Summit Therapeutics (SMMT)2024-10-30 11:06Clinical 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 $235 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 $37.7 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 $56.3 million, compared to $21.2 million in the same period of the prior year[25] - Summit's Q3 2024 net loss was $56.3 million, compared to $21.2 million in Q3 2023, with a net loss per share of $0.08[42] - Research and development expenses increased to $37.7 million in Q3 2024, up from $15.3 million in Q3 2023[42] - Total operating expenses for Q3 2024 were $58.1 million, compared to $20.7 million in Q3 2023[42] - Cash and cash equivalents increased to $487.0 million as of September 30, 2024, up from $186.2 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 $57.3 million in the same period of 2023[44] - Non-GAAP Research and Development Expense for Q3 2024 was $31.9 million, compared to $15.2 million in Q3 2023[45] - Non-GAAP General and Administrative Expenses for Q3 2024 were $6.8 million, down from $4.8 million in Q3 2023[45] - Non-GAAP Net Loss for Q3 2024 was $36.9 million, compared to $20.5 million in Q3 2023[45] - Non-GAAP Net Loss Per Basic and Diluted Common Share for Q3 2024 was $0.05, compared to $0.03 in Q3 2023[45] - GAAP Net Loss for Q3 2024 was $56.3 million, compared to $21.2 million in Q3 2023[45] - Stock-based compensation for Q3 2024 was $19.4 million, compared to $0.7 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 $520.9 million in the same period in 2023[45] - Non-GAAP Operating Expenses for Q3 2024 were $38.7 million, compared to $20.0 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]