Event Material 8-K Thursday (2023)

Figure 99.1



The dose-limiting toxicity (DLT) observation period was eliminated with a more frequent intensive dosing regimen of CAB-AXL BA3011; projected reading of the leiomyosarcoma (LMS) cohort in the second half of 2023

Initiate potential Phase 2 Part 2 registration study BA3011 Undifferentiated Pleomorphic Sarcoma (UPS) in 1H23, including more frequent dose intensive regimens

Towards filing a meeting request with the Food and Drug Administration (FDA) for Phase 2 Study BA3011, Part 2, of Study BA3011 in non-small cell lung cancer (NSCLC), potentially registrable in 1H23; await both FDA feedback and the start of Phase 2, Part 2 in 2H23

First Admitted Patient (FPI) for Squamous Cell Carcinoma of the Head and Neck Study (SCCHN) CAB-ROR2 BA3021 Phase 2

Initiation of Phase 2 NSCLC study BA3021, including more frequent intensive dosing regimens; expect preliminary reading in 2H23

DLT-free observation period for CAB-CTLA-4 (BA3071) 210 mg (3 mg/kg) Q3W in combination with nivolumab 3 mg/kg Q3W; Phase 1 dose escalation is ongoing, with data reading and the start of Phase 2 expected in the second half of 2023

Received FDA approval for an investigational new drug (IND) for the bispecific T-cell activator (TCE) CAB-EpCAMxCAB-CD3 (BA3182); expect FPI for Phase 1 study in 1H23

Cash balances at year-end 2022 of $215.5 million are expected to enable funding in 2025

Management will host a conference call and webcast at 4:30 p.m. today. m, eastern time

SAN DIEGO, March 23, 2022 – BioAtla, Inc. (Nasdaq: BCAB), a global, clinical-stage biotechnology company focused on developing conditionally active biological antibody (CAB) therapies for the treatment of solid tumors, today announced its financial results for the fourth quarter and full year ended December 31, 2022, providing highlights their clinical programs.

“In 2022, BioAtla has completed five ongoing Phase 2 studies targeting multiple tumor types for our two CAB-ADC product candidates, BA3011 and BA3021, and for our other promising CAB clinical compound, BA3071 (antibody CTLA- 4), excellent progress made. ), and we are excited to bring our potential first bispecific T-cell activating antibody CAB-EpCAMxCAB-CD3 (BA3182) to the clinic following its recent IND clearance,” said Jay M. Short, Ph.D. ., Chairman, CEO and Co-Founder of BioAtla, Inc. “Looking forward, there are several important milestones and value inflection points that we aim to achieve and communicate throughout 2023, including progress on our potential Phase 2 registration, part 2 Study of BA3011 in NSCLC, Completion of Phase 2 study of BA3021 in NSCLC, allowing for FDA discussions of a possible pivotal study and initiation of a Phase 2 study of BA3071. All of our studies target areas of high unmet medical need where our CAB

The technology has the potential to further differentiate itself from other technologies in terms of efficacy and safety. As we advance the registration of these important drug candidates, we continue to manage our resources to ensure the Company achieves these and other important milestones through 2025."

Key developments, operational updates and upcoming milestones

Phase 2 study of mecbotamab vedotin in patients with:

AXL-positive soft tissue and bone sarcomas (BA3011, NCT03425279)

Phase 2, Part 1:

(Video) Zhu (Drew) Zhang: Forecasting Firm Material Event Sequences from SEC 8-K Reports

Closed UPS study cohort. Phase 1 and Phase 2 Part 1 (n=10 TmPS ≥50%) 50% overall objective response rate (ORR), median PFS of 11 months and longer duration of response
8 Fun

Observation Period for DLT with a More Frequent Intensive Dosing Regimen in Patients in the Phase 2 LMS Study, Part 1; early reading of the LMS cohort in the second half of 2023

IPF in the UPS cohort with more frequent dose-intensive therapies expected in 1H23

NSCLC positive for AXL (BA3011, NCT04681131)

Phase 2, Part 1 study in patients who had previously failed PD-1/L1, EGFR, or ALK inhibitor therapy (mean failure of 3 lines of therapy):

Enroll in a more frequent dosing regimen as part of Phase 2, Part 1; Read ahead in 2H23

