SAN DIEGO – Kintara Therapeutics, Inc. (NASDAQ:KTRA), a biopharmaceutical company, today announced the launch of a clinical trial for REM-001, a treatment for cutaneous metastatic breast cancer (CMBC). The study will involve 15 patients and aims to confirm the planned dose and optimize the study design in preparation for a Phase 3 clinical trial.
The primary goal of the open-label trial is to assess the Best Overall Objective Response Rate (bORR) of the target treatment fields at any time up to 24 weeks post-treatment. REM-001 is a second-generation photodynamic therapy (PDT) photosensitizer agent, and the trial will evaluate a 0.8 mg dose.
In June 2023, Kintara received a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001 in CMBC. This grant is expected to cover the majority of the costs associated with the clinical study.
Robert E. Hoffman, President and CEO of Kintara, expressed confidence in REM-001’s potential to help CMBC patients, citing an 80% complete response rate for evaluable lesions in CMBC patients observed in previous late-stage clinical trials. The therapy has also received Fast Track Designation from the FDA.
Dr. Alina Markova, Principal Investigator of the study and Section Head at Memorial Sloan Kettering Cancer Center, highlighted the limited treatment options for CMBC and the importance of developing new therapies for these patients.
The prevalence of CMBC is significant, with over 40,000 cases annually in the United States. Kintara focuses on the development of novel cancer therapies for patients with unmet medical needs. REM-001 Therapy has been studied in four Phase 2/3 clinical trials and has a robust safety database of approximately 1,100 patients across multiple indications.
The information in this article is based on a press release statement from Kintara Therapeutics.
As Kintara Therapeutics (NASDAQ:KTRA) embarks on a new clinical trial for REM-001, investors are closely monitoring the company’s financial health and market performance. According to InvestingPro data, Kintara’s market capitalization stands at a modest $0.42 million, reflecting the small size of the biopharmaceutical firm. The company’s P/E ratio, both standard and adjusted for the last twelve months as of Q1 2024, is deeply negative at -0.02 and -0.03 respectively, indicating that the company is not currently generating profits.
InvestingPro Tips shed light on some critical aspects of Kintara’s financial situation. Management’s aggressive share buyback strategy could be seen as a vote of confidence in the company’s future prospects, despite the fact that Kintara is quickly burning through cash. Moreover, the company’s weak gross profit margins and the fact that short-term obligations exceed liquid assets present challenges that investors should consider. Analysts contributing to InvestingPro do not anticipate Kintara will be profitable this year, which aligns with the negative P/E ratio.
Furthermore, Kintara’s stock performance has been underwhelming, with significant price declines over the last year, three months, and six months, as evidenced by the negative total returns of -98.03%, -67.49%, and -96.5% respectively. These trends are important for potential investors to consider, especially those looking for long-term growth opportunities.
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