Terns Pharmaceuticals (TERN) Provides Program Updates

Terns Pharmaceuticals, Inc. (Nasdaq: TERN) today announced that management will participate in the TD Cowen 45^th Annual Healthcare Conference taking place from March 3-5, 2025 in Boston and provided program updates across the Company’s development programs as outlined below.

“Since our positive interim data readout from the TERN-701 CARDINAL study, we have maintained strong enrollment momentum and continue to see compelling safety and clinical activity across the dose range. We look forward to sharing additional data from CARDINAL later this year,” said Emil Kuriakose, chief medical officer at Terns. “Additionally, we are excited to share new drug-drug interaction (DDI) data showing TERN-701 has a superior DDI profile compared to asciminib, allowing for safer co-administration of many commonly prescribed drugs, including statins. This is meaningful for patients with chronic myeloid leukemia (CML) who are on life-long therapy with tyrosine kinase inhibitors (TKIs). The compelling early data from CARDINAL, along with the lack of food effect and improved DDI compared to asciminib, reinforce TERN-701's class-leading potential in CML.”

“Oral, small molecule GLP-1R agonists have shown meaningful, consistent weight loss in clinical trials over 12-weeks. However, the major limitation within the class continues to be poor gastrointestinal tolerability, necessitating complicated dose titration schedules that are burdensome for patients,” said Amy Burroughs, chief executive officer at Terns. “The unique pharmaceutical properties of TERN-601 allowed for rapid titration in our 28-day Phase 1 study, resulting in competitive weight loss without dose interruptions, reductions, or discontinuations. Our goal in Phase 2 is to generate 12-week data that achieves competitive weight loss and best-in-class tolerability without the need for complicated dose titrations. Further establishing this differentiated profile will be an important catalyst in determining next steps for the program.”

Program Updates

TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML)

• Dose escalation in Phase 1 CARDINAL study is complete as of January 2025, with dose expansion portion expected to initiate in the second quarter of 2025
  • Backfill dosing of new participants continues in existing cohorts of dose escalation
• New data on drug-drug interactions (DDIs) from the ongoing healthy volunteer study demonstrate that TERN-701 is not a clinically relevant inhibitor of CYP3A4 or OATB1/3
  • Over 60% of FDA-approved small molecule drugs are primarily metabolized by the CYP3A4 pathway¹; OATB1/3 is a transporter for cholesterol lowering statins
  • Results support dosing of TERN-701 with common concomitant medications and represent a key safety differentiation of TERN-701 within the allosteric TKI class
  • Side effects from DDIs may include corrected QT interval (QTc) prolongation and decreases in TKI concentrations, which may reduce efficacy
  • Terns expects to publish DDI data at a future scientific conference
• Terns previously announced positive early data from the Phase 1 CARDINAL trial of TERN-701, demonstrating:
  • Compelling molecular responses starting at the lowest dose in heavily pre-treated patients with high baseline BCR-ABL transcript levels
  • Encouraging safety profile with no dose limiting toxicities, adverse event-related treatment discontinuations or dose reductions across all dose escalation cohorts
• Additional safety and efficacy data are expected in the fourth quarter of 2025
  • Data expected to include a larger cohort of patients with longer durations of treatment and read through to approval endpoint of 6-month major molecular response (MMR)

TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity

• Terns announces design of the FALCON Phase 2 clinical trial, expected to initiate early in the second quarter of 2025 with 12-week data expected in the second half of 2025
  • U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601
  • Once-daily dosing without regard to food in adults with overweight or obesity, without diabetes (BMI ranges from ≥30 to <50 kg/m² or ≥27 to <30 kg/m² with at least one weight-related comorbidity)
  • Patients randomized to one of four active cohorts (n=30 per cohort): 250 mg, 500 mg, 500 mg slow titration, 750 mg or placebo
  • Primary endpoint is percent change from baseline in body weight compared to placebo over 12 weeks
  • Secondary endpoints include safety, tolerability and proportion of patients achieving 5% weight loss or greater
• Doses and titration schema for Phase 2 were selected based on positive results from the Phase 1 trial, announced in September 2024, demonstrating weight loss over 28-days up to 5.5% and favorable safety and tolerability despite rapid dose titration every three days
  • Phase 2 titration will range between two to four weeks at each intermediate dose before achieving the target dose
  • Titration design features the fewest steps and lowest fold change to target dose amongst leading oral, small-molecule GLP-1R agonists in a 12-week study
  • Slower titration aims to achieve competitive 12-week weight loss, best-in-class tolerability and simplest titration amongst the oral, small-molecule class

TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist

• Terns continues to evaluate opportunities for TERN-501 in metabolic diseases
• Based on non-clinical studies, THR-β is a complementary mechanism to GLP-1, potentially providing broader metabolic and liver benefits in addition to increased weight loss
  • Posters are available on Terns’ scientific publications website

TERN-800 Series: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) modulators

• Discovery efforts are ongoing for small molecule GIPR modulators for obesity, which have the potential for combination with GLP-1 receptor agonists, such as TERN-601
• Terns is prioritizing its discovery efforts on nominating a GIPR antagonist development candidate based on in-house discoveries and growing scientific rationale supporting the potential of GLP-1 agonist/GIPR antagonist combinations for obesity

Financial Update

Terns’ third quarter cash balance as of September 30, 2024, was $372.8 million which is expected to provide cash runway into 2028.

Investor Conferences

Members of Terns’ senior leadership team will participate at the following upcoming investor conference in March:

TD Cowen 45^th Annual Health Care Conference
Date: March 3-5, 2025
Location: Boston, MA
Format: Corporate Presentation
Date/Time: Tuesday, March 4^th at 2:30PM ET

A live webcast will be available on the investor relations page of the Terns Pharmaceuticals website at http://ir.ternspharma.com. A replay of the webcast will be archived on Terns’ website for at least 30 days following the event.

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