On May 11, 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 first quarter ended March 31, 2021 and provided an update on clinical and corporate developments (FilingPress release, Fusion Pharmaceuticals, MAY 11, 2021, View Source [SID1234579685]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We continue to advance our Phase 1 study of FPI-1434," said Chief Executive Officer John Valliant, Ph.D. "In anticipation of data and determination of a recommended Phase 2 dose in the first half of 2022, we are amending the study protocol to define tumor-specific cohorts based upon IGF-1R expression and tumor uptake as seen to date in the Phase 1 study."
Dr. Valliant continued, "In parallel, we are building a diverse pipeline of alpha-emitting radiopharmaceuticals. We expect to file our investigational new drug (IND) application for FPI-1966 in the second quarter of this year. In addition, we recently completed the acquisition of IPN-1087, a first-in-class small molecule beta-emitting radiopharmaceutical targeting neurotensin receptor 1 (NTSR1), which is expressed on multiple solid tumors and which we plan to convert into alpha-emitting FPI-2059. These programs demonstrate the depth and versatility of Fusion’s radiopharmaceutical platform and our potential to treat a broad array of solid tumors with high unmet medical need.
"Evidenced by our recent presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, we are excited about the potential to evaluate Fusion’s TATs in combination with the latest generation of cancer therapies, including checkpoint inhibitors and DNA damage response inhibitors (DDRis). Our recently announced collaborations with Merck and AstraZeneca enable us to explore these combination therapies and highlight the growing interest in TAT therapies."
Recent Highlights and Future Milestones
Corporate Updates
On May 6, Fusion announced that it has entered a clinical trial collaboration with a subsidiary of Merck to evaluate FPI-1434 in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with solid tumors expressing insulin-like growth factor 1 receptor (IGF-1R). The planned Phase 1 combination trial will evaluate safety, tolerability and pharmacokinetics of the combination and is expected to initiate approximately six to nine months after achieving the recommended Phase 2 dose in the ongoing Phase 1 study of FPI-1434 monotherapy. Under the terms of the agreement, Fusion will sponsor the study and Merck will supply KEYTRUDA.
On April 10, Fusion announced the presentation of preclinical data at the 2021 AACR (Free AACR Whitepaper) Virtual Annual Meeting. The posters, titled "Combination of IGF-1R Targeted Alpha Therapy with Olaparib Results in Synergistic Efficacy Against Colorectal and Lung Cancer Xenografts" and "Combination of IGF-1R Targeted Alpha Therapy with Checkpoint Inhibitors Results in Synergistic Efficacy in Colorectal Cancer Syngeneic Model," highlight the potential of Fusion’s targeted alpha therapies (TATs) as both monotherapies and combination therapies.
On April 1, Fusion announced the closing of its acquisition of Ipsen’s assets and intellectual property related to IPN-1087. IPN-1087, previously studied in a Phase 1 trial, is a small molecule targeting NTSR1, a protein expressed on multiple solid tumor types. Fusion is using IPN-1087 to create a first-in-class alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. The Company expects to submit an IND application in the first half of 2022.
FPI-1434 Monotherapy
Fusion continues to advance the multi-dose portion of its Phase 1 study evaluating FPI-1434 in patients with advanced solid tumors. The dose-finding study is enrolling patients at sites in Canada, the United States and Australia.
Fusion anticipates reporting Phase 1 multi-dose safety and imaging data, and the recommended Phase 2 dose and 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.
As noted above, Fusion anticipates 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
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.
First Quarter 2021 Financial Results
Cash and Investments: As of March 31, 2021, Fusion held cash, cash equivalents and investments of $278.2 million, compared to cash of $299.5 million as of December 31, 2020. Fusion expects its cash, cash equivalents and investments as of March 31, 2021 will enable the Company to fund its operations through the end of 2023.
R&D Expenses: Research and development expenses for the first quarter of 2021 were $10.7 million, compared to $4.4 million for the same period in 2020. The increase was primarily related to increased platform development and research activities, clinical activities related to the ongoing Phase 1 clinical trial of FPI-1434, and preclinical research and manufacturing costs.
G&A Expenses: General and administrative expenses for the first quarter of 2021 were $7.0 million, compared to $4.3 million for the same period in 2020. The increase was primarily related to general corporate expenses, including increased professional and consulting fees as a result of public company activities, as well as increased salaries, benefits and stock compensation costs due to hiring.
Net Loss: For the first quarter of 2021, Fusion reported a net loss of $17.5 million, or $0.42 per share, compared with a net loss attributable to common shareholders of $11.6 million, or $6.01 per share, for the same period in 2020. On a non-GAAP basis, excluding a change in fair value of preferred share tranche right liability and warrant liability, net loss was $8.8 million for the first quarter of 2020.
Impact of COVID-19
While Fusion continues to progress 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 results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.