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NervGen Announces Clinical Leadership Transition as NVG-291 Continues to Advance Toward Late-Stage Development and Regulatory Milestones

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NervGen Pharma (OTCQB: NGENF), a clinical-stage biotech company, announced the resignation of Chief Medical Officer Daniel Mikol, MD, Ph.D. Dr. Randall Kaye, recently appointed Chief Medical Advisor, will expand his role while the company searches for a new CMO.

The transition comes as NervGen advances its lead candidate NVG-291 following positive topline results in a Phase 1b/2a clinical trial for chronic cervical spinal cord injury. Dr. Mikol completed the chronic cohort study before his departure, and the company is now preparing for regulatory engagement as it moves toward late-stage development.

[ "Positive topline results achieved in Phase 1b/2a trial for NVG-291 in chronic cervical spinal cord injury", "Seamless leadership transition with Dr. Randall Kaye expanding his role as Chief Medical Advisor", "Successfully completed chronic cohort study before CMO transition" ]

NervGen Pharma (OTCQB: NGENF), una società biotecnologica in fase clinica, ha annunciato le dimissioni del Chief Medical Officer Daniel Mikol, MD, Ph.D. Il dottor Randall Kaye, recentemente nominato Chief Medical Advisor, amplierà il suo ruolo mentre l'azienda cerca un nuovo CMO.

La transizione avviene mentre NervGen porta avanti il suo candidato principale NVG-291 dopo i risultati positivi ottenuti in uno studio clinico di fase 1b/2a per lesioni croniche del midollo cervicale. Il dottor Mikol ha completato lo studio sul gruppo cronico prima della sua partenza e l’azienda si sta ora preparando per l’interazione con le autorità regolatorie in vista dello sviluppo in fase avanzata.

NervGen Pharma (OTCQB: NGENF), una empresa biotecnológica en etapa clínica, anunció la renuncia del Director Médico Daniel Mikol, MD, Ph.D. El Dr. Randall Kaye, recientemente nombrado Asesor Médico Principal, ampliará su rol mientras la compañía busca un nuevo CMO.

La transición se produce mientras NervGen avanza con su candidato principal NVG-291 tras resultados positivos preliminares en un ensayo clínico de fase 1b/2a para lesión crónica de la médula cervical. El Dr. Mikol completó el estudio de cohorte crónica antes de su salida y la empresa se está preparando para el compromiso regulatorio mientras avanza hacia el desarrollo en etapas avanzadas.

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ì´ë²ˆ ì „í™˜ì€ NervGenì� 만성 경추 척수 ì†ìƒì—� 대í•� 1b/2aìƒ� ìž„ìƒì‹œí—˜ì—서 ê¸ì •ì ì¸ 예비 ê²°ê³¼ë¥� 바탕으로 주력 후보물질 NVG-291ì� 개발ì� 진전시키ê³� 있는 ê°€ìš´ë° ì´ë£¨ì–´ì¡ŒìŠµë‹ˆë‹�. Mikol 박사ëŠ� 떠나ê¸� ì „ì— ë§Œì„± 코호íŠ� 연구ë¥� 완료했으ë©�, 회사ëŠ� 후기 개발 단계ë¡� 나아가ê¸� 위해 규제 ë‹¹êµ­ê³¼ì˜ í˜‘ì˜ë¥� 준ë¹� 중입니다.

NervGen Pharma (OTCQB : NGENF), une entreprise biotechnologique en phase clinique, a annoncé la démission de son directeur médical, le Dr Daniel Mikol, MD, Ph.D. Le Dr Randall Kaye, récemment nommé conseiller médical principal, étendra son rôle pendant que la société recherche un nouveau directeur médical.

Cette transition intervient alors que NervGen fait progresser son principal candidat NVG-291 suite à des résultats positifs préliminaires lors d’un essai clinique de phase 1b/2a sur les lésions chroniques de la moelle épinière cervicale. Le Dr Mikol a achevé l’étude de cohorte chronique avant son départ, et la société se prépare désormais à engager des discussions réglementaires en vue du développement en phase avancée.

NervGen Pharma (OTCQB: NGENF), ein biotechnologisches Unternehmen in der klinischen Entwicklungsphase, gab den Rücktritt des Chief Medical Officer Daniel Mikol, MD, Ph.D., bekannt. Dr. Randall Kaye, kürzlich zum Chief Medical Advisor ernannt, wird seine Rolle erweitern, während das Unternehmen nach einem neuen CMO sucht.

Der Übergang erfolgt, während NervGen seinen führenden Kandidaten NVG-291 nach positiven Zwischenergebnissen in einer Phase-1b/2a-Studie zur chronischen zervikalen Rückenmarksverletzung weiterentwickelt. Dr. Mikol hat die Studie der chronischen Kohorte vor seinem Ausscheiden abgeschlossen, und das Unternehmen bereitet sich nun auf die behördliche Abstimmung vor, um in die späte Entwicklungsphase einzutreten.

