On March 22, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the year ended December 31, 2021 and provided a business update (Press release, Phio Pharmaceuticals, MAR 22, 2022, View Source [SID1234610599]).
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!
"Over the past year, we have made significant progress moving towards the initiation of our first-in-human clinical studies for our lead program, PH-762, in 2022. Currently, we are on track to start enrolling patients in the first of these trials, a Phase 1b study of PH-762 in advanced melanoma, in the coming weeks," said Dr. Gerrit Dispersyn, President and CEO of Phio. "I am proud of the Phio team’s execution of our preclinical program for PH-762, which has generated a steady stream of positive data and supported our regulatory strategy. These studies were conducted during the second year of the ongoing global pandemic, which has proven to be a difficult period of time for the team, yet we incurred only minor delays to our original timelines. I believe the achievement of these milestones within the stated timeframes speak to the strength of our team and the assets in our pipeline, as well as our INTASYL platform. We look forward to continuing to deliver on our current development pipeline in 2022 as our business fulfills its transition into a clinical stage company."
Quarter in Review and Recent Corporate Updates
Granted clinical trial authorization (CTA) by the French National Agency for the Safety of Medicines and Health Products to proceed with a first-in-human clinical trial for PH-762 to treat patients with melanoma at the Gustave Roussy Institute, one of the largest cancer centers in Europe.
Presented new data in an in vivo hepatocarcinoma model that show PH-762 administered locally cleared untreated distal tumors, which indicates a systemic immune response.
Initiated efficacy animal studies with INTASYL-based antiviral compounds against SARS-CoV-2 infection, the virus that causes COVID-19, following collection of positive results from in vitro studies under this development program.
Upcoming Pipeline Milestones for 2022
Expect to start patient enrollment in a Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma in the first quarter of 2022.
Expect to initiate a first-in-human clinical study on the use of PH-762 in tumor infiltrating lymphocytes (TILs) in adoptive cell therapy (ACT) in patients with advanced melanoma in the second quarter of 2022.
Scheduled to present new study data regarding PH-894, a BRD4-targeting, self-delivering RNAi, at the AACR (Free AACR Whitepaper) Annual Meeting 2022, which is being held in New Orleans, Louisiana, from April 8-13, 2022.
Expect to finalize IND-enabling studies for PH-894 in the second half of 2022.
Additional data publications on the Company’s pipeline programs.
Financial Results
Cash Position
At December 31, 2021, the Company had cash of $24.1 million as compared with $14.2 million at December 31, 2020. The Company expects its current cash will be sufficient to fund currently planned operations to the second quarter of 2023.
Research and Development Expenses
Research and development expenses were approximately $8.9 million for the year ended December 31, 2021, compared to approximately $3.7 million for the year ended December 31, 2020. The increase in research and development expenses was primarily due to manufacturing costs for the Company’s PH-762 and PH-894 INTASYL compounds, fees for the required preclinical studies in support of the Company’s clinical trials for PH-762 and CRO and consulting related costs to support the initiation of the Company’s clinical trials as compared to the same period in the prior year.
General and Administrative Expenses
General and administrative expenses were approximately $4.6 million for the year ended December 31, 2021, compared to approximately $5.1 million for the year ended December 31, 2020. The decrease in general and administrative expenses was primarily due to a decrease in patent and legal fees partially offset by increases in the use of an outside consultant to support business development activities and corporate insurance premiums.
Net Loss
Net loss was $13.3 million, or $1.04 per share, for the year ended December 31, 2021, compared with $8.8 million, or $1.92 per share, for the year ended December 31, 2020. The increase in net loss was primarily attributable to the increase in research and development expenses related to the Company’s manufacturing of its INTASYL compounds and preclinical activities in preparation for the start of its clinical trial with PH-762, as described above. The change in net loss per share was primarily due to an increase in the number of shares outstanding as a result of the Company’s capital raise activities as compared to the prior year period.