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 September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ 617-514-7149 (Registrant's telephone number, including area code) Not Applicable Commission Fil ...

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 June 30, 2022 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 in ...

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, 2022 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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________ FORM 10-K _____________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 in ...

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 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 in its charter) _____________________ (State or ...

PART I - FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Financial statements for June 30, 2021, show increased cash and equity from a $75 million rights offering, despite wider net losses due to higher R&D expenses [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2021, total assets increased to $145.5 million and stockholders' equity to $119.4 million, driven by a rise in cash to $103.4 million from a rights offering Balance Sheet Highlights (in thousands) | Account | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $103,386 | $66,417 | | Total current assets | $121,482 | $87,674 | | Total assets | $145,517 | $102,498 | | **Liabilities & Equity** | | | | Total liabilities | $26,090 | $23,045 | | Total stockholders' equity | $119,427 | $79,453 | [Condensed Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Net losses widened for the six months ended June 30, 2021, to $41.9 million from $21.4 million, primarily due to a significant increase in research and development expenses Statement of Loss Summary (in thousands, except per share data) | Metric | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Revenue | $249 | $494 | | Research and development | $42,302 | $26,484 | | Operating loss | ($40,653) | ($24,696) | | Net loss | ($41,904) | ($21,413) | | Loss per share (Basic & Diluted) | ($0.48) | ($0.32) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity increased from $79.5 million to $119.4 million by June 30, 2021, primarily driven by $74.9 million in net proceeds from a rights offering - A rights offering of common stock resulted in net proceeds of **$74.9 million** (**$75.0 million** gross minus **$118k** costs) in the six months ended June 30, 2021[26](index=26&type=chunk) - Stock-based compensation expense for the first six months of 2021 was **$4.5 million**[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2021, net cash used in operating activities increased to $39.8 million, offset by $76.0 million from financing activities, resulting in a $37.0 million increase in cash Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($39,843) | ($23,491) | | Net cash used in investing activities | ($190) | ($327) | | Net cash provided by financing activities | $75,979 | $3 | | **Increase / (decrease) in cash** | **$36,969** | **($27,432)** | - Financing activities in H1 2021 included **$75.0 million** in proceeds from a rights offering and **$1.1 million** from the exercise of stock options[28](index=28&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight the company's CDI antibiotic focus, going concern status, revenue sources, other income, and a $75 million rights offering with significant CEO participation - The company is a biopharmaceutical firm focused on discovering and developing novel antibiotics, with a Phase 3 clinical program for C. difficile infection (CDI)[30](index=30&type=chunk) - Management believes existing cash resources are sufficient to fund operating plans for at least the next twelve months, but the company will need to raise additional capital in the future to continue operations[42](index=42&type=chunk)[43](index=43&type=chunk) - In May 2021, the company closed a fully subscribed rights offering, raising gross proceeds of **$75.0 million**[65](index=65&type=chunk) - The company engaged in significant related-party transactions with its CEO, Mr. Duggan, including two **$55.0 million** promissory notes (subsequently repaid) and his purchase of shares in the rights offering, resulting in his beneficial ownership of approximately **71%** of outstanding common stock[69](index=69&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Operating loss increased significantly in H1 2021 due to higher R&D for ridinilazole's Phase 3 trial, with COVID-19 impacting enrollment, yet liquidity remains strong at $103.4 million from a $75 million rights offering - The company is focused on its lead CDI product candidate, ridinilazole, and recently combined its two ongoing Phase III trials into a single study[74](index=74&type=chunk) - The COVID-19 pandemic has negatively impacted clinical trial enrollment, leading to slower progress and increased development costs[80](index=80&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) For the six months ended June 30, 2021, R&D expenses rose 59.7% to $42.3 million, increasing operating loss to $40.7 million, while revenue from Eurofarma