Summit Therapeutics (SMMT) - 2025 Q2 - Quarterly Results

Report Overview & Highlights Second Quarter 2025 Highlights Summit Therapeutics achieved significant clinical milestones for ivonescimab in Q2 2025, including positive Phase III results for NSCLC and a new collaboration - The global Phase III HARMONi trial showed that ivonescimab with chemotherapy significantly improved Progression-Free Survival (PFS) in patients with EGFRm NSCLC after TKI therapy, with a positive trend in Overall Survival (OS) also observed[1] - In China, the HARMONi-2 study showed a positive OS trend for ivonescimab versus pembrolizumab, leading to NMPA approval for 1L PD-L1 positive advanced NSCLC[1] - The HARMONi-6 study in China demonstrated that ivonescimab with chemotherapy achieved statistically significant and clinically meaningful superiority in PFS compared to tislelizumab (a PD-1 inhibitor) plus chemotherapy in 1L squamous NSCLC[1] - Summit entered a clinical collaboration with Revolution Medicines to evaluate ivonescimab in combination with three different RAS(ON) inhibitors for RAS mutant tumors[1] Operational & Corporate Updates Ivonescimab (SMT112) Development Progress Ivonescimab, a bispecific antibody, is being advanced globally in three Phase III NSCLC trials following its in-licensing - Ivonescimab is an investigational bispecific antibody that blocks both PD-1 (immunotherapy) and VEGF (anti-angiogenesis)[2] - Over 2,800 patients have been treated with ivonescimab in global clinical studies since Summit in-licensed the drug from Akeso in January 2023[2] - Summit is conducting three main Phase III trials for NSCLC: - HARMONi: For EGFR-mutated NSCLC post-TKI therapy - HARMONi-3: For first-line metastatic NSCLC - HARMONi-7: For first-line metastatic NSCLC with high PD-L1 expression[2][3] Key Clinical Trial Results Recent Phase III trials, including global HARMONi and China's HARMONi-2 and HARMONi-6, reported significant positive results for ivonescimab in NSCLC HARMONi Trial Topline Results (May 2025) | Metric | Result | p-value | | :--- | :--- | :--- | | Progression-Free Survival (PFS) | Hazard Ratio: 0.52 (95% CI: 0.41 - 0.66) | <0.00001 | | Overall Survival (OS) | Hazard Ratio: 0.79 (95% CI: 0.62 - 1.01) | 0.057 | - Based on the HARMONi results, Summit intends to file a Biologics License Application (BLA) with the FDA[3] - Akeso's HARMONi-6 trial in China showed ivonescimab plus chemotherapy had statistically significant and clinically meaningful improvement in PFS versus tislelizumab (PD-1 inhibitor) plus chemotherapy in squamous NSCLC[4] - Akeso's HARMONi-2 trial in China led to NMPA approval for ivonescimab monotherapy after a requested interim OS analysis showed a positive trend with a hazard ratio of 0.777[4] Collaborations and Ongoing Trials Summit is expanding ivonescimab's clinical evaluation through a new collaboration with Revolution Medicines and ongoing global Phase III trials - Announced a clinical collaboration with Revolution Medicines in June 2025 to evaluate ivonescimab with three RAS(ON) inhibitors in solid tumors with RAS mutations[4] - Enrollment is ongoing in Summit's global Phase III trials, HARMONi-3 and HARMONi-7[4] - Partner Akeso is enrolling patients in several Phase III studies in China for indications beyond NSCLC, including biliary-tract cancer, triple-negative breast cancer, and pancreatic cancer[4] Financial Highlights Financial Position Summit's cash position decreased to $297.9 million by Q2 2025, prompting an ATM offering for up to $360.0 million in common stock Cash and Short-term Investments (in millions) | Date | Amount | | :--- | :--- | | June 30, 2025 | $297.9 | | December 31, 2024 | $412.3 | - On August 11, 2025, the company established an at-the-market (ATM) offering to potentially sell up to $360.0 million of its common stock[8] Stock-Based Compensation Modification A Q2 2025 modification of 44.5 million stock options to service-based vesting resulted in a $466.6 million non-cash compensation expense - On April 29, 2025, the company modified 44.5 million unvested performance-based stock options to require only service-based vesting[8] - This modification led to a total non-cash stock-based compensation expense of $466.6 million being recognized in Q2 2025[8] - An additional $454.6 million in unrecognized non-cash stock-based compensation expense will be recognized over the future service period[8] Operating Expenses, R&D, G&A, and Net Loss Q2 2025 GAAP operating expenses and net loss significantly increased due to a $466.6 million stock-based compensation charge, while Non-GAAP figures reflected rising clinical costs Q2 2025 vs Q2 2024 Financial Summary (in millions, except per