Core Insights - BioAtla, Inc. announced promising Phase 2 trial results for Ozuriftamab Vedotin (Oz-V) in HPV+ OPSCC patients, showing a 45% overall response rate (ORR) and a 100% disease control rate (DCR) [1][4] - The trial highlights a significant unmet need in the second-line and beyond HPV+ OPSCC patient population, where standard treatments have reported an ORR of only 3.4% [1][4] - The company plans to finalize the Phase 3 trial design for Oz-V with the FDA [1] Group 1: Clinical Trial Details - In the Phase 2 clinical trial, 40 heavily pretreated SCCHN patients received Oz-V at a dosage of 1.8 mg/kg, administered either every two weeks or on specific days of a 21-day cycle [2][7] - Tumor assessments were conducted via CT or MRI every 6 weeks for the first 12 weeks, then every 8 weeks up to one year [2] - Among the 40 patients, 22 had HPV+ OPSCC, with a median of 3 prior lines of therapy and a high failure rate of previous anti–PD-1 and platinum therapies [7] Group 2: Efficacy and Safety Data - In HPV+ OPSCC patients, Oz-V demonstrated an ORR of 45% (5 out of 11 patients) and a DCR of 100% (11 out of 11 patients) [7] - The median duration of response was 9.9 months, with median progression-free survival at 4.7 months and median overall survival at 11.6 months [7] - Most adverse events were low grade, with fatigue (57%) and anemia (32%) being the most common; only 15% experienced grade ≥3 adverse events [7] Group 3: Regulatory and Market Potential - The company believes there is potential for accelerated approval and full approval of Oz-V in the HPV+ OPSCC market [4] - Oz-V has received Fast Track Designation from the FDA to facilitate discussions regarding the proposed Phase 3 study [7][8] - The drug targets ROR2, a receptor associated with poor prognosis and resistance to therapies, indicating a strategic focus on addressing significant market needs in solid tumors [8]

Summary of BioAtla (BCAB) Conference Call Company Overview - BioAtla is a clinical stage oncology company based in San Diego, California with four clinical assets, three of which are in phase two [4][5] - The company utilizes a conditionally active biologic platform that enhances the therapeutic index of its therapies, increasing both potency and safety [4][5] Key Points on Clinical Assets - The platform allows for immediate binding to tumor targets without requiring an activation step, which enhances the therapeutic window [7][8] - BioAtla is engaged in multiple discussions to advance its molecules into phase three trials with partners [5] Axle Program - The Axle program targets MKRAS mutations in lung cancer, with a reported overall survival rate of 59% over two years, significantly higher than previous treatments [11][34] - Historical data shows that previous treatments for MKRAS non-small cell lung cancer had one and two-year survival rates of less than 40% and 20%, respectively [34] - The company is in discussions to randomize against docetaxel in preparation for a phase three trial [38] EpCAM Program - The EpCAM program is in a phase one dose escalation study, targeting various adenocarcinomas, including non-small cell lung cancer and colorectal cancer [14][30] - The dual cab technology allows for enhanced selectivity, with a potential market opportunity estimated in the multi-billion dollar range [30][31] - Initial data shows patients with colorectal cancer experiencing over a year without progression [15] Market Potential - The EpCAM target is expressed in 100% of colon cancer tumors, presenting a unique opportunity in the oncology market [31] - The potential for a pan-cancer drug across adenocarcinomas is highlighted, with significant market implications if successful [30] Future Steps and Partnerships - BioAtla is focused on advancing its clinical programs, particularly the EpCAM and Axle assets, with plans for potential partnerships to enhance development and funding [41][50] - The company has a cash position of $32 million, sufficient to carry operations into 2026, while actively seeking non-dilutive financing through partnerships [57][59] Conclusion - BioAtla is positioned in a promising space within oncology, with innovative technologies and strong survival data supporting its clinical programs. The company is optimistic about future partnerships and the potential for significant market impact with its therapies [52][56]

