iTeos Therapeutics(ITOS)

Search documents
iTeos Therapeutics(ITOS) - 2021 Q2 - Earnings Call Transcript
2021-08-13 06:54
iTeos Therapeutics Inc. (NASDAQ:ITOS) Q2 2021 Earnings Conference Call August 12, 2021 8:00 AM ET Company Participants Ryan Baker – Head-Investor Relations Michel Detheux – President and Chief Executive Officer Matthew Gall – Chief Financial Officer Joe Lager – Chief Medical Officer Conference Call Participants Chris Raymond – Piper Sandler Daina Graybosch – SVB Leerink Swayampakula Ramakanth – H.C. Wainwright Anupam Rama – JP Morgan Operator Good morning and welcome to the iTeos Therapeutics’ Second Quarte ...
iTeos Therapeutics(ITOS) - 2021 Q2 - Quarterly Report
2021-08-11 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 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: 001-39401 iTeos Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Dela ...
iTeos Therapeutics(ITOS) - 2021 Q1 - Earnings Call Transcript
2021-05-14 23:07
iTeos Therapeutics, Inc. (NASDAQ:ITOS) Q1 2021 Earnings Conference Call May 13, 2021 4:30 PM ET Company Participants Ryan Baker – Head of Investor Relations Michel Detheux – President and Chief Executive Officer Joe Lager – Chief Medical Officer Matthew Gall – Chief Financial Officer Conference Call Participants Chris Raymond – Piper Sandler Daina Graybosch – SVB Leerink Anupam Rama – JP Morgan Arthur He – HC Wainwright David Nierengarten – Wedbush Securities Operator Good afternoon and welcome to the iTeos ...
iTeos Therapeutics(ITOS) - 2021 Q1 - Quarterly Report
2021-05-13 20:24
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 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: 001-39401 iTeos Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Del ...
iTeos Therapeutics(ITOS) - 2020 Q4 - Annual Report
2021-03-24 21:15
Part I [Business](index=8&type=section&id=Item%201.%20Business) iTeos Therapeutics is a clinical-stage biopharmaceutical company developing immuno-oncology therapeutics with lead candidates inupadenant and EOS-448, leveraging tumor microenvironment expertise and retaining worldwide rights - The company is a clinical-stage biopharmaceutical firm specializing in differentiated immuno-oncology therapeutics designed to improve clinical benefits by targeting the tumor microenvironment[29](index=29&type=chunk) - The pipeline features two main clinical-stage programs: inupadenant (an A2AR antagonist) and EOS-448 (a TIGIT antagonist), both targeting novel immuno-oncology pathways[29](index=29&type=chunk) - iTeos retains worldwide rights to develop and commercialize all of its product candidates and plans to nominate an additional product candidate for IND-enabling studies by the end of 2021[29](index=29&type=chunk) [Overview and Pipeline](index=8&type=section&id=Overview%20and%20Pipeline) iTeos is a clinical-stage biopharmaceutical company with lead candidates inupadenant and EOS-448 in Phase 1/2a trials for solid tumors, holding worldwide rights and planning new IND-enabling studies - The most advanced product candidate, inupadenant, is a selective small molecule antagonist of the A2AR, currently in a Phase 1/2a clinical trial for advanced solid tumors[29](index=29&type=chunk) - The lead antibody product candidate, EOS-448, is an antagonist of TIGIT and is also being evaluated in a Phase 1/2a clinical trial for advanced solid tumors, with initial data expected in April 2021[29](index=29&type=chunk) - The company plans to nominate an additional product candidate for Investigational New Drug (IND) enabling studies before the end of 2021[29](index=29&type=chunk) [Strategy](index=10&type=section&id=Strategy) The company's strategy involves advancing lead candidates inupadenant and EOS-448 through clinical development, expanding the pipeline with new candidates, and pursuing strategic collaborations while retaining worldwide commercial rights - Advance lead product candidate, inupadenant, through clinical development as a single agent and in combination with standard cancer treatments like pembrolizumab and chemotherapy[38](index=38&type=chunk) - Advance EOS-448, an FcγR engaging anti-TIGIT antibody, through clinical development, evaluating it in multiple solid tumors and hematological malignancies in combination with existing therapies[38](index=38&type=chunk) - Leverage deep understanding of immune pathways to identify novel product candidates, with plans to advance an additional candidate into IND-enabling studies in 2021[43](index=43&type=chunk) - Selectively