Phio Pharmaceuticals to Present at the H.C. Wainwright 27th Annual Global Investment ConferenceSeptember 03, 2025 7:45 AM EDT | Source: Phio Pharmaceuticals Corp.Clinical trial advances to anticipated final cohort for INSTASYL siRNA lead product candidate PH-7625th cohort patients now being treated in on-going clinical studyKing of Prussia, Pennsylvania--(Newsfile Corp. - September 3, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company developing the ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36304 Phio Pharmaceuticals Corp. (Exact name of registrant as specified in its charter) Delaware 45-3215903 (State or oth ...

[Business Update](index=1&type=section&id=Business%20Update) This section provides an overview of Phio Pharmaceuticals' recent clinical advancements, scientific presentations, and post-quarter financial activities [PH-762 Clinical Progress](index=1&type=section&id=PH-762%20Clinical%20Progress) The Phase 1b clinical trial for PH-762 is progressing with the 5th cohort enrollment, showing the drug is well-tolerated with positive pathologic responses in cutaneous carcinomas, and a manufacturing agreement has been secured - The Phase 1b trial has treated **15 patients** across four cohorts, showing PH-762 is well-tolerated with no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects[2](index=2&type=chunk) Pathologic Response in cSCC Patients (n=13) | Response Category | Number of Patients | | :--- | :--- | | Complete Response (100% clearance) | 5 | | Near Complete Response (>90% clearance) | 1 | | Partial Response (>50% clearance) | 1 | | Non-Response (<50% clearance) | 6 | - The company is now enrolling the **5th and final cohort** for the Phase 1b trial and has entered into a cGMP manufacturing agreement for PH-762 with a U.S. company[4](index=4&type=chunk) [Scientific News](index=2&type=section&id=Scientific%20News) Phio Pharmaceuticals presented its INTASYL technology and Phase 1b clinical trial data at key scientific conferences, including SID, ITOC, and ASCO, during Q2 2025 - The company delivered podium presentations on its INTASYL technology and Phase 1b clinical trial results at major conferences[5](index=5&type=chunk) - Society of Investigative Dermatology (SID) in May 2025 - 11th Annual Immunotherapy of Cancer (ITOC 11) in April 2025 - American Society of Clinical Oncology (ASCO) in June 2025[5](index=5&type=chunk) [Subsequent Events](index=2&type=section&id=Subsequent%20Events) Post-quarter, on July 25, 2025, the company successfully raised approximately $2.2 million in net proceeds through warrant inducement agreements with existing warrant holders - On July 25, 2025, the company raised approximately **$2.2 million** after expenses through warrant inducement agreements[6](index=6&type=chunk) - The financing involved certain holders exercising existing warrants to purchase an aggregate of **928,596 shares** of common stock[6](index=6&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) This section details Phio Pharmaceuticals' financial performance for Q2 2025, highlighting increased cash reserves, rising operating expenses, and a higher net loss compared to the prior year [Financial Highlights](index=2&type=section&id=Financial%20Highlights) For Q2 2025, Phio Pharmaceuticals reported a strengthened cash position of $10.8 million, increased operating expenses, and a net loss of $2.2 million Key Financial Metrics (Q2 2025 vs. Prior Periods) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $1.1M | $0.9M | $1.9M | $2.0M | | G&A Expenses | $1.2M | $1.0M | $2.2M | $1.8M | | Net Loss | $2.2M | $1.8M | - | - | - Cash and cash equivalents increased to approximately **$10.8 million** at June 30, 2025, compared to **$5.4 million** at December 31, 2024[7](index=7&type=chunk) - The increase in Q2 R&D expenses was primarily due to higher CRO costs from increased patient enrollment, while the rise in G&A expenses was driven by higher salary-related costs[8](index=8&type=chunk)[10](index=10&type=chunk) [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, the company reported total operating expenses of $2.3 million and a net loss of $2.2 million, or ($0.45) per share, compared to $1.9 million and $1.8 million respectively in 2024 Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | | **Operating expenses:** | | | | Research and development | $1,074 | $866 | | General and administrative | $1,235 | $1,048 | | **Total operating expenses** | **$2,309** | **$1,914** | | **Operating loss** | **($2,309)** | **($1,914)** | | Total other income (expense), net | $143 | $68 | | **Net loss** | **($2,166)** | **($1,846)** | | **Basic and diluted net loss per share** | **($0.45)** | **($3.62)** | | Weighted average shares outstanding | 4,794,857 | 510,188 | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Phio's balance sheet shows total assets of $11.3 million, driven by a rise in cash to $10.8 million, with total liabilities at $1.2 million and stockholders' equity at $10.1 million Condensed Consolidated Balance Sheets (Unaudited, in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $10,775 | $5,382 | | Total current assets | $11,294 | $5,736 | | **Total assets** | **$11,301** | **$5,738** | | **LIABILITIES AND EQUITY** | | | | Total current liabilities | $1,206 | $1,015 | | **Total liabilities** | **$1,206** | **$1,015** | | **Total stockholders' equity** | **$10,095** | **$4,723** | | **Total liabilities and stockholders' equity** | **$11,301** | **$5,738** | [About Phio Pharmaceuticals Corp.](index=3&type=section&id=About%20Phio%20Pharmaceuticals%20Corp.) Phio Pharmaceuticals is a clinical-stage biopharmaceutical company developing immuno-oncology therapeutics using its proprietary INTASYL siRNA gene silencing technology, with lead program PH-762 in Phase 1b for skin cancers - Phio is a clinical-stage siRNA biopharmaceutical company using its INTASYL gene silencing technology for immuno-oncology therapeutics[13](index=13&type=chunk) - The company's lead clinical program, PH-762, silences the PD-1 gene and is in a Phase 1b trial for treating cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma[13](index=13&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward%20Looking%20Statements) This section provides a standard safe harbor statement, cautioning that the press release contains forward-looking statements subject to risks and uncertainties, advising readers to refer to SEC filings for detailed risk factors - The press release includes forward-looking statements regarding the potential of its INTASYL technology, clinical trial timelines, and financial sufficiency[15](index=15&type=chunk) - Investors are warned that actual results may differ due to various risks and uncertainties, which are detailed under the "Risk Factors" section of the company's Form 10-K and 10-Q filings with the SEC[16](index=16&type=chunk)

