SAN DIEGO - BioAtla, Inc. (NASDAQ:BCAB), a biotechnology firm specializing in the development of antibody therapeutics, has released Phase 2 clinical trial data demonstrating significant efficacy of its drug ozuriftamab vedotin in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The study results were presented at the European Society for Medical Oncology (ESMO) Annual Meeting.
The trial evaluated the response of 32 heavily pretreated patients to two dosing regimens of ozuriftamab vedotin, a conditionally active biologic (CAB) targeting the ROR2 receptor. With a 32% overall response rate (ORR) and a disease control rate (DCR) of 77%, the drug showed a promising profile in a patient population with a high unmet medical need.
Patients enrolled in the trial had previously experienced treatment failure with PD-1/L1 inhibitors and/or platinum-based chemotherapy. Ozuriftamab vedotin was administered at 1.8 mg/kg either every other week or on days 1 and 8 of ongoing three-week cycles. The responses, which included one complete response (CR), nine partial responses (PRs), and 14 cases of stable disease (SD), were observed across both dosing regimens.
The drug was well tolerated, with most adverse events being low-grade. Fatigue, anemia, and nausea were the most frequent side effects, and only six patients (19%) experienced grade 3 treatment-related adverse events. There were no grade 5 treatment-related adverse events reported, and only two patients discontinued due to adverse events related to the study drug.
Given the positive data, BioAtla intends to discuss a potential registrational trial with the FDA in the second half of 2024. The company aims to evaluate ozuriftamab vedotin monotherapy against the investigator's choice for patients with recurrent or metastatic SCCHN who have previously received platinum/PD-1 inhibitor agents.
Ozuriftamab vedotin has been granted FDA Fast Track Designation and is part of BioAtla's portfolio of CAB antibody therapeutics targeting solid tumors. The company boasts extensive patent coverage for its CAB technology and products, with more than 765 active patent matters, including over 500 issued patents.
This news is based on a press release statement from BioAtla, Inc., and the presentation materials are expected to be available on the company's website following the conference.
In other recent news, BioAtla Inc. has been reaffirmed as a 'Buy' by BTIG, in anticipation of significant milestones expected in the second half of 2024. These include regulatory guidance on multiple assets, partnerships for non-dilutive financing, and advancing a program to a registrational path. In the company's second quarter 2024 earnings call, BioAtla reported a net loss of $21.1 million, with cash and cash equivalents totaling $61.7 million. This is expected to fund operations through the third quarter of 2025.
BioAtla's ozuriftamab vedotin monotherapy in head and neck cancer has received Fast Track designation from the FDA. The company also highlighted the potential of its evalstotug antibody for combined immune checkpoint inhibition. BioAtla is set to present data at upcoming medical meetings and is optimistic about establishing partnerships later this year.
However, the company reported a significant decrease in cash reserves from $111.5 million at the end of 2023 to $61.7 million as of June 30, 2024. Lastly, no additional patients will be enrolled in the monotherapy study of the CTLA-4 antibody, with a focus shifting to combination approaches.
InvestingPro Insights
BioAtla, Inc. (NASDAQ:BCAB) has shown promising results in its recent Phase 2 clinical trial, but an analysis of the company's financial health and market performance reveals a complex picture. According to InvestingPro data, BioAtla has a market capitalization of approximately $84.15 million, indicating a relatively small player in the biotech industry. The company's negative P/E ratio of -0.82, adjusted to -0.84 for the last twelve months as of Q2 2024, suggests that investors are not expecting earnings in the near term. Additionally, the company's price/book ratio stands at 2.79, which could be seen as a reasonable valuation in relation to its book value.
On the operational front, InvestingPro Tips indicate that BioAtla holds more cash than debt, which is a positive sign of financial stability. Moreover, liquid assets exceed short-term obligations, providing the company with some financial flexibility. However, analysts have raised concerns about the company's cash burn, weak gross profit margins, and the lack of profitability over the last twelve months. This is reflected in the substantial negative operating income of -$109.98 million and an EBITDA of -$108.88 million for the same period. Despite these challenges, two analysts have revised their earnings upwards for the upcoming period, hinting at potential optimism in the company's future performance.
It is also worth noting that BioAtla does not pay dividends, which is not uncommon for biotech firms that often reinvest earnings into research and development. For investors interested in a deeper dive into BioAtla's financials and market performance, InvestingPro provides additional tips, with a total of 9 InvestingPro Tips available at https://www.investing.com/pro/BCAB, offering more nuanced insights into the company's prospects.
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