\nSummit Therapeutics Inc. (NASDAQ: SMMT) (\u201cSummit,\u201d \u201cwe,\u201d or the \u201cCompany\u201d) today reports its financial results and provides an update on operational progress for the fourth quarter and year-ended December 31, 2024.<\/p>\n
Operational & Corporate Updates<\/b><\/p>\n
\nOperational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:<\/p>\n
- \n
- \nIn January 2023, we closed our Collaboration and License Agreement with Akeso Inc. (Akeso, HKEX Code: 9926.HK) for ivonescimab (SMT112), with which over 2,300 patients have been treated in clinical studies globally. Summit has rights to develop and commercialize ivonescimab in the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa while Akeso retains development and commercialization rights for the rest of the world, including China.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nSince in-licensing ivonescimab, we have begun our development for ivonescimab in non-small cell lung cancer (\u201cNSCLC\u201d), specifically launching Phase III clinical trials in the following proposed indications:<\/p>\n<\/li>\n<\/ul>\n
- \n
- HARMONi<\/i>: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI)\n<\/li>\n<\/ul>\n
- \n
- HARMONi-3<\/i>: Ivonescimab combined with chemotherapy in first-line metastatic NSCLC patients\n<\/li>\n<\/ul>\n
- \n
- \nIn addition, we have begun to activate clinical trial sites in the United States for a Phase III clinical study in the following proposed indication:<\/p>\n<\/li>\n<\/ul>\n
- \n
- HARMONi<\/i>–7<\/i>: Ivonescimab monotherapy in first-line metastatic NSCLC patients with high PD-L1 expression\n<\/li>\n<\/ul>\n
- \n
- \nIn October 2024, we completed enrollment in our HARMONi clinical trial. We expect to disclose topline results from HARMONi in mid-2025, depending upon maturation of the data per the protocol.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nThe U.S. Food and Drug Administration (\u201cFDA\u201d) has granted Fast Track designation for the proposed use of ivonescimab in combination with platinum-based chemotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR mutation, who have experienced disease progression following EGFR-TKI therapy.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nIn the fourth quarter of 2024, we amended the HARMONi-3 protocol to, amongst other changes, include patients with both squamous and non-squamous histologies, significantly increasing the population of patients eligible for treatment in the proposed indication. Enrollment has begun in all regions for patients with squamous tumors; the protocol amendment is effective and enrollment has begun in United States for patients with non-squamous tumors.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nRecently, we announced a clinical trial collaboration with Pfizer in which Pfizer will contribute multiple antibody drug conjugates (ADCs) to be evaluated in combination with ivonescimab in unique solid tumor settings. The goal of the collaboration is to accelerate the advancement of potentially landscape-changing therapeutic combinations, which seek to improve the standards of care for patients facing serious unmet needs.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nUnder the terms of the agreement, Summit will provide ivonescimab for use in the proposed studies, and Pfizer will be responsible for conducting the operations of the studies, including associated costs. The studies will be overseen by both Summit and Pfizer. Both parties retain their respective rights to their products. The studies combining ivonescimab with Pfizer\u2019s vedotin ADCs are planned to begin in the middle of this year. Further details on the clinical trials will be announced at a later date.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nWe intend to explore further clinical development of ivonescimab in solid tumor settings outside of metastatic non-small cell lung cancer, Additionally, institutions with whom we have collaborated have begun opening investigator-sponsored trials across multiple oncology settings. We plan to review the data generated from these clinical trials as a part of our consideration for advancing our clinical development for ivonescimab beyond non-small cell lung cancer.<\/p>\n<\/li>\n<\/ul>\n
Financial Highlights<\/b><\/p>\n
Cash and Cash Equivalents & Short-term Investments<\/span><\/p>\n
- \n
- \nAggregate cash and cash equivalents and short-term investments were $412.3 million and $186.2 million at December 31, 2024 and December 31, 2023, respectively.<\/p>\n<\/li>\n<\/ul>\n
GAAP and Non-GAAP Research and Development (R&D) Expenses<\/span><\/p>\n
- \n
- \nGAAP R&D expenses according to generally accepted accounting principles in the U.S. (\u201cGAAP\u201d) were $150.8 million for the full year of 2024, compared to $59.4 million for the full year of 2023.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nNon-GAAP R&D expenses were $134.8 million for the full year of 2024, compared to $55.0 million for the full year of 2023.<\/p>\n<\/li>\n<\/ul>\n
GAAP and Non-GAAP General and Administrative (G&A) Expenses<\/span><\/p>\n
- \n
- \nGAAP G&A expenses were $60.5 million for the full year of 2024, compared to $30.3 million for the full year of 2023.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nNon-GAAP G&A expenses were $25.5 million for the full year of 2024, compared to $20.6 million for the full year of 2023.<\/p>\n<\/li>\n<\/ul>\n
GAAP and Non-GAAP Operating Expenses<\/span><\/p>\n
- \n
- \nGAAP operating expenses were $226.3 million for the full year of 2024, compared to $610.6 million for the full year of 2023.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nNon-GAAP operating expenses were $175.3 million for the full year of 2024, compared to $596.5 million for the full year of 2023. The decrease is primarily related to the decrease in acquired in-process R&D expenses of $505.9 million, offset by the increase in R&D expenses due to expansion of clinical studies and development costs related to ivonescimab and increases in people costs as we continue to build out our team.<\/p>\n<\/li>\n<\/ul>\n
