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

BIOATLA ANNOUNCES FIRST QUARTER 2021 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

May 12, 2021

  • 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

March 25, 2021
  • 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

February 22, 2021

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

January 8, 2021

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

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 AND BEIGENE REVISE GLOBAL DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

October 6, 2020

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

July 15, 2020

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

June 28, 2019

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