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, obesity and non-alcoholic
steatohepatitis (NASH), today reported financial results for the
quarter ended September 30, 2023 and provided corporate updates.
“Throughout the third quarter and in recent weeks, we made
meaningful progress across all three of our clinical development
programs, opening U.S. Investigational New Drug (IND) applications,
both for our allosteric BCR-ABL inhibitor TERN-701 for chronic
myeloid leukemia (CML) and our lead small molecule oral GLP-1
agonist TERN-601 for obesity, and releasing Phase 2 data for our
thyroid hormone receptor β agonist TERN-501 from the DUET study in
NASH patients. We are now preparing for a data-rich 2024, with
expected proof of concept readouts from our clinical trials in CML
and obesity,” stated Erin Quirk, MD, president and head of research
and development at Terns. “The advances we are making, which are
supported by strong clinical and scientific data, give us even
greater confidence in our approach to bring better chemistry to the
development of small-molecule candidates with clinically validated
mechanisms to address oncologic and metabolic diseases with large
unmet medical needs.”
“We are excited to have dosed the first participant in our
first-in-human trial of TERN-601 to treat obesity as preclinical
data suggest it has potential for broad metabolic benefits in
obesity, oral once-daily dosing, and suitability for combination
therapy. We are also looking forward to dosing the first
participants in our Phase 1 trial of TERN-701 as a treatment for
CML while leveraging insights from our partner’s ongoing Phase 1
trial in China to support a starting dose that appears safe and
clinically active based on emerging early clinical data,” added Dr.
Quirk.
Recent Pipeline Developments and Anticipated
Milestones
TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor
(TKI) for CML
- In October, Terns announced the
Investigational New Drug (IND) clearance from the U.S. FDA and
design of the CARDINAL Phase 1 clinical trial of TERN-701 for the
treatment of CML
- 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 participants
with previously treated CML
- The dose escalation portion (Part 1)
of the trial will evaluate once-daily TERN-701 monotherapy in
approximately 24-36 adults living with CML to be enrolled in up to
five dose cohorts; screening for Part 1 is anticipated to begin in
December 2023
- Primary endpoints of the CARDINAL
dose escalation portion include incidence of dose limiting
toxicities (DLTs) during the first treatment cycle and additional
measures of safety and tolerability
- Secondary endpoints include PK and
efficacy assessments, such as hematologic and molecular responses
as measured by the change from baseline in BCR-ABL transcript
levels
- The starting dose is 160 mg QD
(once-daily), with the option to explore a lower dose of 80 mg
QD
- The dose expansion portion (Part 2)
of the CARDINAL trial will initiate after dose escalation data are
available and will enroll approximately 40 patients, randomized to
once-daily treatment with one of two doses of TERN-701 to be
selected based on data from Part 1
- The primary endpoint of the CARDINAL
dose expansion portion is efficacy, measured by hematologic and
molecular responses. Secondary endpoints include safety,
tolerability and PK
- The CARDINAL trial plans to enroll
at sites in the United States, Europe and other global
territories
- Global site identification and trial
start-up activities are ongoing, with interim top-line readouts
from initial cohorts expected in the second half of 2024
TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1)
receptor agonist for obesity
- Earlier this month, Terns announced
that the first participant was dosed in the Phase 1 first-in-human
clinical trial of TERN-601 for obesity
- The Phase 1 trial is a randomized,
double-blind, placebo-controlled single and multiple-ascending dose
(SAD and MAD) trial to assess the safety, tolerability, PK and
pharmacodynamics (PD) of TERN-601 in healthy adults with obesity or
who are overweight
- Part 1 (SAD) is a SAD study that
will evaluate up to six once-daily TERN-601 dose levels in
approximately 40 healthy participants
- The starting TERN-601 dose is 30 mg,
with subsequent dose levels based on review of emerging safety and
PK data from prior cohorts
- Part 2 (MAD) of the trial will
enroll approximately 72 obese and overweight healthy participants
and will include cohorts incorporating titration of TERN-601
administered for 28-days at doses to be selected based on data from
Part 1
- Top-line, 28-day proof of concept
weight loss data from the Phase 1 trial is expected in the second
half of 2024
TERN-501: Oral, thyroid hormone receptor-β (THR-β) agonist for
NASH
- Phase 2a DUET trial data evaluating
TERN-501 for the treatment of NASH was featured in an oral
late-breaking presentation at The Liver Meeting 2023:
- The oral presentation titled,
“Topline results from a 12-week Phase 2a Trial (DUET) evaluating
TERN-501, a highly selective thyroid hormone receptor (THR) β
agonist, either as monotherapy or in combination with TERN-101, a
nonsteroidal farnesoid X receptor (FXR) agonist, demonstrated
significant reductions in MR-based liver fat content and
fibroinflammation in patients with presumed NASH,” was delivered by
Mazen Noureddin, MD, MHSc, Professor of Medicine, Academic
Institute at Houston Methodist, Director of Houston Research
Institute
- Terns reported positive top-line
data from the Phase 2a DUET trial of TERN-501 for the treatment of
NASH in August
- TERN-501 met all primary and
secondary endpoints
- TERN-501 demonstrated dose dependent
MRI-PDFF reductions at Week 12 as a once-daily, low dose, and
combinable oral therapy
- TERN-501 (6 mg) showed statistically
significant mean relative liver fat content reduction of 45% as
assessed by MRI-PDFF with 64% of patients achieving >30% PDFF
reduction
- All TERN-501 doses were
well-tolerated with no gastrointestinal and no cardiovascular
safety signals
Corporate Updates
- In August 2023, Terns announced the
departure of Senthil Sundaram, the Company’s former chief executive
officer, for health reasons. Terns is conducting an ongoing search
for a permanent chief executive officer. In the interim, Dr. Quirk
continues to assume day-to-day leadership of the Company and serve
as principal executive officer. In addition, the Board has engaged
board director, Jill M. Quigley, JD as senior advisor and strategy
