Dr_Microbe Summit Therapeutics (NASDAQ:SMMT) will release its latest earnings on 6 August, while the company also has trial data released in September. This could be the catalyst for further upside. Summit to release second-quarter earnings Summit Therapeutics will release its second-quarter earnings and operational update on 6 August. In its first-quarter earnings, Summit reported progress on its work with Ivonescimab (SMT112), a "potentially first-in-class antibody combining the effects of immunotherapy v ...

Summit Therapeutics (SMMT) is a clinical-stage biopharmaceutical company focused on the development and marketing of medicinal therapies to treat oncology indications with serious unmet needs. In the past month, the company's stock has risen 57.1%. This upside came after management reported encouraging results from the phase III HARMONi-2 study, wherein treatment with ivonescimab bested Merck's (MRK) blockbuster oncology drug Keytruda in treating certain patients with non-small cell lung cancer (NSCLC). Per ...

Investors continue to react negatively to recent late-stage results for Summit's experimental cancer therapy. Shares of Summit Therapeutics (SMMT -23.67%) were sinking 22.6% as of 11:10 a.m. ET on Tuesday. This sell-off follows a similar steep decline of 22% on Friday after Summit revealed late-stage data for its lead candidate, ivonescimab, in combination with chemotherapy in treating non-small cell lung cancer (NSCLC). Investors reacted negatively to the late-stage data for ivonescimab. However, there was ...

Financial Data and Key Metrics - Non-GAAP operating expenses were $33 million, with $28.3 million allocated to research and development, primarily focused on the clinical development of ivonescimab [27] - GAAP R&D expenses increased to $30.9 million in Q1 2024 from $24.8 million in Q4 2023, while non-GAAP R&D expenses rose to $28.5 million from $22.4 million [68] - GAAP G&A expenses were $11.7 million in Q1 2024, slightly up from $11.6 million in Q4 2023, while non-GAAP G&A expenses decreased to $4.6 million from $5.3 million [55] - The company ended Q1 2024 with a strong cash position of $157 million, sufficient to fund operations through Q1 2025 [54] Business Line Data and Key Metrics - Over 1,600 patients have been treated with ivonescimab, with 19 clinical trials globally evaluating its efficacy, including 4 Phase III trials and 15 Phase I/II trials [13] - The HARMONi trial, a Phase III study for non-small cell lung cancer (NSCLC) patients with EGFR mutations, is on track to complete enrollment in H2 2024 [43] - The HARMONi-3 trial, evaluating ivonescimab as a frontline treatment for squamous NSCLC, began enrollment in Q4 2023 and is expanding rapidly [18] - Akeso's HARMONi-A trial in China, which overlaps with the HARMONi trial, completed enrollment and submitted an NDA for marketing approval in China, with a decision expected in Q2 2024 [16][44] Market Data and Key Metrics - Ivonescimab has shown promising Phase II data in NSCLC patients with brain metastases, achieving a 34% intracranial response rate and a median intracranial progression-free survival of 19.3 months [48] - The company is actively engaging health authorities to design Phase III trials based on upcoming Phase II data from Akeso, with plans to expand ivonescimab's development beyond NSCLC [61][50] - Akeso's Phase II AK112-201 trial demonstrated a median progression-free survival of 8.5 months and a median overall survival of 22.5 months in NSCLC patients with EGFR mutations [20] Company Strategy and Industry Competition - The company is focused on advancing ivonescimab, a PD-1/VEGF bispecific antibody, through Phase III trials, aiming to improve efficacy and safety profiles compared to existing therapies [41][42] - Summit is collaborating with Akeso to leverage data from multiple solid tumor studies, supporting the clinical development of ivonescimab in licensed territories [41] - The company plans to expand ivonescimab's clinical program beyond NSCLC, exploring potential indications in gynecological tumors, head and neck cancer, triple-negative breast cancer, and colorectal cancer [51] Management Commentary on Operating Environment and Future Outlook - Management remains optimistic about ivonescimab's potential, citing strong Phase II data and ongoing collaborations with Akeso as key drivers for future success [22][46] - The company expects to share more details on its clinical development plan for ivonescimab in the next 6-9 months, including potential investigator-sponsored trials (ISTs) [50][51] - Summit is preparing for technology transfer to enable a second supply source for ivonescimab manufacturing, ensuring scalability for future demand [25] Other Important Information - The company strengthened its leadership team with the appointment of Dr. Mostafa Ronaghi, a renowned genomicist, to its Board of Directors [37] - Summit continues to participate in key medical conferences, including ASCO, to educate healthcare leaders about ivonescimab's potential [24][36] Summary of Q&A Session Question: How does the Phase II data from ELCC support the strategy of pursuing frontline squamous NSCLC in Phase III trials? - The Phase II data remains consistent and strong, supporting the decision to pursue frontline squamous NSCLC in Phase III trials [57] Question: What is the status of Akeso's 303 interim analysis plan? - No interim analysis has been performed yet, with data expected in Q2 2024 [59] Question: Are there any changes planned for the HARMONi trial based on Akeso's data? - No changes are currently contemplated for the HARMONi trial [73] Question: Will Summit receive Akeso's HARMONi-A data simultaneously with the public? - Summit will become aware of the HARMONi-A data when it is publicly disclosed, with no prior access [72] Question: What are the broader plans for ivonescimab at ASCO? - The company is actively engaging health authorities to design Phase III trials based on upcoming Phase II data from Akeso, with plans to expand ivonescimab's development beyond NSCLC [61]

Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2024 Miami, Florida, May 1, 2024 - Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on its operational progress for the first quarter ended March 31, 2024. Operational & Corporate Updates • Our operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________ FORM 10-Q _________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 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 Inc. (NASDAQ:SMMT) Q4 2023 Earnings Conference Call February 20, 2024 9:00 AM ET Company Participants Dave Gancarz - Chief Business and Strategy Officer Bob Duggan - Chairman of the Board and CEO Maky Zanganeh - CEO and President Ankur Dhingra - CFO Dr. Allen Yang - CMO Manmeet Soni - COO Conference Call Participants Brad Canino - Stifel Hartaj Singh - Oppenheimer Operator Good morning and welcome to Summit's Fourth Quarter and Year End 2023 Earnings Call. [Operator Instructions] Please ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________ FORM 10-K _____________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 in ...

Summit Therapeutics Inc. (NASDAQ:SMMT) Q3 2023 Results Conference Call November 7, 2023 9:00 AM ET Company Participants Dave Gancarz - Chief Business and Strategy Officer Bob Duggan - Chairman of the Board and Chief Executive Officer Dr. Maky Zanganeh - Chief Executive Officer and President Ankur Dhingra - Chief Financial Officer Dr. Allen Yang - Chief Medical Officer Manmeet Soni - Chief Operating Officer Conference Call Participants Brad Canino - Stifel Operator Good morning, and welcome to the Summit The ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________ FORM 10-Q _________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 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 specifi ...