decreased to $0.2 million Comparison of Operating Results (Six Months Ended June 30) | (in thousands) | 2021 | 2020 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Revenue | $249 | $494 | ($245) | (49.6)% | | Research and development | $42,302 | $26,484 | $15,818 | 59.7% | | General and administrative | $10,169 | $9,346 | $823 | 8.8% | | Operating loss | ($40,653) | ($24,696) | ($15,957) | (64.6)% | | Net loss | ($41,904) | ($21,413) | ($20,491) | (95.7)% | - The increase in R&D expenses was primarily driven by a **$10.4 million** increase in investment in the CDI program, related to the Phase 3 clinical trials of ridinilazole[94](index=94&type=chunk)[95](index=95&type=chunk) - Other operating income for H1 2021 was **$11.6 million**, comprising **$3.3 million** from the BARDA contract and **$7.9 million** from U.K. R&D tax credits[99](index=99&type=chunk)[100](index=100&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2021, the company had **$103.4 million** in cash, sufficient for the next twelve months, primarily due to a **$75 million** rights offering offsetting **$39.8 million** in cash used for operations - The company had cash and cash equivalents of **$103.4 million** as of June 30, 2021[106](index=106&type=chunk) - The company received net proceeds of **$74.9 million** from a rights offering in May 2021, which was used in part to repay an unsecured promissory note[104](index=104&type=chunk)[114](index=114&type=chunk) - Net cash used in operating activities increased to **$39.8 million** for H1 2021 from **$23.5 million** in H1 2020, reflecting higher operating costs[110](index=110&type=chunk)[111](index=111&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has indicated that this section is not applicable - Not applicable[122](index=122&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2021, management concluded the company's disclosure controls and procedures were effective at a reasonable level of assurance - Management concluded that as of June 30, 2021, the company's disclosure controls and procedures were effective at a reasonable level of assurance[123](index=123&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - We are not currently subject to any material legal proceedings[125](index=125&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors from the 10-K, except for a new risk regarding combining two Phase III ridinilazole trials, which could cause delays and add commercialization uncertainty - A new risk factor has been added concerning the determination to combine two pivotal Phase III clinical trials for ridinilazole into a single study[127](index=127&type=chunk) - This combination could cause delays, affect future expenses, add uncertainty to commercialization, and impact the likelihood of successful clinical development[127](index=127&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[128](index=128&type=chunk) [Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[129](index=129&type=chunk) [Mine Safety Disclosures](index=29&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - None[130](index=130&type=chunk) [Other Information](index=29&type=section&id=Item%205%20Other%20Information) There is no other information to report for the period - None[131](index=131&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications and XBRL data files - The exhibits filed include CEO/CFO certifications under Sarbanes-Oxley Sections 302 and 906, and XBRL interactive data files[134](index=134&type=chunk)

[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Presents unaudited condensed consolidated financial statements for Summit Therapeutics Inc. as of March 31, 2021, and for the three months ended March 31, 2021 and 2020, detailing financial position and performance [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2021, total assets increased, driven by cash, while total liabilities significantly rose due to a new promissory note, resulting in decreased stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $102,194 | $66,417 | | Total current assets | $125,217 | $87,674 | | Total assets | $140,794 | $102,498 | | **Liabilities & Equity** | | | | Promissory note payable to a related party | $54,963 | $0 | | Total current liabilities | $73,052 | $19,890 | | Total liabilities | $76,389 | $23,045 | | Total stockholders' equity | $64,405 | $79,453 | [Condensed Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) For Q1 2021, the company reported a significantly increased net loss, primarily driven by higher research and development expenses and a decrease in other operating income Q1 2021 vs Q1 2020 Performance (in thousands, except per share data) | Metric | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Revenue | $192 | $324 | | Research and development expenses | $18,379 | $12,912 | | General and administrative expenses | $4,185 | $3,572 | | Operating loss | $(16,923) | $(9,340) | | Net loss | $(17,488) | $(6,134) | | Basic and Diluted Loss per share | $(0.21) | $(0.09) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Total stockholders' equity decreased primarily due to the net loss for the quarter, partially offset