{"success":true,"data":{"pressRelease":{"id":"71810","rtpr_id":"nNFC3ktmK9","ticker":"PHIO","exchange":"NASDAQ","all_tickers":["PHIO"],"title":"Phio Pharmaceuticals Reaches Key Milestone in Advancing Lead Candidate PH-762","author":"Newsfile Corp","published_at":"2026-06-24T11:00:14.225Z","article_body":"Nitto Denko Avecia begins first commercial-scale cGMP production of PH-762\ndrug substance\n\nNewly manufactured supply will support upcoming clinical trial in next\ndevelopment phase\n\nKing of Prussia, Pennsylvania--(Newsfile Corp. - June 24, 2026) - Phio\nPharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical\ncompany focused on developing therapeutics using its proprietary INTASYL(®)\ngene silencing technology to eliminate cancer, today announced that the\nmanufacture of the first commercial-scale cGMP batch of PH-762 drug substance\nhas commenced at Nitto Denko Avecia, Inc.\n\nPhio entered into a comprehensive drug substance services agreement with Nitto\nDenko Avecia, Inc. in June 2025. Under the agreement to date, Avecia has\nsuccessfully concluded a series of important preliminary activities that\ninvolve analytical and process development, method validation, cGMP\nmanufacturing, and testing services for Phio's lead clinical development\ncompound, PH-762.\n\nThis commercial-scale production of PH-762 drug substance is an important step\nin progressing Phio's intratumoral program as it moves into its next phase of\ndevelopment. The Company has recently completed its Phase 1b dose-escalation\nstudy of PH-762 in the treatment of cutaneous carcinomas.\n\n\"We appreciate our partnership with Nitto Denko Avecia, an organization\nrecognized for its quality and expertise in oligonucleotide chemistry and\nsequencing,\" said Robert Bitterman, President and Chief Executive Officer of\nPhio Pharmaceuticals. \"The production of our first commercial scale cGMP batch\nof PH-762 drug substance underscores meaningful progress toward the next stage\nof development of our lead clinical compound.\"\n\nAbout Phio Pharmaceuticals Corp.\n\nPhio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA\nbiopharmaceutical company advancing its INTASYL(®) gene silencing technology\nfocused on immuno-oncology therapeutics. Phio's INTASYL(®) compounds are\ndesigned to enhance the body's immune cells to more effectively kill cancer\ncells. Phio's lead clinical program is an INTASYL(®) compound, PH-762, that\nsilences the PD-1 gene implicated in various forms of skin cancer. The\nrecently completed Phase 1b trial (NCT# 06014086) evaluated PH-762 for the\nneoadjuvant treatment of cutaneous squamous cell carcinoma, melanoma, and\nMerkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin\ncancers.\n\nFor additional information, visit the Company's website, www.phiopharma.com.\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995. Forward-looking\nstatements can be identified by words such as \"intends,\" \"believes,\"\n\"anticipates,\" \"indicates,\" \"plans,\" \"expects,\" \"suggests,\" \"may,\" \"would,\"\n\"should,\" \"potential,\" \"designed to,\" \"will,\" \"ongoing,\" \"estimate,\"\n\"forecast,\" \"target,\" \"predict,\" \"could\" and similar references, although not\nall forward-looking statements contain these words. These statements, which\ninclude statements, among other things, regarding the anticipated benefits of\nour INTASYL™ RNAi platform, our belief that PH-762 is a potential\nnon-surgical treatment for skin cancers, our belief that our first commercial\nscale cGMP batch of PH-762 drug substance underscores meaningful progress\ntoward the next stage of development of PH-762, the results from our ongoing\nclinical trials, our expectations that our cash runway will extend into the\nfirst half of 2027, our expectations regarding timing of FDA submissions\nintended to propose and seek guidance for next steps in clinical study design\nfor PH-762, our expectations that such FDA submissions and any related FDA\nmeetings will clarify next steps in advancing the PH-762 development program,\ndetails regarding our planned non-clinical toxicology study, and our ability\nto support ongoing clinical development, operational requirements and\nstrategic initiatives with the capital we currently have on hand, are based\nonly on our current beliefs, expectations and assumptions and are subject to\ninherent uncertainties, risks and changes in circumstances that are difficult\nto predict and many of which are outside of our control. Our actual results\nmay differ materially from those indicated in the forward-looking statements\nas a result of a number of important factors, including, but not limited to,\nthe impact of future FDA interactions on the development of our product\ncandidates; the impact to our business and operations by inflationary\npressures; recession fears; the development of our product candidates, results\nfrom our nonclinical, preclinical and clinical activities, our ability to\nexecute on business strategies, our ability to develop our product candidates\nwith collaboration partners, and the success of any such collaborations, the\ntimeline and duration for advancing our product candidates into clinical\ndevelopment, the timing or likelihood of regulatory filings and approvals, the\nsuccess of our efforts to commercialize our product candidates if approved,\nour ability to manufacture and supply our product candidates for clinical\nactivities, and for commercial use if approved, the scope of protection we are\nable to establish and maintain for intellectual property rights covering our\ntechnology platform, our ability to obtain future financing, market and other\nconditions and those risks identified in our most recent Annual Report on Form\n10-K and subsequent Quarterly Reports on Form 10-Q under the caption \"Risk\nFactors\" and in other filings the Company periodically makes with the U.S.