Nuvalent Outlines Recent Pipeline and Business Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2025 Financial Results

PR Newswire

CAMBRIDGE, Mass., May 8, 2025

Topline pivotal data expected for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population in the first half of 2025 in support of anticipated first NDA submission by mid-year 2025

Initiation of ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC planned for first half of 2025

Pivotal data for neladalkib in TKI pre-treated ALK-positive NSCLC population anticipated by year-end 2025

Strengthened leadership team with key internal promotions

CAMBRIDGE, Mass., May 8, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline and business progress, reiterated key anticipated milestones, and reported first quarter 2025 financial results.

"2025 is a critical year of execution for Nuvalent as we continue to transition toward becoming a fully integrated commercial-stage biopharmaceutical company," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We expect multiple meaningful milestones this year, including pivotal data for TKI pre-treated patients from both of our parallel lead programs, and our first potential NDA submission for zidesamtinib for TKI pre-treated patients with ROS1-positive NSCLC."

Dr. Porter continued, "The continued progress across our portfolio is a direct reflection of the strength and dedication of our team--it is their deep expertise, operational excellence, and commitment to patients that drive our ability to execute. In recognition of their significant contributions, we're pleased to announce the leadership promotions of Ruth Adams to Senior Vice President, Clinical Operations; Dr. Joshua Horan to Senior Vice President, Chemistry; and Jessie Lin to Senior Vice President, Corporate Strategy and Portfolio Management. With strong product candidates, a solid financial position, and an experienced team unified by an unwavering commitment to patient impact, we believe we are well-positioned to achieve our goals."

Recent Pipeline and Business Highlights

ROS1 Program

   -- Evaluation of zidesamtinib, the company's novel ROS1-selective inhibitor, 
      is ongoing in the ARROS-1 Phase 1/2 trial for patients with advanced 
      TKI-naïve and TKI pre-treated ROS1-positive non-small cell lung 
      cancer (NSCLC) and other solid tumors. The company expects to report 
      pivotal data for TKI pre-treated patients with advanced ROS1-positive 
      NSCLC in the first half of 2025 in support of an anticipated New Drug 
      Application (NDA) submission by mid-year 2025. 
 
   -- A manuscript reinforcing the rational molecular design of zidesamtinib as 
      a novel ROS1-selective inhibitor was published in Molecular Cancer 
      Therapeutics, a journal of the American Association for Cancer Research 
      (AACR), in conjunction with the presentation of new preclinical data at 
      the AACR meeting detailing the first crystal structure of ROS1 G2032R in 
      complex with zidesamtinib. The crystal structure further supports 
      zidesamtinib's molecular design and provides structural insights into how 
      the ROS1 G2032R mutation affects TKI binding. The publication 
      additionally explores the activity of zidesamtinib and other approved or 
      investigational ROS1 TKIs at clinically relevant concentrations against 
      ROS1 resistance mutations, including the most commonly occurring 
      resistance mutation, ROS1 G2032R, in preclinical mutagenesis screens and 
      an intracranial ROS1 G2032R xenograft model. Findings presented in the 
      manuscript show that, at clinically relevant concentrations, zidesamtinib 
      suppressed on-target resistance in ENU mutagenesis screens simulating 
      first-line and later-line treatment and inhibited ROS1 G2032R brain 
      tumors more effectively than the other ROS1 TKIs evaluated. 

ALK Program

   -- Evaluation of neladalkib, its novel ALK-selective inhibitor, is ongoing 
      in the ALKOVE-1 Phase 1/2 trial for patients with advanced ALK-positive 
      NSCLC and other solid tumors. The company expects to report pivotal data 
      for TKI pre-treated patients with advanced ALK-positive NSCLC and other 
      solid tumors by year-end 2025. 
 
   -- Nuvalent presented new preclinical data at the AACR Annual Meeting 
      demonstrating that neladalkib suppressed resistance in ENU mutagenesis 
      screens simulating first-line and later-line treatment. 
 
   -- The company plans to initiate the ALKAZAR Phase 3 trial, its front-line 
      development strategy for the company's ALK program, in the first half of 
      2025. The Phase 3 ALKAZAR trial will be a global, randomized, controlled 
      trial designed to evaluate neladalkib versus the current standard of care 
      for the treatment of patients with TKI-naïve ALK-positive NSCLC. 
      Patients will be randomized 1:1 to receive neladalkib monotherapy or 
      ALECENSA$(R)$ (alectinib) monotherapy. The company will present a "Trial in 
      Progress" poster including background and study design for ALKAZAR at the 
      2025 American Society of Clinical Oncology (ASCO) Annual Meeting. 

HER2 Program

   -- Enrollment is ongoing in the HEROEX-1 Phase 1a/1b trial evaluating the 
      overall safety and tolerability of NVL-330, the company's novel 
      HER2-selective inhibitor, for pre-treated patients with 
      HER2-altered NSCLC. Additional objectives include determination of the 
      recommended Phase 2 dose, characterization of NVL-330's pharmacokinetic 
      profile, and preliminary evaluation of anti-tumor activity. A "Trial in 
      Progress" poster including background and study design for HEROEX-1 will 
      be presented at the 2025 ASCO Annual Meeting. 

