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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date
of earliest event reported): June 17, 2024
AEROVATE THERAPEUTICS, INC.
(Exact name of registrant as specified in its
charter)
| Delaware |
|
001-40544 |
|
83-1377888 |
|
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
Aerovate Therapeutics, Inc.
930 Winter Street, Suite M-500, Waltham, Massachusetts 02451
(Address of principal executive offices, including
zip code)
(617) 443-2400
(Registrant’s telephone number, including
area code)
N/A
(Former Name or Former Address, if Changed Since
Last Report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
|
Trade Symbol(s) |
|
Name of each exchange on which registered |
| Common Stock, $0.0001 par value per share |
|
AVTE |
|
The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act.
| Item 7.01 | Regulation FD Disclosure |
On June 17, 2024, Aerovate Therapeutics, Inc.
(“Aerovate” or the “Company”) issued a press release titled “Aerovate Therapeutics Announces 24-Week Topline
Results from the Phase 2b Portion of IMPAHCT Study Evaluating AV-101 for the Treatment of Pulmonary Arterial Hypertension.” A copy
of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information under Item 7.01 of this Current
Report on Form 8-K (including Exhibit 99.1) is intended to be furnished and shall not be deemed “filed” for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that
section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange
Act, except as expressly set forth by specific reference in such filing.
On June 17, 2024, the Company announced topline
results from the Phase 2b portion of the Phase 2b/Phase 3 Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (“IMPAHCT”).
Results showed that, while AV-101 was well tolerated across all dose groups, the study did not meet its primary endpoint for improvement
in pulmonary arterial hypertension (“PVR”) compared to placebo for any of the studied doses or show meaningful improvements
in the secondary endpoint of change in six minute walk distance (“6MWD”).
Primary
Endpoint – ITT analysis of PVR (dynes*sec/cm^5)
| Dose |
Least-squares mean difference as compared with placebo (95% CI) |
P value |
| 10mg BID (N=50) |
42.8
(-80.57 to 166.09) |
0.4968 |
| 35mg BID (N=49) |
-5.5
(-129.16 to 118.18) |
0.9306 |
| 70mg BID (N=51) |
-57.0 (-181.14 to 67.20) |
0.3685 |
Secondary Endpoint – ITT analysis of 6MWD (meters)
| Dose |
Least-squares mean difference as compared with placebo (95% CI) |
| 10mg BID (N=50) |
-11.7 (-34.75 to 11.26) |
| 35mg BID (N=49) |
-4.2
(-27.74 to 19.37) |
| 70mg BID (N=51) |
+1.3
(-22.09 to 24.60) |
The Company has also reviewed data from several
additional secondary endpoints of the Phase 2b portion of IMPAHCT, which also failed to show meaningful improvements. Based upon these
results, Aerovate, in agreement with the independent study advisory committee, is halting enrollment and shutting down the Phase 3 portion
of IMPAHCT as well as the long-term extension study. Aerovate plans to release full data from the Phase 2b portion of IMPAHCT at a later
date, the timing of which is to be determined.
As of June 15, 2024, Aerovate has approximately
$100 million of cash, cash equivalents and short-term investments.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
Aerovate Therapeutics, Inc. |
| |
|
| Date: June 17, 2024 |
By: |
/s/ George A. Eldridge |
| |
|
George A. Eldridge |
| |
|
Chief Financial Officer |
Exhibit 99.1
Aerovate Therapeutics
Announces 24-Week Topline Results from the Phase 2b Portion of
IMPAHCT Evaluating AV-101 for the Treatment of Pulmonary
Arterial Hypertension
AV-101 did not meet the primary endpoint of
change in pulmonary vascular resistance (PVR) for any of the studied doses
WALTHAM, Mass., June 17, 2024 -- Aerovate Therapeutics, Inc.
(Nasdaq: AVTE) today announced topline results from the Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial
Hypertension Clinical Trial (IMPAHCT), a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multi-national
trial of AV-101, a novel dry powder inhaled formulation of imatinib, in adults with pulmonary arterial hypertension (PAH).
The objective of the Phase 2b portion of IMPAHCT was to assess the
efficacy, safety and tolerability of three different doses of AV-101 compared to placebo. The primary endpoint for the Phase 2b portion
of IMPAHCT is change in PVR compared with placebo. Results showed that, while AV-101 was well tolerated across all dose groups, the study
did not meet its primary endpoint for improvement in PVR compared to placebo for any of the studied doses or show meaningful improvements
in the secondary endpoint of change in six minute walk distance (6MWD).
Primary
Endpoint – ITT analysis of PVR (dynes*sec/cm^5)
| Dose |
Least-squares mean difference as compared with placebo (95% CI) |
P value |
| 10mg BID (N=50) |
42.8 (-80.57 to 166.09) |
0.4968 |
| 35mg BID (N=49) |
-5.5 (-129.16 to 118.18) |
0.9306 |
| 70mg BID (N=51) |
-57.0 (-181.14 to 67.20) |
0.3685 |
Secondary Endpoint – ITT analysis of 6MWD (meters)
| Dose |
Least-squares mean difference as compared with placebo (95% CI) |
| 10mg BID (N=50) |
-11.7 (-34.75 to 11.26) |
| 35mg BID (N=49) |
-4.2 (-27.74 to 19.37) |
| 70mg BID (N=51) |
+1.3 (-22.09 to 24.60) |
The Company has also reviewed data from several additional secondary
endpoints of the Phase 2b portion of IMPAHCT, which also failed to show meaningful improvements. Based upon these results, Aerovate, in
agreement with the independent study advisory committee, is halting enrollment and shutting down the Phase 3 portion of IMPAHCT as well
as the long-term extension study.
"The results of the Phase 2b portion of IMPAHCT were unexpected
and disappointing. Our immediate focus is on transparently sharing these findings with investigators, patients and the PAH community.
In the coming weeks, we will engage closely with the IMPAHCT study advisory committee and the PAH community to thoroughly discuss these
data and their implications,” said Tim Noyes, Chief Executive Officer of Aerovate. “We extend our heartfelt gratitude to all
trial participants, investigators, and site teams for their dedication to advancing therapeutic options for the treatment of pulmonary
arterial hypertension.”
Aerovate plans to release full data from the Phase 2b portion of IMPAHCT
at a later date, the timing of which is to be determined.
As of June 15, 2024, Aerovate has approximately $100 million of
cash, cash equivalents and short-term investments.
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. 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.
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 continuously enrolled
patients from Phase 2b to Phase 3. The Phase 2b portion of the trial evaluated 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. 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 X (formerly known as 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 X (formerly known
as 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 Phase 2b/Phase 3 IMPAHCT, including the future release of full clinical data and the Company’s plan to
halt the Phase 3 portion of the IMPAHCT 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-Q 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.
Media Contact
Marites
Coulter
marites.coulter@vergescientific.com
Investor
Contact
IR@Aerovatetx.com
v3.24.1.1.u2
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Aerovate Therapeutics (NASDAQ:AVTE)
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Aerovate Therapeutics (NASDAQ:AVTE)
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