On March 16, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the fourth quarter ended December 31, 2022 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, MAR 16, 2023, View Source [SID1234628894]).
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Chief Executive Officer John Valliant, Ph.D. commented, "We have made significant progress towards our goal of bringing the power of targeted alpha therapies (TATs) to patients with cancers of high unmet need, while continuing to build on our radiopharmaceutical capabilities, including actinium supply. We have an exciting and diversified pipeline that includes one Phase 2 and three Phase 1 clinical programs, and our first program under the collaboration with AstraZeneca is progressing towards Phase 1 as planned.
"We believe Fusion is well positioned for further progress in 2023 with preliminary data from the FPI-1434 Phase 1 trial expected in the second quarter of 2023. We are also advancing our newest clinical program, FPI-2265, a small molecule TAT targeting prostate specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and are driving towards the opportunity to be first-to-market with an actinium-based PSMA agent to meet a significant and growing need for patients. Our deep pipeline of cancer therapeutic candidates continues to be underpinned by our R&D expertise, and our investments in actinium supply and manufacturing which is a critical element of success in the radiopharmaceutical space. We look forward to providing meaningful updates on our diverse pipeline of TATs in the months ahead."
Portfolio Update
FPI-2265
In February 2023, Fusion acquired an investigational new drug application (IND) for an ongoing Phase 2 clinical trial (the "TATCIST" trial) evaluating 225Ac-PSMA I&T, a small molecule targeting PSMA expressed on prostate cancers. The alpha-emitting radiopharmaceutical being evaluated in the TATCIST trial is now known as FPI-2265.
The TATCIST trial is designed to evaluate patients with mCRPC with progressive disease, including patients who are naïve to PSMA targeted radiopharmaceuticals and those who have been pre-treated with 177Lu-based PSMA radiopharmaceuticals such as PLUVICTO. Fusion plans to expand the Phase 2 program to additional sites and expects to report data on approximately 20 to 30 patients in the first quarter of 2024.
FPI-1434
In the Phase 1 trial, Fusion is exploring various dose levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone, and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434. The Company anticipates reporting safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, from the Phase 1 trial in the second quarter of 2023. Fusion continues to anticipate the initiation of a Phase 1 combination trial with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.
FPI-1966
The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3 is intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Patient enrollment and dosing is ongoing. The first cohort of the Phase 1 portion of this trial is designed to evaluate various doses of vofatamab ("cold antibody") to assess the impact of pre-dosing on tumor uptake and will inform the dosing regimen for the remainder of the trial. The Company anticipates providing a preliminary clinical data update in 2024.
FPI-2059
The Phase 1, non-randomized, open-label clinical trial of FPI-2059 in patients with solid tumors expressing NTSR1 is intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Site initiation and patient screening is ongoing. Fusion plans to provide guidance on timelines for the FPI-2059 program following site activations and initial experience with patient screening and patient enrollment.
Recent Updates
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In February, Fusion announced the acquisition of a Phase 2 program for 225Ac-PSMA I&T, a radiopharmaceutical targeting mCRPC now known as FPI-2265. In connection with the acquisition, Fusion announced gross proceeds of $60.0 million in a private placement of its common shares. New and existing investors in the private placement financing include Avidity Partners, Federated Hermes Kaufmann Funds, a fund affiliated with Deerfield Management Company, L.P., Invus, Perceptive Advisors, and Woodline Master Fund LP.
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In January, Fusion and BWXT Medical announced an actinium-225 partnership to scale supply for developing targeted alpha therapies. Under the preferred partner agreement, BWXT Medical will provide predetermined amounts of Fusion’s actinium supply needs at volume-based pricing. Actinium-225 is an alpha-emitting isotope used in targeted alpha therapies (TATs) that combine the isotope with specific tumor-seeking targeting vectors to kill cancer cells while minimizing the impact to healthy tissues.
Fourth Quarter 2022 Financial Results
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Cash and Investments: As of December 31, 2022, Fusion held cash, cash equivalents and investments of $186.6 million, compared to cash, cash equivalents and investments of $220.8 million as of December 31, 2021. Fusion expects its existing cash, cash equivalents and investments as of December 31, 2022, plus the proceeds of the recently announced private placement, will be sufficient to fund operations into the first quarter of 2025.
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Collaboration Revenue: For the fourth quarter of 2022, Fusion recorded $0.1 million of revenue under the AstraZeneca collaboration agreement, compared to $0.6 million for the same period in 2021.
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R&D Expenses: Research and development expenses for the fourth quarter of 2022 were $17.6 million, compared to $11.8 million for the same period in 2021. The increase was primarily due to manufacturing-related milestone payments to our collaboration partners that occurred during the fourth quarter of 2022, as well as increased personnel-related costs.
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G&A Expenses: General and administrative expenses for the fourth quarter of 2022 were $6.9 million, compared to $6.3 million for the same period in 2021. The increase was primarily due to an increase in personnel-related costs.
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Net Loss: For the fourth quarter of 2022, Fusion reported a net loss of $24.6 million, or $0.55 per share, compared with a net loss of $17.2 million, or $0.40 per share, for the same period in 2021.
Presentations at AACR (Free AACR Whitepaper) Annual Meeting 2023
Fusion announced that it will present data from three preclinical studies in poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held in Orlando, Fla., April 14-19, 2023.
Title: NTSR1-targeted alpha therapeutic [Ac-225]-FPI-2059 induces growth inhibition in a preclinical colorectal tumor model
Session: Theranostics and Radionuclides / Pharmacologic Approaches
Session Date and Time: Tuesday April 18, 2023, 1:30 PM – 5:00 PM ET
Location: Poster Section 19
Abstract Number: 5045
Title: TEM-1 targeted alpha therapeutic [Ac-225]-FPI-1848 induces regression in pre-clinical sarcoma xenograft models
Session: Theranostics and Radionuclides / Pharmacologic Approaches
Session Date and Time: Tuesday April 18, 2023, 1:30 PM – 5:00 PM ET
Location: Poster Section 19
Abstract Number: 5041
Title: EGFRvIII-targeted alpha therapy shows significant therapeutic efficacy as both a single-agent and in combination with standard of care against preclinical GBM models
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Session Date and Time: Wednesday April 19, 2023, 9:00 AM – 12:30 PM ET
Location: Poster Section 35
Abstract Number: LB313
The posters will be available on Fusion’s website following the presentations. For more details about the AACR (Free AACR Whitepaper) Annual Meeting, please visit: View Source