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Kintara Therapeutics, Inc. (NASDAQ: KTRA), based in San Diego, California, is a biopharmaceutical company focused on developing novel cancer therapies to address unmet medical needs. The company's core business involves the research and development of oncology drugs that target solid tumors. Kintara is currently advancing two late-stage, Phase 3-ready therapeutics: VAL-083 and REM-001. VAL-083 is a small-molecule chemotherapeutic with a unique mechanism of action, demonstrating clinical activity against a range of cancers including glioblastoma multiforme (GBM), central nervous system cancers, ovarian cancer, and other solid tumors. On the other hand, REM-001 is a photodynamic therapy (PDT) under evaluation for cutaneous metastatic breast cancer (CMBC).
In recent developments, Kintara has received an extension from Nasdaq to regain compliance with the Listing Rule 5550(b), ensuring they meet the required financial benchmarks. The company has also partnered with Ladenburg Thalmann & Co. Inc. to explore strategic alternatives aimed at maximizing shareholder value.
Recent Projects and Financial Health
Kintara launched a new 15-patient clinical trial for REM-001 for CMBC in February 2024, funded primarily by a $2.0 million grant from the National Institutes of Health (NIH). The trial aims to optimize dosage and study design ahead of a Phase 3 initiation. Financial results for the fiscal third quarter ended March 31, 2024, reveal a cash reserve of approximately $6.35 million, reflecting strengthened financials from recent stock sales and cost-cutting initiatives.
Another significant update is Kintara's planned merger with TuHURA Biosciences, Inc., a Phase 3 immuno-oncology company. This all-stock transaction, expected to complete by Q3 2024, will result in a combined entity focused on advancing personalized cancer vaccines and bi-functional antibody drug conjugates, promising to overcome major obstacles in immunotherapy.
Conclusion
Kintara Therapeutics is dedicated to revolutionizing cancer treatment through innovative therapeutic solutions. With a robust pipeline, strategic partnerships, and a strong financial foundation, Kintara is poised to address significant gaps in cancer treatment and provide new hope to patients with limited options.
TuHURA Biosciences has entered into an Exclusivity and Right of First Offer Agreement with Kineta for the potential acquisition of the anti-VISTA antibody KVA12123 and related assets. KVA12123 targets VISTA, a checkpoint on quiescent T-cells, to reverse immune suppression and remodel the tumor microenvironment. This inhibitor is currently in Phase 1/2 clinical trials, showing favorable safety and tolerability. Concurrently, TuHURA secured a $5 million investment from an existing shareholder to support its Phase 3 trial and ADC development. The agreement includes a payment of $2.5 million at signing, with an additional $2.5 million due by July 15, 2024, and a 90-day exclusivity period.
Kintara Therapeutics and TuHURA Biosciences have announced significant corporate and clinical advances. In April 2024, both companies entered a merger agreement where TuHURA will become a wholly-owned subsidiary of Kintara, expected to close in Q3 2024. Kintara's existing stockholders will own roughly 5.5% of the combined company's stock, including a contingent value right linked to the REM-001 study milestones.
TuHURA is set to advance a Phase 3 trial for its IFx-2.0 personalized cancer vaccine in the second half of 2024. Moreover, TuHURA's ADCs offer potential partnering opportunities. A $31 million financing will support the merger, extending financial runway into late 2025. Kintara also received a 180-day Nasdaq compliance extension to December 9, 2024.
On the clinical front, Kintara has advanced its REM-001 study for cutaneous metastatic breast cancer, having dosed four patients as of June 26, 2024. The study is supported by a $2 million NIH grant. Near-term milestones include closing the merger in Q3 2024 and commencing TuHURA's Phase 3 trial in 2H 2024.
TuHURA Biosciences and Kintara Therapeutics have announced positive results from a Phase 1b trial of their personalized cancer vaccine, IFx-2.0. The trial targeted patients with advanced Merkel Cell Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (cSCC) who were resistant to immune checkpoint inhibitors (ICIs). The vaccine was well-tolerated and showed promising efficacy, with 80% of ICI-naïve patients achieving a durable response.
Data from the study were presented at the 2024 ASCO Annual Meeting. The trial's success has led to the planning of a Phase 3 trial, expected to start in the second half of 2024, using IFx-2.0 in combination with Keytruda to improve tumor response rates.
Additionally, TuHURA has entered into an all-stock transaction with Kintara and secured a $31 million financing to advance their oncology pipeline. The combined company will focus on personalized cancer vaccines and bi-functional Antibody Drug Conjugates (ADCs), operating under the name TuHURA Biosciences and trading on Nasdaq under the ticker HURA.
Kintara Therapeutics (Nasdaq: KTRA) announced its fiscal Q3 2024 financial results ending March 31, 2024. Key developments include a definitive merger agreement with TuHURA Biosciences. Post-merger, Kintara stockholders will own 2.85% to 5.45% of the combined company. The merger is expected to close in Q3 2024. Kintara expanded the inclusion criteria for its REM-001 study and initiated a study in CMBC patients, funded by a $2M NIH grant. Financially, Kintara saw a net loss of $2M ($0.05/share) compared to $3.3M ($1.94/share) in Q3 2023, attributed to lower R&D costs. Cash and equivalents were $6.35M, up from $1.54M in June 2023.
FAQ
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