0001831363false00018313632025-03-202025-03-20

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 20, 2025

 

 

Terns Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39926

98-1448275

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

1065 East Hillsdale Blvd.

Suite 100

 

Foster City, California

 

94404

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 525-5535

 

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

TERN

 

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On March 20, 2025, Terns Pharmaceuticals, Inc. issued a press release announcing its financial results for the year ended December 31, 2024. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in Item 2.02 and Item 9.01 (including Exhibit 99.1) of this Current Report on Form 8-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

No.

 

Description

 

 

 

99.1

 

Press Release issued by Terns Pharmaceuticals, Inc. on March 20, 2025.

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

TERNS PHARMACEUTICALS, INC.

 

 

 

Date: March 20, 2025

By:

/s/ Elona Kogan

 

 

Elona Kogan

 

 

Chief Legal Officer

 

 


Exhibit 99.1

img52906712_0.jpg

 

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

 

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:
o
Compelling molecular responses starting at the lowest dose in heavily pre-treated CML patients with high baseline BCR-ABL transcript levels
o
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
o
Results support dosing of TERN-701 with common concomitant medications and represent a key safety differentiation within the allosteric TKI class
o
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
o
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
o
U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601
o
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)
o
Patients randomized to one of four active cohorts (n=30 per cohort): 250 mg, 500 mg, 500 mg slow titration, 750 mg or placebo
o
Primary endpoint is percent change from baseline in body weight compared to placebo over 12 weeks
o
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
o
Phase 2 titration will range between two to four weeks at each intermediate dose before achieving the target dose
o
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
o
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.

Condensed 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

 

 


v3.25.1
Document And Entity Information
Mar. 20, 2025
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Mar. 20, 2025
Entity Registrant Name Terns Pharmaceuticals, Inc.
Entity Central Index Key 0001831363
Entity Emerging Growth Company true
Entity File Number 001-39926
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 98-1448275
Entity Address, Address Line One 1065 East Hillsdale Blvd.
Entity Address, Address Line Two Suite 100
Entity Address, City or Town Foster City
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94404
City Area Code (650)
Local Phone Number 525-5535
Entity Information, Former Legal or Registered Name N/A
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Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Ex Transition Period false
Title of 12(b) Security Common Stock, $0.0001 par value per share
Trading Symbol TERN
Security Exchange Name NASDAQ

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