Phio Pharmaceuticals Reports 2025 Year-End Financial Results and Business Update
Rhea-AI Summary
Phio Pharmaceuticals (NASDAQ: PHIO) reported 2025 year-end results and a business update. Key milestones include completion of the Phase 1b dose‑escalation for lead candidate PH‑762 with favorable safety and pathology signals, strengthening the balance sheet via financings and warrant exercises that generated $23.7 million in net proceeds, and cash of approximately $21.0 million at December 31, 2025.
The company advanced CMC and toxicology work, secured cGMP drug substance services, initiated a non‑clinical toxicology agreement, and targets an FDA meeting in Q2 2026 to seek guidance on next clinical steps.
Positive
- Net proceeds of $23.7 million from 2025 financings
- Cash balance of $21.0 million at December 31, 2025
- Phase 1b dose‑escalation for PH‑762 completed with favorable safety signals
- cGMP drug substance agreement in place to support pivotal development
Negative
- Net loss widened to $8.7 million in 2025 from $7.2 million in 2024
- R&D expenses increased 27% year‑over‑year
- G&A expenses increased 23%, raising burn rate risk
Key Figures
Market Reality Check
Peers on Argus
PHIO gained 13.86% while closely ranked biotech peers showed mixed moves, and only one peer appeared in momentum scans, moving down. This points to a stock-specific reaction rather than a broad sector swing.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 13 | Q3 2025 earnings | Positive | -9.1% | Q3 2025 results, PH-762 max-dose responses, and warrant inducement financing. |
| Aug 14 | Q2 2025 earnings | Positive | -0.5% | Q2 2025 results, PH-762 cohort data, stronger cash position, and added financing. |
| May 15 | Q1 2025 earnings | Positive | +3.4% | Q1 2025 results, improved PH-762 responses, higher cash and reduced net loss. |
| Mar 31 | 2024 year-end results | Positive | -5.4% | 2024 results, early PH-762 trial progress, cost cuts, and capital raises. |
| Nov 14 | Q3 2024 earnings | Positive | -0.9% | Q3 2024 results with early PH-762 responses, lower R&D spend, and warrant cash. |
Earnings and year-end updates have generally been followed by modest negative moves despite operational and clinical progress highlights.
Over the past five earnings and financial updates from Nov 2024 through Nov 2025, Phio repeatedly paired PH-762 clinical progress with balance-sheet actions such as offerings and warrant exercises. Cash levels and cost controls were recurring themes, while early PH-762 response data steadily improved across cohorts. Market reactions to these earnings-tagged events were usually slightly negative, with only Q1 2025 showing a positive 24-hour move, making today’s favorable response stand out against a history of mild post-earnings pressure.
Historical Comparison
In the last 5 earnings-related releases, PHIO’s average 24-hour move was -2.49%. Today’s +13.86% reaction to year-end results is a notable positive outlier versus that pattern.
Earnings updates show a progression from early PH-762 cohorts in 2024 to more mature, multi-cohort response data in 2025, alongside recurring financings that strengthened cash while advancing toward pivotal development.
Regulatory & Risk Context
An effective resale registration covers up to 11,763,800 warrant shares, with potential proceeds of $24.5 million to Phio upon full cash exercise. The company itself is not selling shares under this prospectus, but future warrant exercises could add to the public float while supplying additional capital for PH-762 development.
Market Pulse Summary
This announcement combined 2025 year-end results with a PH-762 program update, noting completion of treatment in the Phase 1b trial and cash and equivalents of $21.0 million after raising $23.7 million through financings and warrant exercises. Historically, similar earnings updates have produced modest share-price moves. Investors may focus on how rising R&D and G&A expenses, the extended runway into H1 2027, and progress toward pivotal PH-762 studies balance development opportunity against ongoing funding needs.
Key Terms
sirna medical
phase 1b medical
neoadjuvant medical
cgmP technical
toxicology medical
pathology medical
warrant exercises financial
AI-generated analysis. Not financial advice.
Treatment Phase for Lead Clinical Candidate PH-762 Dose Escalation Trial is Complete with Favorable Safety, Tolerability and Pathology Data
2025 Financings and Warrant Exercises Strengthen Balance Sheet with
King of Prussia, Pennsylvania--(Newsfile Corp. - March 5, 2026) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer. Phio today reported its financial results for the year ended December 31, 2025, and provided a business update.
"Final cohort results mark the culmination of a productive 2025 fiscal year for Phio," said Robert Bitterman, Present and CEO. "Concluding the Phase 1b study with favorable safety, tolerability and pathology data, advancing the CMC and toxicology initiatives while extending our cash runway into 2027 are noteworthy milestones on our continuing pathway to potential approval."
Recent Corporate Updates
PH-762 Clinical Progress
PH-762 is currently being evaluated in a U.S. multi-center Phase 1b dose-escalating clinical trial through the intratumoral injection of PH-762 for the treatment of patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. The trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or dose range for continued study of PH-762. The study was fully enrolled in November 2025 with a total of 22 patients, 20 with cutaneous squamous cell carcinoma, one with melanoma and one with Merkel cell carcinoma. While final study data is pending formal analysis, an FDA submission intended to propose and seek guidance for next steps in clinical study design for PH-762 is targeted for the second quarter of 2026.
In July 2025, Phio entered into a comprehensive drug substance development services agreement with a US manufacturer. The manufacturer will provide analytical and process development and cGMP manufacture of Phio's lead development compound PH-762. The cGMP material will support future pivotal clinical development of PH-762.
In December 2025, Phio entered into a development services agreement with a US laboratory to conduct a non-clinical toxicology study, which is required by the FDA prior to commencing a pivotal human clinical trial for registration purposes.
