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BioAtla Enters into Agreements for up to $22.5 Million Flexible Financing
Globenewswire· 2025-11-21 05:25
Core Viewpoint - BioAtla, Inc. has secured a total of $7.5 million in advance funding through agreements with Yorkville Advisors and Anson Advisors, aimed at maintaining operational momentum while finalizing a strategic partnership that is expected to enhance shareholder value [1][2][7] Financial Agreements - The pre-paid advance agreement involves $7.5 million purchased at 95% of face value, resulting in gross proceeds of $7.125 million at closing, with an interest rate of 4% [2] - The Standby Equity Purchase Agreement allows Yorkville to purchase up to $15 million of common stock at a 3% discount to market prices over three years, contingent on certain conditions [1][2] Strategic Partnership - The company is in advanced stages of finalizing a strategic transaction with a potential partner, with expectations to complete this by year-end [2][7] - These financial agreements are designed to provide flexibility and support operations during the partnership finalization process [7] Company Overview - BioAtla is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors, with operations in San Diego and Beijing [6] - The company utilizes its proprietary CAB platform technology to create novel monoclonal and bispecific antibodies, aiming for selective targeting and reduced toxicity compared to traditional antibodies [6] Product Pipeline - Ozuriftamab vedotin (Oz-V) is a key clinical asset targeting ROR2 in various solid tumors, with FDA Fast Track Designation for recurrent or metastatic SCCHN [8] - BA3182, a bispecific T-cell engager antibody, is under Phase 1 study for advanced adenocarcinoma, designed for selective binding in the tumor microenvironment [9]
BioAtla(BCAB) - 2025 Q3 - Earnings Call Transcript
2025-11-13 22:30
Financial Data and Key Metrics Changes - As of September 30, 2025, the company reported cash and cash equivalents of $8.3 million, which does not include a recent $2 million milestone payment received in October 2025 [12] - The net loss for the third quarter of 2025 was $15.8 million, an increase from a net loss of $10.6 million in the same quarter of 2024, primarily due to the absence of collaboration revenue recorded in 2024 [12][13] - Research and development (R&D) expenses decreased to $9.5 million in Q3 2025 from $16.4 million in Q3 2024, driven by reduced program development costs and lower headcount-related expenses [13] - General and administrative (G&A) expenses were $4.2 million for Q3 2025, down from $5.9 million in Q3 2024, attributed to reduced personnel costs [14] Business Line Data and Key Metrics Changes - The company is preparing to initiate a phase 3 study for OSV, which has shown promising clinical activity in heavily pretreated patients with HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) [5][7] - The dual CAB, EpCAM, T-cell engager program is progressing well, with preliminary data indicating a manageable safety profile and encouraging signs of tumor reductions across various indications [10] Market Data and Key Metrics Changes - The worldwide peak sales estimate for OSV in second-line and later OPSCC is approximately $800 million, with the total worldwide OPSCC market projected to reach $3 billion by 2032 [7] - The broader HPV-positive solid tumor market, including cervical cancer, is valued at over $7 billion globally [8] Company Strategy and Development Direction - The company is in advanced stages to finalize a strategic transaction with a potential partner by year-end, indicating a focus on collaboration and partnerships [4][5] - The company aims to address critical unmet needs in oncology through its prioritized programs, particularly the dual CAB, EpCAM, TCE program, which has the potential to treat over 1 million adenocarcinoma cancer patients annually [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming phase 3 trial for OPSCC, which addresses a significant unmet need and represents a substantial commercial opportunity [15] - The company anticipates key clinical trial readouts in the first half of next year, with several important events related to its programs throughout 2026 [15] Other Important Information - The company achieved FDA alignment on the phase 3 OSV registrational trial design, which includes dual primary endpoints of overall response rate and overall survival [4][5] - A development milestone was achieved under the license agreement with Context Therapeutics, validating the T-cell engager platform [5] Q&A Session Summary Question: Can you provide details on the patient number for the ROR-2 program's phase 3 study and control arm stratification? - The pivotal trial design for full approval involves approximately 300 patients, with an interim analysis for accelerated approval occurring earlier [18][19] Question: What data can be expected from the 3182 program next year? - The next data output is anticipated in the first half of next year, with comprehensive reporting on additional dose and schedule evaluations [21][22]
BioAtla Reports Third Quarter 2025 Financial Results and Highlights Recent Progress
Globenewswire· 2025-11-13 21:05
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].
BioAtla Presents Promising Interim Data from its Phase 1 Trial with BA3182 in Patients with Treatment Refractory Metastatic Adenocarcinoma at ESMO 2025
Globenewswire· 2025-10-20 12:00
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]
BioAtla to Announce Second Quarter 2025 Financial Results and Provide Business Highlights on August 7, 2025
GlobeNewswire News Room· 2025-08-04 12:00
Core Viewpoint - BioAtla, Inc. is set to discuss its financial results for Q2 2025 and provide business highlights during a conference call on August 7, 2025 [1][2] Company Overview - BioAtla is a global clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][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]
BioAtla Announces Upcoming Oral Presentation at the 2025 European Society for Medical Oncology (ESMO) TAT Asia Meeting
Globenewswire· 2025-07-17 12:00
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 present a first-in-human phase I study of a dual-CAB EpCAM x CD3 bispecific T-cell engager (TCE), BA3182, targeting treatment refractory metastatic adenocarcinoma at the 2025 ESMO TAT Asia Meeting [2] Company Overview - BioAtla operates in San Diego, California, and has a presence in Beijing, China through a partnership with BioDuro-Sundia for preclinical development services [3] - 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 [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]
BioAtla Reports First Quarter 2025 Financial Results and Highlights Recent Progress
Globenewswire· 2025-05-06 20:05
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].
BioAtla to Participate in the Citizens Life Sciences Conference
Globenewswire· 2025-04-30 12:00
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]
BioAtla to Announce First Quarter 2025 Financial Results and Provide Business Highlights on May 6, 2025
Globenewswire· 2025-04-29 12:00
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].
BioAtla Announces Upcoming Poster Presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
Globenewswire· 2025-04-23 14:05
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 present a Phase 2 trial of ozuriftamab vedotin (BA3021) at the 2025 ASCO Annual Meeting [1][2] Company Overview - BioAtla operates in San Diego, California, and Beijing, China, through a partnership with BioDuro-Sundia 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 [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] Clinical Development - BioAtla's first dual CAB bispecific T-cell engager antibody, BA3182, is in Phase 1 development, targeting EpCAM on 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 [3]