Core Viewpoint - H.C. Wainwright has raised the target price for Summit Therapeutics Inc. (SMMT.US) from $44 to $50 while maintaining a "Buy" rating, indicating a positive outlook for the company [1] Company Overview - Summit Therapeutics is a biopharmaceutical company focused on the research and commercialization of innovative therapies aimed at addressing significant unmet medical needs [1] - The company's current clinical development projects primarily target Clostridium difficile infection (CDI) [1] Market Position - The report highlights that now is an opportune time to invest in Summit, as it serves as a partner for CanSino Biologics (09926) in the U.S. market, providing a unique advantage [1] Clinical Data - The report mentions that CanSino's ivonescimab Phase III study HARMONi-A data validates clinical results in China, demonstrating its efficacy superior to Keytruda [1]

Group 1 - H.C. Wainwright raised the target price for Summit Therapeutics Inc. from $44 to $50 while maintaining a "Buy" rating [1] - The report highlights that the phase III study HARMONi-A data from Kangfang Biotech validates clinical results in China, demonstrating efficacy superior to Keytruda [1] - Summit Therapeutics is positioned as a unique partner for Kangfang Biotech in the U.S. market, presenting a favorable opportunity for investment [1] Group 2 - Summit Therapeutics is a biopharmaceutical company focused on developing and commercializing innovative therapies for serious unmet medical needs [1] - The company's current clinical development projects primarily target Clostridium difficile infection (CDI) [1] - Summit's products emphasize benefits for patients, families, healthcare providers, and society, aiming to extend life and improve quality of life [1]

Core Viewpoint - The article identifies Pfizer, Summit Therapeutics, and Vertex Pharmaceuticals as strong investment opportunities in the pharmaceutical sector, highlighting their growth potential and current market conditions. Group 1: Pfizer - Pfizer is considered a top stock in healthcare due to its low valuation, high yield, and growth prospects, appealing to both dividend and growth investors [3][7] - Despite facing challenges this year related to tariffs and healthcare reform, Pfizer's underlying financials remain solid, with an adjusted EPS guidance increase to between $2.90 and $3.10 from a previous forecast of $2.80 to $3.00 [4] - The company has seen strong growth across major segments, including primary care (12%), specialty care (7%), and oncology (11%), and currently offers a dividend yield of around 6.7% [5] Group 2: Summit Therapeutics - Summit Therapeutics has experienced a significant stock increase of nearly 2,000% over three years, now holding a market cap of $18 billion [8] - The leading candidate, ivonescimab, has shown promising results in clinical trials for non-small cell lung cancer, potentially challenging the market leader, Keytruda [9][10] - Analysts project ivonescimab could generate approximately $4.4 billion in sales by 2030, indicating substantial future growth potential [11] Group 3: Vertex Pharmaceuticals - Vertex Pharmaceuticals' stock has declined over 20% due to recent pipeline setbacks, but it is viewed as a buying opportunity [13] - The company has three new products expected to drive significant sales growth, including Alyftrek for cystic fibrosis and Casgevy for rare blood disorders [14] - Vertex's new pain medication, Journavx, is gaining traction, and the company is investing in its sales and marketing efforts [15] - Vertex's PEG ratio is notably low at 0.58, suggesting it is undervalued relative to its growth prospects [17]

Summit Therapeutics Inc SMMT and Akeso said ivonescimab, a PD-1xVEGF bispecific antibody, can extend patients' lives for EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) progressed after EGFR-TKI treatment.Akeso said that the clinical trial’s final overall survival (OS) analysis showed that ivonescimab met the OS clinical endpoint.A "statistically significant and clinically meaningful" overall survival (OS) benefit has been observed in the final analysis of ivones ...

