Nuvalent(NUVL) - 2025 Q2 - Quarterly Results

Nuvalent Highlights, Milestones, and Q2 2025 Financial Results Nuvalent highlighted pipeline and business achievements, reiterated key milestones, and reported Q2 2025 financial results - Nuvalent outlined pipeline and business achievements, reiterated key anticipated milestones, and reported second quarter 2025 financial results[3] - Initiated rolling NDA submission for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, targeting completion in Q3 2025[2][4] - Initiated ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC[2][4] - Topline pivotal data for neladalkib for TKI pre-treated patients with advanced ALK-positive NSCLC expected by year-end 2025[2][4] - Jason Waters, MBA, promoted to Senior Vice President, Commercial, to build commercial infrastructure[2][4] Recent Pipeline Achievements and Anticipated Milestones This section details recent advancements in Nuvalent's ROS1, ALK, and HER2 programs and outlines key upcoming milestones ROS1 Program (zidesamtinib) Nuvalent initiated a rolling NDA submission for zidesamtinib for TKI pre-treated ROS1-positive NSCLC, with target completion in Q3 2025, and the FDA accepted it into the RTOR pilot program - Rolling NDA submission for zidesamtinib, a novel ROS1-selective inhibitor, initiated for TKI pre-treated patients with advanced ROS1-positive NSCLC[5] - FDA accepted the NDA for participation in the Real-Time Oncology Review (RTOR) pilot program, facilitating an earlier start to the FDA's evaluation, with completion of the NDA submission targeted for Q3 2025[5][6] - NDA submission is based on positive pivotal data from the global ARROS-1 Phase 1/2 clinical trial for TKI pre-treated patients, with preliminary data from the ongoing Phase 2 TKI-naïve cohort (104 patients enrolled as of June 16, 2025) also reported[6] ALK Program (neladalkib) The ALK program saw the initiation of the ALKAZAR Phase 3 trial for TKI-naïve ALK-positive NSCLC and anticipates pivotal data from the ALKOVE-1 trial for TKI pre-treated patients by year-end 2025 - Dosing of the first patient in ALKAZAR, a global Phase 3 randomized, controlled trial evaluating neladalkib for TKI-naïve ALK-positive NSCLC, has been announced[10] - Patients in ALKAZAR will be randomized 1:1 to receive neladalkib monotherapy or alectinib monotherapy, a front-line standard of care[10] - Pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC from the ALKOVE-1 Phase 1/2 trial are expected by year-end 2025[10] - Preliminary data from the Phase 2 exploratory cohort for patients with ALK-positive solid tumors beyond NSCLC will be presented at the ESMO Congress 2025 (October 17-21, 2025)[8][10] HER2 Program (NVL-330) Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial for NVL-330 in HER2-altered NSCLC, focusing on safety, tolerability, dose determination, pharmacokinetics, and preliminary anti-tumor activity - Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC[8] - Additional objectives of the HEROEX-1 trial include determination of the recommended Phase 2 dose, characterization of NVL-330's pharmacokinetic profile, and preliminary evaluation of anti-tumor activity[8] Business Updates This section provides updates on Nuvalent's leadership appointments and promotions, strengthening its commercial and strategic capabilities Leadership Appointments and Promotions Nuvalent strengthened its commercial leadership with the promotion of Jason Waters to Senior Vice President, Commercial, and enhanced its board of directors with the appointment of Christy Oliger - Jason Waters, MBA, was promoted to Senior Vice President, Commercial, bringing over 20 years of biopharma experience, including 15 years in commercial oncology focused on product launches and commercialization[9][11] - Christy Oliger was appointed to Nuvalent's board of directors, contributing over 30 years of commercial and business experience in the pharmaceutical and biotechnology industry, including senior leadership roles at Genentech[11] Second Quarter 2025 Financial Results This section presents Nuvalent's financial performance for Q2 2025, including key metrics, consolidated statements of operations, and selected balance sheet data Key Financial Highlights Nuvalent's cash, cash equivalents, and marketable securities stood at $1.0 billion as of June 30, 2025, providing a runway into 2028, with a net loss of $99.7 million for Q2 2025 Q2 2025 Key Financials (in millions) | Metric | Q2 2025 (in millions) | | :----- | :-------------------- | | Cash, cash equivalents and marketable securities (as of June 30, 2025) | $1,005.6 | | R&D Expenses | $80.9 | | G&A Expenses | $23.7 | | Net Loss | $(99.7) | - Nuvalent continues to believe its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028[4][15] Consolidated Statements of Operations For Q2 2025, Nuvalent reported a net loss of $99.7 million, an increase from $57.2 million in Q2 2024, with R&D expenses significantly increasing to $80.9 million Consolidated Statements of Operations (Unaudited, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $80,913 | $49,166 | $155,331 | $87,800 | | General and administrative | $23,658 | $15,984 | $44,052 | $29,938 | | Total operating expenses | $104,571 | $65,150 | $199,383 | $117,738 | | Loss from operations | $(104,571) | $(65,150) | $(199,383) | $(117,738) | | Total other income (expense), net | $5,063 | $8,154 | $15,450 | $16,643 | | Loss before income taxes | $(99,508) | $(56,996) | $(183,933) | $(101,095) | | Net loss | $(99,653) | $(57,166) | $(184,235) | $(101,648) | | Net loss per share (basic and diluted) | $(1.39) | $(0.88) | $(2.57) | $(1.58) | | Weighted average shares outstanding | 71,843,774 | 64,605,308 | 71,726,313 | 64,377,948 | Selected Balance Sheet Data As of June 30, 2025, Nuvalent reported cash, cash equivalents, and marketable securities of $1.0 billion, a decrease from $1.1 billion at December 31, 2024 Selected Balance Sheet Data (Unaudited, in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Cash, cash equivalents and marketable securities | $1,005,598 | $1,118,302 | | Working capital | $944,463 | $1,078,428 | | Total assets | $1,040,543 | $1,141,752 | | Total liabilities | $100,801 | $71,960 | | Total stockholders' equity | $939,742 | $1,069,792 | About Nuvalent Nuvalent is a clinical-stage biopharmaceutical company focused on developing precisely targeted cancer therapies to overcome limitations of existing treatments - Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome limitations of existing therapies for clinically proven kinase targets[3][13] - The company leverages deep expertise in chemistry and structure-based drug design to develop innovative small molecules with the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses[13] - 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[13] Forward-Looking Statements This section details Nuvalent's forward-looking statements, acknowledging inherent risks in drug development and commercialization - This press release contains forward-looking statements regarding Nuvalent's strategy, business plans, financial runway, expected timing of data announcements, NDA submissions, FDA product approvals, and clinical development programs for zidesamtinib, neladalkib, and NVL-330[14] - Drug development and commercialization involve a high degree of risk, and actual events or results may differ materially from those expressed or implied due to various factors, including clinical trial enrollment, unexpected data, regulatory approvals, costs, and intellectual property risks[16][17] - Nuvalent explicitly disclaims any obligation to update any forward-looking statements[17] Contacts This section provides contact information for investor relations and media inquiries - Investor Contact: Chelcie Lister, Nuvalent, Inc., clister@nuvalent.com[18] - Media Contact: Josie Butler, 1AB, josie@labmedia.com[18]