On November 14, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage biotechnology company exploring new pathways towards a cancer-free future by using its INTASYL siRNA gene silencing technology designed to make the body’s immune cells more effective in killing cancer cells reported its financial results for the quarter ended September 30, 2024 and provided a business update (Press release, Phio Pharmaceuticals, NOV 14, 2024, View Source [SID1234648410]).
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!
Recent Corporate Updates
The Phase 1b dose escalation clinical trial for our lead product candidate, PH-762, previously received a positive safety recommendation to advance to the next highest dose from the Safety Monitoring Committee (SMC) for the first cohort. The second cohort is fully enrolled, and screening for the 3rd cohort will open on 10 Dec 2024. Each enrolled subject receives four (4) intratumoral (IT) doses of PH-762. The currently enrolled patients were diagnosed with cutaneous squamous cell carcinoma (6 patients) and metastatic melanoma (1 patient). Two of the three patients in the second cohort have completed the treatment and the follow-up phase.
At Day 36 (tumor excision), while each patient in the first cohort had stable disease, the following results were described for two patients who have completed treatment in the second cohort:
· Complete response (100% tumor clearance) reported for 1 patient with cutaneous squamous cell carcinoma
· Partial response (90% tumor clearance) reported for 1 patient with cutaneous squamous cell carcinoma
A sixth clinical trial site, Paradigm Clinical Research Centers in San Diego, CA, was selected for the Phase 1b study of PH-762 and will join the other five sites engaged in the study: Banner MD Anderson Cancer Center in Gilbert, Arizona. The George Washington University-Medical Faculty Associates in Washington, D.C; The University of Pittsburgh Medical Center (UPMC) Department of Dermatology; Integrity Research Clinical Associates in Delray Beach, Florida; and Centricity Research in Dublin Ohio.
Cancer Immunology, Immunotherapy, a peer reviewed journal, highlighted the INTASYL compound PH-804. The article, issued on Oct 3, 2024, was authored by M Maxwell et al. entitled "INTASYL Self-Delivering RNAi Decreases TIGIT Expression, Enhancing NK Cell Cytotoxicity: A Potential Application to Increase the Efficacy of NK-Adoptive Cell Therapy Against Cancer".
Presented new data on Phio’s INTASYL self-delivering siRNA technology applications for immuno-oncology therapy at several conferences:
· 9th Annual CAR-TCR Summit held on Sept 17th showcased INTASYL siRNA technology-an innovative and flexible solution designed specifically to enhance cell potency and improve overall yield for adoptive cell therapy.
· 20th Annual Oligonucleotide Therapeutics Society (OTS) held on October 8th showcased INTASYL’s role in helping immune cells target and kill cancer cells.
· The American Society of Gene and Cell Therapy’s 2024 Advancing Cancer Conference held Oct 16-17 reported on INTASYL Compound PH-894: A potent and specific silencing of BRD4 in NK Cells.
· 39th Annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held November 9th reported on new clinical data from the Phase 1b clinical trial for its INTASYL Compound PH-762.
Phio Pharmaceuticals is currently participating in the Renmark Financial Virtual Non-Deal Roadshow series that features Phio’s CEO and Chairman of the Board, Robert Bitterman, presentation on its INTASYL technology. The presentations are directed to the retail investor communities including those in the Chicago, Denver, Dallas, Atlanta, and Boston areas. These roadshows have been on-going since late August 2024.
Financial Results
Cash Position
At September 30, 2024, the Company had cash of $5.4 million as compared with $8.5 million at December 31, 2023.
In July 2024, the Company entered into inducement letter agreements with certain holders of the Company’s existing warrants to purchase up to an aggregate of 545,286 shares of common stock at a reduced exercise price of $5.45 per share. In consideration for the immediate exercise of the existing warrants, the Company agreed to issue five and one-half year term Series C warrants to purchase up to 583,098 shares of common stock and eighteen month term Series D warrants to purchase up to 507,474 shares of common stock, both at an exercise price of $5.45. The net proceeds to the Company were approximately $2.6 million, after deducting placement agent fees and offering expenses.
Research and Development Expenses
Research and development expenses were $0.6 million for the three months ended September 30, 2024 as compared with $1.8 million for the three months ended September 30, 2023, a decrease of 64%. The decrease was primarily driven by non-recurring clinal program direct start-up costs in the 3rd Quarter 2023 and reductions in research compensation attributable to reductions in headcount of participants during the 3rd Quarter 2024.
General and Administrative Expenses
General and administrative expenses were $0.95 million for the three months ended September 30, 2024 as compared with $0.97 million for the three months ended September 30, 2023, a decrease of 2%. The decrease was primarily due to decreases in salary-related expenses compared to the prior year period.
Net Loss
Net loss was $1.5 million for the three months ended September 30, 2024 as compared with $2.8 million for the three months ended September 30, 2023. The decrease in net loss was primarily due to the changes in research and development expenses, as described above.