Upcoming Events

   -- Guggenheim's Inaugural Healthcare Innovation Conference: Management will 
      be participating in a fireside chat on Wednesday, November 13, 2024, at 
      9:00 a.m. ET in Boston. 
 
   -- Stifel 2024 Healthcare Conference: Management will be participating in a 
      fireside chat on Tuesday, November 19, 2024, at 3:35 p.m. ET in NYC. 

A live webcast of each fireside chat 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.

Third Quarter 2024 Financial Results

   -- Cash Position: Cash, cash equivalents and marketable securities were $1.2 
      billion as of September 30, 2024. The company's cash, cash equivalents 
      and marketable securities as of September 30, 2024, inclusive of the 
      proceeds from the $575 million public offering, are expected to extend 
      the company's operating runway into 2028. 
 
   -- R&D Expenses: Research and development (R&D) expenses were $60.6 million 
      for the third quarter of 2024. 
 
   -- G&A Expenses: General and administrative (G&A) expenses were $15.8 
      million for the third quarter of 2024. 
 
   -- Net Loss: Net loss was $84.3 million for the third quarter of 2024. 

About OnTarget 2026

OnTarget 2026 delineates Nuvalent's 3-year operating plan towards bringing new, potential best-in-class medicines to patients with cancer. As part of this plan announced in January 2024, Nuvalent outlined the following anticipated milestones throughout 2024, leading to the company's first potential pivotal data in 2025 and first potential approved product in 2026:

   -- 2024: Execute on Global Registrational Strategies 
 
          -- Progress the Phase 2 portion of its ARROS-1 trial of zidesamtinib 
             in patients with advanced ROS1-positive NSCLC with registrational 
             intent; 
 
          -- Initiate the Phase 2 portion of its ALKOVE-1 trial of NVL-655 in 
             patients with advanced ALK-positive NSCLC with registrational 
             intent; 
 
          -- Launch the front-line development strategy for its ALK program; 
 
          -- Present interim data from its ongoing ARROS-1 and ALKOVE-1 
             clinical trials at medical meetings; and, 
 
          -- Initiate the Phase 1 trial for its HER2 program. 
 
   -- 2025: First Pivotal Data 
 
   -- 2026: First Approved Product 

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, including the projections in our OnTarget 2026 operating plan; the clinical development programs for zidesamtinib, NVL-655 and NVL-330; the design and timing of the ALKAZAR trial, including alignment with the FDA regarding the design of the trial; the potential clinical effects of Nuvalent's product development candidates; 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 June 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.

 
                                         CONSOLIDATED STATEMENTS OF OPERATIONS 
                                   (In thousands, except share and per share amounts) 
                                                      (Unaudited) 
 
                            Three Months Ended September 30,                    Nine Months Ended September 30, 
                  ----------------------------------------------------  ------------------------------------------------ 
                            2024                       2023                      2024                     2023 
                  -------------------------  -------------------------  -----------------------  ----------------------- 
Operating 
expenses 
 Research and 
  development       $                60,551    $                29,611     $            148,351    $              77,658 
 General and 
  administrative                     15,780                      9,172                   45,718                   25,397 
Total operating 
 expenses                            76,331                     38,783                  194,069                  103,055 
                  -------------------------  -------------------------  -----------------------  ----------------------- 
Loss from 
 operations                        (76,331)                   (38,783)                (194,069)                (103,055) 
                  -------------------------  -------------------------  -----------------------  ----------------------- 
Other income 
(expense) 
 Change in fair 
  value of 
  related party 
  revenue share 
  liability                        (16,600)                         --                 (16,600)                       -- 
 Interest income 
  and other 
  income 
  (expense), 
  net                                 8,626                      5,138                   25,269                   15,128 
Total other 
 income 
 (expense), net                     (7,974)                      5,138                    8,669                   15,128 
                  -------------------------  -------------------------  -----------------------  ----------------------- 
Loss before 
 income taxes                      (84,305)                   (33,645)                (185,400)                 (87,927) 
Income tax 
 provision                               40                         --                      593                       -- 
                  -------------------------  -------------------------  -----------------------  ----------------------- 

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