8-K: TuHURA Biosciences Announces Fiscal Year 2024 Results and Provides Corporate Update, Highlights Phase 3 Trial and Kineta Acquisition

TuHURA Biosciences reports its 2024 financial results, provides a corporate update focusing on its Phase 3 trial for IFx-2.0 and the planned acquisition of Kineta, Inc.

Summary

• TuHURA Biosciences announced its financial results for the year ended December 31, 2024, and provided a corporate update.
• A Phase 3 trial of IFx-2.0 as an adjunctive therapy with Keytruda for advanced Merkel cell carcinoma (MCC) is planned to initiate enrollment in Q2 2025.
• The MCC Phase 3 trial will be conducted under a Special Protocol Assessment (SPA) Agreement with the FDA.
• TuHURA entered into a definitive agreement to acquire Kineta, Inc., including its Phase 2 ready VISTA inhibiting antibody, with the transaction targeted for completion in Q2 2025.
• The company is expanding its discovery team for a first-in-class immune modulating Antibody Drug or Peptide Conjugate Program.
• TuHURA raised $36 million in 2024 to fund development programs and operations through late fourth quarter of 2025 and secure the right to acquire the VISTA inhibiting antibody.
• Research and development (R&D) expense was $13.3 million for the year ended December 31, 2024, compared to $9.4 million in 2023.
• General and administrative (G&A) expenses were $4.3 million for the year ended December 31, 2024, compared to $4.1 million in 2023.

Sentiment

Score: 7

Explanation: The document presents a positive outlook with the planned Phase 3 trial, acquisition, and financial results, but also acknowledges risks and uncertainties associated with the merger and clinical development.

Positives

• The FDA granted a successful SPA agreement for the Phase 3 trial of IFx-2.0.
• The Phase 3 trial incorporates a key secondary endpoint (PFS) which, if achieved, may satisfy post approval confirmatory trial requirement.
• TuHURA successfully listed on NASDAQ (HURA) via a reverse merger with Kintara Therapeutics, Inc.
• The company is advancing novel technologies to overcome resistance to cancer immunotherapy.
• The FDA's Oncology Center of Excellence (OCE) recommended investigating IFx-2.0 in the first line setting rather than in patients progressing on first line therapy.

Negatives

• The Phase 3 trial is currently subject to a partial clinical hold relating to completion of certain CMC requirements.
• The company is reliant on the successful closing of the Kineta acquisition to advance its VISTA inhibiting antibody program.
• The company incurred increased R&D expenses of $13.3 million in 2024.

Risks

• The completion of the Mergers on anticipated terms and timing is not guaranteed.
• Uncertainties related to Kinetas cash level and ability to continue as a going concern exist.
• The price of TuHURA Common Stock and Kineta Common Stock could change before the completion of the Mergers.
• Uncertainties as to access to available financing, including the Concurrent Investment, to complete the Mergers upon acceptable terms and on a timely basis or at all exist.
• The effect of the announcement or pendency of the transaction on Kinetas or TuHURAs business relationships, competition, business, financial condition, and operating results is a risk.
• The ability of TuHURA to successfully integrate Kinetas business or fully realize the anticipated synergies or other benefits expected from the Mergers is not guaranteed.

Future Outlook

TuHURA plans to advance its late-stage clinical programs in 2025, aiming to complete enrollment in its Phase 3 trial next year, and continue developing novel Antibody Drug or Antibody Peptide Conjugates.

Management Comments

• James Bianco, President and CEO of TuHURA, commented that 2024 was a transformative year, highlighting the NASDAQ listing, capital raise, and the agreement to acquire a best-in-class VISTA inhibiting antibody.

Industry Context

TuHURA is operating in the competitive immuno-oncology space, focusing on overcoming resistance to cancer immunotherapy, a significant challenge in the field. The acquisition of Kineta and its VISTA inhibitor positions TuHURA to compete with other companies developing checkpoint inhibitors and combination therapies.

Comparison to Industry Standards

• TuHURA's approach of using IFx technology to activate the immune system by making tumors look like bacteria is similar to approaches used by companies like BioNTech and Moderna, which utilize mRNA technology to stimulate immune responses.
• The development of VISTA inhibitors puts TuHURA in competition with companies like Jounce Therapeutics and Compugen, which are also developing VISTA-targeting therapies.
• The focus on overcoming resistance to checkpoint inhibitors aligns with the broader industry trend of developing combination therapies to improve the efficacy of cancer immunotherapies, similar to strategies employed by companies like Bristol-Myers Squibb and Merck.

Stakeholder Impact

• Shareholders may be impacted by the potential dilution of ownership percentage after the Mergers.
• Employees of both TuHURA and Kineta may be affected by the integration of the two companies.
• Patients with advanced Merkel cell carcinoma could benefit from the potential approval of IFx-2.0.
• The merger may impact the business relationships of both Kineta and TuHURA.

Next Steps

• Initiate enrollment in the IFx-2.0 Phase 3 accelerated approval trial in Q2 2025.
• Target closing of the Kineta acquisition in Q2 2025.
• Initiate a checkpoint inhibitor resistant metastatic cancer basket trial in Q3 2025.
• Advance characterization toward lead compound selection for IFx-3.0 in Q4 2025.
• Initiate Phase 2 trial VISTA trial in NPM1 mutated AML in Q4 2025.

Key Dates

Keywords

TuHURA Biosciences, Kineta, IFx-2.0, VISTA inhibitor, Phase 3 trial, Merkel cell carcinoma, Immunotherapy, Acquisition, Financial results, Corporate update