UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 27, 2025 |
BIOATLA, INC.
(Exact name of Registrant as Specified in Its Charter)
Delaware |
001-39787 |
85-1922320 |
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(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
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11085 Torreyana Road |
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San Diego, California |
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92121 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: 858 558-0708 |
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Common Stock, $0.0001 par value per share |
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BCAB |
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Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On March 27, 2025, BioAtla, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 31, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The information set forth in Item 2.02 of this Current Report on Form 8-K (“Current Report”), including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information set forth in Item 2.02 of this Current Report, including Exhibit 99.1 attached hereto, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing.
Item 2.05 Costs Associated with Exit or Disposal Activities.
On March 27, 2025, the Company announced a workforce reduction of approximately 30%. The foregoing actions were committed to on March 21, 2025 and are intended to streamline the Company’s operating cost structure to support development of its prioritized programs and set the Company up for long-term success.
The total cash payments related to this workforce reduction are estimated to be between $0.5 and $0.6 million related to employee severance and benefit costs. The Company expects to pay for the majority of these costs in the second quarter of 2025.
The estimates of the charges and expenditures that the Company expects to incur in connection with the above, and the timing thereof, are subject to a number of assumptions, and actual amounts may differ materially from estimates.
Forward-Looking Statements
Item 2.05 of this Current Report contains forward-looking statements. All statements other than statements of historical facts contained herein, including, but not limited to, statements regarding the percentage of workforce affected by, the estimated cash payment related to, and the timing of costs incurred from the reduction in force are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause the Company’s actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the ability to achieve the expected benefits or our workforce reduction, factors that raise substantial doubt about the Company’s ability to continue as a going concern and that we will need additional funding to continue development of the Company’s CAB technology platform and CAB product candidates; potential delays in clinical and preclinical trials; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, or regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether regulatory authorities will be satisfied with the design of and results from the clinical studies or take favorable regulatory actions based on results from the clinical studies; the Company’s dependence on the success of the Company’s CAB technology platform; the Company’s ability to enroll patients in the Company’s ongoing and future clinical trials; the successful selection and prioritization of assets to focus development on selected product candidates and indications; the Company’s ability to form collaborations and partnerships with third parties and the success of such collaborations and partnerships; the Company’s reliance on third parties for the manufacture and supply of the Company’s product candidates for clinical trials; the Company’s reliance on third parties to conduct clinical trials and some aspects of the Company’s research and preclinical testing; and potential adverse impacts due to geopolitical or macroeconomic events outside of the Company’s control, including health epidemics or pandemics. For a description of additional risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, see the risk factors set forth in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 27, 2025 and subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this Current Report speak only as of the date hereof, and the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File-the cover page XBRL tags are embedded within the Inline XBRL document. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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BioAtla, Inc. |
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Date: |
March 27, 2025 |
By: |
/s/ Richard A. Waldron |
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Richard A. Waldron |
BIOATLA REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS
AND HIGHLIGHTS RECENT PROGRESS
SAN DIEGO, March 27, 2025 – BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced its financial results for the fourth quarter and full year ended December 31, 2024, and provided highlights on its clinical programs.
“We are encouraged by the differentiated clinical outcomes observed in our evolving CAB platform program datasets,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc., “In our Phase 1 dose-escalation study evaluating dual conditionally-binding EpCAM and CD3 in the exciting T cell engager space, we continue to observe encouraging results, with multiple patients achieving tumor reduction and tolerating the therapy over many months without progression. Dose escalation continues and we remain on track for this clinical data readout in mid-2025. We are also observing meaningful improvement in our clinical datasets across our CAB platform programs in terms of tumor reduction and overall survival in key unmet need patient populations. As a result, we continue to advance multiple discussions with potential collaborators on our Phase 2 assets, as well as initiate new ones. Finally, we restructured the organization to further reduce costs, extend runway and prioritize new patient recruitment to programs that we believe can provide transformative results for our patients and shareholders alike.”
