Financial Data and Key Metrics Changes - Research and development (R&D) expenses for Q4 2024 were $11.6 million, down from $22.7 million in Q4 2023, a decrease of $11.1 million due to lower clinical development expenses [30] - General and administrative expenses were $4.6 million for Q4 2024, compared to $5.9 million in Q4 2023, a decrease of $1.3 million primarily due to lower stock-based compensation and personnel-related costs [31] - Net loss for Q4 2024 was $14.9 million, compared to a net loss of $26.9 million in Q4 2023 [31] - Cash and cash equivalents as of December 31, 2024, were $49 million, down from $111.5 million as of December 31, 2023 [32] Business Line Data and Key Metrics Changes - The CAB platform clinical programs are advancing, with promising results from the EpCAM and CAB CD3 bispecific T-cell engager antibody, showing tumor reduction in patients [9][12] - Mecbotamab Vedotin (Mec-V) demonstrated ongoing antitumor activity with multiple confirmed responses among 21 evaluable patients, with a median overall survival not yet reached at 35 months [15] - Ozuriftamab Vedotin (Oz-V) is showing a compelling clinical profile in treatment-refractory head and neck cancer patients, with a 100% disease control rate in HPV-positive patients [20][21] Market Data and Key Metrics Changes - The company is targeting a worldwide commercial opportunity of over $1 billion in peak sales for the second-line plus head and neck cancer population [22] - The overall survival rates for patients with MKRAS non-small cell lung cancer treated with Mec-V were reported at 66% and 58% at one and two years, respectively, exceeding standard care outcomes [15] Company Strategy and Development Direction - The company is focusing on advancing its internal priority programs while streamlining resources, including a workforce reduction of over 30% [28] - Discussions with potential collaborators for Phase 2 assets are ongoing, with a focus on the promising results from the CAB program [33] - The company is open to partnering discussions for various programs, including ROR2 and CTLA-4, to maximize shareholder value [78] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the clinical outcomes from the CAB program, highlighting its potential to transform treatment options for patients [33] - The company anticipates that the compelling results from its clinical trials will serve as important catalysts for future growth and partnerships [34] Other Important Information - The company has received fast track designation and actionable guidance from the FDA for the Oz-V monotherapy trial design [18] - The safety profile of Evalstotug, a CAB-CTLA-4 antibody, is differentiated with a low incidence of immune-mediated adverse events compared to traditional therapies [25] Q&A Session Summary Question: Update on partnered programs and discussions - Management indicated that discussions are ongoing for the ROR2 and CTLA-4 programs, with new interest expected due to recent data [36][38] Question: Data expectations for BA3182 - The company expects to report on the 300 microgram cohort data in the coming months, with potential for higher doses depending on patient recruitment [44][49] Question: HPV positive patients in head and neck cancer - Management noted that they do not have smoking correlation data for HPV positive patients but will obtain it post-call [63][66] Question: Future patient data for AXL program - The company plans to add more patients to the AXL program and is currently prioritizing the EpCAM program due to its broad applicability [75][76] Question: Strategic partnerships beyond ROR2 and CTLA-4 - Management is open to partnerships for other promising programs and is actively exploring various strategies to maximize shareholder value [78]

