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 September 30, 2023, and recent business highlights.
Recent Highlights
IMPAHCT Global Phase 2b/Phase 3 Clinical
Trial on Track for Topline Data in the Second Quarter of
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 125 clinical sites activated in over
20 countries and continue to enroll patients to participate in the
Phase 2b portion of IMPAHCT. We expect to report topline data from
the Phase 2b portion of IMPAHCT in the second quarter of 2024.
Expanded Intellectual Property
Portfolio. We continued expanding our intellectual
property portfolio in 2023 with the issuance of one patent. Since
June 30, 2023, the United States Patent and Trademark Office issued
Patent 11,806,349 to us bringing total issued patents to five. We
continue prosecuting multiple additional applications to cover our
product globally.
Third Quarter 2023 Financial
Results
Financial guidance: We expect
that our cash, cash equivalents and available-for-sale securities
will be sufficient to fund our operations into 2026, based on our
current operating plan.
Cash, cash equivalents and available-for sale
securities totaled $135.2 million as of September 30, 2023,
compared to $129.2 million as of December 31, 2022. The increase
was primarily driven by net proceeds from our “at-the-market”
program, offset by operational costs for the nine-month period
ended September 30, 2023.
R&D expenses: Research and
development (R&D) expenses for the third quarter ended
September 30, 2023 were $16.9 million as compared to $10.8 million
for the third quarter ended September 30, 2022. The increase in
R&D expenses was due primarily to higher headcount-related
costs, contract manufacturing costs, and clinical trial costs in
2023 as compared to 2022.
G&A expenses: General and
administrative (G&A) expenses for the third quarter ended
September 30, 2023 were $4.5 million as compared to $3.4 million
for the third quarter ended September 30, 2022. The increase in
G&A expenses was due primarily to higher headcount-related
costs in 2023 as compared to 2022.
Net loss: Net loss for the
third quarter ended September 30, 2023 was $19.6 million as
compared to $13.6 million for the third quarter ended September 30,
2022. Net loss included stock-based compensation expense of $3.2
million and $1.5 million for the three months ended September 30,
2023 and 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 cellular hyperproliferation and resistance to
apoptosis, driven by improper signaling in cells of the distal
pulmonary arteries. 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 published in ERJ
Open Research 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 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 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 2026; our business plans and
objectives for AV-101, including expectations regarding timing and
success of our Phase 2b/Phase 3 clinical trial.
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 public health crises 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) |
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
2023 |
|
2022 |
|
Assets |
|
|
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities |
|
$ |
135,199 |
|
$ |
129,220 |
|
Other assets |
|
|
5,677 |
|
|
6,081 |
|
Total assets |
|
|
140,876 |
|
|
135,301 |
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
Accounts payable and accrued and other current liabilities |
|
$ |
14,274 |
|
$ |
7,397 |
|
Other liabilities |
|
|
879 |
|
|
1,161 |
|
Total liabilities |
|
|
15,153 |
|
|
8,558 |
|
Total stockholders’ equity |
|
|
125,723 |
|
|
126,743 |
|
Total liabilities and
stockholders' equity |
|
$ |
140,876 |
|
$ |
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 September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
16,884 |
|
|
$ |
10,783 |
|
|
$ |
46,406 |
|
|
$ |
26,401 |
|
General and administrative |
|
|
4,484 |
|
|
|
3,369 |
|
|
|
12,937 |
|
|
|
10,984 |
|
Total operating expenses (1) |
|
|
21,368 |
|
|
|
14,152 |
|
|
|
59,343 |
|
|
|
37,385 |
|
Loss from operations |
|
|
(21,368 |
) |
|
|
(14,152 |
) |
|
|
(59,343 |
) |
|
|
(37,385 |
) |
Total other income |
|
|
1,805 |
|
|
|
564 |
|
|
|
4,235 |
|
|
|
896 |
|
Net loss |
|
$ |
(19,563 |
) |
|
$ |
(13,588 |
) |
|
$ |
(55,108 |
) |
|
$ |
(36,489 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.71 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.13 |
) |
|
$ |
(1.49 |
) |
Weighted-average shares of
common stock outstanding, basic and diluted |
|
|
27,640,542 |
|
|
|
24,454,786 |
|
|
|
25,872,118 |
|
|
|
24,425,390 |
|
(1) Non-cash charges were $3.2
million and $8.7 million, and $1.5 million and $3.7 million for the
three and nine months ended September 30, 2023 and 2022,
respectively.
Media
Contactinfo@aerovatetx.com
Investor
Contactir@aerovatetx.com
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