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 and obesity, today reported financial
results for the quarter ended June 30, 2024 and provided corporate
updates.
“We are excited about the remainder of 2024 as we progress
towards multiple important milestones across our metabolic and
oncology franchises,” said Amy Burroughs, chief executive officer
of Terns. “In September, we plan to release top-line data from the
Phase 1 trial of TERN-601 for obesity. We are encouraged by recent
data supporting allosterics as an important new class of therapy
for patients with CML. In December, we look forward to sharing
interim dose escalation data from the ongoing Phase 1 CARDINAL
trial of our differentiated allosteric BCR-ABL inhibitor, TERN-701
in CML. Both upcoming readouts represent critical steps forward in
our mission to deliver potential best-in-class small-molecule
therapies to patients.”
Recent Pipeline Developments and Anticipated
Milestones
TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor
(TKI) for chronic myeloid leukemia (CML)
- Interim data from initial dose
escalation cohorts in Terns’ ongoing Phase 1 CARDINAL trial of
TERN-701 in CML expected in December 2024
- CARDINAL is a global, multicenter,
open-label, two-part Phase 1 clinical trial to evaluate the safety,
pharmacokinetics (PK), and efficacy of TERN-701 in patients with
previously treated CML
- In April, Terns announced findings from a concurrent Phase 1 PK
study of TERN-701 in U.S. healthy volunteers, which indicated
TERN-701 can be administered once-daily (QD) with or without food
at doses that achieve clinically efficacious exposures
- Terns plans to host a TERN-701-focused virtual key opinion
leader (KOL) event on August 20, 2024 at 10am ET
- The event will feature a discussion on how to interpret early
CML datasets with Andreas Hochhaus, M.D., Professor of Internal
Medicine Hematology and Oncology and Interim Head of the Department
of Hematology and Medical Oncology at the University Medical Center
Jena in Germany
- Registration for the event can be accessed here
TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1)
receptor agonist for obesity
- On track to report safety and 28-day
weight loss data in September 2024 from the Phase 1 first-in-human
clinical trial of TERN-601, Terns’ lead oral GLP-1 receptor
agonist, in obese and overweight participants
- Primary endpoints include safety and tolerability
assessments
- Secondary and exploratory endpoints include PK and change in
body weight over 28 days
- Preliminary safety findings continue to be unremarkable to date
with no observations of liver enzyme elevations, drug induced liver
injury or discontinuations due to treatment-related adverse
events
- Preparations are underway to rapidly progress to a 12-week,
Phase 2a clinical trial for obesity, following supportive data from
the Phase 1 trial
TERN-501: Oral, thyroid hormone receptor-beta (THR-β)
agonist
- In June, Terns presented new
preclinical data at the American Diabetes Association (ADA) 84th
Scientific Sessions supporting TERN-501 in combination with a GLP-1
receptor agonist for obesity
- Preclinical findings demonstrated TERN-501 in combination with
semaglutide significantly enhanced weight loss and showed
proportionally greater loss of fat mass relative to lean mass
compared to semaglutide alone
- Results support the potential for TERN-501 as a combination
partner for injectable and oral GLP-1 agonists for use in obesity
and other metabolic disorders
- The full poster is available on Terns’ scientific publications
website
- Terns continues to evaluate opportunities for TERN-501 in
metabolic diseases
TERN-800 Series: Oral, small-molecule glucose-dependent
insulinotropic polypeptide receptor (GIPR) modulators
- Discovery efforts are ongoing for
small molecule GIPR modulators for obesity, which have the
potential for combination with GLP-1 receptor agonists
- Terns is prioritizing its discovery
efforts on nominating a GIPR antagonist development candidate based
on in-house discoveries and growing scientific rationale supporting
the potential of GLP-1 receptor agonist/GIPR antagonist
combinations for obesity
Corporate Updates
- In July 2024, Terns announced the
appointment of Elona Kogan as chief legal officer of Terns and the
upcoming departure of Bryan Yoon, chief operating officer
- Terns also announced a planned
transition for Mark Vignola Ph.D., chief financial officer. A
search for a new CFO is underway. Dr. Vignola will continue to
serve as CFO through the end of January 2025, or until a successor
is found
Second Quarter 2024 Financial Results
Cash Position: As of June 30, 2024, cash, cash
equivalents and marketable securities were $225.3 million, as
compared with $263.4 million as of December 31, 2023. 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 $18.4 million for the quarter ended June 30,
2024, as compared with $14.2 million for the quarter ended June 30,
2023.
