Phio Pharmaceuticals(PHIO)

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Phio Pharmaceuticals Announces Exercise of Warrants for Approximately $2.5 Million Gross Proceeds
Newsfile· 2025-07-25 19:04
Phio Pharmaceuticals Announces Exercise of Warrants for Approximately $2.5 Million Gross ProceedsJuly 25, 2025 3:04 PM EDT | Source: Phio Pharmaceuticals Corp.King of Prussia, Pennsylvania--(Newsfile Corp. - July 25, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer, today announced the entry into definitive agreements to exercise certain outsta ...
Phio Pharmaceuticals Announces Pathology Results for Four of Five Patients in Fourth Cohort
Newsfile· 2025-07-25 16:36
Phio Pharmaceuticals Announces Pathology Results for Four of Five Patients in Fourth CohortJuly 25, 2025 12:36 PM EDT | Source: Phio Pharmaceuticals Corp.Complete Pathologic Response in patient with cutaneous squamous cell carcinoma Partial Response in Stage 4 metastatic Merkel cell patientKing of Prussia, Pennsylvania--(Newsfile Corp. - July 25, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary I ...
Phio Pharmaceuticals Announces Agreement with U.S. Manufacturing Source for Drug Substance
Newsfile· 2025-07-25 11:45
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]
Phio Pharmaceuticals Announces Positive Safety Monitoring Committee Recommendation to Advance INTASYL PH-762 Skin Cancer Clinical Trial to Fifth Dose Escalation Cohort
Newsfile· 2025-06-25 11:45
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].
Phio Pharmaceuticals Announces Strategic Initiative to Create Awareness of the Comprehensive INTASYL siRNA Portfolio
Newsfile· 2025-06-06 11:45
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]
Phio Pharmaceuticals(PHIO) - 2025 Q1 - Quarterly Report
2025-05-15 20:34
Part I [Financial Statements (Unaudited)](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited condensed consolidated financial statements for Phio Pharmaceuticals Corp. as of March 31, 2025, and for the three months ended March 31, 2025 and 2024 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's cash and cash equivalents significantly increased to **$13,278 thousand** as of March 31, 2025, from **$5,382 thousand** at the end of 2024, primarily due to financing activities. Total assets grew to **$13,440 thousand**, and total stockholders' equity rose to **$12,170 thousand** from **$4,723 thousand**, reflecting the capital raised during the quarter Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $13,278 | $5,382 | | Total current assets | $13,436 | $5,736 | | **Total assets** | **$13,440** | **$5,738** | | **Liabilities & Equity** | | | | Total current liabilities | $1,270 | $1,015 | | **Total liabilities** | **$1,270** | **$1,015** | | **Total stockholders' equity** | **$12,170** | **$4,723** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, the company reported a net loss of **$1,769 thousand**, an improvement from a net loss of **$2,154 thousand** in the same period of 2024. The reduced loss was driven by lower operating expenses, specifically a decrease in both Research and Development and General and Administrative costs Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | | :--- | :--- | :--- | | Research and development | $886 | $1,148 | | General and administrative | $986 | $1,061 | | **Total operating expenses** | **$1,872** | **$2,209** | | **Operating loss** | **($1,872)** | **($2,209)** | | Interest income, net | $125 | $53 | | **Net loss** | **($1,769)** | **($2,154)** | | Net loss per share (basic and diluted) | ($0.41) | ($0.47) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity increased from **$4,723 thousand** at the end of 2024 to **$12,170 thousand** at March 31, 2025, primarily driven by the issuance of common stock and warrants, which added **$6,490 thousand** to additional paid-in capital, and the exercise of warrants, which added another **$2,680 thousand**, offset by the net loss for the period - Key changes in stockholders' equity for Q1 2025 included **$2,680 thousand** from the exercise of warrants and **$6,490 thousand** from the issuance of common stock and warrants[14](index=14&type=chunk) - The net loss of **$1,769 thousand** for the quarter reduced the accumulated deficit[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The company experienced a net cash increase of **$7,896 thousand** in Q1 2025, a significant turnaround from a **$2,015 thousand** decrease in Q1 2024, due to **$9,173 thousand** in net cash provided by financing activities from stock and warrant issuances, which more than offset the **$1,275 thousand** cash used in operating activities Cash Flow Summary (in thousands) | Activity | Q1 2025 (in thousands) | Q1 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,275) | ($2,011) | | Net cash used in investing activities | ($2) | $0 | | Net cash provided by (used in) financing activities | $9,173 | ($4) | | **Net increase (decrease) in cash** | **$7,896** | **($2,015)** | | **Cash at end of period** | **$13,278** | **$6,475** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's basis of