Request FDA comments on the design of the potential Phase 2 Part 2 registration study in 1H23; Expected FDA comments for 2H23

initiation of a potential registration study part 2 phase 2; expected 2H23

Preliminary data from the investigator-initiated phase 2 BA3011 study (n=10) in platinum-resistant ovarian cancer (NCT04918186), expected in 2H23

Phase 2 studies of ozuriftamab vedotin in patients with:

positive MSC ROR2 (BA3021, NCT03504488)

Study in patients who had previously failed therapy with PD-1/L1, EGFR or ALK inhibitors

(Video) Wall Street Words word of the day = Form 8-K

Sign up for a more frequent dose-intensive regime; expected interim reading in 2H23

Melanoma ROR2 positive (BA3021, NCT03504488)

Ongoing study in patients who had previously failed PD-1 therapy

Identification of patients with validated liquid biopsy; Expect a signup update at or around the 1Q23 earnings call in May

SCCHN ROR2 positive (BA3021, NCT05271604)

Ongoing study in patients who had previously failed PD-1 therapy alone or in combination with platinum therapy

Preliminary data from the investigator-initiated phase 2 BA3021 study (n=10) in platinum-resistant ovarian cancer (NCT04918186), expected in 2H23

Phase 1/2 dose escalation study of CAB-CTLA-4 (BA3071, NCT05180799) in multiple types of solid tumors responsive to CTLA-4

DLT observation period clearance for BA3071 210 mg (3 mg/kg) Q3W in combination with nivolumab 3 mg/kg Q3W

Admission to a higher dose cohort of 350 mg (5 mg/kg) in combination with nivolumab 3 mg/kg every 3 weeks

Expect to read phase 1 data in 2H23

Phase 2 trial is expected to begin in 2H23

(Video) Section 2 of Form 8-K

IND FDA approval for CAB-EpCAMxCAB-CD3 TCE (BA3182)

Expect IPF for Phase 1 trial at 1H23 in treatment of advanced adenocarcinoma

Potential additional IND filings for next-generation bispecific preclinical CABs and ADC candidates in 2023-2024

Poster presented on March 21, 2023 at the European Society for Medical Oncology (ESMO) Annual Congress on CAB-AXL-ADC Trial in Progress (TIP) entitled:

"A Phase I/II Study of Mecbotamab Vedotin (BA3011), a CAB-AXL-ADC, in Patients With Advanced Sarcoma, Including Undifferentiated Pleomorphic Sarcoma"

Two TIP poster presentations at the upcoming European Lung Cancer Congress (ELCC) March 29-April 1, 2023 on CAB-ADC entitled:

“A phase 2 study of mecbotamab vedotin (BA3011), a CAB-AXL-ADC, alone and in combination with nivolumab in adult patients with metastatic NSCLC who have had prior disease progression or are intolerant to a PD-1/L1, EGFR or ALK inhibitors”

"Phase 1/2 dose escalation and dose expansion study of ouriftamab vedotin (BA3021) alone and in combination with nivolumab in patients with advanced solid tumors, including non-small cell lung cancer"

Five poster presentations of BioAtla's preclinical data related to next-generation ADCs and various bispecific compounds at the upcoming American Association for Cancer Research (AACR) Annual Meeting in April 2023 entitled:

"Development of Anti-IL-22 Therapies for Inflammation and Cancer"

"Conditionally active biologics kill senescent cells in cancer and aging"

Novel conditionally active bispecific HER2 x CD3 T cell activator targeting solid tumors”

A Novel CAB Nectin-4 x CD3 Double Bispecific Antibody Targeting Solid Tumors”

NextGen Conditionally Active Biological (CAB) Anti-Nectin-4 ADC with Improved Stability and Safety”

Financial results for the fourth quarter and full year 2022

(Video) Form 8-K

Cash and cash equivalents were $215.5 million as of December 31, 2022 compared to $245.0 million as of December 31, 2021. We anticipate that current cash and cash equivalents will be sufficient to to fund the planned operations, including all ongoing CAB product development programs, through 2025.

Research and development (R&D) expenses were $21.9 million for the quarter ended December 31, 2022 compared to $16.5 million for the same quarter of 2021. The increase of $5.4 million Dollar was primarily due to our clinical product development efforts. R&D spending for full year 2022 was $79.3 million compared to $58.3 million in 2021. We expect our R&D spending to remain variable quarter to quarter.

Quarterly and generally increasing as we continue to invest in research and development to advance our product candidates and clinical programs.

