Aerovate Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date
of earliest event reported):
(Exact name of registrant as specified in its charter)
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
Aerovate Therapeutics, Inc.
(Address of principal executive offices, including zip code)
(
(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 | ||
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
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.
| Item 8.01 | Other Events |
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
| Exhibit Number |
Description | |
| 99.1 | Press release issued by Aerovate Therapeutics, Inc. on June 17, 2024, furnished herewith. | |
| 104 | Cover Page Interactive Data File |
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 | ||