TNG-462

BOSTON--( BUSINESS WIRE )--Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported its financial results for the second quarter ended June 30, 2024, and provided business highlights. “ In the second quarter, we continued to advance the dose expansion portions of the TNG908 and TNG462 phase 1/2 clinical trials. We are progressing these molecules with the intent of remaining a leader in developing PRMT5 inhibitors for multiple cancers. We look forward to sharing a comprehensive clinical data update for the PRMT5 program later this year,” said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. “ In addition, we continue to advance TNG260 for cancers with STK11 loss-of-function mutations and patient enrollment is ongoing in the phase 1/2 clinical trial.” Recent Business Highlights Pipeline Update TNG908, a blood-brain barrier penetrant, MTA-cooperative PRMT5 inhibitor Enrollment in the dose expansion portion of the TNG908 phase 1/2 clinical trial is ongoing. Expansion cohorts are being enrolled in MTAP-deleted solid tumors in glioblastoma (GBM), non-small cell lung and pancreatic cancers at 600 mg BID. MTAP deletions occur in approximately 10%-15% of all human cancers, including 40% of GBM. TNG462, a potentially best-in-class MTA-cooperative PRMT5 inhibitor The dose expansion portion of the TNG462 phase 1/2 clinical trial is ongoing. Two doses are being evaluated (200 mg QD and 300 mg QD) in non-small cell lung and pancreatic cancer, as well as a histology-agnostic cohort enriched for cholangiocarcinoma, mesothelioma, sarcoma and bladder cancers. TNG260, a first-in-class, highly selective CoREST complex inhibitor The TNG260 phase 1/2 clinical trial is ongoing, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of TNG260 in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors with an STK11 loss-of-function mutation. To date, safety, tolerability and pharmacokinetic profiles are favorable. STK11 mutations occur in approximately 15% of non-small cell lung, 15% of cervical, 10% of carcinoma of unknown primary, 5% of breast and 3% of pancreatic cancers. Business Highlights Gilead strategic collaboration In June, Gilead licensed a drug discovery program for a $12.0 million license fee. Upcoming Milestones A comprehensive update of the PRMT5 program, including clinical data from the ongoing phase 1/2 clinical trials of TNG908 and TNG462, is expected in 2H 2024. Financial Results As of June 30, 2024, the Company held $322.1 million in cash, cash equivalents and marketable securities, which the Company expects to be sufficient to fund operations into 2027. Collaboration revenue was $7.8 million for the three months ended June 30, 2024, compared to $9.6 million for the same period in 2023, and $14.2 million for the six months ended June 30, 2024 compared to $15.4 million for the same period in 2023. Research costs incurred under the collaboration were lower during the three months ended June 30, 2024 which resulted in lower collaboration revenue amounts recognized. License revenue was $12.1 million for the three and six months ended June 30, 2024, compared to $5.0 million for both the three and six months ended June 30, 2023. The increase is primarily due to licensing a drug discovery program to Gilead for $12.0 million during the second quarter of 2024. Research and development expenses were $38.7 million for the three months ended June 30, 2024, compared to $28.7 million for the same period in 2023, and $76.7 million for the six months ended June 30, 2024 compared to $56.7 million for the same period in 2023. The change is due to increased spend related to the advancement of our clinical and preclinical programs and personnel-related costs to support our research and development activities. General and administrative expenses were $10.8 million for the three months ended June 30, 2024, compared to $9.2 million for the same period in 2023, and $21.4 million for the six months ended June 30, 2024 compared to $17.2 million for the same period in 2023. The change was primarily due to increases in personnel-related costs. Net loss for the three months ended June 30, 2024 was $25.6 million, or $0.24 per share, compared to a net loss of $20.7 million, or $0.23 per share, in the same period in 2023. Net loss for the six months ended June 30, 2024 was $63.5 million, or $0.58 per share, compared to a net loss of $48.7 million, or $0.55 per share, in the same period in 2023. About Tango Therapeutics Tango Therapeutics is a clinical-stage biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. For more information, please visit www.tangotx.com . Forward-Looking Statements Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events, Tango’s future operating performance and goals, the anticipated benefits of therapies and combination therapies (that include a Tango pipeline product), as well as the expectations, beliefs and development objectives for Tango’s product pipeline and clinical trials. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “goal”, “estimate”, “anticipate”, “believe”, “predict”, “designed,” “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. For example, implicit or explicit statements concerning the following include or constitute forward-looking statements: the Company is progressing its molecules with the intent of remaining a leader in developing PRMT5 inhibitors for multiple cancers; the Company expects cash runway into 2027 and this cash runway is expected to fund all clinical programs through proof-of-concept; the Company is enrolling patients in the dose expansion portion of the TNG908 and TNG462 phase 1/2 clinical trials; the Company expects to share a comprehensive clinical data update on our PRMT5 program later this year; the Company continues to advance TNG260 for cancers with STK11 loss-of-function mutations, with patient enrollment ongoing in the phase 1/2 clinical trial; Tango is committed to discovering and delivering the next generation of precision cancer medicines; and the expected timing of: (i) development candidate declaration for certain targets; (ii) initiating IND-enabling studies; (iii) filing INDs; (iv) clinical trial initiation, dose escalation and dose expansion and (v) disclosing initial, interim, additional and final clinical trial results; and the expected benefits of the Company's development candidates and other product candidates. