Welcome to our dedicated page for Phio Pharmaceuticals news (Ticker: PHIO), a resource for investors and traders seeking the latest updates and insights on Phio Pharmaceuticals stock.
About Phio Pharmaceuticals Corp
Phio Pharmaceuticals Corp (NASDAQ: PHIO) is a clinical-stage biotechnology company that is reshaping the landscape of cancer treatment through its proprietary INTASYL siRNA gene silencing technology. As a company focused on immuno-oncology therapeutics, Phio is dedicated to improving the ability of the body’s immune cells to target and eliminate tumor cells. Backed by rigorous scientific research and collaborative partnerships with leading research institutions, the company is committed to advancing next-generation treatments that address the immune suppression often induced by tumors.
Core Technology and Therapeutic Approach
The cornerstone of Phio Pharmaceuticals’ approach is its INTASYL platform, a unique self-delivering RNAi technology that bypasses the conventional need for specialized drug delivery systems. Unlike other RNAi therapies, INTASYL can target virtually any gene with high specificity, ensuring that immune cells are better equipped to kill cancer cells without impacting non-harmful cells. This innovative technology is specifically designed to silence genes responsible for tumor-induced immune suppression, thereby enhancing the efficacy of adoptive cell therapy as well as other immuno-oncology treatments.
Clinical-Stage Programs and Product Pipeline
Phio’s product development strategy centers on a portfolio of therapeutics that leverage INTASYL to selectively silence key checkpoint proteins. Its lead clinical program, PH-762, is an INTASYL compound aimed at silencing PD-1, a protein that inhibits the immune response by dampening T cell activity. This approach offers a potential non-surgical treatment option for various skin cancers such as cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. In addition, the company is developing other compounds, including ones that target TIGIT and PD-L1, to broaden its impact in the immuno-oncology space.
The ongoing Phase 1b clinical trials utilize an intratumoral injection strategy, which not only provides localized treatment but also enhances the immune system's ability to combat tumors systemically. The safety and efficacy profiles observed in early cohorts underscore the potential of Phio’s approach, with early clinical data emphasizing tumor clearance in patients while maintaining a manageable safety profile.
Scientific Collaborations and Research Excellence
Phio Pharmaceuticals collaborates with renowned institutions across the globe, including partnerships with collaborative research centers and academic institutions. These collaborations, with entities like Gustave Roussy, Medigene AG, and Helmholtz Zentrum, underscore the company’s commitment to scientific excellence and innovation. Working jointly with experts in immunology and oncology, Phio benefits from access to advanced research methodologies and clinical expertise, further solidifying its position as an innovator in the RNAi and immuno-oncology domains.
Market Position and Competitive Landscape
Operating within the competitive realm of biotechnology and cancer therapeutics, Phio Pharmaceuticals distinguishes itself by leveraging a novel technology platform that integrates precision medicine with the power of the immune system. The ability of the INTASYL platform to effectively silence genes without the need for extensive formulation upgrades positions the company uniquely amongst peers and potential collaborators. This technological edge is particularly significant in the context of adoptive cell therapy, where streamlined delivery and strong gene specificity are critical for success.
Technological Advantages of INTASYL
The INTASYL siRNA technology offers several key advantages:
- Self-Delivery: Eliminates the need for complex delivery vehicles, reducing development hurdles and potential complications.
- High Specificity: Capable of silencing target genes with a high degree of precision across a wide range of cell types, thereby mitigating off-target effects.
- Versatility: The platform’s ability to target virtually any gene affords tremendous flexibility in addressing various pathways associated with tumor immune suppression.
- Enhanced Immune Function: By targeting immunosuppressive proteins, Phio’s therapies aim to activate and bolster the body's natural defenses against cancer cells.
Understanding the Business Model
Phio Pharmaceuticals generates value by advancing its clinical-stage pipeline through strategic investments in research and development, clinical trials, and collaborations with academic and research centers. While the company is primarily in the research and development phase, its focus on breakthrough technologies and innovative therapeutic approaches forms the backbone of its long-term strategy. By maintaining a diversified pipeline that targets multiple immune regulatory pathways, Phio effectively manages scientific risk while paving the way for potential future therapies that address the multifaceted challenges of cancer treatment.