General and Administrative (G&A) Expenses:
G&A expenses were $7.2 million for the quarter ended June 30,
2024, as compared with $7.0 million for the quarter ended June 30,
2023.
Net Loss: Net loss was $22.7 million for the
quarter ended June 30, 2024, as compared with $17.9 million for the
quarter ended June 30, 2023.
Financial Tables
Terns Pharmaceuticals, Inc. |
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of
Operations |
|
|
|
|
|
|
|
|
(Unaudited; in thousands except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
18,352 |
|
|
$ |
14,151 |
|
|
$ |
36,939 |
|
|
$ |
31,207 |
|
General and administrative |
|
|
7,185 |
|
|
|
7,008 |
|
|
|
14,044 |
|
|
|
14,109 |
|
Total
operating expenses |
|
|
25,537 |
|
|
|
21,159 |
|
|
|
50,983 |
|
|
|
45,316 |
|
Loss from
operations |
|
|
(25,537 |
) |
|
|
(21,159 |
) |
|
|
(50,983 |
) |
|
|
(45,316 |
) |
Interest income |
|
|
2,876 |
|
|
|
3,395 |
|
|
|
6,058 |
|
|
|
6,088 |
|
Other expense, net |
|
|
(14 |
) |
|
|
(60 |
) |
|
|
(26 |
) |
|
|
(64 |
) |
Loss before
income taxes |
|
|
(22,675 |
) |
|
|
(17,824 |
) |
|
|
(44,951 |
) |
|
|
(39,292 |
) |
Income tax expense |
|
|
(61 |
) |
|
|
(72 |
) |
|
|
(158 |
) |
|
|
(132 |
) |
Net
loss |
|
$ |
(22,736 |
) |
|
$ |
(17,896 |
) |
|
$ |
(45,109 |
) |
|
$ |
(39,424 |
) |
|
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
|
$ |
(0.31 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.61 |
) |
|
$ |
(0.56 |
) |
Weighted
average common stock outstanding, basic and diluted |
|
|
74,459,774 |
|
|
|
71,364,110 |
|
|
|
74,429,576 |
|
|
|
70,575,645 |
|
|
|
|
|
|
|
|
|
|
Terns Pharmaceuticals, Inc. |
|
|
|
|
Selected Balance Sheet Data |
|
|
|
|
(Unaudited; in thousands) |
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
December 31, 2023 |
Cash, cash equivalents and marketable securities |
|
$ |
225,297 |
|
|
$ |
263,440 |
|
Total
assets |
|
|
230,880 |
|
|
|
268,517 |
|
Total
liabilities |
|
|
12,199 |
|
|
|
13,150 |
|
Total
stockholders’ equity |
|
|
218,681 |
|
|
|
255,367 |
|
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 and obesity. Terns’
pipeline contains three clinical stage development programs
including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1
receptor agonist, a THR-β agonist, and a preclinical GIPR modulator
discovery effort, prioritizing a GIPR antagonist nomination
candidate. For more information, please visit:
www.ternspharma.com.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements about the Company within the meaning of the federal
securities laws, including those related to expectations, 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 Company’s plans and expectations
around the addition of key personnel; 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, 2023. 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)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
Terns Pharmaceuticals (NASDAQ:TERN)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024