Core Insights - Summit Therapeutics (SMMT) reported a second-quarter 2025 loss per share of $0.76, significantly wider than the Zacks Consensus Estimate of a loss of $0.10, and compared to a loss of $0.09 in the same period last year [1][7] - The company currently has no marketed products, resulting in no recorded revenues for the quarter [2] - Year-to-date, SMMT shares have increased by 58.3%, outperforming the industry average increase of 5.3% [2] Financial Performance - Adjusted research and development expenses reached $79.4 million, a 190.8% increase year-over-year, primarily due to higher costs for expanding clinical studies for ivonescimab [4] - Adjusted general and administrative expenses rose by 64.5% year-over-year to $10.2 million, driven by costs associated with developing infrastructure for ivonescimab [4] - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $297.9 million, down from $361.3 million as of March 31, 2025 [5] Pipeline Developments - Summit's only pipeline drug, ivonescimab, is a first-in-class bispecific antibody targeting PD-1 and VEGF, currently undergoing three late-stage studies for non-small cell lung cancer (NSCLC) [8] - The phase III HARMONi study showed that ivonescimab plus chemotherapy reduced the risk of disease progression by 48% compared to chemotherapy alone, but did not achieve statistically significant overall survival benefits [9][10] - The company plans to file for approval of the ivonescimab-chemo combination for previously treated EGFR-mutated NSCLC, pending further discussions with the FDA regarding the need for statistically significant overall survival benefits [10] Recent Study Results - Positive results were reported from the Akeso-sponsored phase III HARMONi-6 study, where ivonescimab plus chemotherapy showed significant improvement in progression-free survival compared to BeiGene's PD-1 inhibitor [11] - The HARMONi-3 study is evaluating ivonescimab against Merck's Keytruda in first-line metastatic NSCLC patients [12] - The HARMONi-2 study previously demonstrated that ivonescimab outperformed Keytruda in patients with positive PD-L1 expression [13] Collaborations and Approvals - Akeso has secured approval for ivonescimab in a second indication for front-line PD-L1 positive advanced NSCLC based on HARMONi-2 results [14] - Summit has entered clinical trial collaborations with Pfizer and Revolution Medicines to evaluate ivonescimab in combination with their drugs across various solid tumor settings [15]

Core Viewpoint - A class action lawsuit has been filed against Summit Therapeutics Inc. for alleged violations of securities laws related to misleading statements about its drug study results [1][4]. Group 1: Lawsuit Details - The lawsuit is based on violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 [1]. - Investors who purchased securities between March 17, 2022, and September 22, 2022, are encouraged to participate in the lawsuit [2]. - The class has not yet been certified, meaning potential participants are not currently represented by an attorney [3]. Group 2: Allegations Against the Company - The complaint alleges that Summit Therapeutics made false and misleading statements regarding the results of its Pinnacle Study of poziotinib, a treatment for lung cancer [4]. - The misleading public statements caused investors to suffer damages once the truth about the company's situation was revealed [4].

[Report Overview & Highlights](index=1&type=section&id=Report%20Overview%20%26%20Highlights) [Second Quarter 2025 Highlights](index=1&type=section&id=Second%20Quarter%202025%20Highlights) 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](index=1&type=chunk) - 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](index=1&type=chunk) - 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](index=1&type=chunk) - Summit entered a clinical collaboration with Revolution Medicines to evaluate ivonescimab in combination with three different RAS(ON) inhibitors for RAS mutant tumors[1](index=1&type=chunk) [Operational & Corporate Updates](index=1&type=section&id=Operational%20%26%20Corporate%20Updates) [Ivonescimab (SMT112) Development Progress](index=1&type=section&id=Ivonescimab%20(SMT112)%20Development%20Progress) 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](index=2&type=chunk) - 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](index=2&type=chunk) - 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](index=2&type=chunk)[3](index=3&type=chunk) [Key Clinical Trial Results](index=2&type=section&id=Key%20Clinical%20Trial%20Results) 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](index=3&type=chunk) - 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](index=4&type=chunk) - 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](index=4&type=chunk) [Collaborations and Ongoing Trials](index=3&type=section&id=Collaborations%20and%20Ongoing%20Trials) 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](index=4&type=chunk) - Enrollment is ongoing in Summit's global Phase III trials, HARMONi-3 and HARMONi-7[4](index=4&type=chunk) - 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](index=4&type=chunk) [Financial Highlights](index=4&type=section&id=Financial%20Highlights) [Financial Position](index=4&type=section&id=Financial%20Position) 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](index=8&type=chunk) [Stock-Based Compensation Modification](index=4&type=section&id=Stock-Based%20Compensation%20Modification) 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](index=8&type=chunk) - This modification led to a total non-cash stock-based compensation expense of **$466.6 million** being recognized in Q2 2025[8](index=8&type=chunk) - An additional **$454.6 million** in unrecognized non-cash stock-based compensation expense will be recognized over the future service