Commitment to Scientific Rigor and Transparency
In its quest to provide a thorough understanding of its technologies and clinical developments, Phio Pharmaceuticals embraces a transparent approach to research and data reporting. The company regularly presents data at industry conferences and in peer-reviewed journals, thereby contributing to the broader scientific community’s understanding of RNAi and immuno-oncology. This commitment to transparency not only enhances its credibility among investors and researchers but also underscores the company’s dedication to advancing scientific knowledge in a challenging and dynamic field.
Conclusion
Phio Pharmaceuticals Corp stands at the intersection of innovation and clinical research, leveraging a unique self-delivering RNAi technology to address the unmet needs in cancer therapy. Its comprehensive approach, which combines precision gene silencing with enhanced immune cell activity, positions it as a notable participant in the biotechnology arena. By continuously advancing its clinical programs and forging strategic collaborations, Phio demonstrates a firm commitment to improving patient outcomes through cutting-edge science and technology.
Phio Pharmaceuticals (NASDAQ: PHIO) announced two podium presentations at the 11th Annual Immunotherapy of Cancer Conference in Munich, Germany on April 3, 2025. The presentations focus on their lead INTASYL siRNA product candidates:
1. PH-762: An INTASYL siRNA compound targeting PD-1, currently in clinical trials (NCT 06014086) as a neoadjuvant intratumoral therapy for cutaneous malignancies. The therapy has shown promising preclinical efficacy and favorable tolerability.
2. PH-894: An INTASYL siRNA compound that selectively silences BRD4, enhancing NK cell activation and proliferation without off-target effects, aimed at improving adoptive cell therapy.
The presentations will be delivered by Melissa Maxwell, Phio's Director of Research and Program Management, in Plenary Sessions 3 and 11 on April 3rd and 5th, 2025, respectively.
Phio Pharmaceuticals (NASDAQ: PHIO) reported its 2024 financial results and provided updates on its PH-762 clinical trial progress. The company's Phase 1b trial for PH-762, treating cutaneous carcinomas through intratumoral injection, showed promising results with 2 complete responses and 1 partial response in the second cohort. The third cohort is fully enrolled, with study completion expected in Q3 2025.
Financial highlights include raising $9.2 million through offerings and $2.9 million from warrant exercises. The company reported cash position of $5.4 million as of December 31, 2024, with net loss decreasing to $7.2 million ($9.08 per share) from $10.8 million in 2023. Research and development expenses decreased by 42% to $2.7 million, while general and administrative expenses reduced by 14% to $3.7 million.
The company implemented cost rationalization measures, including relocating to a smaller facility and terminating its Clinical Co-Development Agreement with AgonOx. Phio's patent portfolio includes 77 issued patents, with 69 covering its INTASYL technology.
Phio Pharmaceuticals (NASDAQ: PHIO) presented interim results from its Phase 1b clinical study of PH-762 at the American Academy of Dermatology's Late-Breaking Research session. The study evaluates the safety and tolerability of intratumoral PH-762 in cutaneous carcinomas.
In the second dose cohort of four patients, two patients with cutaneous squamous cell carcinoma (cSCC) achieved complete response (100% pathological cure), one achieved partial response (90% pathological cure), and one showed stable disease. The study has completed required safety enrollment for its third dose cohort, with the fourth dose cohort screening planned for early April.
PH-762 utilizes INTASYL® siRNA gene silencing technology to enhance immune cells' effectiveness in killing cancer cells. The research focuses on cSCC, melanoma, and Merkel cell carcinoma, with stages 1 and 2 cSCC representing 77% of all new cSCC cases annually.
Phio Pharmaceuticals (NASDAQ: PHIO) has completed enrollment for the third safety cohort in its Phase 1b dose-escalation clinical trial of PH-762. The study (NCT 06014086) is evaluating the intratumoral administration of PH-762 as a neoadjuvant treatment for various skin cancers, including cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma.
