On March 16, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported its pipeline and business progress and fourth quarter and full year 2022 financial results (Press release, Nuvalent, MAR 16, 2023, View Source [SID1234628909]).

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"2022 was a remarkable year of progress for Nuvalent. The first half of the year marked our transition to a clinical-stage company with the initiation of dosing in clinical trials for both of our parallel-lead programs, ROS1-selective inhibitor, NVL-520, and ALK-selective inhibitor, NVL-655. The team continued to execute through the second half of the year with our first clinical data presentation demonstrating preliminary clinical proof-of-concept data for NVL-520, as well as the nomination of our third novel development candidate, NVL-330, for HER2 exon 20-positive cancers," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "Going into 2023, we remain committed to following the data and opportunities to carry this positive progress forward. Enrollment continues in the Phase 1 portions of our ARROS-1 and ALKOVE-1 clinical trials, and we continue to progress NVL-330 towards IND as well as pursue further expansion of our discovery pipeline."

Dr. Porter continued, "To have discovered and advanced a pipeline of novel candidates to this point in just a few years from company creation is a testament to our team’s expertise, ability to execute, and commitment to bringing new therapies to patients as quickly as possible. In recognition of their embodiment of these qualities and outstanding contributions to date, we are pleased to promote Dr. Henry Pelish to Senior Vice President, Drug Discovery, and Dr. John Soglia to Senior Vice President, Translational Development. I’m incredibly excited about the future of Nuvalent and believe that with a promising portfolio, dedicated and expert team, and a solid cash position, we are well-positioned to continue advancing towards our goal of delivering precisely targeted therapies for patients with cancer."

Key Achievements

To date, Nuvalent has achieved a number of milestones across its pipeline of novel kinase inhibitors and its research efforts, including:

NVL-520:

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Presented preliminary Phase 1 data supportive of the potential best-in-class profile of NVL-520 as a brain-penetrant, ROS1-selective inhibitor from the ongoing Phase 1/2 ARROS-1 study for patients with advanced ROS1-positive NSCLC and other solid tumors;
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Presented preclinical data supporting the potential for broad clinical utility of NVL-520 across an expanded set of ROS1 fusion partners, resistance mutations, and tumor types beyond NSCLC; and,
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Published the organization’s first manuscript in Cancer Discovery describing the design and characterization of NVL-520 and detailing Nuvalent’s approach to rationally targeting ROS1.

NVL-655:

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Initiated clinical development with parallel-lead candidate, NVL-655, a brain penetrant, ALK-selective inhibitor, in the Phase 1 portion of its ongoing ALKOVE-1 Phase 1/2 study for patients with advanced ALK-positive NSCLC and other solid tumors; and,
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Presented preclinical data in multiple patient derived models that continued to support the potential best-in-class preclinical profile of NVL-655.

Earlier-stage Pipeline:

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Declared a third development candidate, NVL-330, a novel HER2-selective inhibitor for patients with HER2 exon 20 insertion-positive cancers; and,
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Continued to advance pipeline expansion efforts with multiple discovery-stage research programs.

In addition, Nuvalent raised $264.5 million in an upsized public offering and strengthened its leadership with key internal promotions and appointments to its Board of Directors.

Recent Leadership Promotions

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Henry Pelish, Ph.D., Promoted to Senior Vice President, Drug Development: Dr. Pelish contributed to the creation of Nuvalent and joined the company as Biology lead in 2018, bringing over 15 years of experience in cancer biology, chemical biology and organic synthesis. At Nuvalent, Dr. Pelish leads discovery efforts and oversaw the discovery and early-stage development of NVL-520, NVL-655 and NVL-330. Prior to joining Nuvalent, Dr. Pelish was a group leader in the laboratory of Professor Matthew Shair at Harvard University. In that role, he led a team that discovered a new target, mechanism of action and therapeutic opportunity for treatment of acute myeloid leukemia, culminating in a licensing deal and research agreement between Harvard and Merck in 2016. Dr. Pelish earned his Ph.D. in chemistry from Harvard University.
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John Soglia, Ph.D., Promoted to Senior Vice President, Translational Development: Dr. Soglia joined Nuvalent in January 2020 and has since led the strategy and execution of translational development activities of the company’s lead programs, including ADME, nonclinical safety and clinical pharmacology. Prior to Nuvalent, Dr. Soglia was at Decibel Therapeutics where, in addition to leading the DMPK, clinical pharmacology and regulated bioanalytical functions, he was the early Product Development Scientific Lead on the DB-020 program. Previously, he served as head of DMPK at Infinity Pharmaceuticals and was also the eganelisib (IPI-549) product development team leader, successfully leading the cross-functional team to IND submission and into early clinical development. Prior to Infinity Pharmaceuticals, he held various positions of increasing responsibility at GlaxoSmithKline and Pfizer. Dr. Soglia earned his Ph.D. in chemistry from Northeastern University.

Fourth Quarter and Full Year 2022 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $472.2 million as of December 31, 2022. Nuvalent believes the existing cash, cash equivalents and marketable securities are expected to be sufficient to fund its current operating plan into the second half of 2025.
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R&D Expenses: Research and development (R&D) expenses were $22.9 million for the fourth quarter of 2022 and $63.7 million for the year ended December 31, 2022, compared to $13.2 million for the fourth quarter of 2021 and $35.6 million for the year ended December 31, 2021.
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G&A Expenses: General and administrative (G&A) expenses were $6.4 million for the fourth quarter of 2022 and $22.4 million for the year ended December 31, 2022, compared to $4.2 million for the fourth quarter of 2021 and $10.3 million for the year ended December 31, 2021.

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Net Loss: Net loss was $26.1 million for the fourth quarter of 2022 and $81.9 million for the year ended December 31, 2022, compared to $17.3 million for the fourth quarter of 2021 and $46.3 million for the year ended December 31, 2021.