officer on an interim basis until a permanent chief executive
officer is appointed.
Third Quarter 2023 Financial Results
Cash Position: As of September 30, 2023, cash,
cash equivalents and marketable securities were $266.6 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 $14.8 million for the quarter ended September
30, 2023, as compared with $12.2 million for the quarter ended
September 30, 2022.
General and Administrative (G&A) Expenses:
G&A expenses were $18.4 million for the quarter ended September
30, 2023, as compared with $5.1 million for the quarter ended
September 30, 2022.
Net Loss: Net loss was $29.8 million for the
quarter ended September 30, 2023, as compared with $16.8 million
for the quarter ended September 30, 2022.
Terns Pharmaceuticals, Inc. |
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Condensed Consolidated Statements of
Operations |
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(Unaudited; in thousands except share and per share
amounts) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating
expenses: |
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Research and development |
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$ |
14,831 |
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$ |
12,161 |
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$ |
46,038 |
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$ |
28,959 |
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General and administrative |
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18,353 |
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5,131 |
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32,462 |
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16,242 |
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Total
operating expenses |
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33,184 |
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17,292 |
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78,500 |
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45,201 |
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Loss from
operations |
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(33,184 |
) |
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(17,292 |
) |
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(78,500 |
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(45,201 |
) |
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Interest income |
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3,480 |
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499 |
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9,568 |
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782 |
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Other expense, net |
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(5 |
) |
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(14 |
) |
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(69 |
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(64 |
) |
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Loss before
income taxes |
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(29,709 |
) |
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(16,807 |
) |
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(69,001 |
) |
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(44,483 |
) |
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Income tax expense |
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(58 |
) |
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(13 |
) |
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(190 |
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(40 |
) |
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Net
loss |
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$ |
(29,767 |
) |
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$ |
(16,820 |
) |
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$ |
(69,191 |
) |
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$ |
(44,523 |
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Net loss per
share, basic and diluted |
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$ |
(0.42 |
) |
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$ |
(0.44 |
) |
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$ |
(0.98 |
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$ |
(1.50 |
) |
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Weighted
average common stock outstanding, basic and diluted |
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71,530,180 |
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38,511,655 |
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70,897,320 |
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29,743,579 |
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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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September 30, 2023 |
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December 31, 2022 |
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Cash, cash
equivalents and marketable securities |
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$ |
266,600 |
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$ |
283,114 |
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Total
assets |
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271,687 |
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287,026 |
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Total
liabilities |
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13,262 |
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10,083 |
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Total
stockholders’ equity |
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258,425 |
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276,943 |
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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, obesity and NASH.
Terns’ pipeline includes 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
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 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, 2022. Except as required by law, the Company
undertakes no obligation to update publicly any forward-looking
statements for any reason.
Contacts for
TernsInvestorsJustin
Nginvestors@ternspharma.com
MediaJenna UrbanBerry & Company Public
Relationsmedia@ternspharma.com
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