Terns Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update
March 30 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 fourth quarter and full year ended December
31, 2020 and provided a corporate update.
2020 Business Highlights and Recent
Developments
TERN-101 - Liver-distributed farnesoid X receptor (FXR)
agonist
- Completed patient enrollment in the Phase 2a LIFT study in
January 2021; reported final results from a Phase 1 clinical trial,
which confirmed sustained liver FXR activation and a favorable
tolerability profile
TERN-201 - Vascular adhesion protein-1 (VAP-1) inhibitor
- Reported positive results from the completed Phase 1 SAD/MAD
clinical trial that demonstrated robust and sustained target
engagement and tolerability
TERN-501 - Thyroid hormone receptor-beta (THR-β) agonist
- Initiated dosing in a first-in-human Phase 1 SAD/MAD clinical
trial
Expanded board of directors
- Appointed three industry leaders to the board of directors:
David Fellows, most recently Chief Executive Officer (CEO) of
Nightstar Therapeutics, Jeff Kindler, CEO of Centrexion
Therapeutics and former CEO of Pfizer, and Jill M. Quigley Chief
Operating Officer at Passage Bio
Key management team appointments
- Added Senthil Sundaram, formerly Chief Financial Officer (CFO)
of Nightstar Therapeutics, as CEO and Board Director, Mark Vignola,
Ph.D., formerly CFO of Applied Therapeutics, as CFO, and Bryan
Yoon, formerly Chief Administrative Officer, General Counsel and
Secretary of LogicBio Therapeutics, as Chief Operating Officer and
General Counsel, and promoted Erin Quirk, M.D., to President
Strengthened balance sheet
- Closed an $87 million Series C financing led by Deerfield
Management Company alongside a strategic equity investment from Eli
Lilly and Company in December 2020 and completed an upsized $147
million initial public offering in February 2021
Anticipated 2021 Milestones
TERN-101
- Report top-line data from the ongoing Phase 2a LIFT study in
NASH patients in July 2021
TERN-201
- Initiate 12-week Phase 1b clinical trial in NASH patients in
1H21 with expected top-line data in 1H22
TERN-501
- Report top-line data from the ongoing Phase 1 trial in
2H21
GLP1-R agonist (oral):
- Nominate a final candidate for further development in NASH in
2H21
“2020 was a year of significant growth and momentum at Terns,
during which the team made tremendous progress advancing our
pipeline of single-agent and combination NASH therapies which in
turn allowed us to significantly strengthen our financial
position,” said Senthil Sundaram, CEO at Terns. “With the recent
initiation of our Phase 1 clinical trial of TERN-501, we now have
three clinical-stage NASH programs focused on clinically validated
targets. As we look ahead to 2021 and 2022, we anticipate data
readouts for all three of our ongoing clinical programs and look
forward to initiating our first combination clinical trial of
TERN-101 and TERN-501 – all with the goal of developing
best-in-class therapies we hope can change the lives of people with
NASH.”
Full Year and Fourth Quarter Financial
Results
- Cash, Cash Equivalents and Investments
Position: As of December 31, 2020, cash, cash
equivalents and investments were $74.9 million as
compared with $19.7 million as of December 31, 2019.
Based on its current operating plan, Terns expects its cash and
cash equivalents will be sufficient to fund its planned operating
expenses into 2024.
- Research and Development (R&D)
Expenses: R&D expenses were $7.8
million and $28.0 million for the quarter and year
ended December 31, 2020, respectively, as compared
with $7.6 million and $61.5 million for the
quarter and year ended December 31, 2019, respectively.
- General and Administrative (G&A)
Expenses: G&A expenses were $1.0
million and $9.0 million for the quarter and year
ended December 31, 2020, respectively, as compared
with $2.4 million and $8.7 million for the
quarter and year ended December 31, 2019, respectively.
- Net Loss: Net loss was $9.9 million
and $40.6 million for the quarter and year
ended December 31, 2020, respectively, as compared
with $10.0 million and $68.8 million for the quarter
and year ended December 31, 2019, respectively.
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Terns Pharmaceuticals, Inc. |
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Consolidated Statements of Operations |
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(Unaudited; in thousands except share and per share
amounts) |
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Quarter Ended December 31, |
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Year Ended December 31, |
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2020 |
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2019 |
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2020 |
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2019 |
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Operating
expenses: |
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Research and development |
$ |
7,770 |
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$ |
7,556 |
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$ |
28,029 |
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$ |
61,534 |
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General and administrative |
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998 |
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2,388 |
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8,996 |
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8,663 |
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Total
operating expenses |
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8,768 |
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9,944 |
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37,025 |
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70,197 |
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Loss from
operations |
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(8,768 |
) |
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(9,944 |
) |
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(37,025 |
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(70,197 |
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Interest income |
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2 |
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107 |
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55 |
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1,204 |
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Change in fair value of loans payable |
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(521 |
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- |
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(2,887 |
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- |
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Other income (expense), net |
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69 |
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(207 |
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99 |
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154 |
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Loss
before income tax (expense) benefit |
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(9,218 |
) |
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(10,044 |
) |
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(39,758 |
) |
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(68,839 |
) |
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Income tax (expense) benefit |
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(711 |
) |
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(2 |
) |
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(813 |
) |
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20 |
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Net
loss |
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(9,929 |
) |
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(10,046 |
) |
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(40,571 |
) |
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(68,819 |
) |
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Extinguishment of Series B convertible preferred stock |
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10,701 |
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- |
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10,701 |
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- |
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Net loss
attributable to noncontrolling interest |
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- |
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(271 |
) |
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(518 |
) |
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(208 |
) |
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Series A
and C participating preferred stock |
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(772 |
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- |
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- |
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- |
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Net loss
attributable to common stockholders - basic |
$ |
- |
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$ |
(9,775 |
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$ |
(29,352 |
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$ |
(68,611 |
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Effect of
dilutive securities: |
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Extinguishment of Series B convertible preferred stock |
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(10,701 |
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- |
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- |
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- |
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Net loss
attributable to common stockholders - diluted |
$ |
(10,701 |
) |
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$ |
(9,775 |
) |
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$ |
(29,352 |
) |
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$ |
(68,611 |
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Net loss
per share attributable to common stockholders, basic |
$ |
- |
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$ |
(45.28 |
) |
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$ |
(102.93 |
) |
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$ |
(374.39 |
) |
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Weighted
average common stock outstanding, basic |
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328,941 |
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215,890 |
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285,162 |
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183,262 |
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Net loss
per share attributable to common stockholders, diluted |
$ |
(3.65 |
) |
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$ |
(45.28 |
) |
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$ |
(102.93 |
) |
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$ |
(374.39 |
) |
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Weighted
average common stock outstanding, diluted |
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2,929,586 |
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215,890 |
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285,162 |
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183,262 |
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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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December 31, |
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2020 |
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2019 |
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Cash,
cash equivalents and investments |
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$ |
74,854 |
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$ |
19,650 |
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Total
assets |
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92,290 |
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23,904 |
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Total
liabilities |
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23,698 |
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5,580 |
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Preferred
stock and noncontrolling interest |
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186,033 |
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109,084 |
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Stockholders’ deficit |
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(117,441 |
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(90,760 |
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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 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, 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 prospectus
dated February 4, 2021. Except as required by law, the Company
undertakes no obligation to update publicly any forward-looking
statements for any reason.
Contacts for Terns
InvestorsMark Vignola
investors@ternspharma.com
MediaCory
Trombleemedia@ternspharma.com
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