Tempest Further Strengthens Leadership Team with Appointment of Sheldon Mullins as Vice President, Regulatory Affairs
Tempest Therapeutics (Nasdaq: TPST) has appointed Sheldon Mullins as Vice President of Regulatory Affairs, strengthening its leadership team as it prepares for the pivotal study of amezalpat in first-line hepatocellular carcinoma (HCC). This appointment follows the recent addition of Troy Wagner as VP of Quality Assurance, both bringing late-stage development expertise to the company.
The company has also updated titles for Darrin Bomba and Henry Johnson to reflect their roles in late-stage development. CEO Stephen Brady emphasized the importance of expanding the team's global clinical capabilities as Tempest transitions to a late clinical company. Mullins brings over 25 years of regulatory affairs experience, spanning pre-IND to post-approval activities across various therapeutic areas.
Tempest Therapeutics (Nasdaq: TPST) ha nominato Sheldon Mullins come Vicepresidente delle Questioni Regolatorie, rafforzando il suo team di leadership mentre si prepara per lo studio cruciale di amezalpat nel carcinoma epatocellulare (HCC) in prima linea. Questa nomina segue l'aggiunta recente di Troy Wagner come VP di Assicurazione Qualità, entrambi portando esperienza nello sviluppo avanzato all'azienda.
L'azienda ha anche aggiornato i titoli di Darrin Bomba e Henry Johnson per riflettere i loro ruoli nello sviluppo avanzato. Il CEO Stephen Brady ha sottolineato l'importanza di ampliare le capacità cliniche globali del team mentre Tempest si sta trasformando in un'azienda clinica avanzata. Mullins porta con sé oltre 25 anni di esperienza nelle questioni regolatorie, coprendo attività che vanno dalla pre-IND alle approvazioni post-approvazione in vari ambiti terapeutici.
Tempest Therapeutics (Nasdaq: TPST) ha nombrado a Sheldon Mullins como Vicepresidente de Asuntos Regulatorios, fortaleciendo su equipo directivo mientras se prepara para el estudio pivotal de amezalpat en carcinoma hepatocelular (HCC) de primera línea. Este nombramiento sigue a la reciente incorporación de Troy Wagner como VP de Aseguramiento de Calidad, ambos aportando experiencia en el desarrollo avanzado a la empresa.
La empresa también ha actualizado los títulos de Darrin Bomba y Henry Johnson para reflejar sus roles en el desarrollo avanzado. El CEO Stephen Brady enfatizó la importancia de expandir las capacidades clínicas globales del equipo a medida que Tempest se convierte en una empresa clínica avanzada. Mullins aporta más de 25 años de experiencia en asuntos regulatorios, abarcando actividades desde pre-IND hasta actividades post-aprobación en diversas áreas terapéuticas.
템페스트 테라퓨틱스(나스닥: TPST)가 셜든 멀린스를 규제업무 부사장으로 임명하여, 1차 간세포암(HCC)에 대한 아메잘파트의 중대한 연구를 준비하며 리더십 팀을 강화했습니다. 이 임명은 트로이 웨그너가 품질 보증 부사장(VP)으로 최근에 합류한 것에 이어 이루어졌으며, 두 사람 모두 회사에 후기 개발 전문성을 제공합니다.
회사는 또한 다린 봄바와 헨리 존슨의 직함을 업데이트하여 그들의 후기 개발에서의 역할을 반영했습니다. CEO 스티븐 브래디는 템페스트가 후기 임상 회사로 전환하는 동안 팀의 글로벌 임상 능력을 확장하는 것의 중요성을 강조했습니다. 멀린스는 다양한 치료 분야에서 사전 IND부터 승인 후 활동까지 25년 이상의 규제업무 경험을 보유하고 있습니다.
Tempest Therapeutics (Nasdaq: TPST) a nommé Sheldon Mullins au poste de Vice-Président des Affaires Réglementaires, renforçant son équipe de direction alors qu’elle se prépare pour l'étude déterminante d'amézalpat dans le carcinome hépatocellulaire (CHC) en première ligne. Cette nomination fait suite à l'ajout récent de Troy Wagner en tant que VP de l’Assurance Qualité, apportant tous deux une expertise en développement avancé à l'entreprise.
