Core Insights - Summit Therapeutics announced that its main asset ivonescimab, developed in collaboration with Chinese partner Kangfang Biopharma, achieved its primary endpoint in a clinical trial for lung cancer treatment [1][2] - The phase 3 HARMONi trial demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) when ivonescimab was combined with chemotherapy, although the overall survival (OS) did not show statistically significant differences [1] - The trial focused on patients with locally advanced or metastatic non-squamous non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutations, who are resistant to third-generation EGFR tyrosine kinase inhibitors [1] Trial Results - The HARMONi trial showed that approximately 57% of patients receiving ivonescimab plus chemotherapy experienced grade 3 or higher treatment-related adverse events, compared to about 50% in the control group [1] - The results align with the HARMONi-A trial conducted in China, which led to the approval of ivonescimab combined with chemotherapy for lung cancer treatment by Chinese regulatory authorities [2] Regulatory Plans - Summit plans to utilize the HARMONi trial data to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of ivonescimab in combination with chemotherapy for the specified lung cancer patient population [2] Market Reaction - Following the announcement, Summit's stock experienced volatility, initially rising over 16% before dropping more than 12% in pre-market trading [3]

Summit Therapeutics PLC (SMMT) closed the last trading session at $25.85, gaining 10.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $37.38 indicates a 44.6% upside potential.The average comprises eight short-term price targets ranging from a low of $30 to a high of $44, with a standard deviation of $5.71. While the lowest estimate indicates an increase of 16.1% from the current ...

Group 1: Applied Digital - Applied Digital has a market cap of approximately $1.3 billion and a share price below $6, with significant growth potential due to rising demand for data centers and cloud infrastructure [3][4] - The stock has increased nearly 60% over the past year but remains about 50% below its peak in February 2025, indicating potential for price recovery [4] - The company operates multiple data centers in North Dakota and other states, and plans to sell its cloud services business to fund investments in AI and high-performance computing [5][6] Group 2: IonQ - IonQ is a leader in quantum computing technology, with a current market cap around $8.2 billion and a share price just over $33, targeting a total addressable market of $87 billion by 2035 [7][8] - The company offers the Forte Enterprise system, which is the only quantum hardware available on major cloud platforms, showcasing its competitive advantage [8][9] - IonQ has secured partnerships with major companies, including SK Telecom, Toyota Tsusho, General Dynamics, and Nvidia, highlighting its industry relevance [10] Group 3: Summit Therapeutics - Summit Therapeutics has a market cap of roughly $17.2 billion and is focused on developing ivonescimab, an immunotherapy for non-small cell lung cancer, with results expected in mid-2025 [11][12] - The company has a strong chance of U.S. approval for ivonescimab, supported by its partner Akeso's previous successes in China [13] - Summit is also exploring ivonescimab for other cancer types, indicating substantial growth potential if the drug meets expectations [14]

Summit Therapeutics Q1 2025 Earnings Call May 1, 2025 4:30pm ET Forward Looking Statement Any statements in this presentation about the Company's future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company's product candidates, entry into and actions related to the Company's partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company's product candidates, the pot ...

Summit Therapeutics PLC (SMMT) closed the last trading session at $28.02, gaining 61.8% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $37.38 indicates a 33.4% upside potential.The mean estimate comprises eight short-term price targets with a standard deviation of $5.71. While the lowest estimate of $30 indicates a 7.1% increase from the current price level, the most optimistic an ...

Core Viewpoint - Summit Therapeutics reported a narrower loss per share in Q1 2025 compared to estimates, but still lacks any marketed products, resulting in no quarterly revenues [1][2]. Financial Performance - The company reported a loss per share of 9 cents, which is better than the Zacks Consensus Estimate of a loss of 10 cents, but wider than the 6 cents loss from the previous year [1]. - Adjusted research and development expenses increased by 65% year over year to $47.1 million, primarily due to rising clinical costs [4]. - Adjusted general and administrative expenses surged 95% year over year to $8.6 million, attributed to higher headcount and commercial readiness efforts [4]. - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling $361.3 million, down from $412.3 million as of December 31, 2024 [5]. Pipeline Developments - Summit has one pipeline drug, ivonescimab, currently undergoing three late-stage studies for non-small cell lung cancer (NSCLC) [6]. - Positive results were reported from the Akeso-sponsored phase III HARMONi-6 study, showing significant improvement in progression-free survival compared to BeiGene's Tevimbra [7]. - The HARMONi-6 study is notable as the first late-stage study in NSCLC to demonstrate significant improvement over a PD-(L)1 inhibitor combined with chemotherapy [8]. - The company is also conducting the HARMONi-3 study, which compares ivonescimab plus chemotherapy against Merck's Keytruda [8]. - Akeso has secured approval for ivonescimab in a second indication based on HARMONi-2 results, although the interim overall survival analysis was not statistically significant [9]. - Summit is exploring partnerships for ivonescimab development across multiple disease areas, including a collaboration with Pfizer to evaluate the drug in combination with several of Pfizer's antibody-drug conjugates [10]. Stock Performance - SMMT's stock has surged 38% year to date, contrasting with a 2% decline in the industry [2].

