On February 27, 2025 Tango Therapeutics, Inc. (NASDAQ: 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.
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"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.
(Press release, Tango Therapeutics, FEB 27, 2025, View Source [SID1234662364])