enter into strategic collaborations to maximize the value of product candidates while retaining worldwide development and commercial rights[43](index=43&type=chunk) [Inupadenant (A2AR Antagonist Program)](index=12&type=section&id=Inupadenant%20(A2AR%20Antagonist%20Program)) Inupadenant, a selective A2AR antagonist, showed preliminary clinical benefit and good tolerability in a Phase 1/2a trial, with ongoing development in monotherapy and combination settings - Inupadenant is engineered to be a highly selective and potent A2AR antagonist that maintains efficacy at high adenosine concentrations found in tumors and is designed not to cross the blood-brain barrier, minimizing potential CNS side effects[58](index=58&type=chunk)[59](index=59&type=chunk)[63](index=63&type=chunk) - In the dose escalation part of the Phase 1/2a trial, inupadenant showed preliminary clinical benefit in **7 of 21 heavily pre-treated patients**, including **two confirmed partial responses** in patients with CPI-refractory metastatic melanoma and metastatic castration-resistant prostate cancer (CRPC)[74](index=74&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) - The recommended Phase 2 dose for monotherapy is **80 mg BID**, which provided continuous inhibition of A2AR. A new formulation is expected to be available for a clinical bridging study in Q2 2021[71](index=71&type=chunk)[82](index=82&type=chunk) - As of July 7, 2020, inupadenant was generally well-tolerated with no dose-limiting toxicities observed in the dose-finding portion of the trial and one possibly drug-related serious adverse event of pericardial effusion[83](index=83&type=chunk) [EOS-448 (Anti-TIGIT Antibody Program)](index=24&type=section&id=EOS-448%20(Anti-TIGIT%20Antibody%20Program)) EOS-448, a fully human IgG1 anti-TIGIT antibody, is designed to restore immune responses through FcγR engagement, showing potent preclinical antitumor activity and currently in a Phase 1/2a clinical trial - EOS-448 is an anti-TIGIT antibody designed to restore immune responses by blocking TIGIT and engaging FcγR, which can lead to the depletion of immunosuppressive Tregs and exhausted T cells within the tumor microenvironment[89](index=89&type=chunk)[98](index=98&type=chunk)[108](index=108&type=chunk) - Preclinical studies showed that FcγR binding is crucial for the antibody's antitumor activity, as it increases IFNγ-producing CD8+ T cells and decreases Tregs within the tumor[113](index=113&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk) - A Phase 1/2a clinical trial of EOS-448 in adult patients with refractory solid tumors is currently underway, with plans to share preliminary results at the 2021 AACR Annual Meeting in April[122](index=122&type=chunk) - Future development plans include evaluating EOS-448 in combination with pembrolizumab, inupadenant, and an IMID in multiple myeloma[123](index=123&type=chunk) [Collaborations, Competition, and Manufacturing](index=34&type=section&id=Collaborations%2C%20Competition%2C%20and%20Manufacturing) The company collaborates with Adimab for antibody discovery and WuXi Biologics for manufacturing, faces significant competition in A2AR and anti-TIGIT programs, and relies solely on third-party CDMOs - Entered into a collaboration with Adimab for antibody discovery, which includes potential milestone payments up to **$42.8 million** for the first three products and low to mid-single-digit royalties. EOS-448 was licensed under this agreement[126](index=126&type=chunk)[128](index=128&type=chunk) - A manufacturing agreement with WuXi Biologics for EOS-448 stipulates a low single-digit royalty or a one-time milestone payment in the low tens of millions if a different commercial manufacturer is used[132](index=132&type=chunk)[133](index=133&type=chunk) - Faces competition from major pharmaceutical companies developing A2AR antagonists (AstraZeneca, Corvus, Arcus) and anti-TIGIT antibodies (Roche/Genentech, Merck, Bristol-Myers Squibb)[136](index=136&type=chunk)[137](index=137&type=chunk) - The company relies on third-party contract development and manufacturing organizations (CDMOs) for all preclinical, clinical, and potential commercial manufacturing, with no current plans to own or operate its own facilities[142](index=142&type=chunk) [Intellectual Property and Government Regulation](index=36&type=section&id=Intellectual%20Property%20and%20Government%20Regulation) iTeos' A2AR and anti-TIGIT programs are protected by patent families expiring up to 2040, and the