by stock option exercises and stock-based compensation - The primary driver for the decrease in stockholders' equity was the **net loss of $17.5 million** incurred during the quarter[26](index=26&type=chunk) - Positive contributions to equity included **$0.9 million** from the issuance of common stock from exercised stock options and **$0.9 million** from stock-based compensation[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash and cash equivalents increased significantly in Q1 2021, primarily driven by financing activities from a related-party promissory note, despite increased cash usage in operations Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(20,669) | $(4,959) | | Net cash used in investing activities | $(39) | $(194) | | Net cash provided by financing activities | $55,897 | $3 | | **Increase / (decrease) in cash** | **$35,777** | **$(8,899)** | - Financing activities were the main source of cash, with **$55.0 million** received from a related party promissory note and **$0.9 million** from the exercise of stock options[29](index=29&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide critical context to the financial statements, detailing the company's business, going concern status, revenue recognition, other operating income, related party transactions, and subsequent financing events - The company is a biopharmaceutical firm focused on discovering and developing novel antibiotics, with a Phase 3 clinical program for C. difficile infection (CDI)[31](index=31&type=chunk) - Management concluded there is substantial doubt about the company's ability to continue as a going concern, but expects existing cash and proceeds from a May 2021 rights offering to fund operations until **Q4 2022**[45](index=45&type=chunk)[46](index=46&type=chunk) - Revenue of **$0.2 million** in Q1 2021 was recognized from the license and commercialization agreement with Eurofarma Laboratórios S.A[51](index=51&type=chunk)[55](index=55&type=chunk) - Other operating income for Q1 2021 totaled **$5.4 million**, comprising **$1.8 million** from BARDA and **$3.7 million** from UK R&D tax credits[57](index=57&type=chunk)[63](index=63&type=chunk) - On March 24, 2021, the company received a **$55.0 million** loan from its CEO, Robert W. Duggan, via an unsecured promissory note[67](index=67&type=chunk)[74](index=74&type=chunk) - Subsequent to the quarter end, in May 2021, the company closed a fully subscribed rights offering, raising gross proceeds of **$75.0 million**[80](index=80&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2021 financial performance, noting increased net loss due to higher R&D expenses, and details liquidity from recent financing expected to fund operations into Q4 2022 [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Q1 2021 saw a widened operating loss, primarily due to increased R&D expenses for Phase 3 clinical trials and a decrease in other operating income Comparison of Operations (in thousands) | Line Item | Q1 2021 | Q1 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $192 | $324 | $(132) | (40.7)% | | Research and development | $(18,379) | $(12,912) | $(5,467) | (42.3)% | | General and administrative | $(4,185) | $(3,572) | $(613) | (17.2)% | | Other operating income | $5,449 | $6,820 | $(1,371) | (20.1)% | | Operating loss | $(16,923) | $(9,340) | $(7,583) | (81.2)% | | Net loss | $(17,488) | $(6,134) | $(11,354) | (185.1)% | - R&D expenses increased by **$5.5 million** primarily due to increased clinical and manufacturing activities for the Phase 3 trials of ridinilazole[93](index=93&type=chunk)[94](index=94&type=chunk) - Other operating income decreased as BARDA contract income fell by **$3.1 million**, partially offset by a **$1.9 million** increase in UK R&D tax credits[91](index=91&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is supported by existing cash and recent financing, expected to fund operations until Q4 2022, though additional capital is needed for Phase 3 trials - The company had cash and cash equivalents of **$102.2 million** as of March 31, 2021[103](index=103&type=chunk) - Recent financing includes a **$55.0 million** promissory note in March/April 2021 and a **$75.0 million** rights offering in May 2021[101](index=101&type=chunk) - Current capital resources are expected to fund the operating plan until **Q4 2022**, but are insufficient to complete all activities for the Phase 3 trials without additional funding[103](index=103&type=chunk) [Cash Flows](index=23&type=section&id=Cash%20Flows) Q1 2021 saw a significant increase in cash from financing activities, primarily a related-party promissory note, offsetting higher cash usage in operations Cash Flow Summary (in thousands) | Activity | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(20,669) | $(4,959) | | Net cash used in investing activities | $(39) | $(194) | | Net cash provided by financing activities | $55,897 | $3 | | **Net change in cash** | **$35,777** | **$(8,899)** | - The increase in cash used in operations was primarily due to higher operating costs and changes in working capital, including an increased R&D tax credit