Summit Therapeutics (SMMT)
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Summit Therapeutics (SMMT) - 2023 Q1 - Earnings Call Transcript
2023-05-11 16:49
Financial Data and Key Metrics Changes - The net loss for the quarter was $542.4 million, which included $520.9 million in IP R&D expenses related to the upfront payment made to Akeso for ivonescimab [16] - Excluding the one-time payment, the pro forma net loss was approximately $22 million, with operating expenses at $16.8 million [16] - The company exited the quarter with $242 million in cash and investments, which is deemed sufficient to fund operating costs and working capital needs for planned clinical trials into the second half of 2024 [34] Business Line Data and Key Metrics Changes - The company announced it would cease investment in its anti-infectives business to focus resources on the development of ivonescimab [15] - Significant groundwork has been laid for the announcement of two late-stage multi-region trials and the treatment of the first patient in the initial trial [17] Market Data and Key Metrics Changes - The collaboration with Akeso includes rights to ivonescimab in the U.S., Canada, Europe, and Japan, with an upfront payment of $500 million and potential regulatory and commercialization milestones totaling up to $4.5 billion [12] Company Strategy and Development Direction - The company aims to make a significant positive impact on human healthcare by improving the quality and duration of patient lives through ivonescimab [6] - The strategic focus is on executing multiple large clinical trials and building an experienced oncology team [34] - The company is preparing to expand its supply chain for clinical and commercial supply for multiple sources [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to make a meaningful impact on patients' lives with ivonescimab, particularly in non-small cell lung cancer and other solid tumors [13] - The company is actively engaging with health authorities, including the FDA, to discuss Phase III clinical trials for ivonescimab [28] Other Important Information - The company has initiated its first clinical study, HARMONi, and enrolled the first patient within 3.5 months after closing the deal with Akeso [30] - The company has added Dr. Michelle Xia, CEO of Akeso, to its Board of Directors, enhancing corporate governance and expertise [25] Q&A Session Summary Question: Will the company be able to submit data compiled by Akeso for the Phase III clinical trials? - Yes, the company will utilize information from both Akeso and its own generated data, having designed trials in agreement with the FDA [38] Question: What can the company do to seek FDA designations such as breakthrough therapy and Fast Track? - The company has appreciated and incorporated FDA feedback in finalizing the design of its clinical studies and is likely to pursue Fast Track designation [20][49]
Summit Therapeutics (SMMT) - 2022 Q4 - Earnings Call Transcript
2023-03-10 23:43
Financial Data and Key Metrics Changes - The company closed a fully subscribed $500 million rights offering, which was oversubscribed with over 1,500 accounts acquiring shares [12][13] - The company currently has approximately $235 million in cash and cash equivalents, with a loan of $100 million on the balance sheet [15] Business Line Data and Key Metrics Changes - The company is focusing entirely on the development of ivonescimab, transitioning away from anti-infectives and other discovery-related work [15][16] - The upfront payment of $500 million to Akeso was made in two tranches, totaling $474.9 million, with Akeso also acquiring 10 million shares of Summit common stock valued at $25.1 million [14] Market Data and Key Metrics Changes - The partnership with Akeso allows Summit to develop ivonescimab in North America and Europe, with ongoing Phase III trials in China [10][11] - Ivonescimab has received breakthrough therapy designations in three indications in China [10] Company Strategy and Development Direction - The company aims to build a significant presence in the late-stage bispecific oncology space, focusing on clinical trials for ivonescimab [11][15] - Summit is establishing manufacturing capabilities outside of China to mitigate geopolitical risks [17] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the potential of ivonescimab and the strategic partnership with Akeso, emphasizing the importance of improving patient outcomes [5][6] - The company is in communication with the FDA and other health authorities to align on development strategies for clinical trials [11][21] Other Important Information - The company has taken noncash charges, including impairments of anti-infectives-based intangible assets, as part of its transition to focus solely on oncology [16] - The collaboration with Akeso is specific to ivonescimab, with no other products included in the deal [22] Q&A Session Summary Question: Does the company have rights to manufacture the