Core Insights - Summit Therapeutics (SMMT) reported a third-quarter 2025 loss per share of 31 cents, significantly wider than the Zacks Consensus Estimate of a loss of 14 cents, and compared to a loss of 8 cents in the same period last year [1][2][9] - The company currently has no marketed products, resulting in no recorded revenues for the quarter [2] - Adjusted research and development expenses rose to $90.5 million, a 184% increase year over year, primarily due to higher clinical costs [3] - Adjusted general and administrative expenses increased by 82% year over year to $12.9 million, driven by costs associated with developing ivonescimab [3] - As of September 30, 2025, the company had cash and short-term investments totaling $238.6 million, down from $297.9 million as of June 30, 2025 [4] Pipeline Developments - Summit has one pipeline drug, ivonescimab, a bispecific antibody targeting PD-1 and VEGF, currently undergoing three late-stage studies for non-small cell lung cancer (NSCLC) [5] - The company plans to submit a regulatory filing to the FDA by year-end for ivonescimab plus chemotherapy for adults with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC [6] - Data from the HARMONi study indicated a favorable trend in overall survival, despite not meeting the primary endpoint [6] - Additional data from the HARMONi-6 study showed ivonescimab reduced the risk of disease progression or death by 40% compared to BeOne Medicines' Tevimbra [7] - Major protocol amendments were announced for the HARMONi-3 study, which will now include separate analyses for squamous and non-squamous NSCLC [8] - The company is expanding ivonescimab's development to include a phase III study for unresectable metastatic colorectal cancer (CRC), with enrollment expected to start before year-end [12][13] Market Reaction - Shares of Summit fell nearly 5% following the announcement of the amended HARMONi-3 protocol, reflecting investor concerns over the changes and the wider-than-expected loss reported [9][10] - Year to date, the stock has risen over 12%, outperforming the industry average increase of 9% [10]

​Summit Therapeutics Inc. (NASDAQ:SMMT) is one of the Best Growth Stocks Under $25 to Buy Right Now. On October 17, Summit Therapeutics Inc. (NASDAQ:SMMT) announced the expansion of its Phase 3 clinical development program called HARMONi-GI3, for its candidate Ivonescimab. ​Ivonescimab is a novel biospecific antibody that combines with chemotherapy in patients with unresectable metastatic colorectal cancer. The phase 3 trials will compare ivonescimab plus chemotherapy with bevacizumab plus chemotherapy as ...

ConversationJeffrey Rosenfeld Good morning, ladies and gentlemen. My name is Professor Jeffrey Rosenfeld, and I have the privilege of being the Chair of CLINUVEL Pharmaceuticals Limited. As Chair of today's meeting, it is my pleasure to welcome you to CLINUVEL's 2025 AGM. I note that we have complied with the relevant requirements for convening this meeting and that a quorum is present. As the time is now 10:00 a.m. in Melbourne, just after, I formally declare the meeting open. Before the formal business ...

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Summit Therapeutics Inc. (NASDAQ:SMMT) stock is trading lower on Monday. The company shared progress on its lead drug candidate and third-quarter financial results.On Sunday, Summit Therapeutics shared results from the Phase 3 HARMONi-6 trial, conducted in China by its partner, Akeso Inc.The data were presented at the European Society for Medical Oncology 2025 Congress.The trial showed that Ivonescimab and chemo reduced the risk of progression or death by 40% compared with BeOne Medicines Inc.’s (NASDAQ:ONC ...