period[8](index=8&type=chunk) [Operating Expenses, R&D, G&A, and Net Loss](index=4&type=section&id=Operating%20Expenses%2C%20R%26D%2C%20G%26A%2C%20and%20Net%20Loss) 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](index=8&type=chunk) - The increase in Non-GAAP operating and R&D expenses was due to the expansion of clinical studies and development costs for ivonescimab[8](index=8&type=chunk)[12](index=12&type=chunk) [About Ivonescimab and Summit Therapeutics](index=6&type=section&id=About%20Ivonescimab%20and%20Summit%20Therapeutics) [About Ivonescimab (SMT112)](index=6&type=section&id=About%20Ivonescimab%20(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](index=14&type=chunk) - 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](index=14&type=chunk)[15](index=15&type=chunk) - 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](index=15&type=chunk)[16](index=16&type=chunk) [Clinical Development Program for Ivonescimab](index=6&type=section&id=Clinical%20Development%20Program%20for%20Ivonescimab) 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](index=17&type=chunk) - Akeso has completed three positive Phase III trials in China: HARMONi-A, HARMONi-2, and HARMONi-6, all in NSCLC[20](index=20&type=chunk) - Ivonescimab has received Fast Track designation from the US FDA for the HARMONi clinical trial setting[23](index=23&type=chunk) [About Summit Therapeutics](index=7&type=section&id=About%20Summit%20Therapeutics) 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](index=24&type=chunk) - Founded in 2003, it is headquartered in Miami, Florida, with additional offices in California and the UK[25](index=25&type=chunk) - The company's stock is listed on the Nasdaq Global Market with the symbol "**SMMT**"[25](index=25&type=chunk) [Financial Statements and Non-GAAP Reconciliation](index=9&type=section&id=Financial%20Statements%20and%20Non-GAAP%20Reconciliation) [GAAP Condensed Consolidated Financial Statements](index=9&type=section&id=GAAP%20Condensed%20Consolidated%20Financial%20Statements) 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](index=11&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Measures) 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](index=38&type=chunk)[39](index=39&type=chunk) [Appendix](index=13&type=section&id=Appendix) [Glossary of Critical Terms](index=13&type=section&id=Glossary%20of%20Critical%20Terms) 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](index=44&type=chunk) - Defines **VEGF** (Vascular Endothelial Growth Factor) as a signaling protein that promotes angiogenesis (the formation of blood vessels), which tumors need to grow[49](index=49&type=chunk) - 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](index=45&type=chunk)

[FORM 10-Q](index=1&type=section&id=FORM%2010-Q) [CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=3&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) [PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, stockholders' equity, and cash flows, along with detailed notes on organization, accounting policies, segment reporting, key agreements, and financial performance [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--------------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $297,872 | $104,862 | | Short-term investments | — | $307,487 | | Total current assets | $309,240 | $423,750 | | Total assets | $324,037 | $435,560 | | Total current liabilities | $60,325 | $41,729 | | Total liabilities | $64,598 | $46,812 | | Total stockholders' equity | $259,439 | $388,748 | - Cash and cash equivalents increased significantly from **$104.86 million to $297.87 million**, while short-term investments were fully liquidated[16](index=16&type=chunk) - Total assets decreased by approximately **25.6%** from **$435.56 million to $324.04 million**[16](index=16&type=chunk) - Total liabilities increased by approximately **37.9%** from **$46.81 million to $64.60 million**[16](index=16&type=chunk) - Total stockholders' equity decreased by approximately **33.3%** from **$388.75 million to $259.44 million**[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric (in thousands) | 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 | $208,021 | $30,798 | $259,286 | $61,671 | | Acquired in-process R&D | — | $15,007 | — | $15,007 | | General and administrative | $360,416 | $13,812 | $376,002 | $25,328 | | Total operating expenses | $568,437 | $59,617 | $635,288 | $102,006 | | Net loss | $(565,708) | $(60,385) | $(628,621) | $(103,858) | | Basic and diluted EPS | $(0.76) | $(0.09) | $(0.85) | $(0.15) | - Net loss for the three months ended June 30, 2025, increased significantly to **$565.71 million** from **$60.39 million** in the prior year period[18](index=18&type=chunk) - Research and development expenses surged to **$208.02 million** in Q2 2025 from **$30.80 million** in Q2 2024, and general and administrative expenses increased to **$360.42 million** from **$13.81 million**[18](index=18&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) | Metric (in thousands) | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :------------ | | Common Stock (Amount) | $7,376 | $7,428 | | Additional Paid-In Capital | $1,598,230 | $2,097,957 | | Accumulated Deficit | $(1,214,573) | $(1,843,194) | | Total Stockholders' Equity | $388,748 | $259,439 | - Total stockholders' equity decreased by **$129.31 million** from **$388.75 million** at December 31, 2024, to **$259.44 million** at June 30, 2025[21](index=21&type=chunk) - The accumulated deficit increased by **$628.62 million**, reflecting the net loss incurred during the period[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(127,912) | $(63,136) | | Net cash provided by (used in) investing activities | $310,918 | $(180,208) | | Net cash provided by financing activities | $9,899 | $200,697 | | Increase (decrease) in cash, cash equivalents and restricted cash | $193,004 | $(42,671) | | Cash, cash equivalents and restricted cash at end of period | $298,191 | $28,754 | - Net cash used in operating activities increased by over **100%** to **$127.91 million** in H1 2025 from **$63.14 million** in H1 2024[23](index=23&type=chunk) - Investing activities shifted from a net cash outflow of **$180.21 million** in H1 2024 to a net cash inflow of **$310.92 million** in H1 2025, primarily due to maturities of short-term investments[23](index=23&type=chunk) - Financing activities provided **$9.90 million** in H1 2025, a significant decrease from **$200.70 million** in H1 2024, which included proceeds from a private placement[23](index=23&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Organization](index=8&type=section&id=1.