UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Information. |
As previously announced, BioAtla, Inc. (the “Company”) will host a virtual Key Opinion Leader Event (“KOL Event”) on Monday, December 4, 2023 at 11:00 a.m. Eastern Time. The KOL Event will feature Carl M. Gay, MD, PhD (MD Anderson Cancer Center), who will review the Phase 2 clinical trial data of mecbotamab vedotin (BA3011), a CAB-AXL-ADC, in refractory non-small cell lung cancer (NSCLC) and include a discussion of AXL as a contributor of therapeutic resistance and a marker of poor prognosis in NSCLC.
Select slides included in the presentation materials to be used at the KOL Event are filed as Exhibit 99.1 hereto and incorporated by reference herein.
Forward-looking statements
Statements in this Current Report on Form 8-K (this “Current Report”) contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this Current Report 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 the Company makes regarding its business plans and prospects and whether its clinical trials will support registration; achievement of milestones; results, conduct, progress and timing of its research and development programs and clinical trials; expectations with respect to enrollment and dosing in its clinical trials, plans and expectations regarding future data updates, clinical trials, regulatory meetings and regulatory submissions; plans to form collaborations or other strategic partnerships for selected assets; the potential regulatory approval path for its product candidates; expectations about the sufficiency of its cash and cash equivalents to fund planned operations, which includes plans to not explore additional dosing regimens, delaying certain pre-clinical development programs and to prioritize and focus development on selected assets and indications; and expected R&D and G&A expenses. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond the Company’s control, difficult to predict and could cause actual results to differ materially from what the Company expects. 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; 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 its CAB technology platform; the Company’s ability to enroll patients in its 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 its product candidates for clinical trials; the Company’s reliance on third parties to conduct its clinical trials and some aspects of its research and preclinical testing; potential adverse impacts due to any resurgence of COVID-19 and its variants and those other risks and uncertainties described in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 23, 2023, in its Quarterly Reports on Form 10-Q filed with the SEC on May 11, 2023, August 1, 2023 and November 7, 2023 and its other reports as filed with the SEC. Forward-looking statements contained in this Current Report are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit Number |
Description | |
| 99.1 | Slides from KOL Event, dated December 4, 2023. | |
| 104 | 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.
| BioAtla, Inc. | ||||||
| Date: December 4, 2023 | By: | /s/ Richard Waldron | ||||
| Richard Waldron Chief Financial Officer | ||||||
Exhibit 99.1 Phase 2 Trial of Mecbotamab Vedotin (BA3011), CAB-AXL-ADC, Alone or in Combination with Nivolumab in Patients with Non- Squamous NSCLC BA3011 AXL NSCLC December 4, 2023 BioAtla | Overview 1 confidential
Important Notices & Disclaimers This presentation (the “Presentation”) by BioAtla, Inc. (“we”, “us”, “our”, “BioAtla”, or the “Company”) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations and financial conditions, including but not limited to statements regarding business plans and prospects and whether our clinical trials will support registration; achievement of milestones; results, conduct, 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; plans to form 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 and plans to prioritize and focus development on selected assets and indications. Words such as, but not limited to, “anticipate”, “believe”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “potential”, “predict”, “project”, “should”, “will”, “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes, identify forward-looking statements. These forward-looking statements reflect management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Presentation and are subject to risks and uncertainties, including those described in the Company's filings with the SEC, including but not limited to the Company's latest Quarterly Report on Form 10-Q. Moreover, the Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for management to predict all risks, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The Company qualifies all the forward-looking statements in this Presentation by these cautionary statements. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Statements contained herein are made as of the date of this Presentation unless stated otherwise, and this Presentation shall not under any circumstances create an implication that the information contained herein is correct as of any time after such date or that the information will be updated or revisited to reflect information that subsequently becomes available or changes occurring after that date hereof. Certain information contained in this Presentation relates to or is based on statistical and other industry and market data obtained from independent industry publications and research, surveys and studies conducted by independent third parties as well as the Company’s own estimates of the prevalence of certain diseases and conditions. The market data used in this Presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. The Company’s estimates of the patient population with the potential to benefit from treatment with any product candidates the Company may develop include several key assumptions based on its industry knowledge, industry publications and third-party research, which may be based on a small sample size and may fail to accurately reflect the addressable patient population. While the Company believes that its internal assumptions are reasonable, no independent source has verified such assumptions. This Presentation may contain trademarks, trade names, or service marks belonging to other entities. The Company does not intend the use or display of other parties’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of, or by these other parties. None of the Company or any of its directors, officers, employees, contractors, agents, consultants, advisors or other representatives makes any representation or warranty, express or implied, as to the accuracy or completeness of the information contained in this Presentation.
