Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage
biopharmaceutical company focused on developing drugs that
meaningfully improve the lives of patients with rare
cardiopulmonary disease, today announced financial results for the
quarter ended March 31, 2023, and recent business highlights.
“One of our priorities over the past year was
opening clinical trial sites globally, and we have made excellent
progress on our stated objective with more than 100 sites currently
activated,” said Tim Noyes, Chief Executive Officer of Aerovate.
“Patient enrollment has been slower than expected, in part related
to post-COVID factors, and based on our current enrollment metrics,
we project topline Phase 2b data in the second quarter of 2024.
Importantly, clinical investigators and KOLs globally continue to
express enthusiasm for AV-101 and our clinical trial, and the pace
of enrollment is steadily increasing.”
Recent Highlights
Progress Continued on the IMPAHCT Global
Phase 2b/Phase 3 Clinical Trial, Topline Phase 2b Data Expected in
Q2 2024. IMPAHCT (Inhaled iMatinib Pulmonary Arterial
Hypertension Clinical Trial) is a Phase 2b/Phase 3 trial of AV-101,
our self-administered, twice daily dry powder inhaled formulation
of the antiproliferative drug imatinib for the treatment of
pulmonary arterial hypertension (PAH), a devastating disease
impacting approximately 70,000 people in the United States and
Europe. We now have more than 100 clinical sites activated in 20
countries and continue to activate experienced clinical sites to
participate in the Phase 2b portion and Phase 3 portion of IMPAHCT.
Based on current enrollment metrics, we expect to report topline
data from the Phase 2b portion of IMPAHCT in the second quarter of
2024.
First Quarter 2023 Financial
Results
Financial guidance: We expect
that our cash, cash equivalents and available-for-sale investments
will be sufficient to fund our operations into the second half of
2025, based on our current operating plan.
Cash, cash equivalents and short-term
investments totaled $118.9 million as of March 31, 2023, compared
to $129.2 million as of December 31, 2022. The decrease was
primarily driven by operational costs for the three-month period
ended March 31, 2023.
R&D expenses: Research and
development (R&D) expenses for the first quarter ended March
31, 2023 were $13.5 million as compared to $7.3 million for the
first quarter ended March 31, 2022. The increase in R&D
expenses was due primarily to clinical trial costs and
headcount-related costs, offset by lower contract manufacturing
costs in 2023 as compared to 2022.
G&A expenses: General and
administrative (G&A) expenses for the first quarter ended March
31, 2023 were $4.2 million as compared to $3.8 million for the
first quarter ended March 31, 2022. The increase in G&A
expenses was due primarily to headcount-related costs in 2023 as
compared to 2022.
Net loss: Net loss for the
first quarter ended March 31, 2023 was $16.5 million as compared to
$10.9 million for the first quarter ended March 31, 2022. Net loss
included stock-based compensation expense of $2.4 million and $1.0
million for the first quarter ended March 31, 2023 and March 31,
2022, respectively.
About AV-101
AV-101 is an investigational, proprietary dry
powder inhaled formulation of the antiproliferative drug imatinib.
Developed specifically for pulmonary arterial hypertension (PAH),
AV-101 targets the abnormal cellular hyperproliferation in the
distal pulmonary arteries, caused by an imbalance of activity
between growth factors and apoptosis. By targeting the
proliferation and accumulation of cells in the arteries of the
lungs, we believe AV-101 has the potential to provide meaningful
improvements for patients beyond the capabilities of currently
approved therapies. AV-101 is designed for delivery by an
easy-to-use dry powder inhaler, directly into the lungs to maximize
potential clinical benefit and limit systemic adverse effects.
Phase 1 results presented at the 2022 American Thoracic Society
(ATS) annual meeting showed that AV-101 delivered by dry powder
inhalation was generally well-tolerated by healthy adult volunteers
with no serious adverse events reported. Aerovate is enrolling
patients in the IMPAHCT Phase 2b/Phase 3 clinical trial to evaluate
the safety and efficacy of different doses of AV-101 in adults with
PAH.
About the IMPAHCT Trial
IMPAHCT (Inhaled iMatinib Pulmonary Arterial
Hypertension Clinical Trial) is a multi-national,
placebo-controlled Phase 2b/Phase 3 trial in adults with PAH that
will continuously enroll patients as the study progresses from
Phase 2b to Phase 3. The Phase 2b portion of the trial will
evaluate three doses of AV-101 over 24 weeks, compared to placebo,
to identify an optimal dose based on the primary endpoint, change
in pulmonary vascular resistance (PVR), and safety, tolerability,
and other clinical measures. The Phase 3 portion of the trial will
compare patients taking the optimal dose of AV-101, selected from
the Phase 2b data, to placebo. The primary endpoint of the Phase 3
portion of the trial will be change in six-minute walk distance
(6MWD) over 24 weeks versus placebo. More information about this
trial is available at
https://clinicaltrials.gov/ct2/show/NCT05036135.
