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]

Financial Performance - GAAP operating expenses for Q1 2024 were $42.6 million, a significant decrease from $537.7 million in Q1 2023[6] - Non-GAAP net loss for Q1 2024 was $34.0 million, or $0.05 per share, compared to a net loss of $18.6 million, or $0.04 per share, in Q1 2023[13] - The net loss for Q1 2024 was $43.5 million, compared to a net loss of $542.3 million in Q1 2023, indicating a reduction of 91.9%[25] - Basic and diluted loss per share for Q1 2024 was $0.06, significantly improved from $1.43 in Q1 2023[25] Cash and Investments - Cash and cash equivalents, restricted cash, and short-term investments totaled $157.0 million as of March 31, 2024, down from $186.2 million at the end of 2023[7] - Operating cash outflow for Q1 2024 was $30.1 million, compared to $13.1 million in Q1 2023[7] - The company updated its cash runway guidance, indicating operations will be funded through Q1 2025[1] - Cash and cash equivalents decreased to $157.0 million as of March 31, 2024, down from $186.2 million at the end of 2023[27] Research and Development - R&D expenses under GAAP were $30.9 million for Q1 2024, compared to $9.9 million for the same period in the prior year[7] - Research and development expenses for Q1 2024 were $30.9 million, up from $9.9 million in Q1 2023, reflecting a significant increase of 212.1%[25] - The HARMONi Phase III trial is expected to complete enrollment in the second half of 2024, focusing on ivonescimab combined with chemotherapy for specific NSCLC patients[3] - Ivonescimab demonstrated a 34% intracranial response rate in NSCLC patients with brain metastases, with a median intracranial progression-free survival of 19.3 months[4] - The company anticipates ongoing clinical trials and potential commercialization of its product candidates, including ivonescimab, with future regulatory submissions expected[23] Company Leadership - The company appointed Dr. Mostafa Ronaghi to its Board of Directors in April 2024, enhancing its leadership team[4] Assets and Liabilities - Total assets decreased to $176.8 million as of March 31, 2024, compared to $202.9 million at the end of 2023[27] - Total liabilities increased to $132.6 million as of March 31, 2024, up from $125.3 million at the end of 2023[27] Operating Expenses - Non-GAAP operating expenses for Q1 2024 were $33.1 million, up from $14.0 million in the same period last year[8] - Q1 2024 operating expenses totaled $42.6 million, a decrease of 92.1% compared to $537.7 million in Q1 2023[25] Cash Flow - Net cash used in operating activities for Q1 2024 was $30.1 million, compared to $13.1 million in Q1 2023, reflecting an increase of 129.0%[28] Signaling Proteins - VEGF is a signaling protein that promotes angiogenesis, crucial for both anti- and pro-angiogenic therapies[43]

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 ...

Financial Performance - Revenue for the year ended December 31, 2023 was $0, a decrease of $0.7 million compared to $0.7 million in 2022, attributed to the full recognition of $4.8 million in milestone payments in 2022 [427][428]. - The operating loss for 2023 was $609.6 million, compared to a loss of $72.1 million in 2022, indicating a significant increase in financial strain [427]. - Net loss for the year ended December 31, 2023 was $614.9 million, compared to a net loss of $78.8 million in 2022, highlighting the company's financial challenges [427]. - The company incurred a net loss of $614.9 million for the year ended December 31, 2023, with cash flows used in operating activities amounting to $76.8 million [447]. - Net cash used in operating activities for the year ended December 31, 2023 was $76.8 million, compared to $41.6 million in 2022, reflecting a significant increase in operational losses [456][458]. - Net cash provided by financing activities for 2023 was $86.5 million, down from $620.2 million in 2022, largely due to the repayment of $395.3 million under the Duggan Promissory Note [460][462]. Research and Development - Research and development expenses increased to $59.4 million in 2023 from $52.0 million in 2022, reflecting ongoing clinical trials for ivonescimab [427]. - Total research and development expenses rose by $7.4 million to $59.4 million, primarily due to increased oncology investment and compensation-related costs [433]. - The investment in ivonescimab totaled $520.9 million for the year ended December 31, 2023, including upfront milestone payments under the License Agreement with Akeso [435]. - The company initiated Phase III clinical trials for ivonescimab in non-small cell lung cancer, specifically targeting two patient groups [407]. - The company has entered into a License Agreement with Akeso for ivonescimab, which closed in January 2023, marking a strategic shift in its operations [406]. Operating Expenses - Total operating expenses surged to $610.6 million in 2023, up from $87.2 million in 2022, primarily due to $520.9 million in in-process research and development costs [427]. - Oncology expenses increased to $31.0 million for the year ended December 31, 2023, reflecting a strategic shift from anti-infectives to oncology [430]. - General and administrative expenses increased by $3.6 million to $30.3 million, driven by higher stock-based compensation and legal fees [437]. - The company anticipates continued increases in general and administrative expenses as it expands its workforce to support clinical trials and commercialization efforts [423]. Funding and Capital Requirements - The company has terminated all prior development and marketing activities related to ridinilazole, focusing instead on ivonescimab and other future activities [408]. - Funding income from BARDA decreased by $8.1 million to $0 for the year ended December 31, 2023, due to the termination of development activities related to ridinilazole [439]. - The company expects to continue incurring significant operating losses and will need to raise additional capital to fund ongoing operations [448]. - Future capital requirements will depend on various factors, including the ability to generate substantial product revenues [450]. - The company has contractual commitments estimated at approximately $37.7 million as of December 31, 2023, with the majority due within one year [470]. - The company entered into additional contractual commitments of approximately $23.0 million related to clinical trials from December 31, 2023, to February 9, 2024 [471]. - The company has no capital commitments as of December 31, 2023 [463]. - The company expects to finance operations through public or private equity or debt financings until significant revenue from product sales is generated [488]. Tax and Financial Obligations - The company has recorded unrecognized tax positions of $1.1 million as of December 31, 2023, compared to nil in 2022 [484]. - The company has $1.8 million of research and development tax credits outstanding as of December 31, 2023 [492]. - The principal balance payable on promissory notes was $520 million as of December 31, 2022, and reduced to $100 million by December 31, 2023 [491]. - The company is required to pay royalties or milestone payments under agreements with Akeso and other entities, but the amounts and timing are currently uncertain [472]. - The company has lease commitments totaling $6.6 million, with $2.8 million due within one year [465]. - The company has extended the maturity date of the Duggan February Note to April 1, 2025, with interest accruing at a minimum of 12% [468]. Stock-Based Compensation - Stock-based compensation expense is recognized based on the estimated fair value of awards, with adjustments made quarterly based on performance conditions [480]. - The company uses the Black-Scholes option pricing model to estimate the fair value of stock options, which involves subjective assumptions [480]. - The company has a full valuation allowance against deferred tax assets, indicating that it is unlikely to realize tax benefits [483]. Currency Risk - The company monitors foreign currency exchange rate risk, particularly against the pound sterling and euro, but currently does not consider the impact material [489].

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 ...

[Information Regarding Forward-Looking Statements](index=3&type=section&id=INFORMATION%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section cautions that forward-looking statements in the Form 10-Q involve substantial risks, and actual results may differ materially - The report contains forward-looking statements regarding strategy, future operations, financial position, revenues, costs, prospects, plans, and objectives[10](index=10&type=chunk) - Key forward-looking statements encompass the ability to develop successful product candidates like **ivonescimab**, raise additional funds, manage clinical trial timing, achieve market acceptance, and secure intellectual property[13](index=13&type=chunk) - Readers are cautioned against undue reliance on these statements, as actual results could materially differ due to factors outlined in the 'Risk Factors' section[11](index=11&type=chunk) [PART I - Financial Information](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, with detailed explanatory notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets and cash significantly decreased from December 2022 to September 2023, primarily due to short-term investments and Akeso payments, while total liabilities also saw a substantial reduction Condensed Consolidated Balance Sheet Summary | Metric | Sep 30, 2023 (in thousands) | Dec 31, 2022 (in thousands) | Change (in thousands) | % Change | | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------- | :------- | | Cash and cash equivalents | $23,792 | $348,607 | $(324,815) | -93.18% | | Restricted cash | — | $300,000 | $(300,000) | -100.00% | | Short-term investments | $175,153 | — | $175,153 | N/A | | Total current assets | $204,951 | $656,712 | $(451,761) | -68.80% | | Total assets | $218,476 | $664,168 | $(445,692) | -67.11% | | Total current liabilities | $113,742 | $38,782 | $74,960 | 193.29% | | Total liabilities | $119,097 | $537,514 | $(418,417) | -77.84% | | Total stockholders' equity | $99,379 | $126,654 | $(27,275) | -21.54% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss significantly increased for the nine months ended September 30, 2023, driven by a substantial in-process research and development expense for the ivonescimab license agreement Condensed Consolidated Statements of Operations Summary | Metric (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Revenue | $— | $220 | $— | $705 | | R&D Expenses | $15,323 | $17,049 | $34,657 | $46,613 | | In-process R&D | $— | $— | $520,915 | $— | | G&A Expenses | $5,434 | $5,573 | $18,690 | $19,165 | | Total Operating Exp. | $20,757 | $22,622 | $574,262 | $65,778 | | Operating Loss | $(20,492) | $(16,940) | $(573,440) | $(51,790) | | Net Loss | $(21,268) | $(21,385) | $(578,361) | $(59,553) | | Basic & Diluted EPS | $(0.03) | $(0.10) | $(0.98) | $(0.37) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased from **$126.65 million** to **$99.38 million** due to a significant net loss, partially offset by a rights offering and common stock issuance for the Akeso upfront payment Condensed Consolidated Statements of Stockholders' Equity Summary | Metric (in thousands) | Dec 31, 2022 | Sep 30, 2023 | | :-------------------- | :----------- | :----------- | | Common Stock (shares) | 