Financial Performance - Net loss for Q3 2025 was $15.8 million, compared to a net loss of $10.6 million in Q3 2024, with the increase primarily due to the absence of collaboration revenue recorded in 2024[13] - Net loss for the three months ended September 30, 2025, was $15,778, compared to a net loss of $10,586 for the same period in 2024, indicating an increase of approximately 49.5%[26] - Net loss per common share for the three months ended September 30, 2025, was $0.27, compared to $0.22 for the same period in 2024, indicating a worsening of approximately 22.7%[26] Expenses - Research and development (R&D) expenses for Q3 2025 were $9.5 million, down from $16.4 million in Q3 2024, reflecting a 42% decrease primarily due to lower program development costs and workforce reduction[9] - General and administrative (G&A) expenses decreased to $4.2 million in Q3 2025 from $5.9 million in Q3 2024, a reduction of 29% attributed to lower personnel costs[12] - Total operating expenses decreased to $13,789 for the three months ended September 30, 2025, compared to $22,270 in the same period of 2024, representing a reduction of approximately 38.2%[26] - Research and development expenses for the three months ended September 30, 2025, were $9,539, down from $16,395 in the same period of 2024, a decrease of approximately 41.5%[26] - General and administrative expenses decreased to $4,250 for the three months ended September 30, 2025, from $5,875 in the same period of 2024, a reduction of approximately 27.6%[26] Cash and Assets - Cash and cash equivalents as of September 30, 2025, were $8.3 million, excluding a recent $2 million milestone payment from Context Therapeutics[13] - Cash and cash equivalents decreased significantly to $8,320 as of September 30, 2025, down from $49,046 as of December 31, 2024[28] - Total assets decreased to $15,908 as of September 30, 2025, compared to $52,422 as of December 31, 2024, reflecting a decline of approximately 69.7%[28] Liabilities and Equity - Total liabilities increased to $47,145 as of September 30, 2025, compared to $38,157 as of December 31, 2024, representing an increase of approximately 23.5%[28] - Total stockholders' equity showed a deficit of $31,237 as of September 30, 2025, compared to a positive equity of $14,265 as of December 31, 2024[28] Clinical Trials and Developments - The company achieved FDA alignment on the Phase 3 Oz-V trial design for the treatment of 2L+ OPSCC, which has the potential for accelerated approval[5] - The ongoing BA3182 trial in advanced adenocarcinomas is evaluating various dosing schedules, with preliminary data expected in the first half of 2026[9] - A confirmed partial response at 0.6 mg of BA3182 has been ongoing for over six months in a patient with intrahepatic cholangiocarcinoma[10] - The Phase 2 study of Mecbotamab vedotin (Mec-V) showed a median overall survival of 21.5 months among 44 evaluable patients, with a 12-month OS rate of 73%[10] Strategic Partnerships - BioAtla is in advanced stages to finalize a strategic partnership transaction by year-end 2025[5] - Context Therapeutics triggered a $2 million milestone payment under the CAB-Nectin4-TCE program, reflecting continued progress in BioAtla's T-cell engager platform[11] - Collaboration and other revenue remained unchanged at $11,000 for both the three and nine months ended September 30, 2025[26]

Core Insights - BioAtla, Inc. reported its financial results for Q3 2025, highlighting progress in clinical programs and a strategic partnership expected to be finalized by year-end [1][2][4]. Financial Performance - Research and development (R&D) expenses decreased to $9.5 million in Q3 2025 from $16.4 million in Q3 2024, primarily due to lower program development costs and workforce reductions [8]. - General and administrative (G&A) expenses also fell to $4.2 million in Q3 2025 from $5.9 million in Q3 2024, attributed to reduced personnel costs [10]. - The net loss for Q3 2025 was $15.8 million, compared to a net loss of $10.6 million in Q3 2024, with the increase largely due to the absence of collaboration revenue recorded in the previous year [11]. Clinical Developments - The company achieved FDA alignment on the Phase 3 trial design for Ozuriftamab vedotin (Oz-V) targeting 2L+ oropharyngeal squamous cell carcinoma (OPSCC), with potential for accelerated approval [4][5]. - Ongoing trials for BA3182 in advanced adenocarcinomas are evaluating various dosing schedules, with preliminary data showing prolonged tumor control [5][8]. - The Phase 2 study of Mecbotamab vedotin (Mec-V) reported a median overall survival of 21.5 months among patients with treatment-refractory soft tissue sarcomas [5][14]. Strategic Initiatives - BioAtla is in advanced stages of finalizing a strategic transaction with a potential partner, aiming for completion by the end of 2025 [4][11]. - A $2 million milestone payment was triggered by Context Therapeutics under the license agreement for the CAB-Nectin4-TCE program, reflecting progress in the T-cell engager platform [9]. Upcoming Milestones - The company expects to initiate the Oz-V Phase 3 study in early 2026 and anticipates additional readouts from ongoing trials later in 2026 [5][8].

