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Item 7.01. Regulation FD Disclosure.
On July 1, 2024, Kintara Therapeutics, Inc. (“Kintara”)and TuHURA Biosciences, Inc. (“TuHURA”) issued a press release providing an overview of Kintara’s and TuHURA’s recent corporate and clinical advancements and outlining upcoming expected near term milestones.
The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission (the “SEC”), and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.
Item 8.01 Other Events.
On July 1, 2024, Kintara and TuHURA provided an overview of Kintara’s and TuHURA’s recent corporate and clinical advancements and outlined upcoming expected near term milestones.
As previously disclosed, in April 2024, Kintara entered into a definitive merger agreement (the “Merger Agreement”) with TuHURA, pursuant to which Kayak Mergeco, Inc., Kintara's wholly-owned subsidiary will merge with and into TuHURA with TuHURA surviving the merger and becoming Kintara's direct, wholly-owned subsidiary (the "Merger"). The Merger is expected to close in the third quarter of 2024. Kintara’s existing stockholders will own approximately 5.5% of combined company’s common stock at the closing of the Merger, inclusive of the contingent value right (“CVR”) linked to the achievement of enrollment of a minimum of 10 patients in the REM-001 study, with such patients each completing 8 weeks of follow-up on or before December 31, 2025.
TuHURA is expected to advance a single Phase 3 trial for IFx-2.0 personalized cancer vaccine as adjunctive therapy with Keytruda® in first-line treatment for advanced Merkel cell carcinoma in the second half of 2024 under FDA's accelerated approval pathway. TuHURA’s first-in-class bifunctional Antibody Drug Conjugates (“ADCs”) represent potential upside partnering opportunities. TuHURA has secured $31 million subscribed financing in connection with the Merger Agreement which is expected to provide cash runway into late 2025.
As previously disclosed, on June 12, 2024, Kintara received a 180-day extension until December 9, 2024 from The Nasdaq Stock Market LLC (“Nasdaq”) to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, in accordance with Nasdaq Listing Rule 5810(c)(3)(A).
Kintara has also advanced enrollment, dosing and clinical site expansion in Kintara’s open label 15-patient REM-001 study in cutaneous metastatic breast cancer (“CMBC”). As of June 26, 2024, four patients have been dosed in the open label 15-patient REM-001 study CMBC. In addition to Memorial Sloan Kettering Cancer Center, Montefiore Medical Center and the University Hospital for Albert Einstein College of Medicine will soon begin screening patients. The majority of the costs to run this study will be covered by the $2.0 million Small Business Innovation Research (“SBIR”) grant Kintara was awarded from the National Institutes of Health (“NIH”). In March 2024, Kintara expanded inclusion criteria in the open label 15-patient REM-001 study in CMBC to include patients receiving pembrolizumab (KEYTRUDA®) for at least three months at screening. This is expected to significantly increase the pace of enrollment.
Kintara and TuHURA expect to close the Merger by the third calendar quarter of 2024. Kintara expects to complete enrollment and an 8-week follow-up of 10 patients in the REM-001 study by the fourth calendar quarter of 2024. TuHURA expects to commence its Phase 3 trial for IFx-2.0 personalized cancer vaccine for advanced Merkel cell carcinoma under FDA's accelerated approval pathway by the second half of calendar year 2024.
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