SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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|Item 8.01.||Other Events.|
On July 21, 2022, BioXcel Therapeutics, Inc. (the “Company”) announced that it received two Notices of Allowance from the U.S. Patent and Trademark Office (“USPTO”) for patent applications related to IGALMI™ (dexmedetomidine) sublingual film. A Notice of Allowance is issued after the USPTO makes a determination that a patent should be granted from an application. The patents, issuing from Patent Application Nos. 17/560,392 and 17/560,423, are expected to cover film formulations containing dexmedetomidine and methods of treating agitation using the films. Both patents are expected to be issued in the third quarter of 2022, and the Company plans to list the patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluation.
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. Forward-looking statements in this Form 8-K include but are not limited to the expected timelines for issuance and coverage of the patents and the Company’s plans to list the patents in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluation. When used herein, words including “anticipate,” “will,” “plan,” “may,” “continue,” “intend,” “designed,” “goal” and similar expressions are intended to identify forward-looking statements. 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, the Company’s ability to protect its intellectual property and its exposure to patent infringement lawsuits; its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; 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; the Company’s ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; the Company’s ability to commercialize its products and 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 March 31, 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.
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: July 21, 2022||BIOXCEL THERAPEUTICS, INC.|
|/s/ Javier Rodriguez|
|Chief Legal Officer and Corporate Secretary|