GAAP and Non-GAAP Net Loss<\/span><\/p>\n
- \n
- \nGAAP net loss in the full year of 2024 and 2023 was $221.3 million or $(0.31) per basic and diluted share, and $614.9 million or $(0.99) per basic and diluted share, respectively.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nNon-GAAP net loss in the full year of 2024 and 2023 was $170.3 million or $(0.24) per basic and diluted share, and $600.8 million or $(0.97) per basic and diluted share, respectively.<\/p>\n<\/li>\n<\/ul>\n
Use of Non-GAAP Financial Measures<\/span><\/p>\n
\nThis release includes measures that are not in accordance with U.S. generally accepted accounting principles (\u201cNon-GAAP measures\u201d). These Non-GAAP measures should be viewed in addition to, and not as a substitute for, Summit’s reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit\u2019s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. For further information regarding these Non-GAAP measures, please refer to the tables presenting reconciliations of our Non-GAAP results to our U.S. GAAP results and the \u201cNotes on our Non-GAAP Financial Information\u201d that accompany this press release.<\/p>\n
Fourth Quarter 2024 Earnings Call<\/b><\/p>\n
\n
\n \u00a0<\/td>\n<\/tr>\n \n \n Summit Therapeutics Inc.<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n GAAP Condensed Consolidated Statements of Operations<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n (in millions, except per share data)<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n Three Months Ended
\n
December 31,<\/b><\/p>\n<\/td>\n\n \n\u00a0<\/p>\n<\/td>\n
\n Twelve Months Ended
\n
December 31,<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n 2024<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2023<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2024<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2023<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n Operating expenses:<\/b><\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nResearch and development<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n51.4<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n24.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n150.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n59.4<\/p>\n<\/td>\n<\/tr>\n
\n \n \nAcquired in-process research and development<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u2014<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u2014<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n15.0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n520.9<\/p>\n<\/td>\n<\/tr>\n
\n \n \nGeneral and administrative<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n14.4<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n11.6<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n60.5<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n30.3<\/p>\n<\/td>\n<\/tr>\n
\n \n Total operating expenses<\/b><\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n65.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n36.4<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n226.3<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n610.6<\/p>\n<\/td>\n<\/tr>\n
\n \n \nOther operating income, net<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n0.2<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n0.2<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n0.3<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n1.0<\/p>\n<\/td>\n<\/tr>\n
\n \n Operating loss<\/b><\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(65.6)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(36.2)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(226.0)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(609.6)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nOther income, net<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n4.4<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n2.5<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n13.4<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n11.2<\/p>\n<\/td>\n<\/tr>\n
\n \n \nInterest expense<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u2014<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(2.9)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(8.7)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(16.5)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nLoss before income tax<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(61.2)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(36.6)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(221.3)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(614.9)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nNet loss<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(61.2)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(36.6)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(221.3)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(614.9)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nNet loss per share attributable to common shareholders per share, basic and diluted<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(0.08)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(0.05)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(0.31)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(0.99)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n<\/table>\n \n