Recent Leadership Promotions

   -- Ruth Adams, Promoted to Senior Vice President, Clinical Operations: Ruth 
      joined Nuvalent in 2020, bringing more than 20 years of experience in 
      research and development for oncology therapeutics. This promotion 
      recognizes Ruth's continued excellence in overseeing clinical trial 
      execution, exemplified by her leadership in the global operationalization 
      of Nuvalent's ARROS-1, ALKOVE-1, HEROEX-1, and ALKAZAR studies. 
 
   -- Joshua Horan, Ph.D., Promoted to Senior Vice President, Chemistry: Joshua 
      joined the Nuvalent team in 2018, bringing more than 15 years of drug 
      discovery experience spanning the fields of immunology, nephrology, 
      proteopathy, and oncology. This promotion recognizes Joshua's continued 
      excellence in overseeing Nuvalent's discovery chemistry program, which 
      has generated three novel, potential best-in-class drug candidates and 
      continues to advance an active discovery pipeline. 
 
   -- Jessie Lin, Promoted to Senior Vice President, Corporate Strategy & 
      Portfolio Management: Jessie has worked with the Nuvalent team since 
      2020, bringing 15 years of experience driving multidisciplinary strategic 
      growth initiatives across the life sciences industry. This promotion 
      recognizes Jessie's continued excellence in shaping and advancing 
      Nuvalent's mission of becoming a fully integrated biopharmaceutical 
      company capable of discovering, developing, and delivering precisely 
      targeted therapies for patients with cancer. 

Upcoming Events

   -- TD Cowen 6th Annual Oncology Innovation Summit: Management will be 
      participating in a virtual fireside chat on Tuesday, May 27, 2025 at 4:00 
      p.m. ET. A live webcast will be available in the Investors section of 
      Nuvalent's website at www.nuvalent.com, and will be archived for 30 days 
      following the conference. 

First Quarter 2025 Financial Results

   -- Cash Position: Cash, cash equivalents and marketable securities were $1.1 
      billion as of March 31, 2025. Nuvalent continues to believe its existing 
      cash, cash equivalents and marketable securities will be sufficient to 
      fund its current operating plan into 2028. 
 
   -- R&D Expenses: Research and development (R&D) expenses were $74.4 million 
      for the first quarter of 2025. 
 
   -- G&A Expenses: General and administrative (G&A) expenses were $20.4 
      million for the first quarter of 2025. 
 
   -- Net Loss: Net loss was $84.6 million for the first quarter of 2025. 

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 period over which Nuvalent estimates its cash, cash equivalents and marketable securities will be sufficient to fund its future operating expenses and capital expenditure requirements; the expected timing of data announcements, clinical trial initiations and FDA product approvals; the preclinical and clinical development programs for zidesamtinib, neladalkib and NVL-330; the potential benefits and effects of Nuvalent's product development candidates; the design and enrollment of the ARROS-1, ALKAZAR, ALKOVE-1, and HEROEX-1 trials; the potential of Nuvalent's pipeline programs, including zidesamtinib, neladalkib 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 preclinical studies or 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 product candidates; 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; 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 Annual Report on Form 10-K for the fiscal year ended December 31, 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.

 
                    CONSOLIDATED STATEMENTS OF OPERATIONS 
              (In thousands, except share and per share amounts) 
                                 (Unaudited) 
 
                                  Three Months Ended March 31, 
                  ------------------------------------------------------------ 
                              2025                           2024 
                  -----------------------------  ----------------------------- 
Operating 
expenses 
 Research and 
  development      $                     74,418   $                     38,634 
 General and 
  administrative                         20,394                         13,954 
Total operating 
 expenses                                94,812                         52,588 
                  -----------------------------  ----------------------------- 
Loss from 
 operations                            (94,812)                       (52,588) 
                  -----------------------------  ----------------------------- 
Other income 
(expense) 
 Change in fair 
 value of 
 related party 
 revenue share 
 liability                              (1,430)                             -- 
 Interest income 
  and other 
  income 
  (expense), 
  net                                    11,817                          8,489 
Total other 
 income 
 (expense), net                          10,387                          8,489 
                  -----------------------------  ----------------------------- 
Loss before 
 income taxes                          (84,425)                       (44,099) 
Income tax 
 provision                                  157                            383 
                  -----------------------------  ----------------------------- 
Net loss            $                  (84,582)    $                  (44,482) 
                  =============================  ============================= 
Net loss per 
 share 
 attributable to 
 common 
 stockholders, 
 basic and 
 diluted          $                      (1.18)  $                      (0.69) 
                  =============================  ============================= 
Weighted average 
 shares of 
 common stock 
 outstanding, 
 basic and 
 diluted                             71,607,546                     64,150,588 
                  -----------------------------  ----------------------------- 
 
 
                                 SELECTED BALANCE SHEET DATA 
                                        (In thousands) 
                                         (Unaudited) 
 
                              March 31,                              December 31, 
                                 2025                                    2024 
                --------------------------------------  -------------------------------------- 
Cash, cash 
 equivalents 
 and 
 marketable 
 securities       $                          1,073,225    $                          1,118,302 
Working 
 capital          $                          1,011,519    $                          1,078,428 
Total assets      $                          1,105,806    $                          1,141,752 
Total 
 liabilities    $                               94,749  $                               71,960 
Total 
 stockholders' 
 equity           $                          1,011,057    $                          1,069,792 
 

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SOURCE Nuvalent, Inc.

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May 08, 2025 07:31 ET (11:31 GMT)