BOSTON - Allarity Therapeutics, Inc. (NASDAQ: ALLR), a clinical-stage biopharmaceutical company, has announced a milestone in its ongoing Phase 2 clinical trial for stenoparib, a novel therapy for advanced recurrent ovarian cancer. According to a recent press release, two patients in the trial have now surpassed one year of treatment with stenoparib, which is noteworthy given the heavily pre-treated nature of the patients and their limited treatment options.
Stenoparib is a dual inhibitor targeting both PARP and Tankyrase enzymes, which are involved in DNA repair and cell proliferation. The patients who have experienced extended treatment periods were pre-screened using Allarity's proprietary Drug Response Predictor (DRP®) companion diagnostic, which suggested a high likelihood of benefit from the drug.
The trial, which is being conducted at multiple sites in the United States and the United Kingdom, aims to evaluate the safety and efficacy of stenoparib. The treatment has led to a confirmed complete response in some patients, as well as long-term disease stability in others, indicating its potential as a valuable treatment option for this patient group.
Thomas Jensen, CEO of Allarity Therapeutics, expressed optimism about the sustained clinical benefit observed in the trial, emphasizing the significance of extending life in heavily pre-treated ovarian cancer patients. Dr. Fernanda B. Musa, Director of Clinical Research in Gynecology Oncology at the Swedish Cancer Institute and Principal Investigator for the trial, attributed the success to the personalized approach of matching the therapy to the patient's specific tumor profile.
Allarity is actively planning to advance the stenoparib program with a focus on moving towards regulatory approval. The trial's protocol was revised in Q1 2023 to optimize drug exposure by adjusting the dosing regimen. Further updates on the program's progress and future trials are expected in the coming months.
Stenoparib was originally developed by Eisai Co (OTC:ESAIY). Ltd. and Allarity now holds exclusive global rights for its development and commercialization. The DRP® companion diagnostic, which is based on messenger RNA expression profiles from patient biopsies, has been used to select patients for the trial and has shown promise in improving therapeutic benefit rates.
The information reported is based on a press release statement from Allarity Therapeutics. The company, headquartered in the U.S. with a research facility in Denmark, is committed to addressing unmet medical needs in cancer treatment. Further information about the company and its programs can be found on its website.
In other recent news, Allarity Therapeutics has made significant changes in its operations, including alterations to its executive team and financial strategies. The company expanded its At-The-Market (ATM) agreement with Ascendiant Capital Markets, raising the potential sale of company shares to a total of $50 million. In an executive reshuffle, Alexander Epshinsky was appointed as the new CFO, replacing Joan Y. Brown. Epshinsky's compensation includes a base salary of $340,000, a performance-based bonus, and equity in the form of restricted stock units valued at $160,000.
Simultaneously, Allarity Therapeutics executed a 1-for-30 reverse stock split of its common stock, a strategic move aimed at regaining compliance with Nasdaq's listing requirements. The company's stockholders also approved amendments to the company's Certificate of Incorporation, decreasing the number of authorized shares of common stock from 750 million to 250 million.
Moreover, the company's stockholders approved an amendment to the Allarity Therapeutics Inc. 2021 Equity Incentive Plan, increasing the number of shares authorized for grant from approximately 2.2 million to over 10.5 million. These changes align with Allarity's objectives to advance its pipeline of cancer therapies and to maintain its Nasdaq listing. These are the recent developments in Allarity Therapeutics.
InvestingPro Insights
As Allarity Therapeutics, Inc. (NASDAQ: ALLR) makes strides in its Phase 2 clinical trial for stenoparib, it's essential to consider the company's financial health and market performance. An InvestingPro Tip reveals that Allarity holds more cash than debt on its balance sheet, which could provide some financial stability as it continues its clinical trials. However, analysts are not optimistic about the company's profitability in the near term, with expectations set for continued unprofitability this year.
Looking at the real-time data from InvestingPro, Allarity's market capitalization currently stands at a modest $4.82 million, reflecting the company's small size within the biopharmaceutical industry. The stock's Price/Book ratio as of the last twelve months ending in Q2 2024 is 0.24, which may indicate that the stock is potentially undervalued relative to the company's book value. Additionally, the company has experienced a significant decline in stock price, with a one-year total return of -99.4% as of the specified date in 2024, highlighting the stock's volatility and the high-risk nature of investing in this sector.
While the clinical results show promise, investors should also be aware of the company's market performance. The stock has faced a steep decline over various time frames, including a one-month price total return of -32.5% and a three-month price total return of -75.01%, as of the same date in 2024. These metrics underscore the challenges Allarity faces in the market, despite the potential of its drug therapies.
For those interested in a deeper dive into Allarity's performance and future prospects, there are additional InvestingPro Tips available at https://www.investing.com/pro/ALLR. These tips provide valuable insights that could help investors make more informed decisions regarding their interest in Allarity Therapeutics.
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