Financial Data and Key Metrics Changes - The company ended Q3 2025 with a cash position of approximately $238.56 million [38] - Total GAAP operating expenses for Q3 2025 were $234.2 million, a decrease from $568.4 million in Q2 2025, primarily due to a higher stock-based compensation expense recorded in the previous quarter [39] - Non-GAAP operating expenses for Q3 2025 were $103.4 million, an increase from $89.6 million in the previous quarter, mainly due to increased R&D expenses related to ongoing trials [39] Business Line Data and Key Metrics Changes - The HARMONi-3 study is enrolling ahead of goals, with over 80% of the planned 600 squamous patients cohort already enrolled, expected to complete enrollment in Q1 2026 [37] - The non-squamous cohort in HARMONi-3 is also enrolling ahead of plan, with an expected completion for 1,000 patients in the second half of 2026 [37] Market Data and Key Metrics Changes - The company announced the expansion of its clinical development program with the addition of the global phase III HARMONi-GI3 trial, evaluating ivonescimab as first-line therapy in unresectable metastatic colorectal cancer [24] - The HARMONi-6 study demonstrated a significant progression-free survival benefit for ivonescimab in advanced squamous non-small cell lung cancer, with a hazard ratio of 0.60 [18] Company Strategy and Development Direction - The company aims to establish ivonescimab as a new standard of care for advanced squamous non-small cell lung cancer, with ongoing studies to support this goal [20] - The strategic focus includes expanding ivonescimab's application beyond lung cancer to other solid tumors, with a total of 14 planned or ongoing phase III clinical trials [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the results of the HARMONi-6 study and its implications for future studies, highlighting the potential for ivonescimab to address unmet needs in oncology [23] - The company is preparing to submit a Biologics License Application (BLA) for ivonescimab based on the HARMONi study results, with expectations for FDA approval [27][28] Other Important Information - The company has had continuous interactions with the FDA regarding the BLA submission and is confident in the safety and efficacy data generated from the HARMONi studies [54] - The HARMONi-3 study has undergone protocol amendments to separate statistical analyses by histology, which is expected to reduce regulatory risks [74] Q&A Session Summary Question: When could we expect to see the first OS cut from HARMONi-6? - Management indicated that specific timelines are difficult to disclose, but a review in 2026 is a fair estimate [44] Question: What options are being evaluated to extend the runway for funding? - The company has an ATM with approximately $350 million and has received inbound interest for additional capital [48] Question: Can you provide any color on the BLA submission and interactions with the FDA? - Continuous interactions with the FDA have been positive, and the company is moving forward with the BLA submission based on the data from HARMONi [54] Question: What prompted the protocol amendments to HARMONi-3? - The amendments were made to accelerate the front-line lung cancer opportunity and reduce regulatory risks by separating analyses by histology [74]

Financial Data and Key Metrics Changes - The company ended Q3 2025 with a cash position of approximately $238.66 million [38] - Total GAAP operating expenses for 2025 were $234.2 million, a decrease from $568.4 million in the previous year, primarily due to higher stock-based compensation expenses recorded in the previous quarter [39] Business Line Data and Key Metrics Changes - The company announced the extension of its Phase III clinical development programs, including a global Phase III study in first-line colorectal cancer [3][24] - The HARMONY six study demonstrated a median progression-free survival (PFS) of 11.14 months for ivanesumab plus chemotherapy compared to 6.90 months for tislelizumab plus chemotherapy, indicating a significant improvement [12][19] Market Data and Key Metrics Changes - The HARMONY six trial included a predominantly male population with advanced squamous non-small cell lung cancer, showing a consistent benefit across various PD-L1 expression levels [11][19] - The company plans to expand its clinical trials beyond lung cancer, with the addition of the HARMONY GI III trial for unresectable colorectal cancer [24][31] Company Strategy and Development Direction - The company intends to submit a Biologics License Application (BLA) for ivanesumab based on the results of the HARMONY study, aiming to establish it as a new standard of care for advanced squamous non-small cell lung cancer [4][27] - The strategic focus includes increasing the number of ongoing Phase III clinical trials to 14, evaluating ivanesumab in multiple solid tumors [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the results of the HARMONY six study and its implications for future studies, highlighting the potential of ivanesumab to provide clinically meaningful improvements for patients [19][24] - The company is actively engaging with the FDA regarding the BLA submission and is confident in the strength of its data package [55][62] Other Important Information - The HARMONY six study was conducted in China and sponsored by Akeso, with all relevant data generated and analyzed by them [3][10] - The company has plans to activate clinical trial sites in the U.S. for the HARMONY GI III study by the end of 2025 [31] Q&A Session Summary Question: When could the first overall survival (OS) cut from HARMONY six be expected? - Management indicated that while they cannot provide specific timelines, they anticipate something can be reviewed in 2026, but it is event-driven [42][45] Question: What are the funding options being evaluated to extend the runway? - Management mentioned that they have an ATM out there with approximately $350 million and have received inbound interest for additional capital [49][51] Question: Can you provide any color on the BLA submission and interactions with the FDA? - Management confirmed that they are actively finalizing the BLA package and have had continued interactions with the FDA, looking forward to feedback after submission [54][55] Question: What prompted the protocol amendments to HARMONY three? - The amendments were made to accelerate the frontline lung cancer opportunity and reduce regulatory risks by separating the two histologies into individual analyses [80][84]