company is subject to extensive FDA and international regulations covering all stages of product development and commercialization - The A2AR program (inupadenant) is protected by **six patent families** with statutory expirations up to March **2038** and September **2039**[147](index=147&type=chunk) - The anti-TIGIT antibody program (EOS-448) is protected by **two patent families** with statutory expirations up to July **2038** and January **2040**[149](index=149&type=chunk) - Product candidates are subject to extensive regulation by the FDA and other authorities, requiring a rigorous process of preclinical studies, IND submission, multi-phase clinical trials (Phase 1, 2, 3), and eventual submission of an NDA or BLA for marketing approval[150](index=150&type=chunk)[152](index=152&type=chunk)[161](index=161&type=chunk) - The company may utilize FDA's expedited programs such as Fast Track and Breakthrough Therapy designation to accelerate development and review of its product candidates for serious conditions[174](index=174&type=chunk)[175](index=175&type=chunk)[176](index=176&type=chunk) [Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including clinical trial failures, regulatory unpredictability, reliance on third parties, intense competition, funding needs, intellectual property challenges, and COVID-19 impacts - The company's success is heavily dependent on the outcomes of clinical trials for its product candidates, which may fail to demonstrate required safety and efficacy, potentially preventing commercialization[255](index=255&type=chunk) - iTeos relies on third parties for conducting clinical trials and manufacturing product candidates, exposing it to risks of delays, increased costs, and regulatory non-compliance if these partners fail to perform[390](index=390&type=chunk)[402](index=402&type=chunk) - The company faces significant competition from well-resourced biopharmaceutical companies, which may develop safer, more effective, or more rapidly approved products[283](index=283&type=chunk) - Substantial additional financing is required to achieve goals, and failure to obtain necessary capital could force delays, reductions, or termination of development and commercialization efforts[427](index=427&type=chunk) - The ongoing COVID-19 pandemic poses risks to operations, including potential delays in clinical trial enrollment, manufacturing disruptions, and negative impacts on the ability to raise capital[459](index=459&type=chunk)[461](index=461&type=chunk) [Properties](index=114&type=section&id=Item%202.%20Properties) The company leases its principal office in Cambridge, MA, and a larger laboratory and office facility in Charleroi, Belgium, with leases extending to 2022 and 2030 respectively - The company leases its principal office of approximately **2,479 sq. ft.** in Cambridge, MA, with the lease expiring on May 31, 2022[551](index=551&type=chunk) - Its Belgian subsidiary leases a **1,577 sq. meter** facility for lab and office space, and in January 2021, this lease was extended through January 2030 with an expansion of **201 sq. meters**[551](index=551&type=chunk)[553](index=553&type=chunk) [Legal Proceedings](index=115&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, and management anticipates no adverse effects from ordinary course matters - The company is not currently a party to any material legal proceedings[554](index=554&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=116&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 began trading on Nasdaq in July 2020, has not paid dividends, and raised approximately **$210.6 million** in net IPO proceeds - Common stock has been publicly traded on the Nasdaq Global Select Market under the symbol **"ITOS"** since July 24, 2020[558](index=558&type=chunk) - The company has not declared or paid any cash dividends and intends to retain future earnings to finance operations[560](index=560&type=chunk) - The company closed its IPO on July 28, 2020, and with the underwriters' option exercise, received aggregate net proceeds of approximately **$210.6 million**[566](index=566&type=chunk)[569](index=569&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=118&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) As a clinical-stage biopharmaceutical company, iTeos reported a **$38.0 million** net loss in 2020 due to increased R&D and G&A expenses, holding **$336.3 million** in cash expected to fund operations into late 2023 Selected Financial Highlights (in