211,091,425 | 697,851,308 | | Common Stock (amount) | $2,110 | $6,978 | | Additional Paid-In Capital | $504,767 | $1,051,415 | | Accumulated Deficit | $(378,330) | $(956,691) | | Total Stockholders' Equity | $126,654 | $99,379 | - The **2023 Rights Offering** generated **$499.38 million** (net of costs) from the sale of **476,190,471** shares[21](index=21&type=chunk) - **10,000,000** shares of common stock were issued for **$45.90 million** as part of the **Akeso** upfront payment[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Significant cash outflows from investing activities, primarily for the Akeso upfront payment and short-term investments, were partially offset by cash provided by financing activities from a rights offering Condensed Consolidated Statements of Cash Flows Summary | Cash Flow Activity (in thousands) | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(57,301) | $(46,773) | | Net cash used in investing activities | $(648,342) | $(634) | | Net cash provided by financing activities | $80,261 | $100,184 | | Decrease in cash and cash equivalents | $(624,815) | $50,180 | | Cash and cash equivalents at end of period | $23,792 | $121,971 | - Investing activities included **$475.02 million** cash payment to **Akeso** for upfront milestone payments and **$321.02 million** for short-term investments[23](index=23&type=chunk) - Financing activities included **$104.69 million** from the **2023 Rights Offering** and repayment of **$24.69 million** in related party promissory notes[23](index=23&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations and disclosures for the unaudited condensed consolidated financial statements, covering business, accounting policies, liquidity, and significant transactions [Note 1. Nature of Business and Operations and Recent Events](index=9&type=section&id=1.%20Nature%20of%20Business%20and%20Operations%20and%20Recent%20Events) Summit Therapeutics Inc. strategically shifted its focus to oncology, centered on the in-licensed bispecific antibody **ivonescimab**, initiating Phase III trials and completing a major rights offering - The company's strategy has significantly shifted to oncology, focusing on the development of **ivonescimab** (**SMT112**) for non-small cell lung cancer (**NSCLC**)[28](index=28&type=chunk)[141](index=141&type=chunk) - Phase III clinical trials (**HARMONi** and **HARMONi-3**) for **ivonescimab** in **EGFR-mutated** and first-line metastatic squamous **NSCLC** have commenced[29](index=29&type=chunk)[33](index=33&type=chunk)[142](index=142&type=chunk)[151](index=151&type=chunk) - A **2023 Rights Offering** generated **$500 million** in gross proceeds from the sale of **476,190,471** shares of common stock[31](index=31&type=chunk)[145](index=145&type=chunk) - The company entered into a **Note Purchase Agreement** for **$520 million** in unsecured promissory notes with its **Co-CEOs**, with a significant portion repaid through the rights offering[32](index=32&type=chunk)[145](index=145&type=chunk) [Note 2. Basis of Presentation, Use of Estimates, and Risks and Uncertainties](index=10&type=section&id=2.%20Basis%20of%20Presentation%2C%20Use%20of%20Estimates%2C%20and%20Risks%20and%20Uncertainties) The unaudited condensed consolidated financial statements are prepared under **U.S. GAAP**, relying on management's estimates and judgments, while acknowledging potential adverse impacts from COVID-19 and supply chain issues - Financial statements are prepared under **U.S. GAAP**, and management's estimates are crucial for reported amounts[39](index=39&type=chunk)[44](index=44&type=chunk) - The company considers highly liquid investments with a maturity of **90** days or less as cash equivalents, including money market funds and U.S. treasury securities[40](index=40&type=chunk) - Potential adverse impacts from COVID-19 outbreaks and supply chain issues are noted as risks[45](index=45&type=chunk) [Note 3. Recently Issued or Adopted Accounting Pronouncements](index=11&type=section&id=3.%20Recently%20Issued%20or%20Adopted%20Accounting%20Pronouncements) The company adopted **ASU 2016-13** on January 1, 2023, which had no material impact on its financial statements, and other recent guidance is not expected to have a material effect - **ASU 2016-13** (**CECL model**) was adopted on January 1, 2023, with no material impact on financial statements[46](index=46&type=chunk) - **ASU No. 2021-04**, related to equity-classified written call options, had no modifications or exchanges during **2023** or **2022**[47](index=47&type=chunk)[49](index=49&type=chunk) [Note 4. Liquidity and Capital Resources](index=12&type=section&id=4.%20Liquidity%20and%20Capital%20Resources) Significant net losses and cash outflows resulted in a substantial accumulated deficit, raising doubt about the company's ability to continue as a going concern without raising additional capital Liquidity and Capital Resources Summary | Metric (in thousands) | 9 Months Ended Sep 30, 2023 | | :-------------------- | :-------------------------- | | Net loss | $(578,361) | | Cash flows used in operating activities | $(57,301) | | Accumulated deficit | $(956,691) | | Cash and cash equivalents | $23,792 | | Short-term investments | $175,153 | | R&D tax credit receivable | $1,559 | - The company has a **$100 million** promissory note payable to a related party maturing on September 6, 2024, and intends to raise additional capital to repay it[51](index=51&type=chunk) - These conditions raise substantial doubt about the company's ability to continue as a going concern for at least one year from the issuance date of the financial statements[51](index=51&type=chunk) [Note 5. Segment Reporting](index=12&type=section&id=5.%20Segment%20Reporting) The company operates as a single reportable operating segment focused on oncology product research and development, with long-lived assets distributed across the U.K. and the U.S - The company's chief operating decision makers view and manage the business as a single operating segment, primarily oncology product research activities[54](index=54&type=chunk) Long-Lived Assets by Geographic Region | Geographic Region | Sep 30, 2023 (in thousands) | Dec 31, 2022 (in thousands) | | :---------------- | :-------------------------- | :-------------------------- | | United Kingdom | $832 | $2,517 | | United States | $5,800 | $2,564 | | Total | $6,632 | $5,081 | [Note 6. Revenue](index=13&type=section&id=6.%20Revenue) The company recognized no revenue for the three and nine months ended September 30, 2023, as prior period revenue from the **Eurofarma** agreement concluded in 2022 Revenue Summary | Revenue Category | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :--------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Licensing agreements | $— | $220 | $— | $705 | - Revenue from the **Eurofarma** agreement was fully recognized by **2022**, and no additional milestone payments are expected[57](index=57&type=chunk)[159](index=159&type=chunk) [Note 7. Other Operating Income, net](index=14&type=section&id=7.%20Other%20Operating%20Income%2C%20net) Other operating income significantly decreased due to the conclusion of funding from **BARDA** and **CARB-X**, and a reduction in U.K. research and development tax credits Other Operating Income Summary | Income Category (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :----------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Funding income from BARDA | $— | $3,889 | $— | $7,774 | | Research and development tax credits | $265 | $1,224 | $768 | $3,730 | | Grant income from CARB-X | $— | $349 | $45 | $1,779 | | Total | $265 | $5,462 | $822 | $13,283 | - **BARDA** contract ended in **2022**, and **CARB-X** arrangement concluded in **2022**, leading to no further income from these sources[63](index=63&type=chunk)[68](index=68&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) - R&D tax credits decreased due to reduced clinical and manufacturing activity for **ridinilazole** and changes in U.K. tax legislation[170](index=170&type=chunk) [Note 8. Akeso Collaboration and License Agreement](index=15&type=section&id=8.%20Akeso%20Collaboration%20and%20License%20Agreement) Summit in-licensed **ivonescimab** from **Akeso** in January 2023, involving a **$500 million** upfront payment expensed as in-process R&D, with potential future milestones up to **$4.5 billion** - Summit in-licensed **ivonescimab** (**SMT112**) from **Akeso**, a bispecific antibody combining PD-1 blockade and anti-VEGF effects for oncology, with rights in the US, Canada, Europe, and Japan[27](index=27&type=chunk)[30](index=30&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk) - An upfront payment of **$500 million** was made to **Akeso**, consisting of **$274.9 million** cash, **10 million** shares of common stock (fair value **$45.9 million**), and a remaining **$200 million** cash payment[71](index=71&type=chunk)[72](index=72&type=chunk)[166](index=166&type=chunk) - The upfront payment was expensed as **$520.9 million** in-process research and development due to the asset being in clinical development[72](index=72&type=chunk)[166](index=166&type=chunk) - **Akeso** is eligible for up to **$4.5 billion** in regulatory and commercial milestones, plus low double-digit royalties on net sales[73](index=73&type=chunk) [Note 9. Other (Expense) Income, net](index=16&type=section&id=9.%20Other%20(Expense)%20Income%2C%20net) Other (expense) income, net, for the nine months ended September 30, 2023, was a net expense of **$4.92 million**, primarily due to interest expense on related party promissory notes, partially offset by interest income Other (Expense) Income Summary | Metric (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Foreign currency gains (losses) | $(475) | $(3,799) | $344 | $(6,281) | | Interest expense on promissory notes | $(2,722) | $(692) | $(13,564) | $(1,497) | | Interest income | $2,485 | $— | $8,028 | $— | | Total | $(776) | $(4,445) | $(4,921) | $(7,763) | - Interest expense increased significantly due to the **$520 million** promissory notes issued to **Co-CEOs** in December **2022**[76](index=76&type=chunk)[176](index=176&type=chunk) - Interest income increased due to investments in money market funds and U.S. treasury securities[76](index=76&type=chunk)[176](index=176&type=chunk) [Note 10. Loss per Share](index=16&type=section&id=10.%20Loss%20per%20Share) Basic and diluted net loss per share for the nine months ended September 30, 2023, was **$(0.98)**, reflecting a higher net loss, with potentially dilutive securities excluded as anti-dilutive Loss per Share Summary | Metric | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :----- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net loss per share (Basic & Diluted) | $(0.03) | $(0.10) | $(0.98) | $(0.37) | | Weighted-average shares (Basic & Diluted) | 697,739,477 | 208,909,351 | 592,366,880 | 161,846,345 | - Potentially dilutive securities, including stock options and warrants, were excluded from diluted EPS calculation due to the company being in a net loss position[77](index=77&type=chunk)[79](index=79&type=chunk) [Note 11. Fair Value Measurements and Investments](index=17&type=section&id=11.