Market Overview - Equity markets have recently declined due to concerns over deteriorating macroeconomic conditions, particularly influenced by President Trump's trade wars, with the S&P 500 index down nearly 1.5% over the trailing-12-month period and a significant 13.8% drop so far this year [1] Company Performance: Summit Therapeutics - Summit Therapeutics is a clinical-stage biotech company with a market cap of $15.1 billion, notable for having no products on the market [3] - The company's leading candidate, ivonescimab, has shown strong clinical results, leading to a surge in share prices last year [3][5] - Summit has secured licensing rights for ivonescimab from Akeso Biopharma, allowing it to market the drug in multiple regions including North America and Europe [4] - Ivonescimab has already been approved in China and outperformed Keytruda in a phase 3 study for non-small cell lung cancer (NSCLC), a significant market for Keytruda [5] - The company is conducting several phase 3 studies for ivonescimab in the U.S. across various cancer types, indicating potential for future approvals and revenue growth [6][7] Company Performance: Robinhood Markets - Robinhood reported a 58% year-over-year revenue increase in 2024, reaching $2.95 billion, and achieved net earnings per share of $1.56, a turnaround from a loss of $0.61 the previous year [8] - The company's success has been partly attributed to crypto-related trading revenue, although it has shown growth in key metrics such as funded customers and assets under custody [9] - Robinhood is expanding its subscription service, Robinhood Gold, which ended the year with 2.6 million members, providing growth opportunities through increased spending on the platform [10] - The company has launched new products and made acquisitions, including the $300 million purchase of TradePMR, enhancing its position as a comprehensive financial services provider [11] - Despite a stock pullback this year, Robinhood is viewed as a strong long-term investment opportunity [12]

A bad combination compounding for biotech So not only were these stocks slammed by the risk-off mentality in the markets ahead of tariffs coming on April 2, but a key resignation at the Federal Drug Administration (FDA) over the weekend raised questions about the speed and willingness of the agency to approve new drug technologies going forward. The double whammy sent these stocks down much more than the market today. Key FDA regulator Marks abruptly leaves Over the weekend, Dr. Peter Marks, who headed the ...

Summit Therapeutics (SMMT -2.25%) stock did better than a lot of other equities during an otherwise forgettable trading session on Wednesday. In contrast to other titles that fell notably, Summit more or less kept pace with the S&P 500 (^GSPC -1.12%), managing to dip by a relatively modest 2.25% in price. Some investors, at least, were cheered by an analyst's recommendation upgrade on the stock.The high potential of a licensed drugWell before market open, Citigroup pundit Yigal Nochomovitz changed his recom ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

On Friday, Cantor Fitzgerald initiated coverage on Summit Therapeutics Inc. SMMT, citing shares as 67% undervalued.The company’s lead candidate ivonescimab (SMT112) is an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.Akeso Inc. engineered Ivonescimab, which is currently in multiple Phase 3 clinical trials. Over 2,300 patients have been treate ...

A very bullish analyst move was the news generally responsible for Summit Therapeutics' (SMMT -3.62%) healthy mid-week stock price pop. That upward lift was largely holding as of Friday before market open, as according to data compiled by S&P Global Market Intelligence Summit's share price had risen by almost 8% week to date at that point.The next cancer blockbuster drug?The person behind the news was Evercore ISI pundit Cory Kasimov, who on Wednesday launched coverage of Summit stock. He's quite firmly in ...

Core Viewpoint - Summit Therapeutics has experienced a significant stock price increase of 300% over the past year, but recent performance has stagnated, with flat returns since the start of 2025, raising concerns about its high market capitalization of over $13 billion while lacking consistent revenue generation [1][4]. Group 1: Stock Performance and Valuation - The excitement surrounding Summit's stock is largely driven by the potential of its cancer treatment candidate, ivonescimab, which has shown promising results in trials, outperforming Merck's Keytruda for non-small cell lung cancer [2][3]. - Despite the lack of drug approval, investors are pricing in the potential success of ivonescimab, although the company reported a net loss exceeding $221 million last year, which is impacting investor sentiment [4][8]. - Summit's stock has seen a decline of over 10% in the past month as investor enthusiasm has cooled, but positive trial results could lead to a significant increase in valuation [8]. Group 2: Collaboration and Future Prospects - Summit is collaborating with Pfizer on clinical trials to explore the use of ivonescimab in combination with Pfizer's antibody drug conjugates for treating solid tumors, with trials set to begin later this year [5][6]. - Pfizer's investment in next-generation cancer treatments, highlighted by its $43 billion acquisition of Seagen, indicates a strong belief in the potential of ivonescimab, which could open up further opportunities for the drug [7]. - The partnership with Pfizer not only expands the number of trials for ivonescimab but also alleviates some financial burden from Summit, which is crucial given its current high valuation concerns [6].

HONG KONG, Feb. 24, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that its partner on ivonescimab, Summit Therapeutics Inc. (NASDAQ: SMMT) has entered into a clinical trial collaboration with Pfizer Inc. (NYSE: PFE) to evaluate ivonescimab, a novel, investigational PD-1 / VEGF bispecific antibody, in combination with several of Pfizer's antibody drug conjugates (ADCs) across multiple solid tumor settings. "Rapidly developing novel mechanisms that go beyond what is cur ...

