HAMILTON, ON and BOSTON – Fusion Pharmaceuticals Inc. (NASDAQ: FUSN), a clinical-stage oncology company, has announced an exclusive worldwide license agreement with Heidelberg University and Euratom, as represented by the European Commission, Joint Research Centre. This agreement provides Fusion with the rights to develop, manufacture, and commercialize compounds including the 225Ac-PSMA I&T, known as FPI-2265, which is designed for treating PSMA-expressing cancers.
Fusion Pharmaceuticals, specializing in next-generation radiopharmaceuticals, aims to advance FPI-2265 as a leading actinium-based PSMA-targeted radiotherapy. With a dispute related to the inter-parties review of a U.S. patent now settled, Fusion is poised to push forward with its clinical trials.
Mohit Rawat, Fusion's President and Chief Business Officer, expressed optimism about the company's ability to execute the program, citing Fusion's expertise, operational manufacturing facility, and actinium supply. Updates on the program's progress are expected, including results from the TATCIST study in April and the launch of a Phase 2/3 registration study in the second quarter of 2024.
In January 2024, Fusion reached an agreement with the U.S. Food and Drug Administration on the Phase 2/3 protocol for FPI-2265. The development plan includes a Phase 2 dose optimization lead-in, with enrollment completion anticipated by the end of 2024, followed by a Phase 3 registration trial slated to commence in 2025.
The financial terms of the license agreement involve Fusion paying an upfront fee of €1.0 million to the licensors, with additional payments tied to regulatory milestones upon potential approval and low single-digit royalties on future net sales.
Fusion's clinical portfolio also includes other targeted therapies in various stages of development, and the company maintains collaborations with AstraZeneca (NASDAQ:AZN) and Merck to explore novel targeted alpha therapies and combination programs.
The information in this article is based on a press release statement from Fusion Pharmaceuticals.
InvestingPro Insights
As Fusion Pharmaceuticals Inc. (NASDAQ: FUSN) embarks on its journey to advance FPI-2265, a promising treatment for PSMA-expressing cancers, investors are closely monitoring the company's financial health and market performance. Here are some key insights based on real-time data and analysis from InvestingPro:
InvestingPro Data highlights that Fusion holds a market capitalization of approximately $848.6 million. Despite its ambitious clinical developments, the company's revenue over the last twelve months as of Q3 2023 stood at $2.21 million, reflecting a growth of 15.3%. However, with a negative gross profit margin of -2937.27%, Fusion's financials indicate significant investments into its research and development efforts.
InvestingPro Tips suggest that while Fusion Pharmaceuticals is not expected to be profitable this year, with analysts pointing to weak gross profit margins, the company does have a strong liquidity position. It holds more cash than debt on its balance sheet and its liquid assets exceed short-term obligations. This financial stability is crucial as Fusion continues to invest in its clinical pipeline.
The stock has experienced a remarkable run over the past six months, with a 300% price total return, and it is currently trading near its 52-week high, at 95.79% of that peak. This performance is indicative of investor confidence in the company's prospects, despite the lack of dividends and profitability over the last year.
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