Tango Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Highlights

-- TNG462 granted Orphan Drug Designation for treatment of pancreatic cancer --

-- Investigational New Drug $(IND.AU)$ application for TNG456, a next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor, cleared by FDA. Phase 1/2 enrollment expected to begin 1H 2025 --

-- Clinical collaboration with Eli Lilly to evaluate TNG456 in combination with CDK4/6 inhibitor Verzenio$(R)$ (abemaciclib) established --

-- Data update from ongoing TNG462 monotherapy trial expected in 2025 with focus on pancreatic and lung cancer --

-- Cash position of $258 million as of December 31, 2024, with cash runway expected to fund operations into 3Q 2026 --

BOSTON, Feb. 27, 2025 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. $(TNGX)$, a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided business highlights.

"We are starting 2025 with momentum in TNG462, our lead PRMT5 program, with fulsome data focused on pancreatic and lung cancer expected before the end of the year," said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. "PRMT5 is a clinically well-validated target, and we believe that TNG462 and TNG456 are both potentially best-in-class oral small molecules for multiple MTAP-deleted cancers. We expect that the TNG462 data we plan to disclose in 2025 will provide meaningful differentiation and solidify our clinical development plan, with a goal of initiating our first TNG462 monotherapy registrational study in pancreatic cancer next year."

Pipeline Update

TNG462, a potentially best-in-class MTA-cooperative PRMT5 inhibitor

   -- The U.S. Food and Drug Administration (FDA) granted Orphan Drug 
      Designation $(ODD)$ to TNG462 in November 2024 for the treatment of 
      pancreatic cancer. ODD is granted to investigational therapies addressing 
      medical diseases or conditions that affect fewer than 200,000 people per 
      year in the United States. This designation provides for a seven-year 
      marketing exclusivity period upon regulatory approval, as well as certain 
      incentives, including federal grants and tax credits. 
   -- Patients are being enrolled in the TNG462 monotherapy Phase 1/2 clinical 
      trial, with an emphasis on patients with pancreatic and lung cancers. 
   -- In November 2024, the Company reported positive early data for TNG462, 
      demonstrating durable clinical responses across multiple cancer types, 
      including RECIST partial responses in pancreatic and lung cancer, with a 
      safety and tolerability profile that the Company believes is superior to 
      competitors. Additional clinical data are expected in 2025 with a focus 
      on pancreatic and lung cancer. 
   -- Based on these promising early clinical data, the Company plans to 
      initiate multiple targeted and standard of care combination studies with 
      TNG462, including with daraxonrasib (RMC-6236), a RAS$(ON)$ multi-selective 
      inhibitor and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor 
      (Revolution Medicines) and pembrolizumab. These trials are expected to 
      begin enrolling in the first half of 2025. 

TNG456, a next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor

   -- In January 2025, the FDA cleared the TNG456 IND. Preclinical studies 
      suggest that TNG456 will have improved activity to treat glioblastoma 
      compared to TNG908 based on increased exposure in the brain afforded by 
      the increased potency and MTAP-selectivity. The Company expects to begin 
      enrolling patients in a phase 1/2 trial in 1H 2025. 
   -- In the fourth quarter of 2024, the Company entered into a clinical 
      collaboration with Eli Lilly and Company (Lilly) for the supply of the 
      CDK4/6 inhibitor abemaciclib for use in combination with TNG456 for 
      treatment of patients with MTAP-deleted solid tumors, with a focus on 
      glioblastoma. The agreement provides that Lilly will supply abemaciclib 
      at no cost to Tango and that Tango will be the sponsor of the combination 
      trials. Each company will retain commercial rights to their respective 
      compounds and the agreement is mutually non-exclusive. 
   -- In February 2025, the FDA granted Fast Track Designation (FTD) to TNG456 
      for the treatment of solid tumors with MTAP deletion, as well as TNG456 
      in combination with abemaciclib for the treatment of NSCLC with MTAP 
      deletion. FTD is designed to facilitate the development and expedite the 
      review of drugs to treat serious conditions and fulfill an unmet medical 
      need, with the potential to allow important new drugs to reach patients 
      earlier. 

TNG260, a first-in-class, highly selective CoREST complex inhibitor

   -- Proof-of-mechanism has been established for TNG260 based on 
      pharmacodynamic data from on-treatment patient biopsies, with favorable 
      safety, tolerability and pharmacokinetic profiles shown at the expansion 
      dose of 80 mg QD to date. 
   -- The dose expansion phase of the TNG260 phase 1/2 trial is ongoing in lung 
      cancer. The study is evaluating the pharmacokinetics, pharmacodynamics, 
      safety and efficacy of TNG260 in combination with pembrolizumab in 
      patients with an STK11 loss-of-function mutation. 
   -- The Company plans to provide a clinical update on TNG260 in 2025. 

Upcoming Milestones

   -- TNG462 clinical data update expected in 2025 
 
   -- Enrollment in multiple TNG462 combination trials expected to begin 2025 
 
   -- TNG456 phase 1/2 trial enrollment expected to begin 1H 2025 
 
   -- TNG260 clinical data update expected in 2025 

Financial Results

As of December 31, 2024, the Company held $257.9 million in cash, cash equivalents and marketable securities, which the Company expects to be sufficient to fund operations into the third quarter of 2026.

Collaboration revenue was $4.1 million for the three months ended December 31, 2024, compared to $5.4 million for the same period in 2023, and $30.0 million for the twelve months ended December 31, 2024 compared to $31.5 million for the same period in 2023. Collaboration revenue decreased due to lower research costs incurred under the collaboration during the three and twelve months ended December 31, 2024.

License revenue was $0 and $12.1 million for the three and twelve months ended December 31, 2024, respectively, compared to $0 and $5.0 million for the three and twelve months ended December 31, 2023, respectively. The year-to-date increase is primarily due to licensing a drug discovery program to Gilead for $12.0 million during the second quarter of 2024 as compared to Gilead licensing an earlier stage program for $5.0 million during the year ended December 31, 2023.

Research and development expenses were $33.9 million for the three months ended December 31, 2024, compared to $31.3 million for the same period in 2023, and $143.9 million for the twelve months ended December 31, 2024 compared to $115.2 million for the same period in 2023. The increase is due to the advancement of TNG462 and TNG456 and personnel-related costs to support our research and development activities.

General and administrative expenses were $11.1 million for the three months ended December 31, 2024, compared to $9.1 million for the same period in 2023, and $43.7 million for the twelve months ended December 31, 2024 compared to $35.5 million for the same period in 2023. The changes were primarily due to increases in personnel-related costs.

Net loss for the three months ended December 31, 2024 was $37.7 million, or $0.35 per share, compared to a net loss of $30.8 million, or $0.32 per share, in the same period in 2023. Net loss for the twelve months ended December 31, 2024 was $130.3 million, or $1.19 per share, compared to a net loss of $101.7 million, or $1.08 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. 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 advancing TNG462 into clinical trials as a monotherapy and with multiple targeted and standard of care combinations, including with a RAS(ON) multi-selective inhibitor and a RAS(ON) G12-selective inhibitors from Revolution Medicines, Inc.; potential combination strategies for PRMT5 inhibitors; the Company's view that TNG462 and TNG456 have the potential to be a best-in-class small molecules in multiple tumor types, including pancreatic and lung cancers; the Company's plans to release TNG462 data in 2025, solidify its clinical development plan, and initiate

(MORE TO FOLLOW) Dow Jones Newswires

February 27, 2025 07:00 ET (12:00 GMT)