share data) | Metric | Q2 2025 (GAAP) | Q2 2024 (GAAP) | Q2 2025 (Non-GAAP) | Q2 2024 (Non-GAAP) | | :--- | :--- | :--- | :--- | :--- | | Operating Expenses | $568.4 | $59.6 | $89.6 | $48.5 | | R&D Expenses | $208.0 | $30.8 | $79.4 | $27.3 | | G&A Expenses | $360.4 | $13.8 | $10.2 | $6.2 | | Net Loss | $(565.7) | $(60.4) | $(86.9) | $(49.3) | | Net Loss Per Share | $(0.76) | $(0.09) | $(0.12) | $(0.07) | - The primary driver for the increase in GAAP expenses was the non-cash stock-based compensation expense of $466.6 million resulting from the stock option modification[8] - The increase in Non-GAAP operating and R&D expenses was due to the expansion of clinical studies and development costs for ivonescimab[8][12] About Ivonescimab and Summit Therapeutics About Ivonescimab (SMT112) Ivonescimab is a novel bispecific antibody targeting PD-1 and VEGF, designed with a tetravalent structure for enhanced tumor microenvironment targeting - Ivonescimab is a novel bispecific antibody targeting both PD-1 and VEGF[14] - It features a tetravalent structure (four binding sites) and exhibits cooperative binding, meaning its affinity for PD-1 increases in the presence of VEGF, which may better target the drug to tumor tissue[14][15] - The drug has a half-life of 6 to 7 days after the first dose, and over 2,800 patients have been treated with it in global clinical studies[15][16] Clinical Development Program for Ivonescimab Summit is advancing ivonescimab in three global Phase III NSCLC trials, complemented by Akeso's successful completion of three Phase III NSCLC trials in China - Summit is conducting two multiregional Phase III trials, HARMONi and HARMONi-3, and began enrolling for a third, HARMONi-7, in early 2025[17] - Akeso has completed three positive Phase III trials in China: HARMONi-A, HARMONi-2, and HARMONi-6, all in NSCLC[20] - Ivonescimab has received Fast Track designation from the US FDA for the HARMONi clinical trial setting[23] About Summit Therapeutics Summit Therapeutics is an oncology-focused biopharmaceutical company, founded in 2003 and listed on Nasdaq under "SMMT" - Summit is a biopharmaceutical oncology company focused on developing therapies for serious unmet medical needs[24] - Founded in 2003, it is headquartered in Miami, Florida, with additional offices in California and the UK[25] - The company's stock is listed on the Nasdaq Global Market with the symbol "SMMT"[25] Financial Statements and Non-GAAP Reconciliation GAAP Condensed Consolidated Financial Statements Unaudited Q2 2025 GAAP financial statements show a $565.7 million net loss, $324.0 million in total assets, and $127.9 million cash used in operations Condensed Statement of Operations (Three Months Ended June 30, 2025, in millions) | Line Item | Amount | | :--- | :--- | | Total operating expenses | $568.4 | | Other income, net | $2.7 | | Net loss | $(565.7) | | Net loss per share | $(0.76) | Condensed Balance Sheet (As of June 30, 2025, in millions) | Line Item | Amount | | :--- | :--- | | Cash, cash equivalents, and short-term investments | $297.9 | | Total assets | $324.0 | | Total liabilities | $64.6 | | Total stockholders' equity | $259.4 | Condensed Statement of Cash Flows (Six Months Ended June 30, 2025, in millions) | Line Item | Amount | | :--- | :--- | | Net cash used in operating activities | $(127.9) | | Net cash provided by investing activities | $310.9 | | Net cash provided by financing activities | $9.9 | Reconciliation of GAAP to Non-GAAP Financial Measures This section reconciles GAAP to Non-GAAP financial results, primarily adjusting for a $478.8 million stock-based compensation expense in Q2 2025 GAAP to Non-GAAP Reconciliation for Q2 2025 (in millions) | Metric | GAAP | Stock-based Compensation Adjustment | Non-GAAP | | :--- | :--- | :--- | :--- | | Operating Expenses | $568.4 | $(478.8) | $89.6 | | Net Loss | $(565.7) | $478.8 | $(86.9) | - Non-GAAP measures are provided to investors for comparing prior periods and analyzing ongoing business trends by excluding non-cash charges like stock-based compensation[38][39] Appendix Glossary of Critical Terms This glossary defines critical scientific and clinical terms used in the report, enhancing clarity for the reader - Defines PD-1 as a protein on T cells that can act as a brake, preventing them from attacking cancer cells[44] - Defines VEGF (Vascular Endothelial Growth Factor) as a signaling protein that promotes angiogenesis (the formation of blood vessels), which tumors need to grow[49] - Defines PFS (Progression-Free Survival) as a key clinical trial endpoint measuring the time during and after treatment that a patient lives with the disease but it does not get worse[45]