On May 7, 2024 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines, reported financial results for the first quarter ended March 31, 2024, and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, MAY 7, 2024, View Source [SID1234642772]).
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Chief Executive Officer John Valliant, Ph.D., commented, "In the first quarter, we demonstrated the potential of FPI-2265 to serve as an important new treatment option for patients with mCRPC, presenting interim data from the TATCIST trial at the 2024 AACR (Free AACR Whitepaper) Annual Meeting that we believe represent compelling early clinical activity and tolerability data. We look forward to continuing to develop FPI-2265 as the most advanced actinium-based prostate specific membrane antigen (PSMA) targeting therapy and expect to begin a Phase 2 dose optimization trial in the second quarter of this year, followed by a Phase 3 global registrational trial in 2025. In parallel, we are progressing our other clinical-stage programs as part of our diverse portfolio of alpha-emitting RCs."
Corporate Update
On March 19, 2024, Fusion announced that it entered into a definitive agreement to be acquired by AstraZeneca. Under the terms of the definitive 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.
On April 22, 2024 at 11:59pm, the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, expired with respect to the transaction, satisfying one of the closing conditions. On May 1, 2024, the Canadian Competition Bureau issued a no-action letter stating that it would not challenge the transaction, satisfying another closing condition. The transaction is expected to close in the second quarter of 2024, subject to other customary closing conditions, including the approval of Fusion shareholders.
Portfolio Update
FPI-2265: A 225Ac-based RC targeting PSMA for the treatment of patients with mCRPC.
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In April 2024, Fusion presented interim data from the Phase 2 TATCIST trial evaluating FPI-2265 at the 2024 AACR (Free AACR Whitepaper) Annual Meeting. Results demonstrated that FPI-2265 is active in heavily pretreated patients with progressive mCRPC, including patients who received prior lutetium-based radioligand therapy (RLT), and support Fusion’s ongoing FPI-2265 Phase 2/3 development program.
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In January 2024, the Company announced alignment with the FDA on its Phase 2/3 protocol for FPI-2265 in patients with mCRPC with progressive disease who have previously been treated with a 177Lu-based PSMA radiotherapy. The development plan includes a Phase 2 dose optimization lead-in, which
aims to evaluate whether there are added safety and/or efficacy benefits of various dosing regimens in comparison to the validated regimen of 100kBq/kg every eight weeks, expected to be initiated in the second quarter of 2024. This Phase 2 portion is expected to complete enrollment of approximately 60 patients by the end of 2024. Following analysis of the Phase 2 data and an end of Phase 2 meeting to determine the recommended Phase 3 dosing regimen with the FDA, a Phase 3 global registrational trial in approximately 550 patients is expected to begin in 2025.
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Fusion is also pursuing the opportunity to potentially develop this product candidate into earlier lines of treatment with combinations of FPI-2265 and olaparib. Fusion expects to initiate a combination trial in the second quarter of 2024.
FPI-1434: Targeting insulin growth factor 1 receptor (IGF1R)
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In January 2024, Fusion announced encouraging early findings from Cohort 2 in the cold/hot dosing arm of its ongoing Phase 1, multi-center, open-label clinical trial. The trial is designed to investigate the safety, tolerability, and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R. The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. No dose limiting toxicities (DLTs) were observed to date in the 25 kBq/kg dose cohort. Two out of three patients completed the DLT period, and one pancreatic cancer patient discontinued treatment due to disease progression. Evidence of anti-tumor activity was observed in a heavily pre-treated patient with Ewing sarcoma after a single dose and a second patient receiving four cycles of therapy demonstrated stable disease as best response.
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Fusion plans to complete and further evaluate results from Cohort 2 and hold a Safety Review Committee (SRC) meeting to evaluate the emerging data. Fusion plans to share more details on the data and the FPI-1434 development program in mid-2024.
FPI-2059: Targeting neurotensin receptor 1 (NTSR1)
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Patient enrollment and dosing is ongoing in the Phase 1, multi-center, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-2059 as well as preliminary anti-tumor activity in participants with NTSR1 expressing advanced metastatic solid tumors.
FPI-2068: A bispecific, IgG-based, EGFR-cMET targeted radioconjugate.
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FPI-2068 is currently being evaluated in a Phase 1 trial and is jointly developed with AstraZeneca. The investigational new drug application has been cleared and the trial is currently open and recruiting. FPI-2068 is a bispecific IgG-based TAT designed to deliver actinium-225 to various solid tumors that express EGFR-cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.
First Quarter 2024 Financial Results
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Cash and Investments: As of March 31, 2024, Fusion held cash, cash equivalents and investments of $283.1 million, compared to cash, cash equivalents and investments of $247.3 million as of December 31, 2023. The increase was primarily attributed to proceeds from sales of common shares under the Company’s at-the-market equity offering program received in the first quarter, as well as net proceeds from a draw down under the Company’s existing debt facility. Fusion expects its existing cash, cash equivalents and investments as of March 31, 2024 will be sufficient to fund operations into the fourth quarter of 2025.
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Collaboration Revenue: For the first quarter of 2024, Fusion did not record any revenue under the AstraZeneca collaboration agreement. For the same period in 2023, Fusion recorded less than $0.1 million of revenue under the AstraZeneca collaboration agreement.
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R&D Expenses: Research and development expenses for the first quarter of 2024 were $21.3 million, compared to $15.9 million for the same period in 2023. The increase was primarily due to an increase in FPI-2265 program-related costs for our Phase 2 clinical trial of FPI-2265 in patients with mCRPC, and an increase in manufacturing-related costs.
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G&A Expenses: General and administrative expenses for the first quarter of 2024 were $14.5 million, compared to $9.0 million for the same period in 2023. The increase was primarily due to an increase in professional fees due to higher legal and consulting expenses incurred in connection with the definitive agreement to be acquired by AstraZeneca.
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Net Loss: For the first quarter of 2024, Fusion reported a net loss of $33.7 million, or $0.40 per share, compared with a net loss of $24.3 million, or $0.45 per share, for the same period in 2023.