Financial Data and Key Metrics Changes - The company ended Q3 2025 with a cash position of approximately $238.56 million [36] - Total GAAP operating expenses for Q3 2025 were $234.2 million, a decrease from $568.4 million in Q2 2025, primarily due to a higher stock-based compensation expense recorded in the previous quarter [36][37] - Non-GAAP operating expenses for Q3 2025 were $103.4 million, an increase from $89.6 million in the previous quarter, mainly due to increased R&D expenses related to ongoing trials [37] Business Line Data and Key Metrics Changes - The Harmony Three study is enrolling ahead of goals, with over 80% of the planned 600 squamous patients cohort expected to complete enrollment in Q1 2026 [35] - The Harmony GI3 study, evaluating ivonescimab in colorectal cancer, is set to begin activating clinical trial sites in the U.S. by the end of 2025, with an expected enrollment of 600 patients [30][22] Market Data and Key Metrics Changes - The Harmony Six study demonstrated a median progression-free survival (PFS) of 11.14 months for ivonescimab plus chemotherapy compared to 6.90 months for the control group, indicating a significant clinical benefit [10][17] - The study showed consistent benefits across various PD-L1 expression levels, with hazard ratios of 0.55 for negative, 0.63 for low, and 0.71 for high PD-L1 expression [11][17] Company Strategy and Development Direction - The company plans to submit a Biologics License Application (BLA) for ivonescimab based on the Harmony study results, aiming to establish it as a new standard of care for advanced squamous non-small cell lung cancer [24][19] - The clinical development program has expanded to include multiple phase three trials across various solid tumors, indicating a strategic focus on broadening the application of ivonescimab [22][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the results from Harmony Six and its implications for future studies, emphasizing the potential of ivonescimab to improve outcomes for patients with limited treatment options [21][19] - The company is actively engaging with the FDA and is confident in the safety and efficacy data supporting the BLA submission [52][51] Other Important Information - The Harmony Six study was conducted in China and sponsored by Akeso Inc., with all relevant data managed and analyzed by them [2][6] - The company highlighted the importance of the safety profile of ivonescimab, noting low rates of adverse events leading to discontinuation [12][17] Q&A Session Summary Question: When could the first overall survival (OS) cut from Harmony Six be expected? - Management indicated that a review in 2026 is likely, but specific timelines are difficult to disclose [41][43] Question: What options are being evaluated to extend the runway for funding? - The company has an ATM with approximately $350 million and has received inbound interest for additional capital [47][48] Question: Can you provide insights on the BLA submission and interactions with the FDA? - Continuous interactions with the FDA have been positive, and the company is preparing to submit the BLA based on the Harmony data [51][52] Question: What prompted the protocol amendments to Harmony Three? - The amendments were made to accelerate the front-line lung cancer opportunity and reduce regulatory risks by separating analyses for squamous and non-squamous histologies [70][71]

Summit Therapeutics ESMO Update & Q3 2025 Earnings Call October 20, 2025 8:00am ET Forward Looking Statement Any statements in this press release 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 ...