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), obesity and cancer, today reported
financial results for the first quarter ended March 31, 2022 and
business updates.
“The Terns team has continued to advance our pipeline with the
opening of our combination therapy IND for NASH and the
commencement of key IND-enabling activities in our GLP-1 program in
obesity, along with the initiation of a clinical trial for TERN-701
in chronic myeloid leukemia by Hansoh, our development partner in
China,” said Senthil Sundaram, chief executive officer at Terns.
“As we continue this momentum across our diverse pipeline, we
remain committed to a prudent approach to funding our operations.
Following a strategic review of our pipeline, we have decided to
focus our resources on advancing our most promising pipeline
candidates: (1) TERN-501, including combination therapy development
with TERN-101, (2) TERN-601, our oral, small-molecule GLP-1
candidate, and (3) supporting our partner’s clinical development of
TERN-701 for CML in China. This decision extends our expected cash
runway into 2025, enabling key expected clinical trial readouts
across three indications for TERN-501, TERN-601, and TERN-701
during that time period.”
Recent Developments and Anticipated
Milestones
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist for
NASH
- TERN-501 is a THR-β agonist with high metabolic stability,
enhanced liver distribution and greater selectivity for THR-β
compared to other THR-β agonists in development
- Investigational new drug (IND) application for Terns’ NASH
combination therapy program was opened in April 2022, supporting
the planned Phase 2a clinical trial of TERN-501 as monotherapy and
in combination with TERN-101 (Terns’ liver-distributed farnesoid X
receptor (FXR) agonist), as well as future studies of other
combination therapy regimens
- The Phase 2a trial is a multicenter, randomized, double-blind,
placebo-controlled clinical trial in noncirrhotic NASH patients
using a factorial design including both monotherapy and combination
arms of TERN-501 and TERN-101
- The trial is expected to enroll approximately 140 adult
patients with elevated body mass index (BMI ≥ 25 kg/m2) and NASH
with fibrosis, but not cirrhosis, based on prior liver biopsy
and/or imaging and clinical criteria
- All patients must have liver fat content measured by magnetic
resonance imaging proton density fat fraction (MRI-PDFF) of ≥10%,
MRI corrected T1 (cT1) relaxation time of ≥ 800 msec, and meet
other inclusion and exclusion criteria
- The trial includes a 12-week treatment period and a 4-week
follow-up period
- The primary endpoint will be the relative change from baseline
in MRI-PDFF at Week 12 for TERN-501 monotherapy compared with
placebo
- Secondary endpoints include assessment of changes in MRI-PDFF
(combination vs. placebo) and cT1 (TERN-501 monotherapy vs. placebo
as well as 501+101 combination vs. placebo)
- IND has been opened in the United States; Phase 2a trial has
been initiated with screening expected to start in June 2022, and
top-line data expected in the second half of 2023
TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1)
receptor agonist for obesity
- TERN-601 is an oral small-molecule glucagon-like peptide-1
receptor, or GLP-1R, agonist for the treatment of obesity
- Terns screened more than 20,000 molecular permutations through
its proprietary quantitative structure activity relationship (QSAR)
model to identify suitable small-molecule scaffolds with
potentially improved properties relative to other GLP-1-based
approaches
- Terns has identified structures believed to be suitable for
oral administration as a single-agent or in combination with other
drug candidates within its pipeline
- IND-enabling activities for TERN-601, Terns’ lead GLP-1R
development candidate, are underway with the goal of initiating a
first-in-human clinical trial in 2023
- The Phase 1 clinical program for TERN-601 is expected to
include a single ascending dose trial in healthy volunteers and a
multiple ascending dose proof-of-concept trial assessing potential
endpoints such as body weight and HbA1c
TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor
(TKI) for chronic myeloid leukemia
- TERN-701 is Terns’ proprietary, allosteric BCR-ABL TKI,
designed to target the ABL myristoyl pocket, which is in
development for the treatment of chronic myeloid leukemia (CML), a
form of cancer that begins in the bone marrow
- TERN-701 was designed with the goal of achieving improved tumor
suppression against a broader range of mutations, an enhanced
pharmacokinetic profile with an increased half-life and simplified
dosing compared to the only available allosteric BCR-ABL TKI,
recently approved by the FDA
- TERN-701 is out-licensed to Hansoh Pharmaceutical Group Company
Limited for development in the greater China region (referred to as
HS-10382 by Hansoh); Terns retains all worldwide development and
commercialization rights outside of greater China, as well as
access to data generated by Hansoh in China
- A Phase 1 trial of TERN-701 in CML patients in China has been
initiated by Hansoh, with patient dosing currently underway; Hansoh
is responsible for all development and commercialization-related
activities in greater China