Financial Performance - The company reported net losses of $69.8 million and $123.5 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $486.0 million as of December 31, 2024[457]. - The net loss for 2024 was $69.8 million, an improvement from a net loss of $123.5 million in 2023, representing a decrease of approximately 43.5%[522]. - The company has not generated any revenue from product sales to date and does not expect to do so in the near future[461]. - The company reported collaboration and other revenue of $11 million for 2024, compared to no revenue in 2023[522]. Cash and Liquidity - Cash and cash equivalents totaled approximately $49.0 million as of December 31, 2024, raising concerns about the ability to fund ongoing operations for at least the next twelve months[460]. - The company anticipates that its current cash and cash equivalents may not be sufficient to fund ongoing operations for at least twelve months from the date of the financial statements[478]. - Cash provided by financing activities was $9.5 million for the year ended December 31, 2024, primarily from the issuance of common stock and warrants[485]. - Cash provided by financing activities was $77,000 for the year ended December 31, 2023, mainly from the issuance of common stock under the Employee Stock Purchase Plan[486]. - The company experienced a net decrease in cash and cash equivalents of $62.4 million in 2023 and $104.0 million in 2024[481]. - Cash and cash equivalents decreased from $111.5 million at the beginning of 2024 to $49 million at the end of the year, a decline of about 56%[528]. Research and Development - Research and development expenses decreased to $63.1 million in 2024 from $103.7 million in 2023, primarily due to reduced costs in preclinical and clinical programs[472]. - The company incurred $63.1 million in research and development expenses for 2024, with $5.7 million accrued for clinical trial costs as of December 31, 2024[515]. - Total program expenses for the Company's CAB products amounted to $43 million in 2024, down from $81.4 million in 2023[639]. - The Company has a proprietary platform for creating biologics, including several CAB drug candidates currently in clinical development[532]. Operating Expenses - Total operating expenses decreased from $129.7 million in 2023 to $84.9 million in 2024, a reduction of about 34.6%[522]. - General and administrative expenses decreased to $21.8 million in 2024 from $26.0 million in 2023, driven by lower stock-based compensation and insurance costs[473]. - Stock-based compensation expense for the year ended December 31, 2024, totaled $8.9 million, a decrease from $13.5 million in 2023[593]. Financing and Capital Needs - Future funding will depend on the pace and results of development efforts, with potential financing through equity offerings, debt, and collaborations[458]. - The company may need to raise additional capital through equity or debt financing, strategic collaborations, or a combination of these approaches[478]. - The company reported a significant reliance on external funding due to the high costs associated with research and development activities[479]. - The company may face challenges in securing additional financing in a timely manner or on favorable terms due to market volatility and economic conditions[480]. Tax and Regulatory Matters - The Company has federal and state net operating loss carryforwards of approximately $160.6 million and $42.0 million, respectively, with federal losses being carried forward indefinitely[631]. - A valuation allowance of approximately $102.7 million was established to offset deferred tax assets, which increased by approximately $17.0 million during 2024[630]. - The Company reported gross unrecognized tax benefits of approximately $4.6 million as of December 31, 2024, with no impact on the effective tax rate due to the valuation allowance[636]. - The Company is subject to examination by tax authorities since 2021, but is not currently under examination by any jurisdiction[637]. Collaboration and Licensing - The company recognized collaboration revenue of $11.0 million in 2024 from a licensing agreement with Context Therapeutics[462]. - In September 2024, the Company entered into a License Agreement with Context Therapeutics Inc., potentially worth up to $133.5 million in aggregate payments, including upfront cash and royalties on future net sales[608]. - The Company determined that the transfer of the License to Context did not meet criteria for recognizing revenue over time, leading to revenue recognition at the point of execution[611]. - The Company entered into a collaboration agreement with Bristol-Myers Squibb for clinical trials using two CAB ADCs, with no financial impact on the Company's results for 2023 and 2024[607]. Shareholder and Stock Information - The weighted-average shares of common stock outstanding increased from 47.8 million in 2023 to 48.6 million in 2024[522]. - The Company has authorized 200,000,000 shares of preferred stock and 350,000,000 shares of common stock[583]. - As of December 31, 2024, total common stock reserved for future issuance was 20,174,431 shares, up from 8,776,826 shares in 2023[602]. - The expected volatility for stock options granted in 2024 was 88.7%, compared to 77.9% in 2023[598].

Bioatla (BCAB) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants Bruce Mackle - Managing DirectorJay Short - Co-Founder, CEO & ChairmanRichard Waldron - Chief Financial OfficerEric Sievers - Chief Medical OfficerSheri Lydick - Chief Commercial OfficerTony Butler - Senior Managing Director Conference Call Participants Jeet Mukherjee - AnalystNone - AnalystArthur He - Analyst Operator is now my pleasure to turn the conference over to Mr. Bruce Mackle of LifeSci Advisors. Please go ahead, s ...

