TuHURA Biosciences Merges with Kintara Therapeutics

TuHURA Biosciences, Inc., a Phase 3 registration-stage immuno-oncology company, has finalized its merger with Kintara Therapeutics, Inc. Consequently, the new entity will continue under the name "TuHURA Biosciences, Inc." The company is committed to developing innovative technologies aimed at overcoming resistance to cancer immunotherapy. This includes advancing innate immune response agonists and tumor microenvironment modulators, both designed to address the critical limitations of current cancer treatments.

One of the key programs that TuHURA is focusing on is preparing for a Phase 3 accelerated approval registration trial using IFx-2.0. This trial is set to begin in the first half of 2025 and is aimed at treating first-line Merkel Cell carcinoma under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

Starting October 18, 2024, TuHURA's shares will begin trading on The Nasdaq Capital Market under the new ticker symbol "HURA." The company's common stock will be represented by a new CUSIP number, 898920103, following the completion of a reverse stock split and the business combination.

The merger has resulted in legacy Kintara equityholders collectively owning approximately 2.85% of the common stock of the combined company on a fully diluted basis, or 5.45% if certain milestones under the CVR Agreement are achieved. Conversely, TuHURA equityholders own around 97.15% of the combined company's common stock, or 94.55% after the CVR milestones are met.

Dr. James Bianco, President and CEO of TuHURA, noted that this merger is a pivotal milestone for both companies, signifying a crucial step forward in their mission to tackle significant challenges in cancer immunotherapies. The company's primary technology, IFx-2.0, aims to overcome resistance to checkpoint inhibitors. If successful, this could pave the way for treating other oncology indications and create substantial value for all stakeholders involved.

TuHURA’s technological portfolio includes Immune Fx (IFx) Innate Immune Response Agonists and tumor microenvironment modulators. The IFx technology employs proprietary plasmid DNA (pDNA) or messenger RNA (mRNA) to introduce a highly immunogenic bacterial protein (Emm55) to the surface of tumor cells. This approach is designed to combat primary resistance to checkpoint inhibitors. The Phase 3 trial for IFx-2.0 will use it as an adjunctive therapy to Keytruda® (pembrolizumab) for advanced or metastatic Merkel Cell Carcinoma, commencing in the first half of 2025.

Additionally, TuHURA is developing bi-specific immune-modulating Antibody (ADC) or Peptide (PDC) Drug Conjugates that target Myeloid Derived Suppressor Cells. These modulators are intended to inhibit the immune-suppressing effects on the tumor microenvironment, ultimately preventing T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.

The merger agreement stipulates that TuHURA will become a wholly-owned subsidiary of Kintara, effective as of October 18, 2024. Moreover, a Contingent Value Rights Agreement (CVR Agreement) will see the issuance of CVRs to legacy Kintara stockholders. These CVRs will entitle holders to an aggregate of approximately 1,539,918 shares of the combined company’s common stock upon the achievement of specified milestones.

TuHURA's leadership team will be spearheaded by Dr. James Bianco as President and CEO, along with Dan Dearborn as Chief Financial Officer and Dennis Yamashita as Chief Scientific Officer. The Board of Directors will include James Bianco, James Manuso, Alan List, George Ng, and Robert Hoffman.

In summary, TuHURA Biosciences, Inc. is advancing its mission to overcome resistance to cancer immunotherapy through innovative technologies. With a promising pipeline and strong leadership, the company is well-positioned to make significant strides in cancer treatment, starting with the planned Phase 3 trial for Merkel Cell carcinoma.