Morsa Images Summit Therapeutics (NASDAQ:SMMT) and its partner in China Akeso just announced positive data from its phase 3 HARMONi-2 study, which used its PD-1/VEGF bispecific antibody ivonescimab for the treatment of patients with locally advanced or metastatic non-small cell lung cancer [NSCLC] who have positive PD-L1 expression. This is the first drug candidate that has gone toe to toe with Merck (MRK) Keytruda for the treatment of this patient population. That is, ivonescimab is the first type of drug ...

Key Takeaways Summit Therapeutics reported positive results from a Phase 3 trial in China of its lung cancer treatment ivonescimab. The drug reduced the risk of disease progression or death in 49% of those studied compared to other treatments, the company said. The news sent Summit Therapeutics shares to an all-time high. Shares of Summit Therapeutics (SMMT) skyrocketed Monday, rising to an all-time high after the biotech announced positive results from a late-stage trial of its experimental lung cancer tre ...

Core Insights - Summit Therapeutics Inc. released positive data from the Phase 3 HARMONi2 trial of ivonescimab, showing significant efficacy against Merck's Keytruda in treating non-small cell lung cancer [1][2] Trial Results - Ivonescimab demonstrated a statistically significant improvement in progression-free survival (PFS) with a hazard ratio of 0.51, reducing the risk of disease progression or death by 49% compared to Keytruda [2][3] - The median PFS for ivonescimab was 11.14 months, compared to 5.82 months for Keytruda [3] - The overall response rate (ORR) for ivonescimab was 50% versus 38.5% for pembrolizumab, and the disease control rate (DCR) was 89.9% compared to 70.5% [4] Future Plans - Summit plans to initiate the HARMONi-7 trial in early 2025, comparing ivonescimab monotherapy to pembrolizumab in patients with high PD-L1 expression [5] - Data from a Phase 2 trial of ivonescimab alone or in combination with chemotherapy in resectable non-small cell lung cancer was also shared [5] Safety and Efficacy in Neoadjuvant Setting - In a cohort of 39 patients receiving ivonescimab plus chemotherapy, 71.8% experienced a major pathological response, and 43.6% had a pathological complete response [6] - The median event-free survival (EFS) was not reached after 8.9 months of follow-up, with a 12-month EFS rate of 80.3% [7] - The safety profile was manageable, with no treatment-related adverse events leading to surgery delays or patient deaths [7] Market Reaction - Following the announcement, SMMT stock rose by 30.4%, reaching $16.00 in premarket trading [7]

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 ...

Core Insights - Investors are reacting negatively to the late-stage results of Summit Therapeutics' experimental cancer therapy, ivonescimab, leading to a significant decline in stock price [1][2] - The therapy showed a median progression-free survival of 7.06 months when combined with chemotherapy, compared to 4.8 months for chemotherapy alone, but had a high incidence of severe adverse events [2] - Summit received its first regulatory approval in China for ivonescimab as a second-line treatment for advanced or metastatic NSCLC with EGFR mutations [3] - The majority of serious adverse events reported were related to chemotherapy rather than ivonescimab, suggesting a potential silver lining in the safety profile [4] - Some investors may see the stock pullback as a buying opportunity, although many analysts recommend caution due to more attractive options in the market [5]

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 ...