Phio Pharmaceuticals Reports Third Quarter 2026 Financial Results and Business Update as it Advances PH-762 Toward Phase 2b Study Initiation
Phio Pharmaceuticals Corp. (PHIO) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Phio Pharmaceuticals Reports Third Quarter 2026 Financial Results and Business Update as it Advances PH-762 Toward Phase 2b Study Initiation PH-762 Program Accomplishes Major Development Milestones Including Completion of Commercial-Scale cGMP Manufacturing, Treatmen
How this was made
The 30-second read
Why it matters
The 8‑K provides the first public details on Phase 1b outcomes, CMC milestones, and a significant cash decline, all of which are material for investors.
Market read
First‑report disclosure of clinical progress and financials for a micro‑cap biotech, likely to influence PHIO’s share price and sector sentiment.
What to watch
Potential partnership or licensing opportunities for the INTASYL platform are not disclosed but could materially affect valuation.
Phio Pharmaceuticals Reports Third Quarter 2026 Financial Results and Business Update as it Advances PH-762 Toward Phase 2b Study Initiation
Phio reported major PH-762 manufacturing and regulatory milestones, but research and development spending and net loss increased substantially while cash and cash equivalents declined to $10.6 million.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Research and development expenses, three months ended September 30, 2026GAAP | $3.06M | – | 159% |
| General and administrative expenses, three months ended September 30, 2026GAAP | $1.21M | – | decrease of $100 thousand or 9% |
| Total operating expenses, three months ended September 30, 2026GAAP | $4.27M | – | – |
| Operating loss, three months ended September 30, 2026GAAP | −$4.27M | – | – |
| Interest income, net, three months ended September 30, 2026GAAP | 105 | – | – |
| Other income, net, three months ended September 30, 2026GAAP | 3 | – | – |
| Net loss, three months ended September 30, 2026GAAP | −$4.16M | – | – |
| Basic and diluted net loss per share, three months ended September 30, 2026GAAP | $ (0.36 ) | – | – |
| Weighted average number of common shares outstanding, basic and diluted, three months ended September 30, 2026GAAP | 11,689,942 | – | – |
| Research and development expenses, nine months ended September 30, 2026GAAP | $8.94M | – | 180% |
| General and administrative expenses, nine months ended September 30, 2026GAAP | $3.77M | – | 6% |
| Total operating expenses, nine months ended September 30, 2026GAAP | $12.70M | – | – |
| Operating loss, nine months ended September 30, 2026GAAP | −$12.70M | – | – |
| Interest income, net, nine months ended September 30, 2026GAAP | 395 | – | – |
| Other income, net, nine months ended September 30, 2026GAAP | 7 | – | – |
| Net loss, nine months ended September 30, 2026GAAP | −$12.30M | – | – |
| Basic and diluted net loss per share, nine months ended September 30, 2026GAAP | $ (1.06 ) | – | – |
| Weighted average number of common shares outstanding, basic and diluted, nine months ended September 30, 2026GAAP | 11,641,747 | – | – |
| Cash and cash equivalents, September 30, 2026GAAP | $10.61M | – | – |
| Total assets, September 30, 2026GAAP | $11.32M | – | – |
| Total liabilities, September 30, 2026GAAP | 2,697 | – | – |
| Total stockholders' equity, September 30, 2026GAAP | 8,620 | – | – |
Amounts quoted below without a unit are in thousands, as in the filing’s tables. Per-share figures are as printed.
Q1 2027 and November 2026 outlook
- NoteFDA response to the submission is expected by the end of November 2026.
- NoteThe planned Phase 2b clinical program is expected to be initiated in the first quarter of 2027.
- NoteManagement believes that research and development expenses will continue to increase as the Company advances its PH-762 program.
What drove it
- Research and development expense increased primarily because of nonclinical toxicology study costs, drug substance costs, and clinical supplies costs associated with advancing PH-762.
- The Phase 1b study enrolled 22 patients, including 20 patients with cutaneous squamous cell carcinoma, one patient with melanoma, and one patient with Merkel cell carcinoma.
- The Phase 1b clinical trial was completed in June 2026, and the final clinical study report, FDA meeting request, and briefing document were submitted to FDA.
- The Company released its first commercial-scale cGMP batch of PH-762 drug substance and shipped it to its drug product manufacturer.
- The patent portfolio includes 56 issued patents and 34 pending applications worldwide, with protection through at least 2038 and additional pending applications extending potential protection into 2044.
Concerns
- Net loss was $ (4,160 ) for the three months ended September 30, 2026, compared with $ (2,392 ) for the three months ended September 30, 2025.
- Research and development expenses were $ 3,062 for the three months ended September 30, 2026, an increase of 159%.
- Cash and cash equivalents were $ 10,609 at September 30, 2026, compared with $ 21,031 at December 31, 2025.
- Management stated that research and development expenses will continue to increase as it advances the PH-762 program.
- The Phase 2b plan and next development steps remain subject to FDA feedback expected by the end of November 2026.
What to watch
- FDA feedback on the final Phase 1b clinical study report and planned Phase 2b neoadjuvant study in cutaneous squamous cell carcinoma, expected by the end of November 2026.
