Terns Pharmaceuticals Reports First Quarter 2023 Financial Results and Corporate Updates
15 May 2023 - 10:05PM
Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq:
TERN), a clinical-stage biopharmaceutical company developing a
portfolio of small-molecule product candidates to address serious
diseases, including oncology, non-alcoholic steatohepatitis (NASH)
and obesity, today reported financial results for the first quarter
ended March 31, 2023 and corporate updates.
“We are excited to announce plans to share key clinical and
preclinical updates across our three lead programs at upcoming
scientific congresses and look forward to several important
clinical milestones later this year,” said Sen Sundaram, chief
executive officer at Terns. “We anticipate top-line data from our
Phase 2a DUET trial of TERN-501 as a treatment for NASH in the
third quarter and the initiation of Phase 1 clinical trials in our
chronic myeloid leukemia (CML) and obesity programs in the second
half of this year. In addition, I’m impressed with the progress our
partner, Hansoh, has made in enrolling the Phase 1 trial in China
so quickly and hope we will see early data accepted for
presentation by the end of the year. We continue to rapidly advance
our development programs with the goal of making a significant
difference in the lives of people living with serious
diseases.”
Recent Developments and Anticipated
Milestones
TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor
(TKI) for chronic myeloid leukemia (CML)
- Terns expects to initiate a clinical trial for TERN-701 in the
United States in the second half of 2023, with potential top-line
readouts from initial dose-escalation cohorts in 2024
- The Phase 1 trial for TERN-701 is expected to include sites
from U.S., Europe and other countries
- A poster detailing non-clinical xenograft activity of TERN-701
will be presented at the American Society for Pharmacology and
Experimental Therapeutics (ASPET) on May 18, 2023 at 5:00 PM
CDT
- A trial-in-progress (TiP) poster and status update will be
presented at the 2023 ASCO Annual Meeting on June 5, 2023 at 8:00
AM CDT summarizing the ongoing Phase 1 study of TERN-701 (HS-10382)
in China
- The Phase 1 trial is a dose-escalation and dose-expansion trial
(NCT05367700) evaluating the tolerability, efficacy, and
pharmacokinetics of once-daily TERN-701 (HS-10382) in approximately
100 people with CML in China conducted by Terns’ partner Hansoh
Pharmaceutical Group
- Terns welcomed Emil Kuriakose, M.D. as Chief Medical Officer of
Terns Oncology in May 2023. Dr. Kuriakose brings more than a decade
of oncology clinical development and medical affairs
experience
- Terns plans to host a virtual R&D event with a focus on the
evolving CML treatment paradigm and the potential role for TERN-701
in July 2023
TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist
for NASH
- The Phase 2a DUET trial (NCT05415722), evaluating TERN-501 as a
monotherapy and in combination with TERN-101 (farnesoid X receptor
(FXR) agonist), completed enrollment in February 2023 with top-line
data expected in the third quarter of 2023
- Primary endpoint is the relative change from baseline in liver
fat content as measured by MRI protein density fat fraction
(MRI-PDFF) at Week 12 for TERN-501 monotherapy compared with
placebo
- Secondary endpoints include assessment of safety and
tolerability, pharmacokinetics, changes in MRI-PDFF and MRI
corrected T1 (cT1)
- DUET is the first clinical trial assessing a THR-β agonist as
monotherapy and in combination with an FXR agonist in people with
NASH
TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1)
receptor agonist for obesity
- Terns’ lead GLP-1 receptor agonist program remains on track to
initiate a Phase 1 first-in-human clinical trial in subjects with
elevated BMI in the second half of 2023, with top-line data
expected in 2024
- A poster evaluating activity of TERN-601 in transgenic mice
expressing human GLP-1 receptor will be presented at a major
diabetes conference in June 2023
TERN-800: Oral, small-molecule glucose-dependent insulinotropic
polypeptide receptor (GIPR) modulators for obesity
- Lead structural series of GIPR modulators have been identified,
with lead optimization efforts underway
- Candidate nomination and initiation of IND-enabling activities
expected in 2024
- GIPR modulators have the potential for combination with GLP-1
receptor agonists, such as TERN-601
First Quarter 2023 Financial Results
- Cash Position: As of March 31, 2023, cash,
cash equivalents and marketable securities were $297.5 million, as
compared with $283.1 million as of December 31, 2022. Based on its
current operating plan, Terns expects these funds will be
sufficient to support its planned operating expenses into
2026.