\n \n Summit Therapeutics Inc.<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n GAAP Condensed Consolidated Balance Sheet Information<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n (in millions)<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n December 31, 2024<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n December 31, 2023<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n Cash and cash equivalents and short-term investments<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n412.3<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n186.2<\/p>\n<\/td>\n<\/tr>\n
\n \n Total assets<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n435.6<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n202.9<\/p>\n<\/td>\n<\/tr>\n
\n \n Total liabilities<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n46.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n125.3<\/p>\n<\/td>\n<\/tr>\n
\n \n Total stockholders’ equity<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n388.7<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n77.7<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n<\/table>\n \n
\n \n Summit Therapeutics Inc.<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n GAAP Condensed Consolidated Statement of Cash Flows Information<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n (in millions)<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n Twelve Months Ended December 31,<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2024<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2023<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n Net cash used in operating activities<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(142.1)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(76.8)<\/p>\n<\/td>\n<\/tr>\n
\n \n Net cash used in investing activities<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(205.3)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(587.8)<\/p>\n<\/td>\n<\/tr>\n
\n \n Net cash provided by financing activities<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n381.2<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n86.5<\/p>\n<\/td>\n<\/tr>\n
\n \n Effect of exchange rates on cash and cash equivalents<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u2014<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n0.8<\/p>\n<\/td>\n<\/tr>\n
\n \n Increase (decrease) in cash, cash equivalents and restricted cash<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n33.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(577.3)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n<\/table>\n \n
\n \n Summit Therapeutics Inc.<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n Schedule Reconciling Selected Non-GAAP Financial Measures<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n (in millions, except per share data)<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n Three Months Ended
\n
December 31,<\/b><\/p>\n<\/td>\n\n \n Twelve Months Ended
\n
December 31,<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2024<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2023<\/b><\/p>\n<\/td>\n
\n \n 2024<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2023<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n Reconciliation of GAAP to Non-GAAP Research and Development Expense<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nGAAP Research and development<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n51.4<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n24.8<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n150.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n59.4<\/p>\n<\/td>\n<\/tr>\n
\n \n \nStock-based compensation (Note 1)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(4.3)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(2.4)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(16.0)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(4.4)<\/p>\n<\/td>\n<\/tr>\n
\n \n Non-GAAP Research and development<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n47.1<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n22.4<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n134.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n55.0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n Reconciliation of GAAP to Non-GAAP General and Administrative Expenses<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nGAAP General and administrative<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n14.4<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n11.6<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n60.5<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n30.3<\/p>\n<\/td>\n<\/tr>\n
\n \n \nStock-based compensation (Note 1)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(6.7)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(6.3)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(35.0)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(9.7)<\/p>\n<\/td>\n<\/tr>\n
\n \n Non-GAAP General and administrative<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n7.7<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n5.3<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n25.5<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n20.6<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n Reconciliation of GAAP to Non-GAAP Operating Expenses<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nGAAP Operating expenses<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n65.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n36.4<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n226.3<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n610.6<\/p>\n<\/td>\n<\/tr>\n
\n \n \nStock-based compensation (Note 1)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(11.0)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(8.7)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(51.0)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(14.1)<\/p>\n<\/td>\n<\/tr>\n