Financial Data and Key Metrics Changes - The company ended 2024 with a strong cash position of approximately $412 million and is now debt-free [37] - GAAP R&D expenses for 2024 were $150.8 million, up from $59.4 million in the previous year, reflecting the expansion of clinical trials related to Ivonescimab [39] - Non-GAAP R&D expenses were $134.8 million in 2024 compared to $55 million in 2023 [39] - GAAP G&A expenses increased to $60.5 million in 2024 from $30.3 million in the previous year, primarily due to stock-based compensation charges [41] - Overall, non-GAAP operating expenses decreased to $175.3 million in 2024 from $596.5 million in 2023, mainly due to a reduction in acquired in-process R&D expenses [42] Business Line Data and Key Metrics Changes - The company has completed enrollment in four Phase III trials, with two awaiting top-line data readout, including the HARMONi trial [16] - Five Phase III trials are currently ongoing, with two sponsored by the company and three by Akeso, focusing on various cancer types [17] Market Data and Key Metrics Changes - The addressable market for non-small cell lung cancer (NSCLC) could approach $20 billion for checkpoint inhibitors, with a broader market potential of approximately $90 billion globally for all checkpoint inhibitor indications [30][32] - The company is exploring over 50 indications where PD-1, PD-L1, or VEGF therapies have been approved, indicating a significant market opportunity beyond NSCLC [32] Company Strategy and Development Direction - The company aims to expand its clinical development plan beyond NSCLC in 2025 and 2026, with a focus on improving patient lives facing high unmet medical needs [33] - A collaboration with Pfizer was announced to evaluate Ivonescimab in combination with multiple Pfizer antibody drug conjugates (ADCs) in various solid tumor settings [9][10] - The company is committed to exploring additional tumor settings and identifying biomarkers through collaborations, including a $15 million commitment to MD Anderson [21] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the potential of Ivonescimab and its ability to address serious unmet medical needs in oncology [15] - The company is optimistic about the upcoming top-line data from the HARMONi trial, expected in mid-2025, which could provide a path for marketing authorization [24] - Management emphasized the importance of combining Ivonescimab with the best available treatments to enhance therapeutic outcomes [106] Other Important Information - The company has received Fast Track designation for the HARMONi trial, which is a global Phase III trial in patients with EGFR mutated advanced non-small cell lung cancer [11] - The HARMONi-3 trial has been amended to include a larger patient population, significantly expanding the number of patients that Ivonescimab can potentially help [12] Q&A Session Summary Question: Timing for HARMONi-2 overall survival (OS) data - Management indicated that Akeso expects to reach the number of events required for interim analysis by the end of 2025 [49] Question: Need for statistical significance in OS for approval - Management stated that while statistical significance for OS is desired, previous approvals in this space have not required it, as progression-free survival (PFS) has been adequate [52] Question: Timing for top-line readout for HARMONi-3 - Management noted it is too early to provide clarity on the completion of enrollment for HARMONi-3 until all sites are activated [55] Question: Details on the Pfizer collaboration - Management confirmed that multiple ADCs from Pfizer will be involved, with trials expected to start in mid-2025 [58][61] Question: Confidence in ADC targets - Management expressed confidence in the potential of ADCs in solid tumor oncology, noting that data outside of lung cancer has been stronger [66] Question: Plans for future business development opportunities - Management indicated that the collaboration with Pfizer does not preclude additional partnerships and that they are open to exploring various opportunities [115]

Financial Data and Key Metrics Changes - The company ended 2024 with a strong cash position of approximately $412 million and is now debt-free [37] - GAAP R&D expenses for 2024 were $150.8 million, up from $59.4 million in the previous year, reflecting the expansion of clinical trials related to Ivonescimab [39] - Non-GAAP R&D expenses were $134.8 million in 2024 compared to $55 million in 2023 [39] - GAAP G&A expenses increased to $60.5 million in 2024 from $30.3 million in the previous year, primarily due to stock-based compensation charges [41] - Overall, non-GAAP operating expenses decreased to $175.3 million in 2024 from $596.5 million in 2023, mainly due to a reduction in acquired in-process R&D expenses [42] Business Line Data and Key Metrics Changes - The company has completed enrollment in four Phase III trials, with two awaiting top-line data readout, including the HARMONi trial [16] - Five Phase III trials are currently ongoing, with two sponsored by the company in first-line non-small cell lung cancer [17] Market Data and Key Metrics Changes - The addressable market for non-small cell lung cancer could approach $20 billion for checkpoint inhibitors, with a broader market potential of approximately $90 billion globally across all checkpoint inhibitor indications [30][32] Company Strategy and Development Direction - The company aims to expand its clinical development plan beyond non-small cell lung cancer in 2025 and 2026, with ongoing engagement in investigator-sponsored trials [24] - A collaboration with Pfizer was announced to evaluate Ivonescimab in combination with multiple Pfizer antibody drug conjugates in various solid tumor settings [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Ivonescimab to improve patient lives and emphasized the importance of addressing serious unmet medical needs [34] - The company is focused on rapidly developing novel mechanisms to enhance treatment options for patients facing significant challenges from cancer [10] Other Important Information - The company has committed $15 million to a collaboration with MD Anderson to explore additional opportunities for Ivonescimab [21] - Clinical trials associated with the Pfizer collaboration are expected to start in mid-2025 [22] Q&A Session Summary Question: Timing for HARMONi-2 OS data - Management indicated that Akeso expects to reach the number of events required for interim analysis by the end of 2025 [49] Question: Need for statistical significance in OS data for approval - Management stated that while they would prefer to achieve statistical significance for OS, previous approvals in this space have not always required it [52] Question: Timing for top-line readout for HARMONi-3 - Management noted it is too early to provide clarity on the completion of enrollment for HARMONi-3 until all sites are activated [55] Question: Details on the Pfizer collaboration - Management confirmed that multiple ADCs from Pfizer will be involved, with trials expected to be Phase 1b/2 level [58] Question: Confidence in ADC targets - Management expressed confidence in the potential of ADCs across solid tumor oncology, noting that data outside of lung cancer has been stronger [66] Question: Plans for future business development opportunities - Management indicated that the Pfizer collaboration does not preclude additional partnerships or business development activities [115]