\nSecurities and Exchange Commission. Readers are urged to review these risk\nfactors and to not act in reliance on any forward-looking statements, as\nactual results may differ from those contemplated by our forward-looking\nstatements. Phio does not undertake to update forward-looking statements to\nreflect a change in its views, events or circumstances that occur after the\ndate of this release, except as required by law.\n\nContact:\nPhio Pharmaceuticals Corp. \nJennifer Phillips: jphillips@phiopharma.com  \nCorporate Affairs  \n\n\nTo view the source version of this press release, please visit\nhttps://www.newsfilecorp.com/release/302605","article_body_html":"","raw_payload":{"data":{"id":"nNFC3ktmK9","title":"Phio Pharmaceuticals Reaches Key Milestone in Advancing Lead Candidate PH-762","author":"Newsfile Corp","ticker":"PHIO","created":"2026-06-24T11:00:14.225Z","tickers":["PHIO"],"exchange":"NASDAQ","article_body":"Nitto Denko Avecia begins first commercial-scale cGMP production of PH-762\ndrug substance\n\nNewly manufactured supply will support upcoming clinical trial in next\ndevelopment phase\n\nKing of Prussia, Pennsylvania--(Newsfile Corp. - June 24, 2026) - Phio\nPharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical\ncompany focused on developing therapeutics using its proprietary INTASYL(®)\ngene silencing technology to eliminate cancer, today announced that the\nmanufacture of the first commercial-scale cGMP batch of PH-762 drug substance\nhas commenced at Nitto Denko Avecia, Inc.\n\nPhio entered into a comprehensive drug substance services agreement with Nitto\nDenko Avecia, Inc. in June 2025. Under the agreement to date, Avecia has\nsuccessfully concluded a series of important preliminary activities that\ninvolve analytical and process development, method validation, cGMP\nmanufacturing, and testing services for Phio's lead clinical development\ncompound, PH-762.\n\nThis commercial-scale production of PH-762 drug substance is an important step\nin progressing Phio's intratumoral program as it moves into its next phase of\ndevelopment. The Company has recently completed its Phase 1b dose-escalation\nstudy of PH-762 in the treatment of cutaneous carcinomas.\n\n\"We appreciate our partnership with Nitto Denko Avecia, an organization\nrecognized for its quality and expertise in oligonucleotide chemistry and\nsequencing,\" said Robert Bitterman, President and Chief Executive Officer of\nPhio Pharmaceuticals. \"The production of our first commercial scale cGMP batch\nof PH-762 drug substance underscores meaningful progress toward the next stage\nof development of our lead clinical compound.\"\n\nAbout Phio Pharmaceuticals Corp.\n\nPhio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA\nbiopharmaceutical company advancing its INTASYL(®) gene silencing technology\nfocused on immuno-oncology therapeutics. Phio's INTASYL(®) compounds are\ndesigned to enhance the body's immune cells to more effectively kill cancer\ncells. Phio's lead clinical program is an INTASYL(®) compound, PH-762, that\nsilences the PD-1 gene implicated in various forms of skin cancer. The\nrecently completed Phase 1b trial (NCT# 06014086) evaluated PH-762 for the\nneoadjuvant treatment of cutaneous squamous cell carcinoma, melanoma, and\nMerkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin\ncancers.\n\nFor additional information, visit the Company's website, www.phiopharma.com.\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995. Forward-looking\nstatements can be identified by words such as \"intends,\" \"believes,\"\n\"anticipates,\" \"indicates,\" \"plans,\" \"expects,\" \"suggests,\" \"may,\" \"would,\"\n\"should,\" \"potential,\" \"designed to,\" \"will,\" \"ongoing,\" \"estimate,\"\n\"forecast,\" \"target,\" \"predict,\" \"could\" and similar references, although not\nall forward-looking statements contain these words. These statements, which\ninclude statements, among other things, regarding the anticipated benefits of\nour INTASYL™ RNAi platform, our belief that PH-762 is a potential\nnon-surgical treatment for skin cancers, our belief that our first commercial\nscale cGMP batch of PH-762 drug substance underscores meaningful progress\ntoward the next stage of development of PH-762, the results from our ongoing\nclinical trials, our expectations that our cash runway will extend into the\nfirst half of 2027, our expectations regarding timing of FDA submissions\nintended to propose and seek guidance for next steps in clinical study design\nfor PH-762, our expectations that such FDA submissions and any related FDA\nmeetings will clarify next steps in advancing the PH-762 development program,\ndetails regarding our planned non-clinical toxicology study, and our ability\nto support ongoing clinical development, operational requirements and\nstrategic initiatives with the capital we currently have on hand, are based\nonly on our current beliefs, expectations and assumptions and are subject to\ninherent uncertainties, risks and changes in circumstances that