Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on clinical and corporate developments.
Company recently announced definitive agreement to be acquired by AstraZeneca FPI-2265 Phase 2/3 registrational program for patients with metastatic castration-resistant prostate cancer (mCRPC) expected to begin in Q2 2024 Interim data from TATCIST study of FPI-2265 to be presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting in April Fusion is now producing and shipping clinical doses of FPI-2265 from its state-of-the-art GMP manufacturing facility HAMILTON, ON and BOSTON, March 20, 2024 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on clinical and corporate developments. Chief Executive Officer John Valliant, Ph.D., commented, “We entered 2024 with strong momentum focused on execution to advance our pipeline of targeted alpha therapies, and we are pleased to recently have achieved several critical milestones. For our lead program, FPI-2265, we expect to initiate the Phase 2 portion of the registrational program in metastatic castration-resistant prostate cancer (mCRPC) in the second quarter of this year. Acknowledging the substantial and expanding market for patients in the post-PLUVICTO™ setting we believe FPI-2265, which is positioned to be the first actinium-based PSMA targeted radiopharmaceutical to market, will effectively address a crucial unmet need for patients with progressive disease. We look forward to presenting data from the TATCIST trial at AACR in April. Dr. Valliant continued, “We also continue to advance our other clinical-stage programs, including the ongoing Phase 1 study of FPI-1434, which has demonstrated a promising safety profile and early evidence of antitumor activity. We expect to provide an update on this program around mid-year 2024. Underpinning our platform, which has produced a robust pipeline of targeted alpha therapies, is our state-of-the-art GMP manufacturing facility now operational and producing clinical doses of FPI-2265. With a strong balance sheet and secured actinium supply, we are well positioned to execute on our commitment of bringing this next generation of radiopharmaceuticals to patients in need.” Corporate Update On March 19, 2024, Fusion announced the Company has entered into a definitive agreement to be acquired by AstraZeneca. Under the terms of the agreement, AstraZeneca, through a subsidiary, will acquire all of Fusion’s outstanding shares pursuant to a plan of arrangement for a price of $21.00 per share in cash at closing plus a non-transferable contingent value right (CVR) of $3.00 per share in cash payable upon the achievement of a specified regulatory milestone. The upfront cash portion of the consideration represents a transaction value of approximately $2 billion, a 97% premium to Fusion’s closing market price of $10.64 on March 18, 2024. Combined, the upfront and maximum potential contingent value payments represent, if achieved, a transaction value of approximately $2.4 billion, a 126% premium to Fusion’s closing market price on March 18, 2024. As part of the transaction, AstraZeneca will acquire the cash, cash equivalents and short-term investments on Fusion’s balance sheet, which totaled $234 million as of December 31, 2023. The transaction is expected to close in the second quarter of 2024, subject to customary closing conditions, including the approval of Fusion shareholders and regulatory clearances. Portfolio Update FPI-2265: A 225Ac based radiopharmaceutical targeting prostate specific membrane antigen (PSMA) for the treatment of patients with mCRPC.
FPI-1434: Targeting insulin growth factor 1 receptor (IGF1R).
FPI-2059: Targeting neurotensin receptor 1 (NTSR1).
FPI-2068: A bispecific IgG-based targeted alpha therapy (TAT) targeting EGFR-cMET.
Other Recent Updates
Fourth Quarter 2023 Financial Results
Upcoming Presentations Fusion will present data in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting being held in San Diego, CA, April 5-10, 2024.
About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical-stage development portfolio includes lead program, FPI-2265, targeting prostate specific membrane antigen for metastatic castration resistant prostate cancer currently in a Phase 2 trial and novel targeted alpha therapies (TATs) including next-generation antibody drug conjugates (ADCs). Fusion has a collaboration with AstraZeneca to jointly develop novel TATs and combination programs between Fusion’s TATs and AstraZeneca’s DNA damage response inhibitors and immuno-oncology agents. Fusion has a fully operational Good Manufacturing Practice compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for the Company’s growing pipeline of TATs. The Company has strategic actinium supply agreements with Niowave, Inc. and BWXT Medical. Forward-Looking Statements This press release contains “forward-looking statements” for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the future business and financial performance of Fusion Pharmaceuticals Inc. (the “Company”). For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “expect,” “plans,” “anticipates,” “intends,” “will,” and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the risks related to the satisfaction or waiver of the conditions to closing the proposed transaction (including the failure to obtain necessary regulatory, court and Fusion’s shareholder approvals) in the anticipated timeframe or at all, including the possibility that the proposed transaction does not close; risks associated with the disruption of management’s attention from ongoing business operations due to the proposed transaction; and unknown liabilities and the risk of litigation and/or regulatory actions related to the proposed transaction; the Company’s financial condition, liquidity, and potential drug candidates, including any expressed or implied statements regarding the successful development of FPI-2265 or FPI-1434. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline in or to the clinic, to the regulatory process or to commercialization; management’s expectations could be affected by unexpected patient recruitment delays or regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company’s ability to obtain additional funding required to conduct its research, development and commercialization activities; changes in the Company’s business plan or objectives; competition in general; the Company’s ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries; and the Company partners’ ability to advance any technology relating to actinium-225 to development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management’s expectations are described in greater detail under the heading “Risk Factors” in the Company’s quarterly report on Form 10-Q for the period ended September 30, 2023, as filed with the Securities and Exchange Commission (the “SEC”) and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company’s estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company’s views, expectations, or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company’s estimates change. Investors and others should note that Fusion communicates with its investors and the public using the Fusion website, www.fusionpharma.com, including, but not limited to, company disclosures, investor presentations, SEC filings, and press releases. The information that Fusion posts on this website could be deemed to be material information. As a result, Fusion encourages investors, media and others interested to review the information that Fusion posts there on a regular basis. Contact: Amanda Cray
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Company Codes: NASDAQ-NMS:FUSN |