accounting, its status as a clinical-stage biopharmaceutical company, and significant events, including a going concern warning due to recurring losses, the termination of the AgonOx collaboration, and extensive financing activities through stock and warrant offerings in January 2025 - The company is a clinical-stage biopharmaceutical firm focused on its proprietary INTASYL® self-delivering siRNA technology for immuno-oncology therapeutics[20](index=20&type=chunk) - The company has recurring losses and negative cash flows, which raises substantial doubt about its ability to continue as a going concern without raising additional capital[29](index=29&type=chunk) - In May 2024, the company terminated its Clinical Co-Development Agreement with AgonOx. A final settlement payment of **$34,320** was made on March 21, 2025, settling all future obligations[34](index=34&type=chunk)[35](index=35&type=chunk) - In January 2025, the company conducted three separate registered direct offerings and private placements, raising approximately **$6,700 thousand** in net proceeds[49](index=49&type=chunk)[51](index=51&type=chunk)[53](index=53&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's financial condition and operational results, highlighting its focus on the clinical development of PH-762 for cancer treatment, the implementation of a cost rationalization program, and the significant bolstering of its cash position by January 2025 offerings, extending the operational runway into the second quarter of 2026 [Overview](index=17&type=section&id=Overview) Phio is a clinical-stage biopharmaceutical company focused on its INTASYL® siRNA technology to make immune cells more effective at killing tumor cells, having shifted from discovery research to product development and implemented a cost rationalization program that included a >50% headcount reduction to redirect funds to the Phase 1b clinical trial for its lead candidate, PH-762 - The company is focused on developing therapeutics using its proprietary INTASYL® self-delivering siRNA technology to target proteins that inhibit the body's ability to fight cancer[75](index=75&type=chunk) - A cost rationalization program was implemented in 2023, involving a headcount reduction of over **50%** and a shift to remote operations to fund the PH-762 clinical trial[76](index=76&type=chunk) [Product Pipeline Update](index=17&type=section&id=Product%20Pipeline%20Update) The lead product, PH-762, is in a Phase 1b trial for various skin cancers, with promising early results showing a pathologic complete response in 4 of 9 cSCC patients, with enrollment expected to complete in Q3 2025, while the collaboration with AgonOx for a T-cell therapy using PH-762 was terminated in May 2024, and development of a second candidate, PH-894, has been deferred to prioritize PH-762 - PH-762 is being evaluated in a U.S. Phase 1b trial for cutaneous squamous cell carcinoma (cSCC), melanoma, and Merkel cell carcinoma. Enrollment is expected to complete in **Q3 2025**[79](index=79&type=chunk) - Early data from the PH-762 trial showed that out of **9** cSCC patients, **4** had a pathologic complete response (**100%** tumor clearance) and the treatment was well tolerated with no dose-limiting toxicities[79](index=79&type=chunk) - The IND submission for PH-894 has been deferred to focus resources on the clinical advancement of PH-762[85](index=85&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Operating expenses for Q1 2025 were **$1,872 thousand**, a decrease of **$337 thousand** from **$2,209 thousand** in Q1 2024, with Research and Development expenses falling by **23%** (**$262 thousand**) due to lower salary and consulting costs, and General and Administrative expenses decreasing by **7%** (**$75 thousand**), which the company considers an immaterial fluctuation Operating Expenses Comparison (in thousands) | Expense Category | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Dollar Change (in thousands) | | :--- | :--- | :--- | :--- | | Research and development | $886 | $1,148 | ($262) | | General and administrative | $986 | $1,061 | ($75) | | **Total operating expenses** | **$1,872** | **$2,209** | **($337)** | - The **23%** decrease in R&D expenses was primarily driven by a **$106,000** decrease in salary-related costs and a **$94,000** decrease in consulting expense[91](index=91&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had **$13,278 thousand** in cash and cash equivalents, but recurring losses and negative cash flows raise substantial doubt about its ability to continue as a going concern without additional funding, despite a significant inflow of **$9,173 thousand** from financing activities during the quarter - The company has limited cash resources and recurring losses, raising substantial doubt about its ability to continue as a going concern. Its continuation depends on raising additional capital[95](index=95&type=chunk) Cash Flow Summary (in thousands) | Activity | Q1 2025 (in thousands) | Q1 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,275) | ($2,011) | | Net cash provided by financing