chair in Immunology, Director of the Parker Institute for Cancer Research, and the Executive Director of the Immunotherapy Platform at The University of Texas MD Anderson Cancer Center (MD Anderson).

 

Among Dr. Allison's most notable discoveries in his distinguished career studying the regulation of T cell responses, are the determination of the T cell receptor structure and that CD28 is the costimulatory molecule that allows full activation of naïve T cells and prevents anergy in T cell clones.  His lab resolved a major controversy by demonstrating that CTLA-4 inhibits T cell activation by opposing CD28-mediated costimulation and that blockade of CTLA-4 could enhance T cell responses, leading to tumor rejection in animal models, and launched the emerging field of immune checkpoint blockade therapy for cancer. Dr. Allison is a member of the National Academies of Science and Medicine.  In addition to recently receiving the Nobel Prize, he received the Lasker-Debakey Clinical Medical Research Award in 2015.

 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including monoclonal antibodies (mAbs), antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

 

About BioAtla, LLC

BioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. Two of the Company's conditionally active drug candidates, BA3011, an AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC), currently are each the subject of a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of the CAB candidate in patients with advanced solid tumors. In addition, two licensed CAB CAR-T antibodies are in clinical trials for solid tumors in China.

 

Learn more at www.bioatla.com.

 

 

Contact:
Richard Waldron

Chief Financial Officer

BioAtla, LLC

rwaldron@bioatla.com

858.356.8945

BIOATLA APPOINTS SCOTT SMITH AS PRESIDENT


Experienced biopharmaceutical executive to drive expansion of operations, product strategy and corporate partnering efforts

 

SAN DIEGO, CA - September 10, 2018 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced the appointment of Scott Smith, as President. Mr. Smith, an experienced biotechnology and pharmaceutical executive, joins the Company from Celgene Corporation, where he was President and Chief Operating Officer.

 

"Scott's experience and proven capabilities in building and leading organizations for the development and commercialization of innovative products makes him ideally suited to help lead the expansion of BioAtla's operations, including business development and partnering activities, new product development and execution of our strategies to advance our CAB platform opportunities worldwide. I look forward to working with Scott to build on and accelerate BioAtla's progress," said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and Co-founder of BioAtla.

 

About Scott Smith

Mr. Smith joins BioAtla with 30 years of biotechnology and pharmaceutical industry experience. In his ten years at Celgene from 2008-2018 his leadership role expanded from Vice President of Global Marketing for Inflammation & Immunology, to Global Head of that division, to President of the Inflammation & Immunology Franchise to his appointment in 2017 as Celgene's President and Chief Operating Officer. With a particular emphasis and interest in immunology, Mr. Smith drove the growth of Celgene's Inflammation and Immunology division from 13 to more than 1,300 people worldwide and oversaw the clinical development, global registration and commercial success of the blockbuster drug Otezla. Mr. Smith's prior experience at Pharmacia (acquired by Pfizer) and at Biovail included global responsibility for sales and marketing, creating and executing commercial and business development strategies and contributing to regulatory and clinical development strategies. Mr. Smith also serves on the board of directors of Titan Pharmaceuticals, Triumvira Immunologics and Springbank Pharmaceuticals. Mr. Smith received both his BSc degree in Chemistry and Biology and his HBSc degree in Pharmacology and Toxicology from the University of Western Ontario and his Masters of International Business Management from the American Graduate School of International Management (Thunderbird).

 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be mAbs, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit an immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

 

 

About BioAtla, LLC

BioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. Two of the Company's conditionally active drug candidates, BA3011, an AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC), currently are the subject of multi-center, open-label, Phase 1/2 studies designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of the CAB candidate in patients with advanced solid tumors. In addition, two licensed CAB CAR-T antibodies are in clinical trials for solid tumors in China.

 

Learn more at www.bioatla.com.

 

Contact:


Richard Waldron

Chief Financial Officer

BioAtla, LLC

rwaldron@bioatla.com

858.356.8945

BIOATLA APPOINTS LAWRENCE FONG, M.D. AS SCIENTIFIC ADVISOR

Leading clinical researcher in cancer immunotherapy will advise BioAtla on clinical trial designs of the company's proprietary CABs in combination therapies

 

SAN DIEGO, CA - July 24, 2018 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced the appointment of Lawrence Fong, M.D., as a scientific advisor. Dr. Fong is a leader in clinical research and has dedicated 20 years to the field of cancer immunotherapy.  Dr. Fong's research focuses on understanding the ways by which immunotherapies can lead to clinical responses as well as to treatment-induced side effects. This work includes tracking antigen-specific T cell responses both in pre-clinical models and in treated cancer patients and developing biomarkers that are associated with clinical outcomes.

 

"The knowledge, experience and insight of Dr. Fong will provide valuable contributions to the direction and prioritization of our CAB development programs.  In particular, his advice will enhance our decisions and design of clinical trials for combination CAB bispecific antibodies and CAB immunotherapies ," said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and President of BioAtla.

 

About Dr. Fong

Lawrence Fong, M.D. is Efim Guzik Distinguished Professor in Cancer Biology and leads the Cancer Immunotherapy Program at the University of California, San Francisco (UCSF).  He is a physician-scientist in the Department of Medicine, Division of Hematology/Oncology directing both a translational research program and an NIH funded research lab. At UCSF he also co-directs the Parker Institute of Cancer Immunotherapy and co-leads the Cancer Immunology Program in the Helen Diller Family Comprehensive Cancer Center. He has served on multiple NIH study sections and committees including the NCI Investigational Drug Steering Committee (IDSC) and Genitourinary Cancers Steering Committee (GUSC). He has also served on multiple scientific advisory boards and journal editorial boards including the Journal of Clinical Oncology and Cancer Immunology Research.


 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood glycolytic metabolism associated with cancer cells, even in the presence of oxygen, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including monoclonal antibodies, antibody drug conjugates (ADCs), bispecific antibodies, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

About BioAtla, LLC

BioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies.

Learn more at www.bioatla.com.