The multi-center trial aims to assess safety, tolerability, and tumor response while determining the recommended dose for future studies. The company utilizes its proprietary INTASYL® siRNA gene silencing technology to enhance the effectiveness of immune cells in targeting cancer cells. Phio plans to begin screening for the fourth dose cohort in early April 2025.
Phio Pharmaceuticals (NASDAQ: PHIO) has announced its participation in the Renmark Financial Communications Virtual Non-Deal Roadshow Series. The event will feature CEO and Chairman Robert Bitterman presenting the company's proprietary INTASYL siRNA technology and ongoing clinical trial of PH-762 for skin cancer treatment.
The presentation and live Q&A session is scheduled for March 5, 2025, at 12:00 pm EST. The virtual event will be accessible to stakeholders, investors, and interested parties, with a replay available on the Renmark Financial Communications website.
Phio Pharmaceuticals (NASDAQ: PHIO), a clinical-stage biotechnology company developing INTASYL® siRNA gene silencing technology for cancer treatment, has appointed David H. Deming to its Board of Directors effective February 19, 2025. Deming will serve on the Board's Nominating Committee, bringing the total board membership to 6 directors, with 5 being independent.
Deming brings over 30 years of experience in investment banking and asset management, including 27 years at JP Morgan where he led the Health Group in investment banking for 12 years. He later joined Integrated Finance , where he developed the SmartNest 401(k) asset allocation product, which was subsequently acquired by Dimensional Fund Advisors in 2010.
Phio Pharmaceuticals (NASDAQ: PHIO) announced its participation in the Renmark Financial Communications Virtual Non-Deal Roadshow Series. The company's CEO and Chairman, Robert Bitterman, will present on February 4, 2025, at 2:00 pm EST, discussing their INTASYL siRNA technology and ongoing clinical trial of PH-762 for skin cancer treatment.
The presentation will include a live Q&A session, with a replay available on Renmark Financial Communications' website. Phio is a clinical-stage biotechnology company developing therapeutics using their INTASYL siRNA gene silencing technology, aimed at enhancing immune cells' effectiveness in fighting cancer cells.
Phio Pharmaceuticals (NASDAQ: PHIO), a clinical-stage biotechnology company, has announced its participation in the Renmark Financial Communications Virtual Non-Deal Roadshow Series scheduled for January 29, 2025, at 2:00 pm EST.
During the presentation, Robert Bitterman, CEO and Chairman of the Board, will showcase the company's proprietary INTASYL siRNA technology and provide updates on their ongoing clinical trial of PH-762 for treating skin cancers. The INTASYL technology is designed to enhance the effectiveness of immune cells in fighting cancer cells.
Stakeholders, investors, and interested parties are invited to attend this live virtual event. A replay will be available on the Renmark Financial Communications website. Participants are advised to use the latest version of Google Chrome for optimal connectivity.
Phio Pharmaceuticals (NASDAQ: PHIO) has closed a $1.83 million registered direct offering of 610,000 common shares at $3.00 per share, along with concurrent private placement warrants for 1,220,000 shares at $3.00 exercise price, expiring in 24 months. Since December 2024, the company has raised total gross proceeds of approximately $12.08 million, including $9.15 million from offerings and $2.9 million from warrant exercises.
The funds will support working capital and development costs for PH-762's Phase 1b clinical trial treating cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. Additionally, proceeds will advance development of PH-894, targeting BRD4 protein in solid tumors. H.C. Wainwright & Co. served as the exclusive placement agent for the offering.
Phio Pharmaceuticals (NASDAQ: PHIO) has announced a $1.83 million registered direct offering priced at-the-market under Nasdaq rules. The company will sell 610,000 shares of common stock at $3.00 per share. Additionally, in a concurrent private placement, Phio will issue unregistered warrants to purchase up to 1,220,000 shares of common stock at an exercise price of $3.00 per share, exercisable upon issuance and expiring in 24 months.
The offering, expected to close around January 17, 2025, is being exclusively placed by H.C. Wainwright & Co. The net proceeds will be used for working capital and general corporate purposes. The common stock shares are being offered under a shelf registration statement, while the warrants are being issued through a private placement under Section 4(a)(2) of the Securities Act.
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