- Terns plans to explore options for the development and
commercialization of TERN-701 outside of greater China, including
additional strategic partnerships
TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor
- Terns reported top-line results from Part 1 of the Phase 1b
AVIATION Trial in March 2022
- Part 1 of the AVIATION Trial met the primary safety endpoint:
TERN-201 10 mg administered once daily to NASH patients was
generally safe and well-tolerated with no meaningful changes in
exploratory serum or imaging NASH biomarkers, including cT1
- Further spend for TERN-201 in NASH has primarily been limited
to the completion of Part 2 (20 mg dose) of the ongoing AVIATION
Trial with results expected in 4Q 2022; Terns plans to evaluate all
AVIATION data at that point to inform next steps for clinical
development in NASH or other indications where VAP-1 is
implicated
Business Update
- Terns completed a proactive and financially disciplined review
of the Company’s operations, resulting in the prioritization of
resources towards development activities related to TERN-501
(including the planned Phase 2a clinical trial of TERN-501 as
monotherapy and in combination with TERN-101) and the GLP-1R
agonist program, including TERN-601, and supporting Hansoh's
clinical development of TERN-701 for CML in China
- As a result of these decisions, Terns anticipates existing cash
to be sufficient to fund operations into 2025, including three
expected clinical trial readouts for three product candidates
across three indications during that time period
Upcoming Investor Events
- Terns will present at the UBS Global Healthcare Conference on
Monday, May 23, 2022 at 8:30am ET. A live webcast of the event will
be available on the investor relations page of the Terns
Pharmaceuticals website at http://ir.ternspharma.com. A replay of
the webcast will be archived on Terns’ website for 30 days
following the presentation
First Quarter 2022 Financial Results
- Cash Position: As of March 31, 2022, cash,
cash equivalents and marketable securities were $151.3 million, as
compared with $166.0 million as of December 31, 2021. Based on its
current operating plan, Terns expects these funds will be
sufficient to support its planned operating expenses into
2025.
- Research and Development (R&D) Expenses:
R&D expenses were $8.1 million for the quarter ended March 31,
2022, as compared with $8.7 million for the quarter ended March 31,
2021.
- General and Administrative (G&A) Expenses:
G&A expenses were $5.7 million for the quarter ended March 31,
2022, as compared with $4.6 million for the quarter ended March 31,
2021.
- Net Loss: Net loss was $13.8 million for the
quarter ended March 31, 2022, as compared with $13.3 million for
the quarter ended March 31, 2021.
Terns Pharmaceuticals, Inc. |
|
|
|
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Condensed Consolidated Statements of
Operations |
|
|
|
|
(Unaudited; in thousands except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Operating
expenses: |
|
|
|
|
Research and development |
|
$ |
8,136 |
|
|
$ |
8,735 |
|
General and administrative |
|
|
5,689 |
|
|
|
4,561 |
|
Total
operating expenses |
|
|
13,825 |
|
|
|
13,296 |
|
Loss from
operations |
|
|
(13,825 |
) |
|
|
(13,296 |
) |
Interest income |
|
|
69 |
|
|
|
11 |
|
Other income (expense), net |
|
|
4 |
|
|
|
(13 |
) |
Loss before
income taxes |
|
|
(13,752 |
) |
|
|
(13,298 |
) |
Income tax expense |
|
|
(21 |
) |
|
|
(39 |
) |
Net
loss |
|
$ |
(13,773 |
) |
|
$ |
(13,337 |
) |
|
|
|
|
|
Net loss per
share attributable to common stockholders, basic and diluted |
|
$ |
(0.55 |
) |
|
$ |
(0.88 |
) |
Weighted
average common stock outstanding, basic and diluted |
|
|
25,269,271 |
|
|
|
15,160,046 |
|
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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, 2022 |
|
December 31, 2021 |
Cash, cash equivalents and marketable securities |
|
$ |
151,268 |
|
$ |
165,982 |
Total
assets |
|
|
156,669 |
|
|
168,070 |
Total
liabilities |
|
|
7,953 |
|
|
7,767 |
Total
stockholders’ equity |
|
|
148,716 |
|
|
160,303 |
|
|
|
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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 to address serious diseases such as
NASH, obesity and cancer. Terns’ pipeline includes four clinical
stage development programs including a THR- β agonist, an FXR
agonist, a VAP-1 inhibitor, an allosteric BCR-ABL inhibitor, 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 Phase 2a combination trial of
TERN-501 and TERN-101, the Phase 1 clinical program for TERN-601,
and the Phase 1 clinical trial for TERN-701; the potential
indications to be targeted by the Company with its single-agent and
combination therapy candidates; 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 their targeted
indications; the potential utility and progress of the Company’s
product candidates in their targeted indications, 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 and potential differentiation
as compared to other products or product candidates; the Company’s
plans for and ability to continue to execute on its current
clinical strategy; 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, 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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