Core Insights - BioAtla, Inc. presented clinical data showing that Mecbotamab Vedotin (Mec-V) achieved a median overall survival (OS) of 21.5 months in patients with treatment-refractory leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma, compared to approximately 12 months with approved agents [1][4][7] - The safety profile of Mec-V, both as a monotherapy and in combination with anti-PD-1 antibody, was manageable and consistent with its mechanism of selectively targeting the tumor microenvironment [1][2][4] Clinical Trial Details - In a Phase 2 clinical trial, 79 patients with advanced soft tissue sarcomas were treated with Mec-V, either as monotherapy (n=54) or in combination with anti-PD-1 antibody (n=25) [3] - A focused efficacy analysis was conducted on a subset of 44 patients who had treatment-refractory leiomyosarcoma, liposarcoma, or undifferentiated pleomorphic sarcoma [3] Efficacy and Safety Data - The median OS was 21.5 months across all patients, with 22.9 months in the combination arm and 18.4 months in the monotherapy arm [7] - The 12-month OS rate was 73%, significantly higher than the approximately 50% historically reported for approved agents in similar populations [7] - The disease control rate (DCR) was 52% across all patients, with two patients achieving partial responses [7] - Adverse events were generally low-grade and manageable, with no treatment-related deaths reported [7] Presentation Information - The data was presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, highlighting the potential of Mec-V to extend survival in patients with limited treatment options [1][6]

Core Insights - BioAtla, Inc. presented clinical data showing that Mecbotamab Vedotin (Mec-V) achieved a median overall survival (OS) of 21.5 months in patients with treatment-refractory leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma, significantly higher than the approximately 12 months observed with approved agents [1][4][7] - The safety profile of Mec-V, both as a monotherapy and in combination with anti-PD-1 antibody, was manageable and consistent with its mechanism of selectively targeting the tumor microenvironment [1][2][4] Clinical Trial Details - In a Phase 2 clinical trial, 79 patients with advanced soft tissue sarcomas were treated with Mec-V, either as monotherapy (n=54) or in combination with anti-PD-1 antibody (n=25) [3] - A focused efficacy analysis was conducted on a subset of 44 patients who had treatment-refractory leiomyosarcoma, liposarcoma, or undifferentiated pleomorphic sarcoma [3] Efficacy and Safety Data - The median OS was 21.5 months across all patients, with 22.9 months in the combination therapy arm and 18.4 months in the monotherapy arm [7] - The 12-month OS rate was 73%, compared to approximately 50% historically reported for similar populations treated with approved agents [7] - The disease control rate (DCR) was 52% across all patients, with two patients achieving partial responses [7] - Adverse events were generally low-grade and manageable, with no treatment-related deaths reported [7] Presentation Information - The data was presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, highlighting the potential of Mec-V to extend survival in patients with limited treatment options [1][6]

Core Insights - BioAtla, Inc. is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][3] - The company will host a conference call on November 13, 2025, to discuss its Q3 2025 financial results and business highlights [1][2] Company Overview - BioAtla operates in San Diego, California, and has a partnership with BioDuro-Sundia in Beijing for preclinical development services [3] - The company 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] - 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 [3]