Financial Performance - Net loss for Q4 2024 was $14.9 million, compared to a net loss of $26.9 million in Q4 2023, indicating improved financial performance[12] - Net cash used in operating activities for the full year 2024 was $72.0 million, down from $104.0 million in 2023[13] - Net loss for the three months ended December 31, 2024, was $14,884, compared to a loss of $26,925 in 2023, indicating a 44.7% improvement[27] - Collaboration and other revenue for the twelve months ended December 31, 2024, was $11,000, compared to $0 in 2023[27] Research and Development - Research and development (R&D) expenses for Q4 2024 were $11.6 million, down from $22.7 million in Q4 2023, reflecting a decrease of $11.1 million due to lower clinical development expenses[10] - The company expects R&D expenses to continue decreasing in the first half of 2025 due to recent restructuring and focus on prioritized programs[10] - Research and development expenses for the three months ended December 31, 2024, were $11,650, a decrease of 48.7% from $22,674 in 2023[27] Cash and Assets - Cash and cash equivalents as of December 31, 2024, were $49.0 million, down from $111.5 million as of December 31, 2023, with expectations of extending runway beyond key clinical readouts in 1H 2026[14] - Cash and cash equivalents decreased to $49,046 as of December 31, 2024, from $111,471 in 2023, reflecting a decline of 56.0%[29] - Total assets decreased to $52,422 as of December 31, 2024, from $119,658 in 2023, a reduction of 56.2%[29] - Total stockholders' equity fell to $14,265 as of December 31, 2024, down from $70,672 in 2023, representing a decline of 79.8%[29] Operating Expenses - Total operating expenses for the twelve months ended December 31, 2024, were $84,943, down from $129,687 in 2023, representing a reduction of 34.5%[27] - Total current liabilities decreased to $14,540 as of December 31, 2024, from $28,344 in 2023, a reduction of 48.6%[29] Clinical Trials and Collaborations - The Phase 1 dose-escalation study for CAB-EpCAM x CAB-CD3 (BA3182) is ongoing, with data readout expected in mid-2025[5] - Mecbotamab vedotin (CAB-AXL-ADC) demonstrated a 66% overall survival rate at one year and 58% at two years among patients with mKRAS NSCLC[5] - Ozuriftamab vedotin (CAB-ROR2-ADC) showed a 45% overall response rate (ORR) in treatment-refractory, metastatic HPV-positive squamous cell carcinoma of the head and neck[8] - The company has initiated discussions for potential collaborations on Phase 2 assets while restructuring to reduce costs and extend operational runway[3] Income and Interest - Interest income for the twelve months ended December 31, 2024, was $3,369, compared to $6,312 in 2023, a decrease of 46.5%[27] - The company reported a total other income of $4,167 for the twelve months ended December 31, 2024, down from $6,225 in 2023, a decline of 32.9%[27] Workforce and Restructuring - The company plans to retain essential employees while reducing workforce by over 30% to support value creation and advance prioritized internal programs[12]

Core Insights - BioAtla, Inc. reported encouraging clinical outcomes from its Conditionally Active Biologic (CAB) platform, particularly in its Phase 1 dose-escalation study for dual conditionally-binding EpCAM and CD3, with multiple patients showing tumor reduction and tolerating therapy without progression [2][4][5] - The company has restructured its organization to reduce costs and extend its financial runway, focusing on prioritizing patient recruitment for programs expected to yield transformative results [2][10][13] Financial Performance - For Q4 2024, research and development (R&D) expenses were $11.6 million, down from $22.7 million in Q4 2023, attributed to lower clinical development expenses due to program prioritization [10] - General and administrative (G&A) expenses decreased to $4.6 million in Q4 2024 from $5.9 million in Q4 2023, primarily due to lower stock-based compensation and personnel costs [11] - The net loss for Q4 2024 was $14.9 million, a reduction from a net loss of $26.9 million in the same quarter of 2023 [11] - Cash and cash equivalents at year-end 2024 stood at $49 million, down from $111.5 million at the end of 2023, with expectations that cost reductions will extend the runway beyond key clinical readouts in 1H 2026 [13][26] Clinical Program Updates - The Phase 1 dose-escalation study for CAB-EpCAM x CAB-CD3 (BA3182) is ongoing, with data readout expected in mid-2025, and dose expansion data anticipated in 1H 2026 [4][5] - Mecbotamab vedotin (CAB-AXL-ADC) demonstrated a 66% overall survival rate at one year and 58% at two years among patients with mKRAS NSCLC, exceeding standard care benchmarks [4][9] - Ozuriftamab vedotin (CAB-ROR2-ADC) showed promising anti-tumor activity in treatment-refractory metastatic HPV-positive squamous cell carcinoma of the head and neck, with a 45% overall response rate [4][19] Corporate Strategy and Future Outlook - The company is advancing multiple discussions with potential collaborators for its Phase 2 assets while initiating new partnerships [2][6] - BioAtla is focusing on its two internal priority programs and has initiated workforce reductions of over 30% to align resources effectively [10][12] - The management plans to host a conference call to discuss these developments and financial results, indicating a commitment to transparency with stakeholders [14]

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 announced two abstracts accepted for poster presentations at the European Lung Cancer Congress (ELCC) 2025 and the Mayo Clinic Multidisciplinary Head and Neck Cancer Symposium 2025 [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 proprietary CAB 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] Clinical Development - BioAtla 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 company is also developing evalstotug, a Phase 2 CAB-CTLA-4 antibody designed to reduce systemic toxicity and enable safer combination therapies with checkpoint inhibitors [3] - The first dual CAB bispecific T-cell engager antibody, BA3182, is currently in Phase 1 development, targeting EpCAM on adenocarcinomas while engaging human CD3 expressing T cells [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] - The company will host a conference call on March 27, 2025, to discuss its financial results for Q4 and the full year ended December 31, 2024 [1][2] Company Overview - BioAtla operates in San Diego, California, and has a partnership in Beijing, China for preclinical development services [3] - The company utilizes proprietary CAB 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 over 780 active patent matters, with more than 500 issued patents, covering methods of making, screening, and manufacturing CAB product candidates [3] Clinical Development - BioAtla 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 company is also developing evalstotug, a CAB-CTLA-4 antibody designed to reduce systemic toxicity and enable safer combination therapies with checkpoint inhibitors [3] - BA3182, the first dual CAB bispecific T-cell engager antibody, is currently in Phase 1 development, targeting EpCAM on adenocarcinomas [3]

