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[8-K] Phio Pharmaceuticals Corp. Reports Material Event

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K
Rhea-AI Filing Summary

Phio Pharmaceuticals (PHIO) filed a Form 8-K dated 25 July 2025 to report two press releases. First, the company executed a comprehensive drug-substance development services agreement with a U.S. manufacturer, securing production for future clinical material. Second, it disclosed that pathology results are now available for four of five patients in the fourth cohort of its ongoing Phase 1b dose-escalation study (NCT 06014086) assessing neoadjuvant INTASYL PH-762. No quantitative safety, efficacy or financial terms were provided; investors must consult Exhibits 99.1 and 99.2 for full details.

Phio Pharmaceuticals (PHIO) ha presentato un modulo 8-K datato 25 luglio 2025 per comunicare due comunicati stampa. In primo luogo, la società ha stipulato un accordo completo per lo sviluppo di sostanze farmaceutiche con un produttore statunitense, assicurando la produzione del materiale clinico futuro. In secondo luogo, ha reso noto che i risultati patologici sono ora disponibili per quattro dei cinque pazienti nel quarto gruppo del suo studio di fase 1b in corso con aumento di dose (NCT 06014086) che valuta il neoadiuvante INTASYL PH-762. Non sono stati forniti dati quantitativi su sicurezza, efficacia o termini finanziari; gli investitori devono consultare gli Allegati 99.1 e 99.2 per i dettagli completi.

Phio Pharmaceuticals (PHIO) presentó un Formulario 8-K fechado el 25 de julio de 2025 para informar sobre dos comunicados de prensa. Primero, la compañía firmó un acuerdo integral de servicios para el desarrollo de sustancias farmacéuticas con un fabricante estadounidense, asegurando la producción de material clínico futuro. Segundo, informó que los resultados patológicos ya están disponibles para cuatro de los cinco pacientes en la cuarta cohorte de su estudio en curso de fase 1b con escalada de dosis (NCT 06014086) que evalúa el neoadyuvante INTASYL PH-762. No se proporcionaron términos cuantitativos de seguridad, eficacia o financieros; los inversionistas deben consultar los Anexos 99.1 y 99.2 para más detalles.

Phio Pharmaceuticals (PHIO)ëŠ� 2025ë…� 7ì›� 25ì¼ìž 8-K ì–‘ì‹ì� 제출하여 ë‘� ê±´ì˜ ë³´ë„ìžë£Œë¥� 보고했습니다. 첫째, 회사ëŠ� 미국 제조업체와 í¬ê´„ì ì¸ 약물 물질 개발 서비ìŠ� 계약ì� 체결하여 향후 ìž„ìƒ ë¬¼ì§ˆ ìƒì‚°ì� 확보했습니다. 둘째, ì§„í–‰ ì¤‘ì¸ 1bìƒ� 용량 ì¦ëŸ‰ 연구(NCT 06014086)ì—서 ë„� 번째 ì½”í˜¸íŠ¸ì˜ ë‹¤ì„¯ ëª� í™˜ìž ì¤� ë„� ëª…ì— ëŒ€í•� 병리 결과가 ì´ì œ 제공 ê°€ëŠ�하다ê³� ë°í˜”습니ë‹�. 안전ì„�, 효능 ë˜ëŠ” 재무 ê´€ë � 정량ì � ì¡°ê±´ì€ ì œê³µë˜ì§€ 않았으며, 투ìžìžë“¤ì€ ì „ì²´ 세부사항ì� 위해 ë¶€ë¡� 99.1 ë°� 99.2ë¥� 참조해야 합니ë‹�.

Phio Pharmaceuticals (PHIO) a déposé un formulaire 8-K daté du 25 juillet 2025 pour annoncer deux communiqués de presse. Premièrement, la société a conclu un accord complet de services de développement de substances médicamenteuses avec un fabricant américain, garantissant la production de matériel clinique futur. Deuxièmement, elle a révélé que les résultats pathologiques sont désormais disponibles pour quatre des cinq patients de la quatrième cohorte de son étude de phase 1b en cours avec escalade de dose (NCT 06014086) évaluant l’INTASYL PH-762 en néoadjuvant. Aucun détail quantitatif sur la sécurité, l’efficacité ou les aspects financiers n’a été fourni ; les investisseurs doivent consulter les annexes 99.1 et 99.2 pour plus d’informations.