receivable[107](index=107&type=chunk) - Financing activities were driven by **$55.0 million** in proceeds from a promissory note from a related party[110](index=110&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Rick) The company indicates this item is not applicable, implying no significant market risk exposures requiring disclosure - Not applicable[118](index=118&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective at a reasonable level of assurance as of March 31, 2021 - Based on an evaluation as of March 31, 2021, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable level of assurance[119](index=119&type=chunk) [PART II - OTHER INFORMATION](index=25&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not currently subject to any material legal proceedings[121](index=121&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the Annual Report on Form 10-K filed on March 31, 2021 - There have been no material changes from the risk factors described in the Form 10-K filed on March 31, 2021[122](index=122&type=chunk) [Other Part II Items](index=25&type=section&id=Other%20Part%20II%20Items) The company reported no unregistered sales of equity securities, no defaults upon senior securities, no mine safety disclosures, and no other information requiring disclosure - Item 2. Unregistered Sales of Equity Securities and Use of Proceeds: None[123](index=123&type=chunk) - Item 3. Defaults Upon Senior Securities: None[124](index=124&type=chunk) - Item 4. Mine Safety Disclosures: None[125](index=125&type=chunk) - Item 5. Other Information: None[126](index=126&type=chunk) [Item 6. Exhibits](index=26&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications and XBRL data files - Exhibits filed include CEO and CFO certifications pursuant to Sarbanes-Oxley Act Sections 302 and 906[129](index=129&type=chunk) - Interactive Data Files (XBRL documents) are also included as exhibits[129](index=129&type=chunk)

PART I [Business](index=5&type=section&id=Item%201.%20Business) Summit Therapeutics is a biopharmaceutical company focused on developing novel antibiotics, with its lead candidate ridinilazole in Phase 3 trials for Clostridioides difficile infection (CDI) [Overview and Pipeline](index=5&type=section&id=Overview%20and%20Pipeline) - Summit Therapeutics is a biopharmaceutical company focused on discovering, developing, and commercializing novel antibiotics for serious infectious diseases, with a lead program in Phase 3 for Clostridioides difficile infection (CDI)[20](index=20&type=chunk) Product Development Pipeline | Program | Discovery/Preclinical | Phase 1 | Phase 2 | Phase 3 | Remarks | | :--- | :--- | :--- | :--- | :--- | :--- | | **Ridinilazole (CDI)** | QIDP & Fast Track Designation | - | - | - | **Ongoing** | Patient enrollment and dosing in Phase 3 clinical trials ongoing | | **DDS-04 (Enterobacteriaceae)** | **Late Lead Optimization** | - | - | - | - | Advancing program targeting infections caused by Enterobacteriaceae | - The company's Neisseria gonorrhoeae program (SMT-571) has been discontinued due to unsuitable qualities for further development found in preclinical toxicology studies[29](index=29&type=chunk) [Our Strategy](index=7&type=section&id=Our%20Strategy) - The company's primary strategic focus is the rapid advancement and development of its lead product candidate, ridinilazole, for the treatment of CDI[32](index=32&type=chunk) - Upon potential regulatory approval, Summit intends to commercialize ridinilazole in the United States with its own specialized sales force, while evaluating options for other key territories[33](index=33&type=chunk) - A key strategy is to expand the product portfolio by identifying new mechanism antibiotics using the proprietary Discuva Platform, targeting pathogens that pose serious healthcare threats[34](index=34&type=chunk) - The company actively seeks and has obtained development funding from governmental and other third-party organizations, such as BARDA and the Wellcome Trust, to support its programs[36](index=36&type=chunk) [Ridinilazole for the Treatment of CDI](index=8&type=section&id=Ridinilazole%20for%20the%20Treatment%20of%20CDI) - Ridinilazole is an orally administered small molecule antibiotic designed to selectively target C. difficile bacteria while preserving the gut microbiome, aiming to reduce CDI recurrence rates[47](index=47&type=chunk) - The pivotal Phase 3 program (Ri-CoDIFy 1 & 2) is designed to assess the superiority of ridinilazole compared to vancomycin in sustained clinical response (SCR). As of December 31, 2020, **494 of the required 1,360 patients were enrolled**[21](index=21&type=chunk)[48](index=48&type=chunk)[53](index=53&type=chunk) Phase 2 Proof of Concept Trial (CoDIFy) Results vs. Vancomycin | Metric | Ridinilazole | Vancomycin | | :--- | :--- | :--- | | **Sustained Clinical Response (SCR)** | **66.7%** | **42.4%** | | Clinical Cure Rate (End of Treatment) | 77.8% | 69.7% | | **Recurrence Rate (30-day post-treatment)** | **14.3%** | **34.8%** | - Clinical and preclinical data indicate ridinilazole has minimal impact on gut microbiome diversity compared to vancomycin and fidaxomicin, preserving