On November 8, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the third quarter ended September 30, 2022 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, NOV 8, 2022, View Source [SID1234623436]).
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Chief Executive Officer John Valliant, Ph.D. commented, "During the third quarter of 2022, we continued to advance our pipeline of targeted alpha therapy programs to treat multiple cancer types not currently addressed by available radiopharmaceutical therapies. Leveraging our platform and radiopharmaceutical expertise, we now have three Phase 1 clinical programs. Our lead program, FPI-1434, remains on track to report Phase 1 data in the first half of 2023. Following the initiation of dosing in our Phase 1/2 study of FPI-1966, we have opened multiple study sites and are actively recruiting patients with FGFR3-expressing solid tumors. We also continue to make progress in our newest clinical program, FPI-2059, which, based on clinical imaging and preclinical data, we believe has the potential to precisely target and kill tumor cells in colorectal, pancreatic and neuroendocrine prostate cancers. Furthermore, we’ve demonstrated Fusion’s proficiency in targeted alpha therapy (TAT) development with the first candidate under our collaboration agreement with AstraZeneca moving promptly through investigational new drug (IND) enabling studies. Our rich pipeline of cancer therapies is underpinned by an experienced internal radiopharmaceutical R&D team, and early investments in actinium supply, bolstered by our manufacturing capabilities. We look forward to providing meaningful updates on our diverse and growing pipeline of TATs in the months ahead."
Portfolio Update
FPI-1434
In the Phase 1 study, 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 Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing regimen, in the first half of 2023. Fusion continues to anticipate the initiation of a Phase 1 combination study 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 company plans to provide updated guidance for preliminary pharmacokinetic, imaging and safety data from the first patient cohort following experience with patient screening in order to better predict the cadence of patient enrollment.
FPI-2059
FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors, including neuroendocrine differentiated (NED) prostate, colorectal, and pancreatic cancers. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, which is overexpressed in several solid tumors. FPI-2059 is based upon Ipsen’s IPN-1087 (previously studied in a Phase 1 clinical trial as a beta-emitting radiopharmaceutical), which Fusion acquired in 2021, and converted to an alpha-emitting radiopharmaceutical using actinium-225.
The U.S. Food and Drug Administration (FDA) cleared Fusion’s IND application for FPI-2059 in June 2022 and study initiation activities are ongoing in a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing NTSR1, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. 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
In August, Fusion announced first patient dosed in Phase 1/2 study of FPI-1966 in patients with advanced solid tumors expressing FGFR3. The Phase 1/2 multi-center, open-label clinical trial is designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-1966 in patients with FGFR3-expressing advanced, inoperable, metastatic, and/or recurrent solid tumors. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-1966. The first cohort will comprise sub-groups in which various doses of non-radiolabeled vofatamab ("cold antibody") will be evaluated to assess the impact of pre-dosing on tumor uptake and pharmacokinetics. As part of the trial, patients will be administered an imaging analogue of FPI-1966, FPI-1967, and only those who upon imaging meet predefined tumor uptake will go on to receive FPI-1966. The Phase 2 portion of the study will consist of two tumor-specific cohorts and one basket cohort.
In September, Fusion drew down $25 million under the previously announced debt agreement with Oxford Finance LLC. To date, the Company has drawn down a total of $35 million. The loan agreement, as amended, provides for up to four tranches totaling $75 million. With the additional $25 million in debt funding, Fusion now expects its cash, cash equivalents and investments will be sufficient to fund operations into the third quarter of 2024.
On November 7, Fusion announced the appointment of Dmitri Bobilev, M.D., as chief medical officer. Dr. Bobilev joins Fusion from Checkmate Pharma, where he was vice president, head of clinical development until the company’s acquisition by Regeneron earlier in 2022. At Checkmate, he was responsible for clinical development and registration strategy for vidutolimod.
Third Quarter 2022 Financial Results
Cash and Investments: As of September 30, 2022, Fusion held cash, cash equivalents and investments of $205.5 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 September 30, 2022, will be sufficient to fund operations into the third quarter of 2024.
Collaboration Revenue: For the third quarter of 2022, Fusion recorded $0.2 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the third quarter of 2022 were $16.6 million, compared to $12.7 million for the same period in 2021. The increase was primarily due to discrete items that occurred during the third quarter of 2022, including a common share issuance and cash payment pursuant to our asset purchase agreement to acquire vofatamab from Rainier Therapeutics. Additionally, there was an increase in direct costs related to FPI-2059, specifically related to the initiation of the Phase 1 clinical trial as well as preclinical research and manufacturing costs.
G&A Expenses: General and administrative expenses for the third quarter of 2022 were $7.4 million, compared to $7.2 million for the same period in 2021. The increase was primarily due to an increase in personnel-related costs, partially offset by a decrease in corporate costs and professional fees.
Net Loss: For the third quarter of 2022, Fusion reported a net loss of $24.0 million, or $0.55 per share, compared with a net loss of $19.4 million, or $0.45 per share, for the same period in 2021.