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[8-K] Ocuphire Pharma, Inc. Common Stock Reports Material Event

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8-K
Rhea-AI Filing Summary

On 22 Jul 2025 Opus Genetics (Nasdaq: IRD) executed a Funding & License Agreement with Eyes on the Future and RDH12 Fund for Sight to advance its RDH12 gene-therapy program for inherited retinal degeneration. The Funding Parties will supply up to $1.6 million in milestone-driven, non-dilutive capital that must be used under a mutually agreed development plan.

Opus must meet specific development milestones; failure to do so or other License Trigger Events would give the Funding Parties a non-exclusive, worldwide, royalty-free license to the program. Opus would gain reciprocal access to the generated data and may negotiate for exclusivity, but it cannot grant a third party an exclusive U.S. license during the term without Funding Party consent.

The agreement ends upon (i) dosing three patients in a Phase 1a/2b trial before a trigger event, or (ii) first commercial sale after regulatory approval, and includes standard termination for breach or bankruptcy. The deal is disclosed under Item 1.01; a related press release is furnished as Exhibit 99.1.

Il 22 luglio 2025 Opus Genetics (Nasdaq: IRD) ha stipulato un Accordo di Finanziamento e Licenza con Eyes on the Future e RDH12 Fund for Sight per sviluppare il suo programma di terapia genica RDH12 per la degenerazione retinica ereditaria. Le Parti Finanziatrici forniranno fino a 1,6 milioni di dollari in capitale non diluitivo basato su tappe di sviluppo concordate che dovranno essere utilizzate secondo un piano di sviluppo condiviso.

Opus dovrà raggiungere specifiche tappe di sviluppo; il mancato raggiungimento di queste o altri Eventi di Attivazione della Licenza concederebbero alle Parti Finanziatrici una licenza non esclusiva, mondiale e senza royalty sul programma. Opus avrà accesso reciproco ai dati generati e potrà negoziare l'esclusività, ma non potrà concedere a terzi una licenza esclusiva per gli Stati Uniti durante la durata dell'accordo senza il consenso delle Parti Finanziatrici.

L'accordo termina al verificarsi di (i) somministrazione a tre pazienti in uno studio di Fase 1a/2b prima di un evento di attivazione, o (ii) prima vendita commerciale dopo l'approvazione regolatoria, includendo clausole standard di risoluzione per inadempienza o fallimento. L'accordo è divulgato ai sensi dell'Articolo 1.01; un comunicato stampa correlato è fornito come Allegato 99.1.

El 22 de julio de 2025, Opus Genetics (Nasdaq: IRD) firmó un Acuerdo de Financiamiento y Licencia con Eyes on the Future y RDH12 Fund for Sight para avanzar en su programa de terapia génica RDH12 para la degeneración retiniana hereditaria. Las Partes Financiadoras proporcionarán hasta 1,6 millones de dólares en capital no dilutivo basado en hitos, que deberá utilizarse bajo un plan de desarrollo mutuamente acordado.

Opus debe cumplir con hitos específicos de desarrollo; el incumplimiento de estos o cualquier otro Evento de Activación de Licencia otorgaría a las Partes Financiadoras una licencia no exclusiva, mundial y libre de regalías sobre el programa. Opus tendrá acceso recíproco a los datos generados y podrá negociar exclusividad, pero no podrá conceder a terceros una licencia exclusiva en EE.UU. durante la vigencia sin el consentimiento de las Partes Financiadoras.

El acuerdo finaliza al (i) tratar a tres pacientes en un ensayo de Fase 1a/2b antes de un evento de activación, o (ii) primera venta comercial tras la aprobación regulatoria, e incluye terminación estándar por incumplimiento o quiebra. El acuerdo se divulga bajo el Punto 1.01; un comunicado de prensa relacionado se proporciona como Anexo 99.1.

2025년 7월 22일, Opus Genetics(Nasdaq: IRD)는 Eyes on the Future 및 RDH12 Fund for Sight와 유전성 망막 퇴행증 치료를 위한 RDH12 유전자 치료 프로그램을 진전시키기 위한 자금 지원 및 라이선스 계약을 체결했습니다. 자금 제공자들은 상호 합의된 개발 계획에 따라 사용되어야 하는 마일스톤 기반의 비희석성 자본 최대 160만 달러를 지원합니다.

