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 News Release - July 20, 2022

Nuvalent Announces Leadership Promotions

Darlene Noci, A.L.M. promoted to Chief Development Officer

Benjamin Lane, Ph.D. promoted to Senior Vice President, Technical Operations


CAMBRIDGE, Mass., July 20, 2022 -- (Healthcare Sales & Marketing Network) -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced two leadership team promotions. Darlene Noci, A.L.M. has been promoted to Chief Development Officer and will continue to oversee all global Product Development and Regulatory Affairs activities. Benjamin Lane, Ph.D. has been promoted to Senior Vice President, Technical Operations and will continue to oversee all Pharmaceutical Development and Quality Assurance activities.

Ms. Noci joined Nuvalent in 2021 as Senior Vice President, Product Development and Regulatory Affairs, bringing over 20 years of experience as an accomplished product development leader specializing in global regulatory affairs and strategic oversight of early and late-stage programs in oncology and rare diseases. At Nuvalent, Ms. Noci has driven the parallel design and execution of global development and regulatory strategies for its two lead programs, NVL-520 and NVL-655, leading to the successful and expedient submission of two INDs and initiation of two ongoing Phase 1/2 studies all within one year. Prior to joining Nuvalent, Ms. Noci held various regulatory, quality assurance and global development team leadership positions with increasing responsibility at X4 Pharmaceuticals, EMD Serono, Infinity, Sanofi, and Genzyme. Throughout her career, Ms. Noci contributed to several successful drug approvals, including Fabrazyme®, Mozobil®, Clolar®, and Bavencio®. Ms. Noci received her Master's in Government from Harvard University.

Dr. Lane joined Nuvalent in 2020 as Vice President, Pharmaceutical Development, bringing over 17 years of experience in process chemistry and the development of pre-clinical through commercial programs at both large and small biotech companies. At Nuvalent, Dr. Lane has built high-performing and integrated pharmaceutical development and quality assurance teams, which have seamlessly delivered clinical supply for two parallel lead programs while navigating the complexities of an evolving global supply-chain. Prior to joining Nuvalent, Dr. Lane has held various roles of increasing responsibility at Agios, Infinity, and Biogen and contributed to the development, scale up, and transition to commercial manufacturing of small molecule therapeutics in hematology, oncology, and neurology including Copiktra®, Tibsovo®, and Pyrukynd®. Dr. Lane earned his Ph.D. from Texas A&M University and held a postdoctoral position at Columbia University.

"These promotions reflect the significant contributions made by Darlene and Ben in establishing Nuvalent as a clinical-stage company with strong expertise in the development of novel oncology therapies," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We are pleased to recognize their talent and dedication and look forward to their continued leadership in advancing our mission to discover, develop, and deliver a pipeline of precisely targeted therapies for patients with cancer."

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 parallel lead programs in ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC), along with multiple discovery-stage research programs. We routinely post information that may be important to investors on our website at www.nuvalent.com. Follow us on Twitter (@nuvalent) and LinkedIn.

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 clinical development programs for NVL-520 and NVL-655 and the timing thereof; the potential clinical effect of NVL-520 and NVL-655; the design and enrollment of the ARROS-1 and ALKOVE-1 studies and the timing thereof; the potential of Nuvalent's pipeline programs, including NVL-520 and NVL-655; Nuvalent's research and development programs for the treatment of cancer; risks and uncertainties associated with drug development; and capital allocation. 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 the ARROS-1 or ALKOVE-1 studies or that enrollment will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its HER2 Exon 20 and ALK IXDN programs; the direct or indirect impact of COVID-19 or other global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations, including the ARROS-1 and ALKOVE-1 studies; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and obtaining, maintaining, and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, as well as any 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.

Fabrazyme® is a registered trademark of Genzyme Therapeutic Products Limited Partnership.

Mozobil® and Clolar® are registered trademarks of Genzyme Corporation.

Bavencio® is a registered trademark of Merck KGAA.

Copiktra® is a registered trademark of Secura Bio, Inc.

Tibsovo® is a registered trademark of Servier Pharmaceuticals, LLC.

Pyrukynd® is a registered trademark of Agios Pharmaceuticals, Inc.


Source: Nuvalent

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