Tango Therapeutics(TNGX) - 2023 Q4 - Annual Report

PART I Item 1. Business Tango Therapeutics is a precision oncology company developing drugs that target tumor suppressor gene loss - Tango Therapeutics focuses on discovering and developing precision medicines targeting tumor suppressor gene loss in cancer patients using a synthetic lethality approach[26] - The company has four product candidates in Phase 1/2 clinical trials: TNG908, TNG462, TNG260, and TNG348[27][28][29] - A key strategic collaboration exists with Gilead Sciences, focused on identifying and developing novel immune evasion targets[31][103] Our Pipeline and Strategy The company advances four clinical-stage candidates and discovers new synthetic lethal targets via collaborations Tango Therapeutics Product Pipeline | Program | Target | Indication | Development Stage | | :--- | :--- | :--- | :--- | | TNG908 | PRMT5 | MTAP-del Cancers (incl. GBM) | Phase 1/2 | | TNG462 | PRMT5 | MTAP-del Cancers (excl. GBM) | Phase 1/2 | | TNG260 | CoREST | STK11-mutant Cancers | Phase 1/2 | | TNG348 | USP1 | BRCA1/2-mutant & HRD+ Cancers | Phase 1/2 | | Gilead Collaboration | Multiple | Immune Evasion | Discovery/Preclinical | - Core strategic components include advancing the four lead clinical programs, discovering next-generation synthetic lethal targets, and maximizing the value of strategic collaborations[34][38] Our Programs The clinical portfolio includes four targeted therapies in Phase 1/2 trials for genetically defined cancers - TNG908 and TNG462 are potent, selective, oral small molecule MTA-cooperative inhibitors of PRMT5, designed to be synthetic lethal with MTAP deletion, a genetic alteration present in 10-15% of all human tumors[41][43] - TNG260 is a CoREST inhibitor developed to reverse immune evasion in STK11-mutant cancers and is being tested in combination with pembrolizumab[79][80] - TNG348 is a novel allosteric inhibitor of USP1 for treating BRCA-mutant and other HRD+ cancers, showing preclinical synergy with PARP inhibitors[90] Collaboration and License Agreements The company maintains a key collaboration with Gilead for immune evasion targets and a license agreement with Medivir for its USP1 program - The collaboration with Gilead leverages Tango's platform to identify up to 15 immune evasion targets, with $175 million in upfront payments received and potential for over $410 million per program in milestones[103][104] - Tango retains rights to all cell-autonomous targets, and its lead programs are outside the scope of the Gilead collaboration[107] - The company licensed its USP1 program from Medivir AB and is obligated to pay up to approximately $32.1 million in potential milestones plus royalties[108][109] Manufacturing, Intellectual Property, and Government Regulation Tango relies on third-party CDMOs for manufacturing, protects its assets with a growing patent portfolio, and is subject to extensive FDA regulation - The company does not own manufacturing facilities and relies on third-party CDMOs, with a single source for its clinical trial drug substance[112] - Tango owns multiple patent families covering its lead candidates, with expected expirations extending into the 2040s[116][118][120] - The FDA has granted Fast Track designation to all four clinical candidates and Orphan Drug Designation to TNG908 and TNG462 for specific indications[121][142][144] Competition and Human Capital The company faces direct competition for its key programs and employed 140 full-time staff as of year-end 2023 - Direct competition for PRMT5 inhibitors TNG908 and TNG462 comes from clinical-stage programs at Bristol Myers Squibb, Amgen, and AstraZeneca[192] - The USP1 inhibitor TNG348 faces competition from clinical programs at Roche and Exelixis[195] - As of December 31, 2023, Tango had 140 full-time employees, with 104 in R&D and 36 in G&A functions[200] Item 1A. Risk Factors The company faces risks from its limited operating history, net losses, funding needs, and reliance on third parties - The company has a limited operating history, has incurred significant net losses since inception ($371.3 million accumulated deficit as of Dec 31, 2023), and expects to continue incurring losses[211][212] - Substantial additional funding will be required to continue operations, and failure to raise capital could force program delays or elimination[220] - The company relies on a limited number of third parties for manufacturing, including a sole source for the active pharmaceutical ingredient (API), which increases supply chain risk[308][314] - The company faces direct competition for its PRMT5 inhibitor programs from Bristol Myers Squibb, Amgen, and AstraZeneca[280] Item 1B. Unresolved Staff Comments The company reports that there are no unresolved staff comments - Not Applicable[450] Item 1C. Cybersecurity The company's cybersecurity program is based on the NIST framework and is overseen by the Audit Committee - The cybersecurity risk management program is based on the National Institute of Standards and Technology (NIST) Cybersecurity Framework[451] - Oversight of cybersecurity is delegated to the Audit Committee of the Board of Directors, with day-to-day management led by the Head of IT[454] - The program includes annual penetration testing, monitoring of critical risks, assessment of third-party vendor practices, and employee awareness training[452] Item 2. Properties The company leases approximately 64,805 square feet of office and laboratory space in Boston, Massachusetts - The company leases approximately 64,805 square feet of office and laboratory space for its corporate headquarters at 201 Brookline Avenue, Boston, Massachusetts[456] - The lease for this facility expires on January 31, 2033[456] Item 3. Legal Proceedings The company is not currently a party to any material legal proceedings - The company is not currently a party to any litigation or legal proceedings expected to have a material adverse effect on the business[457] Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable[458] PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on