Financial Data and Key Metrics Changes - Research and development (R&D) expenses decreased to $12.4 million for Q1 2025 from $18.9 million in Q1 2024, a reduction of $6.5 million primarily due to lower clinical development expenses [12] - General and administrative (G&A) expenses were $5.3 million for Q1 2025, down from $5.6 million in Q1 2024, reflecting a decrease of $300,000 [13] - Net loss for Q1 2025 was $15.3 million compared to a net loss of $23.2 million in Q1 2024, indicating improved financial performance [13] - Cash and cash equivalents as of March 31, 2025, were $32.4 million, down from $49 million as of December 31, 2024 [13] Business Line Data and Key Metrics Changes - The Phase one dose escalation study for the dual conditionally binding EpCAM and CD3 T cell engager is progressing well, with multiple patients achieving tumor reduction [6] - The MACV ADC demonstrated a two-year landmark survival of 59% in MKRAS non-small cell lung cancer patients, significantly higher than the less than 20% reported for standard care [7] - The OSV ADC showed a 100% disease control rate and a 45% overall response rate in treatment-refractory HPV positive head and neck cancer patients [9] Market Data and Key Metrics Changes - The company is focusing on the HPV positive head and neck cancer segment, which is currently underserved by existing treatments [9] - The overall survival data for MACV across different solid tumor types, including soft tissue sarcomas, indicates a strong market potential for the product [8] Company Strategy and Development Direction - The company is committed to advancing its CAD platform and is focusing on two internal priority programs while seeking partnerships for others [14][42] - Ongoing discussions with potential collaborators aim to maximize the value of the company's assets, particularly in the context of pivotal trials and accelerated approval opportunities [26][44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the progress of clinical programs and the potential impact of their therapies on patients with challenging solid tumors [15] - The company anticipates that cost reductions from recent restructuring will provide sufficient runway to fund operations and achieve key clinical readouts in the first half of 2026 [14] Other Important Information - The company has received Fast Track designation from the FDA for its OSV program, facilitating discussions regarding treatment options for metastatic HPV positive squamous cell carcinoma [10] - Management highlighted the importance of overall survival as a key metric in evaluating the effectiveness of their therapies compared to standard care [38] Q&A Session Summary Question: Will the poster presentation for the ROAR-two program at ASCO contain an updated data cut? - Yes, there will be an updated data cut including additional safety data and long-term outcomes [20] Question: Any thoughts on a pivotal design for the actual program and options for accelerated approval? - The pivotal trial would likely be randomized against docetaxel in second and third line patients, with FDA guidance supportive of this approach [25][26] Question: Can you provide details on tumor regressions and patient therapy duration for the EpCAM program? - Two patients with colorectal adenocarcinoma have shown extended progression-free intervals, with ongoing dose escalation and no concerning safety issues reported [33][34] Question: What is the ideal partnership structure for the company? - The company seeks multiple partnerships, aiming to maintain substantial value in North America while generating cash value through upfront and near-term milestones [41][44]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39787 BIOATLA, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 85-1922320 ( State or other jurisdiction of i ...

