UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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In this report, “we” and “our” refer to Longboard Pharmaceuticals, Inc.
Item 7.01 Regulation FD Disclosure.
On August 23, 2023, we issued a press release announcing that we completed enrollment of our Phase 1b/2a PACIFIC Study evaluating LP352, an oral, centrally acting 5-HT2C receptor superagonist, in participants with Developmental and Epileptic Encephalopathies (DEEs).
A copy of the press release is furnished as Exhibit 99.1. For important information about forward-looking statements, see the section of the press release titled “Forward-Looking Statements” in Exhibit 99.1 attached hereto.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any filing we make with the U.S. Securities and Exchange Commission (“SEC”), whether before or after the date hereof, regardless of any general incorporation language in such filing.
Item 8.01 Other Events.
As noted in Item 7.01, on August 23, 2023, we announced that we completed enrollment of our Phase 1b/2a PACIFIC Study evaluating LP352, an oral, centrally acting 5-HT2C receptor superagonist, in participants with DEEs.
The PACIFIC Study enrolled 52 participants with a broad range of DEEs, including Lennox-Gastaut syndrome, Dravet syndrome, SCN2A-related epilepsies, and CDKL5 deficiency disorder, among others. The primary objectives of the PACIFIC Study are to assess the safety and tolerability of LP352. The study will also evaluate change in seizure frequency over the treatment period. Topline results from the PACIFIC Study are expected around the end of 2023.
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, our expectations regarding completion of the PACIFIC Study and the availability of topline results around the end of 2023. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they prove incorrect or do not fully materialize, could cause our results to differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, risks and uncertainties related to: the timing and results of preclinical and clinical trials; topline data may not reflect the complete or final results of a particular study or trial, and are subject to change; our ability to advance, obtain regulatory approval of and ultimately commercialize our product candidates; the risk that positive results in a clinical trial may not be replicated in subsequent trials or successes in early stage clinical trials may not be predictive of results in later stage trials and preliminary interim data readouts of ongoing trials may show results that change when such trials are completed; our ability to fund development activities and achieve development goals; our ability to protect our intellectual property; the direct and indirect impacts geopolitical and macroeconomic events on our business; and other risks and uncertainties described under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, our subsequently filed Quarterly Reports on Form 10-Q, and the other documents we file from time to time with the SEC. These forward-looking statements speak only as of the date of this Current Report on Form 8-K, and we undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.
Item 9.01 Financial Statements and Exhibits. (d) Exhibits.
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99.1 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 thereunto duly authorized.
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Longboard Pharmaceuticals, Inc. |
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Date: August 23, 2023 |
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By: |
/s/ Kevin R. Lind |
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Kevin R. Lind |
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President and Chief Executive Officer |