Contact:
Richard Waldron
Chief Financial Officer
BioAtla, LLC
rwaldron@bioatla.com
858.356.8945

BIOATLA ANNOUNCES FIRST PATIENT TREATED IN PHASE1/2 BA3021-001 CLINICAL TRIAL FOR CAB-ROR2-ADC THERAPEUTIC

CAB-ROR2-ADC in clinical testing for treatment of several solid tumor types

SAN DIEGO, CA - June 28, 2018 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today the treatment of the first patient in its clinical trial BA3021-001 for BioAtla's BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of BA3021 in patients with advanced solid tumors including non-small cell lung cancer (NSCLC), triple negative breast cancer and soft tissue sarcoma. CAB-ROR2-ADC is BioAtla's second CAB investigational product to enter clinical trials following BA3011, CAB-AXL-ADC in February of this year.

 

The first patient in the BA3021 clinical study was enrolled and dosed at Sarah Cannon Research Institute at Tennessee Oncology in Nashville, TN under the direction of the principal investigator, Howard A. "Skip" Burris III, MD. Dr. Burris, a recognized leader in clinical oncology, serves as chief medical officer and president of clinical operations at Sarah Cannon. "Innovative advancements in the treatment of cancer include tumor specific activation of therapy and promoting appropriate immune response. Providing access to cutting-edge therapies in clinical trials, such as the BA3021 clinical study, further supports our mission to advance care for cancer patients," said Dr. Burris.

 

The ROR2 transmembrane protein tyrosine kinase is an onco-fetal protein that acts as a non-canonical Wnt 5A receptor.  ROR2 is found to be highly expressed during embryonic development and in several important cancer types, and the level of expression in tumors is tightly correlated with patient prognosis.  Recently, ROR2 and its ligand Wnt 5A have been shown to be induced in cancers that are resistant to treatment with immune checkpoint inhibitors such as anti-PD-1 antibody immune therapy suggesting a mechanistic role of this receptor-ligand axis in resistance to standard cancer treatments resulting in relapsing, minimal residual disease.  However, low to moderate levels of expression of ROR2 in multiple normal adult tissues are predicted based on RNA expression, histological analysis and functional studies. To minimize the risk of potential disruption of normal function of ROR2 receptors on normal cells, BioAtla applies its proprietary CAB technology to develop its CAB antibody-drug conjugate (ADC) targeting ROR2 with the intent to activate binding to the ROR2 receptor only in the tumor microenvironment and deliver the toxic payload to the cancerous cells.  The CAB-ROR2-ADC BA3021 is designed to maximize efficacy on ROR2 expressing tumors while minimizing toxicity, leading to better clinical outcomes.  

 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

 

About BioAtla, LLC

BioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies.

 

 

Contact:


Richard Waldron

Chief Financial Officer

BioAtla, LLC

rwaldron@bioatla.com

858.356.8945

BioAtla Announces FDA Clearance of Investigational New Drug Application For CAB-ROR2-ADC Therapeutic

CAB-ROR2-ADC to be clinically tested for treatment of several solid tumor cancers

 SAN DIEGO, CA - April 16, 2018 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has cleared BioAtla's Investigational New Drug application (IND) for BA3021, a first-in-class conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC), in patients with solid tumors. Under this IND, the company intends to initiate a first-in-human, open label, multicenter, dose escalation and dose expansion study of CAB-ROR2-ADC in patients with locally advanced or metastatic solid tumors. CAB-ROR2-ADC will be BioAtla's second CAB investigational product to enter clinical trials in the United States with BioAtla initiating patient dosing in February of this year with CAB-AXL-ADC for treatment of solid tumors.

 

ROR2 is a developmentally restricted receptor tyrosine kinase (RTK) that interacts with Wnt ligands.  Although essential for embryonic development, ROR2 expression is rare in normal adult tissues. Many of the activities associated with ROR2 in development have been implicated also in cancer including cell migration and invasiveness. ROR2 has been found to be overexpressed in multiple types of cancer including breast, renal, colorectal, melanoma, pancreatic, non-small cell lung cancer (NSCLC), and gastrointestinal stromal tumor (GIST). In general, ROR2 expression is associated with more aggressive disease states and poorer patient prognosis.  Furthermore, recent studies by others indicate that overexpression of either ROR2 or AXL receptor is associated with resistance to anti-PD-1 therapy thereby suggesting immuno-oncology roles for BioAtla's first two clinical stage CAB candidates that target these receptors.

 

ROR2 is a cell surface Wnt5a receptor that is overexpressed in cancer cells making it an attractive target for therapy. BioAtla applies its proprietary CAB technology to develop its CAB antibody-drug conjugate (ADC) targeting ROR2 with the intent to activate binding to the ROR2 receptor in the tumor microenvironment and deliver the toxic payload only to the cancerous cells.

 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

BioAtla Announces First Patient Treated in CAB-AXL-ADC Phase 1/2 Clinical Trial BA3011-001

CAB-AXL-ADC in clinical testing for treatment of several solid tumor cancers

SAN DIEGO, CA - February 28, 2018 - BioAtla© LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today the treatment of the first patient in its clinical trial BA3011-001 for BioAtla's BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC). This is a multi-center, open-label, Phase 1/2 study (NCT03425279) designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of BA3011 in patients with advanced solid tumors including non-small cell lung cancer (NSCLC), castration resistant prostate cancer and pancreatic cancer. CAB-AXL-ADC is BioAtla's first CAB investigational product to enter clinical trials.

The first patient in the BA3011 clinical study was enrolled and dosed at Sarah Cannon Research Institute at Tennessee Oncology in Nashville, TN under the direction of the trial's principal investigator, Howard A. "Skip" Burris III, MD. Dr. Burris, a recognized leader in clinical oncology, serves as chief medical officer and president of clinical operations at Sarah Cannon. "Innovative advancements in the treatment of cancer include tumor specific activation of therapy and promoting appropriate immune response. Providing access to cutting-edge therapies in clinical trials, such as the BA3011 clinical study, further supports our mission to advance care for people facing cancer in communities across the U.S. and UK," said Dr. Burris.