Key Developments, Operational Updates and Upcoming Milestones
Programs Advancing Internally
Phase 2 Programs Planned for Advancement Through Corporate Partnerships
Corporate Updates
Presentations
Fourth Quarter and Full Year 2024 Financial Results
Research and development (R&D) expenses were $11.6 million for the quarter ended December 31, 2024 compared to $22.7 million for the same quarter in 2023. The decrease of $11.1 million was due to lower clinical development expenses in 2024 due to lower overall enrollment across our clinical trials due to our program prioritization in 2023. We expect our R&D expenses to continue to decrease overall in the 1H of 2025 due to our recent restructuring and as we complete Phase 2 trials for several indications and focus our ongoing development on our prioritized programs.
General and administrative (G&A) expenses were $4.6 million for the quarter ended December 31, 2024 compared to $5.9 million for the same quarter in 2023. The $1.3 million decrease was primarily due to lower stock based compensation, personnel related costs and D&O insurance premiums.
Net loss for the quarter ended December 31, 2024 was $14.9 million compared to a net loss of $26.9 million for the same quarter in 2023.
Net cash used in operating activities for the full year ended December 31, 2024 was $72.0 million compared to net cash used in operating activities of $104.0 million for the same period in 2023. Cash used for the quarter ended December 31, 2024 was $7.5 million.
Cash and cash equivalents as of December 31, 2024 were $49.0 million, compared to $111.5 million as of December 31, 2023. We expect that cost reductions to be subsequently realized from our realignment of resources and focus on our two internal priority programs will provide the Company with sufficient runway to fund operations and achieve key clinical readouts in the first half of 2026.
Fourth Quarter and Full Year 2024 Conference Call and Webcast Details
The management of BioAtla, Inc. will host a conference call and webcast for the investment community today, March 27, 2025, at 4:30 pm Eastern Time. A live webcast may be accessed here:
https://viavid.webcasts.com/starthere.jsp?ei=1706186&tp_key=5cbe8a8a0e. The conference call can be accessed by dialing toll-free (800) 245-3047 or (203) 518-9765 (international). The passcode for the conference call is BIOATLA.
A replay of the webcast and slides with topline interim clinical data referenced on the call will be available through “Events & Presentations” in the Investors section of the company’s website after the conclusion of the presentation and will be archived on the BioAtla website for one year.
About CAB-EpCAM x CAB-CD3 Bispecific T-cell Engager Antibody
BioAtla is developing BA3182 as a potential anticancer therapy for patients with advanced adenocarcinoma. BA3182 is a (CAB) EpCAM x (CAB) CD3 bispecific T cell engager antibody that contains two binding sites for EpCAM and two binding sites for CD3ε. The binding sites for EpCAM and CD3ε have been designed to bind their respective targets specifically and reversibly under the conditions found in the TME and to have reduced binding outside of the TME. The CAB selective binding to both the CAB EpCAM and CAB CD3ε arms are required to activate the T cell engagement against the tumor, thus enabling the combined selectivity of each CAB binding arm in the bispecific antibody. BioAtla continues to advance the ongoing Phase 1 study to evaluate the safety, pharmacokinetics, and efficacy of BA3182 in advanced adenocarcinoma patients.
About Mecbotamab Vedotin
Mecbotamab vedotin (Mec-V), CAB-AXL-ADC, is a conditionally and reversibly active antibody drug conjugate targeting the receptor tyrosine kinase AXL. This Phase 2 stage clinical asset is targeting multiple solid tumor indications, including mKRAS NSCLC patients who have previously progressed on PD-1/L1, epidermal growth factor receptor or ALK inhibitor therapies.
About Ozuriftamab Vedotin
Ozuriftamab vedotin (Oz-V), CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a transmembrane receptor tyrosine kinase that is present across many different solid tumors including head and neck, lung, triple-negative breast cancer and melanoma.
Overexpression of ROR2, a noncanonical wnt5A signaling receptor, forms a cancer axis that is associated with poor prognosis and resistance to chemo- and immunotherapies. This Phase 2 stage clinical asset is targeting multiple solid tumor indications, including initially the treatment of SCCHN HPV+ and HPV- patients who have previously progressed on PD-1/L1 therapies with or without platinum chemotherapy. The FDA granted Fast Track Designation to ozuriftamab vedotin for the treatment of patients with recurrent or metastatic SCCHN.