- Research and Development (R&D) Expenses:
R&D expenses were $17.1 million for the quarter ended March 31,
2023, as compared with $8.1 million for the quarter ended March 31,
2022.
- General and Administrative (G&A) Expenses:
G&A expenses were $7.1 million for the quarter ended March 31,
2023, as compared with $5.7 million for the quarter ended March 31,
2022.
- Net Loss: Net loss was $21.5 million for the
quarter ended March 31, 2023, as compared with $13.8 million for
the quarter ended March 31, 2022.
Terns Pharmaceuticals, Inc. |
|
|
|
|
Condensed Consolidated Statements of
Operations |
|
|
|
|
(Unaudited; in thousands except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
17,056 |
|
|
$ |
8,136 |
|
General and administrative |
|
|
7,101 |
|
|
|
5,689 |
|
Total operating expenses |
|
|
24,157 |
|
|
|
13,825 |
|
Loss from operations |
|
|
(24,157 |
) |
|
|
(13,825 |
) |
Interest income |
|
|
2,693 |
|
|
|
69 |
|
Other (expense) income, net |
|
|
(4 |
) |
|
|
4 |
|
Loss before income taxes |
|
|
(21,468 |
) |
|
|
(13,752 |
) |
Income tax expense |
|
|
(60 |
) |
|
|
(21 |
) |
Net loss |
|
$ |
(21,528 |
) |
|
$ |
(13,773 |
) |
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ |
(0.31 |
) |
|
$ |
(0.55 |
) |
Weighted average common stock outstanding, basic and diluted |
|
|
69,778,420 |
|
|
|
25,269,271 |
|
|
|
|
|
|
Terns Pharmaceuticals, Inc. |
|
|
|
|
Selected Balance Sheet Data |
|
|
|
|
(Unaudited; in thousands) |
|
|
|
|
|
|
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
Cash, cash equivalents and marketable securities |
|
$ |
297,526 |
|
$ |
283,114 |
Total assets |
|
|
301,285 |
|
|
287,026 |
Total liabilities |
|
|
13,602 |
|
|
10,083 |
Total stockholders’ equity |
|
|
287,683 |
|
|
276,943 |
About Terns PharmaceuticalsTerns
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company
developing a portfolio of small-molecule product candidates to
address serious diseases, including oncology, NASH and obesity.
Terns’ pipeline includes two clinical stage development programs
including an allosteric BCR-ABL inhibitor and a THR-β agonist (+/-
an FXR agonist), and preclinical small-molecule GLP-1 receptor
agonist and GIPR modulator programs. 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 clinical trials and other development
activities of the Company and its partners; the potential
indications to be targeted by the Company with its small-molecule
product candidates; the therapeutic potential of the Company’s
small-molecule product 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, including the results of
any interactions with regulatory authorities on its programs; the
Company’s expectations regarding the profile of its product
candidates, including efficacy, 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
development strategy, including potential combinations involving
multiple product candidates; the impact of new legislation and
regulatory developments on the Company’s plans for its product
candidates, such as the effect of the Inflation Reduction Act of
2022; and the Company’s expectations with regard to its cash runway
and sufficiency of its cash resources. 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. 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, 2022. 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
Terns Pharmaceuticals (NASDAQ:TERN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Terns Pharmaceuticals (NASDAQ:TERN)
Historical Stock Chart
From Jul 2023 to Jul 2024