On November 9, 2021 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, 2021 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, NOV 9, 2021, View Source [SID1234594931]).

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Clinical Update

FPI-1434

Fusion now expects to provide multi-dose safety and imaging data, and recommended Phase 2 dose, in the second half of 2022 rather than in the first half of 2022. The shift in timelines is primarily associated with a decrease in patient enrollment rates attributable to the impact of the COVID-19 pandemic.

Chief Executive Officer John Valliant, Ph.D. commented, "Despite our efforts to mitigate the impacts of the COVID-19 pandemic, including the addition of new trial sites in multiple geographic regions, we have seen patient enrollment rates decline largely due to resourcing and reduced staffing issues at trial sites. Longer timelines to enroll patients have persisted and therefore we are shifting our expectation for multi-dose data to the second half of 2022. We continue to make patient recruitment a top priority, are working closely with our trial sites to support their efforts and believe that with increased vaccination rates recruitment will return to previous levels."

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. In addition, the study arm exploring the impact on biodistribution and tumor uptake of administration of a dose of naked ("cold") IGF-1R antibody prior to each dose of FPI-1434 is ongoing.

Dr. Valliant continued, "Although the Phase 1 study of FPI-1434 is experiencing delays during these unprecedented times, we continue to believe in the significant opportunity we have to address a broad array of tumor types with high unmet need and we are working diligently to optimize the development program and progress the study for the benefit of patients."

FPI-1966

The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose, has been initiated with the first study site open to recruitment. Fusion expects to dose the first patient in the first quarter of 2022 and expects interim data from the first patient cohort in the first quarter of 2023.

FPI-2059

FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, that is overexpressed in multiple solid tumors. FPI-2059 combines Ipsen’s IPN-1087, which Fusion acquired in 2021, with actinium-225. Fusion continues to anticipate submitting an IND application for FPI-2059 in the first half of 2022.

Recent News and Highlights

In August, Fusion and TRIUMF, Canada’s particle accelerator centre, announced that the companies have entered into the next phase of their collaboration agreement for the development, production, and supply of actinium-225. Fusion will provide to TRIUMF funding to further develop technology to produce actinium-225 and in return Fusion will have rights, including preferred access and pricing, to the resulting alpha-emitting medical isotope.
Fusion recently expanded its executive leadership team with the appointments of Mohit Rawat as president and chief business officer, and Christopher Leamon, Ph.D. as chief scientific officer, and Eric S. Hoffman, Ph.D. as senior vice president, business development.
In October, Fusion announced the presentation of preclinical data that provide further support of its FPI-1966 and FPI-2059 targeted alpha therapies (TATs) at the 34th Annual European Association of Nuclear Medicine Congress. These data reinforce the clinical dosing regimen of FPI-1966 and highlight the potential of FPI-2059 as an actinium-225 labelled precision medicine targeting NTSR1.
Dr. Valliant said, "We are building a fully integrated radiopharmaceutical company based upon our platform, reflecting a diverse pipeline of TATs in development. We are also making strategic investments in critical areas of manufacturing and supply chain to support the growth of our business, and we are attracting top industry leaders to join Fusion in our mission to impact the cancer therapy landscape with this new generation of targeted radiopharmaceuticals."

Third Quarter 2021 Financial Results

Cash and Investments: As of September 30, 2021, Fusion held cash, cash equivalents and investments of $238.2 million, compared to cash, cash equivalents and investments of $299.5 million as of December 31, 2020. Fusion expects its cash, cash equivalents and investments as of September 30, 2021 will enable the Company to fund its operations through the end of 2023.
Collaboration Revenue: For the third quarter of 2021, Fusion recorded $0.3 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the third quarter of 2021 were $12.7 million, compared to $4.5 million for the same period in 2020. The increase was primarily related to costs associated with the FPI-1434 Phase 1 clinical trial, as well as preclinical research and manufacturing costs, platform development and personnel-related costs.
G&A Expenses: General and administrative expenses for the third quarter of 2021 were $7.2 million, compared to $5.8 million for the same period in 2020. The increase was primarily related to personnel-related costs and general corporate costs, partially offset by a decrease in professional fees.
Net Loss: For the third quarter of 2021, Fusion reported a net loss of $19.4 million, or $0.45 per share, compared with a net loss of $10.0 million, or $0.24 per share, for the same period in 2020.
Impact of COVID-19

Fusion is experiencing material delays in patient recruitment and enrollment as a result of continued resourcing issues related to COVID-19 at trial sites.

There also remains uncertainty relating to the trajectory of the pandemic, hospital staffing and resource issues, and whether they may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in further difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The continued impact of COVID-19 on results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.