product elsewhere besides China? - Yes, the company has entered into a supply agreement and plans to establish manufacturing capabilities within its licensed territories [17] Question: Have clinical trials from another country been accepted in the United States? - The company is working through its development strategy and plans to provide more information based on FDA feedback [21] Question: Is the deal specific to SMT112 or are there other Akeso products involved? - The transaction is entirely specific to SMT112 [22] Question: What percentage of Summit does Akeso currently own, and did they participate in the rights offering? - Akeso's participation in the rights offering is not public information, but they elected to acquire 10 million shares as part of the upfront payment [23]
Summit Therapeutics (SMMT) - 2022 Q4 - Annual Report
2023-03-09 21:53
[PART I](index=7&type=section&id=PART%20I) [Business](index=7&type=section&id=Item%201.%20Business) Summit Therapeutics pivoted to oncology with ivonescimab, discontinuing anti-infective programs and relying on third-party manufacturing and regulatory compliance [Overview and Strategic Shift](index=7&type=section&id=Overview%20and%20Strategic%20Shift) - The company has shifted its strategic focus to oncology following the in-licensing of ivonescimab from Akeso, Inc. in December 2022[26](index=26&type=chunk)[27](index=27&type=chunk) - Development and marketing activities for the previous lead anti-infective candidate, ridinilazole, are being terminated, and the asset is being reviewed for partnership or divestiture[27](index=27&type=chunk)[28](index=28&type=chunk) - Future operations will be centered on the development of ivonescimab[27](index=27&type=chunk) [Akeso Collaboration and License Agreement](index=7&type=section&id=Akeso%20Collaboration%20and%20License%20Agreement) - Summit obtained the rights to develop and commercialize ivonescimab (SMT112) in the United States, Canada, Europe, and Japan[26](index=26&type=chunk)[30](index=30&type=chunk) - An upfront payment was made in Q1 2023, consisting of **$474.9 million** in cash and 10 million shares of common stock (in lieu of **$25.1 million** cash)[30](index=30&type=chunk) - Akeso retains development and commercialization rights for all other regions, including China[30](index=30&type=chunk) [Ivonescimab (SMT112)](index=8&type=section&id=Ivonescimab%20(SMT112)) - Ivonescimab is a novel, potential first-in-class PD-1/VEGF bispecific antibody that combines immunotherapy (PD-1 blockade) with anti-angiogenesis (VEGF blockade) in a single molecule[32](index=32&type=chunk) - The drug has received Breakthrough Therapy Designation status in China for three separate indications in non-small cell lung cancer (NSCLC)[33](index=33&type=chunk)[35](index=35&type=chunk) - In a Phase II study in China for NSCLC patients who failed EGFR-TKI treatment, ivonescimab combined with chemotherapy showed an overall response rate (ORR) of **68.4%** and a median Progression-Free Survival (mPFS) of **8.2 months**[33](index=33&type=chunk) - Summit is initiating its own development activities for ivonescimab, starting with NSCLC indications in its licensed territories[35](index=35&type=chunk) [Status of Anti-Infectives Pipeline](index=9&type=section&id=Status%20of%20Anti-Infectives%20Pipeline) - The company is seeking partners or divestiture for ridinilazole, its former lead candidate for C. difficile infection, and has discontinued its pediatric clinical trial[28](index=28&type=chunk) - The Discuva Platform, a technology for discovering new antibiotics, will no longer receive further investment. An impairment charge of **$8.5 million** was recognized for the intangible asset in 2022[42](index=42&type=chunk) - The company will continue to pursue partnerships for the further development of SMT-738, a preclinical candidate for combating carbapenem-resistant Enterobacteriaceae (CRE) infections[29](index=29&type=chunk)[44](index=44&type=chunk) [Competition](index=13&type=section&id=Competition) - Ivonescimab is the most advanced PD-1/VEGF bispecific antibody in clinical development, with no known approved competitors in its class in the licensed territories[64](index=64&type=chunk)[65](index=65&type=chunk) - The NSCLC market is highly competitive, with established treatments including immuno-oncology drugs like pembrolizumab, atezolizumab, nivolumab, and durvalumab, often used in combination with chemotherapy[66](index=66&type=chunk) - The company faces competition from major pharmaceutical and biotechnology companies with significantly greater financial resources and expertise[61](index=61&type=chunk) [Manufacturing](index=14&type=section&id=Manufacturing) - The company does not own or operate manufacturing facilities and relies on third parties for the production of its product candidates[67](index=67&type=chunk) - Akeso will be the initial sole supplier of the drug substance for ivonescimab for both clinical and commercial use in the licensed