On August 8, 2023 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, non-alcoholic steatohepatitis (NASH) and obesity, reported financial results for the quarter ended June 30, 2023 and corporate updates (Press release, Terns Pharmaceuticals, AUG 8, 2023, View Source [SID1234633993]).
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"This afternoon, we reported positive data from our Phase 2a DUET clinical trial, in which TERN-501 showed dose dependent and statistically significant reductions in liver fat content and fibro-inflammation with a class-leading safety and tolerability profile," stated Erin Quirk, M.D., president and head of research and development at Terns. "These positive data underscore the potential for TERN-501 to be the THR-β monotherapy of choice and possibly a mainstay backbone of NASH combination therapies for this difficult-to-treat disease with no FDA approved treatments."
"Beyond our successful DUET clinical trial, we were also delighted to share compelling clinical updates and preclinical data that support each of our three lead development programs at key medical and scientific congresses during the second quarter. We are looking forward to initiating our Phase 1 studies with TERN-701 for chronic myeloid leukemia (CML) and TERN-601 for obesity in the second half of this year. We have a strong balance sheet to support our efforts to achieve these important milestones that bring us one step closer to our goal of bringing safe and effective new medicines to people battling serious oncologic and metabolic diseases," added Dr. Quirk.
Recent Developments and Anticipated Milestones
TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist for NASH
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Terns reported positive top-line data from the Phase 2a DUET trial of TERN-501 administered as a monotherapy or in combination with TERN-101, a liver-distributed farnesoid X receptor (FXR) agonist, for the treatment of NASH. Key takeaways from the data include:
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TERN-501 met all primary and secondary endpoints
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TERN-501 demonstrated dose dependent MRI-PDFF reductions at Week 12 as a once-daily, low dose, and combinable oral therapy
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TERN-501 (6 mg) showed statistically significant mean relative liver fat content reduction of 45% as assessed by MRI-PDFF with 64% of patients achieving >30% PDFF reduction
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All TERN-501 doses were well-tolerated with no gastrointestinal and no cardiovascular safety signals
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Terns has completed drug manufacturing to enable the initiation of a Phase 2b trial of TERN-501 in NASH
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Terns intends to submit the DUET data to a medical conference later in 2023.
TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML)
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Terns expects to initiate a clinical trial for TERN-701 in the second half of 2023, with potential interim top-line readouts from initial dose-escalation cohorts in 2024
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Terns has completed drug manufacturing to enable the initiation of its Phase 1 trial for TERN-701
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The Phase 1 trial for TERN-701 is expected to include sites from the U.S., Europe and other countries
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A poster demonstrating that TERN-701 outperformed asciminib in certain xenograft mouse models (K562 and Ba/F3T315I) at equivalent doses was presented at the American Society for Pharmacology and Experimental Therapeutics (ASPET) in May 2023
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A trial-in-progress (TiP) poster was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting (ASCO) (Free ASCO Whitepaper) in June, summarizing the ongoing Phase 1 study (NCT05367700) of TERN-701 (HS-10382) conducted by Terns’ partner, Hansoh, and highlighting the completion of enrollment of Cohort 5 of the Phase 1 dose-escalation portion of the study as of April 2023
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Management hosted a virtual Key Opinion Leader event in July 2023, with a focus on the evolving CML treatment landscape and the potential role for TERN-701. An archive of the event can be accessed here
TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity
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Terns’ lead GLP-1 receptor agonist program remains on track to initiate a Phase 1 first-in-human clinical trial in subjects with elevated body mass index (BMI) in the second half of 2023, with top-line data expected in 2024
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Data in transgenic mice expressing human GLP-1 receptor showing TERN-601 significantly improved glucose tolerance, suppressed food intake and slowed gastric emptying was presented at the American Diabetes Association’s (ADA) 83rd Annual Scientific Sessions in June 2023
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Management hosted a webinar that reviewed Terns’ obesity franchise, including the TERN-601 program and additional development efforts underway in obesity. The archive of this event can be accessed here
TERN-800: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) modulators for obesity
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Lead structural series of GIPR modulators have been identified, with lead optimization efforts underway
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Candidate nomination and initiation of IND-enabling activities expected in 2024
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GIPR modulators have the potential for combination with GLP-1 receptor agonists, such as TERN-601
Second Quarter 2023 Financial Results
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Cash Position: As of June 30, 2023, cash, cash equivalents and marketable securities were $285.6 million, as compared with $283.1 million as of December 31, 2022. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.
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Research and Development (R&D) Expenses: R&D expenses were $14.2 million for the quarter ended June 30, 2023, as compared with $8.7 million for the quarter ended June 30, 2022.
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General and Administrative (G&A) Expenses: G&A expenses were $7.0 million for the quarter ended June 30, 2023, as compared with $5.4 million for the quarter ended June 30, 2022.
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Net Loss: Net loss was $17.9 million for the quarter ended June 30, 2023, as compared with $13.9 million for the quarter ended June 30, 2022.