Third Harmonic Bio, Inc. (Nasdaq: THRD), a clinical-stage
biopharmaceutical company focused on advancing the next wave of
medicine for allergy and inflammation, today announced financial
results for the quarter ended September 30, 2022 and provided
a corporate update.
"With the recent close of our successful initial
public offering, we believe we have the capital resources and
experienced team in place to advance the continued development of
THB001 for the treatment of urticaria, or chronic hives, and asthma
- two inflammatory diseases where, despite current treatment
options, a significant unmet medical need remains,” said Natalie
Holles, chief executive officer of Third Harmonic Bio. “We expect
to initiate a Phase 1b clinical trial in asthma during the first
half of 2023 and report results from our Phase 1b clinical trial in
chronic inducible urticaria during the second half of 2023.”
Recent Business Highlights
Completed Upsized $213.1 Million Initial
Public Offering Third Harmonic Bio closed its initial
public offering of 12,535,000 shares of its common stock, including
the full exercise of the underwriters’ option to purchase up to
1,635,000 additional shares of common stock. The gross proceeds
from the offering, before deducting underwriting discounts and
commissions and other offering expenses payable by Third Harmonic
Bio, were approximately $213.1 million.
Patient Dosing Underway in Phase 1b trial
in Chronic Inducible Urticaria Third Harmonic Bio
completed its Phase 1a clinical trial of THB001 and expects to
present full results of the trial at an upcoming medical meeting
during the first half of 2023. Third Harmonic also began dosing
patients in its Phase 1b clinical trial in chronic inducible
urticaria. The trial is evaluating three dose levels of THB001 over
12 weeks of treatment. The objectives of the clinical trial are to
evaluate safety and tolerability, efficacy and pharmacokinetics.
Additional details about the study can be found under
clinicaltrials.gov identifier NCT05510843.
Recent Leadership Updates Third
Harmonic Bio continued to strengthen its leadership team and board
of directors by appointing Adrian S. Ray, Ph.D., as Chief
Scientific Officer, Edward R. Conner, M.D., as Chief Medical
Officer and Julie Person, as Chief Administrative Officer, and
Thomas M. Soloway to its Board of Directors.
Upcoming Milestones Third
Harmonic Bio expects to deliver on the following milestones:
- Submit a clinical trial application (CTA) in Canada for THB001
to support the initiation of a Phase 1b trial in asthma during the
first half of 2023.
- Report initial clinical data from its Phase 1b proof-of-concept
clinical trial in chronic inducible urticaria during the second
half of 2023.
- Submit both a CTA in Europe and an investigational new drug
application in the United States to support the initiation of a
Phase 2 trial in chronic spontaneous urticaria in the first half of
2024.
- Report initial data from the Phase 1b asthma trial in the
second half of 2024.
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled
$299.5 million as of September 30, 2022. Based upon current
internal infrastructure and pipeline initiatives, Third Harmonic
Bio believes it has sufficient cash to fund operations through
2025.
R&D Expenses: Research and
development (R&D) expenses decreased to $4.8 million for the
three months ended September 30, 2022 from $4.9 million for
the same period in 2021 due to the timing of non-clinical and
clinical activities. R&D expenses for the nine months ended
September 30, 2022 increased to $15.2 million from $11.5
million for the same period in 2021, primarily due to higher
clinical trial expenses related to THB001.
G&A Expenses: General and
administrative (G&A) expenses increased to $3.8 million for the
three months ended September 30, 2022 from $0.8 million for
the same period in 2021. G&A expenses for the nine months ended
September 30, 2022 increased to $9.0 million from $1.8 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 September 30, 2022 was $8.2 million compared to a
net loss of $7.4 million for the same period in 2021. Net loss for
the nine months ended September 30, 2022 was $23.7 million
compared to a net loss of $13.8 million for the same period in
2021.
About Third Harmonic Bio, Inc.
Third Harmonic Bio is a clinical-stage biopharmaceutical company
focused on advancing the next wave of medicine for allergy and
inflammation. Third Harmonic’s lead product candidate, THB001, is a
highly selective, oral small-molecule inhibitor of KIT, a cell
surface receptor that serves as the master regulator of mast cell
function and survival. THB001 is currently being evaluated in a
Phase 1b proof-of-concept study in chronic inducible urticaria.
With promising drug-like properties and an encouraging early
clinical profile, THB001 has the potential to revolutionize the
treatment of a broad range of dermatologic, respiratory and
gastrointestinal allergic and mast-cell-mediated inflammatory
diseases. 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 results and timing of clinical
trials and regulatory submissions for THB001, 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’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 prospectus dated September 14,
2022 filed with the U.S. Securities and Exchange Commission (SEC)
on September 15, 2022, and Third Harmonic Bio’s annual and
quarterly reports and 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@captivate-comms.com
Investor Contact: Bob Ho
rho@thirdharmonicbio.com
|
THIRD
HARMONIC BIO, INC.Condensed consolidated balance
sheet data(Unaudited)(In thousands) |
|
|
|
|
|
|
|
December 31,2021 |
|
|
September 30,2022 |
|
Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
128,280 |
|
|
$ |
299,516 |
|
Other current assets |
|
884 |
|
|
|
4,053 |
|
Non-current assets |
|
— |
|
|
|
1,193 |
|
Total assets |
$ |
129,164 |
|
|
$ |
304,762 |
|
Liabilities |
|
|
|
|
|
Current liabilities |
$ |
5,686 |
|
|
$ |
6,340 |
|
Non-current liabilities |
|
— |
|
|
|
— |
|
Total liabilities |
|
5,686 |
|
|
|
6,340 |
|
Redeemable convertible preferred stock |
|
170,184 |
|
|
|
— |
|
Stockholders' equity |
|
(46,706 |
) |
|
|
298,422 |
|
Total liabilities and stockholders' equity |
$ |
129,164 |
|
|
$ |
304,762 |
|
|
|
|
|
|
|
|
THIRD
HARMONIC BIO, INC.Condensed consolidated
statements of operations(Unaudited)(In
thousands of, except per share and share amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,917 |
|
|
$ |
4,757 |
|
|
$ |
11,463 |
|
|
$ |
15,150 |
|
General and administrative |
|
|
780 |
|
|
|
3,831 |
|
|
|
1,790 |
|
|
|
9,008 |
|
Total operating expenses |
|
|
5,697 |
|
|
|
8,588 |
|
|
|
13,253 |
|
|
|
24,158 |
|
Loss
from operations |
|
|
5,697 |
|
|
|
8,588 |
|
|
|
13,253 |
|
|
|
24,158 |
|
Other (income) expense, net |
|
|
1,684 |
|
|
|
(383 |
) |
|
|
574 |
|
|
|
(493 |
) |
Net
loss |
|
$ |
7,381 |
|
|
$ |
8,205 |
|
|
$ |
13,827 |
|
|
$ |
23,665 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share of common stock, basic and diluted |
|
$ |
0.90 |
|
|
$ |
0.69 |
|
|
$ |
3.46 |
|
|
$ |
2.26 |
|
Weighted-average common stock outstanding, basic and diluted |
|
|
8,159,044 |
|
|
|
11,827,663 |
|
|
|
3,994,784 |
|
|
|
10,451,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grafico Azioni Third Harmonic Bio (NASDAQ:THRD)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Third Harmonic Bio (NASDAQ:THRD)
Storico
Da Giu 2023 a Giu 2024