Phase 2 BA3011 Non-Squamous NSCLC Monotherapy 1.8 mg/kg Q2W shows encouraging efficacy signals Data Cut Date: 30Jun23 Prior PD-1/L1 treatment EGFR wild-type (N=15) Prior PD-1/L1 treatment (N=18) Best Overall Response, n (%) Confirmed PR 3 (20.0) 3 (16.7) Unconfirmed PR 2 (13.3) 2 (11.1) SD 7 (46.7) 10 (55.6) PD 2 (13.3) 2 (11.1) NA (early discontinuation due to AE) 1 (6.7) 1 (5.6) Response Rate n (%) 5 (33.3) 5 (27.8) Exact 95% CI 11.8, 61.6 9.7, 53.5 Disease Control Rate n (%) 8 (53.3) 10 (55.6) Exact 95% CI 26.6, 78.7 30.8, 78.5 • Monotherapy median Duration of Response was estimated to be 4.8 months with a range of 2.3-12.1+ months* * • Combination therapy (n=17) : o Evaluable patients (majority with 4+ prior lines of therapy) received BA3011 + nivolumab o One patient experienced an ongoing complete response (CR), 2 patients experienced PR, and 8 patients experienced stable disease (SD) BioAtla | Overview 13 *As of November 20, 2023
BA3011-002 NSCLC interim analysis BA3011 Monotherapy 1.8 mg/kg Q2W confirmed BioAtla | Overview 14 Data Cut Date: 30Jun23
BA3011-002 NSCLC interim analysis BA3011 Monotherapy 1.8 mg/kg Q2W BioAtla | Overview 15 Data Cut Date: 30Jun23
Summary of Treatment Emergent Adverse Events (non-squamous NSCLC) BA3011 BA3011 + Total monotherapy nivolumab (N=40) (n=23) (n=17) TEAEs with CTCAE grade 3 or 4 15 (65.2) 8 (47.1) 23 (57.5) Related grade 3 or 4 AEs 8 (34.8) 3 (17.6) 11 (27.5) Any serious TEAEs 9 (39.1) 5 (29.4) 14 (35.0) Related SAEs 3 (13.0) 1 (5.9) 4 (10.0) TEAEs leading to treatment d/c 1 (4.3) 1 (5.9) 2 (5.0) Related AEs leading to treatment d/c 1 (4.3) 1 (5.9) 2 (5.0) TEAEs leading to death 0 1 (5.9) 1 (2.5) Related AEs leading to death 0 0 0 BioAtla | Overview 19 Data Cut Date: 30Jun23
Treatment Emergent Adverse Events (Non-Squamous NSCLC) * Any grade (≥15% of patients) OR grade ≥3 (≥3% of patients) in the study population Preferred term TEAEs of any grade, n (%) TEAEs of grade 3, n (%) Fatigue 14 (35.0) 1 (2.5) Diarrhea 10 (25.0) 1 (2.5) Constipation 9 (22.5) 0 Decreased appetite 9 (22.5) 1 (2.5) Anemia 8 (20.0) 2 (5.0) Nausea 8 (20.0) 0 Peripheral neuropathy 7 (17.5) 1 (2.5) Increased AST 7 (17.5) 3 (7.5) Dyspnea 6 (15.0) 2 (5.0) Neutropenia 6 (15.0) 2 (5.0) Increased ALT 5 (12.5) 3 (7.5) * No grade 4+ TEAEs among most frequent. BioAtla | Overview 20 Data Cut Date: 30Jun23
BA3011 NSCLC Randomized Registrational Study Design Two Potentially Registrational Paths Enabled via the FDA Type C Meeting nd 2 Line + • Open-label; control: docetaxel • Patients with NSCLC who have been previously treated with at least one prior line of therapy for metastatic disease • Dual primary endpoints: Progression Free Survival and Overall Survival rd 3 Line + • Blinded; control: chemo monotherapy • Patients with NSCLC who have been previously treated with at least two prior lines of therapy for metastatic disease • Primary endpoint: Overall Survival BioAtla | Overview 23