About Evalstotug
Evalstotug, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy at least comparable to the approved anti-CTLA-4 antibodies, but with lower toxicities due to the CAB's tumor microenvironment (TME)-restricted activity. This is anticipated to enable safer anti-CTLA-4 antibody combination therapies, such as with anti-PD-1 antibody checkpoint inhibitors, and potentially broaden the patient population tolerant to combination therapy and deliver greater efficacy. Like our other CAB candidates, this Phase 2 clinical asset is designed to be conditionally and reversibly active in the TME. Evalstotug is being developed as a potential therapeutic for multiple solid tumor indications that are known to be responsive to CTLA-4 treatment in combination with a PD-1 blocking agent.
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-Sundia, a provider of preclinical development services. Utilizing its proprietary CAB platform technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies 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 platform technology and products with greater than 780 active patent matters, more than 500 of which are issued patents. 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’s first dual CAB bispecific T-cell engager antibody, BA3182, is currently in Phase 1 development. BA3182 targets EpCAM, which is highly and frequently expressed on many adenocarcinomas while engaging human CD3 expressing T cells. The Company also has two first-in-class CAB programs currently in Phase 2 clinical testing, mecbotamab vedotin, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The Phase 2 stage CAB-CTLA-4 antibody, evalstotug, 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 BioAtla’s business plans and prospects and whether our clinical trials will support registration; achievement of milestones; results, progress and timing of our research and development programs and clinical trials; expectations with respect to enrollment and dosing in our clinical trials, plans and expectations regarding future data updates, clinical trials, regulatory meetings and regulatory submissions; the timing of and the ability to establish collaborations or other strategic partnerships for selected assets; the potential regulatory approval path for our product candidates; expectations about the sufficiency of our cash and cash equivalents to fund operations and expectations regarding R&D expenses and cash burn, and expected cost reductions from our workforce reduction.
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: factors that raise substantial doubt about our ability to continue as a going concern and that we will need additional funding to continue development of our CAB technology platform and our CAB product candidates; potential delays in clinical and preclinical trials; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, or regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether regulatory authorities will be satisfied with the design of and results from the clinical studies or take favorable regulatory actions based on results from the clinical studies; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the successful selection and prioritization of assets to focus development on selected product candidates and indications; our ability to form collaborations and partnerships with third parties and the success of such collaborations and partnerships; our reliance on third parties for the manufacture and supply of our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; potential adverse impacts due to geopolitical or macroeconomic events outside of our control, including health epidemics or pandemics; 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 (the “SEC”) on March 27, 2025 and our other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable laws.
Internal Contact:
Richard Waldron
Chief Financial Officer
BioAtla, Inc.
rwaldron@bioatla.com
858.356.8945
External Contact:
Bruce Mackle
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
BioAtla, Inc.
Unaudited Statements of Operations and Comprehensive Loss
(in thousands)
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Three Months Ended December 31, |
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Twelve Months Ended December 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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Collaboration and other revenue |
$ — |
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$ — |
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$ 11,000 |
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$ — |
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Operating expenses: |
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Research and development expense |
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11,650 |
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22,674 |
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63,095 |
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103,731 |
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General and administrative expense |
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4,594 |
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5,862 |
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21,848 |
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25,956 |
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Total operating expenses |
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16,244 |
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28,536 |
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84,943 |
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129,687 |
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Loss from operations |
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(16,244) |
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(28,536) |
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(73,943) |
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(129,687) |
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Other income: |
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Interest income |
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554 |
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1,638 |
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3,369 |
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6,312 |
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Gain (loss) on warrant liability |
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807 |
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— |
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807 |
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— |
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Other expense |
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(1) |
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(27) |
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(9) |
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(87) |
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Total other income |
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1,360 |
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1,611 |
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4,167 |
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6,225 |
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Net loss and comprehensive loss |
$ |
(14,884) |
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$ |
(26,925) |
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$ |
(69,776) |
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$ |
(123,462) |
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BioAtla, Inc.
Balance Sheet Data
(in thousands)
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December 31, |
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December 31, |
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(unaudited) |
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Cash and cash equivalents |
$ |
49,046 |
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$ |
111,471 |
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Total assets |
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52,422 |
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119,658 |
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Total current liabilities |
14,540 |
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28,344 |
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Total liabilities |
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38,157 |
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48,986 |
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Total stockholders’ equity |
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14,265 |
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70,672 |
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Total liabilities and stockholders’ equity |
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52,422 |
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119,658 |
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