About Aerovate Therapeutics,
Inc.
Aerovate is a clinical-stage biopharmaceutical
company focused on developing drugs that meaningfully improve the
lives of patients with rare cardiopulmonary disease. Aerovate’s
initial focus is on advancing AV-101, its proprietary dry powder
inhaled formulation of the drug imatinib for the treatment of
patients with PAH. Learn more at aerovatetx.com or follow the
company on Twitter and LinkedIn.
Available Information
Aerovate announces material information to the
public about the Company, its products and services, and other
matters through a variety of means, including filings with the U.S.
Securities and Exchange Commission (SEC), press releases, public
conference calls, webcasts, the investor relations section of the
Company website at ir.aerovatetx.com, and the Company’s Twitter
account @AerovateTx in order to achieve broad, non-exclusionary
distribution of information to the public and for complying with
its disclosure obligations under Regulation FD.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended. Forward-looking statements can be
identified by words such as “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “future,” “goal,” “intend,” “look
forward to,” “may,” “plan,” “potential,” “predict,” “project,”
seek,” “strategy,” “should,” “target,” “will,” “would” and similar
expressions regarding future periods. These forward-looking
statements include, but are not limited to, statements regarding
the therapeutic potential and clinical benefits of AV-101; our
expectations regarding clinical site activation and patient
enrollment for our Phase 2b/Phase 3 trial; our anticipated timing
for the release of topline data from the Phase 2b portion of our
clinical trial; our belief that we will have capital to fund
Aerovate into the second half of 2025; our business plans and
objectives for AV-101, including expectations regarding timing and
success of our Phase 2b/Phase 3 clinical trial, potential
regulatory submissions and approvals for AV-101; and our growth and
goals as a company.
Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, those risks and uncertainties related to the
therapeutic potential and clinical benefits of AV-101; the timing
associated with the identification and activation of clinical
sites, patient enrollment, initiation, delivery of drug supply and
continuation of our Phase 2b/Phase 3 trial of AV-101 in PAH
patients; the impact of the COVID-19 pandemic on our business,
clinical trials, operations and goals; positive results from a
clinical study may not necessarily be predictive of the results of
future or ongoing clinical studies; regulatory developments in the
United States and foreign countries; as well as those risks and
uncertainties set forth more fully under the caption “Risk Factors”
in our most recent Annual Report on Form 10-K filed with the SEC
and subsequent filings with the SEC. We caution you not to place
undue reliance on any forward-looking statements, which speak only
as of the date they are made. We disclaim any obligation to
publicly update or revise any such statements to reflect any change
in expectations or in events, conditions or circumstances on which
any such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent our views only as of the
date hereof and should not be relied upon as representing its views
as of any subsequent date.
Aerovate Therapeutics,
Inc.Condensed Consolidated Balance
Sheets(Unaudited)(in thousands)
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
118,929 |
|
$ |
129,220 |
Other assets |
|
5,464 |
|
|
6,081 |
Total assets |
|
124,393 |
|
|
135,301 |
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
Accounts payable and accrued and other current liabilities |
$ |
10,264 |
|
$ |
7,397 |
Other liabilities |
|
1,034 |
|
|
1,161 |
Total liabilities |
|
11,298 |
|
|
8,558 |
Total stockholders’ equity |
|
113,095 |
|
|
126,743 |
Total liabilities and
stockholders' equity |
$ |
124,393 |
|
$ |
135,301 |
|
|
|
|
|
|
|
|
|
|
|
|
Aerovate Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive Loss(Unaudited)(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
13,488 |
|
|
$ |
7,255 |
|
General and administrative |
|
4,151 |
|
|
|
3,764 |
|
Total operating expenses (1) |
|
17,639 |
|
|
|
11,019 |
|
Loss from operations |
|
(17,639 |
) |
|
|
(11,019 |
) |
Total other income |
|
1,119 |
|
|
|
109 |
|
Net loss |
$ |
(16,520 |
) |
|
$ |
(10,910 |
) |
Net loss per share, basic and
diluted |
$ |
(0.67 |
) |
|
$ |
(0.45 |
) |
Weighted-average shares of
common stock outstanding, basic and diluted |
|
24,777,847 |
|
|
|
24,410,393 |
|
|
|
|
|
|
|
|
|
(1) Non-cash charges were $2.4 million and $1.0
million for the first quarter ended March 31, 2023 and 2022,
respectively.
Media
Contactinfo@aerovatetx.com
Investor
Contactir@aerovatetx.com
Aerovate Therapeutics (NASDAQ:AVTE)
Historical Stock Chart
From Apr 2024 to May 2024
Aerovate Therapeutics (NASDAQ:AVTE)
Historical Stock Chart
From May 2023 to May 2024