BioXcel Therapeutics Files 8-K

Ticker: BTAI · Form: 8-K · Filed: Apr 22, 2024 · CIK: 1720893

Bioxcel Therapeutics, INC. 8-K Filing Summary
FieldDetail
CompanyBioxcel Therapeutics, INC. (BTAI)
Form Type8-K
Filed DateApr 22, 2024
Risk Levellow
Pages5
Reading Time7 min
Key Dollar Amounts$0.001 B
Sentimentneutral

Sentiment: neutral

Topics: sec-filing, 8-k

Related Tickers: BTAI

TL;DR

BioXcel filed an 8-K, standard procedure, no major news in this snippet.

AI Summary

BioXcel Therapeutics, Inc. filed an 8-K on April 22, 2024, to report on other events and financial statements. The filing does not contain specific details about new material events, significant financial figures, or material agreements within the provided text.

Why It Matters

This filing indicates BioXcel Therapeutics is fulfilling its reporting obligations with the SEC, though the provided excerpt lacks specific material updates.

Risk Assessment

Risk Level: low — The filing is a routine 8-K without immediate disclosed material events, suggesting low immediate risk from this specific filing.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing for BioXcel Therapeutics, Inc.?

The primary purpose of this 8-K filing is to report on Other Events and Financial Statements and Exhibits, as indicated by the Item Information section.

When was the earliest event reported in this filing?

The earliest event reported in this filing was on April 22, 2024.

What is BioXcel Therapeutics, Inc.'s principal executive office address?

BioXcel Therapeutics, Inc.'s principal executive office is located at 555 Long Wharf Drive, New Haven, CT 06511.

What is the Commission File Number for BioXcel Therapeutics, Inc.?

The Commission File Number for BioXcel Therapeutics, Inc. is 001-38410.

Does the provided text of the 8-K filing contain specific details about new material agreements or financial results?

No, the provided text of the 8-K filing is a header and does not contain specific details about new material agreements or financial results.

Filing Stats: 1,643 words · 7 min read · ~5 pages · Grade level 16.2 · Accepted 2024-04-22 07:10:39

Key Financial Figures

Filing Documents

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On April 22, 2024, BioXcel Therapeutics, Inc. (the "Company" or "BioXcel") issued an updated corporate presentation, including its clinical development programs and business strategy. A copy of the presentation is furnished hereto as Exhibit 99.1 and is incorporated herein by reference and will also be available through the "Investors & Media" page of the Company's website at http://www.bioxceltherapeutics.com. The information in this Item 7.01 on this Current Report on Form 8-K, including Exhibit 99.1 hereto, 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 to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

01. Other Events

Item 8.01. Other Events. On April 22, 2024, the Company provided the following updates regarding the planned design of its SERENITY At-Home Phase 3 trial (which refers to the Company's redesigned SERENITY III trial) to evaluate BXCL501, the Company's investigational proprietary, orally dissolving film formulation of dexmedetomidine, as a potential acute treatment for agitation associated with bipolar disorders or schizophrenia in the home setting. The Company's plan to conduct this trial using a 120 mcg dose is based on feedback received from the U.S. Food and Drug Administration (FDA) following the recent receipt of minutes from the Type C meeting held with the agency on March 6, 2024. SERENITY At-Home Pivotal Phase 3 Trial Design Summary The SERENITY At-Home Phase 3 trial is designed as a double blind, placebo-controlled study to evaluate the safety and efficacy of a 120 mcg dose of BXCL501 over a 12-week period. The outpatient trial is expected to enroll a total of approximately 200 patients with agitation associated with bipolar disorder or schizophrenia. Patients will self-administer 120 mcg of BXCL501 or placebo when agitation episodes occur over the trial period. The primary objective is safety with efficacy measures as exploratory endpoints to evaluate use in the outpatient setting. In addition, the Company expects to enroll approximately 30 patients in a separate study to evaluate the correlation between patient-reported or informant-reported efficacy with trained rater-reported efficacy using Positive and Negative Syndrome Scale-Excitatory Component (PEC) measurements.

Forward-Looking Statements

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. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking as amended. All statements contained in this Form 8-K other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the planned trial design of the SERENITY At-Home Phase 3 trial; and the potential for the results from the Company's completed, ongoing and proposed clinical trials to support regulatory approvals for its product candidates in both the care-facility and at-home settings. 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

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 BioXcel Therapeutics, Inc. April2024 Presentation 104 Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document)

SIGNATURES

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: April22, 2024 BIOXCEL THERAPEUTICS, INC. /s/ Richard Steinhart By: Richard Steinhart Title: Chief Financial Officer

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