BioAtla(BCAB) - 2024 Q2 - Quarterly Results

Executive Summary & Recent Progress BioAtla achieved key clinical milestones, including FDA Fast Track Designation for ozuriftamab vedotin and favorable safety profiles for evalstotug and mecbotamab vedotin, while projecting cash to fund operations through Q3 2025 Key Clinical Milestones & Progress BioAtla achieved significant clinical milestones, including FDA Fast Track Designation for ozuriftamab vedotin and a trend for improved overall survival with mecbotamab vedotin - Ozuriftamab vedotin (CAB-ROR2-ADC) granted Fast Track Designation by FDA in squamous cell carcinoma of the head and neck (SCCHN); anticipate FDA meeting for SCCHN potential registrational trial in 2H 2024[1] - Evalstotug (CAB-CTLA-4 antibody) demonstrated a similar low incidence and severity of immune-related adverse events across both Phase 1 and 2 studies; Phase 2 combination with pembrolizumab study continues to enroll and on track for initial data readout in 2H 2024[1] - Mecbotamab vedotin (CAB-AXL-ADC) Phase 2 trial in NSCLC showed trend for improved overall survival among treated patients with tumors expressing mutated KRAS variants compared to KRAS wildtype; anti-tumor activity across multiple KRAS mutation variants including G12A, G12C, and G12V[1] Financial Highlights & Outlook BioAtla projects its current cash balance to fund operations through Q3 2025, sufficient to deliver clinical readouts and advance strategic collaboration discussions - Current cash balance projected to fund operations through Q3 2025, sufficient to deliver clinical readouts in multiple indications, position programs for one or more potentially registrational trials, and enhance strategic collaboration discussions[1] Clinical Program Updates This section provides updates on BioAtla's clinical programs, including ozuriftamab vedotin, evalstotug, mecbotamab vedotin, and BA3182 Ozuriftamab Vedotin (CAB-ROR2-ADC) The Phase 2 trial for ozuriftamab vedotin in treatment-refractory SCCHN demonstrated clinical responses in 11 out of 29 evaluable patients, leading to FDA Fast Track Designation, with data to be presented at ESMO - In the 29 evaluable patients to date, a total of 11 responses observed at the combined 2Q3W and Q2W dose regimens in treatment-refractory SCCHN[3] - Granted Fast Track Designation by FDA[3] - Data to be presented at upcoming poster presentation at ESMO in September[3] Evalstotug (CAB-CTLA-4 antibody) Evalstotug demonstrated a consistent low incidence of immune-related adverse events across Phase 1 and 2 studies, with confirmed responses in combination with PD-1, and initial Phase 2 data expected in 2H 2024 - Confirmed responses (3/8) with evalstotug (350 mg) in combination with PD-1 in patients who experienced failure of prior PD1 treatment[3] - Across 14 different tumor types, 10 patients with stable disease following monotherapy treatment; multiple patients experienced prolonged PFS (>10 months) to date[3] - Combined Phase 1 and Phase 2 safety (n=40) demonstrated low rate of grade 3 immune-related adverse events (irAEs) (4/40); no related grade 4 or 5 events; incidence and severity of irAEs consistent across Phase 1 and Phase 2 studies[3] - Phase 2 first-line melanoma and first-line NSCLC patients in combination with pembrolizumab continues to enroll; on track for initial melanoma data readout in 2H 2024[3] Mecbotamab Vedotin (CAB-AXL-ADC) The Phase 2 trial for mecbotamab vedotin in NSCLC showed anti-tumor activity correlated with AXL expression and multiple confirmed responses in patients with mutated KRAS variants, including a trend for improved overall survival - AXL expression ≥1% correlated with anti-tumor activity in both Q2W and 2Q3W dosing regimens[3] - Overall survival benefit trend observed among treated patients whose tumors express mutated KRAS compared to those with wildtype KRAS genotype[3] - Responses observed across patients with tumors expressing multiple KRAS mutation variants (G12A, G12C, and G12V), including a patient with prior sotorasib failure[3] - Manageable safety continues with no new safety signals identified[4] CAB-EpCAM x CAB-CD3 TCE (BA3182) The Phase 1/2 dose-escalation study for BA3182, a bispecific T-cell engager antibody, is progressing, with data readout from the Phase 1 study anticipated in 2H 2024 - Phase 1/2 dose-escalation study for CAB-EpCAM x CAB-CD3 TCE (BA3182) is progressing and on track for data readout of Phase 1 study in 2H 2024[4] Second Quarter 2024 Financial Results This section details BioAtla's financial performance for Q2 2024, highlighting operating expenses, net loss, and liquidity Operating Expenses Research and development expenses significantly decreased by $14.8 million year-over-year due to the completion of preclinical development for the Nectin-4 ADC and prioritization of clinical programs | Expense Type | Q2 2024 (in thousands) | Q2 2023 (in thousands) | Change (YoY) | | :------------------------------- | :--------------------- | :--------------------- | :----------- | | Research and development expense | $16,198 | $30,960 | -$14,762 | | General and administrative expense | $5,774 | $6,241 | -$467 | - The decrease in R&D expenses was primarily due to completion of pre-clinical development for the Nectin-4 ADC and the impact of prioritization of clinical programs in 2023[5] Net Loss The net loss for Q2 2024 significantly narrowed to $21.1 million, down from $35.8 million in Q2 2023, reflecting reduced operating expenses | Metric | Q2 2024 (in thousands) | Q2 2023 (in thousands) | Change (YoY) | | :----------------------------------- | :--------------------- | :--------------------- | :----------- | | Net loss and comprehensive loss | $(21,072) | $(35,752) | $14,680 | | Net loss per common share, basic and diluted | $(0.44) | $(0.75) | $0.31 | Cash Flow and Liquidity Net cash used in operating activities for the six months ended June 30, 2024, was $50.0 million. The company's cash and cash equivalents stood at $61.7 million as of June 30, 2024, which is projected to fund operations through Q3 2025 | Metric | June 30, 2024 (in thousands) | December 31, 2023 (in thousands) | Change | | :----------------------------------- | :--------------------------- | :------------------------------- | :----- | | Cash and cash equivalents | $61,662 | $111,471 | -$49,809 | - Net cash used in operating activities for the six months ended June 30, 2024, was $50.0 million, compared to $46.7 million for the same period in 2023[6] - Current cash and cash equivalents are expected to fund planned operations through Q3 of 2025[7] Product Candidate Descriptions This section provides detailed descriptions of BioAtla's key product candidates, including their mechanisms of action and targeted indications About Ozuriftamab Vedotin (BA3021) Ozuriftamab vedotin (CAB-ROR2-ADC) is a conditionally and reversibly active antibody drug conjugate targeting ROR2, a transmembrane receptor tyrosine kinase overexpressed in many solid tumors and associated with poor prognosis and resistance to therapies - Ozuriftamab vedotin is a conditionally and reversibly active antibody drug conjugate (ADC) directed against ROR2[9] - ROR2 is a transmembrane receptor tyrosine kinase present across many different solid tumors, including head and neck, lung, TNBC, and melanoma, and is associated with poor prognosis and resistance to chemo- and immunotherapies[9] - This Phase 2 clinical asset is targeting multiple solid tumor indications, including SCCHN patients who have previously progressed on PD-1/L1 therapies[9] About Evalstotug (BA3071) Evalstotug is a CAB anti-CTLA-4 antibody designed to deliver efficacy comparable to approved anti-CTLA-4 antibodies but with lower toxicities due to its tumor microenvironment-restricted activity, potentially enabling safer combination therapies with checkpoint inhibitors - Evalstotug is a CAB anti-CTLA-4 antibody developed as an immuno-oncology agent with tumor microenvironment-restricted activity to deliver efficacy with lower toxicities[10] - Aims to enable safer anti-CTLA-4 antibody combination therapies, such as with anti-PD-1 antibody checkpoint inhibitors, and potentially broaden the patient population tolerant to combination therapy[10] - Being developed as a potential therapeutic for multiple solid tumor indications responsive to CTLA-4 treatment in combination with a PD-1 blocking agent[10] About Mecbotamab Vedotin (BA3011) Mecbotamab vedotin (CAB-AXL-ADC) is a conditionally and reversibly active antibody drug conjugate targeting the receptor tyrosine kinase AXL. It has received Orphan Drug Designation for soft tissue sarcoma and targets multiple solid tumor indications, including NSCLC - Mecbotamab vedotin is a conditionally and reversibly active antibody drug conjugate (ADC) targeting the receptor tyrosine kinase AXL[11] - The Office of Orphan Products Development (OOPD) at FDA granted Orphan Drug Designation to mecbotamab vedotin for the treatment of soft tissue sarcoma[11] - This Phase 2 clinical asset is targeting multiple solid tumor indications, including NSCLC patients who have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapies[11] About CAB-EpCAM x CAB-CD3 Bispecific T-cell Engager Antibody (BA3182) BA3182 is a dual CAB bispecific T-cell engager antibody designed to selectively bind EpCAM (highly expressed on adenocarcinomas) and CD3ε in the tumor microenvironment, activating T-cell engagement against the tumor with reduced binding outside the TME - BA3182 is a (CAB) EpCAM x (CAB) CD3 bispecific T cell engager antibody that contains two binding sites for EpCAM and two binding sites for CD3ε[12] - The binding sites for EpCAM and CD3ε have been designed to bind their respective targets specifically