Capital Sourcing
During 2025, Phio strengthened its balance sheet through a series of equity financings and warrant exercises that generated approximately
Patent Portfolio Enhancement and Rationalization
Phio's patent portfolio includes 54 issued patents, 49 of which cover our INTASYL platform, and of those 27 cover immuno-oncology compounds and therapeutic uses. There are 20 pending patent applications, encompassing what we believe to be important new RNAi compounds and their use as therapeutics, chemical modifications of RNAi compounds that improve the compounds suitability for therapeutic uses and compounds directed to specific targets. The patents that may issue from these pending applications will, if issued, be set to expire between 2029 and 2044.
Scientific News
During 2025, Phio presented new data on PH-762 at several conferences including American Academy of Cancer Research (AACR), Society for Immunotherapy of Cancer (SITC), American Society of Gene and Cell Therapy (ASGCT), and at the Annual Oligonucleotide Therapeutics Society (OTS). The Company was also invited to present its Phase 1b clinical trial data for PH-762 at the American Academy of Dermatology (AAD) in the Late-Breaking Research Session.
Financial Results
Cash Position
At December 31, 2025, the Company had cash and cash equivalents of approximately
During the year ended December 31, 2025, we completed multiple financings generating total net proceeds of approximately
Research and Development Expenses
Research and development expenses for the year ended December 31, 2025 increased
General and Administrative Expenses
General and administrative expenses for the year ended December 31, 2025 increased
Net Loss
Net loss was approximately
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company advancing its proprietary INTASYL® siRNA gene silencing technology to eliminate cancer. Phio's INTASYL compounds are designed to enhance the body's immune cells to more effectively kill cancer cells. Phio's lead clinical development program is an INTASYL compound, PH-762, that silences the PD-1 gene implicated in various forms of skin cancer. The Phase 1b trial (NCT# 06014086) is evaluating PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin cancers.
For additional information, visit the Company's website, www.phiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "intends," "believes," "anticipates," "indicates," "plans," "expects," "suggests," "may," "would," "should," "potential," "designed to," "will," "ongoing," "estimate," "forecast," "target," "predict," "could" and similar references, although not all forward-looking statements contain these words. These statements, which include statements regarding the anticipated benefits of our INTASYL™ RNAi platform, the results from our ongoing clinical trials, our expectations that our cash runway will extend into the first half of 2027, our expectations regarding timing of FDA submissions intended to propose and seek guidance for next steps in clinical study design for PH-762, details regarding our planned non-clinical toxicology study, and our ability to support ongoing clinical development, operational requirements and strategic initiatives with the capital we currently have on hand, are based only on our current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements as a result of a number of important factors, including, but not limited to, the impact to our business and operations by inflationary pressures, rising interest rates, recession fears, the development of our product candidates, results from our preclinical and clinical activities, our ability to execute on business strategies, our ability to develop our product candidates with collaboration partners, and the success of any such collaborations, the timeline and duration for advancing our product candidates into clinical development, the timing or likelihood of regulatory filings and approvals, the success of our efforts to commercialize our product candidates if approved, our ability to manufacture and supply our product candidates for clinical activities, and for commercial use if approved, the scope of protection we are able to establish and maintain for intellectual property rights covering our technology platform, our ability to obtain future financing, market and other conditions and those risks identified in our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption "Risk Factors" and in other filings the Company periodically makes with the SEC. Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. Phio does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release, except as required by law.
Contact:
Phio Pharmaceuticals Corp.
Jennifer Phillips: jphillips@phiopharma.com
Corporate Affairs
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
| Year Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 4,618 | $ | 3,643 | ||||
| General and administrative | 4,602 | 3,744 | ||||||
| Total operating expenses | 9,220 | 7,387 | ||||||
| Operating loss | (9,220 | ) | (7,387 | ) | ||||
| Interest income, net | 520 | 231 | ||||||
| Other income, net | 2 | 6 | ||||||
| Net loss | $ | (8,698 | ) | $ | (7,150 | ) | ||
| Net loss per common share: | ||||||||
| Basic and diluted | $ | (1.45 | ) | $ | (9.08 | ) | ||
| Weighted average number of common shares outstanding | ||||||||
| Basic and diluted | 5,984,017 | 787,466 | ||||||
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
| December 31, 2025 | December 31, 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 21,031 | $ | 5,382 | ||||
| Prepaid expenses and other current assets | 445 | 354 | ||||||
| Total current assets | 21,476 | 5,736 | ||||||
| Property and equipment, net | 11 | 2 | ||||||
| Total assets | $ | 21,487 | $ | 5,738 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 435 | $ | 253 | ||||
| Accrued expenses | 905 | 762 | ||||||
| Total liabilities | 1,340 | 1,015 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' equity | ||||||||
| Series D Preferred stock, | - | - | ||||||
| Common stock, | 1 | - | ||||||
| Additional paid-in capital | 175,200 | 151,079 | ||||||
| Accumulated deficit | (155,054 | ) | (146,356 | ) | ||||
| Total stockholders' equity | 20,147 | 4,723 | ||||||
| Total liabilities and stockholders' equity | $ | 21,487 | $ | 5,738 | ||||
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/286264
FAQ
What did Phio announce about the Phase 1b PH-762 trial (PHIO) on March 5, 2026?
How much cash does Phio (PHIO) have and how long is the runway after 2025 financings?
What are the key 2025 expense and loss figures for Phio (PHIO)?
What manufacturing and toxicology steps did Phio (PHIO) take for PH-762 in 2025?
When does Phio (PHIO) plan to engage the FDA about next clinical steps for PH-762?