General and administrative (G&A) expenses were $6.7 million for the quarter ended December 31, 2022, compared to $7.0 million for the same quarter in 2021. The change of $0.3 million was recorded attributed to a decrease in stock-based compensation for the 2022 period. Administrative expenses were $28.8 million for full year 2022 compared to $38.4 million in 2021. The $9.6 million change was on driving a decrease in stock-based compensation for the 2022 period of our product candidates, further developing our intellectual property portfolio, supporting focused pre-market activities for our product candidate mecbotamab vedotin (BA3011) and meeting the requirements as a public company.

Net loss for the quarter ended December 31, 2022 was $27.5 million compared to a net loss of $23.4 million for the same quarter in 2021. Net loss for the full year 2022 was 106.5 million compared to a net loss of $95.4 million in 2021.

Net cash used for the full year ended December 31, 2022 was $90.4 million compared to a net cash use of $62.2 million for the same period in 2021. 2022 is primarily due to one Increase in research and development expenses related to our program development efforts compared to 2021.

Fourth Quarter and Full Year 2022 Conference Call and Webcast Details

BioAtla, Inc. management will host a conference call and webcast for the investor community today, March 23, 2023 at 4:30 p.m. m, eastern time. A live webcast can be found here:https://viavid.webcasts.com/starthere.jsp?ei=1597401&tp_key=0a629e4f65. The conference call can be reached toll-free at (877) 425-9470 or (201) 389-0878 (international). The access code for the conference call is 13736283.

A replay of the webcast and key preliminary clinical data slides referenced in the conference call will be available via "events and presentations' in the investor section of the company's website upon completion of the presentation and will be archived on the BioAtla website for one year.

About Mecbotamab Vedotin (BA3011)

Mecbotamab vedotin, CAB-AXL-ADC, is a conditionally and reversibly active antibody-drug conjugate that targets the AXL receptor tyrosine kinase. This phase 2 clinical compound targets multiple types of solid tumors, including bone and soft tissue sarcomas and non-small cell lung cancer (NSCLC), that have previously progressed on PD-1/L1 inhibitor therapies, EGFR or ALK. We also support a multi-center, investigator-initiated clinical trial in combination with durvalumab, a PD-L1 blocking antibody, in patients with platinum-resistant ovarian cancer and for other potential future indications. The FDA's Office of Orphan Drugs (OODP) has granted orphan drug designation to mecbotamab vedotin for the treatment of soft tissue sarcomas.

About ozuriftamab vedotin (BA3021)

Ozuriftamab vedotin, CAB-ROR2-ADC, is a conditionally and reversibly active antibody-drug conjugate directed against ROR2, a receptor tyrosine kinase overexpressed in a wide variety of solid tumors including lung, head and neck, and melanoma . We are advancing this phase 2 clinical compound for multiple solid tumor types, including NSCLC that previously progressed on PD-1/L1, EGFR, or ALK inhibitor therapies, melanoma that previously progressed on PD-1 therapy/L1, and SCCHN that

have previously progressed on PD-1/L1 therapies with or without platinum-based chemotherapy. We also support a multi-center, investigator-initiated clinical trial in combination with durvalumab, a PD-L1-blocking antibody, in patients with platinum-resistant ovarian cancer, with other possible indications in the future.

About BA3071

BA3071 is a CAB anti-CTLA-4 antibody being developed as an immuno-oncology agent with the aim of providing at least comparable potency to approved anti-CTLA-4 antibodies, but with lower toxicity due to the CAB tumor microenvironment. -Restricted activity. This may enable safer anti-CTLA-4 antibody combination therapies, such as B. anti-PD-1 antibody checkpoint inhibitors, and potentially expand the patient population tolerant to combination therapy and provide greater efficacy. Like our other CAB candidates, BA3071 is designed to be conditionally and reversibly active in the tumor microenvironment. BA3071 is being developed as a potential therapeutic for several solid tumor indications known to be responsive to CTLA treatment in combination with a PD-1 blocker.

