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]

Financial Performance - The net loss for the three months ended June 30, 2025, was $18.7 million, a decrease of approximately $2.4 million compared to a net loss of $21.1 million for the same period in 2024[97]. - Total operating expenses for the six months ended June 30, 2025, were $36.3 million, a decrease of $10.2 million compared to $46.4 million for the same period in 2024[103]. - Research and development expenses decreased to $26.0 million for the six months ended June 30, 2025, down from $35.1 million in 2024, a reduction of approximately $9.0 million[104]. - General and administrative expenses were $10.2 million for the six months ended June 30, 2025, compared to $11.4 million in 2024, reflecting a decrease of about $1.2 million[105]. - Interest income fell to $0.6 million in the first half of 2025 from $2.1 million in the same period of 2024, a decline of $1.5 million[106]. Cash Position and Concerns - Cash and cash equivalents totaled approximately $18.2 million as of June 30, 2025, raising substantial doubt about the company's ability to continue operations for at least the next twelve months[87]. - As of June 30, 2025, the company had cash and cash equivalents of $18.2 million, with aggregate net losses and negative cash flows from operations anticipated to continue[108]. - The company anticipates that current cash and cash equivalents may not be sufficient to fund ongoing operations for at least twelve months, raising substantial doubt about its ability to continue as a going concern[111]. Research and Development - Research and development expenses for the three months ended June 30, 2025, were $13.7 million, down from $16.2 million in 2024, primarily due to a $1.2 million decrease in headcount-related expenses following a workforce reduction[98]. - Research and development expenses are expected to decrease in the near term as the company completes certain Phase 2 trials, but may increase with the initiation of new clinical trials[92]. Cost Management - The company has implemented cost-reduction initiatives, including a 30% workforce reduction and a significant reduction in lease footprint, to extend its cash runway[85]. - Net cash used in operating activities was $30.4 million for the six months ended June 30, 2025, compared to $50.0 million in 2024, indicating a decrease of $19.6 million[114][115]. Future Outlook - The company does not expect to generate meaningful revenue from product sales in the near future, relying on collaborations and licensing agreements for potential future milestone and royalty payments[88][89]. - Future funding requirements will depend on various factors, including the progress of clinical trials and the ability to secure additional financing[110]. Warrant Liability - The loss on warrant liability for the three months ended June 30, 2025, was $0.3 million, reflecting changes in the fair value of warrants issued in December 2024[102]. - The company reported a gain on warrant liability of $1.6 million for the six months ended June 30, 2025, compared to no gain in 2024[107]. Financing Activities - The December 2024 Offering raised approximately $9.2 million before expenses, with 9,679,158 shares issued at $0.9520 per share[109]. - The company has not entered into any off-balance sheet arrangements as defined by SEC regulations[120].

BioAtla's CAB Platform and Pipeline - BioAtla is a clinical-stage company focused on transforming cancer therapy with Conditionally Active Biologics (CABs)[9] - The CAB platform maximizes the therapeutic window and has broad applicability in solid tumors[10, 15] - BioAtla has proprietary technology with over 500 issued patents[10] BA3182 (CAB-EpCAM x CAB-CD3 TCE) - BA3182 is in Phase 1 dose escalation, with updated data expected in Q4 2025 and dose expansion planned for 1H 2026[10] - BA3182 targets EpCAM, which is expressed in a high percentage of various cancers, including 81% of breast cancers, 99% of prostate and pancreatic cancers, and 100% of colon cancers[37] - Preliminary data shows objective tumor size reductions in multiple tumor types, including a 13% reduction in intrahepatic cholangiocarcinoma[58, 59] - In a Phase 1 study with subcutaneous dosing (N=22), 91% of patients experienced any adverse events, but most were low-grade and manageable[56] Mecbotamab Vedotin (CAB-AXL-ADC) - Mecbotamab Vedotin (Mec-V) is being developed for mKRAS Non-Small Cell Lung Cancer (NSCLC)[63] - AXL is overexpressed in 70% to 85% of mKRAS NSCLC, driving aggressive tumor characteristics and resistance to therapies[72] - Mec-V at 1.8 mg/kg Q2W showed a 31% overall response rate (confirmed and unconfirmed) and a 67% one-year landmark overall survival in mKRAS NSCLC patients[74] Ozuriftamab Vedotin (CAB-ROR2-ADC) - Ozuriftamab Vedotin (Oz-V) is being developed for HPV+ Oropharyngeal Squamous Cell Carcinoma (OPSCC)[88] - In SCCHN patients, Oz-V at 1.8 mg/kg Q2W showed a 45% overall response rate (confirmed and unconfirmed) and a median overall survival of 11.6 months in p16+ patients[104] - A meeting with the FDA is planned in Q3 2025 to confirm the proposed Phase 3 study design in 2L+ HPV+ OPSCC[10, 120] Evalstotug (CAB-CTLA-4) - Evalstotug is a next-generation adaptation of Ipilimumab, selectively active in the tumor microenvironment to reduce immune-mediated adverse events[122] - In a study of 17 patients treated with Evalstotug at 350 mg in combination with PD-1, the overall response rate was 44%[141] - In unresectable and/or metastatic cutaneous melanoma patients treated with Evalstotug (5 – 14.3 mg/kg) in combination with a PD-1 antibody, the overall response rate was 67% and the disease control rate was 92%[146, 163]

