SAN DIEGO - Kintara Therapeutics, Inc. (NASDAQ:KTRA), a biopharmaceutical company, and TuHURA Biosciences, Inc., an immune-oncology firm, have announced their recent corporate and clinical advancements, including a definitive merger agreement and progress in cancer therapy development. The merger, which is expected to close in the third quarter of 2024, will result in TuHURA becoming a direct, wholly-owned subsidiary of Kintara.
Kintara's stockholders will own approximately 5.5% of the combined company's common stock after the merger, which includes a contingent value right linked to the enrollment of patients in the REM-001 study.
TuHURA plans to advance a Phase 3 trial for its IFx-2.0 personalized cancer vaccine as an adjunctive therapy with Keytruda® for advanced Merkel cell carcinoma in the second half of 2024 under the FDA's accelerated approval pathway.
In clinical developments, Kintara has advanced enrollment and dosing in its open-label 15-patient REM-001 study for cutaneous metastatic breast cancer (CMBC), with four patients dosed as of June 26, 2024.
Montefiore Medical Center will soon begin screening patients for the study, the majority of whose costs are covered by a $2.0 million NIH grant. In March 2024, Kintara expanded the study's inclusion criteria to accelerate enrollment.
The anticipated near-term milestones include the merger's completion, the enrollment and follow-up completion of 10 patients in the REM-001 study by the fourth quarter of 2024, and the commencement of TuHURA's Phase 3 trial in the second half of 2024.
Kintara is developing REM-001 Therapy for CMBC, which has shown an 80% complete response rate in evaluable lesions and has a safety database of approximately 1,100 patients. TuHURA's pipeline includes a personalized cancer vaccine candidate and bifunctional Antibody Drug Conjugates targeting immune suppression in the tumor microenvironment.
The information provided is based on a press release statement from Kintara Therapeutics and does not constitute a solicitation or an offer to buy or sell securities. The press release also contains forward-looking statements that are not guarantees of future performance and are subject to risks and uncertainties.
In other recent news, TuHURA Biosciences, in collaboration with Kintara Therapeutics, has reported positive results from a Phase 1b trial of its leading cancer vaccine candidate, IFx-2.0. The trial revealed that IFx-2.0 was safe and well-tolerated, with 80% of patients with advanced Merkel Cell Carcinoma (MCC) achieving a durable response after treatment.
CEO of TuHURA, Dr. James Bianco, highlighted the vaccine's ability to overcome resistance to immune checkpoint inhibitor (ICI) therapies in 63% of patients with advanced MCC.
These encouraging results have set the stage for a planned Phase 3 trial of IFx-2.0 as an adjunctive therapy with Keytruda®. This trial is expected to commence in the second half of 2024 under the FDA's Accelerated Approval Pathway.
In other developments, TuHURA and Kintara Therapeutics have announced a definitive merger agreement to create a combined company specializing in late-stage oncology treatments. The all-stock transaction is expected to close in the third quarter of 2024.
The merger aims to leverage both companies' technologies to develop therapies that address resistance to current cancer immunotherapies. The combined company will be headquartered in Tampa, Florida, with Dr. James Bianco serving as President and CEO.
InvestingPro Insights
As Kintara Therapeutics, Inc. (NASDAQ:KTRA) aligns with TuHURA Biosciences, Inc. to bolster its stance in the biopharmaceutical arena, the financial health and market performance of Kintara provide additional context to the merger and its potential impact.
InvestingPro data reveals a market capitalization of $14.94 million USD for Kintara, reflecting the company's size and market value as of the last twelve months ending Q3 2024. Despite the promising clinical developments, Kintara's financial metrics indicate significant challenges.
With an adjusted P/E ratio of -1.57, the company is not currently generating profits relative to its share price. Moreover, the company's operating income stands at a loss of $9.41 million USD, underscoring the financial hurdles it faces amidst its research and development endeavors.
The stock's performance has been marked by high volatility, a characteristic that investors should consider. Over the last three months, the price total return has surged by 175.61%, suggesting a recent uptick in investor confidence or speculative interest. This is reinforced by the significant 59.26% year-to-date price total return, which may intrigue investors looking for short-term gains.
Two InvestingPro Tips that are particularly germane to Kintara's current situation include the company's position of holding more cash than debt on its balance sheet, which could provide a buffer against financial strain, and the fact that the firm's liquid assets exceed its short-term obligations, offering some assurance of near-term financial stability.
For investors seeking a deeper dive into Kintara's financials and market prospects, additional InvestingPro Tips are available. There are 12 more tips that provide insights into Kintara's performance and outlook, which can be found at https://www.investing.com/pro/KTRA. For those interested in gaining complete access to these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
The provided data and tips should be considered alongside the clinical and corporate advancements of Kintara as they merge with TuHURA Biosciences, offering a comprehensive view of the company's potential trajectory in the evolving landscape of cancer therapy development.
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