Press Release: Tango Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Highlights

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Tango Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Highlights

-- Positive TNG462 clinical activity across multiple tumor types in the phase 1/2 clinical trial, program moving into full development with multiple combination studies --

-- Clinical collaboration established with Revolution Medicines to evaluate TNG462 in combination with RAS$(ON)$ multi- and G12D-selective inhibitors --

-- Next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor, TNG456, planned to enter the clinic in 1H 2025 --

-- Strong cash position of $293 million as of September 30, 2024, with cash runway into 3Q 2026 to prioritize resourcing of TNG462 and TNG456 clinical trials --

BOSTON--(BUSINESS WIRE)--November 06, 2024-- 

Tango Therapeutics, Inc. $(TNGX)$, a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported its financial results for the third quarter ended September 30, 2024, and provided business highlights.

"We have made great progress with our PRMT5 development program, including positive data from the TNG462 phase 1/2 clinical trial that showcase the best-in-class potential of TNG462 in multiple tumor types, including pancreatic and non-small cell lung cancers (NSCLC). Based on these early data, we are advancing TNG462 into trials with multiple targeted and standard of care combinations, including two RAS(ON) tri-complex inhibitors from Revolution Medicines. Given that nearly all MTAP-deleted pancreatic cancer has a co-occurring RAS mutation, we believe this could be a powerful approach to changing the treatment landscape for this challenging cancer," said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. "As part of the expanded capabilities needed to rapidly move TNG462 development forward, Dr. Maeve Waldron-Lynch, M.D. is joining Tango as Senior Vice President, Head of Clinical Development. Dr. Waldron-Lynch has extensive late-stage oncology clinical development and regulatory experience and will be invaluable as we prepare to advance TNG462 to registration."

In a separate press release issued earlier today, Tango Therapeutics provided an update on its ongoing PRMT5 clinical development program:

   -- Data from the ongoing phase 1/2 clinical trial of TNG462, a potentially 
      best-in-class MTA-cooperative PRMT5 inhibitor, demonstrate clinical 
      activity across multiple tumor types, including NSCLC and pancreatic 
      cancer. Of note, this includes an ORR of 43% in cholangiocarcinoma (n=7). 
      Substantive durability and a good safety and tolerability profile also 
      were observed in this ongoing trial. The next clinical update is expected 
      in 2025. 
 
   -- The Company plans to initiate multiple targeted and standard of care 
      combinations with TNG462 including RAS(ON) multi-selective and RAS(ON) 
      G12D-selective inhibitors (Revolution Medicines), osimertinib 
      (AstraZeneca) and pembrolizumab (Merck). These studies are expected to 
      begin enrolling in 1H 2025. 
 
   -- TNG908, an MTA-cooperative brain-penetrant PRMT5 inhibitor, is clinically 
      active and well-tolerated across non-CNS cancers in the phase 1/2 
      clinical trial. In particular, there were a total of nine evaluable 
      pancreatic cancer patients, two with partial responses (ORR 22%) and five 
      with stable disease as best response to date. The five ongoing pancreatic 
      cancer patients have been on study for an average of 24 weeks, the 
      longest for 72 weeks. 
 
   -- TNG908 did not demonstrate activity in glioblastoma (n=23 at active 
      doses) likely because CNS exposure did not meet the required exposure 
      threshold for clinical efficacy. 
 
   -- TNG908 enrollment is being stopped to allow full resourcing of TNG462 as 
      a potential best-in-class molecule. In particular, the notably longer 
      time on treatment observed -- 24 weeks and still increasing for TNG462 
      versus 16 weeks for TNG908 -- the superior target coverage, and the 
      safety and tolerability profile all support selection of TNG462 for 
      further development. 
 
   -- TNG456 is a next-generation brain-penetrant MTA-cooperative PRMT5 
      inhibitor that is 55X selective for MTAP deletion with 20 nM potency. 
      Preclinical studies suggest TNG456 central nervous system exposure has 
      the potential to be sufficient for meaningful efficacy in glioblastoma 
      and brain metastases. 
 
   -- The Company expects to begin enrolling patients in the planned phase 1/2 
      trial during 1H 2025. 

Business Highlights

Clinical collaboration with Revolution Medicines

   -- In November 2024, the Company entered into a clinical collaboration with 
      Revolution Medicines to evaluate the efficacy and safety of TNG462 in 
      combination with RMC-6236, a RAS(ON) multi-selective inhibitor, and with 
      RMC-9805, a RAS(ON) G12D-selective inhibitor. 
 
   -- The agreement provides that Revolution Medicines will supply RMC-6236 and 
      RMC-9805 to Tango and that Tango will be the sponsor of any combination 
      trials. Each company will retain commercial rights to their respective 
      compounds and the agreement is mutually non-exclusive. 

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

   -- The TNG260 phase 1/2 clinical trial is ongoing, evaluating 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. 

Upcoming Milestones

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

Additional Business and Pipeline Highlights

Leadership Update

Maeve Waldron-Lynch, M.D. will join Tango as Senior Vice President, Head of Clinical Development later this month. In this role, Dr. Waldron-Lynch will lead clinical development functions under Adam Crystal, M.D., Ph.D., President of Research and Development at Tango. Dr. Waldron-Lynch most recently served as VP and Global Clinical Program Head at MorphoSys, where she oversaw the clinical program for tafasitamab. Prior to MorphoSys, she was a Clinical Development Medical Director at Novartis. Dr. Waldron-Lynch also has served as Senior Clinical Director, Oncology at Roche, and as Associate Director of Medical Science, Oncology at Mundipharma. Dr. Waldron-Lynch graduated from the University College Cork School of Medicine and served as a Specialty Registrar Medical Oncology at the Royal College of Physicians of Ireland, and a Clinical Fellow in Medical Oncology at the Yale University School of Medicine.

Financial Results

As of September 30, 2024, the Company held $293.3 million in cash, cash equivalents and marketable securities, which the Company expects to be sufficient to fund operations into the third quarter of 2026, including for additional planned TNG462 and TNG456 clinical trials.

Collaboration revenue was $11.6 million for the three months ended September 30, 2024, compared to $10.7 million for the same period in 2023, and $25.9 million for the nine months ended September 30, 2024 compared to $26.1 million for the same period in 2023. Collaboration revenue increased due to changes to estimated costs expected to be incurred under the collaboration during the three months ended September 30, 2024.

License revenue was $0 and $12.1 million for the three and nine months ended September 30, 2024, respectively, compared to $0 and $5.0 million for the three and nine months ended September 30, 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 a program for $5.0 million during the second quarter of 2023.

Research and development expenses were $33.3 million for the three months ended September 30, 2024, compared to $27.1 million for the same period in 2023, and $110.0 million for the nine months ended September 30, 2024 compared to $83.9 million for the same period in 2023. The change is due to increased spend related to the advancement of TNG462, preclinical programs and personnel-related costs to support our research and development activities.

General and administrative expenses were $11.2 million for the three months ended September 30, 2024, compared to $9.2 million for the same period in 2023, and $32.7 million for the nine months ended September 30, 2024 compared to $26.4 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 September 30, 2024 was $29.2 million, or $0.27 per share, compared to a net loss of $22.3 million, or $0.23 per share, in the same period in 2023. Net loss for the nine months ended September 30, 2024 was $92.6 million, or $0.85 per share, compared to a net loss of $71.0 million, or $0.78 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.

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