UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 November 14, 2023, Terns Pharmaceuticals, Inc. issued a press release announcing its financial results for the three and nine months ended September 30, 2023. 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 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, 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. |
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Description |
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99.1 |
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Press Release issued by Terns Pharmaceuticals, Inc. on November 14, 2023. |
104 |
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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.
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TERNS PHARMACEUTICALS, INC. |
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Date: November 14, 2023 |
By: |
/s/ Bryan Yoon |
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Bryan Yoon |
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Chief Operating Officer & General Counsel |
Exhibit 99.1
Terns Pharmaceuticals Reports Third Quarter 2023 Financial Results and Corporate Updates
Announced global Phase 1 clinical trial design of TERN-701 (allosteric BCR-ABL) for CML with patient screening anticipated in December 2023 and interim top-line data expected in the second half of 2024
Dosed first participant in Phase 1 clinical trial of TERN-601 (oral GLP-1) for obesity with top-line data expected in the second half of 2024
Reported positive top-line data from Phase 2a DUET clinical trial that demonstrated TERN-501 (THR-β) has best-in-class potential based on overall profile of efficacy, tolerability and combinability
Cash, cash equivalents and marketable securities of $267 million expected to provide runway into 2026
FOSTER CITY, Calif., Nov. 14, 2023 (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, obesity and non-alcoholic steatohepatitis (NASH), today reported financial results for the quarter ended September 30, 2023 and provided corporate updates.
“Throughout the third quarter and in recent weeks, we made meaningful progress across all three of our clinical development programs, opening U.S. Investigational New Drug (IND) applications, both for our allosteric BCR-ABL inhibitor TERN-701 for chronic myeloid leukemia (CML) and our lead small molecule oral GLP-1 agonist TERN-601 for obesity, and releasing Phase 2 data for our thyroid hormone receptor β agonist TERN-501 from the DUET study in NASH patients. We are now preparing for a data-rich 2024, with expected proof of concept readouts from our clinical trials in CML and obesity,” stated Erin Quirk, MD, president and head of research and development at Terns. “The advances we are making, which are supported by strong clinical and scientific data, give us even greater confidence in our approach to bring better chemistry to the development of small-molecule candidates with clinically validated mechanisms to address oncologic and metabolic diseases with large unmet medical needs.”
“We are excited to have dosed the first participant in our first-in-human trial of TERN-601 to treat obesity as preclinical data suggest it has potential for broad metabolic benefits in obesity, oral once-daily dosing, and suitability for combination therapy. We are also looking forward to dosing the first participants in our Phase 1 trial of TERN-701 as a treatment for CML while leveraging insights from our partner’s ongoing Phase 1 trial in China to support a starting dose that appears safe and clinically active based on emerging early clinical data,” added Dr. Quirk.
Recent Pipeline Developments and Anticipated Milestones
TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for CML
TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity
TERN-501: Oral, thyroid hormone receptor-β (THR-β) agonist for NASH
Corporate Updates
Third Quarter 2023 Financial Results
Terns Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(Unaudited; in thousands except share and per share amounts)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
14,831 |
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$ |
12,161 |
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$ |
46,038 |
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$ |
28,959 |
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General and administrative |
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18,353 |
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5,131 |
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32,462 |
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16,242 |
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Total operating expenses |
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33,184 |
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17,292 |
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78,500 |
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45,201 |
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Loss from operations |
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(33,184 |
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(17,292 |
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(78,500 |
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(45,201 |
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Interest income |
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3,480 |
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499 |
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9,568 |
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782 |
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Other expense, net |
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(5 |
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(14 |
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(69 |
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(64 |
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Loss before income taxes |
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(29,709 |
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(16,807 |
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(69,001 |
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(44,483 |
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Income tax expense |
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(58 |
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(13 |
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(190 |
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(40 |
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Net loss |
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$ |
(29,767 |
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$ |
(16,820 |
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$ |
(69,191 |
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$ |
(44,523 |
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Net loss per share, basic and diluted |
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$ |
(0.42 |
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$ |
(0.44 |
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$ |
(0.98 |
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$ |
(1.50 |
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Weighted average common stock outstanding, basic and diluted |
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71,530,180 |
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38,511,655 |
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70,897,320 |
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29,743,579 |
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Terns Pharmaceuticals, Inc.
Selected Balance Sheet Data
(Unaudited; in thousands)
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September 30, 2023 |
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December 31, 2022 |
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Cash, cash equivalents and marketable securities |
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$ |
266,600 |
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$ |
283,114 |
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Total assets |
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271,687 |
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287,026 |
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Total liabilities |
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13,262 |
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10,083 |
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Total stockholders’ equity |
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258,425 |
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276,943 |
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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, obesity and NASH. Terns’ pipeline includes 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 program. For more information, please visit: www.ternspharma.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s expectations of 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 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, 2022. 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
Berry & Company Public Relations
media@ternspharma.com