The AXL receptor tyrosine kinase is often highly expressed in several cancer types that can lead to poor prognosis. A principal role of AXL appears to be in sustaining a major mechanism of resistance to diverse anticancer therapies. In addition, AXL is a factor in the repression of the innate immune response which may also limit response to treatment including immuno-oncology (IO) therapy.  While this makes the AXL receptor an attractive target for tumor therapy, the AXL receptor is also prevalent in normal tissue of several organs in the body.  To minimize on-target off-tumor toxicity of binding to AXL receptors on normal cells, BioAtla applies its proprietary CAB technology to develop its CAB antibody-drug conjugate (ADC) targeting AXL with the intent to activate binding to the AXL receptor only in the tumor microenvironment and deliver the toxic payload to the cancerous cells.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

BioAtla Announces FDA Clearance of IND Application for CAB-AXL-ADC Therapeutic

CAB-AXL-ADC to be clinically tested for treatment of several solid tumor cancers

SAN DIEGO, CA - January 24, 2018 - BioAtla© LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has cleared BioAtla's Investigational New Drug application (IND) for BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), in patients with solid tumors. Under this IND, the company intends to initiate a first-in-human, open label, multicenter, dose escalation and dose expansion study of CAB-AXL-ADC in patients with locally advanced or metastatic solid tumors. CAB-AXL-ADC will be BioAtla's first CAB investigational product to enter clinical trials in the United States.

The AXL receptor tyrosine kinase is often highly expressed in several cancer types that can lead to poor prognosis. A principal role of AXL appears to be in sustaining a major mechanism of resistance to diverse anticancer therapies. In addition, AXL is a factor in the repression of the innate immune response which may also limit response to treatment including immuno-oncology (IO) therapy.  While this makes the AXL receptor an attractive target for tumor therapy, the AXL receptor is also prevalent in normal tissue of several organs in the body.  To minimize on-target-off-tumor toxicity of binding to AXL receptors on normal cells, BioAtla applies its proprietary CAB technology to develop its CAB antibody-drug conjugate (ADC) targeting AXL with the intent to activate binding to the AXL receptor only in the tumor microenvironment and deliver the toxic payload to the cancerous cells.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

Clinical Trial Utilizing BioAtla’s Conditionally Active Biologics in CAR-T Candidates for Solid Tumors to be Initiated in China

Axl and Ror2 targeted CAB-CAR-T cellular products to be tested in patients with refractory, metastatic kidney cancer

SAN DIEGO, CA - January 8, 2018 - BioAtla© LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today that Shanghai Sinobioway Sunterra Biotechnology, a partner of F1 Oncology, Inc., has received ethics committee approval of a clinical trial for two novel, conditionally active chimeric antigen receptor T cell (CAB-CAR-T) product candidates targeting Axl and Ror2 for the treatment of metastatic renal cell carcinoma. The precision medicine-driven clinical trial will enroll patients in China with multi-organ, recurrent/refractory metastatic renal cell carcinoma based on expression of the Axl or Ror2 targets in tumor biopsy. F1 Oncology, BioAtla's partner in CAB technology applications for adoptive cellular therapies (ACTs), combines BioAtla's CAB technology with F1 Oncology's proprietary technologies with the goal of developing and commercializing CAB-CAR-T therapies for the treatment of solid tumor malignancies. CAB-CAR-T cell therapies are designed to be conditionally active only in the tumor microenvironment and may therefore help reduce potential adverse events associated with on-target, off-tumor effects of CAR-T therapies.

In 2016 BioAtla granted F1 Oncology an exclusive worldwide license under patents and know-how controlled by BioAtla to discover, develop, manufacture and commercialize ACT preparations and treatments for cancer. The amended financial terms of this license to F1 Oncology include a mid-single digit royalty outside of China, Hong Kong, Macau and Taiwan (the Territory) and a low single-digit royalty within the Territory. BioAtla has a majority, non-controlling interest in the outstanding capital stock of F1 Oncology and has no funding or financial obligation.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

BioAtla® Appoints James Allison PhD and Padmanee Sharma MD PhD as Scientific Advisors

Leading researchers in immuno-oncology will advise BioAtla on company's proprietary CAB programs and design of combination therapies

SAN DIEGO, CA - November 16, 2017 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced the appointments of James Allison, Ph.D. and Padmanee Sharma, M.D., Ph.D. as scientific advisors.  Drs. Allison and Sharma are leading researchers in the field of immuno-oncology.  Dr. Allison's pioneering research in the regulation of T cell responses and strategies for cancer immunotherapy led to the development of the ipilimumab antibody to CTLA-4, the first immune checkpoint blockade therapy approved by the U.S. Food and Drug Administration.  Dr. Sharma has participated in numerous impactful research studies since 1996, focusing primarily on immunotherapy in collaboration with Dr. Allison.  In their collaborative work, Dr. Sharma is exploring combinations of immunological therapies and targeted drugs in preclinical studies to more effectively treat a variety of cancers.

"The knowledge, experience and insights of Drs. Allison and Sharma will provide valuable contributions to the direction and prioritization of our CAB development programs.  In particular, their advice will enhance our decisions and design of combination CAB immunotherapies and CAB bispecifics," said Jay M. Short, Ph.D., chairman, president and chief financial officer of BioAtla.

About Dr. Allison

James Allison, Ph.D., is Chair of the Department of Immunology, the Vivian L. Smith Distinguished Chair in Immunology, Director of the Parker Institute for Cancer Research, and the Executive Director of the Immunotherapy Platform at The University of Texas MD Anderson Cancer Center (MD Anderson).

Among Dr. Allison's most notable discoveries in his distinguished career studying the regulation of T cell responses, are the determination of the T cell receptor structure and that CD28 is the costimulatory molecule that allows full activation of naïve T cells and prevents anergy in T cell clones.  His lab resolved a major controversy by demonstrating that CTLA-4 inhibits T cell activation by opposing CD28-mediated costimulation and that blockade of CTLA-4 could enhance T cell responses, leading to tumor rejection in animal models, and launched the emerging field of immune checkpoint blockade therapy for cancer. Dr. Allison is a member of the National Academies of Science and Medicine and received the Lasker-Debakey Clinical Medical Research Award in 2015.

About Dr. Sharma

Padmanee Sharma, M.D., Ph.D., is Professor of Genitourinary Medical Oncology and Immunology in the Division of Cancer Medicine at MD Anderson. Dr. Sharma is also Scientific Director, Immunotherapy Platform, and Co-Director, Parker Institute for Cancer Immunotherapy at M. D. Anderson Cancer Center.  She has tested novel cancer immunotherapy strategies in clinical trials that permitted access to surgical samples or longitudinal biopsy samples, which allowed her to identify mechanisms of response and resistance to therapy. She has won numerous awards during her career including the Doris Duke Clinical Scientist Development Award, the Prostate Cancer Foundation Challenge Award, the MD Anderson Cancer Center Faculty Scholar Award and the Emil Frei Award for Translational Research. 