Phio Pharmaceuticals (PHIO) reichte am 25. Juli 2025 ein Formular 8-K ein, um zwei Pressemitteilungen zu melden. Erstens schloss das Unternehmen eine umfassende Vereinbarung über die Entwicklung von Arzneistoffen mit einem US-amerikanischen Hersteller ab und sicherte so die Produktion von zukünftigen klinischen Materialien. Zweitens gab es bekannt, dass Pathologieergebnisse nun für vier von fünf Patienten in der vierten Kohorte seiner laufenden Phase-1b-Dosissteigerungsstudie (NCT 06014086) zur Bewertung des neoadjuvanten INTASYL PH-762 vorliegen. Quantitative Angaben zu Sicherheit, Wirksamkeit oder finanziellen Bedingungen wurden nicht gemacht; Investoren sollten die Anhänge 99.1 und 99.2 für vollständige Details konsultieren.

Positive
  • Secures U.S. manufacturing partner via a drug-substance development services agreement, strengthening supply-chain readiness.
  • Phase 1b PH-762 trial advancing with pathology data now collected for the majority of fourth-cohort patients.
Negative
  • None.

Insights

TL;DR � Deal secures supply, trial advances; limited data, modest near-term impact.

The manufacturing services agreement reduces future CMC risk by lining up a domestic source of drug substance, a critical step as PH-762 progresses. Cohort-4 pathology read-outs confirm the Phase 1b study is moving forward, but without safety or efficacy metrics investors cannot assess therapeutic potential. Overall disclosure is constructive yet too thin to materially change valuation until data and economics are released.

TL;DR � Trial milestone noted, but no outcome metrics.

Reporting pathology availability for 4/5 patients signals the fourth dose level has completed surgery and sample analysis. However, the 8-K omits response, toxicity or pharmacodynamic results, limiting insight into benefit–risk. The filing is therefore informational rather than value-inflecting.

Phio Pharmaceuticals (PHIO) ha presentato un modulo 8-K datato 25 luglio 2025 per comunicare due comunicati stampa. In primo luogo, la società ha stipulato un accordo completo per lo sviluppo di sostanze farmaceutiche con un produttore statunitense, assicurando la produzione del materiale clinico futuro. In secondo luogo, ha reso noto che i risultati patologici sono ora disponibili per quattro dei cinque pazienti nel quarto gruppo del suo studio di fase 1b in corso con aumento di dose (NCT 06014086) che valuta il neoadiuvante INTASYL PH-762. Non sono stati forniti dati quantitativi su sicurezza, efficacia o termini finanziari; gli investitori devono consultare gli Allegati 99.1 e 99.2 per i dettagli completi.

Phio Pharmaceuticals (PHIO) presentó un Formulario 8-K fechado el 25 de julio de 2025 para informar sobre dos comunicados de prensa. Primero, la compañía firmó un acuerdo integral de servicios para el desarrollo de sustancias farmacéuticas con un fabricante estadounidense, asegurando la producción de material clínico futuro. Segundo, informó que los resultados patológicos ya están disponibles para cuatro de los cinco pacientes en la cuarta cohorte de su estudio en curso de fase 1b con escalada de dosis (NCT 06014086) que evalúa el neoadyuvante INTASYL PH-762. No se proporcionaron términos cuantitativos de seguridad, eficacia o financieros; los inversionistas deben consultar los Anexos 99.1 y 99.2 para más detalles.

Phio Pharmaceuticals (PHIO)ëŠ� 2025ë…� 7ì›� 25ì¼ìž 8-K ì–‘ì‹ì� 제출하여 ë‘� ê±´ì˜ ë³´ë„ìžë£Œë¥� 보고했습니다. 첫째, 회사ëŠ� 미국 제조업체와 í¬ê´„ì ì¸ 약물 물질 개발 서비ìŠ� 계약ì� 체결하여 향후 ìž„ìƒ ë¬¼ì§ˆ ìƒì‚°ì� 확보했습니다. 둘째, ì§„í–‰ ì¤‘ì¸ 1bìƒ� 용량 ì¦ëŸ‰ 연구(NCT 06014086)ì—서 ë„� 번째 ì½”í˜¸íŠ¸ì˜ ë‹¤ì„¯ ëª� í™˜ìž ì¤� ë„� ëª…ì— ëŒ€í•� 병리 결과가 ì´ì œ 제공 ê°€ëŠ�하다ê³� ë°í˜”습니ë‹�. 안전ì„�, 효능 ë˜ëŠ” 재무 ê´€ë � 정량ì � ì¡°ê±´ì€ ì œê³µë˜ì§€ 않았으며, 투ìžìžë“¤ì€ ì „ì²´ 세부사항ì� 위해 ë¶€ë¡� 99.1 ë°� 99.2ë¥� 참조해야 합니ë‹�.

