Nuvalent Appoints Grant Bogle to Board of Directors

Rhea-AI Summary

Nuvalent (NUVL) has appointed Grant Bogle to its Board of Directors, bringing nearly four decades of biotechnology leadership experience. Bogle's previous roles include CEO of Epizyme and Chief Commercial Officer at TESARO, both of which were successfully acquired by larger pharmaceutical companies.

The appointment comes as Nuvalent prepares for potential pivotal data readouts in 2025 from two parallel-lead programs: the ARROS-1 trial of zidesamtinib (ROS1-selective inhibitor) and the ALKOVE-1 trial of NVL-655 (ALK-selective inhibitor). The company anticipates its first pipeline approval in 2026 and plans to initiate the Phase 3 ALKAZAR trial in early 2025, comparing NVL-655 to ALECENSA for ALK-positive NSCLC treatment.

Positive

• Strategic board appointment with extensive commercialization experience
• Two potential pivotal data readouts expected in 2025
• First pipeline approval anticipated in 2026
• Advancing multiple clinical trials in parallel

Negative

• None.

CAMBRIDGE, Mass., Dec. 9, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Grant Bogle to its Board of Directors.

"Grant's demonstrated success in leading the growth and evolution of oncology biotechnology companies augments our Board as we work towards a potential first approval from our pipeline of novel kinase inhibitors in 2026," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We welcome his collaboration and insights in navigating the transition from development to commercialization as we prepare for anticipated pivotal data readouts from both of our parallel-lead programs in 2025 and we build the additional infrastructure needed to bring our therapies to patients with cancer, if approved."

Mr. Bogle brings nearly four decades of proven leadership in building and growing biotechnology companies to the Nuvalent Board. Throughout his career, he has served in senior leadership roles at several specialty pharmaceutical and biotechnology companies and worked alongside oncologists as part of the leadership of US Oncology, the largest network of community oncology practices in the United States. He has a proven track record of success in the field of oncology and has guided numerous products from early-stage development to commercialization. Most recently, Mr. Bogle was the Chief Executive Officer at Epizyme, Inc., and oversaw the 2022 acquisition of the company by Ipsen. Prior to that, Mr. Bogle was Senior Vice President and Chief Commercial Officer of TESARO, which was acquired by GlaxoSmithKline in 2018. Earlier, he served as Senior Vice President of Pharmaceutical and Biotech Solutions at McKesson Specialty Health/U.S. Oncology.

"Nuvalent has demonstrated an uncompromising commitment to realizing transformational change for patients through the development of molecules designed to address clear physician-identified medical needs. Its patient-centric approach has paved a direct path from discovery through clinical development, and the company is now working to make its vision of delivering a new generation of precisely targeted therapies to patients with cancer a reality," said Mr. Bogle. "It is a privilege to be joining the Board of Directors at such an exciting time in the company's journey, and I look forward to working alongside this team towards our shared mission of bringing positive impact to as many patients as we can."

Mr. Bogle currently serves on the board of Myrobalan Therapeutics and the American School for the Deaf in Hartford, CT. He previously served on the Board of Epizyme prior to his appointment to CEO and functioned as a member of the compensation committee. Mr. Bogle earned a B.A. in Economics from Dartmouth College, an M.B.A from Columbia University and was a 2020 Fellow in the Advanced Leadership Initiative at Harvard University.

Nuvalent is currently enrolling patients in the global Phase 2 portions of the ARROS-1 clinical trial of zidesamtinib, its novel ROS1-selective inhibitor, and the ALKOVE-1 clinical trial of NVL-655, its novel ALK-selective inhibitor. The company expects to report pivotal data from both trials in 2025. Additionally, the company plans to initiate the Phase 3 global, randomized, controlled ALKAZAR trial in the first half of 2025 to evaluate NVL-655 versus the current standard of care, ALECENSA® (alectinib), for the treatment of patients with TKI-naïve ALK-positive NSCLC. Zidesamtinib and NVL-655 are designed with the aim to address the clinical challenges of emergent treatment resistance, off-target CNS adverse events, and brain metastases that may limit the use of currently available kinase inhibitors. The company is also enrolling patients in the Phase 1a/1b HEROEX-1 trial evaluating NVL-330, its novel HER2-selective inhibitor, for patients with HER2-altered NSCLC, and continues to advance an active discovery pipeline.

About Nuvalent
Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; the expected timing of data announcements, clinical trial initiations and FDA product approvals; the clinical development programs for zidesamtinib, NVL-655 and NVL-330; the design and timing of the ALKAZAR trial; the design and enrollment of Nuvalent's clinical trials, including for ARROS-1 and ALKOVE-1 their intended pivotal registration-directed design; the potential of Nuvalent's pipeline programs, including zidesamtinib, NVL-655 and NVL-330; the implications of data readouts and presentations; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "aim," "goal," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented.

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: risks that Nuvalent may not fully enroll its clinical trials or that enrollment will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our zidesamtinib or NVL-655 product candidates; risks that Nuvalent may not achieve the goals and milestones set forth in its OnTarget 2026 operating plan; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations, including the ARROS-1, ALKOVE-1, ALKAZAR and HEROEX-1 trials; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Nuvalent's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024, as well as any prior and subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements.

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SOURCE Nuvalent, Inc.

FAQ

When will Nuvalent (NUVL) report pivotal data from ARROS-1 and ALKOVE-1 trials?

Nuvalent expects to report pivotal data from both the ARROS-1 and ALKOVE-1 trials in 2025.

When will Nuvalent (NUVL) initiate the Phase 3 ALKAZAR trial?

Nuvalent plans to initiate the Phase 3 ALKAZAR trial in the first half of 2025.

When does Nuvalent (NUVL) expect its first pipeline approval?

Nuvalent anticipates its first pipeline approval in 2026.

Who is the newest board member appointed to Nuvalent (NUVL)?

Grant Bogle, former CEO of Epizyme and Chief Commercial Officer of TESARO, has been appointed to Nuvalent's Board of Directors.