Terns Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Updates

Rhea-AI Summary

Terns Pharmaceuticals (TERN) has reported its Q4 and full year 2024 financial results, highlighting significant clinical progress in its pipeline. The company ended 2024 with $358.2 million in cash and equivalents, providing runway into 2028.

Key developments include:

• Phase 1 CARDINAL trial of TERN-701 for chronic myeloid leukemia (CML) completed dose escalation, with dose expansion expected in Q2 2025
• First patient enrolled in Phase 2 FALCON trial of TERN-601 for obesity, with 12-week data expected in Q4 2025
• TERN-601 demonstrated weight loss up to 5.5% over 28 days in Phase 1 trials

Financial results show R&D expenses of $70.1 million for 2024 (up from $63.5 million in 2023), G&A expenses of $31.8 million (down from $39.1 million in 2023), and a net loss of $88.9 million (improved from $90.2 million in 2023).

Positive

• Strong cash position of $358.2M providing extended runway into 2028
• Positive Phase 1 TERN-701 data showing molecular responses in CML patients
• Promising TERN-601 Phase 1 results with 5.5% weight loss over 28 days
• Reduction in G&A expenses from $39.1M to $31.8M year-over-year
• No safety concerns or dose-limiting toxicities in TERN-701 trials

Negative

• Increased R&D expenses from $63.5M to $70.1M year-over-year
• Continued net losses of $88.9M in 2024

Insights

Biotech Financial Analyst

Terns Pharmaceuticals' Q4/FY2024 results reveal an exceptionally strong financial position with $358.2 million in cash (up from $263.4 million YoY), providing runway into 2028. This substantial cash reserve supports their advancing clinical pipeline through multiple value-inflection points without immediate financing concerns.

The company is executing efficiently on both clinical programs with clear development timelines. TERN-701, their BCR-ABL TKI for CML, completed Phase 1 dose escalation with compelling interim data showing molecular responses in heavily pre-treated patients and favorable safety. The upcoming dose expansion in Q2 2025 represents significant progress.

TERN-601, their oral GLP-1 receptor agonist for obesity, has advanced to Phase 2 after encouraging Phase 1 data showing up to 5.5% weight loss over just 28 days. The first patient enrollment in the FALCON trial positions Terns competitively in the high-value obesity market, with differentiation through simplified titration and promising tolerability.

While R&D expenses increased to $70.1 million for 2024 (vs $63.5 million in 2023), this represents appropriate investment in advancing clinical programs. The net loss of $88.9 million actually improved slightly from 2023's $90.2 million, demonstrating disciplined financial management despite clinical advancement.

Pharmaceutical Development Expert

The advancements in Terns' clinical pipeline demonstrate increasingly promising therapeutic potential. TERN-701's completed Phase 1 dose escalation revealed molecular responses beginning at the lowest dose levels in heavily pre-treated CML patients—a particularly encouraging signal. The favorable drug-drug interaction profile, showing TERN-701 is not a clinically relevant inhibitor of CYP3A4 or OATP1B1/3, represents a critical differentiator from other allosteric TKIs, potentially enabling broader clinical utility.

For TERN-601, the obesity program's advancement to Phase 2 follows meaningful Phase 1 results. The 5.5% weight loss over just 28 days compares favorably against competitive benchmarks. The Phase 2 FALCON trial design incorporates important refinements—slower titration over 2-4 weeks should improve tolerability while maintaining efficacy. This approach directly addresses limitations seen with other oral GLP-1 candidates where titration complexity and GI tolerability have been challenging.

The company's methodical approach to titration schema design—featuring the fewest steps and lowest fold change amongst oral small-molecule GLP-1 competitors—shows strategic clinical development planning. Additionally, their parallel work on GIPR antagonist discovery for potential combination with GLP-1 demonstrates forward-thinking pipeline development aligned with emerging scientific rationale for multi-targeting approaches in metabolic disease.

Dose expansion in Phase 1 CARDINAL trial of TERN-701 for chronic myeloid leukemia (CML) expected to initiate in 2Q25 with additional safety and efficacy data in 4Q25

First patient enrolled in Phase 2 FALCON trial of TERN-601 for obesity with 12-week data expected 4Q25

Cash, cash equivalents and marketable securities of $358 million, expected to provide runway into 2028

FOSTER CITY, Calif., March 20, 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 reported financial results for the fourth quarter and full year ended December 31, 2024, and provided corporate updates.

“2024 was a year of significant clinical progress across our lead pipeline programs that was highlighted by two compelling data readouts, which underscore the best-in-class potential of both TERN-701 in CML and TERN-601 in obesity,” said Amy Burroughs, chief executive officer of Terns. “We look forward to building on this positive momentum in 2025, as we prepare to initiate the dose expansion portion of the TERN-701 CARDINAL trial in the second quarter of 2025, with additional data expected in the fourth quarter of 2025. Additionally, we are pleased to announce that the first patient has been enrolled in the FALCON trial of TERN-601, with 12-week data also expected in the fourth quarter. We continue to operate from a position of strength and remain well-funded through significant, near-term clinical data readouts.”