Core Insights - Summit Therapeutics has seen a remarkable stock increase of 512% over the past year, primarily due to the clinical progress of its leading candidate, ivonescimab [1][2] - The company has licensed ivonescimab from Akeso, a China-based biopharmaceutical firm, and holds marketing rights in most regions outside of China, including the U.S. and Europe [3] - Ivonescimab is currently not approved in the U.S. but has received approval in China and is undergoing multiple clinical trials [4] Clinical Trial Results - A recent phase 3 clinical trial in China for ivonescimab in advanced squamous non-small cell lung cancer (NSCLC) showed statistically significant improvement in progression-free survival compared to Tevimbra, a competitor drug [5] - However, preliminary data from another phase 3 trial against Merck's Keytruda indicates that ivonescimab has not yet achieved a statistically significant improvement in overall survival [6][7] - Despite the mixed results, ivonescimab is involved in over a dozen other clinical trials targeting various cancer types, with NSCLC being a particularly attractive market due to its high mortality rate [8] Future Outlook - Ivonescimab has the potential to be a "pipeline in a drug," suggesting that it could lead to multiple label expansions beyond its initial indication [9] - The company is expected to continue experiencing volatility in the short term due to its clinical-stage status and broader market conditions, but long-term investment could yield significant returns [10]

Financial Data and Key Metrics Changes - The company ended Q1 2025 with a strong cash position of approximately $361 million and is now debt-free after paying off all debt in Q4 2024 [40]. - GAAP R&D expenses for Q1 2025 were $51.2 million, slightly down from $51.4 million in Q4 2024, while non-GAAP R&D expenses remained flat at $47.1 million [41]. - GAAP G&A expenses increased to $15.6 million in Q1 2025 from $14.2 million in Q4 2024, primarily due to increased professional services [42]. Business Line Data and Key Metrics Changes - The company is advancing its lead investigational asset, ivanismab, with significant progress in clinical trials, including four Phase 3 trials completed and five ongoing [13][14]. - The HARMONY trials are pivotal, with HARMONY three and HARMONY seven evaluating ivanismab against pembrolizumab in frontline non-small cell lung cancer [15][32]. Market Data and Key Metrics Changes - The addressable market for non-small cell lung cancer is expected to approach $20 billion for checkpoint inhibitors, with a broader market opportunity of approximately $90 billion globally across all checkpoint inhibitor indications [33][34]. - The company is exploring additional indications beyond non-small cell lung cancer, including colorectal cancer and pancreatic cancer, where ivanismab has shown promise [34]. Company Strategy and Development Direction - The company aims to build a viable organization that addresses serious unmet medical needs, focusing on ivanismab's potential as a platform blockbuster drug [11][33]. - Strategic collaborations, such as with MD Anderson and Pfizer, are in place to expand clinical development and explore innovative combinations [20][21]. Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the ongoing clinical progress and the potential of ivanismab, particularly in the context of upcoming data releases from the HARMONY trials [5][13]. - The management team highlighted the importance of demonstrating the differentiated mechanism of action for ivanismab compared to existing therapies [22][28]. Other Important Information - The company has strengthened its leadership team with the appointment of a new Chief Commercial Officer to refine its commercial strategy [39]. - The full dataset for the HARMONY six trial is planned to be presented at a major medical conference later this year, which is expected to provide further insights into ivanismab's efficacy [24]. Q&A Session Summary Question: What is the bar for success regarding the upcoming HARMONY eGFR dataset? - The company is not prescribing a specific bar but emphasizes the importance of overall data package consistency with prior data from China [48]. Question: Will there be separate hazard ratios for geographic data in HARMONY? - The top-line data will provide qualitative context, and a forest plot may be used to illustrate geographic breakdowns [58]. Question: What is the expected overall survival benefit to replace PD-1 standard of care? - A statistically significant improvement of two to three months in overall survival is generally considered transformative by clinicians [90]. Question: How does the safety profile in global populations compare to that in China? - The safety profile reported in trials has been reassuring, and while there may be minor cultural differences in reporting adverse events, significant differences are not expected [79]. Question: What are the plans for accelerated approval discussions with the FDA? - The company has had multiple discussions with the FDA regarding HARMONY three but does not disclose specific details of these conversations [96].

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________ FORM 10-Q _________________ (Mark One) or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-36866 Summit Therapeutics Inc. (Exact name of registrant as specified i ...

Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2025 Ivonescimab in Combination with Chemotherapy Achieves Statistically Significant Superiority in PFS vs. Tislelizumab (PD-1 Inhibitor) Plus Chemotherapy in First-Line Treatment of Patients with Advanced Squamous NSCLC in HARMONi-6 Study Conducted by Akeso in China Enrollment Continues in Global Phase III Trial HARMONi-3 in First-Line Treatment of Patients with Metastatic NSCLC Ivonescimab Receives ...