%20Fair%20Value%20Measurements%20and%20Investments) The company's financial assets measured at fair value primarily consist of money market funds and U.S. Government treasury bills, with short-term investments totaling **$175.15 million** as of September 30, 2023 Fair Value Measurements and Investments Summary | Asset Category (in thousands) | Level 1 | Level 2 | Level 3 | Total | | :---------------------------- | :------ | :------ | :------ | :---- | | Money market funds | $4,711 | $— | $— | $4,711 | | U.S. Government treasury bills | $— | $175,153 | $— | $175,153 | | Total financial assets | $4,711 | $175,153 | $— | $179,864 | - All short-term investments, primarily U.S. Government treasury bills, are due within one year[88](index=88&type=chunk) [Note 12. Goodwill and Intangible Assets](index=19&type=section&id=12.%20Goodwill%20and%20Intangible%20Assets) Goodwill remained stable at **$1.81 million**, while intangible assets, including the **Discuva** platform and **Utrophin** program, are fully amortized or impaired, resulting in a net carrying amount of zero Goodwill Summary | Metric (in thousands) | Sep 30, 2023 | Dec 31, 2022 | | :-------------------- | :----------- | :----------- | | Goodwill | $1,814 | $1,798 | Intangible Assets Summary | Intangible Asset (in thousands) | Gross Carrying Amount | Accumulated Amortization and Impairment | Net | | :------------------------------ | :-------------------- | :-------------------------------------- | :-- | | Discuva platform acquired | $13,019 | $(13,019) | $— | | Utrophin program acquired | $— | $— | $— | | Other licenses | $134 | $(134) | $— | | Total | $13,977 | $(13,977) | $— | - The **Utrophin** program intangible assets were fully impaired and removed from accounting records due to the dissolution of **Muox Limited**[92](index=92&type=chunk) [Note 13. Leases](index=19&type=section&id=13.%20Leases) The company holds operating leases for office space, with a new lease in Menlo Park, California, and the termination of a U.K. lease due to strategic reprioritization towards **ivonescimab** - A new operating lease for office space in Menlo Park, California, commenced, adding **$4.25 million** in right-of-use assets[94](index=94&type=chunk) - The Cambridge, U.K. laboratory and office space lease was terminated, disposing of **$788 thousand** in right-of-use assets, as the company reprioritized investments to **ivonescimab**[94](index=94&type=chunk) Lease Cost Summary | Lease Cost (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Fixed lease costs | $678 | $444 | $1,535 | $1,033 | | Variable lease costs | $2 | $53 | $71 | $91 | | Total lease cost | $680 | $497 | $1,606 | $1,124 | [Note 14. Promissory Notes Payable to Related Parties](index=20&type=section&id=14.%20Promissory%20Notes%20Payable%20to%20Related%20Parties) The company issued **$520 million** in unsecured promissory notes to its **Co-CEOs** in December 2022, with **$420 million** repaid by September 2023, leaving a **$100 million** note outstanding - The company issued **$520 million** in unsecured promissory notes to **Co-CEOs Mr. Duggan** and **Dr. Zanganeh** in December **2022**[98](index=98&type=chunk)[119](index=119&type=chunk) - The **$20 million Zanganeh Note** and **$400 million Duggan Promissory Note** were repaid in February **2023**, largely through the **2023 Rights Offering**[100](index=100&type=chunk)[121](index=121&type=chunk) - A **$100 million Duggan September Note** remains outstanding, maturing on September 6, 2024[103](index=103&type=chunk)[105](index=105&type=chunk) - Interest expense on these notes for the nine months ended September 30, 2023, was **$13.56 million**[103](index=103&type=chunk) [Note 15. Stock-Based Compensation and Warrants](index=22&type=section&id=15.%20Stock-Based%20Compensation%20and%20Warrants) The company's **2020 Stock Incentive Plan** had **20.55 million** options outstanding, with stockholders approving an increase of **70 million** shares, and total stock-based compensation expense was **$5.36 million** Stock Option Activity Summary | Stock Option Activity | 9 Months Ended Sep 30, 2023 | | :-------------------- | :-------------------------- | | Outstanding at Dec 31, 2022 | 19,476,359 | | Granted | 3,921,450 | | Forfeited | (2,672,305) | | Exercised | (177,237) | | Outstanding at Sep 30, 2023 | 20,548,267 | | Weighted average exercise price | $3.24 | - Stockholders approved an increase of **70,000,000** shares for the **2020 Stock Incentive Plan**[108](index=108&type=chunk) Stock-Based Compensation Expense Summary | Stock-Based Compensation (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $149 | $1,162 | $1,962 | $3,300 | | General and administrative | $556 | $1,636 | $3,393 | $5,990 | | Total | $705 | $2,798 | $5,355 | $9,290 | [Note 16. Related Party Transactions](index=23&type=section&id=16.%20Related%20Party%20Transactions) The company engaged in various related party transactions, including sublease agreements, the issuance and repayment of **$520 million** in promissory notes to **Co-CEOs**, and the **Akeso License Agreement** - Sublease agreements for office space with **Maky Zanganeh and Associates, Inc.** (**MZA**), an entity related to **Co-CEO Dr. Zanganeh**, resulted in payments of **$730 thousand** for the nine months ended September 30, 2023[113](index=113&type=chunk)[114](index=114&type=chunk) - The **$520 million Note Purchase Agreement** with **Co-CEOs Mr. Duggan** and **Dr. Zanganeh** was a significant related party financing event, with **$420 million** repaid by February **2023**[119](index=119&type=chunk)[121](index=121&type=chunk) - The **Akeso License Agreement** led to **Dr. Yu (Michelle) Xia**, **Akeso's** founder, being appointed to **Summit's** Board of Directors[124](index=124&type=chunk) - In the **2023 Rights Offering**, **Mr. Duggan's $395.31 million** subscription price was satisfied by extinguishing a portion of his outstanding promissory note[125](index=125&type=chunk) [Note 17. Commitments and Contingencies](index=25&type=section&id=17.%20Commitments%20and%20Contingencies) The company has lease commitments, **$6.36 million** in non-cancellable purchase commitments for clinical trials, and unestimable contingent payment obligations for milestones and royalties under various agreements - New lease for office space in Menlo Park, California, with total payments of **$4.7 million** over **36** months[129](index=129&type=chunk)[198](index=198&type=chunk) - Termination of Cambridge, U.K. laboratory and office space lease due to strategic reprioritization[129](index=129&type=chunk)[198](index=198&type=chunk) - Approximately **$6.36 million** in non-cancellable purchase commitments associated with clinical trials as of September 30, 2023[132](index=132&type=chunk)[200](index=200&type=chunk) - Contingent payment obligations for royalties or milestone payments under agreements with **Akeso**, **Wellcome Trust**, **University College London**, and others are currently unestimable[133](index=133&type=chunk)[199](index=199&type=chunk) [Note 18. Subsequent Events](index=26&type=section&id=18.%20Subsequent%20Events) On October 16, 2023, **Mr. Manmeet Soni** was appointed Chief Operating Officer and purchased **2,976,190** shares of common stock for **$5 million** via a private placement - **Mr. Manmeet Soni** was appointed Chief Operating Officer on October 16, 2023[38](index=38&type=chunk)[136](index=136&type=chunk)[153](index=153&type=chunk) - **Mr. Soni** purchased **2,976,190** shares of common stock for **$5 million** in a private placement, effective October 13, 2023[38](index=38&type=chunk)[136](index=136&type=chunk)[153](index=153&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, emphasizing the strategic shift to oncology with **ivonescimab**, the financial impact of the **Akeso** license, and the ongoing need for additional capital due to significant operating losses and debt obligations [Company Overview](index=27&type=section&id=Company%20Overview) Summit Therapeutics Inc. is a biopharmaceutical company that strategically shifted its focus to oncology, with **ivonescimab** as its primary product candidate in-licensed from **Akeso**, Inc - The company is a biopharmaceutical firm focused on oncology, aiming to develop patient-friendly, new-era standard-of-care medicines[139](index=139&type=chunk) - **Ivonescimab** (**SMT112**), a potential first-in-class bispecific antibody, is the key product candidate, in-licensed from **Akeso** for development and commercialization in the US, Canada, Europe, and Japan[140](index=140&type=chunk) - The company's strategy has significantly changed, with future operations focused on **ivonescimab** development, and anti-infective activities being reviewed for partnership opportunities[141](index=141&type=chunk) [Recent Events](index=27&type=section&id=Recent%20Events) Recent events include the in-licensing of **ivonescimab** and initiation of its Phase III clinical trials, a **$500 million** rights offering, and **$520 million** in related party promissory notes, with most repaid - The Collaboration and License Agreement for **ivonescimab** with **Akeso**, Inc. closed in January **2023**[143](index=143&type=chunk) - Phase III clinical studies for **ivonescimab** in **NSCLC** (**HARMONi** and **HARMONi-3**) were initiated, with the first US patient enrolled in **HARMONi** in May **2023**[149](index=149&type=chunk) - A **$500 million 2023 Rights Offering** was completed, and **$520 million** in promissory notes were issued to **Co-CEOs**, with **$420 million** repaid by February **2023**[145](index=145&type=chunk)[147](index=147&type=chunk) - The **2020 Stock Incentive Plan** was amended to increase authorized shares by **70 million**, and **Mr. Manmeet Soni** was appointed COO, purchasing **$5 million** in common stock[152](index=152&type=chunk)[153](index=153&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) The company reported a net loss of **$578.4 million** for the nine months ended September 30, 2023, primarily due to a **$520.9 million** in-process R&D expense for **ivonescimab** Consolidated Statements of Operations Summary | Metric (in millions) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Revenue | $— | $0.2 | $— | $0.7 | | Operating Loss | $(20.4) | $(16.9) | $(573.5) | $(51.8) | | Net Loss | $(21.2) | $(21.3) | $(578.4) | $(59.6) | [Revenue](index=30&type=section&id=Revenue) Revenue for the three and nine months ended September 30, 2023, was zero, attributed to the full recognition of milestones from the **Eurofarma** license agreement in 2022 Revenue Summary | Metric (in millions) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Revenue | $— | $0.2 | $— | $0.7 | - The decrease in revenue is due to the **Eurofarma** license and commercialization agreement milestones being fully recognized by **2022**, with no additional milestones expected[159](index=159&type=chunk) [Operating Expenses](index=30&type=section&id=Operating%20Expenses) Total operating expenses significantly increased to **$574.3 million** for the nine months ended September 30, 2023, primarily driven by a **$520.9 million** in-process R&D expense for **ivonescimab** Operating Expenses Summary | Metric (in millions) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $15.3 | $17.0 | $34.7 | $46.6 | | In-process research and development | $— | $— | $520.9 | $— | | General and administrative | $5.4 | $5.6 | $18.7 | $19.2 | | Total operating expenses | $20.7 | $22.6 | $574.3 | $65.8 | [Research and Development Expenses](index=30&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses decreased by **$11.9 million** due to concluding anti-infectives programs, partially offset by investment in oncology (**ivonescimab**) and compensation-related costs Research and Development Expenses by Category | R&D Category (in