Fusion Pharmaceuticals Q1 2024 Financial Results and Clinical Program Updates

Fusion Pharmaceuticals Inc., a clinical-stage oncology company, has reported significant updates for the first quarter ending March 31, 2024. The company, which focuses on next-generation radioconjugates (RCs) for precision cancer treatment, provided insights into its financial status and ongoing clinical trials.

CEO John Valliant, Ph.D., highlighted the promising developments of their lead program, FPI-2265, particularly its potential as a new treatment for metastatic castration-resistant prostate cancer (mCRPC). Interim data from the TATCIST trial, presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting, showcased early clinical activity and tolerability of FPI-2265. This compound is poised to progress through a Phase 2 dose optimization trial starting in the second quarter of 2024, with a Phase 3 global registrational trial anticipated in 2025.

In corporate news, Fusion has entered into a definitive agreement to be acquired by AstraZeneca for up to $2.4 billion. This transaction is slated to close in the second quarter of 2024. Notable regulatory approvals have been secured, including the expiration of the Hart-Scott-Rodino waiting period and a no-action letter from the Canadian Competition Bureau.

Fusion's portfolio continues to expand with several promising candidates. The FPI-2265 has shown activity in patients who previously underwent lutetium-based radioligand therapy, supporting its progression to Phase 2/3 trials. The company plans to enroll approximately 60 patients by the end of 2024 in the Phase 2 trial, aiming to finalize the Phase 3 protocol in collaboration with the FDA. Fusion is also exploring the potential of FPI-2265 in combination therapies, such as with olaparib, and expects to initiate related trials soon.

Another key program, FPI-1434, targets the insulin growth factor 1 receptor (IGF1R). Early data from the ongoing Phase 1 trial showed no dose-limiting toxicities in the 25 kBq/kg dose cohort, with some evidence of anti-tumor activity. Fusion plans to review and share more details on this program by mid-2024.

The FPI-2059 program focuses on the neurotensin receptor 1 (NTSR1), with a Phase 1 trial underway to assess its safety and preliminary anti-tumor activity. Meanwhile, FPI-2068, a bispecific radioconjugate targeting EGFR and cMET, is being developed in collaboration with AstraZeneca. This program is recruiting for a Phase 1 trial to evaluate its efficacy in various solid tumors.

Financially, Fusion reported cash and investments of $283.1 million as of March 31, 2024, up from $247.3 million at the end of 2023. However, the company did not record any collaboration revenue with AstraZeneca for the first quarter of 2024. Research and development expenses rose to $21.3 million, driven by increased costs related to the FPI-2265 program. General and administrative expenses also increased to $14.5 million, primarily due to higher legal and consulting fees associated with the AstraZeneca acquisition. The net loss for the quarter was $33.7 million, or $0.40 per share.

Fusion Pharmaceuticals remains committed to advancing its portfolio of RCs and leveraging its state-of-the-art manufacturing facility to meet future demands. The company's strategic developments and robust financial position aim to support its ongoing and future clinical programs, reinforcing its mission to provide innovative cancer treatments.