Opus는 특정 개발 마일스톤을 달성해야 하며, 이를 달성하지 못하거나 기타 라이선스 발동 이벤트가 발생할 경우 자금 제공자들에게 해당 프로그램에 대한 비독점적, 전 세계적, 로열티 없는 라이선스가 부여됩니다. Opus는 생성된 데이터에 상호 접근할 수 있으며 독점권을 협상할 수 있으나, 자금 제공자의 동의 없이 계약 기간 동안 미국 내 독점 라이선스를 제3자에게 부여할 수 없습니다.

계약은 (i) 트리거 이벤트 발생 전 1a/2b상 시험에서 3명의 환자 투여 완료 시 또는 (ii) 규제 승인 후 최초 상업 판매 시 종료되며, 위반 또는 파산 시 표준 해지 조항이 포함되어 있습니다. 이 계약은 항목 1.01에 따라 공개되었으며, 관련 보도자료는 부록 99.1로 제공됩니다.

Le 22 juillet 2025, Opus Genetics (Nasdaq : IRD) a conclu un accord de financement et de licence avec Eyes on the Future et RDH12 Fund for Sight afin de faire progresser son programme de thérapie génique RDH12 pour la dégénérescence rétinienne héréditaire. Les parties financées fourniront jusqu'à 1,6 million de dollars de capital non dilutif basé sur des jalons, devant être utilisé selon un plan de développement convenu mutuellement.

Opus doit atteindre des jalons de développement spécifiques ; le non-respect de ceux-ci ou d’autres événements déclencheurs de licence donnerait aux parties financées une licence non exclusive, mondiale et sans redevance sur le programme. Opus aura un accès réciproque aux données générées et pourra négocier une exclusivité, mais ne pourra pas accorder à un tiers une licence exclusive aux États-Unis pendant la durée de l’accord sans le consentement des parties financées.

L’accord prend fin soit (i) après l’administration à trois patients dans un essai de phase 1a/2b avant un événement déclencheur, soit (ii) à la première vente commerciale après l’approbation réglementaire, et inclut des clauses standard de résiliation en cas de manquement ou de faillite. L’accord est divulgué conformément à l’Article 1.01 ; un communiqué de presse associé est fourni en Annexe 99.1.

Am 22. Juli 2025 schloss Opus Genetics (Nasdaq: IRD) eine Finanzierungs- und Lizenzvereinbarung mit Eyes on the Future und RDH12 Fund for Sight ab, um sein RDH12-Gentherapieprogramm für erbliche Netzhautdegeneration voranzutreiben. Die Finanzierungspartner stellen bis zu 1,6 Millionen US-Dollar an meilensteinabhängigem, nicht verwässerndem Kapital bereit, das gemäß einem gemeinsam vereinbarten Entwicklungsplan verwendet werden muss.

Opus muss bestimmte Entwicklungsmeilensteine erreichen; das Versäumnis oder andere Lizenz-Auslöseereignisse würden den Finanzierungspartnern eine nicht-exklusive, weltweite, lizenzgebührenfreie Lizenz an dem Programm gewähren. Opus erhält wechselseitigen Zugang zu den generierten Daten und kann Exklusivität verhandeln, darf jedoch ohne Zustimmung der Finanzierungspartner während der Laufzeit keine exklusive US-Lizenz an Dritte vergeben.

Die Vereinbarung endet entweder mit (i) der Behandlung von drei Patienten in einer Phase 1a/2b-Studie vor einem Auslöseereignis oder (ii) dem ersten kommerziellen Verkauf nach behördlicher Zulassung und enthält Standardkündigungsregelungen bei Vertragsbruch oder Insolvenz. Die Vereinbarung wird gemäß Punkt 1.01 offengelegt; eine dazugehörige Pressemitteilung ist als Anlage 99.1 beigefügt.

Positive
  • $1.6 M in non-dilutive funding strengthens cash position for early RDH12 development.
  • External stakeholders’ participation validates scientific approach and may attract further support.
Negative
  • Funding amount is relatively small and unlikely to cover later-stage clinical costs.
  • Failure to meet milestones could trigger a royalty-free license transfer, eroding future exclusivity and value.
  • Agreement restricts out-licensing in the U.S., limiting strategic and M&A flexibility.