%20Organization) - Summit Therapeutics Inc. is a biopharmaceutical company focused on oncology, with ivonescimab as its lead development candidate, a novel bispecific antibody combining PD-1 blockade with anti-VEGF effects[25](index=25&type=chunk)[26](index=26&type=chunk) - The company's cash and cash equivalents are insufficient to fund planned operations for at least one year, raising substantial doubt about its ability to continue as a going concern[31](index=31&type=chunk)[33](index=33&type=chunk) [2. Summary of Significant Accounting Policies and Recent Accounting Pronouncements](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies%20and%20Recent%20Accounting%20Pronouncements) - No significant changes to the company's accounting policies for the six months ended June 30, 2025[35](index=35&type=chunk) - Adopted ASU 2023-09 (Improvements to Income Tax Disclosures) on January 1, 2025, with no material impact[36](index=36&type=chunk) - Currently evaluating the impact of ASU 2024-03 (Disaggregation of Income Statement Expenses) and the One Big Beautiful Bill Act (OBBBA) on financial statements[37](index=37&type=chunk)[38](index=38&type=chunk) [3. Segment Reporting](index=10&type=section&id=3.%20Segment%20Reporting) - The company operates as a single reportable operating segment, with key operating and strategic decisions made by the Co-Chief Executive Officers and Chief Operating Officer/Chief Financial Officer[41](index=41&type=chunk) Segment Expenses (in thousands) | Segment Expenses (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Oncology clinical trial related costs | $67,824 | $19,955 | $104,187 | $41,852 | | Acquired in-process R&D | — | $15,007 | — | $15,007 | | Stock-based compensation | $478,784 | $11,088 | $489,880 | $20,595 | [4. Akeso License and Collaboration Agreement](index=11&type=section&id=4.%20Akeso%20License%20and%20Collaboration%20Agreement) - The company in-licensed ivonescimab from Akeso in December 2022, obtaining rights to develop and commercialize it in the United States, Canada, Europe, and Japan[43](index=43&type=chunk)[45](index=45&type=chunk) - In June 2024, the License Agreement was amended to expand territories to include Latin America, Middle East, and Africa, for an upfront payment of **$15 million**[47](index=47&type=chunk)[48](index=48&type=chunk) - Akeso is eligible for potential milestone payments up to **$4.56 billion** (**$1.05 billion** regulatory, **$3.51 billion** commercial) and low double-digit royalties on net sales[49](index=49&type=chunk) [5. Other Income, net](index=12&type=section&id=5.%20Other%20Income%2C%20net) Other Income, net (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Foreign currency losses | $(199) | $(244) | $(122) | $(36) | | Investment income | $2,981 | $2,578 | $6,842 | $4,407 | | Other income, net | $2,729 | $2,334 | $6,667 | $4,371 | - Other income, net, increased by **$0.4 million** (QoQ) and **$2.3 million** (YoY) primarily due to higher investment income from money market funds and short-term investments[51](index=51&type=chunk) [6. Net Loss per Share](index=12&type=section&id=6.%20Net%20Loss%20per%20Share) Net Loss per Share (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 | | :----- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(565,708) | $(60,385) | $(628,621) | $(103,858) | | Basic and diluted net loss per share | $(0.76) | $(0.09) | $(0.85) | $(0.15) | - Basic and diluted net loss per share are identical for all periods presented because the company was in a loss position, making all potential common share equivalents anti-dilutive[52](index=52&type=chunk) [7. Fair Value Measurements and Short-Term Investments](index=12&type=section&id=7.%20Fair%20Value%20Measurements%20and%20Short-Term%20Investments) - Financial assets included in cash and cash equivalents, primarily money market funds, are classified as Level 1 in the fair value hierarchy[61](index=61&type=chunk) - As of June 30, 2025, the company held no short-term investments, compared to **$307.49 million** in U.S. Government treasury bills (Level 2) at December 31, 2024[61](index=61&type=chunk) - Realized gains on short-term investments were immaterial for all periods presented[64](index=64&type=chunk) [8. Research and Development Prepaid Expenses and Accrued Liabilities](index=14&type=section&id=8.%20Research%20and%20Development%20Prepaid%20Expenses%20and%20Accrued%20Liabilities) R&D Prepaid Expenses and Accrued Liabilities (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | R&D prepaid expenses | $8,155 | $8,338 | | Accrued R&D liabilities | $24,584 | $17,441 | - These amounts are determined based on estimated costs and the current stage of completion for ivonescimab clinical trials[66](index=66&type=chunk) [9. Promissory Note Payable to Related Parties](index=14&type=section&id=9.