millions) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Oncology | $9.4 | $— | $16.7 | $— | | Anti-infectives | $(0.1) | $11.9 | $(1.8) | $28.2 | | Compensation related costs | $4.8 | $3.0 | $14.7 | $12.1 | | Stock-based compensation | $0.1 | $1.2 | $2.0 | $3.3 | | Other R&D costs | $1.1 | $0.9 | $3.1 | $3.0 | | Total | $15.3 | $17.0 | $34.7 | $46.6 | - The company is investing resources in the clinical development of **ivonescimab**, including Phase III **HARMONi** and **HARMONi-3** studies for **NSCLC**[162](index=162&type=chunk)[163](index=163&type=chunk) - Anti-infectives programs for **ridinilazole** and **SMT-738** concluded development activities, resulting in a **$30.0 million** decrease in expenses[164](index=164&type=chunk) [In-process research and development](index=31&type=section&id=In-process%20research%20and%20development) In-process research and development expense totaled **$520.9 million** for the nine months ended September 30, 2023, representing upfront milestone payments for the **ivonescimab** license agreement with **Akeso** In-process Research and Development Expenses Summary | IPR&D Category (in millions) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :--------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Upfront milestone payments | $— | $— | $520.8 | $— | | Direct transaction costs | $— | $— | $0.1 | $— | | Total | $— | $— | $520.9 | $— | - The **$520.9 million** expense includes **$474.9 million** in cash and **$45.9 million** fair value of **10 million** common shares issued to **Akeso**[166](index=166&type=chunk) [General and Administrative Expenses](index=32&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses slightly decreased by **$0.5 million** due to lower stock-based compensation, partially offset by increases in compensation-related costs and legal/professional services General and Administrative Expenses by Category | G&A Category (in millions) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Compensation related costs | $2.3 | $2.1 | $7.3 | $6.3 | | Stock-based compensation | $0.6 | $1.6 | $3.4 | $6.0 | | Legal fees and professional services | $1.3 | $1.0 | $4.9 | $3.9 | | Other G&A expenses | $1.2 | $0.9 | $3.1 | $3.0 | | Total | $5.4 | $5.6 | $18.7 | $19.2 | - Stock-based compensation decreased due to awards becoming fully amortized, lower fair values, and forfeitures[168](index=168&type=chunk) - Compensation-related expenses and legal/professional services increased to support company growth and corporate projects[168](index=168&type=chunk) [Other Operating Income](index=32&type=section&id=Other%20Operating%20Income) Other operating income significantly decreased to **$0.8 million** due to the conclusion of funding from **BARDA** and **CARB-X**, and reduced U.K. research and development tax credits Other Operating Income by Category | Income Category (in millions) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :---------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development tax credits | $0.3 | $1.2 | $0.8 | $3.7 | | Funding income from BARDA | $— | $3.9 | $— | $7.8 | | Grant income from CARB-X | $— | $0.4 | $— | $1.8 | | Total | $0.3 | $5.5 | $0.8 | $13.3 | - **BARDA** and **CARB-X** contracts ended in **2022**, and no further income is expected from these arrangements[171](index=171&type=chunk)[172](index=172&type=chunk) - U.K. R&D tax credits decreased due to reduced clinical and manufacturing activity for **ridinilazole** and changes in U.K. tax legislation[170](index=170&type=chunk) [Other (Expense) Income, net](index=33&type=section&id=Other%20(Expense)%20Income%2C%20net) Other (expense) income, net, was a net expense of **$4.9 million**, an improvement driven by favorable foreign currency gains and increased interest income, partially offset by higher interest expense on related party notes Other (Expense) Income, Net Summary | Metric (in millions) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Foreign currency (losses) gains | $(0.5) | $(3.8) | $0.3 | $(6.3) |\ | Interest expense on promissory notes | $(2.7) | $(0.6) | $(13.6) | $(1.5) |\ | Interest income | $2.5 | $— | $8.0 | $— |\ | Total | $(0.8) | $(4.4) | $(4.9) | $(7.8) | - Interest expense increased by **$12.1 million** due to the **$520 million** promissory notes issued to **Co-CEOs** in December **2022**[176](index=176&type=chunk) - Interest income increased by **$8.0 million** from investments in money market funds and U.S. government securities[176](index=176&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity concerns with an accumulated deficit of **$956.7 million** and insufficient cash to fund operations, raising substantial doubt about its ability to continue as a going concern [Sources of Liquidity](index=33&type=section&id=Sources%20of%20Liquidity) Historically, funding came from stock issuances, license agreements, government funding, and related party promissory notes, with recent financing including a **$100 million** rights offering and **$520 million** in related party notes - Primary funding sources include common stock issuances, license/collaboration agreements, government/philanthropic funding, and related party promissory notes[177](index=177&type=chunk) - The **2022 Rights Offering** generated **$99.9 million** in net proceeds[178](index=178&type=chunk) - In December **2022**, **$520 million** in unsecured promissory notes were issued to **Co-CEOs**, with **$420 million** repaid by February **2023**, leaving a **$100 million** note outstanding[179](index=179&type=chunk)[180](index=180&type=chunk) [Cash Flows](index=36&type=section&id=Cash%20Flows) Net cash used in operating activities was **$57.3 million**, and investing activities used **$648.3 million** (Akeso payment, short-term investments), while financing activities provided **$80.3 million** (rights offering) Cash Flow Activities Summary | Cash Flow Activity (in millions) | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(57.3) | $(46.8) | | Net cash used in investing activities | $(648.3) | $(0.6) | | Net cash provided by financing activities | $80.3 | $100.2 | - Investing activities included **$475.0 million** cash payment to **Akeso** and **$321.0 million** for short-term investments[192](index=192&type=chunk) - Financing activities included **$104.1 million** net proceeds from the **2023 Rights Offering** and repayment of **$24.7 million** in related party promissory notes[194](index=194&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=37&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) The financial statements rely on management's estimates and judgments for revenue, R&D, intangible assets, stock-based compensation, and income taxes, with no material changes since the **2022 Form 10-K** - Management evaluates estimates and judgments related to revenue recognition, R&D expenses, stock-based compensation, intangible assets, goodwill, and income taxes[196](index=196&type=chunk) - No material changes to critical accounting policies and estimates were disclosed since the **2022 Form 10-K**[197](index=197&type=chunk) [Contractual obligations and commitments](index=37&type=section&id=Contractual%20obligations%20and%20commitments) The company has lease commitments, **$6.4 million** in non-cancellable purchase commitments for clinical trials, and unestimable contingent payment obligations for milestones and royalties under various agreements - Lease commitments include a new **36**-month lease for office space in Menlo Park, California, with total payments of **$4.7 million**, and the termination of a U.K. lease[198](index=198&type=chunk) - Approximately **$6.4 million** in non-cancellable purchase commitments are associated with clinical trials as of September 30, 2023[200](index=200&type=chunk) - Contingent payment obligations for royalties or milestone payments under agreements with **Akeso**, **Wellcome Trust**, and others are currently unestimable[199](index=199&type=chunk) [Off-Balance Sheet Arrangements](index=37&type=section&id=Off-Balance%20Sheet%20Arrangements) The company did not have any off-balance sheet arrangements during the periods presented or currently - The company has no off-balance sheet arrangements[201](index=201&type=chunk) [Recently Issued Accounting Pronouncements](index=38&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) For a discussion of recently issued accounting pronouncements, refer to **Note 3** of the condensed consolidated financial statements - Refer to **Note 3** for details on recently issued or adopted accounting pronouncements[202](index=202&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a 'smaller reporting company,' Summit Therapeutics Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is exempt from providing market risk disclosures as it qualifies as a 'smaller reporting company'[203](index=203&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective at a reasonable level of assurance as of September 30, 2023, with no material changes in internal control over financial reporting - Disclosure controls and procedures were evaluated and deemed effective at a reasonable level of assurance as of September 30, 2023[204](index=204&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended September 30, 2023[205](index=205&type=chunk) [PART II - Other Information](index=38&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently subject to any material legal proceedings[135](index=135&type=chunk)[207](index=207&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) The company highlights significant investment risks, including substantial doubt about its ability to continue as a going concern due to insufficient working capital and uncertainty in raising additional funds - There is substantial doubt about the company's ability to continue as a going concern due to insufficient working capital to fund planned operations for the next twelve months and uncertainty in raising additional capital[209](index=209&type=chunk)[210](index=210&type=chunk) - Inadequate funding or disruptions to government agencies (FDA, SEC) could hinder product development, regulatory reviews, and access to capital, negatively impacting the business[211](index=211&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report - No unregistered sales of equity securities or use of proceeds to report[212](index=212&type=chunk) [Item 3. Defaults Upon Senior Securities](index=39&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report - No defaults upon senior securities to report[213](index=213&type=chunk) [Item 4. Mine Safety Disclosures](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) There were no mine safety disclosures to report - No mine safety disclosures to report[215](index=215&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information) There was no other information to report - No other information to report[216](index=216&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed or furnished with the Form 10-Q, including employment agreements, certifications, and **XBRL** taxonomy documents - Exhibits include employment agreements, certifications (**Sarbanes-Oxley Act**), and **XBRL** taxonomy documents[218](index=218&type=chunk) [Signatures](index=40&type=section&id=Signatures) The report is duly signed on behalf of Summit Therapeutics Inc. by **Ankur Dhingra**, Chief Financial Officer, on November 7, 2023 - The report was signed by **Ankur Dhingra**, Chief Financial Officer, on November 7, 2023[220](index=220&type=chunk)

