On March 25, 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 fourth quarter ended December 31, 2020 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, MAR 25, 2021, View Source [SID1234577130]).

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"Advancing the Phase 1 clinical study of our lead program, FPI-1434, continues to be our primary focus," said Chief Executive Officer John Valliant, Ph.D. "We are working towards determining the recommended Phase 2 dose, and defining tumor-specific cohorts, which we expect to occur in the first half of 2022."

Dr. Valliant continued, "Employing Fusion’s adaptable platform, we are expanding our pipeline of targeted alpha therapies using different targeting moieties to treat an array of cancers with high unmet medical need. The recent transactions with Ipsen and AstraZeneca expand and diversify our pipeline and underscore the growing interest in harnessing the power of alpha-emitting radiopharmaceuticals to create innovative precision cancer treatments for patients."

Recent Highlights and Future Milestones

Corporate Updates

On March 2, Fusion announced it has entered into an asset purchase agreement (APA) to acquire Ipsen’s intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. Fusion intends to utilize its expertise and IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. The Company expects to submit an investigational new drug application in the first half of 2022.
FPI-1434 Monotherapy

In December 2020, Fusion announced that the first patient had been dosed in the multi-dose portion of the Phase 1 study evaluating FPI-1434 in patients with advanced solid tumors. The multi-dose portion follows completion of the single-ascending dose portion of the Phase 1 study, which showed that FPI-1434 was generally well tolerated with no dose limiting toxicities or treatment-related serious adverse events reported to date. The multi-dose portion of the study is enrolling patients at sites in Canada, the United States and Australia. The current patient cohort is being dosed with FPI-1434 at 75kBq/kg with repeat cycles every six weeks up to allowable limits.
Fusion anticipates reporting Phase 1 multi-dose safety and imaging data, and the recommended Phase 2 dose/schedule, in the first half of 2022.
FPI-1434 Combination Therapy

Fusion has evaluated FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.
Fusion anticipates the initiation of a Phase 1 combination study with FPI-1434 to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.
FPI-1966

FPI-1966 is designed to target and deliver actinium-225 to tumors expressing FGFR3, a protein that is overexpressed in head and neck and bladder cancers. Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 in the second quarter of 2021.
Fourth Quarter 2020 Financial Results

Cash and Investments: As of December 31, 2020, Fusion held cash, cash equivalents and investments of $299.5 million, compared to cash of $65.3 million as of December 31, 2019. Fusion expects its cash, cash equivalents and investments as of December 31, 2020 will enable the Company to fund its operations through the end of 2023.
R&D Expenses: Research and development expenses for the fourth quarter of 2020 were $5.0 million, compared to $3.4 million for the same period in 2019. The increase was primarily related to increased employee-related costs associated with hiring and increases in clinical, preclinical and discovery activities, partially offset by lower manufacturing expenses.
G&A Expenses: General and administrative expenses for the fourth quarter of 2020 were $6.6 million, compared to $2.7 million for the same period in 2019. The increase was primarily related to increased salaries, benefits and stock compensation costs due to increased hiring, and increased professional and consulting fees as a result of public company activities.
Net Loss: For the fourth quarter of 2020, Fusion reported a net loss of $13.4 million, or $0.32 per share, compared with a net loss of $8.2 million, or $4.25 per share, for the same period in 2019. On a non-GAAP basis, excluding a change in fair value of preferred share tranche right liability, net loss was $5.9 million for the fourth quarter of 2019.
Impact of COVID-19

While Fusion has commenced dosing in the multi-dosing portion of the Phase 1 clinical trial of FPI-1434, the Company has experienced moderate delays in patient recruitment and enrollment as a result of COVID-19.

Fusion is closely monitoring how the spread of COVID-19 is affecting the Company’s employees, business, preclinical studies and clinical trials. In response to the COVID-19 pandemic, certain employees have transitioned to working remotely and travel has been restricted. Fusion’s research labs are operating but with reduced capacity.

At this time, there is significant uncertainty relating to the trajectory of the pandemic and whether it may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in 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 impact of COVID-19 on future results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.