thousands) | (in thousands) | 2020 | 2019 | |---|---|---| | Research and development expenses | $29,900 | $19,211 | | General and administrative expenses | $15,340 | $8,837 | | Loss from operations | $(45,240) | $(28,048) | | Net loss | $(38,033) | $(22,454) | - Research and development expenses increased by **$10.7 million** in 2020, primarily due to increased activities for the inupadenant and EOS-448 clinical trials[605](index=605&type=chunk) - General and administrative expenses increased by **$6.5 million** in 2020, mainly due to higher payroll, stock-based compensation, and D&O insurance costs associated with becoming a public company[607](index=607&type=chunk)[608](index=608&type=chunk) - As of December 31, 2020, the company had **$336.3 million** in cash and cash equivalents, which is expected to fund operations into the second half of 2023[578](index=578&type=chunk)[623](index=623&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=131&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from interest rate and foreign currency fluctuations, primarily the euro, but expects no material impact from a 5% euro exchange rate change due to short-term cash holdings - The company's primary market risk exposures are interest rate sensitivity and foreign currency exchange rate fluctuations, specifically with the euro[650](index=650&type=chunk)[651](index=651&type=chunk) - Due to the short-term nature of its cash and cash equivalents (**$336.3 million** as of Dec 31, 2020), a **10%** change in interest rates is not expected to have a material impact[650](index=650&type=chunk) [Financial Statements and Supplementary Data](index=132&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The company's audited consolidated financial statements for 2020 and 2019 are included, showing **$344.6 million** in total assets, **$21.4 million** in total liabilities, and a **$38.0 million** net loss in 2020 Consolidated Balance Sheet Highlights (as of Dec 31, 2020) | (in thousands) | Amount | |---|---| | **Assets** | | | Cash and cash equivalents | $336,326 | | Total current assets | $339,544 | | Total assets | $344,558 | | **Liabilities & Equity** | | | Total current liabilities | $14,998 | | Total liabilities | $21,361 | | Total stockholders' equity | $323,197 | Consolidated Statement of Operations Highlights (Year ended Dec 31, 2020) | (in thousands) | Amount | |---|---| | Total operating expenses | $45,240 | | Loss from operations | $(45,240) | | Net loss | $(38,033) | [Controls and Procedures](index=132&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls were effective as of December 31, 2020, with no material changes to internal controls reported for the quarter - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2020[656](index=656&type=chunk) - As a newly public company, this report does not include a management's assessment of internal control over financial reporting[657](index=657&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=134&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's leadership includes key executives and an eight-member board of directors, divided into staggered classes with established committees, where all directors except the CEO are independent - Key executive officers include Michel Detheux, Ph.D. (CEO), Matthew Call (COO), Matthew Gall (CFO), and Joanne Jenkins Lager, M.D. (CMO)[664](index=664&type=chunk) - The Board of Directors consists of **eight members**, is chaired by David L. Hallal, and is divided into **three staggered classes** with terms expiring in 2021, 2022, and 2023[664](index=664&type=chunk)[684](index=684&type=chunk)[690](index=690&type=chunk) - The board has determined that all directors are independent, with the exception of CEO Michel Detheux[772](index=772&type=chunk) [Executive Compensation](index=137&type=section&id=Item%2011.