Terns Pharmaceuticals Provides Program Updates and Announces Participation at TD Cowen 45th Annual Healthcare Conference

Rhea-AI Summary

Terns Pharmaceuticals (TERN) has provided program updates across its development pipeline and announced participation at the TD Cowen 45th Annual Healthcare Conference. The company reported strong progress with its TERN-701 CARDINAL study for chronic myeloid leukemia (CML), with dose expansion expected to begin in Q2 2025 and additional data in Q4 2025. New data shows TERN-701 has an improved drug-drug interaction profile compared to asciminib.

For its obesity program, Terns introduced the Phase 2 FALCON study design for TERN-601, an oral GLP-1 receptor agonist, scheduled to begin in early Q2 2025 with 12-week data expected in 2H 2025. The company aims to achieve competitive weight loss with best-in-class tolerability without complicated dose titrations.

Terns continues evaluating opportunities for TERN-501 in metabolic diseases and is advancing its TERN-800 series of GIPR modulators for obesity. With $372.8 million in cash as of September 30, 2024, the company expects runway into 2028.

Positive

• Strong enrollment momentum in TERN-701 CARDINAL study for CML
• TERN-701 shows improved drug-drug interaction profile compared to asciminib
• TERN-601 achieved 5.5% weight loss over 28 days in Phase 1 with favorable tolerability
• Substantial cash position of $372.8 million providing runway into 2028
• TERN-701 demonstrated compelling molecular responses in heavily pre-treated CML patients

Negative

• TERN-701 dose expansion delayed until Q2 2025
• Phase 2 FALCON study for TERN-601 not starting until Q2 2025
• Additional safety and efficacy data for TERN-701 not expected until Q4 2025

TERN-701 CARDINAL study progressing well; dose expansion expected to initiate in 2Q25 with additional safety and efficacy data in 4Q25

New TERN-701 data from ongoing U.S. healthy volunteer PK study shows improved drug-drug interaction profile compared to asciminib

Introduces TERN-601 Phase 2 FALCON obesity study design; on track to initiate study in early 2Q25 with 12-week data expected 2H25

Cash and cash equivalents expected to provide runway into 2028

FOSTER CITY, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, 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. 

About Terns Pharmaceuticals
Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, a THR-β agonist, and a preclinical GIPR modulator discovery effort, prioritizing a GIPR antagonist nomination candidate. For more information, please visit: www.ternspharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about the Company within the meaning of the federal securities laws, including those related to expectations, timing and potential results of the clinical trials and other development activities of the Company and its partners; the potential indications to be targeted by the Company with its small-molecule product candidates; the therapeutic potential of the Company’s small-molecule product candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the Company’s clinical development plans and activities, including the results of any interactions with regulatory authorities on its programs; the Company’s expectations regarding the profile of its product candidates, including efficacy, tolerability, safety, metabolic stability and pharmacokinetic profile and potential differentiation as compared to other products or product candidates; the Company’s plans for and ability to continue to execute on its current development strategy, including potential combinations involving multiple product candidates; the potential commercialization of the Company’s product candidates; the Company’s plans and expectations around the addition of key personnel; and the Company’s expectations with regard to its cash runway and sufficiency of its cash resources. All statements other than statements of historical facts contained in this press release, including statements regarding the Company’s strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2023. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Contacts for Terns

Investors
Justin Ng
investors@ternspharma.com

Media
Jenna Urban
CG Life
media@ternspharma.com

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¹ Mol. Pharmaceutics 2020, 17, 9, 3600–3608

FAQ

When will Terns Pharmaceuticals (TERN) begin the dose expansion for the TERN-701 CARDINAL study?

Terns Pharmaceuticals expects to initiate the dose expansion portion of the TERN-701 CARDINAL study in the second quarter of 2025, with additional safety and efficacy data anticipated in the fourth quarter of 2025.

What is the cash runway for Terns Pharmaceuticals (TERN) based on their Q3 2024 financial position?

Based on Terns Pharmaceuticals' Q3 2024 cash balance of $372.8 million as of September 30, 2024, the company expects to have sufficient runway into 2028.

What advantages does TERN-701 have over asciminib for CML patients according to the latest data?

According to new data, TERN-701 has a superior drug-drug interaction (DDI) profile compared to asciminib, allowing for safer co-administration of many commonly prescribed drugs, including statins. TERN-701 is not a clinically relevant inhibitor of CYP3A4 or OATB1/3.

When will Terns Pharmaceuticals (TERN) release data from the Phase 2 FALCON obesity trial for TERN-601?

Terns Pharmaceuticals expects to release 12-week data from the Phase 2 FALCON obesity trial for TERN-601 in the second half of 2025. The study is scheduled to begin early in the second quarter of 2025.

What were the weight loss results from the Phase 1 trial of TERN-601?

The Phase 1 trial of TERN-601 demonstrated weight loss of up to 5.5% over 28 days with favorable safety and tolerability, despite rapid dose titration every three days.

How is Terns Pharmaceuticals (TERN) designing the titration schedule for TERN-601 in the Phase 2 FALCON study?

The Phase 2 FALCON study will use titration ranging between two to four weeks at each intermediate dose before achieving the target dose, featuring the fewest steps and lowest fold change to target dose amongst leading oral GLP-1R agonists in a 12-week study.