Core Viewpoint - BioAtla, Inc. has announced a registered direct offering of 9,679,158 shares of common stock, aiming to raise approximately $9.2 million to fund its research and development efforts, particularly for its mid-stage clinical programs [1][4]. Group 1: Offering Details - The offering includes warrants to purchase one share of common stock at an exercise price of $1.19 per share, with a combined offering price of $0.9520 per share and warrant [1]. - The closing of the offering is expected to occur on or about December 20, 2024, subject to customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds will be used to fund research and development, including key inflection points for the mid-stage clinical TCell Engager (TCE) and Antibody Drug Conjugate (ADC) programs [4]. - Specific programs mentioned include BA3182 (Phase 1 data expected in 2Q25) and mecbotamab vedotin (Phase 2B data expected in 1H26) [4]. Group 3: Company Overview - BioAtla is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][10]. - The company has two first-in-class CAB programs in Phase 2 clinical testing and a dual CAB bispecific T-cell engager antibody in Phase 1 development [10]. - BioAtla holds extensive patent coverage for its CAB technology, with over 780 active patent matters [10].

Core Insights - BioAtla, Inc. presented data indicating improved one-year overall survival (OS) for patients with treatment-refractory non-small cell lung cancer (NSCLC) expressing mutated KRAS (mKRAS) treated with Mecbotamab Vedotin (Mec-V) compared to those with wild-type KRAS (wtKRAS) [1][2] - The one-year OS was reported at 58% for mKRAS patients versus 23% for wtKRAS patients, suggesting Mec-V's potential as a promising treatment option across all KRAS mutation variants [2][3] - A randomized trial of Mec-V in patients with treatment-refractory mKRAS NSCLC is planned for initiation in 2025 based on these findings [2] Company Overview - BioAtla, Inc. is a global clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][4] - The company has two first-in-class CAB programs currently in Phase 2 clinical testing: Mecbotamab Vedotin targeting AXL and ozuriftamab vedotin targeting ROR2 [5] - BioAtla has extensive patent coverage for its CAB technology, with over 780 active patent matters, including more than 500 issued patents [5] Clinical Trial Data - The Phase 2 trial of Mec-V enrolled 78 patients, with 30.7% having mKRAS NSCLC [3] - Among the 21 efficacy-evaluable patients with mKRAS NSCLC, the overall response rate (ORR) was 28.6%, with notable antitumor activity observed across 9 different mKRAS variants [3] - Treatment with Mec-V was well tolerated, showing a manageable safety profile without new safety signals [3] AXL Expression and KRAS Mutation - A strong correlation was confirmed between KRAS mutations and AXL expression, with 70.3% of NSCLC samples harboring any KRAS mutation showing high AXL expression [2][3] - Among the mKRAS G12C variant subset, 81.8% exhibited high AXL expression, reinforcing the relevance of AXL as a therapeutic target [3]

Core Insights - BioAtla, Inc. presented promising data on Mecbotamab Vedotin (Mec-V) for treatment-refractory non-small cell lung cancer (NSCLC) with mutated KRAS (mKRAS), showing a one-year overall survival (OS) of 58% compared to 23% for wild-type KRAS (wtKRAS) patients [1][3][4] Group 1: Clinical Trial Results - The Phase 2 trial of Mec-V included 78 patients, with 30.7% having mKRAS NSCLC [4] - Among patients with mKRAS NSCLC, the median OS was not yet reached, while the median OS for wtKRAS was 8.7 months [4] - The overall response rate (ORR) for mKRAS NSCLC patients was 28.6%, with notable antitumor activity across 9 different mKRAS variants [4] Group 2: Mechanism and Targeting - Mec-V is a conditionally active antibody-drug conjugate targeting AXL, which is highly expressed in mKRAS NSCLC [6][4] - A strong correlation was confirmed between mKRAS mutations and AXL expression, with 70.3% of NSCLC samples harboring KRAS mutations showing high AXL expression [3][4] Group 3: Future Plans - BioAtla plans to initiate a randomized trial of Mec-V in 2025 for patients with treatment-refractory mKRAS NSCLC based on the encouraging findings [3][4] - The company has received Orphan Drug Designation from the FDA for Mec-V in treating soft tissue sarcoma, indicating its potential across multiple solid tumor indications [6]