Financial Performance - Net loss for Q2 2025 was $18.7 million, an improvement from a net loss of $21.1 million in Q2 2024, reflecting a reduction of 11.4%[12] - For the three months ended June 30, 2025, total operating expenses were $18,647,000, a decrease of 15.8% compared to $21,972,000 for the same period in 2024[27] - The net loss for the three months ended June 30, 2025, was $18,711,000, compared to a net loss of $21,072,000 for the same period in 2024, indicating a reduction of 11.5%[27] - The company reported a net loss per common share of $0.32 for the three months ended June 30, 2025, compared to $0.44 for the same period in 2024, showing an improvement of 27.3%[27] Expenses - Research and development (R&D) expenses for Q2 2025 were $13.7 million, down from $16.2 million in Q2 2024, a decrease of 15.4%[9] - General and administrative (G&A) expenses for Q2 2025 were $5.0 million, compared to $5.8 million in Q2 2024, a decrease of 13.8%[12] - Research and development expenses for the six months ended June 30, 2025, were $26,039,000, down from $35,050,000 in the same period of 2024, representing a 25.7% decrease[27] Cash and Assets - Net cash used in operating activities for the first half of 2025 was $30.4 million, down from $50.0 million in the same period of 2024, a decrease of 39.2%[13] - Cash and cash equivalents as of June 30, 2025, were $18.2 million, down from $49.0 million as of December 31, 2024[14] - Cash and cash equivalents decreased to $18,207,000 as of June 30, 2025, from $49,046,000 at the end of 2024, reflecting a decline of 62.9%[29] - Total assets decreased to $27,129,000 as of June 30, 2025, down from $52,422,000 at the end of 2024, a reduction of 48.2%[29] - Total liabilities increased to $43,874,000 as of June 30, 2025, compared to $38,157,000 at the end of 2024, representing a rise of 15.5%[29] Clinical Trials and Research - The Phase 1 study of BA3182 showed objective tumor size reductions in seven patients, with reductions of up to 25% in non-small cell lung cancer (NSCLC) patients[6] - The Phase 2 trial of ozuriftamab vedotin (Oz-V) demonstrated an overall response rate (ORR) of 45% in treatment-refractory HPV+ oropharyngeal squamous cell carcinoma patients[6] - The median duration of response for Oz-V was 9.9 months, with a median overall survival of 11.6 months[6] - Phase 1 data readout for BA3182 is expected in the second half of 2025, with cohort expansion data readout anticipated in the first half of 2026[5] Future Outlook - The company expects to close at least one transaction in 2025 as it advances partnering discussions across its portfolio[5] - The company anticipates needing additional funding to continue the development of its CAB technology platform and product candidates[23] - Forward-looking statements indicate potential delays in clinical trials and uncertainties in achieving anticipated clinical endpoints[23]