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 pioneering advancements in immuno-oncology through its proprietary INTASYL® siRNA gene silencing technology. Headquartered in Marlborough, Massachusetts, Phio is dedicated to enhancing the body's immune response to cancer by silencing specific genes that suppress immune cell activity. This innovative platform enables the precise targeting of tumor microenvironments, amplifying the effectiveness of immune cells without the need for complex drug delivery systems.
Core Technology: INTASYL® Platform
The INTASYL® platform is a groundbreaking self-delivering RNAi technology designed to silence gene expression with high specificity. Unlike traditional RNAi approaches, INTASYL does not require specialized formulations or delivery vehicles, streamlining its application in both intratumoral injections and adoptive cell therapy (ACT). This platform can target a wide range of genes, enhancing the cytotoxicity and proliferative capacity of immune cells such as T cells and natural killer (NK) cells.
Pipeline and Therapeutic Focus
- PH-762: A lead candidate targeting PD-1, a checkpoint protein that inhibits T-cell activity. PH-762 is being evaluated as a potential non-surgical treatment for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma in an ongoing Phase 1b clinical trial.
- PH-804: Targets TIGIT, a suppressive receptor on T cells and NK cells, to enhance immune activation and cytokine release.
- PH-790: Focuses on silencing PD-L1, a protein that shields tumor cells from immune attack.
These candidates represent a transformative approach to immuno-oncology by addressing immune checkpoint pathways, a critical mechanism in cancer progression.
Collaborations and Research Partnerships
Phio Pharmaceuticals collaborates with leading research institutions, including Gustave Roussy, Helmholtz Zentrum München, and Medigene AG. These partnerships bolster its scientific rigor and accelerate the development of its INTASYL-based therapeutics. Such alliances underscore the company's commitment to leveraging global expertise in advancing RNAi-based cancer therapies.
Competitive Edge
Phio Pharmaceuticals operates in a competitive biotechnology landscape but distinguishes itself through its self-delivering RNAi technology. INTASYL's unique ability to function without additional delivery mechanisms reduces complexity and enhances its therapeutic potential. This positions Phio as a frontrunner in RNAi-based immuno-oncology, targeting unmet needs in cancer treatment.
Market and Industry Context
As cancer immunotherapy continues to gain traction, Phio Pharmaceuticals is strategically positioned within the RNAi therapeutics sector, which is projected to grow significantly. By focusing on immune checkpoint modulation and adoptive cell therapy enhancement, Phio addresses critical gaps in current oncology treatments, offering promising solutions for hard-to-treat cancers.
History and Evolution
Founded in 2011 as RXi Pharmaceuticals Corporation, the company rebranded to Phio Pharmaceuticals Corp in 2018 to reflect its evolving focus on immuno-oncology. Over the years, Phio has built a robust intellectual property portfolio, reinforcing its leadership in RNAi innovation.