territory, as per a forthcoming Supply Agreement[68](index=68&type=chunk) [Intellectual Property](index=15&type=section&id=Intellectual%20Property) Patent Portfolio Summary (as of Dec 31, 2022) | Program/Technology | Granted Patents (U.S. & Foreign) | Pending Applications (Worldwide) | Expected Expiration | | :--- | :--- | :--- | :--- | | **Discuva Platform** | 14 | N/A | 2032 | | **Ridinilazole Program** | 23 | 22 | 2043 | | **SMT-738 Program** | 4 | 23 | 2042 | - The company has in-licensed rights to various Akeso patent applications for ivonescimab in the licensed territory and has rights to control their prosecution in collaboration with Akeso[75](index=75&type=chunk) [Government Regulation](index=16&type=section&id=Government%20Regulation) - The company is subject to extensive regulation by the FDA in the United States and comparable authorities in other countries, covering all stages from research and development to post-approval marketing[82](index=82&type=chunk) - The U.S. drug approval process involves preclinical studies, submitting an Investigational New Drug (IND) application, conducting Phase I, II, and III clinical trials, and submitting a New Drug Application (NDA) or Biologic Licensing Application (BLA) to the FDA[84](index=84&type=chunk) - In the European Union, marketing authorization requires submitting an MAA through a centralized, decentralized, or national procedure, with the centralized procedure being mandatory for certain innovative products like those the company is developing[144](index=144&type=chunk)[145](index=145&type=chunk) - Pricing and reimbursement are subject to significant government control and third-party payor negotiations in both the U.S. and E.U., which can impact commercial success[159](index=159&type=chunk)[166](index=166&type=chunk) [Human Capital](index=31&type=section&id=Human%20Capital) - As of December 31, 2022, the company had **77 total employees**, with **62%** in research and development[174](index=174&type=chunk) - The workforce is split geographically, with approximately **62%** in the U.S. and **38%** in the U.K.[174](index=174&type=chunk) - The company emphasizes diversity, with approximately **63%** of its employees and **62%** of its executive team being female[177](index=177&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial financial, operational, and market risks, including heavy dependence on ivonescimab, need for capital, reliance on third parties, clinical trial uncertainties, intense competition, and complex regulatory and intellectual property challenges [Risks Related to Financial Position and Need for Additional Capital](index=33&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) - The company's success is heavily dependent on a single product candidate, ivonescimab. Failure to successfully commercialize it would materially harm the business[188](index=188&type=chunk) - The company is a development-stage entity with a history of significant losses (**$78.8 million** net loss in 2022) and an accumulated deficit of **$378.3 million** as of year-end 2022[191](index=191&type=chunk) - Substantial additional capital is required to fund operations, make payments under the License Agreement (up to **$5.0 billion** in contingent payments), and service its **$100 million** in outstanding debt as of March 7, 2023[197](index=197&type=chunk)[201](index=201&type=chunk)[204](index=204&type=chunk) [Risks Related to Financial and Intellectual Property Dependencies on Third Parties](index=36&type=section&id=Risks%20Related%20to%20our%20Financial%20and%20Intellectual%20Property%20Dependencies%20on%20Third%20Parties) - The company depends on the intellectual property licensed from Akeso for ivonescimab. Termination of the License Agreement, for reasons such as a material breach or failure to make payments, would result in the loss of its primary product candidate[207](index=207&type=chunk)[209](index=209&type=chunk)[211](index=211&type=chunk) - Reliance on Akeso for the initial manufacturing and supply of ivonescimab presents risks. Any delays, quality issues, or failure to transfer manufacturing knowledge could materially and adversely affect the business[214](index=214&type=chunk)[215](index=215&type=chunk) - The company relies on third-party contract research organizations (CROs) to conduct clinical trials, which reduces direct control over these activities and introduces risks related to performance, compliance, and deadlines[229](index=229&type=chunk)[230](index=230&type=chunk) [Risks Related to Industry and Market](index=42&type=section&id=Risks%20Related%20to%20Our%20Industry%20and%20Market) - The company faces substantial competition in the NSCLC market from established immuno-oncology drugs and chemotherapies, as well as from other therapeutics in development[236](index=236&type=chunk)[237](index=237&type=chunk) - Many competitors have significantly greater financial resources and expertise in R&D, manufacturing, and marketing[240](index=240&type=chunk) [Risks