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Phio Pharmaceuticals Reports First Quarter 2026 Financial Results and Business Update

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Phio Pharmaceuticals (NASDAQ: PHIO) reported Q1 2026 results and a business update on May 7, 2026. The company completed its Phase 1b dose‑escalation trial of PH‑762 with favorable safety/pathology signals and targets an FDA submission in Q2 2026 to define next clinical steps.

Key financials: $17M cash at March 31, 2026; net loss of $4.0M for Q1 2026; R&D spend rose 215% YoY. Capital actions include ~$23.7M net proceeds in 2025 and an ATM for up to $6.36M.

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AI-generated analysis. Not financial advice.

Positive

  • Phase 1b trial of PH‑762 completed with favorable safety/pathology
  • Targeting FDA interface/submission for PH‑762 in Q2 2026
  • Secured nonclinical toxicology and U.S. cGMP manufacturing agreements
  • Raised approximately $23.7M net proceeds during 2025

Negative

  • Cash balance declined to $17 million as of March 31, 2026
  • Research and development expenses increased by 215% year‑over‑year
  • Net loss widened to $4.0 million for Q1 2026
  • At‑the‑market facility available up to $6.36 million (potential dilution)

News Market Reaction – PHIO

-6.14%
4 alerts
-6.14% News Effect
-2.8% Trough Tracked
-$813K Valuation Impact
$12.43M Market Cap
1.4x Rel. Volume

On the day this news was published, PHIO declined 6.14%, reflecting a notable negative market reaction. Argus tracked a trough of -2.8% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $813K from the company's valuation, bringing the market cap to $12.43M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash and equivalents: $17.0 million Cash and equivalents: $21.0 million 2025 financings: $23.7 million +5 more
8 metrics
Cash and equivalents $17.0 million As of March 31, 2026
Cash and equivalents $21.0 million As of December 31, 2025
2025 financings $23.7 million Net proceeds from equity financings and warrant exercises in 2025
ATM capacity $6.36 million Aggregate amount under April 2026 ATM agreement
R&D expenses $2.8 million Three months ended March 31, 2026
R&D increase 215% / $1.9 million Q1 2026 vs Q1 2025
G&A expenses $1.4 million Three months ended March 31, 2026
Net loss $4.0 million Three months ended March 31, 2026 vs $1.8M in Q1 2025

Market Reality Check

Price: $1.0700 Vol: Volume 146,522 is close t...
normal vol
$1.0700 Last Close
Volume Volume 146,522 is close to its 20-day average of 140,395, indicating typical trading activity before this release. normal
Technical Shares at $1.15 are trading below the 200-day MA of $1.57, about 72.55% under the 52-week high and 41.5% above the 52-week low.

Peers on Argus

Peer biotech names show mixed movements, with several like ADAP and PHGE down wh...
1 Up

Peer biotech names show mixed movements, with several like ADAP and PHGE down while only isolated stocks such as XTLB appeared on momentum scanners to the upside. With limited peer confirmation and the target’s direction not specified, trading around this update appears more company-specific than sector-driven.

Previous Earnings Reports

5 past events · Latest: Mar 05 (Positive)
Same Type Pattern 5 events
Date Event Sentiment Move Catalyst
Mar 05 Year-end results Positive -0.8% 2025 year-end results with PH-762 progress and stronger cash balance.
Nov 13 Q3 2025 earnings Positive -9.1% Q3 update on PH-762 responses and planned warrant inducement financings.
Aug 14 Q2 2025 earnings Positive -0.5% Q2 results with promising PH-762 data and improved cash position.
May 15 Q1 2025 earnings Positive +3.4% Q1 progress in PH-762 trial plus higher cash and reduced net loss.
Mar 31 2024 results Positive -5.4% 2024 year-end report with PH-762 advances and reduced annual net loss.
Pattern Detected

Earnings and financial updates have often been followed by negative next-day moves despite generally constructive clinical and balance sheet progress, with only one of the last five tagged earnings events showing a positive price reaction.

Recent Company History

Across the last five earnings-tagged releases since March 2025, Phio has repeatedly highlighted advancement of PH‑762, including dose‑escalation progress, complete responses in cutaneous squamous cell carcinoma, and strengthening of its cash position through offerings and warrant exercises. Cash balances rose from $5.4M at Dec 31, 2024 to about $21.0M by Dec 31, 2025, while net losses remained significant. Despite these operational gains, four of five such announcements saw negative next‑day price reactions.

Historical Comparison

-2.5% avg move · Past five earnings-tagged releases averaged a -2.48% next-day move, with most trading lower even as ...
earnings
-2.5%
Average Historical Move earnings

Past five earnings-tagged releases averaged a -2.48% next-day move, with most trading lower even as PH-762 and cash runway advanced.

