Phio Pharmaceuticals(PHIO) - 2025 Q1 - Quarterly Results

Business Update PH-762 Clinical Progress PH-762's Phase 1b trial progresses, showing promising cSCC efficacy and good tolerability, targeting Q3 2025 enrollment completion - The ongoing Phase 1b trial is evaluating intratumoral PH-762 for treating cSCC, melanoma, and Merkel cell carcinoma[3] - Of the 9 cSCC patients treated, 4 achieved a pathologic complete response (100% tumor clearance), 1 had a near complete response (>90%), and 1 had a partial response (>50%)[4] - PH-762 has been well tolerated with no dose-limiting toxicities observed, and the fourth cohort is currently enrolling, with trial enrollment expected to be completed in the third quarter of 2025[5] Scientific News Phio presented positive INTASYL clinical data for PH-762 and PH-894 at conferences, and RXI-231 was featured in a journal - The company presented its Phase 1b clinical trial results at the American Academy of Dermatology (AAD) and the Society of Investigative Dermatology (SID)[6] - Data on INTASYL compounds PH-762 and PH-894 were presented at the 11th Annual Immunotherapy of Cancer (ITOC 11) conference[6] - The INTASYL compound RXI-231, designed to treat hyperpigmentation disorders, was highlighted in the peer-reviewed journal, Clinical, Cosmetic and Investigational Dermatology[7] Capital Sourcing Phio raised $12.1 million via offerings and warrant exercises, securing capital for the Phase 1b trial's treatment phase - Raised an aggregate of approximately $9.2 million in registered direct offerings and concurrent private placements in December 2024 and January 2025[8] - Secured additional gross proceeds of approximately $2.9 million from the exercise of warrants[8] - With the new proceeds, the company believes it has sufficient capital to complete the treatment phase of the Phase 1b trial[8] Cost Rationalization Cost-saving measures include moving the laboratory to a cheaper lease and terminating the AgonOx Clinical Co-Development Agreement - The company moved to a new laboratory facility with a month-to-month lease of approximately $2,500, a significant reduction from its previous arrangement[9] - In May 2024, the company terminated its Clinical Co-Development Agreement with AgonOx, Inc. and settled all future obligations with a final payment of $34,320 in March 2025[10] First Quarter 2025 Financial Results Financial Highlights Phio improved Q1 2025 cash to $13.3 million via financing, reducing net loss to $1.8 million due to decreased R&D and G&A Financial Highlights (Q1 2025 vs Q1 2024) | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $13.3M | N/A | +$7.9M from YE 2024 | | Research & Development | $0.886M | $1.148M | -23% | | General & Administrative | $0.986M | $1.061M | -7% | | Net Loss | $1.8M | $2.2M | -18% | | Net Loss Per Share | ($0.41) | ($0.47) | Improved | Cash Position Cash and cash equivalents increased to $13.3 million as of March 31, 2025, primarily from $9.2 million in net cash from financing - Cash was approximately $13.3 million at March 31, 2025, compared to $5.4 million at December 31, 2024[11] - Net cash provided by financing activities for Q1 2025 was approximately $9.2 million, mainly from the issuance of common stock and warrants, and the exercise of warrants[12] Operating Expenses Operating expenses decreased year-over-year, with R&D down 23% to $0.886 million and G&A down 7% to $0.986 million - Research and development expenses decreased by 23% to $0.886 million for Q1 2025 from $1.148 million in Q1 2024, primarily due to lower salary-related and consulting costs[13] - General and administrative expenses decreased by 7% to $0.986 million for Q1 2025 from $1.061 million in Q1 2024[14] Net Loss Net loss improved to $1.8 million (or ($0.41) per share) in Q1 2025 from $2.2 million (or ($0.47) per share) in Q1 2024 Net Loss (Three Months Ended March 31) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net Loss | $1.8 million | $2.2 million | | Net Loss per Share | ($0.41) | ($0.47) | Financial Statements Consolidated Statements of Operations Q1 2025 unaudited operations show total operating expenses of $1.872 million and a net loss of $1.769 million, a favorable comparison to Q1 2024 Consolidated Statements of Operations (Amounts in thousands) | (Amounts in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $886 | $1,148 | | General and administrative | $986 | $1,061 | | Total operating expenses | $1,872 | $2,209 | | Operating loss | ($1,872) | ($2,209) | | Interest income, net | $125 | $53 | | Net loss | ($1,769) | ($2,154) | | Net loss per common share | ($0.41) | ($0.47) | Consolidated Balance Sheets The unaudited balance sheet as of March 31, 2025, shows total assets of $13.44 million and total liabilities of $1.27 million, with assets increasing from financing Consolidated Balance Sheets (Amounts in thousands) | (Amounts in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | ASSETS | | | | Cash and cash equivalents | $13,278 | $5,382 | | Total current assets | $13,436 | $5,736 | | Total assets | $13,440 | $5,738 | | LIABILITIES & EQUITY | | | | Total liabilities | $1,270 | $1,015 | | Total stockholders' equity | $12,170 | $4,723 | | Total liabilities and stockholders' equity | $13,440 | $5,738 | Company Information and Disclosures About Phio Pharmaceuticals Corp. Phio Pharmaceuticals is a clinical-stage biopharmaceutical company using INTASYL gene silencing technology for immuno-oncology therapeutics, with lead program PH-762 in Phase 1b - Phio is a clinical-stage siRNA biopharmaceutical company focused on immuno-oncology therapeutics using its INTASYL gene silencing technology[16] - The lead clinical program, PH-762, silences the PD-1 gene and is being evaluated in a Phase 1b trial for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma[16] Forward-Looking Statements Forward-looking statements regarding technology potential, clinical timelines, and capital are subject to risks and uncertainties detailed in SEC filings - The press release includes forward-looking statements about the potential of INTASYL technology, clinical trial timelines, and capital sufficiency[18] - Readers are cautioned that actual results may differ from forward-looking statements due to various risks and uncertainties identified in the company's SEC filings, such as the Annual Report on Form 10-K[19]