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SAN DIEGO - BioAtla, Inc. (NASDAQ:BCAB), a global biotechnology company with a market capitalization of $23.89 million, revealed promising data from a Phase 2 trial of its drug Ozuriftamab Vedotin (Oz-V) in patients with squamous cell carcinoma of the head and neck (SCCHN), specifically those with HPV-positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC). The findings, presented today at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, showed a 45% overall response rate (ORR) and a 100% disease control rate (DCR) in HPV+ OPSCC patients who had previously undergone a median of three lines of therapy. InvestingPro data shows the company maintains a healthy balance sheet with more cash than debt and a strong current ratio of 2.35.
The study involved 40 patients who received Oz-V, with tumor assessments conducted every six weeks up to week 12, then every eight weeks for up to a year. The treatment was administered at a dose of 1.8 mg/kg either once every two weeks or on days 1 and 8 of a 21-day cycle. Notably, all patients had failed prior anti-PD-1 therapy, and 85% had failed platinum therapy.
The efficacy analysis, which included 22 HPV+ OPSCC patients as of May 14, 2025, indicated that Oz-V showed significant antitumor activity. The median duration of response was 9.9 months, with median progression-free survival at 4.7 months and median overall survival at 11.6 months, which is ongoing.
In contrast, standard of care agents such as methotrexate, docetaxel, or cetuximab have demonstrated an ORR of only 3.4% and an overall survival of 4.4 months among HPV+ OPSCC patients. The safety data, based on the full dataset, highlighted that most adverse events were low grade, with fatigue and anemia being the most common. At the 1.8 mg/kg bi-weekly regimen, only three patients experienced related grade ≥3 adverse events, and there were no related serious adverse events.
BioAtla is planning to finalize the design of a Phase 3 trial for Oz-V in 2L+ HPV+ OPSCC with the U.S. Food and Drug Administration (FDA). The drug has already received Fast Track Designation, which could potentially lead to accelerated approval. According to InvestingPro analysis, analysts anticipate sales growth in the current year, despite the company’s current revenue of $11 million in the last twelve months. The stock is currently trading at $0.41, with InvestingPro’s Fair Value analysis suggesting potential upside.
The company aims to address the significant unmet need among the recurrent/metastatic HPV+ OPSCC population with Oz-V. BioAtla’s extensive patent portfolio supports its proprietary Conditionally Active Biologic (CAB) platform technology, which is designed to enhance selective targeting and efficacy of antibody drug conjugates. For investors seeking deeper insights, InvestingPro offers comprehensive analysis through its Pro Research Report, available for BCAB and 1,400+ other US stocks, providing detailed financial health metrics and expert analysis for informed investment decisions.
This news is based on a press release statement from BioAtla, Inc. and does not include any endorsements of the claims.
In other recent news, BioAtla reported a notable performance in its Q1 2025 earnings, surpassing analysts’ expectations with an earnings per share (EPS) of -$0.26 compared to the forecast of -$0.39. This improvement highlights the company’s effective cost management, including a reduction in research and development expenses from $18.9 million to $12.4 million year-over-year. BioAtla’s financial stability is further supported by a cash position of $32.4 million, which is anticipated to extend its cash runway into the first half of 2026. However, the company has received a delisting warning from Nasdaq due to non-compliance with the minimum stockholders’ equity requirement, with a shortfall from the $10 million threshold. BioAtla plans to submit a compliance plan by June 26, 2025, to address this issue.
In terms of analyst ratings, JMP Securities maintained a Market Outperform rating for BioAtla, reaffirming a $1.00 price target, citing optimism about the company’s strategic focus on clinical data and potential partnerships. The upcoming ESMO GI conference, where BioAtla plans to present initial data for its cancer therapeutic candidate BA3182, is seen as a potential catalyst. BioAtla’s pipeline includes three other assets being evaluated for partnership opportunities, which could provide additional financial support. Despite these developments, the broader competitive pressures and the need for further investment remain challenges for the company.
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