Nasdaq under 'TNGX', and it has never paid cash dividends - The company's common stock is traded on The Nasdaq Global Market under the symbol 'TNGX'[461] - The company has never declared or paid cash dividends and does not expect to in the foreseeable future, intending to retain earnings for business growth[463] Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations FY2023 revenue grew to $36.5 million, net loss narrowed, and cash reserves are expected to fund operations into late 2026 Results of Operations (2023 vs. 2022) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Total Revenue | $36,527 | $24,860 | $11,667 | | Collaboration Revenue | $31,527 | $24,860 | $6,667 | | License Revenue | $5,000 | $— | $5,000 | | Total Operating Expenses | $150,700 | $135,931 | $14,769 | | Research and Development | $115,198 | $105,906 | $9,292 | | General and Administrative | $35,502 | $30,025 | $5,477 | | Loss from Operations | ($114,173) | ($111,071) | ($3,102) | | Net Loss | ($101,744) | ($108,176) | $6,432 | - The company believes its cash, cash equivalents, and marketable securities of $336.9 million as of December 31, 2023, plus recent financing, will fund operations at least into late 2026[477][511] - Research and development expenses increased by $9.3 million in 2023, primarily due to higher personnel-related costs and facility expenses[505] - In August 2023, the company raised $79.8 million in net proceeds from a private placement of common stock and pre-funded warrants[480] Item 7A. Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk is interest rate fluctuations affecting its cash and investment portfolio - The company's main market risk is interest rate risk on its $336.9 million portfolio of cash, cash equivalents, and marketable securities[544] - Due to the short-term duration and low-risk profile of its investments, a 1% change in interest rates would not have a material effect on the portfolio's fair market value[544] - The company does not have significant exposure to foreign currency exchange risk and has not seen a significant impact from inflation[545][547] Item 8. Financial Statements and Supplementary Data This section references the company's consolidated financial statements, which begin on page F-1 - The consolidated financial statements and the independent auditor's report are included in the report, beginning on page F-1[548] Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants - None[549] Item 9A. Controls and Procedures Management concluded that the company's disclosure controls and internal control over financial reporting were effective - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[550] - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023, based on the COSO framework[552] - No material changes to internal control over financial reporting occurred during the quarter ended December 31, 2023[551] Item 9B. Other Information A director adopted a Rule 10b5-1 trading plan during the fourth quarter of 2023 - On November 6, 2023, Director Lesley Ann Calhoun adopted a Rule 10b5-1 trading arrangement for the sale of up to 20,000 shares, effective through November 1, 2024[554] Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to the company - Not applicable[556] PART III Items 10-14 Information for these items will be incorporated by reference from the company's 2024 proxy statement - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the forthcoming 2024 proxy statement[558][561][562] PART IV Item 15. Exhibits, Financial Statement Schedules This section provides an index of financial statements and exhibits filed with the Form 10-K - This section references the Index to the Consolidated Financial Statements, which begin on page F-1[566] - An Exhibit Index is provided, listing all required exhibits filed with the report, such as corporate governance documents and material agreements[568][570] Item 16. Form 10-K Summary This item is not applicable to the company - Not applicable[572] Financial Statements Consolidated Financial Statements The company reported a net loss of $101.7 million in FY2023 and ended the year with $336.9 million in cash and equivalents Consolidated Balance Sheet Data | (in thousands) | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $66,385 | $59,968 | | Marketable securities | $270,500 | $306,165 | | Total Assets | $402,567 | $436,470 | | Deferred revenue (current & non-current) | $92,353 | $123,880 | | Total Liabilities | $149,459 | $186,994 | | Total Stockholders' Equity | $253,108 | $249,476 | Consolidated Statement of Operations Data | (in thousands) | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Total Revenue | $36,527 | $24,860 | | Research and development | $115,198 | $105,906 | | General and administrative | $35,502 | $30,025 | | Loss from operations | ($114,173) | ($111,071) | | Net loss | ($101,744) | ($108,176) | | Net loss per share | ($1.08) | ($1.23) | Consolidated Statement of Cash Flows Data | (in thousands) | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($117,982) | ($109,080) | | Net cash provided by investing activities | $41,426 | $26,399 | | Net cash provided by financing activities | $82,406 | $1,615 | | Net change in cash, cash equivalents and restricted cash | $5,850 | ($81,066) | Notes to Consolidated Financial Statements The notes detail accounting policies for revenue recognition, leases, stock compensation, and deferred tax assets - Revenue from the Gilead collaboration is recognized over time using a cost-to-cost input method; as of Dec 31, 2023, the company had $92.4 million in deferred revenue[628][668] - The company's operating lease for its Boston headquarters has total future minimum lease payments of $55.5 million[517][684] - As of Dec 31, 2023, the company had $37.6 million of total unrecognized compensation expense related to stock options and RSUs[704][707] - The company maintains a full valuation allowance against its net deferred tax assets of $113.4 million due to its history of cumulative net losses[711][715]