8-K
Terns Pharmaceuticals, Inc. (TERN)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, 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): August 16, 2021 |
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Terns Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-39926 | 98-1448275 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission File Number) | (IRS Employer<br>Identification No.) |
| 1065 East Hillsdale Blvd.<br><br>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<br>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 August 16, 2021, Terns Pharmaceuticals, Inc. issued a press release announcing its financial results for the three and six months ended June 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<br><br>No. | Description |
|---|---|
| 99.1 | Press Release issued by Terns Pharmaceuticals, Inc. on August 16, 2021. |
| 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: August 16, 2021 | By: | /s/ Bryan Yoon |
| Bryan Yoon | ||
| Chief Operating Officer & General Counsel |
EX-99.1
Exhibit 99.1
Terns Pharmaceuticals Reports Second Quarter 2021 Financial Results and Corporate Highlights
-Top-line data from ongoing Phase 1 proof of concept clinical trial of TERN-501 expected in 4Q 2021
-Top-line data readout from Part 1 of ongoing AVIATION Trial of TERN-201 expected in 1H 2022
-Cash and equivalents of $185.1 million provides runway into 2024
FOSTER CITY, Calif., August 16, 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 for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today reported financial results for the second quarter ended June 30, 2021 and corporate highlights.
“We are pleased to report significant progress across our clinical programs this quarter marked by several important achievements, including initiations of our Phase 1b AVIATION Trial of TERN-201 and the multiple ascending dose (MAD) cohort of our TERN-501 Phase 1 trial, as well as positive top-line data from our Phase 2a LIFT Study of TERN-101,” said Senthil Sundaram, Chief Executive Officer at Terns. “These milestones highlight our commitment to rapidly advance our broad NASH pipeline. We look forward to proof of concept data for TERN-501 later this year and for TERN-201 in 2022.”
Recent Developments and Anticipated Upcoming Milestones
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist
Initiated 14-day multiple ascending dose (MAD) portion of Phase 1 trial in June 2021
Top-line, proof of concept data readout expected in 4Q 2021, including:
o Pharmacodynamic markers of THR-β engagement in the liver linked to NASH efficacy, including sex hormone binding globulin (SHBG) and low-density lipoprotein (LDL) cholesterol
o Indicators of pharmacokinetic stability
o Safety and tolerability
Received Fast Track Designation (FTD) from the U.S. FDA in June 2021
o Provides eligibility for more frequent FDA interactions, accelerated approval and priority review
o TERN-501 is Terns’ third development-stage compound with FTD for the treatment of NASH
TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor
Initiated 12-week Phase 1b AVIATION Trial in NASH in June 2021
Top-line results from Part 1 of AVIATION Trial expected in 1H 2022, including:
o Key efficacy readout in corrected T1 (cT1), an imaging marker of liver inflammation and fibrosis linked to clinical outcomes
o Safety, tolerability and plasma VAP-1 activity
TERN-101: Liver-distributed farnesoid X receptor (FXR) agonist
Reported positive top-line data from 12-week Phase 2a LIFT clinical trial in NASH in June 2021, demonstrating three firsts:
o First FXR agonist trial to demonstrate no discontinuations due to adverse events, including pruritus
o First 12-week placebo-controlled trial of an FXR agonist in NASH to show significant improvements in cT1, an imaging marker of liver inflammation and fibrosis linked to clinical outcomes
o First FXR agonist planned to be studied in combination with a THR-β agonist (TERN-501)
Phase 1 data accepted for publication in Clinical Pharmacology in Drug Development
GLP1-R: Oral, small-molecule glucagon-like peptide-1 (GLP1) receptor agonist
Nomination of final candidate expected in 2H 2021
Second Quarter Financial Results
Cash Position: As of June 30, 2021, cash, cash equivalents and marketable securities were $185.1 million as compared with $74.9 million as of December 31, 2020. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2024
Research and Development (R&D) Expenses: R&D expenses were $6.0 million for the quarter ended June 30, 2021, as compared with $7.6 million for the quarter ended June 30, 2020
General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for the quarter ended June 30, 2021, as compared with $2.5 million for the quarter ended June 30, 2020
Net Loss: Net loss was $10.7 million for the quarter ended June 30, 2021, as compared with $9.7 million for the quarter ended June 30, 2020
Terns Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(Unaudited; in thousands except share and per share amounts)
| Three Months Ended <br>June 30, | Six Months Ended <br>June 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 5,961 | $ | 7,611 | $ | 14,696 | $ | 14,855 | ||||
| General and administrative | 4,857 | 2,486 | 9,418 | 4,665 | ||||||||
| Total operating expenses | 10,818 | 10,097 | 24,114 | 19,520 | ||||||||
| Loss from operations | (10,818 | ) | (10,097 | ) | (24,114 | ) | (19,520 | ) | ||||
| Interest income | 55 | 2 | 66 | 52 | ||||||||
| Other income, net | 39 | 250 | 26 | 417 | ||||||||
| Loss before income tax expense | (10,724 | ) | (9,845 | ) | (24,022 | ) | (19,051 | ) | ||||
| Income tax expense | (14 | ) | - | (53 | ) | - | ||||||
| Net loss | (10,738 | ) | (9,845 | ) | (24,075 | ) | (19,051 | ) | ||||
| Net loss attributable to noncontrolling interest | - | (157 | ) | - | (362 | ) | ||||||
| Net loss attributable to common stockholders - basic and diluted | $ | (10,738 | ) | $ | (9,688 | ) | $ | (24,075 | ) | $ | (18,689 | ) |
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.43 | ) | $ | (33.09 | ) | $ | (1.19 | ) | $ | (73.48 | ) |
| Weighted average common stock outstanding, basic and diluted | 25,109,973 | 292,813 | 20,162,496 | 254,351 |
Terns Pharmaceuticals, Inc.
Selected Balance Sheet Data
(Unaudited; in thousands)
| June 30, 2021 | December 31, 2020 | ||||
|---|---|---|---|---|---|
| Cash, cash equivalents and marketable securities | $ | 185,084 | $ | 74,854 | |
| Total assets | 188,007 | 92,290 | |||
| Total liabilities | 6,675 | 23,698 | |||
| Preferred stock | - | 186,033 | |||
| Total stockholders’ equity (deficit) | 181,332 | (117,441 | ) |
About Terns Pharmaceuticals
Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns’ pipeline includes three clinical stage development programs including an FXR agonist, a VAP-1 inhibitor and a THR-β agonist, and a preclinical GLP-1 receptor agonist program. Terns is focused on developing combination therapies based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. 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; the therapeutic potential of the Company’s single-agent and combination therapy candidates; 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 clinical trials and nonclinical studies conducted by the Company; the Company’s clinical development plans and activities for its single-agent and combination therapy candidates; 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 sufficiency of the Company’s cash on hand to fund its operating expenses and capital expenditures. 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 and results 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 Report on form 10-Q for the three months ended March 31, 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