%20Promissory%20Note%20Payable%20to%20Related%20Parties) - The December 2022 Promissory Notes, totaling **$520 million**, issued to Mr. Duggan and Dr. Zanganeh, were fully repaid by October 1, 2024[67](index=67&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) - The company had no debt as of June 30, 2025, and incurred no interest expense during the three and six months ended June 30, 2025, compared to **$3.10 million** and **$6.22 million**, respectively, in the prior year periods[74](index=74&type=chunk) [10. Stockholders' Equity](index=15&type=section&id=10.%20Stockholders'%20Equity) - The company has **1,000,000,000** shares of Common Stock authorized and **20,000,000** shares of Preferred Stock authorized, with none issued[75](index=75&type=chunk)[76](index=76&type=chunk) - In June 2024, the company sold **22,222,222** shares of Common Stock for approximately **$200 million** in a private placement[77](index=77&type=chunk) - In September 2024, the company sold **10,352,418** shares of Common Stock for approximately **$235 million** in a private placement, with significant participation from Section 16 officers[81](index=81&type=chunk)[82](index=82&type=chunk) - As of June 30, 2025, the company sold **1,807,093** shares under its ATM Agreement for gross proceeds of **$44.22 million**, with **$45.78 million** remaining available[85](index=85&type=chunk) - During the six months ended June 30, 2025, **4,629,988** warrants were exercised at a weighted average exercise price of **$1.58**[86](index=86&type=chunk) [11. Stock-Based Compensation](index=16&type=section&id=11.%20Stock-Based%20Compensation) Stock-Based Compensation (in thousands) | Stock-Based Compensation (in thousands) | 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 | $128,577 | $3,513 | $132,636 | $5,927 | | General and administrative | $350,207 | $7,575 | $357,244 | $14,668 | | Total stock-based compensation expense | $478,784 | $11,088 | $489,880 | $20,595 | - Total stock-based compensation expense increased significantly to **$478.78 million** in Q2 2025 from **$11.09 million** in Q2 2024[93](index=93&type=chunk) - The increase was primarily due to a Type III modification in Q2 2025, converting **44,488,976** unvested performance-based stock options to time-based vesting, resulting in **$466.64 million** expense[92](index=92&type=chunk) - Unrecognized compensation cost associated with this modification was **$454.61 million** as of June 30, 2025, to be expensed over approximately **2.0 years**[92](index=92&type=chunk) [12. Related Party Transactions](index=18&type=section&id=12.%20Related%20Party%20Transactions) - The company has sublease agreements with Maky Zanganeh and Associates, Inc. (MZA) and affiliates of Co-CEO Robert W. Duggan (Genius 24C Inc. and Investments Research LLC)[95](index=95&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - Payments to Akeso for clinical services were **$14.00 million** in Q2 2025 and **$18.74 million** in H1 2025[102](index=102&type=chunk) - Section 16 officers, including Mr. Duggan and Dr. Zanganeh, participated in the September 2024 Private Placement, purchasing **$78.50 million** in shares[103](index=103&type=chunk)[104](index=104&type=chunk) - Mr. Duggan exercised **3,985,055** warrants in March and April 2025 at an exercise price of **$1.58** per share[106](index=106&type=chunk)[107](index=107&type=chunk) - Incurred **$0.4 million** (Q2 2025) and **$0.6 million** (H1 2025) in legal expenses from Wilson Sonsini Goodrich & Rosati P.C., where a board member is a partner[108](index=108&type=chunk) [13. Commitments and Contingencies](index=20&type=section&id=13.%20Commitments%20and%20Contingencies) - The company has undiscounted operating lease commitments of **$22.34 million** for a new Palo Alto office space, expected to commence in Q1 2026[110](index=110&type=chunk) - Unable to estimate the amount, timing, or likelihood of achieving milestones or future product sales for contingent payment obligations under the Akeso agreements[112](index=112&type=chunk) - A derivative lawsuit was filed on March 17, 2025, concerning the December 2022 Notes, alleging breach of fiduciary duty and unjust enrichment[114](index=114&type=chunk) - An unknown third party filed a European Patent Opposition on June 18, 2025, against the ivonescimab patent EP3882275B1, asserting lack of inventive step[199](index=199&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, focusing on its lead oncology candidate ivonescimab, clinical trial progress, financial performance drivers, liquidity challenges, and going concern issues [Company Overview](index=21&type=section&id=Company%20Overview) - Summit Therapeutics is a biopharmaceutical company focused on oncology, with ivonescimab as its lead development candidate, a novel bispecific antibody combining PD-1 blockade with anti-VEGF effects[116](index=116&type=chunk)[117](index=117&type=chunk) - The company is conducting Phase III clinical trials for ivonescimab in non-small cell lung cancer (NSCLC), including HARMONi, HARMONi-3, and HARMONi-7[118](index=118&type=chunk) - The HARMONi clinical trial completed enrollment in October 2024 and announced statistically significant and clinically meaningful improvement in progression-free survival (PFS) in May 2025 (HR **0.52**)[118](index=118&type=chunk)[140](index=140&type=chunk) - Based on HARMONi results, Summit intends to file a Biologics License Application (BLA) for ivonescimab plus chemotherapy[121](index=121&type=chunk)[142](index=142&type=chunk) [Akeso Collaboration and License Agreement](index=22&type=section&id=Akeso%20Collaboration%20and%20License%20Agreement) - Summit holds rights to develop and commercialize ivonescimab in the Licensed Territory (US, Canada, Europe, Japan, Latin America, Middle East, and Africa)[123](index=123&type=chunk) - Upfront payments to Akeso included **$474.9 million** cash and **10 million** shares in 2023, plus **$15 million** cash in Q3 2024 for expanded territories[123](index=123&type=chunk) - Akeso is eligible for up to **$4.56 billion** in regulatory and commercial milestones, plus low double-digit royalties on net sales[123](index=123&type=chunk) [Ivonescimab](index=22&type=section&id=Ivonescimab) - Ivonescimab is a novel, potential first-in-class PD-1 / VEGF bispecific antibody, engineered with Akeso's Tetrabody technology to enhance antitumor activity by cooperatively binding targets in the tumor micro-environment[125](index=125&type=chunk)[127](index=127&type=chunk) - The design aims to improve efficacy and safety profiles by directing ivonescimab to tumor tissue versus healthy tissue[127](index=127&type=chunk) - Ivonescimab has been dosed in more than **2,800** patients globally across multiple Phase III and early-phase trials[128](index=128&type=chunk) [Akeso-Sponsored Ivonescimab Trials](index=23&type=section&id=Akeso-Sponsored%20Ivonescimab%20Trials) - HARMONi-A (China-based Phase III) achieved its primary endpoint of PFS (HR: **0.46**) in NSCLC patients who progressed after EGFR-TKI, leading to approval in China[130](index=130&type=chunk) - HARMONi-2 (China-based Phase III) demonstrated statistically significant PFS improvement (HR: **0.51**) as monotherapy versus pembrolizumab in first-line PD-L1 positive NSCLC, approved in China in April 2025[132](index=132&type=chunk)[134](index=134&type=chunk) - HARMONi-6 (China-based Phase III) showed statistically significant PFS improvement when ivonescimab combined with platinum-based chemotherapy in previously untreated advanced NSCLC[135](index=135&type=chunk) - Akeso is also conducting multiple other Phase III clinical trials for ivonescimab in various solid tumors[129](index=129&type=chunk) [Product Pipeline (Summit Sponsored Ivonescimab Trials)](index=25&type=section&id=Product%20Pipeline%20(Summit%20Sponsored%20Ivonescimab%20Trials)) - Summit is investigating ivonescimab in global Phase III clinical trials for NSCLC within its Licensed Territory[138](index=138&type=chunk) - The HARMONi study (2L+ EGFRm NSCLC) completed enrollment in North America and Europe in October 2024, with topline results in May 2025 showing statistically significant PFS (HR **0.52**)[139](index=139&type=chunk)[140](index=140&type=chunk) - The HARMONi-3 study (1L metastatic NSCLC) is actively enrolling patients in North America, China, and Europe, comparing ivonescimab plus chemotherapy to pembrolizumab plus chemotherapy[144](index=144&type=chunk)[145](index=145&type=chunk) - The HARMONi-7 study is enrolling patients for first-line metastatic NSCLC with high PD-L1 expression, comparing ivonescimab monotherapy to pembrolizumab monotherapy[146](index=146&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Results of Operations (in millions) | Metric (in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total operating expenses | $568.4 | $59.6 | $635.3 | $102.0 | | Other income, net | $2.7 | $2.3 | $6.7 | $4.3 | | Interest expense | — | $(3.1) | — | $(6.2) | | Net loss | $(565.7) | $(60.4) | $(628.6) | $(103.9) | - Net loss for Q2 2025 was **$(565.7) million**, a significant increase from **$(60.4) million** in Q2 2024, primarily due to higher operating expenses[151](index=151&type=chunk) [Operating Expenses](index=26&type=section&id=Operating%20Expenses) Operating Expense (in millions) | Operating Expense (in millions) | 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 | $208.0 | $30.8 | $259.3 | $61.7 | | General and administrative | $360.4 | $13.8 | $376.0 | $25.3 | - Research and development expenses increased by **$162.2 million** (QoQ) and **$182.6 million** (YoY) for the three and six months ended June 30, 2025, primarily due to a **$123.7 million** increase in stock-based compensation from option modification and increased oncology clinical trial costs[155](index=155&type=chunk) - General and administrative expenses increased by **$346.6 million** (QoQ) and **$350.7 million** (YoY) for the three and six months ended June 30, 2025, mainly driven by a **$342.9 million** increase in stock-based compensation from option modification, and higher compensation and legal fees[158](index=158&type=chunk)[159](index=159&type=chunk) [Other Income, net](index=28&type=section&id=Other%20Income%2C%20net) - Other income, net, increased by **$0.4 million** (QoQ) and **$2.4 million** (YoY) for the three and six months ended June 30, 2025, primarily due to higher investment income from increased short-term investment balances[161](index=161&type=chunk) [Interest Expense](index=28&type=section&id=Interest%20Expense) - Interest expense decreased to zero for the three and six months ended June 30, 2025, compared to **$3.1 million** and **$6.2 million**, respectively, in the prior year periods, due to the full repayment of promissory notes in October 2024[162](index=162&type=chunk) [Liquidity, Capital Resources and Going Concern](index=28&type=section&id=Liquidity%2C%20Capital%20Resources%20and%20Going%20Concern) - The company incurred a net loss of **$565.7 million** (Q2 2025) and **$628.6 million** (H1 2025), with cash used in operating activities of **$127.9 million** for H1 2025[163](index=163&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$1,843.2 million** and cash and cash equivalents of **$297.9 million**[163](index=163&type=chunk) - The company's cash and cash equivalents are insufficient to fund planned operations for at least one year, raising substantial doubt about its ability to continue as a going concern[164](index=164&type=chunk)[201](index=201&type=chunk) - The company plans to raise additional capital through equity and debt offerings, collaborations, strategic alliances, and licensing arrangements to fund ongoing operations and potential milestone payments of **$4.56 billion** to Akeso[165](index=165&type=chunk)[169](index=169&type=chunk)[171](index=171&type=chunk) [Going Concern](index=28&type=section&id=Going%20Concern) - The