BioAtla® and Sinobioway Expand Collaboration Agreement and Enter Into Services Agreement

Five new CAB antibody candidates to be selected

New services agreement provides for discounted development and manufacturing costs

SAN DIEGO, CA - May 16, 2017 - BioAtla© LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that BioAtla and Beijing Sinobioway Group Company, Limited (Sinobioway) expanded their CAB development and commercialization collaboration agreement with the addition of five new CAB antibody targets, and entered into a new services agreement for Sinobioway to provide specified development and manufacturing services to BioAtla.

In March 2015, BioAtla and Sinobioway entered into a strategic collaboration for the development and commercialization of select CAB antibodies for specific indications in China, Hong Kong, Macau and Taiwan (the Territory). As a result of the selection of the initial four CAB candidates and the specific indications for development under this agreement for 2016, BioAtla received collaboration funding payments from Sinobioway in 2015 and 2016 totaling $40 million. Under the expanded agreement, Sinobioway is obligated to select five additional new CAB antibody indications and to pay BioAtla a total of $50 million, comprised of $30 million in cash and $20 million in the form of credits for future manufacturing and development services to be performed at discounted rates by Sinobioway pursuant to the services agreement.

Of the $30 million cash payment, BioAtla is entitled to receive $5 million in May 2017 and $25 million following the first approval of an Investigational New Drug application (IND) filed by BioAtla with the U.S. Food and Drug Administration (FDA) to commence a Phase 1 clinical trial of a CAB antibody candidate. In addition, pursuant to the expanded agreement, upon the later of BioAtla's first IND approval and March 31, 2018, Sinobioway will be obligated to pay BioAtla upfront payments totaling $40 million in cash for four more antibody candidate indications. BioAtla is currently completing pre-IND development of its CAB Axl-ADC and CAB Ror2-ADC antibody product candidates. CAB Axl-ADC for the treatment of pancreatic cancer and CAB Ror2-ADC for the treatment of triple negative breast cancer are two of the four initial CAB antibody indications previously selected by Sinobioway for the Territory. Under the collaboration agreement, Sinobioway or certain affiliated entities are obligated to fund the development, manufacturing, clinical trials and commercialization costs in the Territory for each of the Sinobioway selected CAB antibody candidate indications.

The new master services agreement allows for BioAtla to have Sinobioway perform development and manufacturing services pursuant to mutually-agreed upon work plans. These services are available for development and manufacturing of BioAtla's own CAB product candidates as well as for CAB product candidates BioAtla may license to partners other than Sinobioway for development and commercialization primarily in the rest of the world outside of Sinobioway's Territory. Such services may include manufacturing product for clinical trials and for commercialization. Because BioAtla expects that most of the CAB candidates it would seek to develop or manufacture through Sinobioway's services would also be licensed to Sinobioway under the collaboration agreement, Sinobioway would also benefit from performing the services for such CAB products.

Pursuant to the services agreement, Sinobioway is obligated to provide BioAtla pricing at a discount of at least 85% to prevailing market prices for services relating to CAB product candidates through Phase 2 development until BioAtla has received an aggregate of $20 million worth of services at the discounted rate. Thereafter, BioAtla is entitled to a discount of 75% to prevailing market prices for services relating to CAB product candidates through Phase 2 development. In addition, BioAtla is entitled to pricing at Sinobioway's "most preferred rate" for services relating to CAB product candidates in Phase 3 development and for commercial supplies of any approved CAB product. Sinobioway is also required to prioritize work under the work plans for each CAB program over all other projects, including use of equipment for manufacturing projects and animals in animal testing.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be mAbs, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g. pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch 'on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

About Beijing Sinobioway Group Company, Limited

Sinobioway was founded in 1992 and is one of the three main industrial groups affiliated with Peking University. Sinobioway is mainly engaged in bioeconomy system establishment and bio-industry development. It primarily invests in biomedicine, bioagriculture, bioenergy, bioenvironment, bioservices, biomanufacturing and biointelligence. Biologic therapeutics is a particular focus of Sinobioway in its plans to develop and commercialize new medicines. Sinobioway is constructing a large biologics production facility, with a long-term capability goal of 100 production lines, in the planned Bio-Economic zone under construction in Hefei.

BioAtla® and F1 Oncology Announce Collaboration to Develop CAB-CAR-T’s for Solid Tumors

Sinobioway affiliates and US entities invest $37M in F1 Oncology, Inc. First clinical trial with CAB CAR-T in solid tumors planned for China in 2017

SAN DIEGO, CA and WEST PALM BEACH, FL - January 6, 2017 - BioAtla© LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, and F1 Oncology, Inc., a biotechnology company discovering and developing a new class of adoptive cellular therapies (ACTs), today announced a global license agreement to combine BioAtla's CAB technology with F1 Oncology's proprietary technologies to develop and commercialize chimeric antigen receptor T-cell (CAR-T) therapies and other ACTs for the treatment of cancer.

F1 Oncology recently completed a $37M Series A financing led by F1 BioVentures LLC, Sinobioway Group, and SunTerra Capital. Through its international affiliates, F1 Oncology also entered into a development and commercialization agreement with Shanghai SunTerra Biotechnology Ltd. and its network of academic investigators to enable clinical investigation of CAB CAR-T candidates in China. F1 Oncology's partners intend to begin clinical trials in China in 2017 targeting a solid tumor indication using F1's first CAB CAR-T therapy candidate. The financial terms of this agreement include technical and regulatory milestone-based equity investments of up to $50 million through 2018, as well as supply-related payments by target and indication. F1 Oncology retains rights to all products outside China, Hong Kong, Macau and Taiwan.

