UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Information. |
On November 30, 2022, BioXcel Therapeutics, Inc. (the “Company”) announced that the first 13 patients have been dosed in Part 1 of the Company’s pivotal Phase 3 SERENITY III trial investigating at-home use of BXCL501, the Company’s proprietary, orally dissolving film formulation of dexmedetomidine. Top-line data from the SERENITY III trial as well as from the Company’s TRANQUILITY II trial for Alzheimer’s-related agitation are expected in the first half of 2023.
SERENITY III is a two-part, double-blinded, placebo-controlled pivotal study designed to evaluate BXCL501 60mcg dose for at-home use. This strategic trial design follows a Type B meeting with the U.S. Food and Drug Administration and observed dose-dependent responses in a prior Phase 1/2b study assessing a range of doses. The first part of the Phase 3 SERENITY III trial is similar to the Phase 3 SERENITY I and II trials and is designed to assess the efficacy and safety of a 60mcg dose in a monitored setting in acutely agitated patients with bipolar disorder or schizophrenia. The primary efficacy endpoint is the change from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours after dosing compared to placebo. In Part 1, approximately 200 patients will be enrolled at up to approximately 20 study sites in the U.S. The second part of the study is designed to assess the safety of a 60mcg dose compared to placebo when self-administered at home. SERENITY III is expected to utilize many of the same investigators and clinical sites as SERENITY I and II.
Forward-Looking Statements
This Current Report on Form 8-K (“Form 8-K”) includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this Form 8-K other than statements of historical fact should be considered forward-looking statements, including, without limitation, the Company’s expected timing of, trial design and data results from, clinical trials of BXCL501. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited experience in drug discovery and drug development; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502 and BXCL701 and other product candidates; its lack of experience in marketing and selling drug products; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; and the other important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this Form 8-K. Any such forward-looking statements represent management’s estimates as of the date of this Form 8-K. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this Form 8-K.
SIGNATURES
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: November 30, 2022 | BIOXCEL THERAPEUTICS, INC. |
| /s/ Richard Steinhart | |
| By: | Richard Steinhart |
| Title: | Chief Financial Officer |
Cover |
Nov. 30, 2022 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Nov. 30, 2022 |
| Entity File Number | 001-38410 |
| Entity Registrant Name | BioXcel Therapeutics, Inc. |
| Entity Central Index Key | 0001720893 |
| Entity Tax Identification Number | 82-1386754 |
| Entity Incorporation, State or Country Code | DE |
| Entity Address, Address Line One | 555 Long Wharf Drive |
| Entity Address, City or Town | New Haven |
| Entity Address, State or Province | CT |
| Entity Address, Postal Zip Code | 06511 |
| City Area Code | 475 |
| Local Phone Number | 238-6837 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Common Stock, par value $0.001 |
| Trading Symbol | BTAI |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | true |
| Elected Not To Use the Extended Transition Period | true |