Related to Development and Commercialization](index=43&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Commercialization%20of%20our%20Product%20Candidates) - Clinical trials are expensive, lengthy, and uncertain. Failure to demonstrate safety and efficacy for ivonescimab could prevent or delay commercialization[245](index=245&type=chunk) - Even if approved, ivonescimab may not achieve market acceptance from physicians, patients, and payors, which is necessary for commercial success[254](index=254&type=chunk) - As a biologic, ivonescimab carries unique manufacturing risks, as production is often complex, costly, and requires specialized facilities and quality control[261](index=261&type=chunk) [Legal, Tax, Regulatory and Compliance Risks](index=46&type=section&id=Legal,%20Tax,%20Regulatory%20and%20Compliance%20Risks) - The business is subject to unfavorable pricing regulations, third-party reimbursement practices, and healthcare reform initiatives (like the Inflation Reduction Act of 2022) that could harm profitability[264](index=264&type=chunk)[308](index=308&type=chunk) - Reliance on Akeso exposes the company to risks associated with doing business in China, including political, economic, legal, and trade policy uncertainties[270](index=270&type=chunk)[271](index=271&type=chunk) - The marketing approval process is expensive and uncertain. Failure to obtain, or delays in obtaining, regulatory approvals from the FDA and other authorities would prevent commercialization[287](index=287&type=chunk) [Risks Related to Intellectual Property, Cybersecurity and Data Privacy](index=55&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property,%20Cybersecurity%20and%20Data%20Privacy) - The company's ability to obtain and maintain patent protection for its technology is uncertain and critical to its success. Patent rights may be challenged, invalidated, or circumvented by competitors[317](index=317&type=chunk)[319](index=319&type=chunk) - The company may become involved in expensive and time-consuming lawsuits to protect its patents or defend against infringement claims from third parties[327](index=327&type=chunk)[328](index=328&type=chunk) - Information technology systems are vulnerable to cybersecurity threats like ransomware, which could disrupt operations, compromise sensitive data (including clinical trial data), and result in significant costs and reputational harm[335](index=335&type=chunk)[337](index=337&type=chunk) - The company is subject to stringent and evolving data privacy laws, such as GDPR in Europe and CCPA in California, and failure to comply could lead to significant fines and penalties[341](index=341&type=chunk)[343](index=343&type=chunk)[345](index=345&type=chunk) [Risks Related to Corporate Governance and Employee Relations](index=60&type=section&id=Risks%20Related%20to%20Corporate%20Governance%20and%20Employee%20Relations) - The company is highly dependent on its key executives, including Executive Chairman and CEO Robert W. Duggan and co-CEO Dr. Mahkam Zanganeh[348](index=348&type=chunk) - As of December 31, 2022, Mr. Duggan beneficially owned approximately **81.8%** of the company's outstanding capital stock, giving him control over all matters submitted to stockholders for approval[350](index=350&type=chunk) - Due to Mr. Duggan's majority ownership, the company qualifies as a "controlled company" under Nasdaq rules, exempting it from certain corporate governance requirements, such as having a majority of independent directors[351](index=351&type=chunk) [Risks Related to Owning Our Common Stock](index=62&type=section&id=Risks%20Related%20to%20Owning%20Our%20Common%20Stock) - The stock price may be volatile and is subject to fluctuation based on clinical trial results, competition, and broader market conditions[353](index=353&type=chunk)[354](index=354&type=chunk) - Substantial future sales of common stock by the principal stockholder, who holds a large number of registered shares, could cause the stock price to decline[356](index=356&type=chunk)[357](index=357&type=chunk) - The company is a "smaller reporting company," which allows for reduced disclosure requirements that may make the stock less attractive to some investors[358](index=358&type=chunk) [Risks Related to the COVID-19 Pandemic](index=65&type=section&id=Risks%20Related%20to%20the%20COVID-19%20Pandemic) - The COVID-19 pandemic could continue to adversely affect business operations, including potential delays in clinical trial enrollment and disruptions to the supply chain for clinical materials[375](index=375&type=chunk)[377](index=377&type=chunk) [Unresolved Staff Comments](index=68&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[380](index=380&type=chunk) [Properties](index=68&type=section&id=Item%202.