\n \n Non-GAAP Operating expense (Note 2)<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n54.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n27.7<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n175.3<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n596.5<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n Reconciliation of GAAP Net Loss to Non-GAAP Net Loss<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nGAAP Net Loss<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(61.2)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(36.6)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(221.3)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(614.9)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nStock-based compensation (Note 1)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n11.0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n8.7<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n51.0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n14.1<\/p>\n<\/td>\n<\/tr>\n
\n \n Non-GAAP Net Loss (Note 2)<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(50.2)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(27.9)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(170.3)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(600.8)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n Reconciliation of GAAP Net Loss to Non-GAAP Net Loss Per Common Share<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nGAAP Net Loss Per Basic and Diluted Common Share<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(0.08)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(0.05)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(0.31)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(0.99)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nStock-based compensation (Note 1)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n0.01<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n0.01<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n0.07<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n0.02<\/p>\n<\/td>\n<\/tr>\n
\n \n Non-GAAP Net loss Per Basic and Diluted Common Share (Note 2)<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(0.07)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(0.04)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(0.24)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(0.97)<\/p>\n<\/td>\n<\/tr>\n
\n \n Basic and Diluted Common Shares<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n737.5<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n700.6<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n718.5<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n619.6<\/p>\n<\/td>\n<\/tr>\n
\n \n \n \n \n \n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n<\/table>\n \n
\n \n Summit Therapeutics Inc.<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n Schedule Reconciling Selected Non-GAAP Financial Measures<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n (in millions)<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n Three Months Ended<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n December
\n
31, 2024<\/b><\/p>\n<\/td>\n\n \n\u00a0<\/p>\n<\/td>\n
\n September
\n
30, 2024<\/b><\/p>\n<\/td>\n\n \n\u00a0<\/p>\n<\/td>\n
\n June 30,
\n
2024<\/b><\/p>\n<\/td>\n\n \n\u00a0<\/p>\n<\/td>\n
\n March 31,
\n
2024<\/b><\/p>\n<\/td>\n\n \n\u00a0<\/p>\n<\/td>\n
\n December
\n
31, 2023<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n Reconciliation of GAAP to Non-GAAP Operating Expenses<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nGAAP Operating expenses<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n65.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n58.1<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n59.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n42.6<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n36.4<\/p>\n<\/td>\n<\/tr>\n
\n \n \nStock-based compensation (Note 1)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(11.0)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(19.4)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(11.1)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(9.5)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(8.7)<\/p>\n<\/td>\n<\/tr>\n
\n \n Non-GAAP Operating Expense (Note 2)<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n54.8<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n38.7<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n48.7<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n33.1<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n27.7<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n Reconciliation of GAAP Net Loss to Non-GAAP Net Loss<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nGAAP Net Loss<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(61.2)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(56.3)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(60.4)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(43.5)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(36.6)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nStock-based compensation (Note 1)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n11.0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n19.4<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n11.1<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n9.5<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n8.7<\/p>\n<\/td>\n<\/tr>\n
\n \n Non-GAAP Net Loss (Note 2)<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(50.2)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(36.9)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(49.3)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(34.0)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(27.9)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n<\/table>\n