Core Insights - BioAtla, Inc. is presenting clinical data on its investigational antibody-drug conjugate, ozuriftamab vedotin (Oz-V), at the International Papillomavirus Society Conference, focusing on its application in treating advanced HPV+ oropharyngeal squamous cell carcinoma (OPSCC) [1][2] Company Overview - BioAtla is a global clinical-stage biotechnology company based in San Diego, California, and Beijing, China, specializing in the development of Conditionally Active Biologic (CAB) antibody therapeutics [6] - The company utilizes its proprietary CAB platform technology to create novel monoclonal and bispecific antibodies, aiming for selective targeting and greater efficacy with lower toxicity [6] Product Details - Ozuriftamab vedotin (Oz-V) targets ROR2, a receptor tyrosine kinase overexpressed in various solid tumors, including OPSCC, driven by HPV infection [4] - In a Phase 2 trial, Oz-V demonstrated an overall response rate (ORR) of 45% and a disease control rate (DCR) of 100% in refractory patients, with a median overall survival (OS) of 11.6 months [4] - The FDA has granted Fast Track Designation to Oz-V for treating recurrent or metastatic squamous cell carcinoma of the head and neck [4] Market Opportunity - The global market opportunity for second-line and beyond OPSCC is over $1 billion, while for first-line HPV+ tumors, it is potentially over $7 billion [5] - OPSCC is rapidly increasing, with HPV infections accounting for approximately 80% of cases in the United States [5]

Core Insights - BioAtla, Inc. announced preliminary clinical data from a Phase 1 study of BA3182, a bispecific T-cell engager targeting EpCAM and CD3, at the ESMO Congress 2025, highlighting its potential for treating treatment-refractory metastatic adenocarcinoma [1][3] Group 1: Clinical Data and Efficacy - BA3182 shows a manageable safety profile with preliminary evidence of antitumor activity [4] - Prolonged tumor control observed with increasing doses of BA3182, including a confirmed partial response at 0.6 mg in a patient with intrahepatic cholangiocarcinoma without progression for over 6 months [6] - Among patients treated at doses of 0.6 mg and higher, there was a higher rate of stable disease and prolonged treatment intervals compared to those receiving lower doses [13] Group 2: Safety Profile - Adverse events were generally transient and manageable, with only 2 cases of cytokine release syndrome reported [6] - No treatment-related deaths occurred, and only one patient discontinued treatment due to an adverse event [6] - Safety profile supports continued dose escalation, with the maximally tolerated dose not yet defined [6] Group 3: Technology and Mechanism - BA3182 is designed to selectively bind within the acidic tumor microenvironment, reducing on-target, off-tumor toxicity associated with traditional antibodies [2][9] - The CAB technology utilized by BioAtla activates only in diseased microenvironments, aiming for more selective targeting and lower toxicity compared to conventional therapies [10] Group 4: Market Potential - BA3182 has the potential to serve over one million patients globally, indicating a significant market opportunity for BioAtla [3]

Core Insights - BioAtla, Inc. is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][4] - The company will present clinical data for its AXL-targeting antibody-drug conjugate, mecbotamab vedotin (BA3011), at the SITC 2025 Annual Meeting [1][2] Presentation Details - The presentation titled "Median OS of 21.5 months among 44 patients with treatment-refractory leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma treated with mecbotamab vedotin, an AXL-targeting ADC" will be delivered by Dr. Mihaela Druta [2] - The abstract (523) will be featured in the poster session, with the specific presentation time to be announced [2] Company Overview - BioAtla operates in San Diego, California, and Beijing, China, through a partnership with BioDuro-Sundia for preclinical development services [4] - The company utilizes its proprietary CAB platform technology to develop novel monoclonal and bispecific antibodies, aiming for selective targeting, greater efficacy, and lower toxicity [4] - BioAtla holds extensive patent coverage for its CAB platform technology, with over 780 active patent matters, including more than 500 issued patents [4]