About BA3182

BioAtla is developing BA3182 as a potential cancer therapy for patients with advanced adenocarcinoma. BA3182 is a conditionally active biological bispecific EpCAM/CD3 T-cell coupler antibody (CAB) that contains two binding sites for EpCAM and two binding sites for CD3ε. The binding sites for EpCAM and CD3ε were engineered to bind specifically and reversibly to their respective targets under conditions found in TME and exhibit reduced binding outside of TME. Selective CAB binding to the CAB-EpCAM and CAB-CD3ε arms is required to activate T cell binding against the tumor, allowing for the combined selectivity of each CAB binding arm on the bispecific antibody. BioAtla recently received IND approval from the FDA to conduct a first-in-human Phase 1 study to evaluate the safety, pharmacokinetics and efficacy of BA3182 in patients with advanced adenocarcinoma.

About EpCAM

EpCAM is involved in maintaining epithelial integrity and its expression is associated with proliferation during morphogenesis, tissue regeneration and maintenance of stem cells. EpCAM expression levels vary between different organs and cell types, with colon, small intestine, lung, pancreatic, liver, and gallbladder epithelia expressing the highest levels of EpCAM protein. Given the functions and properties of the EpCAM protein, high levels of EpCAM expression have been found in many carcinomas. EpCAM is highly and frequently expressed in the vast majority of carcinomas and their metastases and is considered a potential prognostic and therapeutic marker for many carcinomas.

Über BioAtla®, Inc.

BioAtla is a global clinical-stage biotechnology company with offices in San Diego, California and Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of pre-clinical development services. Using its proprietary Conditionally Active Biologics (CAB) technology, BioAtla is developing novel reversibly active monoclonal and bispecific antibodies and other protein therapeutic drug candidates. CAB product candidates are designed to have more selective targeting, higher potency with less toxicity, and cheaper and more predictable manufacturing than traditional antibodies. BioAtla has extensive worldwide patent coverage for its CAB technology and products with 711 patents (435 granted, 5 admitted and 271 pending). Extensive patent coverage in all major markets includes methods for manufacturing, selecting and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two premier CAB programs currently in Phase 2 clinical trials, Mecbotamab Vedotin, BA3011, a novel conditionally active compound

AXL-Targeted Antibody-Drug Conjugate (CAB-AXL-ADC) and Ouriftamab Vedotin, BA3021, a Novel Conditionally Active ROR2-Targeted Antibody-Drug Conjugate (CAB-ROR2-ADC). The phase 1 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 the anti-PD-1 antibody to allow. The company's first bispecific antibody, BA3182, targets EpCAM, which is highly and frequently expressed in many adenocarcinomas, while interacting with human CD3-expressing T cells. For more information about BioAtla, Inc., visitwww.bioatla.com.

forward-looking statements

Statements in this press release contain "forward-looking statements" that involve significant risks and uncertainties. Forward-looking statements in this press release are 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, but are not limited to, statements we make regarding our business plans and prospects, including our plans to initiate and advance an escalation phase 1 clinical trial and dose expansion for BA3182, whether our clinical trials that will support registration; results, conduct, progress and timing of our research and development programs and clinical trials; expectations for enrollment and dosing in our clinical trials, plans for future data updates, clinical trials, regulatory meetings and regulatory filings, the potential regulatory path for our product candidates, expectations about the adequacy of our cash and cash equivalents, and anticipated R&D and G&A expenditures 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. are difficult to predict and could cause actual results to differ materially from our expectations. In addition, certain forward-looking statements are based on assumptions about future events that may not be accurate. Factors that could cause actual results to differ include, but are not limited to: possible delays in preclinical and clinical studies due to the global COVID-19 pandemic; other potential adverse effects due to the global COVID-19 pandemic, such as B. Regulatory review delays, manufacturing and supply chain disruptions, adverse impacts on healthcare systems and disruptions to the global economy; uncertainties inherent in research and development, including the ability to achieve anticipated clinical endpoints, clinical trial start and/or completion dates, regulatory submission dates or regulatory approval dates, as well as the possibility of new adverse clinical data and additional analysis of existing clinical data; whether regulatory authorities will be satisfied with the design and results of the clinical trials or will take favorable regulatory action based on the clinical trial results; 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 dependence on third parties to manufacture and supply our clinical trial candidate products; our dependence 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 "Risk Factors" section of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 23, 2023 and our other reports filed with the SEQ. Forward-looking statements contained in this press release are made as of this date and BioAtla undertakes no obligation to update such information, except as required by applicable law.

Internal contact:

Ricardo Waldron


BioAtla, Inc.



External contact:
Bruce Mackle

Asesores LifeSci, LLC


BioAtla, Inc.

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