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

May 11, 2022
  • 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

May 4, 2022
  • 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

April 8, 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

March 1, 2022
  • 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

January 10, 2022

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

December 21, 2021


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

December 20, 2021

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

November 15, 2021

 

  • 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

September 29, 2021

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

August 13, 2021
  • $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