Phio Pharmaceuticals Corp. filings document material events for a clinical-stage siRNA biopharmaceutical company developing INTASYL® gene-silencing therapeutics in immuno-oncology. Recent 8-K disclosures report quarterly and year-end financial results, PH-762 clinical and safety updates, tumor-response data, and development activities for skin cancer indications including cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma.
The company's regulatory record also covers material agreements and capital-structure matters, including a cGMP drug-product manufacturing services agreement for PH-762 clinical supply and an at-the-market common-stock offering under a shelf registration statement. Governance disclosures include executive employment-agreement amendments and related compensatory arrangements.
Phio Pharmaceuticals Corp. reported a net loss of $4.0M for the quarter ended March 31, 2026, wider than the prior-year loss of $1.8M, as it ramped spending on its lead cancer drug PH-762.
Research and development expenses rose to $2.8M from $0.9M, driven mainly by nonclinical, clinical and manufacturing work on PH-762. General and administrative costs increased to $1.4M from $1.0M, reflecting higher stock-based compensation, bonuses and professional fees.
Cash and cash equivalents were $17.0M at quarter-end, down from $21.0M at December 31, 2025. Management believes this, along with proceeds from 2025 financings, will fund operations for at least 12 months. The company also put in place a new at-the-market equity program allowing sales of up to $6.36M of common stock to support PH-762’s expected Phase 2b/3 trial and general working capital.
Phio Pharmaceuticals Corp. reported first quarter 2026 results and a business update centered on its lead cancer candidate PH-762. The Phase 1b intratumoral dose-escalation trial in skin cancers has completed enrollment with 22 patients, and final data analysis is underway ahead of a planned FDA submission in the second quarter of 2026.
Cash and cash equivalents were about $17.0 million as of March 31, 2026, down from roughly $21.0 million at year-end 2025, after 2025 equity financings and warrant exercises generated about $23.7 million and extended the cash runway into the first half of 2027. Phio also entered an at-the-market agreement allowing up to $6.36 million of additional common stock sales.
Research and development expenses rose to $2.8 million, a 215% increase from the prior-year quarter, mainly from clinical, CMC and toxicology work on PH-762. General and administrative expenses were $1.4 million, up 39%. Net loss widened to about $4.0 million, compared with roughly $1.8 million a year earlier.
Phio Pharmaceuticals Corp. entered into an at-the-market equity offering arrangement allowing it to sell up to $6,360,000 of common stock through H.C. Wainwright & Co. as sales agent. These shares are registered under an effective shelf registration statement and an accompanying prospectus supplement.
The sales agent will use commercially reasonable efforts to place shares under parameters Phio sets, and will earn a 3.0% commission on gross proceeds. Phio can suspend or terminate the program at any time and is not obligated to sell any shares. The company also agreed to reimburse up to $75,000 of the agent’s legal fees related to this arrangement.
Phio Pharmaceuticals Corp. is offering up to $6,360,000 of common stock through an at-the-market (ATM) sales agreement with H.C. Wainwright & Co., under which shares may be sold from time to time on Nasdaq or through other market transactions.
The prospectus supplement states the company’s public float was $19,080,217 (based on 11,563,768 non‑affiliate shares at Feb 13, 2026) and reflects 11,617,250 shares outstanding as of Dec 31, 2025. Sales agent commissions are 3.0%. Net proceeds are intended to fund development of PH-762, other development activities and general working capital.
Phio Pharmaceuticals reported that it has signed a cGMP drug product manufacturing services agreement with a U.S.-based manufacturer to produce its lead siRNA compound, PH-762, for clinical and potential commercial supply. PH-762 is being developed as an intratumoral treatment for cutaneous skin cancers.
In a Phase 1b trial of PH-762, 22 patients completed treatment across five dose-escalation cohorts with no dose-limiting toxicities or serious adverse events. The company reported an approximate 65% pathological response rate in cutaneous squamous cell carcinoma across all dosing cohorts, including 85% pathological response, or 6 of 7 patients, in the highest-dose cohort.
Phio indicated that engagement with the FDA on next-stage clinical development of PH-762 is targeted for the second quarter of 2026 and that its cash and cash equivalents are projected to sustain operations into the first half of 2027.
Phio Pharmaceuticals Corp. is a clinical-stage biopharma company developing cancer immunotherapies based on its proprietary INTASYL RNA interference platform, designed to make immune cells more effective at killing tumors without complex delivery systems.
Lead candidate PH-762, which targets PD-1, is in a U.S. Phase 1b intratumoral trial for cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. Among 20 cutaneous squamous cell carcinoma patients, 65% were pathologic responders, including nine complete responses, with no dose-limiting toxicities reported to date.
