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TAMPA, Fla. - TuHURA Biosciences, Inc. (NASDAQ:HURA), a clinical-stage biotech company with a market capitalization of $171 million and trading at $3.92 per share, announced today the start of a Phase 1b/2a clinical trial for IFx-Hu2.0, an immune therapy designed to treat metastatic Merkel cell carcinoma (MCC) without skin lesions. According to InvestingPro data, analysts have set price targets ranging from $9.25 to $15, suggesting significant upside potential if the trial succeeds. The trial will assess the safety and effectiveness of IFx-Hu2.0 in combination with Keytruda® (pembrolizumab), a checkpoint inhibitor (CPI), in patients with MCC of unknown primary origin (MCCUP).
The trial aims to enroll nine patients with non-cutaneous MCC, targeting three patients for each type of lesion located in the liver, lungs, or abdomen. Participants will receive IFx-Hu2.0 directly injected into a single visceral tumor weekly for three weeks, with pembrolizumab treatment commencing within 48 hours of the first IFx-Hu2.0 injection and continuing every three weeks for six months.
According to TuHURA’s President and CEO, James Bianco, M.D., the study’s primary endpoint is the safety and feasibility of IFx-Hu2.0 as an adjunct therapy, evaluated 28 days after the last IFx-Hu2.0 dose. Secondary endpoints include efficacy measured by RECIST 1.1 criteria at three and six months. Results are expected by the end of 2025 or early 2026. The company maintains a strong liquidity position with a current ratio of 3.68, though it reported a net loss of $22.65 million in the last twelve months.
Dr. Bianco also noted that if the trial demonstrates the feasibility and safety of the treatment for MCC, the company plans to extend enrollment to other non-MCC cancers that poorly respond to CPIs. The effectiveness of IFx-Hu2.0 in overcoming CPI resistance has been previously shown in skin cancers such as melanoma, squamous cell, and MCC.
In addition to this trial, TuHURA is preparing for a Phase 3 accelerated approval trial of IFx-Hu2.0 as an adjunctive therapy to Keytruda® versus Keytruda® plus placebo for first-line treatment of CPI-naïve advanced or metastatic MCC patients. The FDA has agreed that this trial could be conducted under their accelerated approval pathway with the use of Objective Response Rate as the primary endpoint.
The company has reached an agreement with the U.S. Food and Drug Administration (FDA) on lifting a partial clinical hold on the Phase 3 trial and expects to begin enrollment in the second quarter of 2025. With the next earnings report due on May 14, 2025, investors seeking deeper insights into TuHURA’s financial health and growth prospects can access additional analysis and 7 key investment tips through InvestingPro’s comprehensive research platform.
This information is based on a press release statement from TuHURA Biosciences, Inc.
In other recent news, TuHURA Biosciences announced the appointment of Bertrand Le Bourdonnec, PhD, as Executive Vice President, Head of Drug Discovery, Early Development, and Program Management. This strategic hire aims to advance the company’s pipeline, particularly in the development of Antibody Drug Conjugates (ADCs) and Antibody Peptide Conjugates (APCs). In financial developments, H.C. Wainwright adjusted TuHURA Biosciences’ price target to $12 from $13 while maintaining a Buy rating. The adjustment follows a reported net loss of $1.21 per share for 2024, which was wider than the expected loss of $0.35 per share. The company’s research and development expenses were notably higher than anticipated, totaling $13.3 million. TuHURA ended 2024 with approximately $12.7 million in cash, which is expected to support operations into the fourth quarter of 2025. Additionally, TuHURA Biosciences secured over $3 million through warrant exercises, issuing promissory notes with an annual interest rate of 12%. This financial move is part of the company’s broader capital management strategy.
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