Terns Pharmaceuticals Reports Second Quarter 2021 Financial Results and Corporate Highlights
August 16 2021 - 4:05PM
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:
- 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
- Indicators of pharmacokinetic stability
- Safety and tolerability
- Received Fast Track Designation (FTD) from the U.S. FDA in June
2021
- Provides eligibility for more frequent FDA interactions,
accelerated approval and priority review
- 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:
- Key efficacy readout in corrected T1 (cT1), an imaging marker
of liver inflammation and fibrosis linked to clinical outcomes
- 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:
- First FXR agonist trial to demonstrate no discontinuations due
to adverse events, including pruritus
- 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
- 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
June 30, |
|
Six Months Ended
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 PharmaceuticalsTerns
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
StatementsThis 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
Terns Pharmaceuticals (NASDAQ:TERN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Terns Pharmaceuticals (NASDAQ:TERN)
Historical Stock Chart
From Sep 2023 to Sep 2024