Same-tag earnings updates trace PH-762 from early cohort responses to completed dose escalation, alongside a step-up in cash from $5.4M in 2024 to about $21.0M by 2025, while net losses and operating spend remain meaningful.

Regulatory & Risk Context

Active S-3 Shelf · $24.5 million
Shelf Active
Active S-3 Shelf Registration 2025-11-20
$24.5 million registered capacity

An effective resale shelf registered up to 11,763,800 warrant shares, with potential cash proceeds of about $24.5 million upon full exercise. Proceeds from any future exercises are earmarked to support working capital and development of PH‑762, though selling stockholders, not the company, control any resales under this registration.

Market Pulse Summary

The stock moved -6.1% in the session following this news. A negative reaction despite operational pr...
Analysis

The stock moved -6.1% in the session following this news. A negative reaction despite operational progress would fit prior earnings patterns, which averaged about -2.48% next-day moves. The wider $4.0M quarterly net loss and sharply higher R&D and G&A spending could amplify downside concerns even as PH‑762 advances. Availability under a $6.36M ATM and an existing resale shelf may also reinforce dilution risk perceptions.

Key Terms

sirna, phase 1b, neoadjuvant, intratumoral, +3 more
7 terms
sirna medical
"Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company"
Small interfering RNA (siRNA) is a short strand of genetic material that binds to and destroys the messenger RNA that carries instructions for making a specific protein, effectively switching that gene off. Investors care because siRNA is a platform for precise medicines: successful trials or approvals can create high-value drugs, while delivery challenges, manufacturing complexity, patent positions and regulatory risk can sharply affect a biotech company's prospects.
phase 1b medical
"successful completion of our Phase 1b clinical trial which now positions us for upcoming FDA interface"
"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.
neoadjuvant medical
"designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762"
"Neoadjuvant" describes treatments or interventions that are given before the main or primary procedure, such as surgery or a major decision. It’s like preparing the ground before planting seeds, aiming to improve the final outcome. For investors, understanding neoadjuvant approaches can provide insight into how companies enhance results or effectiveness in their processes or products.
intratumoral medical
"dose-escalating clinical trial through the intratumoral injection of PH-762 for the treatment"
"Intratumoral" describes something that occurs or exists within a tumor, which is an abnormal growth of tissue. For investors, understanding intratumoral is important because it relates to medical treatments or research aimed at targeting the tumor directly, potentially leading to more effective therapies. Think of it as focusing treatment straight into the problem area, much like fixing a leak by working directly on the pipe itself.
cgmP technical
"Agreements Secured for Nonclinical Toxicology and U.S. cGMP Clinical Supply Manufacturing"
cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.
at the market agreement financial
"the Company entered into an At The Market Agreement (ATM) with H.C. Wainwright & Co., LLC"
An at the market agreement is a contract that lets a company sell newly issued shares directly into the open market through a broker at whatever the current trading price is, rather than in one large, fixed‑price sale. Investors care because it provides a fast, flexible way for the company to raise cash but can dilute existing holdings and quietly put steady selling pressure on the share price—like adding small amounts of water to a soup over time versus dumping a whole pot in at once.
merkel cell carcinoma medical
"for the treatment of patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma."
Merkel cell carcinoma is a rare, fast-growing form of skin cancer that starts in cells near the base of the skin and often spreads quickly to nearby tissues and organs. For investors, it matters because treatments for this aggressive disease can create high-value opportunities or risks: successful drugs or tests can unlock significant revenue and partnerships, while failed trials or regulatory setbacks can sharply affect a biotech company’s prospects — like a single critical test determining whether a new product succeeds or stalls.

AI-generated analysis. Not financial advice.

Completion of Lead Clinical Candidate PH-762 Dose Escalation Trial for Treatment of Skin Cancer with Favorable Safety and Pathology Data

Key Development Agreements Secured for Nonclinical Toxicology and U.S. cGMP Clinical Supply Manufacturing

King of Prussia, Pennsylvania--(Newsfile Corp. - May 7, 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 March 31, 2026, and provided a business update.

"We are enthusiastic with the successful completion of our Phase 1b clinical trial which now positions us for upcoming FDA interface which we expect will clarify next steps in advancing the PH-762 development program," said Robert Bitterman, President and Chief Executive Officer.

Recent Corporate Updates

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 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. The clinical phase of the trial is complete, and the final data is currently being analyzed. 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.

Capital Sourcing

During 2025, Phio strengthened its balance sheet through a series of equity financings and warrant exercises that generated approximately $23.7 million in net proceeds. These transactions extended the Company's cash runway into the first half of 2027 and will support ongoing clinical development, operational requirements and strategic initiatives.

