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 15, 2021, Terns Pharmaceuticals, Inc. issued a press release announcing its financial results for the three and nine months ended September 30, 2021. 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 15, 2021. |
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 15, 2021 |
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 2021 Financial Results and Corporate Highlights
-Top-line data readout from TERN-201 (VAP-1) clinical trial in NASH expected in 1Q 2022
-Positive top-line data from TERN-501 (THR-β) demonstrated clinical proof of concept, enabling the planned initiation of NASH trial in 1H 2022
-Multiple abstracts detailing positive clinical data for TERN-101 and TERN-501 presented at AASLD 2021
-Cash and equivalents of $177 million provides runway into 2024
FOSTER CITY, Calif., Nov. 15, 2021 – Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates to address serious diseases such as non-alcoholic steatohepatitis (NASH), today reported financial results for the third quarter ended September 30, 2021 and corporate highlights.
“Recent positive clinical data for TERN-101 and TERN-501 presented at AASLD validate part one of Terns’ strategy, which is demonstrating monotherapy proof of concept. Notably, TERN-501 produced significant and dose-dependent changes in sex hormone binding globulin (SHBG), a marker of target engagement linked to NASH efficacy, suggesting that it has potential to be a best-in-class THR-β agonist. We look forward to the top-line data readout from the AVIATION Trial of TERN-201 in the first quarter of 2022, which could mark our third clinical candidate with promising monotherapy data,” said Senthil Sundaram, chief executive officer at Terns. “I am proud of the quality of execution at Terns and the momentum with which we are advancing our pipeline towards the second part of our strategy: achieving compelling and differentiated efficacy results in studies involving multiple clinically validated mechanisms of action. With this goal in mind, we are excited to move towards the planned initiation in the first half of 2022 of Terns’ first clinical trial in NASH patients including both monotherapy and combination arms of TERN-101 and TERN-501.”
Recent Developments and Anticipated Milestones
TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist
TERN-101: Liver-distributed FXR agonist
GLP1-R: Oral, small-molecule glucagon-like peptide-1 (GLP1) receptor agonist
Key Appointments
Third Quarter 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 |
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Nine Months Ended |
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2021 |
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2020 |
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2021 |
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2020 |
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Operating expenses: |
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Research and development |
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$ |
7,153 |
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$ |
5,404 |
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$ |
21,849 |
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$ |
20,259 |
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General and administrative |
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4,715 |
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3,333 |
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14,133 |
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7,998 |
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Total operating expenses |
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11,868 |
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8,737 |
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35,982 |
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28,257 |
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Loss from operations |
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(11,868 |
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(8,737 |
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(35,982 |
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(28,257 |
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Interest income |
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49 |
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1 |
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115 |
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53 |
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Change in fair value of loans payable |
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- |
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(2,366 |
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- |
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(2,366 |
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Other income (expense), net |
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4 |
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(387 |
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30 |
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30 |
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Loss before income tax expense |
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(11,815 |
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(11,489 |
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(35,837 |
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(30,540 |
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Income tax expense |
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(20 |
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(102 |
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(73 |
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(102 |
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Net loss |
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(11,835 |
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(11,591 |
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(35,910 |
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(30,642 |
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Net loss attributable to noncontrolling interest |
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- |
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(156 |
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- |
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(518 |
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Net loss attributable to common stockholders - basic and diluted |
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$ |
(11,835 |
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$ |
(11,435 |
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$ |
(35,910 |
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$ |
(30,124 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.47 |
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$ |
(37.82 |
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$ |
(1.64 |
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$ |
(111.38 |
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Weighted average common stock outstanding, basic and diluted |
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25,148,336 |
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302,336 |
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21,842,706 |
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270,463 |
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Terns Pharmaceuticals, Inc.
Selected Balance Sheet Data
(Unaudited; in thousands)
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September 30, 2021 |
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December 31, 2020 |
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Cash, cash equivalents and marketable securities |
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$ |
177,196 |
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$ |
74,854 |
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Total assets |
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179,890 |
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92,290 |
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Total liabilities |
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7,734 |
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23,698 |
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Preferred stock |
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- |
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186,033 |
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Total stockholders’ equity (deficit) |
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172,156 |
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(117,441 |
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About Terns Pharmaceuticals
Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates to address serious diseases such as non-alcoholic steatohepatitis, or NASH. Terns’ pipeline includes three clinical stage development programs including an FXR agonist, a VAP-1 inhibitor and a THR-β agonist, and a preclinical small-molecule GLP-1 receptor agonist 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 Company’s clinical trials and other development activities, such as the combination trial of TERN-101 and TERN-501 and the AVIATION Trial of TERN-201 in NASH; the therapeutic potential of the Company’s single-agent and combination therapy candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for NASH; the potential utility and progress of the Company’s product candidates in NASH, 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; the Company’s expectations regarding the profile of its product candidates, including tolerability, safety, metabolic stability and pharmacokinetic profile; the Company’s ability to continue to execute on its clinical strategy and plans; and the Company’s expectations with regard to its cash runway. 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. In particular, the impact of the COVID-19 pandemic on the Company’s ability to progress with its research, development, manufacturing and regulatory efforts, including the Company’s clinical trials for its product candidates, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. 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, 2020 and its Quarterly Reports on Form 10-Q for the periods ended March 31, 2021 and June 30, 2021. 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