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GH Research Announces Appointment of Dr. Velichka “Villy” Valcheva to Chief Executive Officer

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GH Research PLC (Nasdaq: GHRS) has announced the promotion of Dr. Velichka "Villy" Valcheva to Chief Executive Officer, succeeding co-founder PD Dr. med. Theis Terwey. Dr. Valcheva, who joined the company in August 2023 and has served as Chief Medical Officer since February 2024, brings over 20 years of pharmaceutical and biotech industry leadership experience.

The company is currently screening patients for its phase 2b trial in treatment-resistant depression, with enrollment expected to complete in September 2024. Additionally, a phase 1 healthy volunteer study using GH Research's proprietary device is actively enrolling in the UK. These developments signify the company's progress in its mission to transform the treatment of psychiatric and neurological disorders.

GH Research PLC (Nasdaq: GHRS) ha annunciato la promozione della Dr.ssa Velichka "Villy" Valcheva a Director Generale, succedendo al co-fondatore PD Dr. med. Theis Terwey. La Dr.ssa Valcheva, che è entrata nell'azienda nell'agosto 2023 e ha ricoperto il ruolo di Chief Medical Officer da febbraio 2024, porta con sé oltre 20 anni di esperienza nella leadership nei settori farmaceutico e biotecnologico.

L'azienda sta attualmente selezionando pazienti per il suo trial di fase 2b sulla depressione resistente ai trattamenti, con un completamento dell'arruolamento previsto per settembre 2024. Inoltre, uno studio di fase 1 per volontari sani che utilizza il dispositivo proprietario di GH Research è attualmente in fase di arruolamento nel Regno Unito. Questi sviluppi segnano i progressi dell'azienda nella sua missione di trasformare il trattamento dei disturbi psichiatrici e neurologici.

GH Research PLC (Nasdaq: GHRS) ha anunciado la promoción de la Dra. Velichka "Villy" Valcheva a Directora Ejecutiva, sucediendo al cofundador PD Dr. med. Theis Terwey. La Dra. Valcheva, quien se unió a la compañía en agosto de 2023 y ha ejercido como Directora Médica desde febrero de 2024, aporta más de 20 años de experiencia en liderazgo en la industria farmacéutica y biotecnológica.

Actualmente, la empresa está seleccionando pacientes para su ensayo de fase 2b en depresión resistente al tratamiento, con la inscripción prevista para completarse en septiembre de 2024. Además, un estudio de fase 1 con voluntarios sanos que utiliza el dispositivo patentado de GH Research se encuentra en activa inscripción en el Reino Unido. Estos desarrollos significan el progreso de la empresa en su misión de transformar el tratamiento de los trastornos psiquiátricos y neurológicos.

GH Research PLC (Nasdaq: GHRS)는 Dr. Velichka "Villy" Valcheva를 CEO로 승진시켰으며, PD Dr. med. Theis Terwey의 후임입니다. Valcheva 박사는 2023년 8월에 회사에 합류했으며 2024년 2월부터 Chief Medical Officer로 재직해왔으며, 제약 및 생명공학 산업에서 20년 이상의 리더십 경험을 가지고 있습니다.

현재 회사는 치료 저항성 우울증에 대한 2b 단계 시험을 위한 환자를 선별하고 있으며, 등록은 2024년 9월에 완료될 것으로 예상됩니다. 또한, GH Research의 독점 장치를 사용한 1상 건강한 자원자 연구가 영국에서 활발히 등록되고 있습니다. 이러한 발전은 정신적 및 신경학적 질환 치료 방식의 혁신을 위한 회사의 진전을 나타냅니다.

GH Research PLC (Nasdaq: GHRS) a annoncé la promotion de Dr. Velichka "Villy" Valcheva au poste de Directrice Générale, succédant au cofondateur PD Dr. med. Theis Terwey. Dr. Valcheva, qui a rejoint l'entreprise en août 2023 et a été Directrice Médicale depuis février 2024, possède plus de 20 ans d'expérience en leadership dans l'industrie pharmaceutique et biotechnologique.

Actuellement, l'entreprise est en train de séléctionner des patients pour son essai de phase 2b sur la dépression résistante au traitement, avec une inscription prévue pour être complétée en septembre 2024. De plus, une étude de phase 1 avec des volontaires sains utilisant le dispositif propriétaire de GH Research est en cours d'inscription au Royaume-Uni. Ces développements signifient les progrès de l'entreprise dans sa mission de transformer le traitement des troubles psychiatriques et neurologiques.

GH Research PLC (Nasdaq: GHRS) hat die Beförderung von Dr. Velichka "Villy" Valcheva zur Geschäftsführerin bekannt gegeben, die dem Mitgründer PD Dr. med. Theis Terwey nachfolgt. Dr. Valcheva, die im August 2023 dem Unternehmen beigetreten ist und seit Februar 2024 als Chief Medical Officer tätig ist, bringt über 20 Jahre Erfahrung in Führungspositionen der pharmazeutischen und biotechnologischen Industrie mit.