beneficial bacteria and bile acid composition[62](index=62&type=chunk)[64](index=64&type=chunk)[69](index=69&type=chunk) - The FDA has granted ridinilazole Qualified Infectious Disease Product (QIDP) designation, which provides for priority review and a five-year extension of statutory exclusivity upon approval, and Fast Track designation[52](index=52&type=chunk) [Infectious Diseases Pipeline and Discuva Platform](index=17&type=section&id=Infectious%20Diseases%20Pipeline%20and%20Discuva%20Platform) - The Discuva Platform is a genetics-based technology used to identify new bacterial targets, elucidate antibiotic mechanisms of action, and understand resistance mechanisms[78](index=78&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk) - The company is advancing its DDS-04 series of new mechanism antibiotics targeting Enterobacteriaceae, which act on a novel target (LolCDE) and have shown preclinical in vivo efficacy in models of sepsis, urinary tract infection, and pneumonia[83](index=83&type=chunk)[84](index=84&type=chunk) - The gonorrhea program, targeting Neisseria gonorrhoeae with the SMT-571 chemotype, was ceased after preclinical toxicology studies indicated it was unsuitable for further development[86](index=86&type=chunk) [Collaborations and Funding Arrangements](index=19&type=section&id=Collaborations%20and%20Funding%20Arrangements) - Summit has a contract with BARDA worth up to **$72.5 million** to partially fund the clinical and regulatory development of ridinilazole. As of December 31, 2020, **$62.4 million was committed** and **$53.3 million had been received**[89](index=89&type=chunk)[90](index=90&type=chunk) - The company has an exclusive license and commercialization agreement with Eurofarma for ridinilazole in Latin America, receiving a **$2.5 million upfront payment** and a **$1.0 million milestone**, with potential for up to **$21.4 million in additional milestones** and sales-based payments[111](index=111&type=chunk)[112](index=112&type=chunk) - Under a revenue sharing agreement with the Wellcome Trust, which provided early-stage funding, Summit will pay low-to-mid-single digit percentages of net revenues from ridinilazole commercialization[100](index=100&type=chunk)[101](index=101&type=chunk) - The collaboration with Sarepta Therapeutics for Duchenne muscular dystrophy was terminated in August 2019 after the Phase 2 trial of ezutromid failed to meet its endpoints[119](index=119&type=chunk) [Competition, Manufacturing, and IP](index=23&type=section&id=Competition%2C%20Manufacturing%2C%20and%20IP) - Ridinilazole faces competition from existing CDI treatments like generic vancomycin and metronidazole, branded fidaxomicin (Dificid™), and Merck's monoclonal antibody bezlotoxumab (Zinplava™). Other approaches in development include fecal biotherapy and vaccines[125](index=125&type=chunk)[127](index=127&type=chunk) - The company does not own manufacturing facilities and relies on third-party manufacturers for the clinical and future commercial supply of its product candidates, including the API and final drug product for ridinilazole[129](index=129&type=chunk)[130](index=130&type=chunk) - The company's CDI patent portfolio includes granted U.S. and European patents covering the use of ridinilazole for CDI and its hydrate forms, with expiration dates scheduled for **2029**[134](index=134&type=chunk)[138](index=138&type=chunk) [Commercialization and Government Regulation](index=26&type=section&id=Commercialization%20and%20Government%20Regulation) - Summit plans to commercialize ridinilazole in the United States with its own focused, specialty sales force targeting hospital and community prescribers[142](index=142&type=chunk) - The company is subject to extensive regulation by the FDA in the United States and comparable authorities in other jurisdictions, covering all stages from research and development to post-approval marketing[145](index=145&type=chunk) - Ridinilazole has been designated as a Qualified Infectious Disease Product (QIDP) under the GAIN Act, which grants an additional **five years of marketing exclusivity** upon FDA approval[199](index=199&type=chunk) - The company is subject to various healthcare laws, including the federal Anti-Kickback Statute and the False Claims Act, which regulate arrangements with providers and payors[230](index=230&type=chunk)[231](index=231&type=chunk) [Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including substantial operating losses, dependence on ridinilazole's clinical success, and operational challenges exacerbated by the COVID-19 pandemic - The company has a history of significant operating losses (**$52.7 million in FY 2020**) and expects to incur losses for the foreseeable future, requiring substantial additional capital to complete development and commercialization[257](index=257&type=chunk)[263](index=263&type=chunk) - The business is heavily dependent on the success of its lead product candidate, ridinilazole. Failure to commercialize it or significant delays would materially harm the business[269](index=269&type=chunk) - The COVID-19 pandemic has caused slower patient enrollment in Phase 3 trials, delaying expected results and potentially increasing costs[278](index=278&type=chunk)[279](index=279&type=chunk) - The company relies on government funding from BARDA, which can be terminated at the government's convenience and imposes complex compliance requirements[328](index=328&type=chunk)[332](index=332&type=chunk) - The CEO, Robert W. Duggan, beneficially owned approximately **69.6% of outstanding capital stock** as of December 31, 2020, giving him control over stockholder matters and qualifying the company as a "controlled company" under Nasdaq rules, exempting it from certain governance requirements[425](index=425&type=chunk)[426](index=426&type=chunk) [Properties](index=82&type=section&id=Item%202.