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 June 30, 2023, and recent business highlights.
Recent Highlights
- Progress Continued for IMPAHCT
Global Phase 2b/Phase 3 Clinical Trial
- Extended Cash Runway into 2026
- Presented Nonclinical
Pharmacokinetic Data at ATS
- Expanded Board of Directors
Progress Continued on the IMPAHCT Global
Phase 2b/Phase 3 Clinical Trial. 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 110 clinical sites activated in
over 20 countries and continue to activate experienced clinical
sites and enroll patients to participate in the Phase 2b portion
and Phase 3 portion of IMPAHCT. We expect to report topline data
from the Phase 2b portion of IMPAHCT in the second quarter of
2024.
Extended Cash Runway into 2026.
We sold an aggregate of $45 million of our common stock under our
existing “at-the-market” program (the ATM Program). With the net
proceeds from such transaction, we expect to fund our operations
into 2026, based on our current operating plan.
Nonclinical Pharmacokinetic Data
Presented at ATS 2023 International Conference. We
presented at the American Thoracic Society (ATS) 2023 International
Conference in Washington, D.C. results in nonclinical species that
(i) direct delivery of imatinib to the lungs demonstrated increased
lung exposure compared with oral or IV dosing and (ii) the type of
formulation impacted lung exposure with dry powder demonstrating
greater lung exposure than suspension or solution and greater lung
exposure vs oral or intravenous delivery.
Expanded Board of Directors. We
appointed Habib Dable to our Board of Directors and our
Compensation Committee. Mr. Dable is the former President and Chief
Executive Officer of Acceleron Pharma Inc. (Acceleron) where he
guided Acceleron to its first blockbuster launch in 2019 and
eventual sale to Merck & Co. in 2021 for over $11 billion. Mr.
Dable brings nearly three decades of experience working with
emerging biotech and big pharma companies.
Second 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 $150.1 million as of June 30, 2023, compared to
$129.2 million as of December 31, 2022. The increase was primarily
driven by net proceeds from our ATM Program, offset by operational
costs for the six-month period ended June 30, 2023.
R&D expenses: Research and
development (R&D) expenses for the second quarter ended June
30, 2023 were $16.0 million as compared to $8.4 million for the
second quarter ended June 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 second quarter ended June
30, 2023 were $4.3 million as compared to $3.9 million for the
second quarter ended June 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
second quarter ended June 30, 2023 was $19.0 million as compared to
$12.0 million for the second quarter ended June 30, 2022. Net loss
included stock-based compensation expense of $3.0 million and $1.2
million for the second quarter ended June 30, 2023 and June 30,
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 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 2026; 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; the anticipated contributions of the members
of our Board of Directors; 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 public health crises, such as 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)
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities |
|
$ |
150,096 |
|
|
$ |
129,220 |
|
Other assets |
|
|
5,659 |
|
|
|
6,081 |
|
Total assets |
|
|
155,755 |
|
|
|
135,301 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Accounts payable and accrued and other current liabilities |
|
$ |
12,905 |
|
|
$ |
7,397 |
|
Other liabilities |
|
|
924 |
|
|
|
1,161 |
|
Total liabilities |
|
|
13,829 |
|
|
|
8,558 |
|
Total stockholders’
equity |
|
|
141,926 |
|
|
|
126,743 |
|
Total liabilities and
stockholders' equity |
|
$ |
155,755 |
|
|
$ |
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 June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
16,034 |
|
|
$ |
8,363 |
|
|
$ |
29,522 |
|
|
$ |
15,618 |
|
General and administrative |
|
|
4,302 |
|
|
|
3,852 |
|
|
|
8,453 |
|
|
|
7,615 |
|
Total operating expenses (1) |
|
|
20,336 |
|
|
|
12,215 |
|
|
|
37,975 |
|
|
|
23,233 |
|
Loss from operations |
|
|
(20,336 |
) |
|
|
(12,215 |
) |
|
|
(37,975 |
) |
|
|
(23,233 |
) |
Total other income |
|
|
1,311 |
|
|
|
224 |
|
|
|
2,430 |
|
|
|
332 |
|
Net loss |
|
$ |
(19,025 |
) |
|
$ |
(11,991 |
) |
|
$ |
(35,545 |
) |
|
$ |
(22,901 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.76 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.42 |
) |
|
$ |
(0.94 |
) |
Weighted-average shares of
common stock outstanding, basic and diluted |
|
|
25,166,505 |
|
|
|
24,410,503 |
|
|
|
24,973,250 |
|
|
|
24,410,448 |
|
(1) Non-cash charges were $3.0 million and $1.2
million for the second quarter ended June 30, 2023 and 2022,
respectively.
Media
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Aerovate Therapeutics (NASDAQ:AVTE)
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Aerovate Therapeutics (NASDAQ:AVTE)
過去 株価チャート
から 5 2023 まで 5 2024