L'entreprise a également mis à jour les titres de Darrin Bomba et Henry Johnson pour refléter leurs rôles dans le développement avancé. Le CEO Stephen Brady a souligné l'importance d'élargir les capacités cliniques mondiales de l'équipe alors que Tempest se transforme en une entreprise clinique avancée. Mullins apporte plus de 25 ans d'expérience en affaires réglementaires, couvrant des activités allant de la pré-IND aux activités post-approbation dans divers domaines thérapeutiques.
Tempest Therapeutics (Nasdaq: TPST) hat Sheldon Mullins zum Vizepräsidenten für Regulierungsangelegenheiten ernannt, um sein Führungsteam zu verstärken, während es sich auf die pivotal Studie zu amezalpat bei hepatozellulärem Karzinom (HCC) in der Erstlinientherapie vorbereitet. Diese Ernennung folgt auf die kürzliche Hinzufügung von Troy Wagner als VP für Qualitätssicherung, die beide Erfahrung in der späten Entwicklungsphase in das Unternehmen bringen.
Das Unternehmen hat auch die Titel von Darrin Bomba und Henry Johnson aktualisiert, um ihre Rollen in der späten Entwicklungsphase widerzuspiegeln. CEO Stephen Brady betonte die Bedeutung der Erweiterung der globalen klinischen Fähigkeiten des Teams, während Tempest sich zu einem Unternehmen in der späten klinischen Phase entwickelt. Mullins bringt über 25 Jahre Erfahrung in Regulierungsangelegenheiten mit, die von der prä-IND bis zu nach der Genehmigung reichen und verschiedene Therapiegebiete abdecken.
- Appointment of experienced Sheldon Mullins as VP of Regulatory Affairs
- Preparation for pivotal Phase 3 study of amezalpat in first-line HCC
- Recent addition of Troy Wagner as VP of Quality Assurance
- Strengthening of global clinical capabilities for late-stage development
- None.
Company welcomes additional late-stage expertise as it prepares for amezalpat pivotal study
BRISBANE, Calif., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced the appointment of Sheldon Mullins as Vice President, Regulatory Affairs. Mr. Mullins' presence on the team builds upon the recent addition of Troy Wagner as Vice President of Quality Assurance, who brought additional late-stage experience to the company. Additionally, in connection with the plan to advance amezalpat into a pivotal study in first-line HCC patients and to reflect their roles in late-stage development, the titles of Darrin Bomba and Henry Johnson have been changed to Vice President, Development Operations and Vice President, CMC & Medicinal Chemistry, respectively.
“The expansion of our leadership team with deeply experienced members strengthens our global clinical capabilities as we transition to a late clinical company,” said Stephen Brady, president and chief executive officer of Tempest. “Sheldon’s extensive experience in leading regulatory efforts for early- and late-stage drug candidates will be invaluable as we move into Phase 3 development of amezalpat to treat first-line hepatocellular carcinoma.”
Mr. Mullins added, “I am thrilled to join Tempest at such an exciting time as the team prepares to advance amezalpat into a pivotal study. Amezalpat has demonstrated very strong results in the treatment of first-line liver cancer, and I am eager to contribute to the team’s efforts to bring this potential life-saving therapy to patients.”
Sheldon Mullins
Mr. Mullins joined Tempest as vice president, regulatory affairs in September 2024, bringing over 25 years of regulatory affairs expertise ranging from pre-IND to licensing application submission and post-approval activities across several therapeutic areas. Prior to joining Tempest, he held regulatory leadership roles at Arrowhead Pharmaceuticals and Ardelyx, Inc., and prior to that, Mr. Mullins held regulatory affairs roles at multiple companies, including Anacor Pharmaceuticals, Onyx Pharmaceuticals, and Genentech. Mr. Mullins obtained a M.S.B.A., in Business Analysis from San Francisco State University and a B.A. in Chemistry from Sonoma State University.
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company’s novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer patients. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at www.tempesttx.com.
Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “could”, “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions. All statements that are not historical facts are forward-looking statements, including any statements regarding: the design, initiation, progress, timing, scope and results of clinical trials; anticipated therapeutic benefit and regulatory development of the Company’s product candidates; the Company’s anticipated cash runway; the Company’s ability to deliver on potential value-creating milestones; the Company’s ability to advance into a late-stage clinical company; and the Company’s ability to achieve its operational plans. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Any factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and other documents filed by the Company from time to time with the Securities and Exchange Commission. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.
Investor Contacts:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
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i If approved by the FDA
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