- Initiation of the planned Phase 2b clinical program, expected in the first quarter of 2027.
- Further nonclinical toxicology, drug substance, and clinical-supply expenditures supporting PH-762.
- Cash resources and the Company's ability to support ongoing clinical development, operational requirements, and strategic initiatives with capital on hand.
Balance sheet and cash flow
- Cash and cash equivalents were $ 10,609 at September 30, 2026, compared with $ 21,031 at December 31, 2025.
- Total current assets were 11,310 at September 30, 2026, compared with 21,476 at December 31, 2025.
- Accounts payable were $ 886 at September 30, 2026, compared with $ 435 at December 31, 2025.
- Accrued expenses were 1,811 at September 30, 2026, compared with 905 at December 31, 2025.
- Total liabilities were 2,697 at September 30, 2026, compared with 1,340 at December 31, 2025.
- No operating cash flow, free cash flow, or debt balance was reported in the filing text.
Analysis
Phio's third-quarter update was centered on execution for PH-762 rather than commercial performance. The Company completed commercial-scale cGMP drug-substance manufacturing, shipped material to its drug product manufacturer, and submitted its final Phase 1b clinical study report and planned Phase 2b materials to FDA. The completed Phase 1b study enrolled 22 patients, and the Company expects an FDA response by the end of November 2026.
The cost profile reflects the transition toward the next development stage. Research and development expense was $ 3,062 for the three months ended September 30, 2026, compared with $ 1,181 in the prior-year period, with the Company citing nonclinical toxicology, drug substance, and clinical-supply costs. General and administrative expense declined to $ 1,206 from $ 1,324, driven by reduced outsourced consulting services, but this did not offset the increase in development spending.
The higher development investment widened the quarterly net loss to $ (4,160 ) from $ (2,392 ). For the nine months ended September 30, 2026, research and development expense was $ 8,936 compared with $ 3,141, while net loss was $ (12,301 ) compared with $ (6,327 ). Management explicitly stated that research and development expenses will continue to increase as the PH-762 program advances.
Liquidity declined during the period. Cash and cash equivalents were $ 10,609 at September 30, 2026, compared with $ 21,031 at December 31, 2025, while total liabilities were 2,697 compared with 1,340. The filing did not provide operating cash flow, free cash flow, debt, or a quantitative financial outlook, making cash resources and future development expenditures central items to monitor.
The principal forward operational milestone is initiation of the planned Phase 2b clinical program in the first quarter of 2027. That timeline follows the Company's expected FDA response by the end of November 2026. The release also highlighted 56 issued patents and 34 pending applications worldwide, but the immediate execution focus remains regulatory feedback, clinical supply preparation, and funding ongoing PH-762 development.
Management, verbatim
We have successfully executed on critical development objectives to advance the PH-762 program toward Phase 2b study initiation.
Robert J. Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals
Commercial-scale drug substance manufacturing was completed and shipped to our drug product manufacturer in preparation for making clinical trial supply material.
Robert J. Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals
We have submitted detailed information to FDA providing final analysis of our Phase 1b clinical trial and the fundamentals of our intended upcoming Phase 2b study.
Robert J. Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals
Not in the filing
stated, not guessed- Revenue and revenue comparisons were not reported.
- Segment revenue and segment operating metrics were not reported.
- Gross profit, gross margin, operating margin, and net margin were not reported.
- Non-GAAP financial metrics were not reported.
- Operating cash flow and free cash flow were not reported.
- Debt balance was not reported.
- Capital returns, including share repurchases and dividends, were not reported.
- Tax rate was not reported.
- Formal quantitative revenue, gross margin, operating expense, or tax-rate guidance was not reported.
- Prior-period outlook was not provided.
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure is checked against the filing text, and a metric the filing does not print, or whose value, prior period and change do not add up, is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
Phio Pharmaceuticals is a clinical‑stage biotech developing siRNA therapeutics using its INTASYL platform, focusing on skin cancers.
Ticker impact
Phio Pharmaceuticals filed its 8‑K reporting Q3 2026 results and announced completion of commercial‑scale cGMP manufacturing and submission of Phase 1b data to the FDA, indicating progress toward a Phase 2b study.
potential upside if FDA feedback is positive, but pressure from cash burn may limit gains
First‑report disclosure of material clinical progress and financials for a micro‑cap biotech typically moves the price; however, the company’s cash position of $10.6 M versus $21 M a year ago raises concerns.
Market effects
Highlights ongoing momentum in the RNAi gene‑silencing sector and may boost peer biotech valuations.
Limited to US biotech investors; no broader regional effect.
Modest, as the news pertains to a niche clinical-stage company.
Counterpoint
Cash depletion and rising R&D expenses could outweigh trial progress, prompting a short‑term sell.
Key entities
- companyPhio Pharmaceuticals Corp.
NASDAQ‑listed biotech (PHIO) reporting Q3 results and trial progress.
- executiveRobert J. Bitterman
President and CEO of Phio Pharmaceuticals, quoted on trial milestones.
