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
year ended December 31, 2022, and recent business highlights.
“Aerovate had a productive year in 2022 as
evidenced by the progress made with our lead pipeline candidate
AV-101 and strategic additions to our management team,” said Tim
Noyes, Chief Executive Officer of Aerovate. “We believe AV-101, if
approved, has the potential to become part of a new standard of
care for patients with PAH by directly delivering a novel
antiproliferative therapy to the pulmonary vasculature in a way
that may offer broad efficacy and a low side effect burden to
complement current and future treatment options. With its
convenient twice daily dosing and easy-to-use pocket-size inhaler,
we are optimistic about the potential of AV-101 to help us deliver
on our vision of providing patients with meaningful treatment
solutions.”
2022 Highlights
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. During 2022, we had additional clinical site
activations and additional patients enrolled. We expect to report
topline data from the Phase 2b portion of the trial in the fourth
quarter of 2023 or first quarter of 2024.
Trial Data Published and Presented at
Scientific Conferences. The Phase 1 AV-101 results,
published in ERJ Open Research and presented at the American
Thoracic Society (ATS) International Conference in May,
demonstrated AV-101 delivered by dry powder inhalation to healthy
adult volunteers was generally well-tolerated at doses from 10mg
twice daily to 90mg twice daily with significantly reduced systemic
exposure compared with 400mg oral imatinib, the dose used in
Novartis’ IMPRES trial in PAH, and no serious treatment-emergent
adverse events reported. In October 2022, the IMPAHCT trial design
was presented at the American College of Chest Physicians Annual
Meeting (CHEST) in a poster session. The adaptive, operationally
seamless trial design for our Phase 2b/Phase 3 trial allows for
continuous enrollment across phases and a more efficient drug
development timeline.
Expanded Intellectual Property
Portfolio. We continued expanding our intellectual
property portfolio in 2022 with the issuance of four patents. The
United States Patent and Trademark Office issued Patents
11,229,650, 11,298,355, 11,413,289, and 11,464,776. to us and we
continue prosecuting multiple additional applications to cover our
product globally.
Strengthened Management Team.
We added four key members to our management team this past year,
including the additions of Marco Verwijs as SVP, CMC (Chemistry,
Manufacturing and Controls), Susan Fischer as SVP, Development
Operations, Stephen Yu as SVP, Quality, and Sanjeev Khindri as SVP,
Clinical Development. All have decades of experience in the
biopharmaceutical space.
Expanded Board of Directors. We
appointed Donald Santel to our Board and our Nominating and
Corporate Governance Committee. Mr. Santel is Chairperson of the
Board of two biopharmaceutical companies and was Chief Executive
Officer for CoTherix, Inc., a biopharmaceutical company focused on
developing therapies for cardiopulmonary disease, including
PAH.
2022 Financial Results
Cash, cash equivalents and short-term
investments totaled $129.2 million as of December 31, 2022,
compared to $142.6 million as of September 30, 2022. The decrease
was primarily driven by operational costs for the three-month
period ended December 31, 2022.
R&D expenses: Research and
development (R&D) expenses for the year ended December 31, 2022
were $38.6 million as compared to $15.0 million for the year ended
December 31, 2021. The increase in R&D expenses was due
primarily to clinical trial costs, manufacturing costs, and
increased headcount-related costs in 2022 as compared to 2021.
G&A expenses: General and
administrative (G&A) expenses for the year ended December 31,
2022 were $14.6 million as compared to $8.0 million for the year
ended December 31, 2021. The increase in G&A expenses was due
primarily to operating as a public company inclusive of insurance
costs, legal and accounting fees, and increased headcount-related
costs in 2022 as compared to 2021.
Net loss: Net loss for the year
ended December 31, 2022 was $51.5 million as compared to $23.0
million for the year ended December 31, 2021. Net loss included
stock-based compensation expense of $5.5 million and $2.0 million
for the years ended December 31, 2022 and December 31, 2021,
respectively.
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.
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 smooth muscle 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,”
“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 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
expectations regarding the strength of our intellectual property
portfolio globally; 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 contribution of the members
of our board of directors and management team to our operations and
progress; 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)
|
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
2022 |
|
2021 |
|
Assets |
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
129,220 |
|
$ |
167,375 |
|
Other assets |
|
|
6,081 |
|
|
7,988 |
|
Total assets |
|
|
135,301 |
|
|
175,363 |
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
Accounts payable and accrued and other current liabilities |
|
$ |
7,397 |
|
$ |
2,358 |
|
Other liabilities |
|
|
1,161 |
|
|
587 |
|
Total liabilities |
|
|
8,558 |
|
|
2,945 |
|
Total stockholders’
equity |
|
|
126,743 |
|
|
172,418 |
|
Total liabilities and
stockholders' equity |
|
$ |
135,301 |
|
$ |
175,363 |
|
Aerovate Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive Loss(Unaudited)(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
12,221 |
|
|
$ |
5,047 |
|
|
$ |
38,622 |
|
|
$ |
14,987 |
|
General and administrative |
|
3,631 |
|
|
|
3,225 |
|
|
|
14,615 |
|
|
|
8,035 |
|
Total operating expenses |
|
15,852 |
|
|
|
8,272 |
|
|
|
53,237 |
|
|
|
23,022 |
|
Loss from operations |
|
(15,852 |
) |
|
|
(8,272 |
) |
|
|
(53,237 |
) |
|
|
(23,022 |
) |
Total other income |
|
856 |
|
|
|
49 |
|
|
|
1,751 |
|
|
|
62 |
|
Net loss before income
taxes |
|
(14,996 |
) |
|
|
(8,223 |
) |
|
|
(51,486 |
) |
|
|
(22,960 |
) |
Provision for income
taxes |
|
25 |
|
|
|
— |
|
|
|
25 |
|
|
|
3 |
|
Net loss |
$ |
(15,021 |
) |
|
$ |
(8,223 |
) |
|
$ |
(51,511 |
) |
|
$ |
(22,963 |
) |
Net loss per share, basic and
diluted |
$ |
(0.61 |
) |
|
$ |
(0.34 |
) |
|
$ |
(2.10 |
) |
|
$ |
(1.87 |
) |
Weighted-average shares of
common stock outstanding, basic and diluted |
|
24,610,723 |
|
|
|
24,410,393 |
|
|
|
24,472,104 |
|
|
|
12,293,629 |
|
Media
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