activities | $9,173 | ($4) | - The company expects its current cash and cash equivalents of **$13,278 thousand** will fund operations into the second quarter of **2026**[101](index=101&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company is a smaller reporting company and is not required to provide this information - As a smaller reporting company, Phio Pharmaceuticals is not required to provide quantitative and qualitative disclosures about market risk[105](index=105&type=chunk) [Controls and Procedures](index=22&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management, including the Principal Executive Officer and Principal Financial Officer, evaluated the company's disclosure controls and procedures as of March 31, 2025, concluding that these controls were effective at a reasonable assurance level, with no material changes to the company's internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of **March 31, 2025**[107](index=107&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[108](index=108&type=chunk) Part II [Legal Proceedings](index=23&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any material legal proceedings - The company is not currently a party to any actual or threatened material legal proceedings[111](index=111&type=chunk) [Risk Factors](index=23&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company highlights significant risks, with a primary focus on maintaining compliance with Nasdaq's continued listing requirements, specifically the minimum stockholders' equity of **$2,500 thousand** and the **$1.00** minimum bid price, noting that a recent reverse stock split limits its ability to use that measure again before July 2025 if the bid price falls, and also addressing potential adverse impacts from changes in U.S. and international trade policies - There is a risk of non-compliance with Nasdaq's continued listing requirement of maintaining at least **$2,500 thousand** in stockholders' equity. As of **March 31, 2025**, stockholders' equity was **$12,170 thousand**[113](index=113&type=chunk) - If the company's stock price falls below the **$1.00** minimum bid requirement before **July 5, 2025**, it may face immediate delisting determination due to a reverse stock split effected on **July 5, 2024**[114](index=114&type=chunk) - Changes in U.S. and international trade policies, such as tariffs on imports from Mexico, Canada, or China, could increase manufacturing costs and disrupt the supply of clinical materials[116](index=116&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) There were no sales or issuances of unregistered securities during the period that have not been previously disclosed in a Current Report on Form 8-K - No unregistered sales of equity securities occurred that were not previously disclosed on a Form 8-K[117](index=117&type=chunk) [Other Information](index=24&type=section&id=ITEM%205.%20OTHER%20INFORMATION) During the first quarter of 2025, no director or officer of the company adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - No director or officer adopted or terminated a Rule 10b5-1 trading plan or other non-Rule 10b5-1 trading arrangement during the three months ended **March 31, 2025**[120](index=120&type=chunk) [Exhibits](index=24&type=section&id=ITEM%206.%20EXHIBITS) This section provides an index of all exhibits filed with or incorporated by reference into the Form 10-Q report, including corporate governance documents, forms of warrants, securities purchase agreements, and Sarbanes-Oxley certifications
Phio Pharmaceuticals(PHIO) - 2025 Q1 - Quarterly Results
2025-05-15 20:31
Business Update [PH-762 Clinical Progress](index=1&type=section&id=PH-762%20Clinical%20Progress) PH-762's Phase 1b trial progresses, showing promising cSCC efficacy and good tolerability, targeting Q3 2025 enrollment completion - The ongoing Phase 1b trial is evaluating intratumoral PH-762 for treating cSCC, melanoma, and Merkel cell carcinoma[3](index=3&type=chunk) - Of the 9 cSCC patients treated, **4 achieved a pathologic complete response** (100% tumor clearance), **1 had a near complete response** (>90%), and **1 had a partial response** (>50%)[4](index=4&type=chunk) - PH-762 has been well tolerated with no dose-limiting toxicities observed, and the fourth cohort is currently enrolling, with trial enrollment expected to be completed in the third quarter of 2025[5](index=5&type=chunk) [Scientific News](index=1&type=section&id=Scientific%20News) Phio presented positive INTASYL clinical data for PH-762 and PH-894 at conferences, and RXI-231 was featured in a journal - The company presented its Phase 1b clinical trial results at the American Academy of Dermatology (AAD) and the Society of Investigative Dermatology (SID)[6](index=6&type=chunk) - Data on INTASYL compounds PH-762 and PH-894 were presented at the 11th Annual Immunotherapy of Cancer (ITOC 11) conference[6](index=6&type=chunk) - The INTASYL compound RXI-231, designed to treat hyperpigmentation disorders, was highlighted in the peer-reviewed journal, *Clinical, Cosmetic and Investigational