Nuvalent, Inc. SEC Filings

Nuvalent, Inc. entered into an underwriting agreement for an underwritten public offering of 4,950,496 shares of its Class A common stock at a price to the public of $101.00 per share, with underwriters purchasing at $95.445 per share. The company estimates net proceeds of approximately $471.9 million after underwriting discounts and expenses.

Selling stockholders granted the underwriters a 30-day option to buy up to 742,574 additional shares, which would provide them with approximately $75 million of gross proceeds; Nuvalent will not receive any proceeds from these additional shares. The company expects the offering to close on November 20, 2025, subject to customary conditions, and estimates that the net proceeds, combined with existing cash, cash equivalents and marketable securities, will fund operating and capital expenditure needs into 2029.

Nuvalent, Inc. (NUVL) filed a Form 4 for its Chief Financial Officer detailing option exercises and stock sales in November 2025. On November 17, 2025, the CFO exercised stock options for 6,875 Class A shares at $6.89 and 13,125 shares at $72.35, then sold multiple blocks of Class A Common Stock at weighted average prices ranging from $93.8 to $103.68. On November 18, 2025, additional options for 729 shares at $72.35 were exercised, with share sales at weighted average prices of $103.61 and $104.54. After these transactions, the CFO directly owned 61,734 Class A shares and held stock options covering 29,101 and 33,646 shares. All reported trades were made under a Rule 10b5-1 trading plan adopted on December 12, 2024.

Nuvalent, Inc. (NUVL) reported insider activity by its Chief Legal Officer on a Form 4. On 11/17/2025, the officer exercised a stock option for 24,200 shares of Class A common stock at an exercise price of $6.89 per share. That same day, the officer sold 15,075 shares at a weighted average price of $105.16, 8,517 shares at $105.98, and 608 shares at $107.04, all under a Rule 10b5-1 trading plan adopted on November 18, 2024. After these transactions, the officer directly owned 49,086 shares of Class A common stock and held 94,608 stock options that remain beneficially owned, with the option covering 24,200 shares fully vested and expiring on 04/29/2031.

Nuvalent, Inc. is offering 4,950,496 shares of its Class A common stock at $101.00 per share, for gross proceeds of $500,000,096 and estimated net proceeds to the company of about $471.9 million after fees and expenses. Selling stockholders have granted underwriters a 30-day option to purchase up to an additional 742,574 shares, from which Nuvalent will receive no proceeds.

Nuvalent is a clinical-stage oncology company developing targeted kinase inhibitors, led by neladalkib (ALK-positive NSCLC), zidesamtinib (ROS1-positive NSCLC) and NVL-330 (HER2-altered tumors). The company reported positive pivotal Phase 1/2 data for neladalkib and zidesamtinib, including objective response rates up to 86% in certain TKI-naïve ALK-positive NSCLC cohorts and 89% in TKI-naïve ROS1-positive NSCLC, with durable responses and intracranial activity, alongside generally well-tolerated safety profiles.

Nuvalent has completed a rolling NDA submission for zidesamtinib in TKI pre-treated ROS1-positive NSCLC and plans a pre-NDA meeting with the FDA for neladalkib. As of September 30, 2025, it held $943.1 million in cash, cash equivalents and marketable securities and expects, with this offering, to fund operations into 2029, though it does not plan to pay dividends and new investors will experience immediate dilution, with as-adjusted net tangible book value of $17.06 per share versus the $101.00 offering price.

Nuvalent, Inc. is offering $500,000,000 of its Class A common stock, with shares listed on Nasdaq under “NUVL.” A 30-day option allows underwriters to buy up to an additional $75,000,000 of stock from selling stockholders, from which Nuvalent will not receive proceeds. Based on an assumed price of $96.50 per share, Nuvalent estimates net proceeds of approximately $471.9 million, increasing as-adjusted net tangible book value from $11.70 to $17.01 per share and causing immediate dilution of $79.49 per share to new investors. As of September 30, 2025, Nuvalent held $943.1 million in cash, cash equivalents and marketable securities and expects this, together with the offering proceeds, to fund operations into 2029.

