Company Overview
TuHURA Biosciences, Inc. (NASDAQ:HURA), formerly known as Kintara Therapeutics, Inc., is a biopharmaceutical company that has undergone a significant transformation, positioning itself as a leader in the development of innovative cancer therapies. With a renewed focus and a robust pipeline, TuHURA Biosciences is poised to make a lasting impact in the oncology landscape.
Historical Background
The company’s history can be traced back to its inception as Kintara Therapeutics in 2009, when it was known as Berry Only, Inc. In 2013, the company underwent a reverse acquisition with Del Mar Pharmaceuticals BC Ltd., solidifying its position in the cancer therapeutics space. Over the years, Kintara Therapeutics navigated the challenges of drug development, focusing its efforts on advancing its lead candidate, REM-001, a second-generation photodynamic therapy (PDT) for the treatment of cutaneous metastatic breast cancer (CMBC).
In 2020, Kintara further expanded its portfolio through the acquisition of Adgero Biopharmaceuticals, a clinical-stage company specializing in photodynamic therapy. This strategic move allowed the company to leverage Adgero’s expertise and strengthen its foothold in the PDT space. The company also officially changed its name to Kintara Therapeutics, Inc. following this merger.
Recent Developments
Despite the inherent challenges of the industry, Kintara continued to make progress with its REM-001 program. In 2017, the company submitted questions to the FDA under a Type C format to review the REM-001 technology and results. This effort culminated in 2022 when Kintara received a Study May Proceed letter from the FDA to begin a 15-patient study evaluating REM-001 for cutaneous metastatic breast cancer.
The company faced a setback in 2023 when it announced preliminary topline results for its VAL-83 program, which did not perform better than current standards of care in glioblastoma. As a result, Kintara made the difficult decision to terminate the development of VAL-83. However, this challenge was offset by a significant achievement in the same year when Kintara was awarded a $2 million grant from the National Institutes of Health (NIH) to support the clinical development of REM-001 for the treatment of cutaneous metastatic breast cancer.
Transformative Merger
The transformative event for the company occurred in 2024, when Kintara entered into a definitive merger agreement with TuHURA Biosciences, a Phase 3 registration-stage immune-oncology company. The all-stock transaction allowed Kintara to combine its expertise and resources with TuHURA’s innovative technologies, creating a synergistic platform to advance a diverse late-stage oncology pipeline.
Under the terms of the merger, Kintara’s stockholders now own approximately 2.85% of the combined company on a fully diluted basis, or 5.45% including the contingent value rights (CVRs) issued in the transaction. The merged entity, operating under the name TuHURA Biosciences, Inc., is well-positioned to capitalize on the complementary strengths of the two companies, with a focus on overcoming resistance to cancer immunotherapy and developing novel treatments for solid tumors.
Pipeline and Clinical Progress
TuHURA’s lead candidate, IFx-2.0, a personalized cancer vaccine, has shown promising results in a Phase 1b trial for advanced Merkel cell carcinoma (MCC) and cutaneous squamous cell carcinoma (cSCC). The data, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated that 80% of ICI-naïve patients with advanced MCC who failed to respond to pembrolizumab or avelumab therapy achieved a durable complete response, pathologic complete response, or partial response following IFx-2.0 therapy and rechallenge with an anti-PD(L)-1 checkpoint inhibitor.
In addition to IFx-2.0, TuHURA’s pipeline includes a promising portfolio of first-in-class bifunctional Antibody Drug Conjugates (ADCs), which represent potential upside partnering opportunities for the combined company. The merger with Kintara has provided TuHURA with a strong balance sheet, with a $31 million subscribed financing expected to extend the company’s cash runway into late 2025.
REM-001, the lead candidate from Kintara’s pipeline, remains a key focus for the combined company. REM-001 is a late-stage photodynamic therapy for the treatment of cutaneous metastatic breast cancer (CMBC). The therapy consists of three parts: the laser light source, the light delivery device, and the REM-001 drug product. The REM-001 API is SnET2 (tin ethyl etiopurpurin), which is a second-generation PDT photosensitizer agent. In four previous Phase 2 and/or Phase 3 clinical studies in CMBC patients, REM-001 Therapy was able to reduce or eliminate a substantial number of the treated CMBC tumors, with approximately 80% of evaluable tumor sites showing a complete response.