Summit Therapeutics Inc.
\n
<\/b>Notes on our Non-GAAP Financial Information<\/b><\/p>\n\nNon-GAAP financial measures adjust GAAP financial measures for the items listed below. These Non-GAAP measures should be viewed in addition to, and not as a substitute for Summit’s reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit\u2019s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results.<\/p>\n
\nEach of non-GAAP Research and Development Expense, non-GAAP General and Administrative Expenses, non-GAAP Operating Expenses, Non-GAAP Net Loss and Non-GAAP EPS differ from GAAP in that such measures exclude the non-cash charges and costs associated with stock-based compensation.<\/p>\n
\nNote 1: Stock-based compensation is a non-cash charge and costs calculated for this expense can vary year-over-year depending on the stock price of awards on the date of grant as well as the timing of compensation award arrangements.<\/p>\n
\nNote 2: Beginning in the fourth quarter of 2024, the Company\u2019s non-GAAP financial measures will no longer exclude acquired in-process research and development expenses (\u201cIPR&D\u201d). Previously reported non-GAAP financial measures for the twelve months ended December 31, 2023 excluded $520.9 million of IPR&D which represented the upfront payment made to Akeso under the Collaboration and License Agreement. Non-GAAP financial measures for the three months ended June 30, 2024 previously excluded $15.0 million of IPR&D which represented an upfront payment made to Akeso under an amendment to the Collaboration and License Agreement. Prior period amounts have been revised to conform to the current period presentation.<\/p>\n
Appendix: Glossary of Critical Terms Contained Herein<\/b><\/p>\n
Affinity<\/b> \u2013 Affinity is the strength of binding of a molecule, such as a protein or antibody, to another molecule, such as a ligand.<\/p>\n
Avidity<\/b> \u2013 Avidity is the accumulated strength of multiple binding interactions.<\/p>\n
Angiogenesis<\/b> \u2013 Angiogenesis is the development, formation, and maintenance of blood vessel structures. Without sufficient blood flow, tissue may experience hypoxia (insufficient oxygen) or lack of nutrition, which may cause cell death.1<\/sup><\/p>\n
Cooperative binding<\/b> \u2013 Cooperative binding occurs when the number of binding sites on the molecule that can be occupied by a specific ligand (e.g., protein) is impacted by the ligand\u2019s concentration. For example, this can be due to an affinity for the ligand that depends on the amount of ligand bound or the binding strength of the molecule to one ligand based on the concentration of another ligand, increasing the chance of another ligand binding to the compound.2<\/sup><\/p>\n
Immunotherapy<\/b> \u2013 Immunotherapy is a type of treatment, including cancer treatments, that help a person\u2019s immune system fight cancer. Examples include anti-PD-1 therapies.3<\/sup><\/p>\n
Intracranial<\/b> – Within the cranium or skull.<\/p>\n
PD-1<\/b> \u2013 Programmed cell Death protein 1 is a protein on the surface of T cells and other cells. PD-1 plays a key role in reducing the regulation of ineffective or harmful immune responses and maintaining immune tolerance. However, with respect to cancer tumor cells, PD-1 can act as a stopping mechanism (a brake or checkpoint) by binding to PD-L1 ligands that exist on tumor cells and preventing the T cells from targeting cancerous tumor cells.4<\/sup><\/p>\n
PD-L1<\/b> \u2013 Programmed cell Death Ligand 1 is expressed by cancerous tumor cells as an adaptive immune mechanism to escape anti-tumor responses, thus believed to suppress the immune system\u2019s response to the presence of cancer cells.5<\/sup><\/p>\n
PD-L1 TPS<\/b> \u2013 PD-L1 T<\/span>umor P<\/span>roportion S<\/span>core represents the percentage of tumor cells that express PD-L1 proteins.<\/p>\n
PFS <\/b>\u2013 Progression-Free Survival.<\/p>\n
RANO <\/b>\u2013R<\/span>esponse A<\/span>ssessment in N<\/span>euro-O<\/span>ncology, the standard for assessing the response of a brain or spinal cord tumor to therapy.<\/p>\n
SQ-NSCLC <\/b>\u2013 Non-small cell lung cancer tumors of squamous histology.<\/p>\n
T Cells<\/b> \u2013 T cells are a type of white blood cell that is a component of the immune system that, in general, fights against infection and harmful cells like tumor cells.6<\/sup><\/p>\n
Tetravalent<\/b> \u2013 A tetravalent molecule has four binding sites or regions.<\/p>\n
Tumor Microenvironment<\/b> \u2013 The tumor microenvironment is the ecosystem that surrounds a tumor inside the body. It includes immune cells, the extracellular matrix, blood vessels and other cells, like fibroblasts. A tumor and its microenvironment constantly interact and influence each other, either positively or negatively.7<\/sup><\/p>\n
VEGF <\/b>\u2013 Vascular Endothelial Growth Factor is a signaling protein that promotes angiogenesis.8<\/sup><\/p>\n
1<\/sup>Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105
\n
2<\/sup>Stefan MI, Le Nov\u00e8re N. Cooperative binding. PLoS Comput Biol. 2013;9(6)
\n
3<\/sup>US National Cancer Institute, a part of the National Institute of Health (NIH). https:\/\/www.cancer.gov\/about-cancer\/treatment\/types\/immunotherapy<\/a>. Accessed April 2024.
\n
4<\/sup>Han Y, et al.<\/i> PD-1\/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.
\n
5<\/sup>Han Y, et al.<\/i> PD-1\/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.
\n
6<\/sup>Cleveland Clinic. https:\/\/my.clevelandclinic.org\/health\/body\/24630-t-cells<\/a>. Accessed April 2024.
\n
7<\/sup>MD Anderson Cancer Center. https:\/\/www.mdanderson.org\/cancerwise\/what-is-the-tumor-microenvironment-3-things-to-know.h00-159460056.html<\/a>. Accessed April 2024.
