SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): October 13, 2020
KARUNA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction of
|33 Arch Street, Suite 3110
|(Address of principal executive offices)||(Zip Code)|
Registrants telephone number, including area code: (857) 449-2244
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:
Name of each exchange
|Common stock, par value $0.0001||KRTX||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 ☒
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 October 13, 2020, Karuna Therapeutics, Inc. (the Company) disclosed during an investor meeting that no incidences of syncope have been reported to the Company in its on-going Phase 1b clinical trial evaluating the safety and tolerability of KarXT in healthy elderly volunteers. The Company commenced the trial in December 2019 and expects to announce topline results early in the second quarter of 2021. The Company cautions investors that data from this on-going trial is not complete, is subject to audit and verification procedures and may not be indicative of the final trial results. As a result, interim data should be viewed with caution until the final data are available. The Company does not currently anticipate releasing future interim or preliminary results of this trial or future planned trials.
The information in this Report on Form 8-K is intended to be furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (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 or the Exchange Act, except as expressly set forth by specific reference in such filing.
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.
Date: October 13, 2020
KARUNA THERAPEUTICS, INC.
|By:||/s/ Troy Ignelzi|
Chief Financial Officer