TuHURA Biosciences Reports $22.6 Million Net Loss for Fiscal Year 2024, Focuses on Cancer Vaccine Development

TuHURA Biosciences, Inc., formerly known as Kintara Therapeutics, Inc., reported a net loss of $22.6 million for the fiscal year ending December 31, 2024, a decrease from a loss of $29.3 million in the previous year. The company attributed this improvement to a significant reduction in total operating expenses, which fell to $17.6 million from $29.8 million in 2023. This decrease was primarily due to the absence of a $16.2 million write-off related to the acquisition of TuHURA Biopharma, which had inflated the previous year's expenses. Research and development costs increased to $13.3 million, driven by ongoing clinical trials for the lead product candidate, IFx-2.0, and preclinical research for IFx-3.0.

The company underwent a significant transformation with the completion of a merger with Legacy TuHURA on October 18, 2024. This merger included a 1-for-35 reverse stock split and a name change to TuHURA Biosciences, Inc. Following the merger, TuHURA's primary focus shifted to developing novel personalized cancer vaccine candidates aimed at overcoming resistance to existing immunotherapies. The merger is expected to enhance the company's capabilities in the immuno-oncology space, particularly with the anticipated initiation of a Phase 3 trial for IFx-2.0 as an adjunctive therapy to Keytruda® in treating advanced Merkel cell carcinoma.

As of December 31, 2024, TuHURA had cash and cash equivalents totaling $12.7 million, which the company believes will be sufficient to fund operations through late 2025. However, the company anticipates needing substantial additional capital to support ongoing research and development activities, particularly as it prepares for the upcoming Phase 3 trial and potential commercialization efforts. The company has indicated that it may seek to raise at least $35 million in financing as a condition for completing the Kineta Merger, which is expected to close in the second quarter of 2025.

TuHURA's workforce consisted of 19 full-time employees as of the end of 2024, with a majority engaged in research and development. The company has emphasized the importance of attracting and retaining qualified personnel to support its growth strategy. Additionally, TuHURA is navigating a complex regulatory landscape as it seeks to obtain necessary approvals for its product candidates, which are subject to rigorous scrutiny by the FDA and other regulatory authorities. The company has entered into a Special Protocol Assessment agreement with the FDA for its Phase 3 trial, which is designed to expedite the approval process for its lead product candidate.

Looking ahead, TuHURA aims to leverage its innovative technologies to address significant unmet needs in cancer treatment. The company is focused on overcoming both primary and acquired resistance to immunotherapies, with the potential to expand its market presence significantly if its product candidates receive regulatory approval. However, the path to commercialization remains fraught with challenges, including the need for successful clinical trial outcomes, regulatory approvals, and effective market strategies to ensure product adoption and reimbursement.