Second program PH-894 targets BRD4 and has completed IND-enabling studies, but its IND filing has been deferred while resources are prioritized to PH-762. The company reports significant funding needs, a history of net losses, reliance on third-party manufacturers and CROs, and risks related to maintaining Nasdaq Capital Market listing.
Phio Pharmaceuticals Corp. is a clinical-stage biopharma company developing cancer immunotherapies based on its proprietary INTASYL RNA interference platform, designed to make immune cells more effective at killing tumors without complex delivery systems.
Lead candidate PH-762, which targets PD-1, is in a U.S. Phase 1b intratumoral trial for cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. Among 20 cutaneous squamous cell carcinoma patients, 65% were pathologic responders, including nine complete responses, with no dose-limiting toxicities reported to date.
Second program PH-894 targets BRD4 and has completed IND-enabling studies, but its IND filing has been deferred while resources are prioritized to PH-762. The company reports significant funding needs, a history of net losses, reliance on third-party manufacturers and CROs, and risks related to maintaining Nasdaq Capital Market listing.
Phio Pharmaceuticals reported 2025 results showing progress in its lead cancer candidate PH-762 and a much stronger balance sheet. The Phase 1b dose-escalation trial of PH-762 completed enrollment with favorable safety, tolerability and pathology data, and the company plans an FDA submission on next-step study design in the second quarter of 2026.
During 2025, equity financings and warrant exercises generated approximately $23.7 million in net proceeds, lifting cash and cash equivalents to about $21.0 million at December 31, 2025, up from $5.4 million a year earlier and extending the cash runway into the first half of 2027. Research and development expenses rose 27% to $4.6 million and general and administrative expenses increased 23% to $4.6 million, reflecting expanded clinical activity and higher professional and compensation costs. Net loss widened to roughly $8.7 million, or $1.45 per share, compared with $7.2 million, or $9.08 per share, in 2024.
Phio Pharmaceuticals reported 2025 results showing progress in its lead cancer candidate PH-762 and a much stronger balance sheet. The Phase 1b dose-escalation trial of PH-762 completed enrollment with favorable safety, tolerability and pathology data, and the company plans an FDA submission on next-step study design in the second quarter of 2026.
During 2025, equity financings and warrant exercises generated approximately $23.7 million in net proceeds, lifting cash and cash equivalents to about $21.0 million at December 31, 2025, up from $5.4 million a year earlier and extending the cash runway into the first half of 2027. Research and development expenses rose 27% to $4.6 million and general and administrative expenses increased 23% to $4.6 million, reflecting expanded clinical activity and higher professional and compensation costs. Net loss widened to roughly $8.7 million, or $1.45 per share, compared with $7.2 million, or $9.08 per share, in 2024.
Phio Pharmaceuticals Corp. updated its employment agreement with President and Chief Executive Officer Robert J. Bitterman. The amendment increases his protection if he is terminated without cause or leaves for good reason, granting severance equal to twelve months of his base salary in those situations.
The amendment also raises Mr. Bitterman’s annual target bonus opportunity to 50% of his base salary, up from 40% under the prior agreement. The full terms are set out in the Second Amendment filed as an exhibit.
CVI Investments, Inc. and Heights Capital Management, Inc. have reported beneficial ownership tied to Phio Pharmaceuticals Corp. common stock. They report 1,194,719 shares beneficially owned, representing 9.9% of Phio’s common stock. This amount consists entirely of shares issuable upon exercise of warrants, rather than currently outstanding shares.
The warrants are subject to a 9.99% beneficial ownership limitation, meaning they cannot be exercised if doing so would push the reporting persons and their affiliates above that threshold. Heights Capital Management, Inc., as investment manager to CVI Investments, Inc., may be deemed to share voting and dispositive power, but both parties disclaim beneficial ownership beyond their pecuniary interest. Phio’s quarterly report indicated 10,764,428 shares outstanding as of November 11, 2025.
Phio Pharmaceuticals Corp. received an updated ownership report from Intracoastal Capital LLC and its principals Mitchell P. Kopin and Daniel B. Asher. As of December 31, 2025, they may be deemed to beneficially own 1,142,556 shares of common stock through a warrant held by Intracoastal.
The filing states this represents approximately 9.1% of Phio’s common stock, calculated using 11,447,952 shares outstanding as of December 4, 2025 plus the warrant shares. Additional warrants for 149,298 and 759,298 shares are subject to 4.99% beneficial ownership blocker provisions and are excluded from this percentage.
Without these blocker provisions, the reporting persons may be deemed to beneficially own 2,051,152 shares. They certify the securities were not acquired to change or influence control of Phio Pharmaceuticals, and that the information is true, complete, and correct.