On August 10, 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 second quarter ended June 30, 2021 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, AUG 10, 2021, View Source [SID1234586249]).

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"We are building a fully integrated radiopharmaceutical company based upon our platform, reflecting a diverse pipeline of targeted alpha therapies in development supported by manufacturing and supply chain expertise," said Chief Executive Officer John Valliant, Ph.D. "We expect to have three clinical programs employing differentiated radiopharmaceuticals underway by mid-next year. In addition to our ongoing Phase 1 study of FPI-1434, the investigational new drug application (IND) of FPI-1966 was recently cleared by the U.S. Food & Drug Administration (FDA), and we intend to submit an IND application for FPI-2059 in the first half of 2022. In parallel, we are quickly advancing programs under our partnership agreement with AstraZeneca and are planning for a combination study of FPI-1434 with KEYTRUDA (pembrolizumab)."

Dr. Valliant continued, "These programs, along with our work to build Fusion’s radiopharmaceutical manufacturing capabilities with a new facility, demonstrate the depth and versatility of our pipeline and the potential to use our expertise to create innovative treatments for a broad array of solid tumors with high unmet medical need."

Recent Highlights and Future Milestones

Corporate Updates

On July 28, Fusion announced the FDA cleared the Company’s Investigational New Drug (IND) application for FPI-1966. FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3), a protein that is overexpressed in multiple tumor types, particularly head and neck and bladder cancers. Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3 intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. The Company anticipates initiating the Phase 1 study around the end of 2021 and reporting interim data from the first patient cohort around the end of 2022.
On June 14, Fusion announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. Results from the first three patient cohorts (n=12) demonstrated a favorable safety profile for FPI-1434. No drug-related serious adverse events and/or dose limiting toxicity were reported in administered activity up to 40kBq/kg body weight and dosimetric results were within normal organ radiation tolerability limits.
On June 14, Fusion also announced preclinical data demonstrating synergistic efficacy against olaparib-resistant colorectal and radioresistant lung cancer xenografts when combining FPI-1434 with olaparib, and preclinical data showing that treatment with FPI-1434 in combination with immune checkpoint inhibitors resulted in complete tumor eradication.
On June 2, Fusion announced that the Company entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be built by McMaster and equipped and validated by Fusion, will be designed to support manufacturing of the Company’s growing pipeline of targeted alpha therapies (TATs).
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.
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-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 anticipates submitting an IND application for FPI-2059 in the first half of 2022.
Second Quarter 2021 Financial Results

Cash and Investments: As of June 30, 2021, Fusion held cash, cash equivalents and investments of $260.5 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 June 30, 2021 will enable the Company to fund its operations through the end of 2023.
Collaboration Revenue: For the second quarter of 2021, Fusion recorded $0.5 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the second quarter of 2021 were $21.1 million, compared to $3.3 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, asset purchase agreements and preclinical research and manufacturing costs.
G&A Expenses: General and administrative expenses for the second quarter of 2021 were $6.6 million, compared to $4.0 million for the same period in 2020. The increase was primarily related to personnel related costs, including salary, benefits and stock compensation due to hiring, as well as general corporate costs, including expenses for general corporate, director and officer insurance.
Net Loss: For the second quarter of 2021, Fusion reported a net loss of $26.9 million, or $0.63 per share, compared with a net loss of $44.7 million, or $18.91 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 $7.1 million for the second quarter of 2020.
Impact of COVID-19

While Fusion is progressing the multi-dosing portion of the Phase 1 clinical trial of FPI-1434, the Company has experienced material delays in patient recruitment and enrollment as a result of continued resourcing issues related to COVID-19 at trial sites.

Moreover, there remains 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 continued impact of COVID-19 on results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.