BioAtla has granted F1 Oncology an exclusive worldwide license under patents and know-how controlled by BioAtla to discover, develop, manufacture and commercialize ACT preparations and treatments for cancer. The financial terms of this license to F1 Oncology include a mid-single digit royalty outside of China, Hong Kong, Macau and Taiwan (the Territory). Within the Territory, the license is royalty-free and fully paid, and BioAtla shares in the product revenue. In exchange for the license rights, as well as BioAtla's agreement not to compete in ACTs, BioAtla received a majority, non-controlling interest of the outstanding capital stock of F1 Oncology and has no funding or financial obligation. BioAtla also has a conditional and time-limited option to acquire at a fixed valuation all of the outstanding equity securities of F1 Oncology held by all other investors.

BioAtla and F1 Oncology have identified CAR-T and other ACT therapies as potential opportunities for the application of CAB technology. BioAtla has demonstrated in preclinical studies that CAB antibodies can be constructed in the same single chain format used by CAR-Ts and can retain their selectivity for binding under conditions representative of the tumor microenvironment (TME) and with minimal to no detectable binding in normal cell conditions. CARs are constructs that contain an antigen-binding domain of an antibody fused to a strong T-cell activator domain. T-cells modified with the CAR construct can bind to the antigen and be stimulated to attack the bound cells. On-target, off-tumor toxicity has largely limited current CAR-T therapies to target blood cancers such as leukemia and some lymphomas. While CAR-T related toxicities are multifactorial and complex, CAR-T cells containing CAB CAR domains targeting solid tumor antigens would be intended to reduce on-target, off-tumor toxicity and potentially increase patient safety.

"We are pleased and excited to collaborate with Dr. Frost and his experienced team at F1 Oncology to combine our CAB technology with F1 Oncology's proprietary technology and manufacturing expertise to develop new CAR-T therapies. Through our combined efforts, F1 Oncology will focus on developing effective and safer therapy to patients and especially to those afflicted with solid tumor cancers representing the great majority of cancer cases," stated Jay M. Short, Ph.D., Chairman, President and Chief Executive Officer of BioAtla. "The structure of our agreements provides for the advancement of CAB opportunities in the important field of ACTs while allowing BioAtla to focus its research, development and management capabilities and financial resources on its primary objectives of creating and commercializing CAB antibodies for cancer therapy and for treatment of other diseases."

"Dr. Short and I have a successful history of early research collaborations in protein evolution that we look forward to applying to this key challenge of adoptive cellular therapy for solid tumors" noted Gregory I. Frost, Ph.D., Chairman and CEO of F1 Oncology, Inc. "While patient safety, CAR-T cell engraftment, and definitive radiologic response are the key milestones from which these first programs must be judged, we are encouraged by the successful generation and pre-clinical testing by F1 Oncology of conditionally active CAR-T cells in primary human lymphocytes with a number of BioAtla's CAB domains in F1 Oncology's CAR-T platform."

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be mAbs, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB-designed mAbs can be programmed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body. CABs have the potential to increase safety because they are designed to be active only in the presence of a particular cellular microenvironment thereby preferentially binding to their intended target protein in the area of disease. In addition, the activation is reversible and can repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa, thereby further reducing chances the CAB would bind to the same protein located in healthy tissue or in other parts of the body and cause undesirable toxicity.

About F1 Oncology, Inc.

F1 Oncology, Inc. is a private Delaware C corporation formed in November 2015 with operations in West Palm Beach, Florida, San Diego, California and international affiliates in George Town, Cayman Islands, Hong Kong, and Shanghai, China. F1 Oncology was founded by Gregory Frost, Ph.D., co-founder and former CEO of Halozyme Therapeutics Inc., Health Sector Chief at Intrexon Corporation, and current managing director of F1 BioVentures, LLC, a biotechnology-focused investment vehicle. F1 Oncology leverages its globally integrated science, development and informatics teams located across multiple time zones to accelerate the design, high-throughput screening, discovery and development of adoptive cellular therapy candidates. The company is developing two CAB-based ACT platforms to develop TME restricted CAR-T therapies for solid tumors, as well as developing highly scalable systems for global deployment, beginning in Asia. Learn more at www.f1oncology.com.

About BioAtla, LLC

BioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. By utilizing its proprietary technologies in product design and development, from target discovery to manufacturing and preclinical studies, BioAtla seeks to develop differentiated, patentable therapeutic proteins for its partners, including Pfizer, Inc., Sinobioway and F1 Oncology, and for its internal programs. BioAtla has over 170 patents issued and pending that cover its platform technologies representing a full complement of therapeutic protein development capabilities.

About Beijing Sinobioway Group Company, Limited 

Sinobioway was founded in 1992 and is one of the three main industrial groups affiliated with Peking University. Sinobioway is mainly engaged in bioeconomy system establishment and bio-industry development. It primarily invests in biomedicine, bioagriculture, bioenergy, bioenvironment, bioservices, biomanufacturing and biointelligence. Biologic therapeutics is a particular focus of Sinobioway in its plans to develop and commercialize new medicines. Sinobioway is constructing a large biologics production facility, with a long-term capability goal of 100 production lines, in the planned 20 billion RMB bio-economic zone under construction in Hefei.

BioAtla® and Sinobioway Complete Selection of First Four Programs for Strategic Collaboration in China Market

BioAtla© receives $36 million as balance of 2016 CAB program selection payments

SAN DIEGO, CA - December 6, 2016 - BioAtla© LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that BioAtla© and Beijing Sinobioway Group Company, Limited (Sinobioway) selected their first four CAB product programs for development. The specific program candidates and the targeted indications are not disclosed. In March 2015, BioAtla and Sinobioway entered into a strategic collaboration for the development and commercialization of select CAB antibodies for specific indications in China, Hong Kong, Macau and Taiwan (the Territory). Related to this agreement and as a result of the selection of all four of the 2016 CAB candidates for development, BioAtla received on November 1, 2016 a $36 million payment from Sinobioway representing the balance of the collaboration funding for the selection of the four 2016 CAB candidates and the specific indications. Including these funds, BioAtla has received more than $100 million in program payments and equity investments relating to its strategic collaboration agreement with Sinobioway.