Das Unternehmen befindet sich derzeit in der Patientenrekrutierung für seine Phase-2b-Studie zu behandlungsresistenter Depression, wobei die Einschreibung voraussichtlich im September 2024 abgeschlossen sein wird. Darüber hinaus läuft eine Phase-1-Studie mit gesunden Freiwilligen, die ein proprietäres Gerät von GH Research verwendet und aktiv im Vereinigten Königreich rekrutiert. Diese Entwicklungen zeigen den Fortschritt des Unternehmens in seiner Mission, die Behandlung psychischer und neurologischer Störungen zu transformieren.

Positive
  • Appointment of experienced leader Dr. Valcheva as CEO
  • Phase 2b trial in treatment-resistant depression on track for enrollment completion in September 2024
  • Active enrollment in phase 1 healthy volunteer study using proprietary device
Negative
  • None.

DUBLIN, Ireland, Sept. 03, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today announced the promotion of Dr. Velichka “Villy” Valcheva, MD, MSc. to Chief Executive Officer of the Company. Dr. Valcheva succeeds PD Dr. med. Theis Terwey, co-founder of GH Research.

Dr. Valcheva has more than 20 years of experience in various leadership roles in the pharmaceutical and biotech industries. Dr. Valcheva joined the company in August 2023 and has served as the Company’s Chief Medical Officer since February 2024 having leadership responsibility, among other things, for the execution of the Company’s clinical development programs. She joined us from Albireo, where, in her position as VP and Head of Medical Affairs International, she played a pivotal role in the company’s late-stage development, scientific communication, regulatory approvals by the U.S. Food and Drug Administration and EMA as well as gaining market access in multiple markets of the rare disease medicine Bylvay. Dr. Valcheva holds a Masters in Pharmaceutical Medicine from Trinity College Dublin, Ireland as well as a Dr. Med. from University of Medicine – Plovdiv, Bulgaria.

Florian Schönharting, Chairman of the Board of Directors, GH Research, said: “We are very pleased to promote Dr. Valcheva to Chief Executive Officer. As Chief Medical Officer, she has proven her operating and execution skills, and she has the experience base and track record to lead GH Research through its next stage of development to achieve our goal of providing effective therapies for patients suffering from depression. I would also like to thank Theis for his dedication, passionate commitment and scientific rigor applied to our mission since we founded the Company together.”

Dr. Valcheva, Chief Executive Officer, GH Research, added: “Since joining GH Research last year, I have worked tirelessly to realize the potential of our product candidates to help patients with depression. As we’re screening the remaining patients for our phase 2b trial in treatment-resistant depression, we’re on track for completion of enrolment in September this year. Additionally, our phase 1 healthy volunteer study using our proprietary device is now actively enrolling in the UK. I’m excited to lead the company through the next phase of development. The foundation that Theis has laid will always be a part of GH Research.”

“Taking part in the founding of GH Research and leading it in its mission has been a great honor for me and I look forward to seeing the company continue to advance its cause,” said departing CEO, Dr. Terwey.

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC's initial focus is on developing its novel and proprietary mebufotenin (5-MeO-DMT) therapies for the treatment of patients with treatment-resistant depression (TRD).

GH Research PLC's annual report on Form 20-F filed with the U.S. Securities and Exchange Commission for the year ended December 31, 2023 is available at www.ghres.com and shareholders may receive a hard copy free of charge upon request.

Forward-Looking Statements

This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, medical devices required to deliver these product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals and their effects on our business strategy, including our plans and expectations related to addressing the clinical hold on the GH001 IND, research and development costs, cash runway, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Relations:
Julie Ryan
GH Research PLC
investors@ghres.com


FAQ

Who is the new CEO of GH Research (GHRS)?

Dr. Velichka "Villy" Valcheva has been appointed as the new Chief Executive Officer of GH Research PLC (Nasdaq: GHRS), succeeding co-founder PD Dr. med. Theis Terwey.

What is the status of GH Research's (GHRS) phase 2b trial in treatment-resistant depression?

GH Research (GHRS) is currently screening patients for its phase 2b trial in treatment-resistant depression, with enrollment expected to be completed in September 2024.

What ongoing clinical studies is GH Research (GHRS) conducting as of September 2024?

As of September 2024, GH Research (GHRS) is conducting a phase 2b trial in treatment-resistant depression and a phase 1 healthy volunteer study using their proprietary device, which is actively enrolling in the UK.

What is Dr. Valcheva's background before joining GH Research (GHRS)?

Before joining GH Research (GHRS), Dr. Valcheva worked at Albireo as VP and Head of Medical Affairs International, where she played a key role in late-stage development, regulatory approvals, and market access for the rare disease medicine Bylvay.

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