Terns Pharmaceuticals Reports Second Quarter 2023 Financial Results and Corporate Updates
08 Août 2023 - 10:15PM
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 quarter ended
June 30, 2023 and corporate updates.
“This afternoon, we reported positive data from our Phase 2a
DUET clinical trial, in which TERN-501 showed dose dependent and
statistically significant reductions in liver fat content and
fibro-inflammation with a class-leading safety and tolerability
profile,” stated Erin Quirk, M.D., president and head of research
and development at Terns. “These positive data underscore the
potential for TERN-501 to be the THR-β monotherapy of choice and
possibly a mainstay backbone of NASH combination therapies for this
difficult-to-treat disease with no FDA approved treatments.”
“Beyond our successful DUET clinical trial, we were also
delighted to share compelling clinical updates and preclinical data
that support each of our three lead development programs at key
medical and scientific congresses during the second quarter. We are
looking forward to initiating our Phase 1 studies with TERN-701 for
chronic myeloid leukemia (CML) and TERN-601 for obesity in the
second half of this year. We have a strong balance sheet to support
our efforts to achieve these important milestones that bring us one
step closer to our goal of bringing safe and effective new
medicines to people battling serious oncologic and metabolic
diseases,” added Dr. Quirk.
Recent Developments and Anticipated
Milestones
TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist
for NASH
- Terns reported positive top-line data from the Phase 2a DUET
trial of TERN-501 administered as a monotherapy or in combination
with TERN-101, a liver-distributed farnesoid X receptor (FXR)
agonist, for the treatment of NASH. Key takeaways from the data
include:
- 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
- Terns has completed drug manufacturing to enable the initiation
of a Phase 2b trial of TERN-501 in NASH
- Terns intends to submit the DUET data to a medical conference
later in 2023
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
second half of 2023, with potential interim top-line readouts from
initial dose-escalation cohorts in 2024
- Terns has completed drug manufacturing to enable the initiation
of its Phase 1 trial for TERN-701
- The Phase 1 trial for TERN-701 is expected to include sites
from the U.S., Europe and other countries
- A poster demonstrating that TERN-701 outperformed asciminib in
certain xenograft mouse models (K562 and Ba/F3T315I) at equivalent
doses was presented at the American Society for Pharmacology and
Experimental Therapeutics (ASPET) in May 2023
- A trial-in-progress (TiP) poster was presented at the American
Society of Clinical Oncology 2023 Annual Meeting (ASCO) in June,
summarizing the ongoing Phase 1 study (NCT05367700) of TERN-701
(HS-10382) conducted by Terns’ partner, Hansoh, and highlighting
the completion of enrollment of Cohort 5 of the Phase 1
dose-escalation portion of the study as of April 2023
- Management hosted a virtual Key Opinion Leader event in July
2023, with a focus on the evolving CML treatment landscape and the
potential role for TERN-701. An archive of the event can be
accessed here.
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 body mass index (BMI) in the second half of 2023, with
top-line data expected in 2024
- Data in transgenic mice expressing human GLP-1 receptor showing
TERN-601 significantly improved glucose tolerance, suppressed food
intake and slowed gastric emptying was presented at the American
Diabetes Association’s (ADA) 83rd Annual Scientific Sessions in
June 2023
- Management hosted a webinar that reviewed Terns’ obesity
franchise, including the TERN-601 program and additional
development efforts underway in obesity. The archive of this event
can be accessed here.
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
Second Quarter 2023 Financial Results
- Cash Position: As of June 30, 2023, cash, cash
equivalents and marketable securities were $285.6 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 $14.2 million for the quarter ended June 30,
2023, as compared with $8.7 million for the quarter ended June 30,
2022.
- General and Administrative (G&A) Expenses:
G&A expenses were $7.0 million for the quarter ended June 30,
2023, as compared with $5.4 million for the quarter ended June 30,
2022.
- Net Loss: Net loss was $17.9 million for the
quarter ended June 30, 2023, as compared with $13.9 million for the
quarter ended June 30, 2022.
Terns Pharmaceuticals, Inc. |
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Condensed Consolidated Statements of
Operations |
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(Unaudited; in thousands except share and per share
amounts) |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating
expenses: |
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Research and development |
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$ |
14,151 |
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$ |
8,662 |
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$ |
31,207 |
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$ |
16,798 |
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General and administrative |
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7,008 |
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5,422 |
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14,109 |
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11,111 |
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Total
operating expenses |
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21,159 |
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14,084 |
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45,316 |
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27,909 |
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Loss from
operations |
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(21,159 |
) |
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(14,084 |
) |
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(45,316 |
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(27,909 |
) |
Interest income |
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3,395 |
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214 |
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6,088 |
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283 |
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Other expense, net |
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(60 |
) |
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(54 |
) |
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(64 |
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(50 |
) |
Loss before
income taxes |
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(17,824 |
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(13,924 |
) |
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(39,292 |
) |
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(27,676 |
) |
Income tax expense |
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(72 |
) |
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(6 |
) |
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(132 |
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(27 |
) |
Net
loss |
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$ |
(17,896 |
) |
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$ |
(13,930 |
) |
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$ |
(39,424 |
) |
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$ |
(27,703 |
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Net loss per
share, basic and diluted |
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$ |
(0.25 |
) |
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$ |
(0.55 |
) |
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$ |
(0.56 |
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$ |
(1.10 |
) |
Weighted
average common stock outstanding, basic and diluted |
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71,364,110 |
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25,304,290 |
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70,575,645 |
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25,286,877 |
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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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June 30, 2023 |
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December 31, 2022 |
Cash, cash equivalents and marketable securities |
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$ |
285,603 |
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$ |
283,114 |
Total
assets |
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289,697 |
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287,026 |
Total
liabilities |
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15,547 |
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10,083 |
Total
stockholders’ equity |
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274,150 |
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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
InvestorsMark
Vignolainvestors@ternspharma.com
MediaJenna UrbanBerry & Company Public
Relationsmedia@ternspharma.com
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