Scientific News

The Company presented its Phase 1b clinical trial data for PH-762 at the American Academy of Dermatology (AAD) in the Late-Breaking Research Session in March 2026. In April 2026, the Company presented its lead clinical candidate, PH-762, and Phase 1b clinical trial results at multiple conferences including Deal Flow, Force Family Office Fireside Chats, the Investival Conference in Miami and the Centri Capital Conference in NYC.

Financial Results

Cash Position

As of March 31, 2026, the Company had cash and cash equivalents of approximately $17 million as compared with approximately $21 million at December 31, 2025.

In April 2026, the Company entered into an At The Market Agreement (ATM) with H.C. Wainwright & Co., LLC pursuant to which the Company may offer and sell shares of our Common Stock, having an aggregate price of up to $6.36 million.

Research and Development Expenses

Research and development expenses for the three months ended March 31, 2026 were $2.8 million, which was an increase of 215%, or $1.9 million, as compared with the three months ended March 31, 2025. This increase in research and development expenses was primarily driven by clinical trial, chemistry, manufacturing and controls (CMC) and toxicology expenses in connection with advancing our PH-762 program. Management believes that research and development expenses will continue to increase as we continue to advance our PH-762 program.

General and Administrative Expenses

General and administrative expenses for the three months ended March 31, 2026 were $1.4 million, which was an increase of 39%, or $400 thousand, as compared with the three months ended March 31, 2025. The increase in general and administrative expenses was primarily driven by employee related costs, investor outreach and professional fees.

Net Loss

Net loss was $ 4.0 million for the three months ended March 31, 2026 as compared with $1.8 million for the three months ended March 31, 2025. The increase in net loss was attributable to increases in research and development and general and administrative expenses cited above.

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, 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, 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


March 31,


2026
2025








Operating expenses:






Research and development
$2,793
$886
General and administrative

1,374

986
Total operating expenses

4,167

1,872
Operating loss

(4,167)
(1,872)
Interest income, net

161

125
Other income, net

3

(22)
Net loss
$(4,003)$(1,769)
Basic and diluted
$(0.34)$(0.41)
Weighted average number of common shares outstanding

 

 
Basic and diluted

11,617,250

4,307,264

 

PHIO PHARMACEUTICALS CORP.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
(Unaudited)



March 31,
December 31,
ASSETS
2026
2025
Current assets:






Cash and cash equivalents
$17,031
$21,031
Prepaid expenses and other current assets

371

445
Total current assets

17,402

21,476
Property and equipment, net

10

11
Total assets
$17,412
$21,487



 

 
LIABILITIES AND STOCKHOLDERS' EQUITY

 

 
Current liabilities:

 

 
Accounts payable
$260
$435
Accrued expenses

690

905
Total liabilities

950

1,340
Commitments and contingencies

 

 
Stockholders' equity:

 

 
Series D Preferred stock, $0.0001 par value, 10,000,000 shares authorized; 0 issued and outstanding at each of March 31, 2026 and December 31, 2025

-

-
Common stock, $0.0001 par value, 100,000,000 shares authorized; 11,617,250 and 11,617,250 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

1

1
Additional paid-in capital

175,518

175,200
Accumulated deficit

(159,057)
(155,054)
Total stockholders' equity

16,462

20,147
Total liabilities and stockholders' equity
$17,412
$21,487

 

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/296434

FAQ

What did PHIO report about the PH‑762 Phase 1b trial on May 7, 2026?

The company completed its Phase 1b dose‑escalation trial of PH‑762 with favorable safety and pathology signals. According to the company, the study enrolled 22 patients and final data is under analysis while an FDA submission is targeted in Q2 2026.

How much cash did PHIO have at March 31, 2026 and what is the runway?

PHIO reported approximately $17 million in cash and cash equivalents at March 31, 2026. According to the company, prior financings extended the cash runway into the first half of 2027 to support ongoing clinical development.

Why did PHIO's research and development expenses increase in Q1 2026?

R&D expenses rose to $2.8 million, a 215% increase year‑over‑year. According to the company, the increase was driven by clinical trial, CMC and toxicology costs advancing the PH‑762 program.

What was PHIO's net loss for Q1 2026 and what drove it?

PHIO reported a net loss of $4.0 million for the quarter ended March 31, 2026. According to the company, the larger loss resulted from higher R&D and general and administrative expenses versus the prior year period.

Did PHIO arrange any capital markets facilities in April 2026?

Yes. PHIO entered an at‑the‑market (ATM) agreement permitting sales of common stock up to $6.36 million. According to the company, the ATM provides optionality to raise capital but could dilute existing shareholders if used.

What near‑term regulatory step did PHIO signal for PH‑762?

PHIO is targeting an FDA submission in Q2 2026 to seek guidance on next clinical study design for PH‑762. According to the company, that interaction is intended to clarify next steps for advancing the development program.