\n
8<\/sup>Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105.<\/p>\n<\/p>\n
View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250224090103\/en\/<\/a><\/span><\/p>\n
Contact Summit Investor Relations:
\n<\/b>
Dave Gancarz
\n
Chief Business & Strategy Officer<\/p>\n\nNathan LiaBraaten
\n
Senior Director, Investor Relations<\/p>\n
- \nNon-GAAP net loss in the full year of 2024 and 2023 was $170.3 million or $(0.24) per basic and diluted share, and $600.8 million or $(0.97) per basic and diluted share, respectively.<\/p>\n<\/li>\n<\/ul>\n
- \nGAAP net loss in the full year of 2024 and 2023 was $221.3 million or $(0.31) per basic and diluted share, and $614.9 million or $(0.99) per basic and diluted share, respectively.<\/p>\n<\/li>\n<\/ul>\n
- \nNon-GAAP operating expenses were $175.3 million for the full year of 2024, compared to $596.5 million for the full year of 2023. The decrease is primarily related to the decrease in acquired in-process R&D expenses of $505.9 million, offset by the increase in R&D expenses due to expansion of clinical studies and development costs related to ivonescimab and increases in people costs as we continue to build out our team.<\/p>\n<\/li>\n<\/ul>\n
- \nGAAP operating expenses were $226.3 million for the full year of 2024, compared to $610.6 million for the full year of 2023.<\/p>\n<\/li>\n<\/ul>\n
- \nNon-GAAP G&A expenses were $25.5 million for the full year of 2024, compared to $20.6 million for the full year of 2023.<\/p>\n<\/li>\n<\/ul>\n
- \nGAAP G&A expenses were $60.5 million for the full year of 2024, compared to $30.3 million for the full year of 2023.<\/p>\n<\/li>\n<\/ul>\n
- \nNon-GAAP R&D expenses were $134.8 million for the full year of 2024, compared to $55.0 million for the full year of 2023.<\/p>\n<\/li>\n<\/ul>\n
- \nGAAP R&D expenses according to generally accepted accounting principles in the U.S. (\u201cGAAP\u201d) were $150.8 million for the full year of 2024, compared to $59.4 million for the full year of 2023.<\/p>\n<\/li>\n<\/ul>\n
- \nAggregate cash and cash equivalents and short-term investments were $412.3 million and $186.2 million at December 31, 2024 and December 31, 2023, respectively.<\/p>\n<\/li>\n<\/ul>\n
- \nWe intend to explore further clinical development of ivonescimab in solid tumor settings outside of metastatic non-small cell lung cancer, Additionally, institutions with whom we have collaborated have begun opening investigator-sponsored trials across multiple oncology settings. We plan to review the data generated from these clinical trials as a part of our consideration for advancing our clinical development for ivonescimab beyond non-small cell lung cancer.<\/p>\n<\/li>\n<\/ul>\n
- \nUnder the terms of the agreement, Summit will provide ivonescimab for use in the proposed studies, and Pfizer will be responsible for conducting the operations of the studies, including associated costs. The studies will be overseen by both Summit and Pfizer. Both parties retain their respective rights to their products. The studies combining ivonescimab with Pfizer\u2019s vedotin ADCs are planned to begin in the middle of this year. Further details on the clinical trials will be announced at a later date.<\/p>\n<\/li>\n<\/ul>\n
- \nRecently, we announced a clinical trial collaboration with Pfizer in which Pfizer will contribute multiple antibody drug conjugates (ADCs) to be evaluated in combination with ivonescimab in unique solid tumor settings. The goal of the collaboration is to accelerate the advancement of potentially landscape-changing therapeutic combinations, which seek to improve the standards of care for patients facing serious unmet needs.<\/p>\n<\/li>\n<\/ul>\n
- \nIn the fourth quarter of 2024, we amended the HARMONi-3 protocol to, amongst other changes, include patients with both squamous and non-squamous histologies, significantly increasing the population of patients eligible for treatment in the proposed indication. Enrollment has begun in all regions for patients with squamous tumors; the protocol amendment is effective and enrollment has begun in United States for patients with non-squamous tumors.<\/p>\n<\/li>\n<\/ul>\n
- \nThe U.S. Food and Drug Administration (\u201cFDA\u201d) has granted Fast Track designation for the proposed use of ivonescimab in combination with platinum-based chemotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR mutation, who have experienced disease progression following EGFR-TKI therapy.<\/p>\n<\/li>\n<\/ul>\n
- \nIn October 2024, we completed enrollment in our HARMONi clinical trial. We expect to disclose topline results from HARMONi in mid-2025, depending upon maturation of the data per the protocol.<\/p>\n<\/li>\n<\/ul>\n
- HARMONi<\/i>–7<\/i>: Ivonescimab monotherapy in first-line metastatic NSCLC patients with high PD-L1 expression\n<\/li>\n<\/ul>\n
- \nIn addition, we have begun to activate clinical trial sites in the United States for a Phase III clinical study in the following proposed indication:<\/p>\n<\/li>\n<\/ul>\n
- HARMONi-3<\/i>: Ivonescimab combined with chemotherapy in first-line metastatic NSCLC patients\n<\/li>\n<\/ul>\n
- HARMONi<\/i>: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI)\n<\/li>\n<\/ul>\n
- \nSince in-licensing ivonescimab, we have begun our development for ivonescimab in non-small cell lung cancer (\u201cNSCLC\u201d), specifically launching Phase III clinical trials in the following proposed indications:<\/p>\n<\/li>\n<\/ul>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20250224090103\/en\/2208782\/3\/2024-Summit-logo-RGB.jpg\"){kind=logo}
<\/td>\n<\/tr>\n