BioAtla and Sinobioway are working collaboratively to develop several CAB candidates for specific indications for the Territory. Sinobioway pays BioAtla pre-determined collaboration fees for each indication it chooses to license and develop. As part of the agreement, Sinobioway has exclusive rights to develop and commercialize selected CAB antibodies for selected indications in the Territory and BioAtla retains the rest of world rights to these products candidates and indications. Sinobioway is obligated to fund the development, manufacturing, clinical trials and commercialization costs in the Territory. BioAtla is further eligible to receive certain milestone payments and double-digit royalties on sales. BioAtla's agreement with Sinobioway is open-ended as there is no annual minimum number of CAB antibody indications that Sinobioway is obligated to select after the initial four and no maximum that BioAtla may nominate and that Sinobioway may select, and the indication nomination and selection process remains active through the term of the agreement. However, in order to maintain exclusivity in the Territory for the CAB antibodies in indications it has licensed, Sinobioway is obligated to select a minimum number of CAB antibodies for certain indications BioAtla nominates each year, which would result in BioAtla's receipt of at least $40 million per year from collaboration fees on an ongoing basis.

This strategic collaboration is the keystone of BioAtla's long-term plans to address the growing demand for innovative therapeutic products in the China pharmaceutical market. BioAtla's patent protected Conditionally Active Biologics platform represents a potentially disruptive technology for the development of a new class of immunotherapeutics that are activated in selected microenvironments within the body, such as those indicative of cancerous tumors. CABs can be generated in several different formats including naked monoclonal antibodies (mAbs), antibody drug conjugates, immune checkpoint inhibitors, bispecific antibodies, and chimeric antigen receptor (CAR) T cells.

"BioAtla's strategy is to broadly pursue novel therapeutic products based on our patented CAB and other proprietary technologies," said Jay M. Short, Ph.D., president, chief executive officer and chairman of the board of BioAtla. "China is an immensely important opportunity for CABs and we are excited to be working with Sinobioway with its demonstrated commitment and strong capabilities to execute and to fulfill our mutual goals. We will continue to build upon our drug development experience to pursue the potential of the CAB platform for our collaboration with Sinobioway, as well as for our collaboration with Pfizer and for our portfolio of proprietary CAB product candidates."

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be mAbs, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB-designed mAbs can be programmed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body. CABs have the potential to increase safety because they are designed to be active only in the presence of a particular cellular microenvironment thereby preferentially binding to their intended target protein in the area of disease. In addition, the activation is reversible and can repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa, thereby further reducing chances the CAB would bind to the same protein located in healthy tissue or in other parts of the body and cause undesirable toxicity.

BioAtla believes CABs can facilitate higher dosing, the development of effective, non-immunogenic drugs, and the use of targets that are validated for cancer cells but traditionally considered too prevalent among normal cells to be used safely in current drug therapies. This could open a potentially rich range of targets for CABs that cannot be addressed using existing technologies.

About Beijing Sinobioway Group Company, Limited

Sinobioway was founded in 1992 and is one of the three main industrial groups affiliated with Peking University. Sinobioway is mainly engaged in bioeconomy system establishment and bio-industry development. It primarily invests in biomedicine, bioagriculture, bioenergy, bioenvironment, bioservices, biomanufacturing and biointelligence. Biologic therapeutics is a particular focus of Sinobioway in its plans to develop and commercialize new medicines. Sinobioway is constructing a large biologics production facility, with a long-term capability goal of 100 production lines, in the planned 20 billion RMB bio-economic zone under construction in Hefei.

BioAtla® and Sinobioway Select First Program for Strategic Collaboration in China Market

BioAtla© receives $19 million in first program payments plus equity

SAN DIEGO, CA - January 6, 2016 - BioAtla© LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that BioAtla© and Beijing Sinobioway Group Company, Limited (Sinobioway) selected their first product programs for development. In May 2015, BioAtla© and Sinobioway entered into a strategic collaboration for the development and commercialization of select CAB antibodies and other CAB-based therapeutics in China, Hong Kong, Macau and Taiwan (the Territory). Related to and as a result of this agreement, BioAtla© received a previously reported $30 million equity investment from a China-based investor group. BioAtla© now receives $19 million in program payments plus equity investment from Sinobioway as a result of the selection of the first CAB candidates and achievement of other corporate objectives. Including these funds, BioAtla© will receive a total of more than $70 million in program payments and equity investment from Sinobioway over the course of the next twelve months.

BioAtla© and Sinobioway are working collaboratively to develop several CAB candidates for the Territory. As part of the agreement, Sinobioway has exclusive rights to develop and commercialize selected CAB antibodies in the Territory and BioAtla© retains the rest of world (ROW) rights to these products. Sinobioway will fund the development, manufacturing, clinical trials and commercialization costs in the Territory and is committed to making recurring product development payments to BioAtla© for additional CAB candidates. BioAtla© is further eligible to receive certain milestone payments and double-digit royalties on sales.

This strategic collaboration is the keystone of BioAtla©'s long-term plans to address the growing high demand for innovative therapeutic products in the China pharmaceutical market. BioAtla©'s patent protected Conditionally Active Biologics platform represents a disruptive technology for the development of a powerful new class of immunotherapeutics that are activated in selected microenvironments within the body, such as those indicative of cancerous tumors. CABs can be generated in several different formats including naked monoclonal antibodies (mAbs), antibody drug conjugates, immune checkpoint inhibitors, bispecific antibodies, and chimeric antigen receptor (CAR) T cells.

"BioAtla©'s strategy is to broadly and rapidly pursue novel therapeutic products based on our patented CAB and other proprietary technologies," said Jay M. Short, Ph.D., president, chief executive officer and chairman of the board of BioAtla©. "China is an immensely important opportunity for CABs and we are excited to be working with Sinobioway with its demonstrated commitment and strong capabilities to execute and to fulfill our mutual goals. Since BioAtla©'s founding in 2007, we have utilized our San Diego and Beijing development and operations capabilities to successfully develop dozens of protein products under contract and shared development. We will continue to build upon our drug development experience to pursue the great prospects of the CAB platform for our collaboration with Sinobioway, as well as for our collaboration with Pfizer that we announced last month on December 8, and for our portfolio of proprietary CAB products."

"Conditionally Active Biologics is an innovative and breakthrough technology to develop the new class of immuno-oncology therapeutics," said Dr. Pan Aihua, chairman of Sinobioway. "The CAB technology and its prospects will be important elements in Sinobioway's mission to advance science and industrial development, and improve health in China through creating and delivering safer and more effective medicines to patients."

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla©'s proprietary protein evolution and expression technologies. These proteins can be mAbs, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof).

