Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical
company focused on advancing the next wave of medicine for
inflammatory diseases, today announced financial results for the
second quarter ended June 30, 2023.
“We are pleased with the speed, rigor and capital efficiency of
our team’s efforts this year to advance our new development
candidate, THB335, toward clinical trials in the first half of
2024,” said Natalie Holles, Chief Executive Officer of Third
Harmonic Bio. “As the development landscape for chronic urticaria
evolves, we continue to believe that an orally available KIT
inhibitor has the potential to be a transformative treatment for
this large yet underserved patient population.”
Recent Corporate Highlights
On July 25, 2023, the company announced its next-generation
product candidate, THB335, and disclosed topline results of the
Phase 1b clinical trial of THB001 for the treatment of chronic
inducible urticaria, which was discontinued in December 2022 due to
observed liver transaminitis in two of five patients enrolled. The
results demonstrated evidence of clinical benefit in four of the
five patients, achieving partial or complete responses despite
early termination of the trial.
In addition, the company shared preliminary results from
extensive studies of THB001 that were conducted to identify the
mechanism for the observed liver toxicity, which was not predicted
by nonclinical toxicology studies. These in-depth studies
identified a metabolic pathway resulting in the formation of an
intermediate reactive metabolite. Reactive metabolite formation has
been previously implicated as a mechanistic basis for drug-induced
liver injury. Structural modifications introduced into THB335 are
believed to address this risk and studies conducted to-date support
its differentiated metabolic profile.
THB335
THB335, the company’s next-generation oral small molecule
wild-type KIT inhibitor product candidate, maintains a similar
potency and selectivity profile of THB001, with structural
modifications which are expected to mitigate the hepatoxicity risk
as well as provide a differentiated metabolic, distribution and
physiochemical profile.
The company plans to file a U.S. IND and initiate clinical
trials of THB335 in the first half of 2024. Phase 2 development is
expected to initially focus on chronic spontaneous urticaria, with
planned expansion into other mast-cell mediated inflammatory
disorders in later phases.
Summary of Financial Results
Cash Position: Cash and cash equivalents
totaled $278.1 million as of June 30, 2023. Based on the
company's current operating plan, Third Harmonic Bio believes that
its existing cash and cash equivalents will be sufficient to fund
its operating expenses and capital expenditure requirements through
at least 2025.
R&D Expenses: Research and development
(R&D) expenses increased to $5.3 million for the three months
ended June 30, 2023, from $4.2 million for the same period in
2022. R&D expenses for the six months ended June 30, 2023
increased to $12.1 million, from $10.4 million for the same period
in 2022. The increases were primarily due to increases in discovery
and development costs relating to the research and nonclinical
development of THB335 and other next-generation discovery
efforts.
G&A Expenses: General and administrative
(G&A) expenses increased to $5.4 million for the three months
ended June 30, 2023, from $3.6 million for the same period in
2022. G&A expenses for the six months ended June 30, 2023
increased to $10.6 million, from $5.2 million for the same period
in 2022. The increases were primarily attributable to increased
costs associated with being a public company and personnel-related
expenses.
Net Loss: Net loss for the three months ended
June 30, 2023 decreased to $7.6 million from a net loss of
$7.7 million for the same period in 2022. Net loss for the six
months ended June 30, 2023 increased to $16.6 million,
compared to a net loss of $15.5 million for the same period in
2022, primarily due to increases in research and development
expenses and public company costs that were partially offset by
increases in interest income.
About Third Harmonic Bio, Inc.
Third Harmonic Bio is a biopharmaceutical company focused on
advancing the next wave of medicine for inflammatory diseases
through the development of novel highly selective, small-molecule
inhibitors of KIT, a cell surface receptor that serves as the
master regulator of mast cell function and survival. Early clinical
studies demonstrate that KIT inhibition has the potential to
revolutionize the treatment of a broad range of mast-cell-mediated
inflammatory diseases, and that a titratable, oral, intracellular
small molecule inhibitor may provide the optimal therapeutic
profile against this target. Third Harmonic’s lead product
candidate, THB335, is a titratable, oral, intracellular small
molecule inhibitor expected to enter clinical trials during the
first half of 2024. For more information, please visit the Third
Harmonic Bio website: www.thirdharmonicbio.com.
Forward-Looking Statements
This press release contains “forward-looking” statements within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995, including, but not
limited to, statements regarding the expected product profile of
THB335 as compared to THB001, the timing of filing a U.S. IND
application for THB335, the expected timing for clinical
activities. Forward-looking statements can be identified by words
such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,”
“project,” “estimate,” “expect,” “strategy,” “future,” “likely,”
“may,” “should,” “will” and similar references to future periods.
These statements are subject to numerous risks and uncertainties,
including risks and uncertainties related to Third Harmonic Bio’s
cash forecasts, ability to advance its product candidates, the
receipt and timing of potential regulatory submissions,
designations, approvals and commercialization of product
candidates, our ability to protect our intellectual property, the
timing and results of preclinical and clinical trials, changes to
laws or regulations, market conditions, geopolitical events, and
further impacts of pandemics or health epidemics, that could cause
actual results to differ materially from what Third Harmonic Bio
expects. Further information on potential risk factors that could
affect Third Harmonic Bio’s business and its financial results are
detailed under the heading “Risk Factors” included in Third
Harmonic Bio’s Quarterly Report on Form 10-Q for the six months
ended June 30, 2023, filed with the U.S. Securities and Exchange
Commission (SEC) on August 10, 2023, and in Third Harmonic Bio’s
other filings filed from time to time with the SEC. Third Harmonic
Bio undertakes no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise.
Investor Contact:Bob
Horho@thirdharmonicbio.com
THIRD HARMONIC BIO, INC.Condensed
consolidated balance sheet
data(Unaudited)(In thousands) |
|
|
|
December 31,2022 |
|
|
June 30,2023 |
Assets |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
288,877 |
|
|
$ |
278,132 |
Other current assets |
|
|
3,958 |
|
|
|
2,233 |
Non-current assets |
|
|
5,840 |
|
|
|
5,457 |
Total assets |
|
$ |
298,675 |
|
|
$ |
285,822 |
Liabilities |
|
|
|
|
|
Current liabilities |
|
$ |
5,653 |
|
|
$ |
4,223 |
Non-current liabilities |
|
|
3,954 |
|
|
|
3,591 |
Total liabilities |
|
|
9,607 |
|
|
|
7,814 |
Stockholders' equity |
|
|
289,068 |
|
|
|
278,008 |
Total liabilities and stockholders' equity |
|
$ |
298,675 |
|
|
$ |
285,822 |
|
|
|
|
|
|
THIRD HARMONIC BIO, INC.Condensed
consolidated statements of
operations(Unaudited)(In thousands of,
except per share and share amounts) |
|
|
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
2023 |
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
10,393 |
|
|
$ |
12,077 |
|
General and administrative |
|
|
5,177 |
|
|
|
10,625 |
|
Total operating expenses |
|
|
15,570 |
|
|
|
22,702 |
|
Loss from
operations |
|
|
15,570 |
|
|
|
22,702 |
|
Other (income) expense, net |
|
|
(110 |
) |
|
|
(6,057 |
) |
Net loss |
|
$ |
15,460 |
|
|
$ |
16,645 |
|
|
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
3.58 |
|
|
$ |
0.42 |
|
Weighted-average common stock
outstanding, basic and diluted |
|
|
4,321,267 |
|
|
|
39,504,882 |
|
|
|
|
|
|
|
|
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