Financial Data and Key Metrics Changes - Research and development (R&D) expenses decreased to $12.4 million for Q1 2025 from $18.9 million in Q1 2024, a reduction of $6.5 million primarily due to lower clinical development expenses [12] - General and administrative (G&A) expenses were $5.3 million for Q1 2025, down from $5.6 million in Q1 2024, reflecting a decrease of $300,000 [14] - Net loss for Q1 2025 was $15.3 million compared to a net loss of $23.2 million in Q1 2024, indicating improved financial performance [14] - Cash and cash equivalents as of March 31, 2025, were $32.4 million, down from $49 million as of December 31, 2024 [14] Business Line Data and Key Metrics Changes - The Phase one dose escalation study for the dual conditionally binding EpCAM and CD3 T cell engager is progressing well, with multiple patients achieving tumor reduction [5] - The MACV ADC demonstrated a two-year landmark survival of 59% in MKRAS non-small cell lung cancer patients, significantly higher than the less than 20% survival reported with standard care [7] - The OSV ADC showed a 100% disease control rate and a 45% overall response rate in treatment-refractory HPV positive head and neck cancer patients [9] Market Data and Key Metrics Changes - The company is focusing on the metastatic HPV positive head and neck cancer segment, which is currently underserved by existing treatments [9] - The overall survival data for MACV across various solid tumor types, including soft tissue sarcomas, indicates a strong market potential for the product [8] Company Strategy and Development Direction - The company is committed to advancing its CAD platform and is focused on aligning with partners to maximize the value of its assets [8] - The strategic focus includes prioritizing two internal programs while exploring partnerships for others, indicating a streamlined approach to resource allocation [15][41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the progress of clinical programs and the potential impact of their therapies on patients with challenging solid tumors [16] - The company anticipates that cost reductions from recent restructuring will provide sufficient runway to fund operations and achieve key clinical readouts in the first half of 2026 [15] Other Important Information - The company has received Fast Track designation from the FDA for its OSV program, facilitating discussions regarding treatment options for metastatic HPV positive squamous cell carcinoma [10] - Ongoing discussions with potential collaborators are aimed at maximizing the value of the company's assets and exploring accelerated approval pathways [27][41] Q&A Session Summary Question: Will the poster presentation for the ROAR-two program at ASCO contain an updated data cut? - Yes, there will be an updated data cut including additional safety data and long-term outcomes [19] Question: Will data from the 300 microgram dose be available in July? - Anticipated data from the 300 microgram dose will be available mid-year [20][23] Question: Can you provide details on tumor regressions seen in the EpCAM program? - Two patients with colorectal adenocarcinoma have shown extended progression-free intervals, with ongoing dose escalation [32] Question: How does the company view the competitive landscape for MEKV? - The company believes its data stands strong against competitors, especially in the second-line setting for mutated KRAS non-small cell lung cancer [35][39] Question: What is the ideal partnership structure for the company? - The company seeks partnerships that maintain substantial value in North America and generate cash value through upfront and near-term milestones [41][43] Question: What regimen is used to control CRS in the study? - The company employs a standard approach with step dosing and prophylaxis strategies to manage CRS [52]

Core Insights - BioAtla, Inc. reported its financial results for Q1 2025, highlighting advancements in its Conditionally Active Biologic (CAB) platform and ongoing clinical trials for cancer therapies [1][8]. Financial Performance - Research and development (R&D) expenses for Q1 2025 were $12.4 million, down from $18.9 million in Q1 2024, primarily due to reduced clinical development costs [8]. - General and administrative (G&A) expenses decreased to $5.3 million in Q1 2025 from $5.6 million in Q1 2024 [9]. - The net loss for Q1 2025 was $15.3 million, compared to a net loss of $23.2 million in the same quarter of 2024 [9]. - Cash and cash equivalents as of March 31, 2025, were $32.4 million, down from $49.0 million at the end of 2024, with expectations to fund operations through key clinical readouts in 1H 2026 [11]. Clinical Developments - The Phase 1 dose-escalation study for CAB-EpCAM x CAB-CD3 (BA3182) is ongoing, with the first three patients dosed at 300 micrograms, and data readout expected in mid-2025 [5][6]. - Mecbotamab vedotin (Mec-V) demonstrated a 2-year landmark survival rate of 59% in mKRAS non-small cell lung cancer (NSCLC) patients, significantly higher than the less than 20% survival rate reported for standard care [5][6]. - Ozuriftamab vedotin (Oz-V) continues to show promising results in HPV-positive squamous cell carcinoma of the head and neck, with a disease control rate of 100% and an overall response rate of 45% [6][5]. Strategic Initiatives - The company is utilizing Fast Track Designation from the FDA for discussions regarding a proposed Phase 3 study for Oz-V in treatment-refractory metastatic HPV-positive SCCHN [13]. - BioAtla is focusing on its two internal priority programs and expects cost reductions from its recent restructuring [11]. Upcoming Events - Management will host a conference call and webcast on May 6, 2025, to discuss the financial results and clinical updates [12]. - BioAtla has presentations scheduled at major oncology conferences, including the ASCO Annual Meeting and ESMO Gastrointestinal Cancers Congress [13].