%20Properties) The company leases three principal facilities for executive office and laboratory use in the United Kingdom and the United States Principal Leased Facilities (as of Dec 31, 2022) | Use | Location | Size (sq. ft.) | Lease Expiration | | :--- | :--- | :--- | :--- | | Executive office | Oxfordshire, UK | 6,781 | Feb 2027 | | Executive office | Menlo Park, CA, US | 5,777 | Dec 2025 | | Laboratory and office | Sawston, UK | 7,644 | Oct 2026 | [Legal Proceedings](index=68&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not currently a party to any material legal proceedings[382](index=382&type=chunk) [Mine Safety Disclosures](index=68&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[383](index=383&type=chunk) [PART II](index=69&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=69&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the Nasdaq Global Market under the symbol "SMMT" and has never paid cash dividends, with recent sales of unregistered securities funding operations and the Akeso license agreement - The company's common stock has traded on the Nasdaq Global Market under the symbol "SMMT" since September 21, 2020[386](index=386&type=chunk) - The company has never paid cash dividends and intends to retain future earnings to fund business development[388](index=388&type=chunk) - In December 2022, the company entered into a Note Purchase Agreement with its CEO and co-CEO for an aggregate of **$520 million** in unsecured promissory notes to help fund the Akeso license agreement[397](index=397&type=chunk) [Selected Financial Data](index=72&type=section&id=Item%206.%20Selected%20Financial%20Data) This item is reserved and no data is provided - Reserved[401](index=401&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=72&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's strategic shift to oncology impacted 2022 financials, resulting in a net loss of **$78.8 million** driven by reduced R&D and an impairment charge, with recent financing expected to fund operations into late 2024 [Results of Operations](index=79&type=section&id=Results%20of%20Operations) Comparison of Operations (in millions) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | $ Change | | :--- | :--- | :--- | :--- | | **Revenue** | $0.7 | $1.8 | $(1.1) | | **Research and development** | $52.0 | $85.4 | $(33.4) | | **General and administrative** | $26.7 | $23.6 | $3.1 | | **Impairment of intangible assets** | $8.5 | $— | $8.5 | | **Other operating income** | $14.4 | $21.0 | $(6.6) | | **Operating loss** | $(72.1) | $(86.2) | $14.1 | | **Net loss** | $(78.8) | $(88.6) | $9.8 | - Research and development expenses decreased by **$33.4 million**, primarily due to reduced clinical and manufacturing activity for the ridinilazole program following the decision to seek a partner or divestiture[439](index=439&type=chunk) - An impairment charge of **$8.5 million** was recognized for the Discuva Platform intangible asset due to the company's strategic shift to oncology[443](index=443&type=chunk) - Other operating income decreased by **$6.6 million**, mainly due to a **$10.7 million** decrease in U.K. R&D tax credits resulting from lower eligible spending on the ridinilazole program[444](index=444&type=chunk)[445](index=445&type=chunk) [Liquidity and Capital Resources](index=82&type=section&id=Liquidity%20and%20Capital%20Resources) - As of December 31, 2022, the company had cash and cash equivalents of **$348.6 million** and restricted cash of **$300.0 million**[452](index=452&type=chunk) - The company believes its financial resources, including proceeds from a March 2023 Rights Offering, are sufficient to fund operations and planned clinical trials for ivonescimab into the second half of 2024[452](index=452&type=chunk) Cash Flow Summary (in millions) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(41.6) | $(72.6) | | **Net cash used in investing activities** | $(0.6) | $(0.3) | | **Net cash provided by financing activities** | $620.2 | $77.9 | - Net cash from financing activities in 2022 was primarily driven by **$545.0 million** in proceeds from related-party promissory notes and **$99.9 million** from a rights offering[463](index=463&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=87&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - Key accounting policies requiring significant judgment include revenue recognition for licensing agreements, impairment of intangible assets, accrual of research and development expenses, valuation of stock-based compensation, and accounting for income taxes[477](index=477&type=chunk)[478](index=478&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=91&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposures are liquidity, foreign currency exchange rate fluctuations due to U.K. operations, and interest rate risk from variable-rate promissory notes - The company's primary market risks are liquidity, foreign currency, and interest rate risk[497](index=497&type=chunk) - Foreign currency risk stems from significant operations in the United Kingdom, with transactions in pounds sterling and euros, while financial statements are presented in U.S. dollars[499](index=499&type=chunk) - Interest