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
fourth quarter and full year ended December 31, 2022.
“Given the promising preliminary clinical activity
observed in our discontinued Phase 1b clinical trial of THB001, we
believe 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,” said Natalie Holles, Chief Executive Officer of Third
Harmonic Bio. “We are making meaningful progress toward selecting a
next-generation KIT inhibitor development candidate in 2023 and
look forward to providing a more substantive update in the near
term.”
Recent Business
Highlights
In December 2022, the Company announced the
discontinuation of its Phase 1b clinical trial of THB001 in chronic
inducible urticaria following observation of asymptomatic liver
transaminitis in two subjects enrolled in the first dose cohort of
200 mg BID. As a result, Third Harmonic Bio initiated nonclinical
studies to elucidate the mechanism for the observed transaminitis,
which was not predicted by extensive GLP toxicology studies of
THB001 nor observed in the Phase 1a clinical trial. Preliminary
analyses showed evidence of pharmacodynamic and clinical activity
at the 200 mg BID dose. The Company plans to present the full data
set from the five enrolled subjects at an upcoming scientific
conference.
In parallel with the early clinical development of
THB001, the company has conducted an extensive medicinal chemistry
effort to identify chemically distinct next-generation oral
wild-type KIT inhibitors and has advanced multiple candidate
molecules into exploratory toxicology studies. Third Harmonic Bio
intends to nominate a development candidate from this program in
early 2023.
Summary of Financial Results
Cash Position: Cash and cash
equivalents totaled $288.9 million as of December 31, 2022.
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 the next twelve months.
R&D Expenses: Research and
development (R&D) expenses increased to $9.3 million for the
three months ended December 31, 2022, from $4.3 million for
the same period in 2021. R&D expenses for the year ended
December 31, 2022, increased to $24.4 million from $15.7
million for the same period in 2021. The increases were primarily
due to increases in discovery and development costs relating to the
research and nonclinical development of next generation molecules
and other discovery programs, as well as increases in personnel
related costs.
G&A Expenses: General and
administrative (G&A) expenses increased to $4.3 million for the
three months ended December 31, 2022, from $1.5 million for
the same period in 2021. G&A expenses for the year ended
December 31, 2022, increased to $13.3 million from $3.3
million for the same period in 2021. The increases were primarily
attributable to increases in costs associated with
personnel-related expenses and the initial public offering.
Net Loss: Net loss for the three
months ended December 31, 2022, decreased to $11.5 million
from a net loss of $15.8 million for the same period in 2021,
primarily due to the change in fair value of the preferred stock
tranche liability partially offset by increases in loss from
operations. Net loss for the year ended December 31, 2022, was
$35.2 million compared to a net loss of $29.6 million for the same
period in 2021.
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 a novel highly selective, oral
small-molecule inhibitor 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. 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 timing of selecting a
next-generation KIT inhibitor development candidate and additional
corporate announcements and presentations, the results and timing
of preclinical studies and clinical trials for future development
candidates, expectations regarding cash forecasts, and planned
clinical and development activities and timelines. 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 the ongoing COVID-19
pandemic, 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 Annual Report on Form 10-K for the
year ended December 31, 2022, filed with the U.S. Securities and
Exchange Commission (SEC) on March 29, 2023, and in Third Harmonic
Bio’s other filings with the SEC 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.
Media Contact: Lori Murray
lori.murray@thirdharmonicbio.com
Investor Contact: Bob Ho
rho@thirdharmonicbio.com
THIRD HARMONIC BIO, INC.
Condensed consolidated balance sheet data
(Unaudited)
(In thousands)
|
|
December 31,2021 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
128,280 |
|
|
$ |
288,877 |
|
Other current assets |
|
|
884 |
|
|
|
3,959 |
|
Non-current assets |
|
|
— |
|
|
|
5,840 |
|
Total assets |
|
$ |
129,164 |
|
|
$ |
298,676 |
|
Liabilities |
|
|
|
|
|
|
Current liabilities |
|
$ |
5,686 |
|
|
$ |
5,653 |
|
Non-current liabilities |
|
|
— |
|
|
|
3,954 |
|
Total liabilities |
|
|
5,686 |
|
|
|
9,607 |
|
Redeemable convertible preferred stock |
|
|
170,184 |
|
|
|
— |
|
Stockholders' equity |
|
|
(46,706 |
) |
|
|
289,068 |
|
Total liabilities and stockholders' equity |
|
$ |
129,164 |
|
|
$ |
298,675 |
|
|
|
|
|
|
|
|
THIRD HARMONIC BIO, INC.
Condensed consolidated statements of operations
(Unaudited)
(In thousands of, except per share and share
amounts)
|
|
Year Ended December 31, |
|
|
|
2021 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
15,748 |
|
|
$ |
24,407 |
|
General and administrative |
|
|
3,256 |
|
|
|
13,301 |
|
Total operating expenses |
|
|
19,004 |
|
|
|
37,708 |
|
Loss
from operations |
|
|
19,004 |
|
|
|
37,708 |
|
Other (income) expense, net |
|
|
10,605 |
|
|
|
(2,553 |
) |
Net
loss |
|
$ |
29,609 |
|
|
$ |
35,155 |
|
|
|
|
|
|
|
|
Net loss per
share of common stock, basic and diluted |
|
$ |
7.32 |
|
|
$ |
2.62 |
|
Weighted-average common stock outstanding, basic and diluted |
|
|
4,043,416 |
|
|
|
13,426,066 |
|
|
|
|
|
|
|
|
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