Recent Pipeline Developments and Anticipated Milestones

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

• Dose escalation in Phase 1 CARDINAL study completed in January 2025
• Terns previously announced positive interim data from the Phase 1 CARDINAL trial of TERN-701, demonstrating:
  • Compelling molecular responses starting at the lowest dose in heavily pre-treated CML 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
• Positive data on drug-drug interactions (DDI) from the ongoing healthy volunteer study demonstrate that TERN-701 is not a clinically relevant inhibitor of CYP3A4 or OATP1B1/3
  • Results support dosing of TERN-701 with common concomitant medications and represent a key safety differentiation within the allosteric TKI class
  • Terns expects to publish DDI data at a future scientific conference
• The dose expansion portion of the Phase 1 CARDINAL study is expected to initiate in the second quarter of 2025 with additional safety and efficacy data 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

• The FALCON Phase 2 clinical trial enrolled its first patient in March 2025, with 12-week data expected in the fourth quarter 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, which demonstrated 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

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

Corporate Updates

• In February 2025, Terns appointed Andrew Gengos, a seasoned public company CFO with 25 years of leadership experience in the biotechnology industry, as chief financial officer of Terns
• In February 2025, Terns appointed Robert Azelby, an experienced biotechnology CEO with more than 25 years of strategic, operational and commercial expertise, to its board of directors
• In November 2024, Terns appointed Heather Turner, former CEO of Carmot Therapeutics, Inc., to its board of directors
  

Fourth Quarter and Full Year 2024 Financial Results

Cash Position: As of December 31, 2024, cash, cash equivalents and marketable securities were $358.2 million, as compared with $263.4 million as of December 31, 2023. 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 $18.0 million and $70.1 million for the quarter and year ended December 31, 2024, respectively, as compared with $17.5 million and $63.5 million for the quarter and year ended December 31, 2023, respectively.

General and Administrative (G&A) Expenses: G&A expenses were $7.9 million and $31.8 million for the quarter and year ended December 31, 2024, respectively, as compared with $6.6 million and $39.1 million for the quarter and year ended December 31, 2023, respectively.

Net Loss: Net loss was $21.8 million and $88.9 million for the quarter and year ended December 31, 2024, respectively, as compared with $21.0 million and $90.2 million for the quarter and year ended December 31, 2023, respectively.

Financial Tables

Terns Pharmaceuticals, Inc.
Consolidated Statements of Operations
(Unaudited; in thousands except share and per share amounts)
	Quarter Ended December 31,								Year Ended December 31,
	2024				2023				2024				2023
Operating expenses:
Research and development	$	18,004			$	17,459			$	70,112			$	63,497
General and administrative	7,945				6,599				31,759				39,061
Total operating expenses	25,949				24,058				101,871				102,558
Loss from operations	(25,949		)		(24,058		)		(101,871		)		(102,558		)
Interest income	4,143				3,333				13,289				12,901
Other income (expense), net	47				(245		)		(11		)		(314		)
Loss before income taxes	(21,759		)		(20,970		)		(88,593		)		(89,971		)
Income tax expense	(40		)		(49		)		(260		)		(239		)
Net loss	$	(21,799	)		$	(21,019	)		$	(88,853	)		$	(90,210	)
Net loss per share, basic and diluted	$	(0.24	)		$	(0.29	)		$	(1.12	)		$	(1.27	)
Weighted average common stock outstanding, basic and diluted	91,240,700				72,333,196				79,507,474				71,259,239

Terns Pharmaceuticals, Inc.
Selected Balance Sheet Data
(Unaudited; in thousands)
	December 31, 2024				December 31, 2023
Cash, cash equivalents and marketable securities	$	358,164			$	263,440
Total assets		363,929				268,517
Total liabilities		18,059				13,150
Total stockholders’ equity		345,870				255,367

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, 2024. 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

FAQ

What are the key milestones expected for TERN-701's CARDINAL trial in 2025?

TERN-701's Phase 1 CARDINAL trial will begin dose expansion in Q2 2025, with additional safety and efficacy data expected in Q4 2025.

How much weight loss did TERN-601 achieve in its Phase 1 obesity trial?

TERN-601 demonstrated weight loss up to 5.5% over a 28-day period in Phase 1 trials.

What is TERN's cash position and expected runway as of December 2024?

Terns has $358.2 million in cash, cash equivalents and marketable securities, expected to provide runway into 2028.

What are the details of TERN's Phase 2 FALCON trial for obesity?

FALCON is a randomized, double-blind, placebo-controlled trial with four active cohorts (250mg, 500mg, 500mg slow titration, 750mg) evaluating TERN-601's efficacy and safety over 12 weeks.

How did TERN's financial performance change from 2023 to 2024?

Net loss improved slightly to $88.9M in 2024 from $90.2M in 2023, with R&D expenses increasing to $70.1M and G&A expenses decreasing to $31.8M.