Financial Performance - Revenue for the three months ended June 30, 2023, was $0, compared to $0.2 million for the same period in 2022, and for the six months ended June 30, 2023, revenue was $0.5 million, down from $0.5 million in 2022[141]. - Total operating expenses for the three months ended June 30, 2023, were $15.8 million, slightly down from $15.9 million in 2022, while for the six months ended June 30, 2023, total operating expenses surged to $553.5 million from $43.2 million in 2022[141]. - The company reported a net loss of $14.7 million for the three months ended June 30, 2023, compared to a net loss of $16.8 million in 2022, and a net loss of $557.0 million for the six months ended June 30, 2023, compared to $38.2 million in 2022[141]. Research and Development - Research and development expenses for the three months ended June 30, 2023, were $9.5 million, compared to $9.0 million in 2022, and for the six months ended June 30, 2023, they were $19.3 million, down from $29.6 million in 2022[141]. - The company has shifted its focus from anti-infectives to oncology, resulting in a decrease of $10.3 million in research and development expenses during the six months ended June 30, 2023, compared to the same period in the prior year[146]. - The company plans to invest in the clinical development of ivonescimab and expand its intellectual property portfolio[166]. Clinical Trials and Studies - The company plans to initiate Phase III clinical studies for ivonescimab in non-small cell lung cancer (NSCLC), with the first patient enrolled in the Phase III HARMONi study on May 9, 2023[137]. - The company reported a median progression-free survival of 11.0 months and an overall response rate of 67% in patients treated with ivonescimab in a Phase II study[138]. - The company anticipates potential delays or issues in clinical trials, regulatory challenges, and the need for additional funding to support ongoing operations[169][170]. Financing and Capital Structure - The company raised $500,000 from the 2023 Rights Offering, selling 476,190,471 shares at $1.05 per share[133]. - The company increased the number of authorized shares of common stock by 650 million, from 350 million to 1 billion, effective January 19, 2023[134]. - The company received net proceeds of $25.0 million from the issuance of unsecured promissory notes on March 10, 2022[162]. - The company issued unsecured promissory notes totaling $520 million to its Co-CEOs in December 2022, with varying maturity dates[163]. - The company has a $100 million promissory note payable to a related party maturing on September 6, 2024, and intends to raise additional capital or seek an extension for repayment[168]. Cash Flow and Financial Position - For the six months ended June 30, 2023, the company incurred a net loss of $557.1 million and cash flows used in operating activities were $42.4 million[167]. - As of June 30, 2023, the company had an accumulated deficit of $935.4 million and cash and cash equivalents of $42.1 million[167]. - The company plans to fund its operating costs and working capital needs for at least the next twelve months with existing financial resources[168]. - Net cash used in investing activities for the six months ended June 30, 2023, was $644.9 million, primarily due to a $475.0 million upfront payment to Akeso[172][175]. - Net cash provided by financing activities was $80.0 million for the six months ended June 30, 2023, mainly from the issuance of common stock[177]. Other Income and Expenses - General and administrative expenses decreased by $0.6 million for the three months ended June 30, 2023, compared to the same period in the prior year, totaling $6.3 million[150]. - Stock-based compensation decreased by $1.2 million for the three months ended June 30, 2023, due to awards becoming fully amortized and lower fair values compared to the prior period[150]. - U.K. research and development tax credits decreased by $0.8 million for the three months ended June 30, 2023, due to reduced clinical and manufacturing activity spend[154]. - Funding income from BARDA decreased by $1.2 million for the three months ended June 30, 2023, as the BARDA contract ended in 2022[155]. - Grant income from CARB-X decreased by $1.0 million for the three months ended June 30, 2023, due to the conclusion of the CARB-X arrangement in 2022[156]. - Other income (expense), net increased by $5.2 million for the three months ended June 30, 2023, primarily due to favorable changes in foreign currency gains and increased interest income[159]. Commitments and Future Plans - The company has approximately $6.9 million of non-cancellable purchase commitments associated with clinical trials as of June 30, 2023[183]. - The company aims to establish a sales, marketing, and distribution infrastructure in jurisdictions where it retains commercialization rights[166]. - The company expects to continue incurring significant expenses and increasing operating losses for at least the next few years due to ongoing research and development efforts[165].

Financial Data and Key Metrics Changes - The company reported a net loss of $14.7 million for the quarter, an improvement from a net loss of $16.8 million in the same quarter of 2022 [25] - The company exited the quarter with $220 million in cash, investments, and receivables, which is expected to fund operating costs and clinical trials through the second half of 2024 [26] Business Line Data and Key Metrics Changes - The company is currently engaged in two Phase III clinical trials for ivonescimab, with the majority of spending reflecting investments in the development of this molecule [25] - The first Phase III trial for ivonescimab commenced in the second quarter, with the first patient treated just over four months after the deal with Akeso closed [12] Market Data and Key Metrics Changes - The company presented data at ASCO showing a median progression-free survival (PFS) of 12.3 months for patients receiving ivonescimab plus chemotherapy in a Phase II study [2] - In a separate Phase II study, 63 treatment-naive patients with squamous cell carcinoma had a median duration of response of 15 months and a disease control rate of 93% [14] Company Strategy and Development Direction - The company plans to expand its clinical development program for ivonescimab beyond the current trials, with a focus on additional indications in non-small cell lung cancer and other solid tumors [21] - The strategic plan includes engaging in investigator-sponsored studies to broaden the use of ivonescimab beyond lung cancer [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of ivonescimab, highlighting the cooperative binding mechanism that enhances its efficacy [30][20] - The company is focused on maintaining a disciplined spending approach to extend its cash runway while investing in the development of ivonescimab [25][26] Other Important Information - The company has a loan of $100 million due in September 2024, with the ability to repay it if a capital raise occurs before that date [26] - Management emphasized the importance of collaboration with Akeso to maximize the impact of ivonescimab in major markets [39] Q&A Session Summary Question: What is the enrollment progress on the Phase III clinical trial? - Management indicated that enrollment is proceeding well and is expected to complete in the first half of 2024 [3][4] Question: What is the expected cost of the Phase III clinical trial for squamous cell carcinoma? - While specific costs were not disclosed, management suggested that estimates could be made based on typical costs for similar trials involving approximately 400 patients [5] Question: How does the data support the approvability of ivonescimab? - Management noted that the fact patients are still alive is a positive indicator, and they are excited about the performance of ivonescimab based on the data observed [6] Question: How many patients are planned to be enrolled in the Phase III clinical trials? - The company plans to enroll 150 patients in the first study and 400 patients in the second study [7] Question: Can data generated by Akeso in Australia be submitted to the FDA? - Management confirmed that the data from the Akeso-run Phase 1 study in Australia could be included in the FDA submission package [8] Question: What is the mechanism of action of ivonescimab? - Management explained that ivonescimab is a bispecific antibody that enhances binding affinity for PD-1 and VEGF, potentially improving treatment efficacy [9][20]

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) Presents the unaudited condensed consolidated financial statements and management's analysis for the reporting period [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited condensed consolidated financial statements, detailing a significant net loss increase and strategic shift to oncology [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Details the company's financial position, including assets, liabilities, and equity at specific reporting dates Condensed Consolidated Balance Sheets (in thousands) | Metric | March 31, 2023 | December 31, 2022 | | :-------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $70,969 | $348,607 | | Restricted cash | — | $300,000 | | Short-term investments | $170,963 | — | | Total current assets | $248,027 | $656,712 | | Total assets | $254,897 | $664,168 | | Total current liabilities | $17,443 | $38,782 | | Promissory note payable to a related party (non-current) | $100,000 | $494,540 | | Total liabilities | $121,415 | $537,514 | | Total stockholders' equity | $133,482 | $126,654 | [Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Reports the company's financial performance, including net loss and other comprehensive income (loss) for the period Condensed Consolidated Statements of Comprehensive Loss (in thousands) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Revenue | $— | $250 | | Research and development | $9,883 | $20,556 | | In-process research and development | $520,915 | $— | | General and administrative | $6,940 | $6,659 | | Total operating expenses | $537,738 | $27,215 | | Other operating income | $584 | $4,807 | | Operating loss | $(537,154) | $(22,158) | | Other (expense) income, net | $(5,222) | $761 | | Net loss | $(542,376) | $(21,397) | | Net loss per share (Basic and diluted) | $(1.43) | $(0.15) | | Weighted-average shares (Basic and diluted) | 378,163,980 | 140,040,370 | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Outlines changes in the company's equity accounts, reflecting stock transactions and net loss Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Metric | Balance at Dec 31, 2022 | Rights offering of common stock | Issuance of common stock for Akeso upfront payment | Net loss | Balance at Mar 31, 2023 | | :-------------------------- | :---------------------- | :------------------------------ | :----------------------------------------- | :--------- | :---------------------- | | Common Stock (Shares) | 211,091,425 | 476,190,471 | 10,000,000 | — | 697,685,365 | | Common Stock (Amount) | $2,110 | $4,762 | $100 | — | $6,976 | | Additional Paid-In Capital | $504,767 | $494,619 | $45,800 | — | $1,048,608 | | Accumulated Deficit | $(378,330) | — | — | $(542,376) | $(920,706) | | Total Stockholders' Equity | $126,654 | $499,381 | $45,900 | $(542,376) | $133,482 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(13,131) | $(19,001) | | Net cash used in investing activities | $(645,063) | $(361) | | Net cash provided by financing activities | $80,112 | $25,187 | | (Decrease) increase in cash and cash equivalents | $(577,638) | $5,659 | | Cash and cash equivalents at end of the period | $70,969 | $77,450 | - Supplemental Disclosure of Non-Cash Investing and Financing Activities: - Consideration for the issuance of common stock for rights offering used to satisfy a portion of a related party promissory note: **$395,314 thousand** (Q1 2023)[24](index=24&type=chunk) - Issuance of common stock pursuant to the Akeso License Agreement: **$45,900 thousand** (Q1 2023)[24](index=24&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and additional information supporting the condensed consolidated financial statements [Note 1. Nature of Business and Operations and Recent Events](index=9&type=section&id=1.