Financial Data and Key Metrics Changes - The company ended Q2 2024 with a cash position of $325.8 million, strengthened by a $200 million unsolicited private placement [23] - GAAP R&D expenses for Q2 2024 were $30.8 million, slightly down from $30.9 million in Q1 2024, while non-GAAP R&D expenses were $27.3 million compared to $28.5 million in Q1 2024 [25] - GAAP G&A expenses increased to $14 million in Q2 2024 from $11.7 million in Q1 2024, with non-GAAP G&A expenses rising to $6.4 million from $4.6 million in Q1 2024 [25] Business Line Data and Key Metrics Changes - The lead investigational asset, ivonescimab, achieved significant milestones, including positive Phase 3 data updates from trials HARMONi-A and HARMONi-2 [4][5] - HARMONi-A results supported ivonescimab's first regulatory approval in China for advanced non-small cell lung cancer [5] - HARMONi-2 demonstrated a statistically significant improvement in progression-free survival (PFS) over pembrolizumab, marking a notable achievement in the competitive landscape [12][18] Market Data and Key Metrics Changes - The company expanded its licensed territories to include Latin America, the Middle East, and Africa, in addition to existing territories in the U.S., Europe, Canada, and Japan [20] - The partnership with MD Anderson Cancer Center aims to accelerate the development of ivonescimab across multiple solid tumor types [19] Company Strategy and Development Direction - The company is focused on executing registrational Phase 3 trials while expanding its clinical development program [7] - A five-year strategic collaboration with MD Anderson was announced to enhance the development of ivonescimab [19] - The company aims to leverage data from multiple solid tumor studies to inform its late-stage clinical development strategy [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of ivonescimab to address serious unmet medical needs in oncology [8] - The company anticipates completing enrollment in the HARMONi trial later this year and expects additional Phase 2 data to be presented at major medical conferences [13] - Management highlighted the importance of ongoing collaborations and the positive trajectory of ivonescimab's development [19] Other Important Information - The company raised $200 million at a premium over the market price, extending its cash runway into Q4 2025 [5][23] - The safety profile of ivonescimab was reported as manageable, with treatment-related adverse events leading to discontinuation at 5.6% in the treatment arm [16] Q&A Session Summary Question: Could you walk through the data disclosure for HARMONi-2? - Management confirmed that HARMONi-2 data is considered a late-breaker abstract at the World Lung Conference, with notifications expected between August 7 and 10 [28][30] Question: What is the latest view on overall survival (OS) maturity? - Management indicated that OS data is still early, and definitive announcements will be made when more time has passed for patient follow-up [32][33] Question: How does the PFS result stand in isolation? - Management refrained from commenting on PFS specifics but indicated that further details would be shared at the upcoming meeting [34] Question: What is the read-through from HARMONi-2 to HARMONi-3? - Management expressed confidence in HARMONi-3, noting that the strength of HARMONi-2 data has bolstered their confidence in the trial [36] Question: How will the MD Anderson partnership intersect with Phase 2 work? - Management highlighted that MD Anderson's expertise will help fill gaps in Phase 2 data and provide insights into tumor types not prevalent in China [41]

Financial Performance - The Company reported a net loss of $60.4 million for the three months ended June 30, 2024, compared to a net loss of $14.7 million for the same period in 2023[114]. - The company reported a net loss of $60.4 million and $103.9 million for the three and six months ended June 30, 2024, respectively[127]. - The company incurred a net loss of $103.9 million for the six months ended June 30, 2024, which included non-cash charges of $33.5 million[136]. - The company expects to continue incurring significant operating losses for the foreseeable future as it invests in clinical development and other operational efforts[125]. - Cash flows used in operating activities for the six months ended June 30, 2024, amounted to $63.1 million[127]. - Net cash used in operating activities for the six months ended June 30, 2024, was $63.1 million, compared to $42.4 million for the same period in 2023[135]. - Net cash provided by financing activities was $200.7 million for the six months ended June 30, 2024, primarily from a $200 million private placement[138]. - The company has $0.3 million of restricted cash associated with an irrevocable letter of credit required by the landlord for a new lease agreement[141]. - The company may face substantial doubt about its ability to continue as a going concern if additional capital is not raised[128]. - The company expects to operate into Q4 2025 based on cash and cash equivalents as of June 30, 2024, and may need to raise additional equity or debt capital[128]. Research and Development - The Company reported operating expenses of $59.8 million for the three months ended June 30, 2024, compared to $15.8 million for the same period in 2023, reflecting a significant increase in research and development costs[114]. - Research and development expenses for the first half of 2024 were $61.7 million, up from $19.3 million in the first half of 2023, indicating a focus on advancing clinical trials[114]. - Research and development expenses (excluding acquired in-process R&D) increased by $21.3 million and $42.4 million for the three and six months ended June 30, 2024, respectively, primarily due to investments in oncology expenses for ivonescimab[115]. - The company expects oncology-related research and development costs to continue to increase as it progresses with the development of ivonescimab[115]. - U.K. research and development tax credits increased by $0.2 million for the three months ended June 30, 2024, due to increased eligible expenditures on ivonescimab[119]. Clinical Trials - The Company has initiated Phase III clinical trials for ivonescimab in non-small cell lung cancer (NSCLC), with patient enrollment expected to complete in the second half of 2024[98][110]. - Ivonescimab demonstrated a 54% reduction in disease progression or death in a Phase III study compared to placebo, achieving its primary endpoint of Progression-free Survival (PFS)[107]. - The Company plans to expand its clinical trial activities for ivonescimab in multiple regions, including North America, Europe, and Asia, with additional sites expected to be activated through early 2025[111]. - The Company plans to support additional study activities through its investigator-initiated study program, collaborating with institutions globally[112]. Licensing and Partnerships - The License Agreement with Akeso included an upfront payment of $474.9 million in cash and 10 million shares of common stock, valued at $25.1 million, for the rights to develop ivonescimab in key markets[100]. - The company has expanded the License Agreement with Akeso to include Latin America, the Middle East, and Africa, with an additional upfront payment of $15.0 million[100]. - The company recorded an upfront payment of $15.0 million to Akeso for expanded licensed territories in Latin America, the Middle East, and Africa, expected to be paid in Q3 2024[116]. - The company has potential milestone payments of $4.56 billion to Akeso, including regulatory milestones of up to $1.05 billion and commercial milestones of up to $3.51 billion[129]. - The company has terminated prior development activities related to ridinilazole and SMT-738, focusing resources on ivonescimab and seeking partnerships for these assets[99]. Operating Expenses - General and administrative expenses increased by $7.7 million and $12.4 million for the three and six months ended June 30, 2024, respectively, mainly due to increased stock-based compensation[118]. - The company incurred charges of $520.9 million for the six months ended June 30, 2023, primarily related to upfront milestone payments under the License Agreement with Akeso[117]. - Total future lease payments as of June 30, 2024, are approximately $4.6 million on an undiscounted basis[141].

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 ...