Terns Pharmaceuticals Reports Second Quarter 2022 Financial Results and Corporate Highlights
09 August 2022 - 6:05AM
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
second quarter ended June 30, 2022 and corporate highlights.
“During the second quarter, Terns saw
significant progress in advancing three of our internally
discovered, small-molecule product candidates towards key clinical
readouts in chronic myeloid leukemia, obesity and NASH,” said Sen
Sundaram, chief executive officer at Terns. “We look forward to
assessing the differentiation of these three product candidates,
each of which target clinically validated mechanisms of
action.”
Recent Developments and Anticipated
Milestones
TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor
(TKI) for chronic myeloid leukemia
- In May 2022, Hansoh Pharmaceutical
Group Company Limited (Hansoh) initiated dosing of TERN-701 in a
Phase 1 dose-escalation and dose-expansion trial in approximately
100 patients with CML (NCT05367700)
- The objectives of this trial are to evaluate the tolerability,
efficacy, and pharmacokinetics of TERN-701 in CML
- TERN-701 is Terns’ proprietary,
allosteric BCR-ABL TKI, designed to target the ABL myristoyl
pocket, for the treatment of chronic myeloid leukemia (CML)
- TERN-701 aims to address limitations of the only FDA-approved
allosteric BCR-ABL TKI with the goal of achieving improved tumor
suppression through a combination of: (1) potent activity against
CML including a broad range of mutations, (2) improved PK to enable
potential once-daily dosing, and (3) minimal food or fasting
requirements
- TERN-701 is out-licensed to Hansoh
for development in the greater China region. Hansoh is responsible
for all development costs in China, including the ongoing Phase 1
trial
- Terns retains all worldwide development and commercialization
rights outside of greater China, as well as access to data
generated by Hansoh in China
- Terns is exploring options for the
development and commercialization of TERN-701 outside of China,
including potential internal development and/or additional
strategic partnerships
TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1)
receptor agonist for obesity
- IND-enabling activities for
TERN-601, Terns’ lead GLP-1R development candidate, are proceeding
on-track 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 and a multiple ascending dose
proof-of-concept trial assessing potential endpoints such as body
weight and HbA1c
- TERN-601 is a Terns’ proprietary orally-administered
small-molecule glucagon-like peptide-1 receptor (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
TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist
for NASH
- In July 2022, Terns initiated
dosing in the DUET Phase 2a clinical trial of TERN-501 (THR-β
agonist) alone and in combination with TERN-101 (FXR agonist) in
approximately 140 adult patients with presumed NASH (NCT05415722)
- Primary endpoint is the relative change from baseline in liver
fat content as measured by 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 MRI cT1 (TERN-501 monotherapy vs.
placebo as well as 501+101 combination vs. placebo)
- Top-line data expected in the
second half of 2023
Key Appointments
- Radhika Tripuraneni, M.D., M.P.H. joined the Company’s Board of
Directors in July 2022. Dr. Tripuraneni serves as the Chief
Development Officer of Prothena Corporation plc and brings to the
Terns Board of Directors more than 15 years of experience in drug
development
- Kerry Russell, M.D., Ph.D. joined
the Company as Chief Medical Officer in June 2022. Dr. Russell was
most recently vice president of late clinical development at
Dicerna Pharmaceuticals, Inc. and was previously an associate
professor at Yale University School of Medicine for over 13
years
Upcoming Investor Events
- Terns will present at the Canaccord
Genuity 42nd Annual Growth Conference on Thursday, August 11, 2022
at 11:30am 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.
Second Quarter 2022 Financial Results
- Cash Position: As of June 30, 2022,
cash, cash equivalents and marketable securities were $139.8
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,
including through the expected proof-of-concept clinical readouts
for TERN-701, TERN-601 and TERN-501
- Research and Development (R&D)
Expenses: R&D expenses were $8.7 million for the quarter ended
June 30, 2022, as compared with $6.0 million for the quarter ended
June 30, 2021
- General and Administrative
(G&A) Expenses: G&A expenses were $5.4 million for the
quarter ended June 30, 2022, as compared with $4.9 million for the
quarter ended June 30, 2021
- Net Loss: Net loss was $13.9
million for the quarter ended June 30, 2022, as compared with $10.7
million for the quarter ended June 30, 2021
Terns Pharmaceuticals, Inc. |
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Condensed Consolidated
Statements of Operations |
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(Unaudited; in thousands except share and per share
amounts) |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
8,662 |
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$ |
5,961 |
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$ |
16,798 |
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$ |
14,696 |
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General and administrative |
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5,422 |
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4,857 |
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11,111 |
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9,418 |
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Total operating expenses |
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14,084 |
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10,818 |
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27,909 |
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24,114 |
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Loss from operations |
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(14,084 |
) |
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(10,818 |
) |
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(27,909 |
) |
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(24,114 |
) |
Interest income |
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214 |
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55 |
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283 |
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66 |
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Other (expense) income, net |
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(54) |
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39 |
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(50) |
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26 |
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Loss before income taxes |
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(13,924 |
) |
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(10,724 |
) |
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(27,676 |
) |
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(24,022 |
) |
Income tax expense |
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(6 |
) |
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(14 |
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(27 |
) |
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(53 |
) |
Net loss |
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$ |
(13,930 |
) |
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$ |
(10,738 |
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$ |
(27,703 |
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$ |
(24,075 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
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$ |
(0.55 |
) |
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$ |
(0.43 |
) |
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$ |
(1.10 |
) |
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$ |
(1.19 |
) |
Weighted average common stock
outstanding, basic and diluted |
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25,304,290 |
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25,109,973 |
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25,286,877 |
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20,162,496 |
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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, 2022 |
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December 31, 2021 |
Cash, cash equivalents and marketable securities |
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$ |
139,810 |
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$ |
165,982 |
Total assets |
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144,860 |
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168,070 |
Total liabilities |
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7,644 |
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7,767 |
Total stockholders’ equity |
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137,216 |
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160,303 |
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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 four
clinical stage development programs including a THR-β agonist, an
allosteric BCR-ABL inhibitor, an FXR agonist, a VAP-1 inhibitor,
and a preclinical small-molecule GLP-1 receptor agonist program.
For more information, please visit: www.ternspharma.com.
Cautionary Note Regarding Forward-Looking
Statements
This 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; 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; 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; and the Company’s expectations with regard to its 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 and its Quarterly Report
on Form 10-Q for the period ended March 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
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