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect, which was first described in the early 1900's and is the basis of the widely-used PET scan cancer detection method today. CAB-designed mAbs can be programmed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body. CABs increase safety because the drug's activation depends on its presence in a particular cellular microenvironment thereby preferentially binding to its intended target protein in the area of disease. In addition, the activation is reversible and can repeatedly switch ‘on and off' should the CAB product move from a diseased to a normal cellular microenvironment and vice versa thereby further reducing chances the CAB would bind to the same protein located in healthy tissue or in other parts of the body and cause undesirable toxicity.

CABs allow for higher dosing, the development of effective, non-immunogenic drugs, and the use of targets that are validated for cancer cells but traditionally considered too prevalent among normal cells to be used safely in current drug therapies. This opens a potentially rich range of targets for CABs that cannot be addressed using existing technologies. CABs may also be employed as diagnostic tools to reveal and pinpoint conditions indicative of cancerous activity.

About Beijing Sinobioway Group Company, Limited

Sinobioway was founded in 1992 and is one of the three main industrial groups affiliated with Peking University. Sinobioway is a leader in establishing a bioeconomy system in China and developing that country's bio-industry. It invests in biomedicine, bioagriculture, bioenergy, bioenvironment, bioservices, biomanufacturing and biointelligence. Biologic therapeutics is a particular focus of Sinobioway in its plans to develop and commercialize new medicines. Sinobioway is constructing a large biologics production facility, with a long-term capability goal of 100 production lines, in the planned 20 billion RMB bio-economic zone under construction in Hefei.

BioAtla® Receives $30M Equity Investment from China-based Investor Group

Proceeds to accelerate proprietary product development and create opportunities in the Chinese pharmaceutical market

San Diego, Calif. - June 11, 2015 - BioAtla©LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that a China-based investor group has purchased $30 million in BioAtla©equity. The proceeds will be used to accelerate the development of the company's CAB antibody drug pipeline. This strategic investment will also advance BioAtla©'s plans to collaboratively develop biotherapeutics with biopharmaceutical companies in China to address the growing demand for innovative therapeutic products in the Chinese pharmaceutical market.

BioAtla©'s patent-protected Conditionally Active Biologics platform represents a disruptive technology for the development of a powerful new class of immunotherapeutics that are activated in selected microenvironments within the body, such as the tumor microenvironment. CABs can be generated in several different formats including naked monoclonal antibodies (mAbs), antibody drug conjugates, immune checkpoint inhibitors, bispecific antibodies, and chimeric antigen receptor (CAR) T cells.

"The $30 million equity investment is a transformative event for BioAtla© and our strategy to broadly and rapidly pursue novel therapeutic products based on our patented CAB and other proprietary technologies," said Jay M. Short, Ph.D., President, Chief Executive Officer, and Chairman of BioAtla©. "Since BioAtla©'s founding in 2007, we have utilized our Beijing development and operations capabilities to successfully develop dozens of protein products under contract and shared development. Our drug development experience and expertise in China, the great prospects of the CAB platform, and our strategy of developing proprietary drugs to defined value inflection points prior to partnering with pharmaceutical companies are attractive features for the investor group. The investor group's contacts and relationships in the China biopharmaceutical field are expected to lead to additional near-term, non-dilutive research and development investments in establishing integrated strategic partnering collaborations in China in the areas of CAB-enhanced antibody therapeutics, including in immuno-oncology and CAR-T therapeutics."

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins (CABs) are generated using BioAtla©'s proprietary protein evolution and expression technologies. These proteins can be monoclonal antibodies (mAbs), enzymes or other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof).

Studies have shown that tumors create highly specific conditions locally that are not found in normal tissue. These cancerous microenvironments are a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect, which was first described in the early 1900's and is the basis of the widely-used PET scan cancer detection method today. CAB-designed mAbs can be programmed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body. CABs increase safety because the drug is reversibly activated when it preferentially binds directly to its intended target protein in the area of disease. In this example, the CAB does not effectively bind to the same protein located in healthy tissue or other parts of the body that can otherwise result in undesirable toxicity.

The CAB antibody's selective activation results from amino acid substitutions of human-like sequences made to ensure compatibility. In addition to reducing risk of immunogenicity, this approach also improves the manufacturing yield of the drug. Reliably good expression and high manufacturing yields are also derived from BioAtla©'s patented Comprehensive Integrated Antibody OptimizationTM (CIAO) technology that allows every step of development and screening of antibody variants until final CAB lead selection to be conducted in the mammalian cell type to be used in manufacturing.

CABs allow for higher dosing, the development of effective, non-immunogenic drugs, and the use of targets that are validated for cancer cells but traditionally considered too prevalent among normal cells to be used safely in current drug therapies. This opens a potentially rich range of targets for CABs that cannot be addressed using existing technologies. CABs may also be employed as diagnostic tools to reveal and pinpoint conditions indicative of cancerous activity.

Bioatla® Receives Broad Patent for Antibody Development

CIAO!™ Technology Maximizes Selectivity of Conditionally Active Antibodies

San Diego, Calif. - October 14, 2014 - BioAtla©, a global biotechnology company focused on the development of Conditionally Active Biologics (CABs), today announced that the United States Patent and Trademark Office (USPTO) has issued to BioAtla U.S. Patent No. 8,859,467, for its proprietary Comprehensive Integrated Antibody Optimization (CIAO!™) technology platform. The BioAtla CIAO! patent broadly covers methods of evolving and screening for antibodies in manufacturing host cells during the discovery stages of drug development. The CIAO! technology platform allows for antibody candidate development in a native cellular environment that generates the best collection of lead candidates that optimize downstream expression yields and in vivo translation of function, thereby increasing the likelihood of preserving selected therapeutic activities in the final drug.

"CIAO!™ and our related proprietary evolution and selection technologies are beneficial, and often critical, in the development of antibodies and other proteins that maximize selectivity, such as those developed from our patented CAB technology," said Jay M. Short, Ph.D., president, chief executive officer and chairman of the board of BioAtla. "CABs can be designed as monoclonal antibodies, antibody drug conjugates (ADCs), CAR-T cells or other therapeutics to target specific tissues in cancerous or distressed conditions associated with unique microenvironments in the body. CAB antibodies are a disruptive technology for the development of a powerful new class of immunotherapeutics and are prime examples of novel potential product opportunities that benefit from the use of CIAO!-based processes."