Dermatology*[7](index=7&type=chunk) [Capital Sourcing](index=2&type=section&id=Capital%20Sourcing) Phio raised **$12.1 million** via offerings and warrant exercises, securing capital for the Phase 1b trial's treatment phase - Raised an aggregate of approximately **$9.2 million** in registered direct offerings and concurrent private placements in December 2024 and January 2025[8](index=8&type=chunk) - Secured additional gross proceeds of approximately **$2.9 million** from the exercise of warrants[8](index=8&type=chunk) - With the new proceeds, the company believes it has sufficient capital to complete the treatment phase of the Phase 1b trial[8](index=8&type=chunk) [Cost Rationalization](index=2&type=section&id=Cost%20Rationalization) Cost-saving measures include moving the laboratory to a cheaper lease and terminating the AgonOx Clinical Co-Development Agreement - The company moved to a new laboratory facility with a month-to-month lease of approximately **$2,500**, a significant reduction from its previous arrangement[9](index=9&type=chunk) - In May 2024, the company terminated its Clinical Co-Development Agreement with AgonOx, Inc. and settled all future obligations with a final payment of **$34,320** in March 2025[10](index=10&type=chunk) First Quarter 2025 Financial Results [Financial Highlights](index=2&type=section&id=Financial%20Highlights) Phio improved Q1 2025 cash to **$13.3 million** via financing, reducing net loss to **$1.8 million** due to decreased R&D and G&A Financial Highlights (Q1 2025 vs Q1 2024) | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $13.3M | N/A | +$7.9M from YE 2024 | | Research & Development | $0.886M | $1.148M | -23% | | General & Administrative | $0.986M | $1.061M | -7% | | Net Loss | $1.8M | $2.2M | -18% | | Net Loss Per Share | ($0.41) | ($0.47) | Improved | [Cash Position](index=2&type=section&id=Cash%20Position) Cash and cash equivalents increased to **$13.3 million** as of March 31, 2025, primarily from **$9.2 million** in net cash from financing - Cash was approximately **$13.3 million** at March 31, 2025, compared to **$5.4 million** at December 31, 2024[11](index=11&type=chunk) - Net cash provided by financing activities for Q1 2025 was approximately **$9.2 million**, mainly from the issuance of common stock and warrants, and the exercise of warrants[12](index=12&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Operating expenses decreased year-over-year, with R&D down **23%** to **$0.886 million** and G&A down **7%** to **$0.986 million** - Research and development expenses decreased by **23%** to **$0.886 million** for Q1 2025 from **$1.148 million** in Q1 2024, primarily due to lower salary-related and consulting costs[13](index=13&type=chunk) - General and administrative expenses decreased by **7%** to **$0.986 million** for Q1 2025 from **$1.061 million** in Q1 2024[14](index=14&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) Net loss improved to **$1.8 million** (or **($0.41)** per share) in Q1 2025 from **$2.2 million** (or **($0.47)** per share) in Q1 2024 Net Loss (Three Months Ended March 31) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **Net Loss** | $1.8 million | $2.2 million | | **Net Loss per Share** | ($0.41) | ($0.47) | Financial Statements [Consolidated Statements of Operations](index=4&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Q1 2025 unaudited operations show total operating expenses of **$1.872 million** and a net loss of **$1.769 million**, a favorable comparison to Q1 2024 Consolidated Statements of Operations (Amounts in thousands) | (Amounts in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $886 | $1,148 | | General and administrative | $986 | $1,061 | | **Total operating expenses** | **$1,872** | **$2,209** | | **Operating loss** | **($1,872)** | **($2,209)** | | Interest income, net | $125 | $53 | | **Net loss** | **($1,769)** | **($2,154)** | | **Net loss per common share** | **($0.41)** | **($0.47)** | [Consolidated Balance Sheets](index=4&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) The unaudited balance sheet as of March 31, 2025, shows total assets of **$13.44 million** and total liabilities of **$1.27 million**, with assets increasing from financing Consolidated Balance Sheets (Amounts in thousands) | (Amounts in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $13,278 | $5,382 | | Total current assets | $13,436 | $5,736 | | **Total assets** | **$13,440** | **$5,738** | | **LIABILITIES & EQUITY** | | | | Total liabilities | $1,270 | $1,015 | | Total stockholders' equity | $12,170 | $4,723 | | **Total liabilities and stockholders' equity** | **$13,440** | **$5,738** | Company Information and Disclosures [About Phio Pharmaceuticals Corp.](index=3&type=section&id=About%20Phio%20Pharmaceuticals%20Corp.) Phio Pharmaceuticals is a clinical-stage biopharmaceutical company using INTASYL gene silencing technology for immuno-oncology therapeutics, with lead program PH-762 in Phase 1b - Phio is a clinical-stage siRNA biopharmaceutical company focused on immuno-oncology therapeutics using its INTASYL gene silencing