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 first quarter ended March 31, 2021 and
provided a corporate update.
“Our development team has continued to rapidly advance our NASH
clinical programs, with top-line data for the Phase 2a LIFT study
of FXR agonist TERN-101 in NASH now accelerated into June 2021. In
the LIFT study, in addition to safety and tolerability, we are
assessing multiple non-invasive endpoints, including MRI-PDFF
(proton density fat fraction), a marker of steatosis, as well as
ELF (enhanced liver fibrosis) and cT1 (MRI corrected T1) which are
markers of fibrosis and/or inflammation linked to clinical outcomes
and histological improvements in chronic liver diseases,” said
Senthil Sundaram, CEO at Terns. “In March, we initiated our first
clinical trial of TERN-501 and look forward to announcing top-line
data in the second half of 2021 that we hope will provide clinical
confirmation of its high metabolic stability and differentiated
pharmacokinetic profile.”
Recent Developments and Anticipated 2021
Milestones TERN-101: Liver-distributed farnesoid X
receptor (FXR) agonist
- Completed patient enrollment in the Phase 2a LIFT study in NASH
patients in January 2021
- Expecting top-line data from the Phase 2a LIFT study in June
2021
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist
- Initiated dosing in a first-in-human Phase 1 SAD/MAD clinical
trial in March 2021
- Expecting top-line data from the ongoing Phase 1 trial in
2H21
- Composition of matter claims allowed by USPTO
TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor
- Expecting to initiate dosing in 12-week Phase 1b clinical trial
in NASH patients in 1H21 with expected top-line data in 1H22
GLP1-R: Oral, small-molecule receptor agonist
- Expecting to nominate a final candidate in 2H21 for further
development
Strengthened balance sheet
- Completed an oversubscribed and upsized $147 million initial
public offering in February 2021
- Cash and equivalents support operations into 2024
Terns also announced today that Erin Quirk, M.D., will assume
the position of Head of Research & Development, in addition to
President and Chief Medical Officer, effective immediately. Weidong
Zhong, Ph.D. will be leaving his position as Chief Scientific
Officer and board member, effective as of July 2, 2021. In the
interim, Dr. Zhong will continue to support Dr. Quirk to ensure a
smooth transition.
Mr. Sundaram continued, “On behalf of our board and our
entire team, I would like to thank Weidong for all of the
contributions he made in founding Terns but also in successfully
building and advancing our diverse NASH pipeline. At the same time,
we are pleased to expand Erin’s title in recognition of her ongoing
role in leading our research, development and manufacturing teams,
which she has done since 2020. With Erin’s leadership, I am
confident that we are well positioned to continue to advance our
current and future pipeline candidates through all stages of
research and development.”
First Quarter Financial Results
- Cash Position: As of March 31, 2021,
cash, cash equivalents and marketable securities were $195.6
million as compared with $74.9 million as
of December 31, 2020. Based on its current operating plan,
Terns expects these will be sufficient to fund its planned
operating expenses into 2024.
- Research and Development (R&D)
Expenses: R&D expenses were $8.7 million for
the quarter ended March 31, 2021, as compared with $7.2
million for the quarter ended March 31, 2020.
- General and Administrative (G&A)
Expenses: G&A expenses were $4.6 million for
the quarter ended March 31, 2021, as compared with $2.2
million for the quarter ended March 31, 2020.
- Net Loss: Net loss was $13.3
million for the quarter ended March 31, 2021, as compared
with $9.2 million for the quarter ended March 31,
2020.
Terns Pharmaceuticals, Inc. |
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Condensed Consolidated Statements of
Operations |
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(Unaudited; in thousands except share and per share
amounts) |
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Three Months Ended March 31, |
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2021 |
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2020 |
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Operating
expenses: |
|
|
|
|
|
Research and development |
|
$ |
8,735 |
|
|
$ |
7,244 |
|
|
General and administrative |
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4,561 |
|
|
|
2,179 |
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Total
operating expenses |
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13,296 |
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|
|
9,423 |
|
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Loss from
operations |
|
|
(13,296 |
) |
|
|
(9,423 |
) |
|
Interest income |
|
|
11 |
|
|
|
50 |
|
|
Other (expense) income, net |
|
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(13 |
) |
|
|
167 |
|
|
Loss before
income tax expense |
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(13,298 |
) |
|
|
(9,206 |
) |
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Income tax expense |
|
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(39 |
) |
|
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- |
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Net
loss |
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(13,337 |
) |
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(9,206 |
) |
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Net loss
attributable to noncontrolling interest |
|
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- |
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(205 |
) |
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Net loss
attributable to common stockholders - basic and diluted |
|
$ |
(13,337 |
) |
|
$ |
(9,001 |
) |
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Net loss per
share attributable to common stockholders, basic and diluted |
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$ |
(0.88 |
) |
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$ |
(41.69 |
) |
|
Weighted
average common stock outstanding, basic and diluted |
|
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15,160,046 |
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|
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215,890 |
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Terns Pharmaceuticals, Inc. |
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Selected Balance Sheet Data |
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(Unaudited; in thousands) |
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March 31, 2021 |
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December 31, 2020 |
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Cash, cash equivalents and marketable securities |
|
$ |
195,581 |
|
$ |
74,854 |
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Total
assets |
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199,241 |
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92,290 |
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Total
liabilities |
|
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9,239 |
|
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23,698 |
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Preferred
stock |
|
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- |
|
|
186,033 |
|
|
Total
stockholders’ equity (deficit) |
|
|
190,002 |
|
|
(117,441 |
) |
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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’
programs are 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 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; the
potential utility and progress of the Company’s product candidates
in NASH; and the sufficiency of our cash on hand to fund our
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. Except as required by
law, the Company undertakes no obligation to update publicly any
forward-looking statements for any reason.
Contacts for Terns
InvestorsJustin Nginvestors@ternspharma.com
MediaCory Trombleemedia@ternspharma.com
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