BioAtla employs CIAO!™ technology in all of its internal development programs for its growing list of pipeline antibody candidates. The high fidelity of the CIAO! platform when combined with BioAtla's evolution technologies allows selection of therapeutic candidates with unique functional characteristics, natural protein folding and glycosylation, high protein expression and faster downstream process development characteristics, all of which enable cost and time efficiencies, as well as maximizing and preserving functionality. This homogenous process of evolution through manufacturing leads to greater predictability and likelihood of therapeutic success. BioAtla has successfully utilized CIAO! in dozens of antibody programs over the past several years including the licensing in early 2014 of an antibody directed at a novel validated target for the treatment of inflammatory bowel diseases (IBD) and colorectal cancer.

About the CIAO!™ Technology Platform

The development of novel therapeutic antibodies is increasingly employing the power of evolution to discover molecules with selected characteristics. A molecule's characteristics reflect all inherent and environmental influences such as amino acid sequence, secondary modifications (e.g. glycosylation), and tertiary characteristics such as folding which is affected by environmental factors including pH, salt, temperature, hydrophobicity, support proteins (e.g. chaperonins), substrate pools; generically, the host environment. While the power of evolution is the ability to discover molecules with selected characteristics, the inherent challenge is that the selection process is dominated by the selection environment or assay. As an example, selecting a molecule in bacteria and subsequently expressing in mammalian cells risks generating molecules that require extra process development costs to adapt to the different host system and poor pK in vivo due to the potential of selecting unnatural secondary and tertiary structures. The power of BioAtla's CIAO! technology is that it selects molecules in a manner that mirrors both the body's environment and the host that will be used for final manufacturing of the drug.

About Conditionally Active Biologics™ (CABs)

Conditionally Active Biologic proteins (CABs) are generated using BioAtla's proprietary protein evolution technologies, including CIAO!, that typically employ selected amino acid substitutions in a protein that work together to confer selective conditional activation found in a range of microenvironments existing in the body. These proteins can be monoclonal antibodies (mAbs), antibody drug conjugates, CAR-T cells, or other therapeutic proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof).

CABs allow for higher dosing or the development of more potent, non-immunogenic drugs. CABs increase safety because the drug is activated and preferentially binds directly to its intended target protein in the microenvironment of the diseased cells and not in normal tissue. This advantage allows CABs to use targets that are present on cancer cells even though the targets may also be prevalent among normal cells. Such targets are considered unusable in current drug therapy approaches because their lack of selectivity risks unwanted on-target toxicity. The higher selectivity resulting from CAB antibody generation is expected to capitalize on the attractiveness of such previously unavailable targets and increase the effectiveness of most therapeutics relative to traditional antibody approaches.

Bioatla® Profiled in Nature Biopharma Dealmakers

The September 2014 issue of Nature Biopharma Dealmakers focused on innovative biotech companies in the field of cancer immunotherapy, and featured a profile of Bioatla© and their Conditionally Active Biologics (CAB) technology.

With this technology antibodies can be engineered for activity only in certain microenvironments (for example the acidic microenvironment of tumor cells), thereby enhancing safety and therapeutic index. The safety of existing antibody drug conjugates can be improved, and new antibodies made to targets that are not specific enough to cancer cells to be suitable drug targets currently.

BioAtla® Receives Broad Patent Covering Conditionally Active Biologics

Proprietary "Smart Antibodies" Allow for Selective Activation in Cancerous Tissues

San Diego, Calif. - April 30, 2014 - BioAtla©, a global biotechnology company focused on the development of differentiated biological therapeutics, today announced that the United States Patent and Trademark Office (USPTO) has issued to BioAtla©U.S. Patent No. 8,709,755, its first patent directed to methods of generating conditionally active antibodies.  Conditionally active antibodies are discovered using sophisticated protein evolution technologies for generating therapeutics that are activated in selected microenvironments within the body, such as those indicative of cancerous tumors.   BioAtla©'s patent covers method-independent approaches of evolving these conditionally active antibodies, thereby providing a novel mechanism for antibody selectivity.

"BioAtla©'s Conditionally Active Biologics (CABs) antibody platform represents a disruptive technology for the development of a powerful new class of immunotherapeutics," said Jay M. Short, Ph.D., president, chief executive officer and chairman of the board of BioAtla©. "CABs can be designed to target specific tissues in cancerous or distressed conditions associated with unique microenvironments in the body.  Most importantly, our technology increases the number of possible tumor targets, improves the selectivity of existing targets, enhances therapeutic safety and enables increased potency of antibody therapeutics by expanding the opportunity to use antibody drug conjugates."

"BioAtla©'s new platform is an important extension of its proprietary protein evolution capabilities that the company has been developing and applying to drug discovery and development for many years. Our first partnered proprietary CAB in development is an anti-tumor compound targeting the KRAS-positive cancers including colorectal, pancreatic and non-small cell lung cancers. The CAB discovery platform promises several novel product candidates and unprecedented "biobetter" antibodies as our strategic direction expands to include developing highly differentiated compounds for our internal pipeline, as well as for our partners. Advancing this class of smart therapeutics offers the hope of new cures for treating devastating, currently untreatable cancers." Dr. Short continued.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins (CABs) are generated using BioAtla©'s proprietary protein evolution technologies that typically employ uniquely selected amino acid substitutions in a protein that work together to confer selective conditional activation. These proteins can be monoclonal antibodies (mAbs) or enzymes designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof).

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect, which was first identified in the 1920's and is the basis of the widely-used PET scan cancer detection method today. CAB-designed mAbs can be programmed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body. CABs increase safety because the drug is activated when it preferentially binds directly to its intended target protein in the area of disease. In this example, the CAB does not effectively bind to the same protein located in healthy tissue or other part of the body that otherwise results in undesirable toxicity.

CABs allow for higher dosing, the development of effective, non-immunogenic drugs, and the use of targets that are validated for cancer cells but traditionally considered too prevalent among normal cells to be used safely in current drug therapies. This opens a potentially rich range of targets for CABs that cannot be addressed using existing technologies. CABs may also be employed as diagnostic tools to reveal and pinpoint conditions indicative of cancerous activity.