The FDA has granted Fast Track Designation for REM-001 in CMBC, highlighting the potential significance of this treatment. Following the $2 million Small Business Innovation Research grant from the National Institutes of Health, the company re-initiated its REM-001 program and has opened enrollment at Memorial Sloan Kettering Cancer Center, with a total of 4 patients initiated as of November 14, 2024. The company expects to complete enrollment of patients in the REM-001 study in the fourth quarter of 2024.
Financials
The combined company’s expertise spans multiple fronts, from Kintara’s experience in photodynamic therapy to TuHURA’s advancements in immune-oncology. This synergistic combination positions TuHURA Biosciences as a formidable player in the oncology space, with the potential to deliver innovative solutions and improve outcomes for patients battling various forms of cancer.
As a clinical-stage biopharmaceutical company, TuHURA Biosciences has not generated revenue in recent fiscal years. For the most recent quarter, the company reported revenue of $76,000, which is likely attributed to grant income or other non-core activities. The net loss for the quarter was $2,505,001, primarily due to continued research and development expenses for the company’s lead candidates, as well as general and administrative costs.
The company’s research and development expenses for the three months ended September 30, 2024, decreased to $252,000, down from $1.86 million in the same period the prior year. This significant reduction was primarily due to the termination of the VAL-83 development program. However, general and administrative expenses increased to $1.96 million, up from $1.10 million in the prior year period, largely due to higher professional fees and special meeting costs related to the merger transaction with TuHURA.
From a cash flow perspective, TuHURA Biosciences used $1,442,000 in operating cash flow and $1,422,000 in free cash flow during the quarter. These figures reflect the company’s ongoing investment in its clinical programs and operational activities.
It’s important to note that as a clinical-stage company, TuHURA Biosciences will require significant additional funding to maintain its clinical trials, research and development projects, and general operations. The company is actively pursuing various financing alternatives, including public or private equity offerings and strategic collaborations, to fund its operations and advance its pipeline.
Liquidity
As of September 30, 2024, TuHURA Biosciences reported cash and cash equivalents of $3,020,000. This cash position, combined with the $31 million subscribed financing expected from the merger, is anticipated to extend the company’s cash runway into late 2025.
The company’s current ratio and quick ratio both stand at 2.45, indicating a relatively healthy short-term liquidity position. However, it’s crucial to note that the company’s ability to continue as a going concern remains uncertain due to the significant funding requirements of its clinical programs.
No information was provided about available credit lines or credit facilities, which suggests that the company may be primarily relying on equity financing and grants to fund its operations. The debt-to-equity ratio was not provided, likely due to the company’s focus on equity financing rather than debt instruments.
Despite the challenges faced by the industry, TuHURA Biosciences has demonstrated resilience and a commitment to its mission. The company’s recent achievements, including the positive results from the IFx-2.0 trial and the transformative merger with Kintara, have laid the foundation for its continued growth and success.
Future Outlook
As TuHURA Biosciences forges ahead, investors and the broader healthcare community will closely watch the company’s progress in advancing its pipeline, exploring strategic partnerships, and leveraging its combined expertise to make a tangible impact on cancer treatment. With a renewed focus, a strengthened balance sheet, and a diversified portfolio of innovative therapies, TuHURA Biosciences is poised to emerge as a leading force in the oncology landscape.
The company’s immediate focus will be on completing the enrollment of patients in the REM-001 study, which is expected in the fourth quarter of 2024. Additionally, the continued development of IFx-2.0 and the exploration of potential partnering opportunities for its bifunctional Antibody Drug Conjugates (ADCs) portfolio will be key areas to watch.
TuHURA Biosciences operates exclusively in the United States, which allows for a focused approach to clinical development and regulatory interactions. However, this also means that the company’s performance is heavily tied to the U.S. healthcare and biotechnology sectors.
As the company moves forward, it will need to carefully manage its cash resources while advancing its clinical programs. The success of its ongoing trials, particularly the REM-001 study and the further development of IFx-2.0, will be critical in attracting additional investment and potential strategic partnerships.
In conclusion, TuHURA Biosciences represents a compelling opportunity in the oncology space, with a diverse pipeline of innovative therapies and a strengthened position following the merger. While challenges remain, particularly in terms of funding and clinical development, the company’s focused strategy and recent progress provide a solid foundation for potential future success in addressing unmet needs in cancer treatment.
Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.