Unprecedented Phase 1 CML efficacy data and potential best-in-disease profile of TERN-701 featured in ASH 2025 abstract
Upcoming ASH oral presentation to feature expanded and updated dataset from CARDINAL trial
Cash, cash equivalents and marketable securities of $295 million, expected to provide runway into 2028
FOSTER CITY, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage oncology company, today reported financial results for the third quarter ended September 30, 2025, and provided corporate updates.
"We're thrilled with the positive momentum of the CARDINAL program generated by the unprecedented Phase 1 MMR achievement rate and encouraging safety/tolerability profile published in the recent ASH abstract. These data continue to reinforce our view of the potential of TERN-701 to become a best-in-disease treatment for patients with chronic myeloid leukemia (CML)," said Amy Burroughs, chief executive officer of Terns Pharmaceuticals. "Our team continues to execute with precision and focus towards an updated and expanded CARDINAL readout at ASH, with an ultimate goal of bringing this important new therapy to CML patients."
Recent Pipeline Developments and Anticipated Milestones
TERN-701: Novel investigational allosteric BCR::ABL1 inhibitor for chronic myeloid leukemia (CML)
-- In November 2025, Terns announced that an abstract with updated data from
the ongoing Phase 1 CARDINAL trial evaluating TERN-701 in patients with
relapsed/refractory CML had been selected for oral presentation at the
67th ASH Annual Meeting and Exposition
-- The abstract reported data from the ongoing dose escalation and dose
expansion parts of the CARDINAL trial. Highlights include from the
abstract include:
-- Overall (cumulative) major molecular response (MMR) rate of 75% by
24 weeks, with 64% achieving MMR and 100% maintaining MMR
-- Overall (cumulative) MMR by 24 weeks in difficult to treat patient
subgroups
-- 69% in patients with lack of efficacy to last tyrosine
kinase inhibitor (TKI)
-- 60% in patients who had prior asciminib
-- 67% in patients with prior asciminib / ponatinib /
investigational TKI
-- No patients had lost MMR at the time of data cutoff
-- Encouraging safety and tolerability profile at all doses evaluated
-- A more expansive and updated dataset from the CARDINAL trial will be
presented at the ASH Annual Meeting:
-- Session Name: 632. Chronic Myeloid Leukemia: Clinical and
Epidemiological: Therapeutic agents to enhance patient outcomes
-- Session Date: December 8, 2025
-- Session Time: 2:45 -- 4:15pm ET
-- Presentation Time: 2:45 -- 3:00pm ET
-- The Company will host a conference call to review the data on December 8,
2025 at 4:30pm ET. The event can be accessed live on the investor
relations section of Terns' website, where it will also be archived
TERN-601: Oral, small-molecule glucagon-like peptide-1 receptor agonist (GLP1-RA) for obesity
-- In October 2025, Terns announced top-line 12-week data from the Phase 2
study of TERN-601 for the treatment of obesity, which showed maximum
placebo-adjusted weight loss of 4.6% with 12% treatment discontinuation
due to adverse events
-- Asymptomatic, reversible grade 3 liver enzyme elevations occurred in
three participants during post-treatment follow-up period, two of which
were deemed drug related
-- The results of the Phase 2 study did not support the Company's further
development of TERN-601 in obesity
-- Terns had previously announced its decision to no longer invest in
metabolic disease
Pipeline and Partnering Programs
"As we continue to sharpen our strategic focus in oncology, earlier this year we decided we would discontinue internal clinical development of our metabolic programs. While these metabolic assets have shown promise, we believe their full potential can best be realized through external partnerships," noted Andrew Gengos, chief financial officer of Terns.
TERN-501: Oral, thyroid hormone receptor-beta (THR-<BETA>) agonist
-- Based on non-clinical studies, THR-<BETA> is a complementary mechanism to
GLP-1, potentially providing broader metabolic and liver benefits in
addition to increased weight loss
-- Terns is seeking a strategic partner to advance this program
TERN-801: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor $(GIPR)$ antagonist
-- In the third quarter of 2025, Terns nominated TERN-801, an oral
small-molecule GIPR antagonist as a development candidate from the
TERN-800 series discovery effort
-- Terns is seeking a strategic partner to advance this program
Third Quarter 2025 Financial Results
Cash Position: As of September 30, 2025, cash, cash equivalents and marketable securities were $295.6 million, as compared with $358.2 million as of December 31, 2024. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2028.
Research and Development (R&D) Expenses: R&D expenses were $19.9 million for the quarter ended September 30, 2025, as compared with $15.2 million for the quarter ended September 30, 2024.
General and Administrative (G&A) Expenses: G&A expenses were $7.8 million for the quarter ended September 30, 2025, as compared with $9.8 million for the quarter ended September 30, 2024.
Net Loss: Net loss was $24.6 million for the quarter ended September 30, 2025, as compared with $21.9 million for the quarter ended September 30, 2024.
Financial Tables
Terns Pharmaceuticals, Inc.
----------------------------------------------------------------------------
Condensed Consolidated Statements of Operations
(Unaudited; in thousands except share and per share
amounts)
----------------------------------------------------------------------------
Three Months Ended Nine Months Ended September
September 30, 30,
-------------------------- ----------------------------
2025 2024 2025 2024
Operating
expenses:
Research and
development $ 19,917 $ 15,169 $ 58,990 $ 52,108
General and
administrative 7,799 9,770 23,536 23,814
Total operating
expenses 27,716 24,939 82,526 75,922
Loss from
operations (27,716) (24,939) (82,526) (75,922)
Interest income 3,141 3,088 10,134 9,146
Other expense,
net (14) (32) (46) (58)
Loss before income
taxes (24,589) (21,883) (72,438) (66,834)
Income tax
expense (46) (62) (198) (220)
Net loss $ (24,635) $ (21,945) $ (72,636) $ (67,054)
========== ========== ========== ==========
Net loss per
share, basic and
diluted $ (0.27) $ (0.28) $ (0.79) $ (0.89)
========== ========== ========== ==========
Weighted average
common stock
outstanding,
basic and
diluted 91,701,529 77,819,658 91,584,339 75,567,851
========== ========== ========== ==========
Terns Pharmaceuticals, Inc.
----------------------------------------------------------------------
Selected Balance Sheet Data
(Unaudited; in thousands)
----------------------------------------------------------------------
September 30, 2025 December 31, 2024
-------------------- ---------------------
Cash, cash equivalents and
marketable securities $ 295,635 $ 358,164
Total assets 301,651 363,929
Total liabilities 17,585 18,059
Total stockholders' equity 284,066 345,870
About Terns Pharmaceuticals
Terns Pharmaceuticals is a clinical-stage oncology company reimagining known biology to deliver high impact medicines. Our lead program TERN-701 is a highly selective, allosteric BCR-ABL inhibitor with a potentially best-in-disease profile that could meaningfully improve upon the efficacy, safety and convenience of existing treatments for CML. 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 that involve substantial risks and uncertainties. Forward-looking statements include statements related to or in connection with expectations, timing and potential results of clinical trials and other development activities, including with respect to the CARDINAL trial; the potential indications to be targeted by the Company with its product candidates; the therapeutic potential of the Company's 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 applicability of expected parameters and benchmarks on which to assess clinical trial results; the Company's clinical development plans and activities, including potential future
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