On April 3, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara"), a biopharmaceutical company investigating REM-001 in an NIH-sponsored and funded open label study in cutaneous metastatic breast cancer, and TuHURA Biosciences, Inc. ("TuHURA"), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported that they have entered into a definitive agreement for an all-stock transaction forming a company with expertise and resources to advance a risk diversified late-stage oncology pipeline (Press release, Kintara Therapeutics, APR 3, 2024, View Source [SID1234641741]). The combined company will focus on advancing TuHURA’s personalized cancer vaccine(s) and first-in-class bi-functional ADCS, two technologies that seek to overcome the major obstacles that limit the effectiveness of current immunotherapies in treating cancer. The combined company is expected to operate under the name "TuHURA Biosciences, Inc." and to trade on The Nasdaq Capital Market ("Nasdaq") under the ticker "HURA". The transaction is expected to close in the third quarter of 2024.
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Robert E. Hoffman, Kintara’s President and Chief Executive Officer, commented, "Following a thorough review and evaluation of opportunities to rebuild value for Kintara shareholders, we believe merging with TuHURA, a Phase 3 immuno-oncology company focused in two compelling areas of research, represents the best path forward for our stockholders and has the potential to deliver near and long-term value. Our board believes that the combined company will be well-positioned to develop powerful new therapies with the potential to overcome resistance to current immunotherapies, an area of significant unmet need."
TuHURA’s technologies are being developed to overcome primary and acquired resistance– two major obstacles to cancer immunotherapy’s ability to treat and cure cancer.
Immune Fx (IFx) Personalized Cancer Vaccines Harnessing the Power of the Innate Immune Response: TuHURA’s IFx technology utilizes a proprietary plasmid DNA ("pDNA") or messenger RNA ("mRNA") which, when introduced into a tumor cell, results in the expression of a highly immunogenic bacterial protein (emm55) on the surface of the tumor cell. TuHURA’s lead program, IFx-2.0, is designed to harness the power of the patient’s innate immune response, which has evolved over time to detect foreign pathogens like bacterial proteins. By making the surface of a tumor look like a bacterium, IFx-2.0 is designed to use the tumor itself as the source of foreign tumor neoantigens to prime and initiate an innate immune response against the tumor, thereby restoring the cancer immunity cycle and allowing checkpoint inhibitors like Keytruda to work where they previously failed to work.
IFx-2.0 expects to be entering a Phase 3 trial as adjunctive therapy with the checkpoint inhibitor Keytruda, to improve tumor response rate when compared to Keytruda alone in the first line treatment of patients with advanced or metastatic Merkel cell carcinoma. This single, placebo-controlled registration directed trial is expected to be conducted under the FDA’s Accelerated Approval Pathway and is expected to begin enrollment in 2H-2024. The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint like Overall Response Rate.
Bi-Functional Antibody Drug Conjugates ("ADCs"): Targeting Myeloid Derived Suppressor Cells ("MDSCs") to Modulate Their Immunosuppressive Effects on the Tumor Microenvironment: Leveraging its proprietary Delta receptor technology, TuHURA is developing first-in-class bi-functional ADCs that target MDSCs, which are cells that are responsible for creating an immunologic sanctuary for the tumor through their immunosuppressing effects on the tumor microenvironment ("TME"). The TME is the tissue surrounding a tumor, and MDSCs are cells that are characterized by the ability to suppress both innate and adaptive immune responses and are generally believed to be responsible for T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. Utilizing its bi-functional ADCs to inhibit the immune suppressing effects of MDSCs, while localizing an immune checkpoint inhibitor or T cell activator in the TME, TuHURA believes it may be able to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies, allowing them to continue working while potentially reducing off-tumor severe side effects resulting from checkpoint released indiscriminate T cell toxicity to normal tissues.
"With IFx-2.0 readying to enter a single Phase 3 registration trial, we believe this is the optimal time for TuHURA to transition from a private company to a public company. This proposed merger with Kintara lets us achieve that goal while combining the resources of the two companies. Coupled with a $31 million subscribed financing by TuHURA in connection with the merger agreement, and which is expected to fund the combined company’s operations and development programs through late 2025, we believe this merger will also allow our combined company the flexibility to focus our resources and efforts on advancing IFx-2.0 to market and our other drug candidates toward human clinical trials," said Dr. James Bianco, President and Chief Executive Officer of TuHURA. "This transaction with Kintara serves as a significant next step in our continued commitment to patients to develop novel therapies to overcome the major obstacles that limit the effectiveness of immunotherapies to treat and cure cancer."
About the Proposed Transaction, Management & Organization
Under the terms of the merger agreement, subject to stockholder approval, on a pro forma basis, post-merger Kintara equityholders are expected to collectively own up to approximately 2.85%, or approximately 5.45% including the shares underlying the contingent value rights (CVR) to be received by certain of Kintara’s equityholders as described below, of the common stock of post-merger combined company on a pro forma fully diluted basis. TuHURA equityholders are expected to collectively own approximately 97.15%, or 94.55% assuming the distribution of the CVR shares, of the common stock of combined company on a pro forma fully diluted basis.
Pre-merger Kintara common stockholders, certain warrant holders and certain preferred stockholders of record of Kintara will receive a CVR, entitling the holder to receive shares of Kintara common stock to be issued upon achievement of the CVR milestone. The Kintara CVR shares will be issued and distributed once 10 patients are enrolled and tracked in a study to determine whether a lower dose of REM-001 elicits a treatment effect similar to that seen in prior REM-001 studies. Once completed, the company will seek to out-license or identify an acquirer for the technology.
The merger agreement has been approved by the boards of directors of both companies and is subject to stockholder approval of both companies and other customary closing conditions. The proposed merger is expected to close in the third quarter of 2024.
Following the merger, the combined company will be headquartered in Tampa, Florida, and the executive officers are expected to be James Bianco, MD as President and Chief Executive Officer, and Dan Dearborn, CPA as Chief Financial Officer. The merger agreement provides that the board of directors of the combined company will be composed of five members, with four members initially designated by TuHURA and one member initially designated by Kintara.
Lucid Capital Markets, LLC is acting as the exclusive financial advisor and Lowenstein Sandler LLP is acting as legal counsel to Kintara. H.C. Wainwright & Co. is acting as the exclusive financial advisor and Foley & Lardner LLP is acting as legal counsel to TuHURA.
Conference Call & Webcast Details
The companies plan to hold a joint conference call and webcast today, April 3, 2024 at 8:30 AM ET to discuss the Merger details.
Interested participants and investors may access the conference call and webcast via the Investors section of the Kintara website at www.kintara.com and on TuHURA’s website, tuhurabio.com. A webcast replay will be available following the live event and will be accessible for 90 days.