Terns Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Highlights
March 03 2022 - 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 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
- Top-line data from AVIATION Trial Part 1 (10 mg) and Part 2 (20
mg) expected in March 2022 and the second half of 2022,
respectively, including:
- Safety and tolerability
- Key imaging endpoint: Corrected T1 (cT1), an imaging marker of
liver inflammation and fibrosis linked to clinical outcomes
- Serum markers: CK-18, ALT, plasma VAP-1 activity
- Initiated Part 2 of Phase 1b AVIATION Trial in the first
quarter of 2022
- Part 2 will evaluate 20 mg of TERN-201 vs placebo for 12
weeks
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist
- Announced positive top-line single-ascending and
multiple-ascending dose (SAD/MAD) data from Phase 1 proof of
concept clinical trial in November 2021, including a presentation
of SAD data at AASLD’s The Liver Meeting® Digital Experience 2021,
demonstrating:
- Significant, dose-dependent effects on sex hormone binding
globulin (SHBG), a key pharmacodynamic marker of THR-β engagement
linked to NASH histologic efficacy
- TERN-501 was generally well-tolerated
- Predictable pharmacokinetic profile with low variability and
median half-life supportive of once-daily dosing
- Potential to be a best-in-class THR-β agonist monotherapy and
the THR-β agonist of choice for coformulations of fixed-dose
combinations for the treatment of NASH
- Data support planned initiation in 1H 2022 of Terns’ first
Phase 2a trial of TERN-501 alone and in combination with farnesoid
X receptor (FXR) agonist TERN-101 in NASH patients with top-line
data expected in 2H 2023
TERN-101: Liver-distributed FXR agonist
- Announced positive data from Phase 2a LIFT Trial in NASH in
June 2021, including multiple presentations at AASLD in November
2021, demonstrating:
- TERN-101 was generally well-tolerated at all doses studied with
no discontinuations due to adverse events, including pruritus
- cT1, an imaging marker of liver inflammation and fibrosis
linked to clinical outcomes, declined significantly as early as
Week 6 with persistent decreases through Week 12 in all TERN-101
groups compared to placebo, with cT1 changes at Week 6 strongly
correlated with changes at Week 12
- TERN-101 treatment led to study population shifts to cT1
categories associated with lower risk of clinical events in chronic
liver disease patients
- In 5 and 10 mg groups of TERN-101, no differences from placebo
in percentage change of low-density lipoprotein cholesterol and
high-density lipoprotein cholesterol from baseline to Week 12
- Data support planned initiation in 1H 2022 of Terns’ first
Phase 2a trial of TERN-101 alone and in combination with THR-β
agonist TERN-501 in NASH patients with top-line data expected in 2H
2023
TERN-601: Glucagon-like peptide-1 (GLP1) receptor agonist
- TERN-601 candidate nominated at year-end 2021 as an oral,
small-molecule GLP-1 receptor agonist targeting metabolic diseases
such as obesity and NASH with the potential for once-daily dosing
- Synthetic GLP-1 peptides have been approved for indications
such as diabetes and obesity, which are conditions often
accompanying NASH
- Terns plans to engage in IND-enabling activities for TERN-601
with the goal of initiating a first-in-human clinical trial in
2023
Key Appointments
- Diana Chung was promoted to senior vice president, chief
development officer in January 2022, and was previously senior vice
president, clinical development and operations at Terns
- Jeffrey Jasper, Ph.D. joined Terns in December 2021 as senior
vice president, head of research, bringing more than 28 years of
experience in the biopharmaceutical industry
- Ann E. Taylor, M.D. joined the Board of Directors in September
2021, bringing more than 35 years of experience in drug
development, having served most recently as chief medical officer
of AstraZeneca plc
- Pamela Danagher joined Terns as vice president and head of
regulatory affairs in August 2021, bringing more than 20 years of
experience in the pharmaceutical and biotechnology sectors
- Terns was appointed to the Steering Committee of the NAIL-NIT
Consortium, a multi-stakeholder effort to link non-invasive tests
(NITs) directly to liver-related outcomes and accelerate the usage
of NITs as surrogate endpoints for NASH
Fourth Quarter and Full Year Financial
Results
- Cash Position: As of December 31, 2021, cash,
cash equivalents and marketable securities were $166.0 million as
compared with $74.9 million as of December 31, 2020. Terns
completed an upsized initial public offering in February 2021,
raising $146.6 million in gross proceeds. Based on its current
operating plan, Terns expects these funds will be sufficient to
support its planned operating expenses into 2024, including through
the clinical readout of its planned NASH Phase 2a combination trial
of TERN-501 and TERN-101.
