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): October 7, 2020
KARUNA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38958 | 27-0605902 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| 33 Arch Street, Suite 3110 Boston, Massachusetts |
02110 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (857) 449-2244
Not Applicable
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 |
Trading Symbol(s) |
Name of each exchange on which registered | ||
| 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
Karuna Therapeutics, Inc. (the “Company”) continues to enroll subjects in its Phase 1b clinical trial evaluating the safety and tolerability of KarXT in healthy elderly volunteers in order to select the most appropriate dose for future KarXT trials to assess efficacy and safety in a dementia-related psychosis patient population. Topline results from this trial were expected by the end of 2020. However, as a result of COVID-19’s impact on enrollment, the Company now anticipates that topline results from this trial will be announced early in the second quarter of 2021. COVID-19 has not affected the anticipated timing of the Company’s other planned clinical trials, including the initiation of the Phase 3 EMERGENT program evaluating KarXT for the treatment of acute psychosis in patients with schizophrenia in 2020. The Company continues to monitor the impact of COVID-19 across all clinical trials, particularly in the elderly population, and will provide updates on enrollment and completion timelines as deemed appropriate.
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.
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.
| Date: October 7, 2020 | KARUNA THERAPEUTICS, INC. | |||
| By: | /s/ Troy Ignelzi | |||
| Troy Ignelzi | ||||
| Chief Financial Officer | ||||