%20Properties) The company leases four properties for its operations, including executive offices and a laboratory, with varying lease expiry dates Leased Properties | Location | Type/Use | Size (sq ft) | Lease Expiry | | :--- | :--- | :--- | :--- | | Oxfordshire, UK | Executive office | 6,781 | Feb 2027 | | Cambridge, MA | Executive office | 996 | Rolling | | Cambridge, UK | Laboratory and office | 8,834 | Dec 2021 | | Menlo Park, CA | Executive office | 4,500 | Sep 2022 | [Legal Proceedings](index=82&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - As of the report date, the company is not a party to any material legal proceedings[445](index=445&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=83&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq, has not paid dividends, and recently completed significant private placements and debt financing - The company's common stock has traded on the Nasdaq Global Market under the symbol "SMMT" since **September 21, 2020**, following the redomiciliation from the UK[449](index=449&type=chunk) - The company has never declared or paid cash dividends and intends to retain future earnings to fund business development[451](index=451&type=chunk) - On **November 6, 2020**, the company issued **14,970,060 shares** of common stock in a private placement for aggregate proceeds of **$50 million**[454](index=454&type=chunk) - On **March 24, 2021**, the company issued a **$55.0 million unsecured promissory note** to its CEO, Robert W. Duggan[455](index=455&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=84&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes the company's financial performance, highlighting a significant net loss in 2020 driven by increased R&D and G&A expenses, and discusses liquidity and capital resources [Results of Operations](index=88&type=section&id=Results%20of%20Operations) Comparison of Financial Results (in thousands) | Metric | Year Ended Dec 31, 2020 | Eleven Months Ended Dec 31, 2019 | | :--- | :--- | :--- | | Revenue | $860 | $743 | | Research and Development Expenses | $53,274 | $39,809 | | General and Administrative Expenses | $19,232 | $11,279 | | Other Operating Income | $19,312 | $22,872 | | **Net Loss** | **($52,697)** | **($29,127)** | - Research and development expenses increased by **$13.5 million** in 2020, primarily due to increased clinical and manufacturing activities for the Phase 3 trials of ridinilazole[494](index=494&type=chunk)[495](index=495&type=chunk) - General and administrative expenses rose by **$7.9 million** in 2020, driven by legal and professional fees related to the Redomiciliation Transaction and increased commercial preparatory activities[499](index=499&type=chunk) - Other operating income in 2020 was **$19.3 million**, primarily consisting of **$9.5 million** from the BARDA contract and **$9.4 million** from UK R&D tax credits[490](index=490&type=chunk)[492](index=492&type=chunk) [Liquidity and Capital Resources](index=94&type=section&id=Liquidity%20and%20Capital%20Resources) - As of December 31, 2020, the company had cash and cash equivalents of **$66.4 million**[522](index=522&type=chunk) - The company believes its existing cash, combined with a **$55 million promissory note** received in March 2021, will be sufficient to fund operations until the **second quarter of 2022**[522](index=522&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Year Ended Dec 31, 2020 | Eleven Months Ended Dec 31, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($48,111) | ($20,757) | | Net cash used in investing activities | ($421) | ($341) | | Net cash provided by financing activities | $50,551 | $49,505 | - Net cash from financing activities in 2020 was **$50.6 million**, primarily from a **$50.0 million private placement** of common stock in November 2020[533](index=533&type=chunk) [Critical Accounting Policies](index=97&type=section&id=Critical%20Accounting%20Policies) - Funding from government contracts, like BARDA, is classified as 'other operating income' and recognized as qualifying expenses are incurred, as it is central to ongoing operations[542](index=542&type=chunk)[543](index=543&type=chunk) - Research and development costs are expensed as incurred. The company records accruals for ongoing R&D costs by analyzing the progress and estimated costs to complete each study[545](index=545&type=chunk)[546](index=546&type=chunk) - The company has recorded a full