Phio Pharmaceuticals Reports Second Quarter 2026 Financial Results and Business Update
Rhea-AI Summary
Phio Pharmaceuticals (NASDAQ: PHIO) reported second quarter 2026 results and a business update focused on lead siRNA candidate PH-762. The company completed a 22-patient U.S. Phase 1b trial in skin cancers, is finalizing comprehensive study documentation for FDA submission, and plans to request an FDA meeting in Q3 2026 on next‑step trial design.
Phio initiated commercial-scale PH-762 API manufacturing and a long-term non-clinical toxicology study, both expected to finish by year-end, and reported new intellectual property actions, including three notices of allowance and one patent grant in the United States, Canada and Japan. Cash and cash equivalents were $13.0 million at June 30, 2026 versus $21.0 million at year-end 2025, with funding runway expected into the second half of 2027. Q2 2026 research and development expenses rose to $3.1 million (up 187% year-over-year), general and administrative expenses were $1.2 million, and net loss widened to $4.1 million from $2.2 million a year earlier. In April 2026, Phio established a $6.36 million at-the-market equity offering program and appointed dermatologist and former FDA advisory committee member Dr. R. Todd Plott to its Board of Directors.
Positive
- Cash runway expected to fund operations into second half of 2027
- Q2 2026 R&D spend $3.1 million, up 187% year-over-year to advance PH-762
- Phase 1b PH-762 trial completed with 22 patients; FDA meeting planned Q3 2026
- Commercial-scale API and long-term tox for PH-762 initiated, targeted completion by year-end 2026
- IP portfolio strengthened with three notices of allowance and one patent grant in US, Canada, Japan
- ATM program up to $6.36 million provides additional potential capital access
Negative
- Cash and equivalents declined to $13.0 million from $21.0 million at year-end 2025
- Q2 2026 net loss widened to $4.1 million from $2.2 million year-over-year
- Six-month 2026 net loss increased to $8.1 million from $3.9 million
- Total operating expenses for Q2 2026 rose to $4.3 million from $2.3 million
- R&D expenses for first half 2026 increased 200% to $5.9 million versus $2.0 million
- ATM equity program up to $6.36 million could lead to shareholder dilution if utilized
News Explained
The
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 07 | 1Q26 earnings | Negative | -6.1% | Net loss widened as PH-762 development spending increased |
| Mar 05 | Year-end earnings | Positive | -0.8% | Clinical progress and financing strengthened the balance sheet |
| Nov 13 | 3Q25 earnings | Positive | -9.1% | Pathology results and financing advanced despite a negative reaction |
| Aug 14 | 2Q25 earnings | Positive | -0.5% | Clinical responses and improved cash position outweighed higher net loss |
| May 15 | 1Q25 earnings | Positive | +3.4% | Clinical responses, fundraising, and reduced net loss supported gains |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Across the five tag-specific earnings events, reactions averaged -2.63% and included more negative than positive outcomes.
Key Terms
siRNA medical
intratumoral injection medical
non-clinical toxicology medical
API technical
CMC technical
at the market (ATM) equity offering financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
Strategic milestone advancements for lead clinical candidate PH-762
Initiation of commercial scale API, long term non-clinical toxicology, completion of Phase 1b pharmacology, and new IP announcements
King of Prussia, Pennsylvania--(Newsfile Corp. - August 6, 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 quarter ended June 30, 2026, and provided a business update.
"We realized significant headway on foundational building blocks advancing the PH-762 development program during the 2nd quarter," said Robert J. Bitterman, President and CEO. "Commencement of commercial scale API and dosing of a long term non-clinical study, both expected to be completed by year end, and final analysis of pharmacology outcomes from the Phase 1b trial should provide strategic flexibility for our next clinical study design, now in its final preparation."
PH-762 Progress
PH-762 was 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) was 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 comprised 22 patients, including 20 with cutaneous squamous cell carcinoma, one with melanoma and one with Merkel cell carcinoma, which was completed in March of this year. Final comprehensive clinical study documentation is in final preparation stage, which will be submitted to the FDA. Phio intends to request an FDA meeting in the third quarter of 2026 to discuss next steps in the clinical trial design and development strategy for PH-762.