Nuvalent is a clinical-stage oncology company advancing three targeted kinase inhibitors: neladalkib (ALK-positive NSCLC), zidesamtinib (ROS1-positive NSCLC) and NVL-330 (HER2-altered tumors). Neladalkib and zidesamtinib have shown positive pivotal Phase 1/2 data, including high response rates and durable intracranial activity in both TKI-pretreated and TKI-naïve lung cancer populations, and the company has initiated a global Phase 3 ALKAZAR trial and completed a rolling NDA for zidesamtinib. NVL-330 is in Phase 1 with preclinical data supporting a brain-penetrant profile. Net proceeds will support commercialization of neladalkib and zidesamtinib, further clinical development of all three programs, and general corporate purposes.

Nuvalent, Inc. reported positive topline pivotal data for neladalkib, its investigational ALK-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global ALKOVE-1 Phase 1/2 trial. Among 253 evaluable TKI pre-treated patients treated at the recommended Phase 2 dose, the objective response rate was 31%, rising to 46% in the 63 lorlatinib‑naïve patients, with high estimated durability of responses through 18 months. Strong activity was also observed in patients with the G1202R resistance mutation and those with measurable brain metastases, including intracranial complete responses.

Nuvalent also shared encouraging preliminary data in 44 TKI‑naïve advanced ALK‑positive NSCLC patients, showing an 86% objective response rate and 9% complete response rate, with most responses ongoing beyond 6 and 12 months. Across 656 NSCLC patients treated at the recommended dose, neladalkib showed a generally well‑tolerated safety profile; the most common side effects were liver enzyme elevations and manageable gastrointestinal and constitutional events, with 17% requiring dose reductions and 5% discontinuing due to adverse events. The company plans a pre‑NDA meeting with the FDA and continues its Phase 3 ALKAZAR trial versus alectinib.

Nuvalent, Inc. (NUVL) reported an insider transaction by its Chief Development Officer on 10/30/2025. The officer exercised 4,000 stock options at $27.85 and, the same day, sold 4,000 Class A shares across multiple trades, executed under a Rule 10b5-1 trading plan adopted on November 18, 2024.

The reported sales were in tranches including 57 shares at $98.91 (weighted average, range $98.16–$99.13) and additional lots at weighted average prices of $100.69, $102.07, $103.09, $104.21, and a final sale at $104.58. Following these transactions, the officer directly held 48,034 Class A shares. Derivative holdings reported after the exercise were 122,329 stock options outstanding, with the option series expiring on 01/06/2033 and vesting monthly over four years from January 6, 2023.

Nuvalent (NUVL) reported insider activity by its Chief Legal Officer on 10/30/2025. The officer exercised 21,800 stock options at an exercise price of $6.89 and sold an equal 21,800 Class A shares in multiple same‑day open‑market transactions with weighted average prices disclosed for each tranche.

Tranche prices reported include weighted averages of $96.65, $97.98, $99.66, $100.96, $102.00, $102.88, $103.90, and $104.78. Following the transactions, the officer directly owned 49,086 shares. The filing notes the trades were effected under a Rule 10b5-1 plan adopted on November 18, 2024, and the option exercised was fully vested; 118,808 derivative securities were beneficially owned after the transactions.

Nuvalent, Inc. (NUVL) reported a larger quarterly loss while advancing its oncology pipeline. For Q3 2025, net loss was $122.4 million versus $84.3 million a year ago as operating expenses rose with clinical activity. Research and development reached $83.8 million (from $60.6 million) and general and administrative was $28.9 million (from $15.8 million).

Liquidity remains strong with cash, cash equivalents and marketable securities of $943.1 million as of September 30, 2025. The company reported an accumulated deficit of $853.7 million and noted its resources are expected to fund operations into 2028. The fair value of a related party revenue share liability increased to $45.2 million from $17.9 million, reflecting updated assumptions.

Program updates included completion of a rolling NDA for zidesamtinib in TKI pre-treated ROS1-positive NSCLC and ongoing Phase 2 work in TKI-naïve patients. Neladalkib advanced with Phase 2 enrollment completed in TKI pre-treated NSCLC and initiation of the Phase 3 ALKAZAR trial in TKI‑naïve ALK‑positive NSCLC. NVL‑330 progressed in Phase 1 with new preclinical data highlighting brain‑penetrant properties.