Insights

TL;DR – $1.6 M non-dilutive cash aids pipeline, but milestone slippage risks loss of exclusivity.

The agreement provides modest yet helpful capital without share dilution, signalling external confidence in Opus’s RDH12 asset. However, the small amount will cover only early work; investors should focus on Opus’s ability to hit the milestone of dosing three patients in Phase 1a/2b. Missing that or other trigger events hands development rights to the funders, reducing Opus’s economic upside. Restrictions on out-licensing also limit strategic optionality. Overall impact is balanced: slight financial positive, offset by execution risk.

TL;DR – Conditional license clauses increase IP risk if diligence falters.

The royalty-free, global, non-exclusive license that activates upon a trigger event is unusually generous to the funders and could undermine Opus’s bargaining power with future partners. While Opus keeps a back-license and negotiation rights, any lapse in diligence could erode exclusivity and future revenue streams. The contractual bar on granting exclusive U.S. licenses without consent further narrows strategic flexibility. Investors should monitor compliance closely.

Il 22 luglio 2025 Opus Genetics (Nasdaq: IRD) ha stipulato un Accordo di Finanziamento e Licenza con Eyes on the Future e RDH12 Fund for Sight per sviluppare il suo programma di terapia genica RDH12 per la degenerazione retinica ereditaria. Le Parti Finanziatrici forniranno fino a 1,6 milioni di dollari in capitale non diluitivo basato su tappe di sviluppo concordate che dovranno essere utilizzate secondo un piano di sviluppo condiviso.

Opus dovrà raggiungere specifiche tappe di sviluppo; il mancato raggiungimento di queste o altri Eventi di Attivazione della Licenza concederebbero alle Parti Finanziatrici una licenza non esclusiva, mondiale e senza royalty sul programma. Opus avrà accesso reciproco ai dati generati e potrà negoziare l'esclusività, ma non potrà concedere a terzi una licenza esclusiva per gli Stati Uniti durante la durata dell'accordo senza il consenso delle Parti Finanziatrici.

L'accordo termina al verificarsi di (i) somministrazione a tre pazienti in uno studio di Fase 1a/2b prima di un evento di attivazione, o (ii) prima vendita commerciale dopo l'approvazione regolatoria, includendo clausole standard di risoluzione per inadempienza o fallimento. L'accordo è divulgato ai sensi dell'Articolo 1.01; un comunicato stampa correlato è fornito come Allegato 99.1.

El 22 de julio de 2025, Opus Genetics (Nasdaq: IRD) firmó un Acuerdo de Financiamiento y Licencia con Eyes on the Future y RDH12 Fund for Sight para avanzar en su programa de terapia génica RDH12 para la degeneración retiniana hereditaria. Las Partes Financiadoras proporcionarán hasta 1,6 millones de dólares en capital no dilutivo basado en hitos, que deberá utilizarse bajo un plan de desarrollo mutuamente acordado.

Opus debe cumplir con hitos específicos de desarrollo; el incumplimiento de estos o cualquier otro Evento de Activación de Licencia otorgaría a las Partes Financiadoras una licencia no exclusiva, mundial y libre de regalías sobre el programa. Opus tendrá acceso recíproco a los datos generados y podrá negociar exclusividad, pero no podrá conceder a terceros una licencia exclusiva en EE.UU. durante la vigencia sin el consentimiento de las Partes Financiadoras.

El acuerdo finaliza al (i) tratar a tres pacientes en un ensayo de Fase 1a/2b antes de un evento de activación, o (ii) primera venta comercial tras la aprobación regulatoria, e incluye terminación estándar por incumplimiento o quiebra. El acuerdo se divulga bajo el Punto 1.01; un comunicado de prensa relacionado se proporciona como Anexo 99.1.

2025년 7월 22일, Opus Genetics(Nasdaq: IRD)는 Eyes on the Future 및 RDH12 Fund for Sight와 유전성 망막 퇴행증 치료를 위한 RDH12 유전자 치료 프로그램을 진전시키기 위한 자금 지원 및 라이선스 계약을 체결했습니다. 자금 제공자들은 상호 합의된 개발 계획에 따라 사용되어야 하는 마일스톤 기반의 비희석성 자본 최대 160만 달러를 지원합니다.