and reversibly under the conditions found in the tumor microenvironment (TME) and to have reduced binding outside of the TME[12] - The CAB selective binding to both the CAB EpCAM and CAB CD3ε arms are required to activate the T cell engagement against the tumor[12] Company Overview This section provides an overview of BioAtla, highlighting its proprietary Conditionally Active Biologics (CAB) technology and its pipeline of clinical-stage product candidates About BioAtla, Inc. BioAtla is a global clinical-stage biotechnology company leveraging its proprietary Conditionally Active Biologics (CAB) technology to develop novel, reversibly active antibody therapeutics. The CAB technology aims for more selective targeting, greater efficacy with lower toxicity, and efficient manufacturing, backed by extensive patent coverage - BioAtla is a global clinical-stage biotechnology company utilizing its proprietary Conditionally Active Biologics (CAB) technology to develop novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates[13] - CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies[14] - BioAtla has extensive and worldwide patent coverage for its CAB technology and products with greater than 765 active patent matters, more than 500 of which are issued patents[14] - The company has two first-in-class CAB programs in Phase 2 (mecbotamab vedotin, ozuriftamab vedotin), a Phase 2 CAB-CTLA-4 antibody (evalstotug), and a first dual CAB bispecific T-cell engager antibody (BA3182) in Phase 1 development[14] Financial Statements This section presents BioAtla's unaudited condensed financial statements, including statements of operations and comprehensive loss, and consolidated balance sheets Unaudited Condensed Statements of Operations and Comprehensive Loss The condensed statements of operations show a significant reduction in net loss for both the three and six months ended June 30, 2024, primarily driven by decreased research and development expenses | Metric (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expense | $16,198 | $30,960 | $35,050 | $52,657 | | General and administrative expense | $5,774 | $6,241 | $11,379 | $13,474 | | Total operating expenses | $21,972 | $37,201 | $46,429 | $66,131 | | Loss from operations | $(21,972) | $(37,201) | $(46,429) | $(66,131) | | Interest income | $900 | $1,460 | $2,123 | $2,940 | | Net loss and comprehensive loss | $(21,072) | $(35,752) | $(44,306) | $(63,212) | | Net loss per common share, basic and diluted | $(0.44) | $(0.75) | $(0.92) | $(1.33) | | Weighted-average shares of common stock outstanding | 48,214,893 | 47,706,426 | 48,151,176 | 47,639,977 | Condensed Consolidated Balance Sheets Data The balance sheet data shows a decrease in cash and cash equivalents, total assets, and total liabilities from December 31, 2023, to June 30, 2024, reflecting ongoing operational activities | Metric (in thousands) | June 30, 2024 (unaudited) | December 31, 2023 | | :----------------------------------- | :------------------------ | :---------------- | | Cash and cash equivalents | $61,662 | $111,471 | | Total assets | $68,638 | $119,658 | | Total current liabilities | $17,462 | $28,344 | | Total liabilities | $37,268 | $48,986 | | Total stockholders' equity | $31,370 | $70,672 | | Total liabilities and stockholders' equity | $68,638 | $119,658 | Forward-Looking Statements This section provides a disclaimer regarding forward-looking statements, outlining inherent risks and uncertainties that could impact BioAtla's future results Forward-Looking Statements Disclaimer This section contains cautionary forward-looking statements regarding BioAtla's business plans, clinical trial outcomes, regulatory approvals, financial projections, and strategic collaborations. It highlights inherent risks and uncertainties that could cause actual results to differ materially from expectations, as detailed in SEC filings - Statements regarding BioAtla's business plans, clinical trial results, regulatory submissions, financial expectations, and strategic collaborations are forward-looking statements[15] - These statements are subject to substantial risks and uncertainties, including potential delays in clinical trials, inherent uncertainties in R&D, regulatory actions, and dependence on the CAB technology platform[15] - Factors that could cause actual results to differ materially are described in the 'Risk Factors' section of the company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC[16] Contact Information This section provides contact information for investor and media inquiries regarding BioAtla, Inc Investor and Media Contact This section provides contact details for investor and media inquiries, directed to BioAtla's Chief Financial Officer - Contact information for BioAtla, Inc.'s Chief Financial Officer, rwaldron@bioatla.com, 858.356.8945, is provided for inquiries[17]