Form 8-K - Current report

false000183216800018321682024-11-072024-11-07

 

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): November 7, 2024

Longboard Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware	1-40192	84-5009619
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
4275 Executive Square, Suite 950 La Jolla, CA		92037
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: [phone]

N/A

(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 per share		LBPH		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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On November 7, 2024, Longboard Pharmaceuticals, Inc. ("Longboard") issued a press release announcing its financial results for the quarter ended September 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1.

 

The information contained under this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing, unless Longboard expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.	Description
99.1	Press release dated November 7, 2024
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

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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.

 

		Longboard Pharmaceuticals, Inc.
Date: November 7, 2024		By:	/s/ Kevin R. Lind
			Kevin R. Lind
			President and Chief Executive Officer

 

 

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Exhibit 99.1

 

 

 

 

 

Longboard Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Corporate Updates

 

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Positive opinion of Paediatric Investigation Plan for bexicaserin issued by European Medicines Agency (EMA) Paediatric Committee (PDCO) for children down to the age of 2 years

•

Recently initiated Phase 3 global clinical trial (the DEEp SEA Study) to evaluate bexicaserin in Dravet syndrome for participants ages 2-65 years

LA JOLLA, Calif., November 7, 2024 – Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today provided a corporate update and reported third quarter 2024 financial results.

 

RECENT UPDATES:

•

In October, announced an agreement for H. Lundbeck A/S (Lundbeck) to acquire Longboard in a strategic deal

 

Bexicaserin (LP352), an oral, centrally acting, 5-HT2C superagonist in development for the potential treatment of seizures associated with DEEs

•

Initiated Phase 3 global DEEp SEA Study in Dravet syndrome evaluating participants ages 2-65 years

•

PACIFIC open-label extension (OLE) interim analysis results continued to demonstrate a sustained, durable response in seizure reduction and a favorable safety and tolerability profile across a broad range of DEEs over an approximate 9-month treatment period

•

U.S. Food and Drug Administration (FDA) granted Orphan Drug designation and Rare Pediatric Disease designation for bexicaserin for the treatment of Dravet syndrome

•

European Medicines Agency (EMA) Paediatric Committee (PDCO) issued positive opinion of Paediatric Investigation Plan for children down to the age of 2 years

 

THIRD QUARTER 2024 FINANCIAL RESULTS:

 

Balance Sheet Highlights

At September 30, 2024, Longboard’s cash, cash equivalents and short-term investments were approximately $288.4 million.

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Operating Results

Research and development expenses were $21.5 million for the three months ended September 30, 2024, an increase of $11.0 million, or 105%, compared to $10.5 million for the three months ended September 30, 2023. The net increase of $11.0 million is primarily related to increases of $5.9 million in clinical trial and preclinical expenses related to bexicaserin, $0.6 million in preclinical programs and other early stage research, $4.1 million in personnel-related expenses and $0.4 million in other miscellaneous research and development related expenses.

 

General and administrative expenses were $6.7 million for the three months ended September 30, 2024, an increase of $3.6 million, or 116%, compared to $3.1 million for the three months ended September 30, 2023. The net increase of $3.6 million is primarily related to increases of $2.1 million in personnel-related expenses, $1.2 million in consulting and professional fees (which includes $0.7 million of merger related expenses), and $0.3 million of miscellaneous expenses.

 

ABOUT LONGBOARD PHARMACEUTICALS

 

Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases. Longboard is working to advance centrally acting product candidates designed to be highly selective for specific G protein-coupled receptors (GPCRs). Longboard’s small molecule product candidates are based on more than 20 years of GPCR research. Bexicaserin (LP352), an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, with no observed impact on 5-HT2B and 5-HT2A receptor subtypes, is being evaluated in a global Phase 3 clinical program (the DEEp Program). The FDA has granted Breakthrough Therapy designation for bexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age and older.

 

Bexicaserin is an investigational compound that is not approved for marketing by the FDA or any other regulatory authority.

 

FORWARD-LOOKING STATEMENTS

 

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. In some cases, you can identify forward-looking statements by words such as “plan”, “focused on”, “potential”, “working to”, “designed to”, the negative, plural or other tenses of these words, references to future dates or time periods, or other comparable language, and they may include, without limitation, statements about the following: the pending acquisition of Longboard by Lundbeck; Longboard’s clinical and preclinical product candidates, including plans, study design, enrollment and timing of study initiation of the global Phase 3 program for bexicaserin, bexicaserin’s potential, design and characteristics; Longboard’s cash position, expenses and runway to support operations; and Longboard’s focus and work. For such statements, Longboard claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Longboard’s expectations. Factors that could cause actual results to differ materially from those stated or implied by Longboard’s forward-looking statements include, but are not limited to, the following: risks related to the satisfaction or waiver of the conditions to closing the proposed acquisition of Longboard by Lundbeck (including the failure to obtain necessary regulatory approvals) in the