company's cash and cash equivalents are not sufficient to fund planned operations for at least one year from the financial statement issuance date, leading to substantial doubt about its ability to continue as a going concern[164](index=164&type=chunk)[201](index=201&type=chunk) - Management is evaluating options to raise additional capital through various financing methods, but there is no assurance that funding will be available on acceptable terms[165](index=165&type=chunk) [Sources of Liquidity](index=29&type=section&id=Sources%20of%20Liquidity) - Operations have been financed primarily through common stock issuances, including a **$235.0 million** private placement in September 2024 and **$44.2 million** from an ATM Agreement in 2024[166](index=166&type=chunk) - The company has a shelf registration statement for up to **$450 million**, with **$45.8 million** remaining under its ATM program as of June 30, 2025[168](index=168&type=chunk) - Future capital requirements will depend on factors such as clinical development of ivonescimab, regulatory approvals, commercialization efforts, and potential milestone payments of **$4.56 billion** to Akeso[169](index=169&type=chunk)[170](index=170&type=chunk) [Cash Flows](index=30&type=section&id=Cash%20Flows) Cash Flow Activity (in millions) | Cash Flow Activity (in millions) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(127.9) | $(63.1) | | Net cash provided by (used in) investing activities | $310.9 | $(180.2) | | Net cash provided by financing activities | $9.9 | $200.7 | - Net cash used in operating activities increased to **$127.9 million** in H1 2025, primarily due to a net loss of **$628.6 million** and a **$15.2 million** net change in working capital, partially offset by **$485.5 million** in non-cash charges (mainly stock-based compensation)[174](index=174&type=chunk) - Net cash provided by investing activities was **$310.9 million** in H1 2025, mainly from **$311.3 million** received from maturities of short-term investments[178](index=178&type=chunk) - Net cash provided by financing activities was **$9.9 million** in H1 2025, from warrant exercises and employee stock awards, a decrease from **$200.7 million** in H1 2024 which included private placement proceeds[180](index=180&type=chunk)[181](index=181&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - There have been no material changes to the company's critical accounting policies and estimates as disclosed in its Annual Report[183](index=183&type=chunk) - Management continues to evaluate estimates and judgments related to research and development expenses, stock-based compensation, and income taxes[182](index=182&type=chunk) [Recently Issued Accounting Pronouncements](index=31&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) - Refer to Note 2 for a discussion of recently issued accounting pronouncements, including the adoption of ASU 2023-09 and the evaluation of ASU 2024-03 and the OBBBA[186](index=186&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines the company's primary exposures to market risk, including liquidity, foreign currency, interest rate, and credit risk, highlighting significant liquidity risk due to ongoing capital needs, while foreign currency and interest rate risks are currently deemed immaterial, and credit risk is considered low [Liquidity Risk](index=32&type=section&id=Liquidity%20Risk) - The company faces significant liquidity risk due to its reliance on equity and debt securities for funding and the potential unavailability of adequate additional financing on acceptable terms[188](index=188&type=chunk) [Foreign Currency Exchange Rate Risk](index=32&type=section&id=Foreign%20Currency%20Exchange%20Rate%20Risk) - The company is exposed to foreign currency exchange rate risk from operating transactions denominated in pound sterling, U.S. dollar, Japanese Yen, and euro, but currently manages exposures through natural hedging, with no material impact[189](index=189&type=chunk) [Interest Rate Risk](index=32&type=section&id=Interest%20Rate%20Risk) - The company has minimal exposure to changes in the fair value of its investment portfolio due to the short-term nature of its cash, cash equivalents, and short-term investments[190](index=190&type=chunk) [Credit Risk](index=32&type=section&id=Credit%20Risk) - The company considers its material counterparties creditworthy and has a low concentration of credit risk, with a high likelihood of collecting **$1.4 million** in research and development tax credits[191](index=191&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms that management, including the Co-Chief Executive Officers and Chief Operating Officer/Chief Financial Officer, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, and reports no material changes in internal control over financial reporting during the quarter [Disclosure Controls and Procedures](index=32&type=section&id=Disclosure%20Controls%20and%20Procedures) - Management concluded that the company's disclosure controls and procedures were effective at a reasonable level of assurance as of June 30, 2025[193](index=193&type=chunk) [Changes in Internal Control over Financial Reporting](index=33&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[194](index=194&type=chunk) [PART II - OTHER INFORMATION](index=34&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) This section details two significant legal proceedings: a derivative lawsuit filed in March 2025 concerning the December 2022 Promissory Notes, alleging breach of fiduciary duty, and a European Patent Opposition filed in June 2025 against the ivonescimab patent [Litigation Relating to the December 2022 Notes Entered into in Connection with the License Agreement](index=34&type=section&id=Litigation%20Relating%20to%20the%20December%202022%20Notes%20Entered%20into%20in%20Connection%20with%20the%20License%20Agreement) - A