News

BIOATLA ANNOUNCES FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS

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

 

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

 

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

 

Mecbotamab Vedotin (BA3011)

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

 

Ozuriftamab Vedotin (BA3021)

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

 

BA3071

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

 

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

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

 

Fourth quarter and full year 2021 financial results

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

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

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

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

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

 

 

About BioAtla, Inc.

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

 

Forward-looking statements

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

 

Contact:
Richard Waldron

Chief Financial Officer

BioAtla, Inc.

rwaldron@bioatla.com

858.356.8945