Conclusion
Phio Pharmaceuticals Corp is at the forefront of RNAi-based cancer immunotherapy, leveraging its INTASYL technology to redefine the treatment landscape. With a strong pipeline, strategic collaborations, and a focus on overcoming immune suppression, the company is well-positioned to make significant contributions to oncology research and patient care.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) has announced the closing of a registered direct offering of 353,983 shares of common stock at a price of $5.65 per share, generating approximately $2 million in gross proceeds. Concurrently, the company issued unregistered Series A and Series B warrants, each allowing the purchase of up to 353,983 shares with an exercise price of $5.40. The proceeds from this offering will be utilized for the development of immuno-oncology programs, working capital, and general corporate purposes. H.C. Wainwright & Co. acted as the exclusive placement agent. The company amended existing warrants to a uniform exercise price of $5.40 from previous higher prices, potentially signaling a strategic move to streamline capital activities.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announced a registered direct offering of 353,983 shares at $5.65 each, with expected gross proceeds of approximately $2 million. This offering will close around April 20, 2023, and includes unregistered Series A and B warrants for the same number of shares, each with an exercise price of $5.40. The funds will support the development of immuno-oncology programs and other corporate needs. H.C. Wainwright & Co. is the exclusive placement agent. The offering is part of a 'shelf' registration under the SEC regulations established in May 2021. Phio will also amend older warrants to reduce their exercise price to $5.40. This announcement may affect investor perceptions and the company's capital structure.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) presented promising preclinical data at the AACR Annual Meeting 2023, showcasing the efficacy of its dual-targeting INTASYL therapy targeting PD-1 and CTLA-4 in mouse models of colon cancer. This innovative approach demonstrated enhanced anti-tumor activity compared to single-target therapies while maintaining a favorable safety profile. Dr. Mary Spellman emphasized the potential of intratumoral administration to mitigate the high incidence of immune-related adverse events associated with systemic treatments. This breakthrough could represent a significant advancement in immuno-oncology, reflecting Phio's commitment to developing effective cancer therapies.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announced new findings from a preclinical study, revealing that its investigational drug mPH-762 induces anti-tumor responses through immune system activation. The study, showcased at the AACR Annual Meeting 2023, demonstrated that mPH-762, when administered intratumorally, generates systemic CD8 T cells that combat untreated tumors, indicating an 'abscopal effect'. Dr. Mary Spellman noted that these results support the clinical use of PH-762, which is currently in a phase 1b trial for advanced melanoma. Additionally, the approach may reduce adverse effects commonly associated with systemic PD-1 inhibition.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) has opened enrollment for the second cohort of its Phase 1b clinical study of PH-762 for advanced melanoma following a positive safety review by the Data Monitoring Committee (DMC). The FDA has confirmed the company can proceed with a planned Phase 1 clinical trial in advanced solid tumors in collaboration with AgonOx. Financially, Phio reported a decreased net loss of $11.5 million for 2022, down 14% from 2021, and a 21% reduction in R&D expenses to $7.0 million. As of December 31, 2022, the company had $11.8 million in cash, which is expected to support operations through Q4 2023.
Phio Pharmaceuticals (Nasdaq: PHIO) appointed Robert Bitterman as President and CEO, effective February 20, 2023. Bitterman has been serving as Interim CEO since September 2022 and will continue as Chair of the Board. The Board of Directors emphasized his strategic leadership and extensive experience as key factors for his appointment during this critical period for the company.
Bitterman stated his commitment to advancing Phio's clinical pipeline and achieving key milestones in 2023 and 2024. Phio specializes in immuno-oncology therapeutics, leveraging its proprietary INTASYL™ RNAi technology to enhance immune cell effectiveness against tumors.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announced on February 13, 2023, that it has regained compliance with Nasdaq's minimum bid price listing requirement. The company has satisfied the Nasdaq Listing Qualifications Panel by ensuring its stock price meets the minimum threshold of $1.00 per share, thereby fulfilling all criteria for continued listing. This marks a significant milestone for Phio as it continues to advance its proprietary INTASYL™ RNAi platform, which enhances the efficacy of immune cells against tumor cells. The matter regarding compliance is now considered closed by Nasdaq.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announced a positive recommendation from an independent Data Monitoring Committee following a review of safety data from its Phase 1b trial of PH-762, aimed at treating advanced melanoma. Conducted at the Gustave Roussy Institute in France, the trial showed no dose-limiting toxicity or severe adverse events, allowing for the continuation of patient enrollment. Phio plans to initiate a US Phase 1b trial targeting cutaneous squamous cell carcinoma in the latter half of 2023. The INTASYL™ RNAi platform aims to enhance immune cell effectiveness against tumor cells by inhibiting PD-1 expression.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) announced a 1-for-12 reverse stock split, effective January 26, 2023, to increase its share price above the minimum $1.00 bid for continued listing on The Nasdaq Capital Market. The outstanding shares will decrease from approximately 13.7 million to 1.1 million. The reverse split will be uniform for all shareholders, with no fractional shares issued—cash payments will be provided instead. This action aims to ensure compliance with Nasdaq's listing standards while maintaining shareholder percentage interests unchanged, barring fractional adjustments.
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