COPENHAGEN - Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage biotechnology company, has announced significant progress in its Phase 2 clinical trial of the EVX-01 cancer vaccine, with the first patient completing the dosing regimen. The trial, which began in September 2022, is evaluating the efficacy and safety of EVX-01 in patients with metastatic melanoma.
EVX-01, Evaxion's lead clinical asset, is a personalized cancer vaccine developed using the company's proprietary AI-Immunology™ platform. The vaccine is tailored to each patient's unique tumor profile and immune system characteristics. Patients in the trial receive a series of ten EVX-01 doses over 78 weeks, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy.
The company reported a favorable safety profile for EVX-01, consistent with findings from an earlier Phase 1 clinical trial. The one-year clinical efficacy readout is expected in the third quarter of 2024. Birgitte Rønø, CSO of Evaxion, expressed optimism about the potential of AI-Immunology™ to save and improve lives through personalized cancer vaccines.
The Phase 2 study is an open-label, single-arm, multi-center trial conducted in collaboration with Merck Sharp (OTC:SHCAY) & Dohme LLC. It involves leading principal investigators and research centers from Italy and Australia and is focused on treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma.
Evaxion's AI-Immunology™ platform aims to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. The company's pipeline includes clinical-stage oncology vaccines and preclinical infectious disease programs.
This announcement is based on a press release statement from Evaxion Biotech and contains forward-looking statements regarding the anticipated outcomes of the clinical trial. Actual results may vary due to a range of factors, including the inherent risks of clinical trial development and potential regulatory hurdles.
InvestingPro Insights
As Evaxion Biotech advances its clinical trials, investors and stakeholders are keeping a close watch on the company's financial health and market performance. According to recent data from InvestingPro, Evaxion's market capitalization stands at a modest 21.07 million USD, reflecting the small but focused nature of this niche player in the biotech industry.
The company's stock has experienced considerable price volatility, a characteristic that has persisted over the last year. This is further evidenced by the notable 36.79% return over the last month, juxtaposed against a steep 76.49% decline over the past year.
Such fluctuations highlight the stock's tendency to move independently of market trends, which could be attributed to investor reactions to clinical trial updates and the inherent risks associated with biotech ventures.
Financially, Evaxion's cash burn is a critical factor to consider, as reflected in the company's negative P/E ratio of -0.49 and an adjusted P/E ratio for the last twelve months as of Q4 2023 at -0.95. This suggests that the company is not currently profitable, a status that analysts do not expect to change within this fiscal year.
With gross profit margins at 100% for the same period, it indicates that while Evaxion is generating revenue, the costs associated with its research and development activities are significantly high, leading to a substantial operating loss of -22.2 million USD.
For those interested in further insights, InvestingPro provides additional InvestingPro Tips for Evaxion, including detailed analysis on stock performance, valuation, and industry positioning. There are a total of 14 tips available on InvestingPro, which can serve as a valuable resource for investors looking to make informed decisions. To explore these tips and gain deeper investment insights, visit https://www.investing.com/pro/EVAX.
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