SAN DIEGO - Kintara Therapeutics, Inc. (NASDAQ:KTRA), a biopharmaceutical company specializing in the development of novel cancer therapies, today announced an update to its ongoing REM-001 clinical trial.
The company has expanded the inclusion criteria for its study on cutaneous metastatic breast cancer (CMBC) to now encompass patients who have been receiving the immunotherapy drug pembrolizumab for a minimum of three months at the time of screening.
The REM-001 study is a small-scale, open-label trial currently screening and dosing 15 CMBC patients. This trial is designed to test a 0.8 mg dose of REM-001, a second-generation photodynamic therapy photosensitizer agent, and to refine the study design before progressing to a Phase 3 trial.
The study's primary endpoint is to measure the Best Overall Objective Response Rate (bORR), which includes both complete and partial responses of the target treatment fields up to and including week 24.
The financial burden of the study is primarily offset by a $2.0 million Small Business Innovation Research (SBIR) grant awarded to Kintara by the National Institutes of Health (NIH).
Robert E. Hoffman, President and CEO of Kintara, expressed optimism about the study's progress, stating that the inclusion of patients treated with pembrolizumab is expected to significantly boost enrollment. Hoffman also noted that Kintara is actively exploring strategic options to enhance shareholder value, underpinned by a strengthened balance sheet.
Kintara's primary focus is the development of REM-001 Therapy for CMBC, a condition that currently has limited treatment options. REM-001 Therapy includes a laser light source, a light delivery device, and the REM-001 drug product.
The therapy has been evaluated in four Phase 2/3 clinical trials, demonstrating a clinical efficacy rate of 80% complete responses in CMBC evaluable lesions, with a robust safety profile established across approximately 1,100 patients in various indications.
The company's forward-looking statements are based on current expectations but recognize that actual results may differ due to various risk factors and uncertainties, including the potential for changes in clinical trial outcomes, regulatory approval processes, and market conditions.
This report is based on a press release statement from Kintara Therapeutics.
InvestingPro Insights
As Kintara Therapeutics, Inc. (NASDAQ:KTRA) continues to advance its REM-001 clinical trial, the company's financial health and market performance provide a broader context for evaluating its prospects.
According to InvestingPro data, Kintara has a modest market capitalization of $3.51 million USD. This relatively small size in the biopharmaceutical landscape may influence its ability to fund ongoing and future trials without significant financial partnerships or support mechanisms like the SBIR grant.
InvestingPro Tips highlight several challenges the company faces. Kintara is quickly burning through its cash reserves, which is a critical factor for a company that is not yet profitable and has no revenue streams from marketed products.
Analysts do not anticipate Kintara will be profitable this year, and the company's weak gross profit margins could further strain its financial position. These considerations are particularly relevant for investors, as the success of clinical trials like REM-001 is often tied to a company's ability to sustain long-term research and development efforts.
The stock's performance also raises concerns, with a significant price drop of over 97% in the last six months and a price that is currently at only 1.5% of its 52-week high. This trend reflects market sentiment and the high-risk nature of investing in early-stage biopharmaceutical companies. However, it's worth noting that Kintara's REM-001 Therapy has shown promise in previous clinical trials, which could provide a basis for future recovery if the ongoing studies yield positive results.
Investors interested in the detailed analysis can find additional InvestingPro Tips for Kintara, which can offer deeper insights into the company's financial health and market performance. For those seeking to explore these insights further, InvestingPro offers a wealth of additional tips, and users can take advantage of a special offer using coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.