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 our financial results for
the quarter ended September 30, 2021, and recent events.
“We continue to make progress with clinical
trial sites to participate in our global Phase 2b/3 trial of AV-101
in PAH and expect to initiate enrollment this year in the Phase 2b
portion of the trial,” said Timothy Noyes, chief executive officer
of Aerovate. “We are also pleased with investor support for our
IPO, which we believe provides sufficient capital to fund Aerovate
into the second half of 2025.”
Recent Events
Raised $126.9 Million in Net Proceeds
from IPO. On July 2, 2021, we closed our initial public
offering (IPO) raising gross proceeds of $139.8 million, which
included full exercise of the underwriters’ option to purchase
additional shares of common stock, at a public offering price of
$14.00 per share. We raised net proceeds of approximately $126.9
million after deducting underwriting discounts and commissions and
other offering expenses payable by us.
Preparation Continues for Global Phase
2b/3 Clinical Trial. We continued preparing for the
initiation of our Phase 2b/3 trial of AV-101, our dry powder
inhaled formulation of imatinib for the treatment of pulmonary
arterial hypertension, or PAH, a devastating disease impacting
approximately 70,000 people in the United States and Europe. Drug
supply has been manufactured and we have begun scheduling site
activation meetings in the United States. We anticipate including
experienced PAH centers from more than 20 countries in our Phase
2b/3 trial. We have obtained orphan drug designation from the U.S.
Food and Drug Administration and the European Medicines Agency for
AV-101 for the treatment of PAH in the United States and the
European Union.
Third Quarter 2021 Financial
Results
Cash and cash equivalents totaled $180.9 million
as of September 30, 2021, compared to $59.2 million as of June 30,
2021. The increase was primarily driven by net proceeds of $126.9
million from the Company’s IPO, which closed on July 2, 2021,
offset by operational costs for the three-month period ending
September 30, 2021.
R&D expenses: Research and
development (R&D) expenses for the third quarter of 2021 were
$3.4 million as compared to $2.0 million for the third quarter of
2020. The increase in R&D expenses was due primarily to
increased clinical trial costs and manufacturing costs in the third
quarter of 2021 as compared to the third quarter of 2020.
G&A expenses: General and
administrative (G&A) expenses for the third quarter of 2021
were $2.8 million as compared to $0.3 million for the third quarter
of 2020. The increase in G&A expenses was due primarily to
increased headcount-related costs, insurance costs, legal fees,
accounting fees and consulting expenses in the third quarter of
2021 as compared to the third quarter of 2020.
Net loss: Net loss for the
third quarter of 2021 was $6.2 million as compared to $2.3 million
for the third quarter of 2020. Net loss included stock-based
compensation expense of $0.8 million for the third quarter of 2021
and $21,000 for the third quarter of 2020.
Financial guidance: We expect
that our cash and cash equivalents will be sufficient to fund our
operations into the second half of 2025, based on our current
operating plan.
About Aerovate Therapeutics
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, our dry powder inhaled
formulation of the drug imatinib for the treatment of pulmonary
arterial hypertension, or PAH. For more information, please visit
www.aerovatetx.com.
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,”
“potential,” 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 of AV-101; our
expectations that we will initiate enrollment in the second half of
2021 for the Phase 2b portion of our Phase 2b/3 trial of AV-101 in
PAH; our expectations of identifying clinical site locations and
recruitment of patients for our Phase 2b/3 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 the our Phase 2b/3
clinical trial, the therapeutic potential and clinical benefits of
AV-101 and potential regulatory submissions and approvals for
AV-101; and our growth as a company and the anticipated
contribution of the members of our board of directors to our
operations and progress.
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 of AV-101, and the timing associated with the
identification of clinical sites, patient recruitment, initiation
and continuation of our Phase 2b/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, and other risks identified in our
filings with the Securities and Exchange Commission (“SEC”),
including our Registration Statement on Form S-1, 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 Balance
Sheets(Unaudited)(in thousands)
|
|
September 30, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
180,878 |
|
|
$ |
4,573 |
|
Prepaid expenses and other current assets |
|
|
2,224 |
|
|
|
103 |
|
Total current assets |
|
|
183,102 |
|
|
|
4,676 |
|
Property and equipment, net |
|
|
162 |
|
|
|
39 |
|
Operating lease right-of-use assets |
|
|
583 |
|
|
|
- |
|
Other long-term assets |
|
|
278 |
|
|
|
- |
|
Total assets |
|
$ |
184,125 |
|
|
$ |
4,715 |
|
|
|
|
|
|
|
|
|
|
Liabilities,
Redeemable Convertible Preferred Stock and Stockholders’ Equity
(Deficit) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,555 |
|
|
$ |
618 |
|
Accrued and other current liabilities |
|
|
1,123 |
|
|
|
1,156 |
|
Operating lease liabilities |
|
|
147 |
|
|
|
- |
|
Total current liabilities |
|
|
3,825 |
|
|
|
1,774 |
|
Operating lease liabilities,
net of current portion |
|
|
452 |
|
|
|
- |
|
Total liabilities |
|
|
4,277 |
|
|
|
1,774 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Series A redeemable convertible preferred stock |
|
|
- |
|
|
|
12,285 |
|
Series Seed redeemable convertible preferred stock |
|
|
- |
|
|
|
4,000 |
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
|
|
Stockholders’ equity (deficit) |
|
|
179,848 |
|
|
|
(13,344 |
) |
Total liabilities, redeemable
convertible preferred stock and stockholders’ equity (deficit) |
|
$ |
184,125 |
|
|
$ |
4,715 |
|
|
|
|
|
|
|
|
|
|
Aerovate Therapeutics,
Inc.Condensed 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, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,418 |
|
|
$ |
1,966 |
|
|
$ |
9,941 |
|
|
$ |
4,643 |
|
General and administrative |
|
|
2,782 |
|
|
|
277 |
|
|
|
4,813 |
|
|
|
583 |
|
Total operating expenses |
|
|
6,200 |
|
|
|
2,243 |
|
|
|
14,754 |
|
|
|
5,226 |
|
Loss from operations |
|
|
(6,200 |
) |
|
|
(2,243 |
) |
|
|
(14,754 |
) |
|
|
(5,226 |
) |
Total other income
(expense) |
|
|
16 |
|
|
|
(64 |
) |
|
|
14 |
|
|
|
(719 |
) |
Net loss and comprehensive loss |
|
$ |
(6,184 |
) |
|
$ |
(2,307 |
) |
|
$ |
(14,740 |
) |
|
$ |
(5,945 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.26 |
) |
|
$ |
(10.13 |
) |
|
$ |
(1.80 |
) |
|
$ |
(25.20 |
) |
Weighted-average shares of common stock outstanding, basic and
diluted |
|
|
23,885,017 |
|
|
|
242,901 |
|
|
|
8,180,359 |
|
|
|
241,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact:
Julio CantreInfo@AerovateTx.com202.930.4762
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