SAN DIEGO, May 6, 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 first quarter ended March 31, 2025 and provided highlights on its clinical programs. "I continue to be encouraged by the progress across our CAB platform, particularly with our Phase 1 dose- escalation study evaluating our dual conditionally- ...

Core Insights - BioAtla, Inc. is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][2] - The company will provide a corporate update and participate in one-on-one investor meetings at the Citizens Life Sciences Conference on May 7-8, 2025, in New York [1][2] Company Overview - BioAtla operates in San Diego, California, and Beijing, China, through a partnership with BioDuro-Sundia for preclinical development services [2] - The company utilizes its proprietary CAB platform technology to develop novel monoclonal and bispecific antibodies, aiming for selective targeting, greater efficacy, lower toxicity, and cost-efficient manufacturing compared to traditional antibodies [2] - BioAtla holds extensive patent coverage with over 780 active patent matters, including more than 500 issued patents, covering methods of making, screening, and manufacturing CAB product candidates [2] Product Development - BioAtla's first dual CAB bispecific T-cell engager antibody, BA3182, is in Phase 1 development, targeting EpCAM, which is commonly expressed in adenocarcinomas [2] - The company has two first-in-class CAB programs in Phase 2 clinical testing: mecbotamab vedotin (CAB-AXL-ADC) and ozuriftamab vedotin (CAB-ROR2-ADC) [2] - The Phase 2 CAB-CTLA-4 antibody, evalstotug, is designed to reduce systemic toxicity and enable safer combination therapies with checkpoint inhibitors [2]

Core Viewpoint - BioAtla, Inc. is set to host a conference call on May 6, 2025, to discuss its Q1 2025 financial results and business highlights [1][2]. Company Overview - BioAtla is a global clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [3]. - The company operates in San Diego, California, and Beijing, China, through a partnership with BioDuro-Sundia for preclinical development services [3]. - BioAtla utilizes its proprietary CAB platform technology to create novel monoclonal and bispecific antibodies, aiming for selective targeting, greater efficacy, lower toxicity, and cost-efficient manufacturing compared to traditional antibodies [3]. - The company holds extensive patent coverage with over 780 active patent matters, including more than 500 issued patents, covering methods of making, screening, and manufacturing CAB product candidates [3]. Product Development - BioAtla's first dual CAB bispecific T-cell engager antibody, BA3182, is in Phase 1 development, targeting EpCAM, which is commonly expressed in adenocarcinomas [3]. - The company has two first-in-class CAB programs in Phase 2 clinical testing: mecbotamab vedotin (CAB-AXL-ADC) and ozuriftamab vedotin (CAB-ROR2-ADC) [3]. - The Phase 2 CAB-CTLA-4 antibody, evalstotug, is designed to reduce systemic toxicity and enable safer combination therapies with checkpoint inhibitors like anti-PD-1 antibody [3].

Core Insights - BioAtla, Inc. is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][3] Presentation Details - BioAtla will present two preclinical posters at the 2025 American Association for Cancer Research (AACR) conference in Chicago from April 25–30, 2025 [1][2] - The first poster discusses novel senolytic targets and CAB-based drug conjugates for eliminating senescence-associated secretory phenotype cells [2] - The second poster highlights BA3361, a tumor-selective CAB anti-Nectin4 antibody-drug conjugate that enhances therapeutic efficacy in pancreatic cancer [2] Company Overview - BioAtla operates in San Diego, California, and Beijing, China, utilizing its proprietary CAB platform technology to develop monoclonal and bispecific antibodies [3] - The CAB technology aims for selective targeting, greater efficacy with lower toxicity, and cost-efficient manufacturing compared to traditional antibodies [3] - The company holds over 780 active patent matters, with more than 500 issued patents covering its CAB technology and products [3][4] Technology Highlights - The CAB anti-Nectin4-ADC shows differentiated preclinical activity with superior efficacy compared to enfortumab vedotin in various cancer models [4] - CAB technology offers a new generation of biologics with an increased safety margin and therapeutic index, targeting senescence-related cells in cancer and age-related diseases [4]