Capital Sourcing 2Q 2026
In April 2026, the Company established an at the market (ATM) equity offering program pursuant to which it may offer and sell, from time to time, through H.C. Wainwright & Co., LLC, acting as sales agent, shares of its common stock, having an aggregate sales price of up to
Scientific News
The Company presented its Phase 1b clinical trial data for PH-762 at multiple conferences and virtual life science events including Force Family Office Fireside Chats, the Life Sciences Investor Forum, and Renmark Financial Virtual Non Deal Road Show events.
The Company has received multiple favorable patent actions encompassing three notices of allowance and one grant decision to further strengthen Phio's global intellectual property portfolio in the United States, Canada, and Japan. This reinforces the Company's commitment to developing and safeguarding breakthrough technologies for the INTASYL compounds.
Recently, the Company announced the appointment of Dr. R. Todd Plott M.D. to the Board of Directors who will serve as a member of the Governance Committee. Todd Plott, M.D., is a board-certified dermatologist, accomplished researcher, inventor, and former FDA advisory committee member with more than 30 years of experience in dermatologic care and innovation.
Financial Results
Cash Position
As of June 30, 2026, we had cash and cash equivalents of
Research and Development Expenses
Research and development expenses for the three months ended June 30, 2026 were
Research and development expenses for the six months ended June 30, 2026 were
Management believes that research and development expenses will continue to increase as we advance our PH-762 program.
General and Administrative Expenses
General and administrative expenses for the three months ended June 30, 2026 were
General and administrative expenses for the six months ended June 30, 2026 were
Net Loss
Net loss was
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, among other things, regarding the anticipated benefits of our INTASYL™ RNAi platform, our ability and plans to continue developing, advancing and protecting the breakthrough technologies underlying our INTASYL™ compounds, the results from our ongoing clinical trials, our expectations that our cash runway will extend into the second half of 2027, our expectations that commencement of commercial scale API and dosing of a long term non-clinical study will both be completed by year end, our belief that final analysis of pharmacology outcomes from the Phase 1b trial should provide strategic flexibility for our next clinical study design, our plans and expectations regarding FDA submissions and related interactions, including our intention to meet with the FDA in the third quarter of 2026 to discuss potential next steps in the clinical trial design and development of PH-762, our expectations that such FDA submissions and any related FDA meetings will clarify next steps in advancing the PH-762 development program, 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 of future FDA interactions on the development of our product candidates; the impact to our business and operations by inflationary pressures; recession fears; the development of our product candidates, results from our nonclinical, 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 most recent 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 U.S. Securities and Exchange Commission. 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)
(Unaudited)
| Three Months Ended | Six Months Ended | |||||||||||
| June 30, | June 30, | |||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 3,082 | $ | 1,074 | $ | 5,874 | $ | 1,960 | ||||
| General and administrative | 1,186 | 1,235 | 2,561 | 2,221 | ||||||||
| Total operating expenses | 4,268 | 2,309 | 8,435 | 4,181 | ||||||||
| Operating loss | (4,268) | (2,309) | (8,435) | (4,181) | ||||||||
| Interest income, net | 130 | 143 | 291 | 246 | ||||||||
| Other income, net | - | - | 3 | - | ||||||||
| Net loss | $ | (4,138) | $ | (2,166) | $ | (8,141) | $ | (3,935) | ||||
| Basic and diluted | $ | (0.36) | $ | (0.45) | $ | (0.70) | $ | (0.86) | ||||
| Weighted average number of common shares outstanding | ||||||||||||
| Basic and diluted | 11,617,250 | 4,794,857 | 11,617,250 | 4,551,061 | ||||||||
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
(Unaudited)
| June 30, | December 31, | |||||
| ASSETS | 2026 | 2025 | ||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 12,996 | $ | 21,031 | ||
| Prepaid expenses and other current assets | 1,302 | 445 | ||||
| Total current assets | 14,298 | 21,476 | ||||
| Property and equipment, net | 9 | 11 | ||||
| Total assets | $ | 14,307 | $ | 21,487 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 901 | $ | 435 | ||
| Accrued expenses | 804 | 905 | ||||
| Total liabilities | 1,705 | 1,340 | ||||
| Commitments and contingencies | ||||||
| Stockholders' equity: | ||||||
| Series D Preferred stock, | - | - | ||||
| Common stock, | 1 | 1 | ||||
| Additional paid-in capital | 175,796 | 175,200 | ||||
| Accumulated deficit | (163,195) | (155,054) | ||||
| Total stockholders' equity | 12,602 | 20,147 | ||||
| Total liabilities and stockholders' equity | $ | 14,307 | $ | 21,487 | ||
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/308057