technology[16](index=16&type=chunk) - The lead clinical program, PH-762, silences the PD-1 gene and is being evaluated in a Phase 1b trial for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma[16](index=16&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward%20Looking%20Statements) Forward-looking statements regarding technology potential, clinical timelines, and capital are subject to risks and uncertainties detailed in SEC filings - The press release includes forward-looking statements about the potential of INTASYL technology, clinical trial timelines, and capital sufficiency[18](index=18&type=chunk) - Readers are cautioned that actual results may differ from forward-looking statements due to various risks and uncertainties identified in the company's SEC filings, such as the Annual Report on Form 10-K[19](index=19&type=chunk)
Phio Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update
Newsfile· 2025-05-15 20:15
Core Insights - Phio Pharmaceuticals reported financial results for Q1 2025, highlighting advancements in its clinical trials for the siRNA lead product candidate PH-762, which aims to enhance immune cell effectiveness against cancer [1][2] Clinical Progress - The ongoing Phase 1b 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 [2] - As of now, 10 patients have been treated across the first three cohorts, with 4 patients achieving a pathologic complete response, indicating 100% tumor clearance [3][4] Financial Results - At March 31, 2025, the company had cash of approximately $13.3 million, a significant increase from $5.4 million at December 31, 2024 [11] - Net cash provided by financing activities for Q1 2025 was approximately $9.2 million, compared to a net cash usage of approximately $4,000 in Q1 2024 [12] - Research and development expenses decreased by 23% to $0.886 million in Q1 2025 from $1.148 million in Q1 2024, primarily due to reduced salary-related costs and consulting expenses [13] - General and administrative expenses also saw a decrease of 7%, from approximately $1.061 million in Q1 2024 to approximately $0.986 million in Q1 2025 [14] - The net loss for Q1 2025 was $1.8 million, down from $2.2 million in Q1 2024, attributed to reduced operating expenses [15] Capital Sourcing - In late 2024 and early 2025, Phio raised approximately $9.2 million through registered direct offerings and private placements, along with an additional $2.9 million from warrant exercises, providing sufficient capital to complete the treatment phase of the Phase 1b trial [8] Cost Rationalization - The company has transitioned to a new laboratory facility with a monthly rent of approximately $2,500, and has contracted for additional working space at a fee of $300 per month [9]
Phio Pharmaceuticals Announces Positive Pathology Results in Third Cohort in INTASYL PH-762 Skin Cancer Clinical Trial
Newsfile· 2025-05-07 11:45
Core Insights - Phio Pharmaceuticals announced positive results from its Phase 1b clinical trial of PH-762, showing a complete pathologic response (100% tumor clearance) in 2 out of 3 patients with cutaneous squamous cell carcinoma (cSCC) in the third dose cohort [1][2][3] - The trial aims to evaluate the safety and tolerability of PH-762 as a neoadjuvant treatment for various stages of cSCC, melanoma, and Merkel cell carcinoma [2][7] - The ongoing trial has treated a total of 10 patients, with 4 achieving complete pathologic response and others showing varying degrees of tumor clearance [3][4] Company Overview - Phio Pharmaceuticals is a clinical-stage siRNA biopharmaceutical company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology [1][6] - The lead clinical program, PH-762, targets the PD-1 gene to enhance immune response against cancer cells [6] - The company plans to present trial results at the Society for Investigative Dermatology Annual Meeting on May 10, 2025 [6] Clinical Trial Details - The trial has not reported any dose-limiting toxicities or significant adverse effects, indicating a favorable safety profile for PH-762 [4][5] - The fourth cohort of the trial is currently enrolling patients, with expectations to complete enrollment by the third quarter of 2025 [4] - The positive pathologic responses observed in the trial support the potential of PH-762 as a non-surgical treatment option for skin cancers [2][5]
Best Value Stocks to Buy for April 23rd
ZACKS· 2025-04-23 11:46
Group 1: Phio Pharmaceuticals Corp. - Phio Pharmaceuticals Corp. is an immuno-oncology biotech company with a Zacks Rank 1 [1] - The Zacks Consensus Estimate for its current year earnings has increased by 14.4% over the last 60 days [1] - The company has a price-to-earnings ratio (P/E) of 0.66, significantly lower than the industry average of 7.20 [2] Group 2: Transportadora de Gas del Sur S.A. - Transportadora de Gas del Sur S.A. is a midstream energy company with a Zacks Rank 1 [2] - The Zacks Consensus Estimate for its current year earnings has increased by 4.6% over the last 60 days [2] - The company has a price-to-earnings ratio (P/E) of 19.11, which is comparable to the S&P average of 19.13 [3]