derivative lawsuit was filed on March 17, 2025, alleging breach of fiduciary duty and unjust enrichment concerning the December 2022 Promissory Notes issued to Mr. Duggan and Dr. Zanganeh[197](index=197&type=chunk)[198](index=198&type=chunk) - The suit seeks unspecified damages and rescission of shares received as prepaid interest payments under the notes[197](index=197&type=chunk) - A motion to dismiss the complaint was filed, and briefing is stayed pending a Delaware Supreme Court decision on similar constitutional questions[198](index=198&type=chunk) [European Patent Opposition](index=34&type=section&id=European%20Patent%20Opposition) - On June 18, 2025, an unknown third party filed a notice of opposition against the company's in-licensed EP3882275B1 patent for ivonescimab in the European Patent Office, asserting lack of inventive step[199](index=199&type=chunk) - The company contests these assertions and intends to work with Akeso to file a timely response[199](index=199&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the Annual Report for a detailed discussion of risk factors, emphasizing the substantial doubt about the company's ability to continue as a going concern due to insufficient working capital and the uncertainty of raising additional funds - There is substantial doubt about the company's ability to continue as a going concern due to insufficient cash and cash equivalents to fund planned operations for the next twelve months[201](index=201&type=chunk) - Inability to raise additional capital could force delays or reductions in research and development programs, product portfolio expansion, or future commercialization efforts, potentially leading to a curtailment or cessation of operations[201](index=201&type=chunk) - No material changes to the risk factors disclosed in the Annual Report other than those explicitly mentioned in this Quarterly Report[202](index=202&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities during the reporting period that had not been previously disclosed in a Current Report on Form 8-K - No unregistered sales of equity securities occurred during the period covered by this Quarterly Report on Form 10-Q that were not previously included in a Current Report on Form 8-K[203](index=203&type=chunk) [Item 3. Defaults Upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms that there were no defaults upon senior securities during the reporting period - None[204](index=204&type=chunk) [Item 4. Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that there are no mine safety disclosures to report - None[206](index=206&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) This section indicates that there are no 10b5-1 trading plans to disclose - No 10b5-1 trading plans are reported[208](index=208&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section provides a comprehensive list of exhibits filed with the Form 10-Q, including corporate governance documents, certifications from executive officers, and XBRL taxonomy files - Exhibits include the Restated Certificate of Incorporation and Amended and Restated Bylaws, along with their amendments[211](index=211&type=chunk) - Certifications from the Chairman and CEO, Executive Director, CEO, President, and Principal Financial Officer are included, pursuant to the Sarbanes-Oxley Act[211](index=211&type=chunk) - XBRL Taxonomy Extension Schema, Calculation, Definition, Label, and Presentation Linkbase Documents, as well as the Cover Page Interactive Data File, are furnished[211](index=211&type=chunk) [SIGNATURES](index=37&type=section&id=SIGNATURES)

Few things can jolt a pharmaceutical company's shares like positive results from highly anticipated clinical trials. Even so, long-term investors should have a balanced approach to potentially positive data readouts. Putting aside the fact that it's impossible to predict the outcome of a clinical trial beforehand, even when the results are up to Wall Street's standards, it's hardly worth investing in the company unless there are other good reasons to think it will perform well over long periods. That's why ...

Core Viewpoint - Summit Therapeutics' shares increased nearly 9% following reports of AstraZeneca's interest in a potential licensing deal worth up to $15 billion for its experimental drug ivonescimab [1][2]. Group 1: Licensing Deal Details - AstraZeneca is considering a deal that may include "several billion dollars" in upfront payments, with the remainder contingent on milestone payments related to ivonescimab's development [2]. - The ongoing discussions have not been confirmed by either AstraZeneca or Summit Therapeutics, and there is a possibility that the deal may not materialize or that Summit may choose a different partner [3]. Group 2: Drug Performance and Development - Ivonescimab has shown promising results in clinical trials, significantly reducing the risk of disease progression or death in patients with advanced non-small cell lung cancer (NSCLC) compared to Merck's Keytruda [4]. - The drug is being developed in collaboration with Akeso, which originally developed ivonescimab, and Summit acquired exclusive rights to market the drug in various regions, including the U.S. and Europe [5]. Group 3: Market Context and Competitive Landscape - The stock of Summit Therapeutics has increased by 38% year-to-date, outperforming the industry average growth of 4% [6]. - The interest from AstraZeneca reflects a broader trend in oncology towards developing bispecific antibodies targeting both PD-1 and VEGF proteins, an area where Summit has established itself as a pioneer [9]. - If the licensing deal is finalized, AstraZeneca would gain a competitive edge in the bispecific antibody market, potentially surpassing competitors like Merck and Pfizer [10].