%20Nature%20of%20Business%20and%20Operations%20and%20Recent%20Events) Describes the company's strategic shift to oncology, recent corporate actions, and clinical development updates - Company's strategy significantly changed to focus on oncology, specifically the development of ivonescimab[29](index=29&type=chunk) - All prior development and marketing activities for ridinilazole (anti-infective) are being terminated, with anti-infectives business activities under review for partnership opportunities[27](index=27&type=chunk)[29](index=29&type=chunk) - In-licensed ivonescimab, a bispecific antibody combining PD-1 blockade with anti-VEGF benefits, from Akeso, Inc. for development and commercialization in the US, Canada, Europe, and Japan[28](index=28&type=chunk) 2023 Rights Offering Details | Metric | Value | | :-------------------- | :---------- | | Gross Proceeds | $500,000 | | Shares Sold | 476,190,471 | | Price Per Share | $1.05 | | Issuance Costs | $619 | - Authorized common stock increased from 350,000,000 to **1,000,000,000 shares** on January 19, 2023[31](index=31&type=chunk) - Repaid **$20,000 thousand** Zanganeh Note and satisfied **$400,000 thousand** Duggan Promissory Note in February 2023[32](index=32&type=chunk) - Announced plans to initiate Phase III clinical studies for ivonescimab in non-small cell lung cancer (NSCLC) in May 2023 (HARMONi and HARMONi-3)[34](index=34&type=chunk) - First US-based patient enrolled in Phase III HARMONi study in May 2023[36](index=36&type=chunk) [Note 2. Basis of Presentation and Use of Estimates](index=10&type=section&id=2.%20Basis%20of%20Presentation%20and%20Use%20of%20Estimates) Explains the accounting principles, estimates, and assumptions used in preparing the financial statements - Unaudited condensed consolidated financial statements prepared in accordance with U.S. GAAP and SEC rules, with interim data including all necessary normal recurring adjustments[37](index=37&type=chunk) - Marketable securities are classified as available-for-sale, recorded at fair value, with unrealized gains and losses in other comprehensive income (loss)[39](index=39&type=chunk) - Estimates for expected credit losses are made when fair value is below amortized cost[40](index=40&type=chunk) - Management makes estimates and assumptions for revenue recognition, accrued R&D expenses, stock-based compensation, intangible assets, goodwill, other long-lived assets, and income taxes[41](index=41&type=chunk)[43](index=43&type=chunk) [Note 3. Recently Issued or Adopted Accounting Pronouncements](index=11&type=section&id=3.%20Recently%20Issued%20or%20Adopted%20Accounting%20Pronouncements) Discusses the impact of new accounting standards on the company's financial reporting - ASU 2021-04 clarifies issuer's accounting for modifications or exchanges of freestanding equity-classified written call options, effective for annual periods beginning after December 15, 2021, with no material impact on the Company's financial statements for 2023 or 2022[44](index=44&type=chunk) - Other recent authoritative guidance is not expected to have a material impact on the Company's consolidated financial statements[45](index=45&type=chunk) [Note 4. Liquidity and Capital Resources](index=11&type=section&id=4.%20Liquidity%20and%20Capital%20Resources) Assesses the company's ability to meet its financial obligations and fund future operations Key Financial Metrics (in thousands) | Metric | As of March 31, 2023 | | :------------------------------------ | :------------------- | | Net loss (three months ended) | $(542,376) | | Cash flows used in operating activities (three months ended) | $(13,131) | | Accumulated deficit | $(920,706) | | Cash and cash equivalents | $70,969 | | Short-term investments (U.S. treasury securities) | $170,963 | | Current and long-term U.K. R&D tax credits receivable | $5,035 | - Existing cash, cash equivalents, and U.K. R&D tax credits are expected to fund operating costs and working capital for ivonescimab clinical trials for at least twelve months from the issuance date of the financial statements[47](index=47&type=chunk) - The Company expects to continue generating operating losses and will need to raise additional capital to fund ongoing operations and capital needs, including potential milestone payments[48](index=48&type=chunk) - Evaluating options such as equity and debt offerings, collaborations, strategic alliances, grants, and licensing arrangements, with no assurance that additional financing will be available on acceptable terms, which could lead to delays or termination of R&D programs[48](index=48&type=chunk) [Note 5. Segment Reporting](index=11&type=section&id=5.%20Segment%20Reporting) Identifies the company's operating segments and provides geographical information on long-lived assets - The Company operates as a single reportable operating segment, covering research and development activities, primarily oncology (ivonescimab) and anti-infectives programs[52](index=52&type=chunk) Long-Lived Assets by Geography (in thousands) | Geography | March 31, 2023 | December 31, 2022 | | :---------------- | :------------- | :---------------- | | United Kingdom | $1,983 | $2,517 | | United States | $2,358 | $2,564 | | **Total** | **$4,341** | **$5,081** | [Note 6. Revenue](index=13&type=section&id=6.%20Revenue) Details the sources and recognition of the company's revenue, including changes from prior periods Revenue by Category (in thousands) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--------------- | :-------------------------------- | :-------------------------------- | | Licensing agreements | $— | $250 | Revenue by Geography (in thousands) | Geography | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :---------- | :-------------------------------- | :-------------------------------- | | Latin America | $— | $250 | Deferred Revenue and Other Income (in thousands) | Metric | March 31, 2023 | March 31, 2022 | | :---------------------------------------------------------------- | :------------- | :------------- | | Ending deferred revenue and other income | $— | $5,097 | - No revenue recognized in Q1 2023[54](index=54&type=chunk) - Q1 2022 revenue related to the Eurofarma license and commercialization agreement for ridinilazole[54](index=54&type=chunk) - Cumulative income from Eurofarma since inception was **$4.7 million** as of December 31, 2022, fully recognized by 2022 due to the decision to seek partners or divest ridinilazole[60](index=60&type=chunk) [Note 7. Other Operating Income](index=15&type=section&id=7.%20Other%20Operating%20Income) Explains the components and changes in other operating income, such as tax credits and grant funding Other Operating Income by Category (in thousands) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Funding income from BARDA | $— | $2,634 | | Research and development tax credits | $542 | $1,696 | | Grant income from CARB-X | $34 | $477 | | Other income | $8 | $— | | **Total** | **$584** | **$4,807** | - BARDA funding contract concluded in December 2022, resulting in no income in Q1 2023 (vs. **$2,634 thousand** in Q1 2022)[63](index=63&type=chunk) - CARB-X grant income decreased due to the arrangement concluding in 2022 and the strategic shift away from anti-infectives[68](index=68&type=chunk) - Research and development tax credits decreased due to reduced clinical and manufacturing activity for ridinilazole and changes in U.K. tax legislation[65](index=65&type=chunk) - R&D tax credit receivable (current): **$4,500 thousand** (March 31, 2023) vs. **$5,766 thousand** (Dec 31, 2022)[67](index=67&type=chunk) [Note 8. Akeso Collaboration and License Agreement](index=16&type=section&id=8.%20Akeso%20Collaboration%20and%20License%20Agreement) Describes the terms and financial impact of the ivonescimab in-licensing agreement - Entered into a Collaboration and License Agreement with Akeso, Inc. on December 5, 2022, for in-licensing ivonescimab (SMT112)[69](index=69&type=chunk) - Agreement closed in January 2023, granting Summit rights to develop and commercialize SMT112 in the US, Canada, Europe, and Japan[70](index=70&type=chunk) - Upfront payment of **$500,000 thousand** to Akeso, paid as **$274,900 thousand** in cash initially, **$200,000 thousand** in cash on March 6, 2023, and 10 million shares of common stock in lieu of **$25,100 thousand** cash (fair value **$45,900 thousand**)[71](index=71&type=chunk) - Total in-process research and development expense for Q1 2023 was **$520,915 thousand**, including direct transaction costs[73](index=73&type=chunk) - Potential milestone payments up to **$4,500,000 thousand** (**$1,050,000 thousand** regulatory, **$3,450,000 thousand** commercial) and low double-digit royalties on net sales[74](index=74&type=chunk) [Note 9. Other (Expense) Income, net](index=17&type=section&id=9.%20Other%20(Expense)%20Income,%20net) Presents the breakdown of non-operating income and expenses, including interest and investment income Other (Expense) Income, net (in thousands) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Foreign currency gains (losses) | $508 | $930 | | Interest expense on promissory notes payable to related parties | $(8,327) | $(152) | | Investment income | $1,761 | $— | | Reclassification of cumulative currency translation gain | $419 | $— | | Other income (expense) | $417 | $(17) | | **Total** | **$(5,222)** | **$761** | - Shift from net income to net expense primarily due to a significant increase in interest expense on related party promissory notes (**$8,327 thousand** in Q1 2023 vs. **$152 thousand** in Q1 2022)[75](index=75&type=chunk) - Partially offset by new investment income (**$1,761 thousand** in Q1 2023) and reclassification of cumulative currency translation gain (**$419 thousand**) from dissolved dormant entities[75](index=75&type=chunk)[76](index=76&type=chunk) [Note 10. Loss per Share](index=17&type=section&id=10.%20Loss%20per%20Share) Provides the calculation of basic and diluted net loss per share and related share data Loss per Share Data | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Net loss (in thousands) | $(542,376) | $(21,397) | | Basic weighted average shares outstanding | 378,163,980 | 140,040,370 | | Diluted weighted average shares outstanding | 378,163,980 | 140,040,370 | | Basic net loss per share | $(1.43) | $(0.15) | | Diluted net loss per share | $(1.43) | $(0.15) | - Potentially dilutive securities (options and warrants) were excluded from diluted EPS calculation as their effect would have been anti-dilutive due to the Company's loss position[76](index=76&type=chunk) - Total anti-dilutive securities: **26,207,731** (March 31, 2023) vs. **19,097,646** (March 31, 2022)[79](index=79&type=chunk) [Note 11. Fair Value Measurements and Investments](index=18&type=section&id=11.