are difficult\nto predict and many of which are outside of our control. Our actual results\nmay differ materially from those indicated in the forward-looking statements\nas a result of a number of important factors, including, but not limited to,\nthe impact of future FDA interactions on the development of our product\ncandidates; the impact to our business and operations by inflationary\npressures; recession fears; the development of our product candidates, results\nfrom our nonclinical, preclinical and clinical activities, our ability to\nexecute on business strategies, our ability to develop our product candidates\nwith collaboration partners, and the success of any such collaborations, the\ntimeline and duration for advancing our product candidates into clinical\ndevelopment, the timing or likelihood of regulatory filings and approvals, the\nsuccess of our efforts to commercialize our product candidates if approved,\nour ability to manufacture and supply our product candidates for clinical\nactivities, and for commercial use if approved, the scope of protection we are\nable to establish and maintain for intellectual property rights covering our\ntechnology platform, our ability to obtain future financing, market and other\nconditions and those risks identified in our most recent Annual Report on Form\n10-K and subsequent Quarterly Reports on Form 10-Q under the caption \"Risk\nFactors\" and in other filings the Company periodically makes with the U.S.\nSecurities and Exchange Commission. Readers are urged to review these risk\nfactors and to not act in reliance on any forward-looking statements, as\nactual results may differ from those contemplated by our forward-looking\nstatements. Phio does not undertake to update forward-looking statements to\nreflect a change in its views, events or circumstances that occur after the\ndate of this release, except as required by law.\n\nContact:\nPhio Pharmaceuticals Corp. \nJennifer Phillips: jphillips@phiopharma.com  \nCorporate Affairs  \n\n\nTo view the source version of this press release, please visit\nhttps://www.newsfilecorp.com/release/302605"},"type":"article","timestamp":"2026-06-24T11:00:14.31439646Z","server_sent_at_ms":1782298814314},"received_at":"2026-06-24T11:00:14.401Z","source_url":"https://www.newsfilecorp.com/release/302605"},"analysis":{"id":"61187","press_release_id":"71810","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Cash runway guidance extends only into the first half of 2027"],"eventType":"operations_update","narrative":"Phio Pharmaceuticals initiated the first commercial-scale cGMP production of its lead candidate PH-762 with partner Nitto Denko Avecia.\n\nThe new drug substance supply is intended to support the upcoming clinical trial phase, following the completion of a Phase 1b dose-escalation study for cutaneous carcinomas.\n\nCEO Robert Bitterman noted that the production milestone underscores meaningful progress toward the next development stage of the company's intratumoral program.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Commercial-scale manufacturing of PH-762 begins, enabling next phase clinical development."},"keyFigures":{"customDimensions":{"cash_runway":"first half of 2027","phaseOfTrial":"Phase 1b"}},"quotedText":"The production of our first commercial scale cGMP batch of PH-762 drug substance underscores meaningful progress toward the next stage of development of our lead clinical compound.","namedEntities":{"people":[{"name":"Robert Bitterman","role":"President and Chief Executive Officer"}],"products":["PH-762","INTASYL"],"companies":[{"name":"Phio Pharmaceuticals Corp.","ticker":"PHIO"},{"name":"Nitto Denko Avecia, Inc.","relationship":"contract manufacturer"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"The commencement of commercial-scale cGMP manufacturing is a necessary de-risking milestone for advancing the lead candidate into the next clinical phase, signaling tangible operational progress."},"tickerRelevance":{"others":[],"primary":"PHIO"},"globalImportance":15,"audienceRelevance":12,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"operational_milestone","sectorWeight":"biotech"}},"event_type":"operations_update","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Phio Pharmaceuticals initiated the first commercial-scale cGMP production of its lead candidate PH-762 with partner Nitto Denko Avecia.\n\nThe new drug substance supply is intended to support the upcoming clinical trial phase, following the completion of a Phase 1b dose-escalation study for cutaneous carcinomas.\n\nCEO Robert Bitterman noted that the production milestone underscores meaningful progress toward the next development stage of the company's intratumoral program.","key_figures":{"customDimensions":{"cash_runway":"first half of 2027","phaseOfTrial":"Phase 1b"}},"named_entities":{"people":[{"name":"Robert Bitterman","role":"President and Chief Executive Officer"}],"products":["PH-762","INTASYL"],"companies":[{"name":"Phio Pharmaceuticals Corp.","ticker":"PHIO"},{"name":"Nitto Denko Avecia, Inc.","relationship":"contract manufacturer"}],"dollarAmounts":[]},"model_name":"qwen3_6_27b_awq","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-06-24T11:20:15.157Z","global_importance":15,"audience_relevance":12,"importance_components":{"tickerTier":"micro-cap","eventGravity":"operational_milestone","sectorWeight":"biotech"}},"durationMs":207964,"modelName":"george-droid-qwen-72b"}}