Phio Pharmaceuticals (PHIO) a déposé un formulaire 8-K daté du 25 juillet 2025 pour annoncer deux communiqués de presse. Premièrement, la société a conclu un accord complet de services de développement de substances médicamenteuses avec un fabricant américain, garantissant la production de matériel clinique futur. Deuxièmement, elle a révélé que les résultats pathologiques sont désormais disponibles pour quatre des cinq patients de la quatrième cohorte de son étude de phase 1b en cours avec escalade de dose (NCT 06014086) évaluant l’INTASYL PH-762 en néoadjuvant. Aucun détail quantitatif sur la sécurité, l’efficacité ou les aspects financiers n’a été fourni ; les investisseurs doivent consulter les annexes 99.1 et 99.2 pour plus d’informations.

Phio Pharmaceuticals (PHIO) reichte am 25. Juli 2025 ein Formular 8-K ein, um zwei Pressemitteilungen zu melden. Erstens schloss das Unternehmen eine umfassende Vereinbarung über die Entwicklung von Arzneistoffen mit einem US-amerikanischen Hersteller ab und sicherte so die Produktion von zukünftigen klinischen Materialien. Zweitens gab es bekannt, dass Pathologieergebnisse nun für vier von fünf Patienten in der vierten Kohorte seiner laufenden Phase-1b-Dosissteigerungsstudie (NCT 06014086) zur Bewertung des neoadjuvanten INTASYL PH-762 vorliegen. Quantitative Angaben zu Sicherheit, Wirksamkeit oder finanziellen Bedingungen wurden nicht gemacht; Investoren sollten die Anhänge 99.1 und 99.2 für vollständige Details konsultieren.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): July 25, 2025

 

PHIO PHARMACEUTICALS CORP.

(Exact name of registrant as specified in its charter)

 

Delaware   001-36304   45-3215903

(State or other jurisdiction of incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification No.)

 

411 Swedeland Road, Suite 23-1080

 
King of Prussia, PA 19406
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (508) 767-3861

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class:   Trading Symbol(s):   Name of each exchange on which registered:
Common Stock, par value $0.0001 per share   PHIO   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

  

 

 

Item 8.01. Other Events.

 

On July 25, 2025, Phio Pharmaceuticals Corp. (“Phio”) issued press releases announcing (i) that it has entered into a comprehensive drug substance development services agreement with a U.S. manufacturing source for drug substance and (ii) pathology results for four of five patients in the fourth cohort in Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) designed to evaluate the safety and tolerability of neoadjuvant use of INTASYL PH-762.

 

The full text of the press releases are attached hereto as Exhibits 99.1 and 99.2 and incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Number   Description
99.1   Press Release, dated July 25, 2025
99.2   Press Release, dated July 25, 2025
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

 2 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Date: July 25, 2025 PHIO PHARMACEUTICALS CORP.
   
     
  By: /s/ Robert J. Bitterman
  Name:
Title:

Robert J. Bitterman

President & Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 3 

FAQ

What did Phio Pharmaceuticals disclose in its 25 July 2025 Form 8-K?

It announced a drug-substance development services agreement and pathology results from cohort 4 of its ongoing Phase 1b PH-762 trial.

Which clinical study is referenced in the 8-K for PHIO?

The Phase 1b dose-escalation trial NCT 06014086 evaluating neoadjuvant INTASYL PH-762.

Did the filing include safety or efficacy data for PH-762?

No; it only states that pathology results are available, with details in Exhibit 99.2.

What type of agreement did PHIO enter into?

A comprehensive drug-substance development services agreement with a U.S. manufacturing source.

Are financial terms of the manufacturing agreement disclosed?

No; the 8-K does not provide cost or volume details.
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