Core Insights - Phio Pharmaceuticals reported its financial results for Q2 2025 and provided updates on its clinical trials, particularly for its lead product candidate PH-762, which utilizes INTASYL siRNA technology to target cancer treatment [1][4]. Clinical Progress - The ongoing Phase 1b clinical trial for PH-762 is evaluating its safety and tolerability in patients with various stages of cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma, with 15 patients treated across four cohorts [2][4]. - No dose-limiting toxicities or significant adverse effects have been reported, and all patients tolerated the treatment well, with no clinical progression observed during the trial [2][3]. Efficacy Results - Among the 13 patients with cutaneous squamous cell carcinoma, five achieved complete response (100% clearance), one had near complete response (>90% clearance), one had partial response (>50% clearance), and six had pathologic non-response (<50% clearance) [3]. - The patient with stage 4 metastatic Merkel cell carcinoma showed a pathological partial response (>50% clearance), while the melanoma patient did not respond (<50% clearance) [3]. Financial Overview - As of June 30, 2025, the company had cash and cash equivalents of approximately $10.8 million, an increase from $5.4 million at the end of 2024 [8]. - Research and development expenses for Q2 2025 were $1.1 million, up from $0.9 million in Q2 2024, primarily due to increased patient enrollment and higher consulting costs [9]. - General and administrative expenses for Q2 2025 were $1.2 million, compared to $1.0 million in the same period last year, driven by increased salary-related costs [11]. Net Loss - The net loss for Q2 2025 was $2.2 million, compared to $1.8 million in Q2 2024, attributed to rising research and development and administrative expenses [13]. Stockholder Equity - Total stockholders' equity increased to $10.1 million as of June 30, 2025, from $4.7 million at the end of 2024, reflecting the company's capital raising efforts [20][21].

Core Viewpoint - Phio Pharmaceuticals Corp. has announced the exercise of warrants that will generate approximately $2.5 million in gross proceeds, aimed at supporting its clinical-stage siRNA biopharmaceutical operations focused on cancer therapeutics [1][4]. Group 1: Warrants and Financial Details - The company entered into agreements to exercise warrants for a total of 928,596 shares of common stock, with exercise prices ranging from $2.00 to $3.00 per share [1]. - The exercise of 100,000 shares will occur at the existing price of $2.00, while 828,596 shares will be exercised at a reduced price of $2.485 per share [1]. - The gross proceeds from this exercise are expected to be around $2.5 million before deducting fees and expenses [1]. Group 2: New Warrants Issuance - In exchange for the immediate cash exercise of the warrants, holders will receive new unregistered warrants for an aggregate of up to 1,857,192 shares at an exercise price of $2.485 per share [3]. - The new warrants will have a term of twenty-four months for 1,538,596 shares and five years for 318,596 shares, effective upon the registration of the shares [3]. Group 3: Use of Proceeds - The company plans to utilize the net proceeds from the offering for working capital and other general corporate purposes [4]. Group 4: Company Overview - Phio Pharmaceuticals is a clinical-stage siRNA biopharmaceutical company that focuses on developing therapeutics using its INTASYL® gene silencing technology, particularly in the field of immuno-oncology [9]. - The lead clinical program, PH-762, targets the PD-1 gene associated with various skin cancers and is currently undergoing a Phase 1b trial [9].