%20Fair%20Value%20Measurements%20and%20Investments) Details the fair value hierarchy and classification of financial assets and investments - Financial assets are measured at fair value using a three-level hierarchy (Level 1: quoted prices in active markets; Level 2: observable inputs other than Level 1 prices; Level 3: unobservable inputs)[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) Fair Value Measurements as of March 31, 2023 (in thousands) | Asset Category | Level 1 | Level 2 | Level 3 | Total | | :-------------------------- | :------ | :-------- | :------ | :------ | | Cash equivalents: Money market funds | $21,090 | $— | $— | $21,090 | | Short-term investments: U.S. Government treasury bills | $— | $170,963 | $— | $170,963 | | **Total financial assets** | **$21,090** | **$170,963** | **$—** | **$192,053** | Investments by Contractual Maturity as of March 31, 2023 (in thousands) | Maturity | Amortized Cost | Fair Value | | :--------------- | :------------- | :--------- | | Due within one year | $169,995 | $170,963 | | **Total** | **$169,995** | **$170,963** | [Note 12. Goodwill and Intangible Assets](index=20&type=section&id=12.%20Goodwill%20and%20Intangible%20Assets) Reports the carrying amounts and changes in goodwill and other intangible assets Goodwill (in thousands) | Metric | March 31, 2023 | December 31, 2022 | | :------- | :------------- | :---------------- | | Goodwill | $1,839 | $1,798 | - Goodwill changes are due to foreign currency movements only; no cumulative goodwill impairments recognized[91](index=91&type=chunk) Intangible Assets (in thousands) | Asset Category | Gross Carrying Amount (Mar 31, 2023) | Accumulated Amortization and Impairment (Mar 31, 2023) | Net (Mar 31, 2023) | | :-------------------------- | :----------------------------------- | :--------------------------------------------------- | :----------------- | | Utrophin program acquired | $4,487 | $(4,487) | $— | | Discuva platform acquired | $13,196 | $(13,196) | $— | | Option over non-financial asset | $835 | $(835) | $— | | Other patents and licenses | $136 | $(136) | $— | | **Total** | **$18,654** | **$(18,654)** | **$—** | - Amortization expense for Q1 2023 was **$0**, compared to **$248 thousand** in Q1 2022[92](index=92&type=chunk) [Note 13. Leases](index=20&type=section&id=13.%20Leases) Outlines the company's lease commitments, costs, and related financial information - The Company has operating leases for real estate, with no new right-of-use assets recorded in Q1 2023 or Q1 2022[93](index=93&type=chunk) - Carrying value of right-of-use assets: **$3,928 thousand** (March 31, 2023) vs. **$4,175 thousand** (Dec 31, 2022)[93](index=93&type=chunk) Lease Costs (in thousands) | Lease Cost Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------ | :-------------------------------- | :-------------------------------- | | Fixed lease costs | $346 | $212 | | Variable lease costs | $43 | $10 | | **Total lease cost** | **$389** | **$222** | Other Lease Information | Metric | March 31, 2023 | March 31, 2022 | | :---------------------------------- | :------------- | :------------- | | Operating cash flows used for operating leases | $367 | $297 | | Weighted average remaining lease term (years) | 3.1 | 4.1 | | Weighted average discount rate | 5.7% | 2.7% | [Note 14. Promissory Notes Payable to Related Parties](index=21&type=section&id=14.%20Promissory%20Notes%20Payable%20to%20Related%20Parties) Details the terms, balances, and activity of promissory notes with related parties Promissory Notes Payable to Related Parties (in thousands) | Metric | March 31, 2023 | December 31, 2022 | | :------------------------------------ | :------------- | :---------------- | | Current notes (Principal amounts) | $— | $20,000 | | Non-current notes (Principal amounts) | $100,000 | $500,000 | | Total promissory notes payable to related parties | $100,000 | $514,310 | - In December 2022, issued **$520,000 thousand** in unsecured promissory notes to Mr. Duggan (**$400,000 thousand** Duggan February Note, **$100,000 thousand** Duggan September Note) and Dr. Zanganeh (**$20,000 thousand** Zanganeh Note)[97](index=97&type=chunk) - The **$20,000 thousand** Zanganeh Note matured and was repaid on February 15, 2023[99](index=99&type=chunk) - The **$400,000 thousand** Duggan Promissory Note matured and was satisfied in connection with the 2023 Rights Offering, using cash proceeds and extinguishment of debt via share subscription[104](index=104&type=chunk) - Only the **$100,000 thousand** Duggan September Note remains outstanding, maturing on September 6, 2024[104](index=104&type=chunk) - Interest expense on promissory notes was **$8,327 thousand** for Q1 2023, significantly up from **$152 thousand** in Q1 2022[100](index=100&type=chunk) - Initial interest rate was 7.5%; adjusted to US prime + 50 bps for three months post-February 15, 2023, then US prime + 300 bps[102](index=102&type=chunk) [Note 15. Stock-Based Compensation and Warrants](index=22&type=section&id=15.%20Stock-Based%20Compensation%20and%20Warrants) Provides information on stock option activity, compensation expense, and outstanding warrants Stock Option Activity (Shares) | Metric | Three Months Ended March 31, 2023 | | :------------------------------------------ | :-------------------------------- | | Outstanding at December 31, 2022 | 19,476,359 | | Granted | 918,950 | | Forfeited | (38,250) | | Exercised | (177,237) | | **Outstanding at March 31, 2023** | **20,179,822** | | Exercisable at March 31, 2023 | 3,920,110 | Total Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $1,086 | $1,874 | | General and administrative | $1,689 | $2,122 | | **Total** | **$2,775** | **$3,996** | - Outstanding and exercisable warrants: **5,821,137** with a weighted average exercise price of **$1.56** as of March 31, 2023[109](index=109&type=chunk) [Note 16. Related Party Transactions](index=23&type=section&id=16.%20Related%20Party%20Transactions) Describes significant transactions and agreements with related parties - Extended sublease agreement with Maky Zanganeh and Associates, Inc. (MZA) for office space through December 31, 2025, adding an additional 1,277 square feet effective August 1, 2022[110](index=110&type=chunk)[111](index=111&type=chunk) - Payments to MZA: **$189 thousand** (Q1 2023) and **$54 thousand** (Q1 2023) for the initial and second amendments, respectively[111](index=111&type=chunk) - December 2022 Note Purchase Agreement with Mr. Duggan and Dr. Zanganeh for **$520,000 thousand** in unsecured promissory notes[115](index=115&type=chunk) - Repaid **$20,000 thousand** Zanganeh Note and satisfied **$400,000 thousand** Duggan Promissory Note in Q1 2023[117](index=117&type=chunk) - Prepaid interest on notes paid in **9,720,291 shares** of common stock[118](index=118&type=chunk) - Dr. Yu (Michelle) Xia, founder of Akeso, Inc., appointed to the Board of Directors, and entered into a Supply Agreement with Akeso for drug substance purchase[119](index=119&type=chunk) - Mr. Duggan and Dr. Zanganeh fully subscribed to their basic rights in the 2023 Rights Offering[121](index=121&type=chunk) - Mr. Duggan's **$395,314 thousand** subscription price was satisfied by extinguishing a portion of his **$400,000 thousand** Duggan Promissory Note[121](index=121&type=chunk) [Note 17. Commitments and Contingencies](index=25&type=section&id=17.%20Commitments%20and%20Contingencies) Discloses the company's contractual obligations and potential contingent liabilities - No capital commitments as of March 31, 2023, with lease commitments for office and laboratory space remaining materially unchanged since Dec 31, 2022, and debt commitments detailed in Note 14[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk) - Commitments under agreements with Akeso (milestones, royalties, manufacturing/purchase commitments), Wellcome Trust, University College London, and former Discuva personnel exist[127](index=127&type=chunk) - Unable to estimate the amount, timing, or likelihood of achieving milestones or making future product sales for these obligations[127](index=127&type=chunk) - The Company is not currently subject to any material legal proceedings[130](index=130&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on Summit Therapeutics Inc.'s financial condition and operational results for the three months ended March 31, 2023 [Company Overview](index=27&type=section&id=Company%20Overview) Provides a high-level summary of Summit Therapeutics Inc.'s business and strategic focus - Summit Therapeutics Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of medicinal therapies in oncology, aiming to improve quality of life and resolve unmet medical needs[133](index=133&type=chunk) [Recent Events](index=27&type=section&id=Recent%20Events) Highlights significant corporate and clinical developments impacting the company's operations and strategy - Entered into a Collaboration and License Agreement with Akeso, Inc. for ivonescimab, a bispecific antibody for oncology, in December 2022 (closed January 2023), representing a significant change in strategy[134](index=134&type=chunk) - Terminating prior ridinilazole development and reviewing anti-infectives for partnership opportunities, with future operations focusing on ivonescimab development and other oncology activities[135](index=135&type=chunk) - Completed a 2023 Rights Offering, generating **$500,000 thousand** in gross proceeds from **476,190,471 shares** at **$1.05 per share**[136](index=136&type=chunk) - Increased authorized common stock to **1,000,000,000 shares**[137](index=137&type=chunk) - Repaid **$20,000 thousand** Zanganeh Note and satisfied **$400,000 thousand** Duggan Promissory Note[138](index=138&type=chunk) - Announced plans to initiate Phase III clinical studies for ivonescimab in non-small cell lung cancer (NSCLC) in May 2023 (HARMONi and HARMONi-3), with the first US-based patient enrolled in the Phase III HARMONi study in May 2023[139](index=139&type=chunk) - Re-prioritizing investments and financial resources towards ivonescimab development, leading to reduced investment in infectious diseases programs and associated costs[140](index=140&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Analyzes the company's financial performance, including revenue, expenses, and net loss, for the reporting period Consolidated Results of Operations (in millions) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change ($ millions) | Change (%) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :------------------ | :--------- | | Revenue | $— | $0.3 | $(0.3) | -100% | | Research and development | $9.9 | $20.6 | $(10.7) | -51.9% | | In-process research and development | $520.9 | $— | $520.9 | N/A | | General and administrative | $6.9 | $6.7 | $0.2 | 3.0% | | Total operating expenses | $537.7 | $27.3 | $510.4 | 1869.6% | | Other operating income | $0.6 | $4.8 | $(4.2) | -87.5% | | Operating loss | $(537.1) | $(22.2) | $(514.9) | 2319.4% | | Other (expense) income, net | $(5.2) | $0.8 | $(6.0) | -750% | | Net loss | $(542.3) | $(21.4) | $(520.9) | 2434.1% | - Revenue decreased to **$0** in Q1 2023 from **$0.3 million** in Q1 2022, as all milestones from the Eurofarma license agreement were fully recognized by 2022, and the Company decided to seek partners or divest ridinilazole[142](index=142&type=chunk) Research and Development Expenses by Category (in millions) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Oncology | $2.4 | $— | | Anti-infectives | $0.4 | $12.5 | | Compensation related costs (excl. stock-based) | $4.8 | $5.0 | | Stock-based compensation | $1.1 | $1.9 | | Other R&D costs | $1.2 | $1.2 | | **Total** | **$9.9** | **$20.6** | - R&D Expenses decreased by **$10.7 million**, primarily due to a **$12.1 million** decrease from winding down anti-infective programs and a **$0.8 million** decrease in stock-based compensation, partially offset by a **$2.4 million** investment in oncology (ivonescimab)[145](index=145&type=chunk) - In-process R&D: **$520.9 million** expense in Q1 2023, mainly from the **$500 million** upfront payment for the ivonescimab License Agreement, including cash and common stock components[148](index=148&type=chunk) General and Administrative Expenses by Category (in millions) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Compensation related costs (excl. stock-based) | $2.5 | $2.0 | | Stock-based compensation | $1.7 | $2.0 | | Legal fees and professional services | $1.7 | $1.6 | | Other G&A expenses | $1.0 | $1.1 | | **Total** | **$6.9** | **$6.7** | - G&A Expenses increased by **$0.2 million**, driven by a **$0.5 million** increase in compensation-related expenses for building the executive management team, partially offset by a **$0.3 million** decrease in stock-based compensation[150](index=150&type=chunk) Other Operating Income by Category (in millions) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development tax credits | $0.6 | $1.7 | | Funding income from BARDA | $— | $2.6 | | Grant income from CARB-X | $— | $0.5 | | **Total** | **$0.6** | **$4.8** | - Other Operating Income decreased by **$4.2 million**, primarily due to the cessation of BARDA funding (**$2.6 million** decrease) and CARB-X grant income (**$0.5 million** decrease) as anti-infective programs wound down, and a **$1.1 million** decrease in U.K. R&D tax credits[152](index=152&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk) Other (Expense) Income, net (in millions) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Foreign currency gains (losses) | $0.5 | $0.9 | | Interest expense on promissory notes payable to related parties | $(8.3) | $(0.1) | | Investment income | $1.8 | $— | | Reclassification of cumulative currency translation gain | $0.4 | $— | | Other income (expense) | $0.4 | $— | | **Total** | **$(5.2)** | **$0.8** | - Other (Expense) Income, net decreased by **$6.0 million**, mainly due to an **$8.2 million** increase in interest expense on related party promissory notes, partially offset by **$1.8 million** in investment income and a **$0.4 million** reclassification of cumulative foreign currency translation gains from dissolved dormant entities[156](index=156&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's ability to meet its financial obligations and fund future operations - Operations financed through common stock issuances, license/collaboration agreements, government funding (BARDA, CARB-X, Innovate UK, Wellcome Trust), and related party promissory notes[157](index=157&type=chunk) Key Liquidity Metrics (in millions) | Metric | As of March 31, 2023 | | :------------------------------------ | :------------------- | | Net loss (three months ended) | $(542.4) | | Cash flows used in operating activities (three months ended) | $(13.1) | | Accumulated deficit | $(920.7) | | Cash and cash equivalents | $71.0 | | Short-term investments (U.S. treasury securities) | $170.963 | | Current and long-term U.K. R&D tax credits receivable | $5.0 | - Current financial resources are expected to fund operating costs and working capital for ivonescimab clinical trials into the second half of 2024[164](index=164&type=chunk) - Significant additional capital will be required for ongoing operations and potential milestone payments to Akeso (up to **$4.5 billion**)[165](index=165&type=chunk) - The Company is exploring various financing options (equity, debt, collaborations) but there is no assurance of availability or acceptable terms, which could impact development and commercialization efforts[165](index=165&type=chunk) [Cash Flows](index=34&type=section&id=Cash%20Flows) Analyzes the company's cash inflows and outflows from operating, investing, and financing activities Summary of Cash Flows (in millions) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(13.1) | $(19.0) | | Net cash used in investing activities | $(645.1) | $(0.4) | | Net cash provided by financing activities | $80.1 | $25.2 | - Net cash used in operating activities decreased to **$13.1 million** (Q1 2023) from **$19.0 million** (Q1 2022), despite a higher net loss, due to adjustments for non-cash charges and cash payments reclassified to investing activities for the Akeso upfront payment[168](index=168&type=chunk)[169](index=169&type=chunk) - Net cash used in investing activities significantly increased to **$645.1 million** (Q1 2023) from **$0.4 million** (Q1 2022), primarily due to **$475.0 million** cash payment to Akeso for the License Agreement and **$170.0 million** for short-term investments[170](index=170&type=chunk) - Net cash provided by financing activities was **$80.1 million** (Q1 2023), mainly from **$104.1 million** net proceeds from the 2023 Rights Offering (net of **$395.3 million** debt extinguishment) and **$0.7 million** from employee stock awards, offset by **$24.7 million** repayment of related party promissory notes[171](index=171&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=34&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Discusses the key accounting policies and estimates that require significant management judgment - Financial statements require estimates and judgments for revenue recognition, R&D costs, intangible assets, stock-based compensation, and income taxes[173](index=173&type=chunk) - No material changes to critical accounting policies and estimates were reported since the Annual Report on Form 10-K for the year ended December 31, 2022[175](index=175&type=chunk) [Contractual obligations and commitments](index=35&type=section&id=Contractual%20obligations%20and%20commitments) Outlines the company's contractual obligations and future financial commitments - Lease commitments for office and laboratory space remain materially unchanged since December 31, 2022[176](index=176&type=chunk) - Contingent payment obligations include commitments under agreements with Akeso (milestones, royalties, manufacturing/purchase), Wellcome Trust, University College London, and former Discuva personnel[177](index=177&type=chunk) - The amount, timing, or likelihood of these contingent payments cannot be estimated as of March 31, 2023[177](index=177&type=chunk) - Most contracts for clinical trials, preclinical research, manufacturing, and other services are cancellable upon notice[178](index=178&type=chunk) [Off-Balance Sheet Arrangements](index=35&type=section&id=Off-Balance%20Sheet%20Arrangements) Discloses any off-balance sheet transactions or arrangements that could have a material effect on the financial condition - The Company did not have any off-balance sheet arrangements during the periods presented[179](index=179&type=chunk) [Recently Issued Accounting Pronouncements](index=35&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) Refers to the discussion of new accounting standards and their potential impact - Refer to Note 3 for a discussion of recently issued or adopted accounting pronouncements[180](index=180&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company" under SEC regulations, Summit Therapeutics Inc. is not required to provide quantitative and qualitative disclosures about market risk - The Company is exempt from providing quantitative and qualitative disclosures about market risk as it qualifies as a "smaller reporting company"[181](index=181&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Details the evaluation of Summit Therapeutics Inc.'s disclosure controls and procedures and reports on changes in internal control over financial reporting [Disclosure Controls and Procedures](index=35&type=section&id=Disclosure%20Controls%20and%20Procedures) Reports on the effectiveness of the company's disclosure controls and procedures - Management, including Co-Chief Executive Officers and Chief Financial Officer, concluded that disclosure controls and procedures were effective at a reasonable level of assurance as of March 31, 2023[183](index=183&type=chunk) [Changes in Internal Control over Financial Reporting](index=36&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) Describes any material changes in the company's internal control over financial reporting - A new Enterprise Resource Planning (ERP) system was implemented during Q1 2023, leading to necessary updates in internal control over financial reporting processes[184](index=184&type=chunk) - No other material changes to internal control over financial reporting occurred during the period[184](index=184&type=chunk) [PART II - OTHER INFORMATION](index=36&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) Contains supplementary disclosures including legal proceedings, risk factors, and exhibit listings [Item 1. Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) Summit Therapeutics Inc. is not currently involved in any material legal proceedings - The Company is not currently subject to any material legal proceedings[186](index=186&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the comprehensive discussion of risk factors in the Company's Annual Report on Form 10-K, noting that no material changes to these risks have occurred since that filing - Information regarding risk factors is discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2023[187](index=187&type=chunk) - No material changes to the previously disclosed risk factors have occurred[187](index=187&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There are no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities and use of proceeds to report[188](index=188&type=chunk) [Item 3. Defaults Upon Senior Securities](index=36&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company has not experienced any defaults upon senior securities during the reporting period - No defaults upon senior securities to report[189](index=189&type=chunk) [Item 4. Mine Safety Disclosures](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) There are no mine safety disclosures applicable to Summit Therapeutics Inc - No mine safety disclosures to report[191](index=191&type=chunk) [Item 5. Other Information](index=36&type=section&id=Item%205.%20Other%20Information) No other information is required to be reported in this section - No other information to report[192](index=192&type=chunk) [Item 6. Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including corporate governance documents, certifications, and XBRL data files - Key exhibits include: - Amendment No. 2 to Restated Certificate of Incorporation[194](index=194&type=chunk) - Certifications of Chairman and CEO, Co-CEO, and Principal Financial Officer (pursuant to Sarbanes-Oxley Act)[194](index=194&type=chunk) - XBRL Taxonomy Extension Schema, Calculation, Definition, Label, and Presentation Linkbase Documents[194](index=194&type=chunk) - Cover Page Interactive Data File[194](index=194&type=chunk) [Signatures](index=37&type=section&id=Signatures) The report is duly signed on behalf of Summit Therapeutics Inc. by its Chief Financial Officer - The report was signed by Ankur Dhingra, Chief Financial Officer, on May 11, 2023[197](index=197&type=chunk)