Positive
  • None.
Negative
  • Loss of Chief Medical Officer during critical development phase
  • Need to search for new CMO could potentially impact development timeline

Vancouver, British Columbia--(Newsfile Corp. - July 1, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing neuroreparative therapeutics, today announced that Daniel Mikol, MD, Ph.D., has resigned from his position as Chief Medical Officer in order to pursue new opportunities. Randall Kaye, MD, who was , will increase the scope of his role as the company initiates a search for Dr. Mikol's replacement.

"We thank Dan for progressing NVG-291 through the chronic cohort of our Phase 1b/2a clinical trial," said Mike Kelly, NervGen's President & CEO. "We are also grateful for the support of Randall, an industry veteran, as we complete the full data analysis of the chronic cohort and prepare for regulatory engagement."

"It has been a pleasure to complete a successful study in chronic cervical spinal cord injury," said Dr. Mikol. "The positive topline results represent exciting progress and new hope for individuals living with spinal cord injury. NervGen is well poised to continue advancing this important program for the spinal cord injury community."

NervGen is initiating a search for a new chief medical officer to lead NVG-291 and other potential future programs through clinical development toward regulatory approval.

About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting nervous system repair. NVG-291's technology is licensed from Case Western Reserve University and is based on academic studies that demonstrated the preclinical efficacy of NVG-291-R, the rodent prototype of NVG-291, in animal models of spinal cord injury. These studies implicated several potential molecular and cellular mechanisms by which NVG-291-R promotes neurorepair and functional improvement in both central and peripheral nervous system injury models. The implicated mechanisms include the promotion of neuronal sprouting, or plasticity, remyelination, and promotion of a non-inflammatory phenotype in the microglial cells. NervGen has received Fast Track designation from the FDA for NVG-291 in individuals with spinal cord injury.

About NervGen
NervGen (TSXV: NGEN) (OTCQB: NGENF) is a clinical-stage biotech company dedicated to developing innovative treatments to promote nervous system repair in settings of neurotrauma and neurologic disease. The company is testing the clinical efficacy of its lead candidate, NVG-291, in a Phase 1b/2a clinical trial in spinal cord injury. (1-10 years post-injury) of this trial showed that NVG-291 met its primary endpoint and demonstrated promising changes in a secondary endpoint assessing hand function. Enrollment in the subacute cohort (20-90 days post-injury) of the trial continues, and more information about participation in the subacute study is available at . In addition, the company has initiated preclinical test of concept evaluation of its pipeline candidate, NVG-300, in models of ischemic stroke and spinal cord injury. For more information about NervGen, visit and follow NervGen on and for the latest news on the company.

Contacts

Huitt Tracey, Investor Relations
[email protected]
604.537.2094

Bill Adams, Chief Financial Officer
[email protected]
778.731.1711

Christy Curran
Sam Brown Healthcare Communications
[email protected]
615.414.8668
646.942.5604

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward-Looking Statements
This news release may contain "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian and United States securities legislation (collectively, "forward-looking statements"). Such forward-looking statements herein include but are not limited to, the Company's current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words "may", "will", "would", "should", "could", "expect", "plan", "intend", "trend", "indication", "anticipate", "believe", "estimate", "predict", "likely" or "potential", or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the expected support for the company from the expanded role of our Chief Medical Advisor in the interim period prior to completing the search for a successor chief medical officer; our anticipated regulatory interactions; the objectives, planned clinical endpoints, timing, expected rate of enrollment, and timing of data readout and study design of our Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury; the future development plans and benefits of NVG-291; the development plans and prospective target indications for NVG-300 and other future programs; and the creation of neuroreparative therapeutics to promote nervous system repair in settings of neurotrauma and neurologic disease.

Forward-looking statements are based on estimates and assumptions made by the company in light of management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, we have relied on various assumptions, including, but not limited to: our ability to obtain future funding on favourable terms or at all; the accuracy of our financial projections; obtaining positive results in our clinical and other trials; our ability to obtain necessary regulatory approvals; our ability to arrange for the manufacturing of our product candidates and technologies; and general business, market and economic conditions.

Many factors could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the "Risk Factors" section of the company's most recently filed prospectus supplement, short form base shelf prospectus, annual information form, financial statements and management discussion and analysis all of which can be found on NervGen's profile on SEDAR+ at . All clinical development plans are subject to additional funding.

Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and we have no intention and undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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FAQ

Why did NervGen Pharma's (NGENF) Chief Medical Officer resign?

According to the announcement, Dr. Daniel Mikol resigned from his position as Chief Medical Officer to pursue new opportunities.

Who will lead NervGen's medical operations after Dr. Mikol's departure?

Dr. Randall Kaye, the recently appointed Chief Medical Advisor, will increase the scope of his role while the company searches for a new Chief Medical Officer.

What are the latest clinical developments for NervGen's NVG-291?

NervGen reported positive topline results from the chronic cohort of their Phase 1b/2a clinical trial in chronic cervical spinal cord injury.

What is the current development stage of NervGen's NVG-291?

NVG-291 has completed the chronic cohort of its Phase 1b/2a clinical trial and is advancing toward late-stage development and regulatory milestones.

What are NervGen's next steps following the CMO transition?

NervGen is initiating a search for a new chief medical officer while completing the full data analysis of the chronic cohort and preparing for regulatory engagement.
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