Core Insights - Phio Pharmaceuticals has reported promising pathology results from its ongoing Phase 1b clinical trial, indicating potential efficacy of its treatment PH-762 for skin cancers [2][3][5]. Group 1: Clinical Trial Results - In the fourth cohort of the trial, one patient with cutaneous squamous cell carcinoma (cSCC) achieved a complete pathologic response, indicating 100% tumor clearance [2][4]. - A patient with Stage 4 metastatic Merkel cell carcinoma showed a partial response with over 50% tumor clearance [2][4]. - Two patients with cSCC exhibited pathologic non-response, with less than 50% tumor clearance, while results for one remaining patient are still pending [2][4]. Group 2: Safety and Tolerability - The Phase 1b trial has treated a total of 15 patients across four cohorts, with no dose-limiting toxicities or significant treatment-emergent adverse effects reported [3][5]. - PH-762 has been well tolerated among all enrolled patients, with no clinical progression of disease observed [3][5]. Group 3: Future Directions - Phio Pharmaceuticals is currently enrolling patients for what is expected to be the fifth and final cohort in the Phase 1b study [5]. - The CEO of Phio Pharmaceuticals expressed optimism that the positive safety and efficacy outcomes suggest PH-762 could serve as a viable non-surgical alternative in the expanding skin cancer market [5][6]. Group 4: Company Overview - Phio Pharmaceuticals is a clinical-stage siRNA biopharmaceutical company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology, particularly in the field of immuno-oncology [6]. - The lead clinical program, PH-762, targets the PD-1 gene associated with various skin cancers, including cSCC, melanoma, and Merkel cell carcinoma [6].

Core Insights - Phio Pharmaceuticals has entered into a comprehensive drug substance development services agreement with a U.S. manufacturer for its lead compound PH-762, which is a significant step in advancing its intratumoral program for treating cutaneous carcinomas [1][2] - The company is currently enrolling patients for the fifth and expected final cohort in its Phase 1b dose escalation study targeting cutaneous squamous cell carcinoma, Merkel cell carcinoma, and melanoma [1][2] Company Overview - Phio Pharmaceuticals Corp. is a clinical-stage siRNA biopharmaceutical company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology aimed at eliminating cancer [1][2] - The lead clinical program, PH-762, is designed to silence the PD-1 gene, which is implicated in various forms of skin cancer, and represents a potential non-surgical treatment option [2]

Core Viewpoint - Phio Pharmaceuticals has received a positive recommendation from the Safety Monitoring Committee to advance its clinical trial for PH-762, a siRNA compound targeting skin cancer, to the fifth dose escalation cohort, indicating a supportive safety profile through the fourth cohort [1][6]. Group 1: Clinical Trial Progress - The Phase 1b clinical trial (NCT 06014086) has enrolled five patients in the fourth cohort, with four diagnosed with cutaneous squamous cell carcinoma (cSCC) and one with Merkel cell carcinoma, all of whom tolerated the injections well without serious adverse events [2][4]. - A total of 15 patients have been treated across the first four cohorts, including 13 with cSCC, one with metastatic melanoma, and one with Merkel cell carcinoma [4]. - The company anticipates completing enrollment in the final cohort by the third quarter of 2025 [6]. Group 2: Efficacy and Safety Profile - Pathological responses at Day 36 showed a complete response (100% tumor clearance) in 4 out of 9 patients with cSCC, with one patient showing near complete response (>90% clearance) and another showing partial response (>50% clearance) [5]. - No patients exhibited clinical progression of disease, and the continuing favorable safety profile of PH-762 suggests it may be a well-tolerated treatment option for skin cancer [6][3]. Group 3: Company Overview - Phio Pharmaceuticals is a clinical-stage siRNA biopharmaceutical company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology, particularly in the field of immuno-oncology [7][8]. - PH-762 is designed to silence the PD-1 gene, which is implicated in various forms of skin cancer, and represents a potential non-surgical treatment option [8].

Core Insights - Phio Pharmaceuticals is launching a strategic initiative to increase awareness of its INTASYL siRNA portfolio, which includes around 30 compounds [1][5] - The company reported positive interim safety and efficacy results for its INTASYL compound PH-762 in an ongoing Phase 1b clinical trial targeting skin cancer [1][5] Leadership Changes - Robert Infarinato has been appointed as VP of Strategic Development, effective June 9, 2025, transitioning from his role as CFO [2] - Lisa Carson has been named VP of Finance and Administration, bringing over 20 years of finance experience [2][4] Product Development - Phio's lead clinical program, PH-762, aims to silence the PD-1 gene associated with various skin cancers and is currently in a Phase 1b trial [5] - The ongoing trial evaluates PH-762 for treating cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma, positioning it as a potential non-surgical treatment option [5]

Registration Link for Presentation to take place Thursday, May 22, 2025 at 10:00 AM ET May 19, 2025 7:45 AM EDT | Source: Phio Pharmaceuticals Corp. Marlborough, Massachusetts--(Newsfile Corp. - May 19, 2025) - 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 announced today that Mr. Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals will ...