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anticipated timeframe or at all, including the possibility that the proposed acquisition does not close; risks related to Longboard’s limited operating history, financial position and need for additional capital; Longboard will need additional managerial and financial resources to advance all of its programs, and you and others may not agree with the manner Longboard allocates its resources; the standard for Breakthrough Therapy designation is not the same as the standard for drug approval, the clinical evidence supporting Breakthrough Therapy designation is preliminary, and not all drugs designated as Breakthrough Therapies ultimately will be shown to have substantial improvement over available therapies; the FDA may later decide to rescind a Breakthrough Therapy designation if it determines the designation is no longer supported by subsequent data; Longboard’s product candidates are in a lengthy research and development process, the timing, manner and outcome of research, development and regulatory review is uncertain, and Longboard’s product candidates, including bexicaserin, may not advance in research or development or be approved for marketing; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; topline or interim data may not accurately reflect the complete results of a particular study or trial and remain subject to audit, and final data may differ materially from topline or interim data; risks related to the development and commercialization of Longboard’s product candidates; enrolling participants in clinical trials is competitive and challenging; risks related to unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Longboard or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; risks related to relying on licenses or collaborative arrangements; other risks related to Longboard’s dependence on third parties; competition; product liability or other litigation or disagreements with others; government and third-party payor actions, including relating to reimbursement and pricing; risks related to regulatory compliance; and risks related to Longboard’s and third parties’ intellectual property rights. Additional factors that could cause actual results to differ materially from those stated or implied by Longboard’s forward-looking statements are disclosed in Longboard’s filings with the Securities and Exchange Commission (SEC). These forward-looking statements represent Longboard’s judgment as of the time of this release. Longboard disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

 

CORPORATE CONTACT:

Megan E. Knight
VP, Head of Investor Relations
[e-mail] 

858.789.9283

 

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Financial Tables Follow

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LONGBOARD PHARMACEUTICALS, INC.

CONDENSED BALANCE SHEETS

(unaudited)

 

 

		September 30,				December 31,
(in thousands, except share and per share data)		2024				2023
ASSETS
Current assets:
Cash and cash equivalents		$	27,610			$	14,331
Short-term investments			260,836				34,167
Prepaid expenses and other current assets			4,584				1,723
Total current assets			293,030				50,221
Right-of-use assets			3,731				472
Property and equipment			—				4
Other long-term assets			244				—
Total assets		$	297,005			$	50,697
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable		$	1,132			$	1,001
Accrued research and development expenses			10,896				4,556
Accrued compensation and related expenses			4,163				3,374
Accrued other expenses			1,894				368
Right-of-use liabilities, current portion			267				475
Total current liabilities			18,352				9,774
Right-of-use liabilities, net of current portion			3,467				—
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value; authorized shares - 10,000,000 at September 30, 2024 and December 31, 2023; issued and outstanding shares - none at September 30, 2024 and December 31, 2023			—				—
Voting common stock, $0.0001 par value; authorized shares - 300,000,000 at September 30, 2024 and December 31, 2023; issued and outstanding shares - 34,419,536 and 22,096,494 at September 30, 2024 and December 31, 2023, respectively			3				2
Non-voting common stock, $0.0001 par value; authorized shares - 10,000,000 at September 30, 2024 and December 31, 2023; issued and outstanding shares - 4,609,500 and 2,420,755 at September 30, 2024 and December 31, 2023, respectively			—				—
Additional paid-in capital			476,358				181,563
Accumulated other comprehensive loss			700				(78	)
Accumulated deficit			(201,875	)			(140,564	)
Total stockholders' equity			275,186				40,923
Total liabilities and stockholders' equity		$	297,005			$	50,697

 

 

 

 

 

 

 

 

 

 

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LONGBOARD PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

 

 

	Three Months Ended September 30,								Nine Months Ended September 30,
(in thousands, except share and per share data)	2024				2023				2024				2023
Operating expenses:
Research and development	$	21,450			$	10,488			$	55,065			$	31,554
General and administrative		6,674				3,094				16,812				9,632
Total operating expenses		28,124				13,582				71,877				41,186
Loss from operations		(28,124	)			(13,582	)			(71,877	)			(41,186	)
Interest income, net		3,655				662				10,693				1,838
Other expense		(71	)			(14	)			(127	)			(41	)
Net loss	$	(24,540	)		$	(12,934	)		$	(61,311	)		$	(39,389	)
Net loss per share, basic and diluted	$	(0.63	)		$	(0.55	)		$	(1.63	)		$	(1.77	)
Weighted-average shares outstanding, basic and diluted		38,957,524				23,487,457				37,724,402				22,299,998
Comprehensive loss:
Net loss	$	(24,540	)		$	(12,934	)		$	(61,311	)		$	(39,389	)
Unrealized gain on short-term investments		1,175				109				778				511
Comprehensive loss	$	(23,365	)		$	(12,825	)		$	(60,533	)		$	(38,878	)

 

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Document and Entity Information	Nov. 07, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 07, 2024
Entity Registrant Name	Longboard Pharmaceuticals, Inc.
Entity Central Index Key	0001832168
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity File Number	1-40192
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	84-5009619
Entity Address, Address Line One	4275 Executive Square
Entity Address, Address Line Two	Suite 950
Entity Address, City or Town	La Jolla
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92037
City Area Code	858
Local Phone Number	789-9283
Entity Information, Former Legal or Registered Name	N/A
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Trading Symbol	LBPH
Title of 12(b) Security	Common stock, par value $0.0001 per share
Security Exchange Name	NASDAQ

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