valuation allowance against its deferred tax assets, as it is not considered more likely than not that a tax benefit will be realized in the foreseeable future[547](index=547&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=100&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks include foreign currency fluctuations due to UK operations and liquidity risk from reliance on external financing - The company's primary market risk is foreign currency risk, as its financial results are reported in U.S. dollars but a significant portion of its operations are conducted in the United Kingdom (pounds sterling)[552](index=552&type=chunk) - The company faces liquidity risk and expects to finance its operations through equity/debt financings and collaborations until it can generate substantial product revenue[555](index=555&type=chunk) - Credit risk is considered low, with receivables primarily due from BARDA. The company does not hold derivative financial instruments, resulting in minimal interest rate risk[553](index=553&type=chunk)[554](index=554&type=chunk) [Controls and Procedures](index=101&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2020 - Management concluded that the company's disclosure controls and procedures were effective as of **December 31, 2020**[558](index=558&type=chunk) - Based on the COSO 2013 framework, management concluded that the company's internal control over financial reporting was effective as of **December 31, 2020**[561](index=561&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the fiscal year ended **December 31, 2020**[563](index=563&type=chunk) PART III [Directors, Executive Officers, Corporate Governance, Compensation, Security Ownership, and Accountant Fees](index=102&type=section&id=Items%2010-14) Information for Items 10 through 14, covering governance, compensation, and ownership, is incorporated by reference from the company's definitive proxy statement - The information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the registrant's definitive Proxy Statement to be filed within **120 days** of the fiscal year-end[566](index=566&type=chunk)[567](index=567&type=chunk)[568](index=568&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=102&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section details the financial statements and exhibits filed with the report, including key corporate documents and material contracts - This item lists all exhibits filed with the report, including the company's Restated Certificate of Incorporation, Amended and Restated Bylaws, and material contracts[574](index=574&type=chunk)[575](index=575&type=chunk) - The consolidated financial statements are included as part of the report, as listed in the index on page F-1[572](index=572&type=chunk) Financial Statements [Consolidated Financial Statements](index=108&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements for 2020 report a significant net loss, with current resources expected to fund operations into Q2 2022, contingent on additional capital Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $66,417 | $63,842 | | Total current assets | $87,674 | $79,628 | | Total assets | $102,498 | $96,248 | | **Liabilities & Equity** | | | | Total current liabilities | $19,890 | $13,767 | | Total liabilities | $23,045 | $17,385 | | Total stockholders' equity | $79,453 | $78,863 | Consolidated Statement of Operations Highlights (in thousands) | Account | Year Ended Dec 31, 2020 | Eleven Months Ended Dec 31, 2019 | | :--- | :--- | :--- | | Revenue | $860 | $743 | | R&D Expenses | $53,274 | $39,809 | | G&A Expenses | $19,232 | $11,279 | | **Net Loss** | **($52,697)** | **($29,127)** | | **Net Loss Per Share (Basic)** | **($0.76)** | **($0.89)** | - The company's ability to continue as a going concern is dependent on its ability to raise additional capital to fund operations, with current resources expected to last until the **second quarter of 2022**[613](index=613&type=chunk)[614](index=614&type=chunk) - A critical audit matter identified by the independent auditor was the estimation of accrued and prepaid research and development costs, which involves significant management judgment regarding the stage of completion of studies[593](index=593&type=chunk)[594](index=594&type=chunk)

Summit Therapeutics plc (NASDAQ:SMMT) Q4 2018 Results Conference Call March 27, 2019 8:00 AM ET Company Participants Richard Pye - VP, Corporate Affairs Glyn Edwards - CEO Melissa Strange - VP, Finance Conference Call Participants Hartaj Singh - Oppenheimer & Company Tim Chiang - BTIG Joseph Hedden - Rx Securities Yun Zhong - Janney Gary Waanders - Bryan Garnier Julie Simmonds - Panmure Gordon Dewey Steadman - Canaccord Operator Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to tod ...

From New Mechanisms to New Standards of Care Corporate Presentation Forward-Looking Statements Statements in this presentation, other than statements of historical fact, constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding Summit's clinical trials supporting the safety and efficacy of its product candidates and the potential novelty of such product candidat ...