Opus는 특정 개발 마일스톤을 달성해야 하며, 이를 달성하지 못하거나 기타 라이선스 발동 이벤트가 발생할 경우 자금 제공자들에게 해당 프로그램에 대한 비독점적, 전 세계적, 로열티 없는 라이선스가 부여됩니다. Opus는 생성된 데이터에 상호 접근할 수 있으며 독점권을 협상할 수 있으나, 자금 제공자의 동의 없이 계약 기간 동안 미국 내 독점 라이선스를 제3자에게 부여할 수 없습니다.

계약은 (i) 트리거 이벤트 발생 전 1a/2b상 시험에서 3명의 환자 투여 완료 시 또는 (ii) 규제 승인 후 최초 상업 판매 시 종료되며, 위반 또는 파산 시 표준 해지 조항이 포함되어 있습니다. 이 계약은 항목 1.01에 따라 공개되었으며, 관련 보도자료는 부록 99.1로 제공됩니다.

Le 22 juillet 2025, Opus Genetics (Nasdaq : IRD) a conclu un accord de financement et de licence avec Eyes on the Future et RDH12 Fund for Sight afin de faire progresser son programme de thérapie génique RDH12 pour la dégénérescence rétinienne héréditaire. Les parties financées fourniront jusqu'à 1,6 million de dollars de capital non dilutif basé sur des jalons, devant être utilisé selon un plan de développement convenu mutuellement.

Opus doit atteindre des jalons de développement spécifiques ; le non-respect de ceux-ci ou d’autres événements déclencheurs de licence donnerait aux parties financées une licence non exclusive, mondiale et sans redevance sur le programme. Opus aura un accès réciproque aux données générées et pourra négocier une exclusivité, mais ne pourra pas accorder à un tiers une licence exclusive aux États-Unis pendant la durée de l’accord sans le consentement des parties financées.

L’accord prend fin soit (i) après l’administration à trois patients dans un essai de phase 1a/2b avant un événement déclencheur, soit (ii) à la première vente commerciale après l’approbation réglementaire, et inclut des clauses standard de résiliation en cas de manquement ou de faillite. L’accord est divulgué conformément à l’Article 1.01 ; un communiqué de presse associé est fourni en Annexe 99.1.

Am 22. Juli 2025 schloss Opus Genetics (Nasdaq: IRD) eine Finanzierungs- und Lizenzvereinbarung mit Eyes on the Future und RDH12 Fund for Sight ab, um sein RDH12-Gentherapieprogramm für erbliche Netzhautdegeneration voranzutreiben. Die Finanzierungspartner stellen bis zu 1,6 Millionen US-Dollar an meilensteinabhängigem, nicht verwässerndem Kapital bereit, das gemäß einem gemeinsam vereinbarten Entwicklungsplan verwendet werden muss.

Opus muss bestimmte Entwicklungsmeilensteine erreichen; das Versäumnis oder andere Lizenz-Auslöseereignisse würden den Finanzierungspartnern eine nicht-exklusive, weltweite, lizenzgebührenfreie Lizenz an dem Programm gewähren. Opus erhält wechselseitigen Zugang zu den generierten Daten und kann Exklusivität verhandeln, darf jedoch ohne Zustimmung der Finanzierungspartner während der Laufzeit keine exklusive US-Lizenz an Dritte vergeben.

Die Vereinbarung endet entweder mit (i) der Behandlung von drei Patienten in einer Phase 1a/2b-Studie vor einem Auslöseereignis oder (ii) dem ersten kommerziellen Verkauf nach behördlicher Zulassung und enthält Standardkündigungsregelungen bei Vertragsbruch oder Insolvenz. Die Vereinbarung wird gemäß Punkt 1.01 offengelegt; eine dazugehörige Pressemitteilung ist als Anlage 99.1 beigefügt.


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 22, 2025

Opus Genetics, Inc.
(Exact name of registrant as specified in its charter)

Delaware
001-34079
11-3516358
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)

8 Davis Drive
Durham, NC

27713
(Address of principal executive offices)

(Zip Code)

(984) 884-6030
(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

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:

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, $0.0001 par value per share
IRD
The Nasdaq Stock Market LLC

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 1.01
Entry into a Material Definitive Agreement.
 