Core Insights - BioAtla, Inc. announced outcomes from its Type B meeting with the FDA regarding its investigational drug Ozuriftamab vedotin (Oz-V) for treating solid tumors, particularly HPV+ oropharyngeal squamous cell carcinoma (OPSCC) [1][4][6] Company Overview - BioAtla is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics using its proprietary CAB platform [1][12] - The company operates in San Diego, California, and has a partnership with BioDuro-Sundia in Beijing for preclinical development services [12] Product Details - Ozuriftamab vedotin (Oz-V) is a conditionally active antibody drug conjugate targeting ROR2, which is overexpressed in various solid tumors, including head and neck cancers [2][7] - The drug has shown a 45% overall response rate (ORR) in a Phase 2 trial for HPV+ OPSCC, with a median overall survival (OS) of 11.6 months, compared to 0-3.4% ORR and 4.4 months OS for standard treatments [3][4] FDA Meeting Outcomes - The pivotal trial design for full approval involves approximately 300 OPSCC patients randomized between two treatment arms: Oz-V and an Investigator's Choice control arm [4][5] - The dosing regimen for Oz-V is set at 1.8 mg/kg every other week [4] - The endpoints for accelerated approval include statistically significant improvement in confirmed ORR and duration of response, while full approval will require significant improvement in OS [5][6] Strategic Implications - The FDA's alignment on the trial design is seen as a significant milestone for BioAtla, facilitating the initiation of the Phase 3 study with a strategic partner [6][8] - The company aims to complete a strategic partnership for one of its advanced clinical assets within the year [8] Market Context - OPSCC is a rapidly growing patient population, with HPV infections accounting for approximately 80% of cases in the U.S., highlighting the unmet medical need in this area [10]

Financial Data and Key Metrics Changes - Research and development (R&D) expenses decreased to $13.7 million for Q2 2025 from $16.2 million in Q2 2024, a reduction of $2.5 million primarily due to workforce reduction and program prioritization [11][12] - General and administrative (G&A) expenses were $5 million for Q2 2025, down from $5.8 million in Q2 2024, reflecting lower stock-based compensation and headcount-related expenses [12] - Net loss for Q2 2025 was $18.7 million compared to a net loss of $21.1 million in Q2 2024, indicating improved financial performance [12] - Cash and cash equivalents as of June 30, 2025, were $18.2 million, down from $49 million as of December 31, 2024, highlighting a significant cash burn [13] Business Line Data and Key Metrics Changes - The dual conditionally binding EpCAM CD3 T cell engager BA-3182 is showing promising results in its Phase 1 dose escalation study, with evidence of objective tumor reductions in patients with various solid tumors [5][6] - The CABWAR2 ADC OSV demonstrated an overall response rate (ORR) of 45% in patients with metastatic HPV-positive head and neck cancer, significantly outperforming the standard of care [8] - The McVe ADC has shown exceptional overall survival rates among heavily pretreated patients with MKRAS non-small cell lung cancer, with one-year and two-year landmark survival rates of 67% and 59%, respectively [9] Market Data and Key Metrics Changes - The company is focusing on indications with high unmet needs, such as colorectal cancer and cholangiocarcinoma, which have shown high expression of EpCAM and limited available therapies [18][19] - The company is progressing with partnering discussions across its CAB portfolio, indicating a strategic focus on collaboration for development and commercialization [10] Company Strategy and Development Direction - The company plans to present its strategy to NASDAQ to regain compliance with listing requirements, indicating a proactive approach to maintain its market position [10] - The company is positioning its OSV asset for a planned Phase III study and is seeking FDA guidance, reflecting a commitment to advancing its clinical pipeline [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in closing one or more partnering transactions this year, which could enhance financial stability and support key clinical activities [14][25] - The company is managing cash resources carefully and expects quarterly cash burn to decrease as it completes Phase II clinical trials [13][14] Other Important Information - The company has completed due diligence for one of its assets and is at the term sheet stage for a potential partnership, indicating progress in its strategic initiatives [10][11] Q&A Session Summary Question: Regarding the expansion cohort study, which indication is being pursued? - Management indicated that colorectal cancer is particularly attractive due to high EpCAM expression and unmet needs, although no formal decision has been made yet [18] Question: What are the tumor reduction levels for patients in the colorectal cancer cohort? - Management confirmed three patients with colorectal cancer have shown tumor reductions of -6%, -8%, and -10%, with additional patients in other cohorts also showing reductions [20] Question: Will there be updates on dosing cohorts? - Management stated that updates will be provided later this year, potentially during the ESMO meeting in October [22]