- Research and Development (R&D) Expenses:
R&D expenses were $9.5 million and $31.3 million for the
quarter and year ended December 31, 2021, respectively, as compared
with $7.8 million and $28.0 million for the quarter and year ended
December 31, 2020, respectively.
- General and Administrative (G&A) Expenses:
G&A expenses were $5.4 million and $19.5 million for the
quarter and year ended December 31, 2021, respectively, as compared
with $1.0 million and $9.0 million for the quarter and year ended
December 31, 2020, respectively.
- Net Loss: Net loss was $14.2 million and $50.2
million for the quarter and year ended December 31, 2021,
respectively, as compared with $9.9 million and $40.6 million for
the quarter and year ended December 31, 2020, respectively.
Terns Pharmaceuticals, Inc. |
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Consolidated Statements of Operations |
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(Unaudited; in thousands except share and per share
amounts) |
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Quarter Ended December 31, |
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Year Ended December 31, |
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2021 |
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2020 |
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2021 |
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2020 |
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Revenue: |
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License revenue |
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$ |
1,000 |
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$ |
— |
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$ |
1,000 |
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$ |
— |
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Operating
expenses: |
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Research and development |
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9,462 |
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7,770 |
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31,311 |
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28,029 |
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General and administrative |
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5,416 |
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|
998 |
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19,549 |
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8,996 |
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Total
operating expenses |
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14,878 |
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8,768 |
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50,860 |
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37,025 |
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Loss from
operations |
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(13,878 |
) |
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(8,768 |
) |
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(49,860 |
) |
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(37,025 |
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Interest income |
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55 |
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2 |
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170 |
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55 |
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Change in fair value of loans payable |
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— |
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(521 |
) |
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— |
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(2,887 |
) |
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Other income, net |
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10 |
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69 |
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40 |
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99 |
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Loss before
income taxes |
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(13,813 |
) |
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(9,218 |
) |
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(49,650 |
) |
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(39,758 |
) |
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Income tax expense |
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(435 |
) |
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(711 |
) |
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(508 |
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(813 |
) |
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Net
loss |
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(14,248 |
) |
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(9,929 |
) |
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(50,158 |
) |
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(40,571 |
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Extinguishment of Series B convertible preferred stock |
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— |
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10,701 |
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— |
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10,701 |
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Net loss
attributable to noncontrolling interest |
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— |
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— |
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— |
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(518 |
) |
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Series A and
C participating preferred stock |
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— |
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(772 |
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— |
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— |
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Net loss
attributable to common stockholders - basic |
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$ |
(14,248 |
) |
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$ |
— |
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$ |
(50,158 |
) |
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$ |
(29,352 |
) |
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Effect of
dilutive securities: |
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Extinguishment of Series B convertible preferred stock |
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— |
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(10,701 |
) |
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— |
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— |
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Net loss
attributable to common stockholders - diluted |
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$ |
(14,248 |
) |
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$ |
(10,701 |
) |
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$ |
(50,158 |
) |
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$ |
(29,352 |
) |
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Net loss per
share attributable to common stockholders, basic |
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$ |
(0.56 |
) |
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$ |
— |
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$ |
(2.21 |
) |
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$ |
(102.93 |
) |
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Weighted
average common stock outstanding, basic |
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25,267,527 |
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328,941 |
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22,705,948 |
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285,162 |
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Net loss per
share attributable to common stockholders, diluted |
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$ |
(0.56 |
) |
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$ |
(3.65 |
) |
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$ |
(2.21 |
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$ |
(102.93 |
) |
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Weighted
average common stock outstanding, diluted |
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25,267,527 |
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2,929,586 |
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22,705,948 |
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285,162 |
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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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2021 |
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2020 |
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Cash, cash
equivalents and marketable securities |
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$ |
165,982 |
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$ |
74,854 |
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Total
assets |
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168,070 |
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92,290 |
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Total
liabilities |
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7,767 |
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23,698 |
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Preferred
stock |
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— |
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186,033 |
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Total
stockholders’ equity (deficit) |
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160,303 |
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(117,441 |
) |
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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
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, 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
InvestorsJustin Nginvestors@ternspharma.com
MediaJenna UrbanBerry & Company Public
Relationsmedia@ternspharma.com
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