Phio Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash and cash equivalents decreased to $10.6 million as of September 30, 2026, from $21.0 million at December 31, 2025.
• Research and development (R&D) expenses for the three months ended September 30, 2026, were $3.0 million, a 159% increase ($1.9 million) compared to $1.2 million in the same period in 2025.
• R&D expenses for the nine months ended September 30, 2026, were $8.9 million, a 180% increase ($5.8 million) compared to $3.1 million in the same period in 2025.
• General and administrative (G&A) expenses for the three months ended September 30, 2026, were $1.2 million, a 9% decrease ($100 thousand) compared to $1.3 million in the same period in 2025.
• G&A expenses for the nine months ended September 30, 2026, were $3.8 million, a 6% increase ($200 thousand) compared to $3.5 million in the same period in 2025.
• Net loss for the three months ended September 30, 2026, was $4.2 million, compared to $2.4 million in the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $12.3 million, compared to $6.3 million in the same period in 2025.
• Basic and diluted net loss per share for the three months ended September 30, 2026, was $0.36, compared to $0.44 in the same period in 2025.
• Basic and diluted net loss per share for the nine months ended September 30, 2026, was $1.06, compared to $1.30 in the same period in 2025.
• Total operating expenses for the three months ended September 30, 2026, were $4.3 million, compared to $2.5 million in the same period in 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $12.7 million, compared to $6.7 million in the same period in 2025.
• Total assets were $11.3 million as of September 30, 2026, compared to $21.5 million as of December 31, 2025.
• Total liabilities were $2.7 million as of September 30, 2026, compared to $1.3 million as of December 31, 2025.
• Total stockholders' equity was $8.6 million as of September 30, 2026, compared to $20.1 million as of December 31, 2025.
• Accumulated deficit increased to $(167.4) million as of September 30, 2026, from $(155.1) million as of December 31, 2025.

Guidance and Future Outlook:

• The Phase 2b neoadjuvant study in cutaneous squamous cell carcinoma (cSCC) is expected to be initiated in the first quarter of 2027.
• Management expects the FDA to respond to the recent submission regarding the Phase 2b development strategy by the end of November 2026.
• Management believes research and development expenses will continue to increase as the PH-762 program advances.
• The company plans to utilize its current capital on hand to support ongoing clinical development and strategic initiatives.

Business Segments and Product Lines:

• PH-762, the lead clinical development program, is an INTASYL compound designed to silence the PD-1 gene implicated in skin cancers including cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma.
• Commercial-scale cGMP manufacturing of the PH-762 drug substance was completed and shipped to the drug product manufacturer.
• The Phase 1b clinical trial (NCT 06014086) enrolled 22 patients (20 with cSCC, 1 with melanoma, 1 with Merkel cell carcinoma) and was completed in June 2026.
• A final clinical study report, including nonclinical and clinical pharmacology programs and Phase 1b results, was submitted to the FDA with a meeting request.
• The company's patent portfolio includes 56 issued patents and 34 pending applications worldwide, providing protection through at least 2038, with potential extension to 2044.

Market and Competitive Landscape:

• PH-762 is positioned as a potential non-surgical treatment for skin cancers.
• The company presented Phase 1b clinical trial data at multiple scientific and investor conferences, including the Life Sciences Future Conference, H.C. Wainwright Conference, and NIBA 153rd Conference.

Risks and Challenges:

• Actual results may differ materially from forward-looking statements due to uncertainties including FDA interactions, inflationary pressures, recession fears, and the success of clinical activities.
• Risks include the timeline and duration for advancing product candidates, the likelihood of regulatory filings and approvals, and the ability to manufacture and supply product candidates.
• The company faces risks related to its ability to obtain future financing and the scope of protection for intellectual property rights.

Management Commentary and Tone:

• Robert J. Bitterman, President and CEO, stated the company successfully executed critical development objectives to advance the PH-762 program toward Phase 2b study initiation.
• Management highlighted the completion of commercial-scale drug substance manufacturing and the submission of detailed information to the FDA as key milestones.
• The tone reflects confidence in the supply chain readiness and the scientific rationale for continued development.

Other Key Points:

• The company has 11,951,632 shares of common stock issued and outstanding as of September 30, 2026, compared to 11,617,250 shares as of December 31, 2025.
• No dividends or stock buybacks were announced.
• The company has no Series D Preferred stock issued or outstanding.
• The increase in R&D expenses was primarily driven by costs associated with nonclinical toxicology studies, drug substance costs, and clinical supplies for the PH-762 program.
• The increase in G&A expenses for the nine-month period was driven by a $1.2 million increase in employee costs, including $0.7 million in stock-based compensation, partially offset by a decrease in outside services.