rate risk exists due to variable interest rates on its outstanding promissory notes payable to related parties[501](index=501&type=chunk) [Financial Statements and Supplementary Data](index=92&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's consolidated financial statements for the years ended December 31, 2022 and 2021, including the Report of Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Stockholders' Equity, Statements of Cash Flows, and the accompanying notes - The financial statements required by this item are included in the Annual Report on Form 10-K, starting on page 88 of the original document[503](index=503&type=chunk)[520](index=520&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=92&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[504](index=504&type=chunk) [Controls and Procedures](index=92&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2022, with no attestation report required as a non-accelerated filer - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[505](index=505&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[508](index=508&type=chunk) [Other Information](index=93&type=section&id=Item%209B.%20Other%20Information) The Compensation Committee approved 2022 bonuses for executives, with co-CEO Dr. Zanganeh receiving **$452,500** and CFO Ankur Dhingra receiving **$381,918** on January 10, 2023 - On January 10, 2023, the company paid a discretionary cash bonus of **$202,500** and an extraordinary bonus of **$250,000** to co-CEO Dr. Zanganeh[511](index=511&type=chunk) - On January 10, 2023, the company paid a discretionary cash bonus of **$131,918** and an extraordinary bonus of **$250,000** to CFO Ankur Dhingra[511](index=511&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=93&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[512](index=512&type=chunk) [PART III](index=93&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=93&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item is incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders - Information is incorporated by reference from the upcoming 2023 proxy statement[514](index=514&type=chunk) [Executive Compensation](index=93&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item is incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders - Information is incorporated by reference from the upcoming 2023 proxy statement[515](index=515&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=93&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item is incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders - Information is incorporated by reference from the upcoming 2023 proxy statement[516](index=516&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=93&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) Information for this item is incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders - Information is incorporated by reference from the upcoming 2023 proxy statement[517](index=517&type=chunk) [Principal Accounting Fees and Services](index=93&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information for this item is incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders - Information is incorporated by reference from the upcoming 2023 proxy statement[518](index=518&type=chunk) [PART IV](index=94&type=section&id=PART%20IV) [Exhibits, Financial Statement Schedules](index=94&type=section&id=Item%2015.%20Exhibits,%20Financial%20Statement%20Schedules) This section lists the exhibits filed as part of the Form 10-K, including corporate governance documents, material contracts, and certifications, with consolidated financial statements included and all schedules omitted as not applicable - The consolidated financial statements are included with the report[520](index=520&type=chunk) - All financial statement schedules have been omitted because they are not applicable or required[521](index=521&type=chunk) [Form 10-K Summary](index=99&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports no summary for this item - None[529](index=529&type=chunk)
Summit Therapeutics (SMMT) - 2022 Q3 - Quarterly Report
2022-11-09 21:20
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 ...
Summit Therapeutics (SMMT) - 2022 Q2 - Quarterly Report
2022-08-11 20:09
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 ...
Summit Therapeutics (SMMT) - 2022 Q1 - Quarterly Report
2022-05-11 20:50
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 ...
Summit Therapeutics (SMMT) - 2021 Q4 - Annual Report
2022-03-17 21:15
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 ...
Summit Therapeutics (SMMT) - 2021 Q3 - Quarterly Report
2021-11-15 13:46
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 ...
Summit Therapeutics (SMMT) - 2021 Q2 - Quarterly Report
2021-08-12 20:16
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)
Summit Therapeutics (SMMT) - 2021 Q1 - Quarterly Report
2021-05-17 20:08
[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)