Phio Pharmaceuticals(PHIO) - 2025 Q2 - Quarterly Results

Business Update This section provides an overview of Phio Pharmaceuticals' recent clinical advancements, scientific presentations, and post-quarter financial activities PH-762 Clinical Progress The Phase 1b clinical trial for PH-762 is progressing with the 5th cohort enrollment, showing the drug is well-tolerated with positive pathologic responses in cutaneous carcinomas, and a manufacturing agreement has been secured - The Phase 1b trial has treated 15 patients across four cohorts, showing PH-762 is well-tolerated with no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects[2] Pathologic Response in cSCC Patients (n=13) | Response Category | Number of Patients | | :--- | :--- | | Complete Response (100% clearance) | 5 | | Near Complete Response (>90% clearance) | 1 | | Partial Response (>50% clearance) | 1 | | Non-Response (<50% clearance) | 6 | - The company is now enrolling the 5th and final cohort for the Phase 1b trial and has entered into a cGMP manufacturing agreement for PH-762 with a U.S. company[4] Scientific News Phio Pharmaceuticals presented its INTASYL technology and Phase 1b clinical trial data at key scientific conferences, including SID, ITOC, and ASCO, during Q2 2025 - The company delivered podium presentations on its INTASYL technology and Phase 1b clinical trial results at major conferences[5] - Society of Investigative Dermatology (SID) in May 2025 - 11th Annual Immunotherapy of Cancer (ITOC 11) in April 2025 - American Society of Clinical Oncology (ASCO) in June 2025[5] Subsequent Events Post-quarter, on July 25, 2025, the company successfully raised approximately $2.2 million in net proceeds through warrant inducement agreements with existing warrant holders - On July 25, 2025, the company raised approximately $2.2 million after expenses through warrant inducement agreements[6] - The financing involved certain holders exercising existing warrants to purchase an aggregate of 928,596 shares of common stock[6] Financial Results This section details Phio Pharmaceuticals' financial performance for Q2 2025, highlighting increased cash reserves, rising operating expenses, and a higher net loss compared to the prior year Financial Highlights For Q2 2025, Phio Pharmaceuticals reported a strengthened cash position of $10.8 million, increased operating expenses, and a net loss of $2.2 million Key Financial Metrics (Q2 2025 vs. Prior Periods) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $1.1M | $0.9M | $1.9M | $2.0M | | G&A Expenses | $1.2M | $1.0M | $2.2M | $1.8M | | Net Loss | $2.2M | $1.8M | - | - | - Cash and cash equivalents increased to approximately $10.8 million at June 30, 2025, compared to $5.4 million at December 31, 2024[7] - The increase in Q2 R&D expenses was primarily due to higher CRO costs from increased patient enrollment, while the rise in G&A expenses was driven by higher salary-related costs[8][10] Consolidated Statements of Operations For the three months ended June 30, 2025, the company reported total operating expenses of $2.3 million and a net loss of $2.2 million, or ($0.45) per share, compared to $1.9 million and $1.8 million respectively in 2024 Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended June 30, | | :--- | :--- | :--- | | | 2025 | 2024 | | Operating expenses: | | | | Research and development | $1,074 | $866 | | General and administrative | $1,235 | $1,048 | | Total operating expenses | $2,309 | $1,914 | | Operating loss | ($2,309) | ($1,914) | | Total other income (expense), net | $143 | $68 | | Net loss | ($2,166) | ($1,846) | | Basic and diluted net loss per share | ($0.45) | ($3.62) | | Weighted average shares outstanding | 4,794,857 | 510,188 | Condensed Consolidated Balance Sheets As of June 30, 2025, Phio's balance sheet shows total assets of $11.3 million, driven by a rise in cash to $10.8 million, with total liabilities at $1.2 million and stockholders' equity at $10.1 million Condensed Consolidated Balance Sheets (Unaudited, in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | ASSETS | | | | Cash and cash equivalents | $10,775 | $5,382 | | Total current assets | $11,294 | $5,736 | | Total assets | $11,301 | $5,738 | | LIABILITIES AND EQUITY | | | | Total current liabilities | $1,206 | $1,015 | | Total liabilities | $1,206 | $1,015 | | Total stockholders' equity | $10,095 | $4,723 | | Total liabilities and stockholders' equity | $11,301 | $5,738 | About Phio Pharmaceuticals Corp. Phio Pharmaceuticals is a clinical-stage biopharmaceutical company developing immuno-oncology therapeutics using its proprietary INTASYL siRNA gene silencing technology, with lead program PH-762 in Phase 1b for skin cancers - Phio is a clinical-stage siRNA biopharmaceutical company using its INTASYL gene silencing technology for immuno-oncology therapeutics[13] - The company's lead clinical program, PH-762, silences the PD-1 gene and is in a Phase 1b trial for treating cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma[13] Forward-Looking Statements This section provides a standard safe harbor statement, cautioning that the press release contains forward-looking statements subject to risks and uncertainties, advising readers to refer to SEC filings for detailed risk factors - The press release includes forward-looking statements regarding the potential of its INTASYL technology, clinical trial timelines, and financial sufficiency[15] - Investors are warned that actual results may differ due to various risks and uncertainties, which are detailed under the "Risk Factors" section of the company's Form 10-K and 10-Q filings with the SEC[16]