On July 22, 2025, Opus Genetics, Inc., together with its wholly owned subsidiary, OpusTX, LLC (collectively, the “Company”), entered into a funding and license agreement (the “Agreement”) with Eyes on the Future (“EOTF”), and RDH12 Fund for Sight (the “Fund,” and together with EOTF, the “Funding Parties”), relating to the Company’s program to develop gene therapies that treat patients with inherited retinal degeneration associated with mutations in the RDH12 gene (the “RDH12 Program”). The Agreement provides for funding by the Funding Parties of up to $1,600,000 to support the development of the RDH12 Program.  The Company is required to use the funding to conduct development activities in accordance with a mutually agreed development plan.
 
Under the Agreement, the Company is subject to certain diligence obligations to develop a product under the RDH12 Program.  If the Company is unable to achieve certain milestones by the specified dates or if certain other events occur (a “License Trigger Event”), then the Funding Parties may exercise their rights under a non-exclusive, global, royalty-free and fully paid-up license granted by the Company to the Funding Parties to develop products under the RDH12 Program.  If the Funding Parties exercise such license rights, then the Company will receive a non-exclusive license under the data and other intellectual property generated by the Funding Parties to develop products under the RDH12 Program, and the right to negotiate an exclusive license to such data and intellectual property to commercialize products under the RDH12 Program.  The Agreement includes certain restrictions on the Company’s ability to out-license rights to the RDH12 Program, and during the term of the Agreement the Company may not grant a third party an exclusive license to develop or commercialize products under the RDH12 Program in the United States without the prior written consent of the Funding Parties.
 
The term of the Agreement continues until the earlier of (a) dosing by the Company of three patients in a Phase 1a/2b clinical trial prior to a License Trigger Event, and (b) the first commercial sale of a product under the RDH12 Program following receipt of regulatory approval in the United States or certain other European countries.  The Agreement will also terminate if an exclusive, global licensee of the Company for the RDH12 Program assumes the Company’s obligations under the Agreement.  The Agreement may be terminated by either party for cause, including material breach or bankruptcy, subject to a cure period, or by the Funding Parties for convenience following a License Trigger Event.
 
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the text of the Agreement, which will be filed with the Company’s next Quarterly Report on Form 10-Q for the quarter ended September 30, 2025.
 
Item 7.01
Regulation FD Disclosure.
 
On July 23, 2025, the Company issued a press release announcing entry into the Agreement. A copy of the press release is furnished herewith as Exhibit 99.1.
 
The information in this Item 7.01 of this Current Report on Form 8-K, and Exhibit 99.1, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such a filing.
 
Item 9.01
Financial Statements and Exhibits.
 
(d)
Exhibits
 
Exhibit No.
Description
99.1
Press Release, dated July 23, 2025.
104.1
Cover Page Interactive Data File (embedded within Inline XBRL document).
 

SIGNATURE

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.

Dated: July 23, 2025
OPUS GENETICS, INC.
     
 
By:
/s/ Dr. George Magrath
 
Name:
Dr. George Magrath
 
Title:
Chief Executive Officer



FAQ

How much funding does Opus Genetics (IRD) receive under the RDH12 agreement?

Up to $1.6 million in milestone-based, non-dilutive financing.

What happens if Opus misses development milestones for RDH12?

The Funding Parties can invoke a non-exclusive, worldwide, royalty-free license to develop the program themselves.

Are there restrictions on Opus licensing RDH12 to other partners?

Yes. Opus cannot grant a third party an exclusive U.S. license during the agreement term without Funding Party consent.

When does the agreement with Eyes on the Future and RDH12 Fund for Sight terminate?

Upon dosing three patients in a Phase 1a/2b trial before a trigger event, first commercial sale post-approval, or standard breach/bankruptcy termination.

Is the information in the 8-K considered filed or furnished?

Item 1.01 is filed; Item 7.01 and Exhibit 99.1 are furnished and not deemed filed under Section 18 of the Exchange Act.
Ocuphire Pharma Inc

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