%20Executive%20Compensation) The 2020 executive compensation included base salary, performance bonuses, and equity awards, with CEO Michel Detheux's total compensation reaching **$16.8 million**, primarily from a **$16.0 million** option award 2020 Named Executive Officer Compensation | Name | Position | Salary ($) | Option Awards ($) | Non-Equity Incentive Plan ($) | Total ($) | |---|---|---|---|---|---| | Michel Detheux, Ph.D. | CEO | 462,500 | 15,982,781 | 242,500 | 16,816,531 | | Joanne Jenkins Lager, M.D. | CMO | 432,500 | 600,438 | 176,000 | 1,305,998 | | Matthew Gall | CFO | 225,759 | 1,449,000 | 160,000 | 1,916,259 | - In 2020, base salaries were adjusted to **$485,000** for the CEO, **$440,000** for the CMO, and set at **$400,000** for the new CFO[701](index=701&type=chunk) - Named executive officers were eligible for and achieved their target bonuses (**50%** of base salary for CEO, **40%** for others) plus an additional special IPO bonus equivalent to **50%** of their annual incentive bonus[702](index=702&type=chunk)[703](index=703&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=145&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 15, 2021, executive officers and directors collectively owned **4.16%** of common stock, while major institutional holders like MPM Capital (**17.27%**) and RA Capital (**12.59%**) held significant stakes Principal Stockholders (as of March 15, 2021) | Holder | Percentage Ownership | |---|---| | Entities Affiliated with MPM Capital | 17.27% | | Entities Affiliated with RA Capital | 12.59% | | Entities Affiliated with Boxer Capital | 12.59% | | RTW Investments, LP | 7.87% | | Funds advised by Janus Henderson Investors | 5.66% | | All executive officers and directors as a group | 4.16% | - As of March 15, 2021, executive officers, directors, and **5%** stockholders beneficially owned approximately **59.84%** of the company's outstanding voting stock[525](index=525&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=148&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company engaged in related party transactions, including **$125.4 million** in Series B-2 preferred stock sales and IPO participation by major stockholders, with the board adopting a related party policy and determining all directors except the CEO are independent - In March 2020, the company sold **$125.4 million** of Series B-2 preferred stock, with significant participation from related parties including entities affiliated with MPM Capital, RA Capital, and Boxer Capital[757](index=757&type=chunk) - Certain **5%** stockholders, including entities affiliated with Boxer Capital, RA Capital, and MPM Capital, purchased shares in the company's IPO[763](index=763&type=chunk)[764](index=764&type=chunk) - The board of directors has adopted a written policy for reviewing and approving related party transactions, overseen by the audit committee[770](index=770&type=chunk) [Principal Accounting Fees and Services](index=153&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Deloitte served as the independent auditor, with total fees increasing to approximately **$1.91 million** in 2020 from **$0.51 million** in 2019, primarily due to IPO-related audit services Auditor Fees (in thousands) | Fee Type | 2020 | 2019 | |---|---|---| | Audit fees | $1,693,414 | $11,057 | | Tax fees | $218,671 | $498,579 | | All other fees | $2,695 | $— | | **Total fees** | **$1,914,780** | **$509,636** | - The significant increase in audit fees in 2020 was due to services provided in connection with the company's IPO in July 2020[783](index=783&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=155&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section details exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and Sarbanes-Oxley Act certifications - This item lists all exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and required certifications[789](index=789&type=chunk)[791](index=791&type=chunk)
iTeos Therapeutics (ITOS) Investor Presentation - Slideshow
2021-03-08 19:32
Pioneering Novel IO Therapies Focused on Key Mechanisms of Immunosuppression March 2021 Disclaimer This Presentation has been prepared by iTeos Therapeutics, Inc. ("we," "us," our "our") and contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions rega ...
iTeos Therapeutics (ITOS) Investor Presentation - Slideshow
2021-03-03 21:38
Pioneering Novel IO Therapies Focused on Key Mechanisms of Immunosuppression JANUARY 2021 Disclaimer This Presentation has been prepared by iTeos Therapeutics, Inc. ("we," "us," our "our") and contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions re ...
iTeos Therapeutics(ITOS) - 2020 Q3 - Quarterly Report
2020-11-12 12:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 2020 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: 001-39401 iTeos Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) ...
iTeos Therapeutics(ITOS) - 2020 Q2 - Quarterly Report
2020-09-01 21:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 2020 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: 001-39401 iTeos Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Dela ...