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Summit Therapeutics (SMMT) - 2024 Q3 - Quarterly Results
SMMTSummit Therapeutics (SMMT)2024-10-30 11:06

Clinical Trial Progress and Results - Ivonescimab monotherapy reduced the risk of disease progression or death by 49% compared to pembrolizumab in the Phase III HARMONi-2 trial for first-line PD-L1 positive advanced NSCLC in China[1][11] - Enrollment completed in the global Phase III HARMONi trial for 2L+ EGFRm advanced NSCLC, with topline data expected in mid-2025[1][3] - Summit plans to expand the HARMONi-3 global Phase III trial to include both squamous and non-squamous histologies, with an estimated total sample size of 1,080 patients[3][4] - Summit intends to initiate the global Phase III HARMONi-7 trial in 1L PD-L1 high, metastatic NSCLC in early 2025, with a planned sample size of 780 patients[7] - In the Phase II AK112-201 trial, first-line non-squamous NSCLC patients (n=72) had a median PFS of 13.3 months, while squamous NSCLC patients (n=63) had a median PFS of 11.1 months[6] - In the Phase II AK112-205 trial, 71.8% of patients (n=39) who received ivonescimab plus chemotherapy in the neo-adjuvant setting experienced a major pathological response (MPR), and 43.6% achieved a pathological complete response (pCR)[13] - In the Phase II study for metastatic MSS CRC, the ORR and DCR for 39 patients were 84.6% and 100%, respectively, with median PFS not reached in either group[17] - Over 1,800 patients have been treated with ivonescimab in clinical studies globally[32] - Summit plans to initiate the HARMONi-7 Phase III clinical trial for ivonescimab in early 2025[32] Financial Performance and Expenses - Summit raised 235millioninprivatefinancinginSeptember2024,increasingitscashbalanceto235 million in private financing in September 2024, increasing its cash balance to 487 million at the end of Q3 2024[20][21] - GAAP R&D expenses for Q3 2024 were 37.7million,upfrom37.7 million, up from 15.3 million in the same period of the prior year, primarily due to expansion of clinical study and development costs related to ivonescimab[22][23] - GAAP net loss for Q3 2024 was 56.3million,comparedto56.3 million, compared to 21.2 million in the same period of the prior year[25] - Summit's Q3 2024 net loss was 56.3million,comparedto56.3 million, compared to 21.2 million in Q3 2023, with a net loss per share of 0.08[42]−Researchanddevelopmentexpensesincreasedto0.08[42] - Research and development expenses increased to 37.7 million in Q3 2024, up from 15.3millioninQ32023[42]−TotaloperatingexpensesforQ32024were15.3 million in Q3 2023[42] - Total operating expenses for Q3 2024 were 58.1 million, compared to 20.7millioninQ32023[42]−Cashandcashequivalentsincreasedto20.7 million in Q3 2023[42] - Cash and cash equivalents increased to 487.0 million as of September 30, 2024, up from 186.2millionattheendof2023[43]−Netcashusedinoperatingactivitiesforthefirstninemonthsof2024was186.2 million at the end of 2023[43] - Net cash used in operating activities for the first nine months of 2024 was 93.4 million, compared to 57.3millioninthesameperiodof2023[44]−Non−GAAPResearchandDevelopmentExpenseforQ32024was57.3 million in the same period of 2023[44] - Non-GAAP Research and Development Expense for Q3 2024 was 31.9 million, compared to 15.2millioninQ32023[45]−Non−GAAPGeneralandAdministrativeExpensesforQ32024were15.2 million in Q3 2023[45] - Non-GAAP General and Administrative Expenses for Q3 2024 were 6.8 million, down from 4.8millioninQ32023[45]−Non−GAAPNetLossforQ32024was4.8 million in Q3 2023[45] - Non-GAAP Net Loss for Q3 2024 was 36.9 million, compared to 20.5millioninQ32023[45]−Non−GAAPNetLossPerBasicandDilutedCommonShareforQ32024was20.5 million in Q3 2023[45] - Non-GAAP Net Loss Per Basic and Diluted Common Share for Q3 2024 was 0.05, compared to 0.03inQ32023[45]−GAAPNetLossforQ32024was0.03 in Q3 2023[45] - GAAP Net Loss for Q3 2024 was 56.3 million, compared to 21.2millioninQ32023[45]−Stock−basedcompensationforQ32024was21.2 million in Q3 2023[45] - Stock-based compensation for Q3 2024 was 19.4 million, compared to 0.7millioninQ32023[45]−AcquiredIn−processResearchandDevelopmentfortheninemonthsendedSeptember30,2024,was0.7 million in Q3 2023[45] - Acquired In-process Research and Development for the nine months ended September 30, 2024, was 15.0 million, compared to 520.9millioninthesameperiodin2023[45]−Non−GAAPOperatingExpensesforQ32024were520.9 million in the same period in 2023[45] - Non-GAAP Operating Expenses for Q3 2024 were 38.7 million, compared to 20.0millioninQ32023[75]−GAAPOperatingExpensesforQ32024were20.0 million in Q3 2023[75] - GAAP Operating Expenses for Q3 2024 were 58.1 million, compared to $20.7 million in Q3 2023[75] - Basic and Diluted Common Shares outstanding as of September 30, 2024, were 726.7 million, compared to 697.7 million in the same period in 2023[45] Ivonescimab Mechanism and Approval - Ivonescimab demonstrated over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro[31] - Ivonescimab's tetravalent structure enables over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro[31] - Ivonescimab was approved for marketing authorization in China in May 2024[37]