On August 11, 2020 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, 2020 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, AUG 11, 2020, View Source [SID1234563440]).

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"By developing targeted alpha therapies (TATs), Fusion is taking a precision medicine approach to radiation therapy," said Chief Executive Officer John Valliant, Ph.D. "In addition to our lead program, FPI-1434, which is currently in a Phase 1 clinical trial, Fusion’s research and development capabilities, manufacturing and supply chain expertise, and our Fast-Clear linker technology provide a platform for creating new TATs and growing our pipeline."

Dr. Valliant continued, "Following a successful initial public offering in June, and achieving a regulatory milestone that triggered the second tranche of our Series B financing in May, we are well-positioned to reach significant inflection points in our clinical programs, expand our pipeline, and invest in our platform to create potent TATs."

"Our near-term priority is to initiate the multi-dosing portion of our Phase 1 trial of FPI-1434, and we are pleased to have received notice from both Health Canada and the U.S. Food and Drug Administration (FDA) that we are able to move forward with these plans," Dr. Valliant concluded.

Recent Highlights and Future Milestones

FPI-1434 Monotherapy

Fusion has completed enrollment, dosing and the dose-limiting toxicity (DLT) evaluation period for the third patient cohort in the ongoing Phase 1 clinical trial of FPI-1434. Fusion plans to convene a Safety Review Committee (SRC) meeting in the third quarter of 2020 to evaluate the safety of the third patient single-dose cohort of 40kBq/kg (cohort three). Fusion anticipates Phase 1 single-dose safety and imaging data to be available in the fourth quarter of 2020.

Fusion received notice from the FDA in May 2020 and a "No Objection Letter" from Health Canada in July 2020 indicating that investigation of the multiple-dose administration in the Phase 1 clinical trial of FPI-1434 may begin.

Fusion anticipates reporting Phase 1 multiple-dose safety and imaging data, and the recommended Phase 2 dose/schedule, approximately nine to eighteen months after the commencement of this portion of the study.

FPI-1434 Combination Therapy

Fusion is currently evaluating 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 initiating Phase 1 combination studies 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 to tumor sites 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 approximately six to twelve months after the Company fully resumes preclinical activities following interruptions caused by COVID-19.

Corporate Updates

In June 2020, Fusion completed an initial public offering of 12,500,000 common shares at a public offering price of $17.00 per share. Gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Fusion, were $212.5 million.

In May 2020, upon acceptance of the clinical trial protocol amendment to move from the single- to multiple-dose regimen of FPI-1434, the Company achieved a regulatory milestone associated with the Class B financing which triggered the closing of the second tranche of $62.5 million in gross proceeds.

Impact 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, most employees have transitioned to working remotely and travel has been restricted.

While Fusion has completed enrollment, dosing and the DLT evaluation period for the third patient cohort in the ongoing Phase 1 clinical trial of FPI-1434, the Company may not be able to enroll additional patient cohorts on the planned timeline due to disruptions at clinical trial sites. Additionally, while certain preclinical activities have restarted, Fusion is currently unable to predict when the Company will fully resume all preclinical activities.

Although the single dose Phase 1 clinical trial has not been materially affected by the COVID-19 pandemic as of June 30, 2020, at this time, there is significant uncertainty relating to the trajectory of the pandemic. 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.

Second Quarter 2020 Financial Results

Cash Position: As of June 30, 2020, Fusion held cash of $318.9 million, compared to cash of $65.3 million as of December 31, 2019. Fusion expects its cash as of June 30, 2020 will enable the Company to fund its operations into 2024.

R&D Expenses: Research and development expenses for the second quarter of 2020 were $3.3 million, compared to $2.1 million for the same period in 2019. The increase was primarily due to costs related to our Phase 1 clinical trial of FPI-1434, as well as other development and personnel-related costs.

G&A Expenses: General and administrative expenses for the second quarter of 2020 were $4.0 million, compared to $1.8 million for the same period in 2019. The increase was primarily due to an increase in professional fees, personnel-related costs and other costs including general corporate, insurance and facilities costs.

Net Loss: For the second quarter of 2020, Fusion reported a net loss of $44.7 million, or $18.91 per share, compared with a net loss of $3.5 million, or $1.79 per share, for the same period in 2019. During the second quarter of 2020, Fusion recorded a non-cash charge of $31.6 million for the final fair value measurement of the Company’s Class B preferred share tranche right liability. The fair value increased in the quarter due primarily to an increase in the fair value of the Class B preferred shares as a result of achieving specified milestones underlying the preferred share tranche rights. Fusion also recorded a non-cash charge of $6.1 million during the second quarter of 2020 for the final fair value measurement of the Company’s Class B preferred share warrant liability. The fair value increased in the quarter due primarily to an increase in the fair value of the underlying Class B preferred shares resulting from the IPO. The tranche right liability and the warrant liability were reclassified to shareholders’ equity during the second quarter of 2020. Excluding these non-cash charges, for the second quarter of 2020 net loss on a non-GAAP adjusted basis was $7.1 million.

Upcoming Events

Fusion will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12 at 9:10am EDT.

Fusion will participate in a virtual "fireside chat" presentation at Morgan Stanley’s 18th Annual Global Healthcare Conference on Thursday, September 17 at 11:00am EDT.