Terns Pharmaceuticals Reports Third Quarter 2021 Financial Results and Corporate Highlights
November 15 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 to address serious diseases such as non-alcoholic
steatohepatitis (NASH), today reported financial results for the
third quarter ended September 30, 2021 and corporate highlights.
“Recent positive clinical data for TERN-101 and TERN-501
presented at AASLD validate part one of Terns’ strategy, which is
demonstrating monotherapy proof of concept. Notably, TERN-501
produced significant and dose-dependent changes in sex hormone
binding globulin (SHBG), a marker of target engagement linked to
NASH efficacy, suggesting that it has potential to be a
best-in-class THR-β agonist. We look forward to the top-line data
readout from the AVIATION Trial of TERN-201 in the first quarter of
2022, which could mark our third clinical candidate with promising
monotherapy data,” said Senthil Sundaram, chief executive officer
at Terns. “I am proud of the quality of execution at Terns and the
momentum with which we are advancing our pipeline towards the
second part of our strategy: achieving compelling and
differentiated efficacy results in studies involving multiple
clinically validated mechanisms of action. With this goal in mind,
we are excited to move towards the planned initiation in the first
half of 2022 of Terns’ first clinical trial in NASH patients
including both monotherapy and combination arms of TERN-101 and
TERN-501.”
Recent Developments and Anticipated
Milestones
TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor
- Fully enrolled Part 1 of Phase 1b AVIATION Trial in NASH in
September 2021
- Top-line data from AVIATION Part 1 expected in 1Q 2022,
including:
- Key efficacy readout in corrected T1 (cT1) levels, an imaging
marker of liver inflammation and fibrosis linked to clinical
outcomes
- Safety, tolerability and plasma VAP-1 activity
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist
- Reported positive top-line data from Phase 1 proof of concept
clinical trial in November 2021, including a presentation at AASLD
2021 demonstrating:
- Significant, dose-dependent effects on SHBG, a key
pharmacodynamic marker of THR-β engagement linked to NASH
histologic efficacy
- TERN-501 was generally safe and well-tolerated with a
predictable pharmacokinetic (PK) profile with low variability
- Significant, dose-dependent reductions in atherogenic lipids
including low-density lipoprotein (LDL) cholesterol and
apolipoprotein B (Apo-B) in all TERN-501 dose groups compared to
placebo
- The safety, PK and PD results support continued development of
TERN-501 and indicate that it is well-suited for co-formulation
with other small molecule NASH agents as an oral, once-daily fixed
dose combination
- Data support plans to initiate in 1H 2022 Terns’ first NASH
trial of a THR-β agonist (TERN-501) alone and in combination with a
farnesoid X receptor (FXR) agonist (TERN-101)
TERN-101: Liver-distributed FXR agonist
- Presented positive data from Phase 2a LIFT clinical trial in
NASH at AASLD’s The Liver Meeting® Digital Experience 2021, which
demonstrated:
- cT1 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 10 and 15 mg groups of TERN-101, numerical reductions in
alanine aminotransferase (ALT) and MRI protein density fat fraction
(MRI-PDFF) were observed, with significant reductions in gamma
glutamyl transferase (GGT) in all dose groups
- TERN-101 was overall safe and well-tolerated at all doses
studied with no discontinuations due to adverse events, including
pruritus
- In 5 and 10 mg groups of TERN-101, no differences from placebo
in LDL cholesterol and high-density lipoprotein (HDL) cholesterol
percentage change from baseline to Week 12 were observed
GLP1-R: Oral, small-molecule glucagon-like peptide-1 (GLP1)
receptor agonist
- Driven by computational interaction mapping, chemical synthesis
and in vitro characterization of approximately 100 GLP-1R agonist
compounds; lead candidates currently undergoing higher species in
vivo profiling
- Synthetic GLP-1 peptides have been approved for indication such
as diabetes and obesity, which are conditions often accompanying
NASH
- Development candidate anticipated to be designated as TERN-601
in 4Q 2021
Key Appointments
- 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
Third Quarter Financial Results
- Cash Position: As of September 30, 2021, cash,
cash equivalents and marketable securities were $177.2 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 $7.2 million for the quarter ended September
30, 2021, as compared with $5.4 million for the quarter ended
September 30, 2020
- General and Administrative (G&A) Expenses:
G&A expenses were $4.7 million for the quarter ended September
30, 2021, as compared with $3.3 million for the quarter ended
September 30, 2020
- Net Loss: Net loss was $11.8 million for the
quarter ended September 30, 2021, as compared with $11.6 million
for the quarter ended September 30, 2020
|
Terns Pharmaceuticals, Inc. |
Condensed
Consolidated Statements of Operations |
(Unaudited; in thousands except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
7,153 |
|
|
$ |
5,404 |
|
|
$ |
21,849 |
|
|
$ |
20,259 |
|
General and administrative |
|
4,715 |
|
|
|
3,333 |
|
|
|
14,133 |
|
|
|
7,998 |
|
Total operating expenses |
|
11,868 |
|
|
|
8,737 |
|
|
|
35,982 |
|
|
|
28,257 |
|
Loss from operations |
|
(11,868 |
) |
|
|
(8,737 |
) |
|
|
(35,982 |
) |
|
|
(28,257 |
) |
Interest income |
|
49 |
|
|
|
1 |
|
|
|
115 |
|
|
|
53 |
|
Change in fair value of loans payable |
|
- |
|
|
|
(2,366 |
) |
|
|
- |
|
|
|
(2,366 |
) |
Other income (expense), net |
|
4 |
|
|
|
(387 |
) |
|
|
30 |
|
|
|
30 |
|
Loss before income tax
expense |
|
(11,815 |
) |
|
|
(11,489 |
) |
|
|
(35,837 |
) |
|
|
(30,540 |
) |
Income tax expense |
|
(20 |
) |
|
|
(102 |
) |
|
|
(73 |
) |
|
|
(102 |
) |
Net loss |
|
(11,835 |
) |
|
|
(11,591 |
) |
|
|
(35,910 |
) |
|
|
(30,642 |
) |
Net loss attributable to
noncontrolling interest |
|
- |
|
|
|
(156 |
) |
|
|
- |
|
|
|
(518 |
) |
Net loss attributable to
common stockholders - basic and diluted |
$ |
(11,835 |
) |
|
$ |
(11,435 |
) |
|
$ |
(35,910 |
) |
|
$ |
(30,124 |
) |
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.47 |
) |
|
$ |
(37.82 |
) |
|
$ |
(1.64 |
) |
|
$ |
(111.38 |
) |
Weighted average common stock
outstanding, basic and diluted |
|
25,148,336 |
|
|
|
302,336 |
|
|
|
21,842,706 |
|
|
|
270,463 |
|
Terns Pharmaceuticals, Inc. |
|
|
|
Selected Balance Sheet
Data |
|
|
|
(Unaudited; in thousands) |
|
|
|
|
|
|
|
|
September 30, 2021 |
|
December 31, 2020 |
Cash, cash equivalents and marketable securities |
$ |
177,196 |
|
$ |
74,854 |
|
Total assets |
|
179,890 |
|
|
92,290 |
|
Total liabilities |
|
7,734 |
|
|
23,698 |
|
Preferred stock |
|
- |
|
|
186,033 |
|
Total stockholders’ equity
(deficit) |
|
172,156 |
|
|
(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 to address serious diseases such as
non-alcoholic steatohepatitis, or NASH. 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 combination trial of TERN-101
and TERN-501 and the 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
NASH; 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 Company’s clinical trials; the
Company’s clinical 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 and June 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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