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Tango and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: benefits of product candidates seen in preclinical tests and analyses may not be evident when tested in later preclinical studies or in clinical trials or when used in broader patient populations (if approved for commercial sale); Tango has limited experience conducting clinical trials (and will rely on a third party to operate its clinical trials) and may not be able to commence the clinical trial (including opening clinical trial sites, dosing the first patient, and continued enrollment and dosing of an adequate number of clinical trial participants) when expected, may not be able to continue dosing, initiate dose escalation and/or dose expansion on anticipated timelines, and may not generate results (including final, initial or additional safety, efficacy data and proof-of-mechanism and proof-of-concept) in the anticipated timeframe (or at all); Tango’s pipeline products may not be safe and/or effective in humans; Tango has a limited operating history and has not generated any revenue to date from product sales, and may never become profitable; other companies may be able to identify and develop product candidates more quickly than the Company and commercially introduce the product prior to the Company; the Company’s proprietary discovery platform is novel and may not identify any synthetic lethal targets for future development; the Company may not be able to identify development candidates on the schedule it anticipates due to technical, financial or other reasons; the Company may not be able to file INDs for development candidates on time, or at all, due to technical or financial reasons or otherwise; the Company may utilize cash resources more quickly than anticipated; Tango will need to raise capital in the future and if we are unable to raise capital when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our development programs or future commercialization efforts (which may delay filing of INDs, dosing patients, initiation of dose expansion, reporting clinical trial results and filing new drug applications); Tango’s approach to the discovery and development of product candidates is novel and unproven, which makes it difficult to predict the time, cost of development, and likelihood of successfully developing any products; the Company may be unable to advance our preclinical development programs into and through the clinic for safety or efficacy reasons or commercialize our product candidates or we may experience significant delays in doing so as a result of factors beyond Tango’s control; the Company may not be able to realize the benefits of orphan drug or Fast Track designation (and such designations may not advance any anticipated approval timelines); Tango may not identify or discover additional product candidates or may expend limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success; the Company’s product candidates may cause adverse or other undesirable side effects (or may not show requisite efficacy) that could, among other things, delay or prevent regulatory approval; our dependence on one or a limited number third parties for conducting clinical trials and producing drug substance and drug product (including drug substance, which is currently sole sourced); government regulation may negatively impact the Company’s business, including the potential approval of the BIOSECURE Act; and our ability to obtain and maintain patent and other intellectual property protection for our technology and product candidates or the scope of intellectual property protection obtained is not sufficiently broad. Additional information concerning risks, uncertainties and assumptions can be found in Tango’s filings with the Securities and Exchange Commission (SEC), including the risk factors referenced in Tango’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as supplemented and/or modified by its most recent Quarterly Report on Form 10-Q. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Tango specifically disclaims any duty to update these forward-looking statements. Consolidated Statements of Operations (In thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Collaboration revenue $ 7,775 $ 9,598 $ 14,246 $ 15,364 License revenue 12,100 5,000 12,100 5,000 Total revenue 19,875 14,598 26,346 20,364 Operating expenses: Research and development 38,654 28,671 76,719 56,710 General and administrative 10,773 9,174 21,434 17,188 Total operating expenses 49,427 37,845 98,153 73,898 Loss from operations (29,552 ) (23,247 ) (71,807 ) (53,534 ) Other income, net 4,066 2,601 8,447 4,880 Loss before income taxes (25,486 ) (20,646 ) (63,360 ) (48,654 ) Provision for income taxes (65 ) (64 ) (105 ) (64 ) Net loss $ (25,551 ) $ (20,710 ) $ (63,465 ) $ (48,718 ) Net loss per common share – basic and diluted $ (0.24 ) $ (0.23 ) $ (0.58 ) $ (0.55 ) Weighted average number of common shares outstanding – basic and diluted 108,314,279 88,354,590 108,692,822 88,281,368 Consolidated Balance Sheets (In thousands) June 30, 2024 December 31, 2023 Assets Current assets: Cash and cash equivalents $ 51,566 $ 66,385 Marketable securities 270,545 270,500 Restricted cash — 856 Prepaid expenses and other current assets 6,299 8,797 Total current assets 328,410 346,538 Property and equipment, net 9,095 9,908 Operating lease right-of-use assets 41,371 43,508 Restricted cash, net of current portion 2,567 2,567 Other assets 10 46 Total assets $ 381,453 $ 402,567 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 1,062 $ 2,785 Accrued expenses and other current liabilities 16,774 15,401 Operating lease liabilities 2,364 2,082 Deferred revenue 23,668 25,670 Total current liabilities 43,868 45,938 Operating lease liabilities, net of current portion 35,473 36,838 Deferred revenue, net of current portion 54,439 66,683 Total liabilities 133,780 149,459 Total stockholders’ equity 247,673 253,108 Total liabilities and stockholders’ equity $ 381,453 $ 402,567