Exhibit 99.1
Terns Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Highlights
-Top-line data readout from TERN-201 (VAP-1 inhibitor) clinical trial in NASH expected in March 2022
-Initiation of Terns’ first NASH trial of TERN-501 (THR-β agonist) alone and in combination with TERN-101 (FXR agonist) planned for first half of 2022 with top-line data expected in second half of 2023
-Nominated TERN-601 (GLP-1 receptor agonist) development candidate with the goal of initiating a first-in-human clinical trial in 2023
-Cash and equivalents of $166 million provides runway into 2024
FOSTER CITY, Calif., March 3, 2022 – 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) and obesity, today reported financial results for the fourth quarter and full year ended December 31, 2021 and corporate highlights.
“2021 was a cornerstone year for Terns, during which we demonstrated monotherapy proof of concept for TERN-501 and TERN-101, nominated an oral small-molecule GLP-1 receptor agonist, TERN-601, as our development candidate to explore various metabolic diseases such as obesity, augmented our leadership team with key hires, and strengthened our financial position though our IPO,” said Senthil Sundaram, chief executive officer at Terns. “We look forward to continuing our momentum with top-line data from the AVIATION trial of TERN-201 in NASH patients later this month. With four differentiated single-agent drug candidates under development, and our first combination therapy trial in NASH expected to initiate in the first half of 2022, we are rapidly advancing and broadening our pipeline to address serious diseases such as NASH and obesity.”
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
TERN-601: Glucagon-like peptide-1 (GLP1) receptor agonist
Key Appointments
Fourth Quarter and Full Year Financial Results
Terns Pharmaceuticals, Inc.
Consolidated Statements of Operations
(Unaudited; in thousands except share and per share amounts)
|
|
Quarter Ended |
|
|
Year Ended |
|
||||||||||
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
License revenue |
|
$ |
1,000 |
|
|
$ |
— |
|
|
$ |
1,000 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
9,462 |
|
|
|
7,770 |
|
|
|
31,311 |
|
|
|
28,029 |
|
General and administrative |
|
|
5,416 |
|
|
|
998 |
|
|
|
19,549 |
|
|
|
8,996 |
|
Total operating expenses |
|
|
14,878 |
|
|
|
8,768 |
|
|
|
50,860 |
|
|
|
37,025 |
|
Loss from operations |
|
|
(13,878 |
) |
|
|
(8,768 |
) |
|
|
(49,860 |
) |
|
|
(37,025 |
) |
Interest income |
|
|
55 |
|
|
|
2 |
|
|
|
170 |
|
|
|
55 |
|
Change in fair value of loans payable |
|
|
— |
|
|
|
(521 |
) |
|
|
— |
|
|
|
(2,887 |
) |
Other income, net |
|
|
10 |
|
|
|
69 |
|
|
|
40 |
|
|
|
99 |
|
Loss before income taxes |
|
|
(13,813 |
) |
|
|
(9,218 |
) |
|
|
(49,650 |
) |
|
|
(39,758 |
) |
Income tax expense |
|
|
(435 |
) |
|
|
(711 |
) |
|
|
(508 |
) |
|
|
(813 |
) |
Net loss |
|
|
(14,248 |
) |
|
|
(9,929 |
) |
|
|
(50,158 |
) |
|
|
(40,571 |
) |
Extinguishment of Series B convertible preferred stock |
|
|
— |
|
|
|
10,701 |
|
|
|
— |
|
|
|
10,701 |
|
Net loss attributable to noncontrolling interest |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(518 |
) |
Series A and C participating preferred stock |
|
|
— |
|
|
|
(772 |
) |
|
|
— |
|
|
|
— |
|
Net loss attributable to common stockholders - basic |
|
$ |
(14,248 |
) |
|
$ |
— |
|
|
$ |
(50,158 |
) |
|
$ |
(29,352 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Extinguishment of Series B convertible preferred stock |
|
|
— |
|
|
|
(10,701 |
) |
|
|
— |
|
|
|
— |
|
Net loss attributable to common stockholders - diluted |
|
$ |
(14,248 |
) |
|
$ |
(10,701 |
) |
|
$ |
(50,158 |
) |
|
$ |
(29,352 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to common stockholders, basic |
|
$ |
(0.56 |
) |
|
$ |
— |
|
|
$ |
(2.21 |
) |
|
$ |
(102.93 |
) |
Weighted average common stock outstanding, basic |
|
|
25,267,527 |
|
|
|
328,941 |
|
|
|
22,705,948 |
|
|
|
285,162 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to common stockholders, diluted |
|
$ |
(0.56 |
) |
|
$ |
(3.65 |
) |
|
$ |
(2.21 |
) |
|
$ |
(102.93 |
) |
Weighted average common stock outstanding, diluted |
|
|
25,267,527 |
|
|
|
2,929,586 |
|
|
|
22,705,948 |
|
|
|
285,162 |
|
Terns Pharmaceuticals, Inc.
Selected Balance Sheet Data
(Unaudited; in thousands)
|
|
December 31, |
|
|||||
|
|
2021 |
|
|
2020 |
|
||
Cash, cash equivalents and marketable securities |
|
$ |
165,982 |
|
|
$ |
74,854 |
|
Total assets |
|
|
168,070 |
|
|
|
92,290 |
|
Total liabilities |
|
|
7,767 |
|
|
|
23,698 |
|
Preferred stock |
|
|
— |
|
|
|
186,033 |
|
Total stockholders’ equity (deficit) |
|
|
160,303 |
|
|
|
(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 to address serious diseases such as NASH and obesity. 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 planned Phase 2a trial of TERN-101 and TERN-501 and the ongoing Phase 1b 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 serious diseases such as NASH and obesity, as well as other indications that may be targeted by the Company; the potential utility and progress of the Company’s product candidates in NASH and other targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the Company’s clinical and preclinical 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, June 30, 2021 and September 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