Longboard Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2022 Financial Results

Rhea-AI Summary

Longboard Pharmaceuticals (Nasdaq: LBPH) reported updates on its clinical studies and third-quarter financial results for 2022. The ongoing PACIFIC study for LP352, aimed at treating developmental and epileptic encephalopathies, is on track for topline data in the second half of 2023. The company has approximately $77.3 million in cash, which supports operations into 2024. R&D expenses rose to $9.4 million, primarily due to clinical trial costs, with a net loss of $11.6 million, or $0.68 per share, compared to a loss of $6.3 million, or $0.38 per share, in Q3 2021.

Positive

• PACIFIC Study for LP352 is on track for topline data in H2 2023.
• Cash reserves expected to support operations into 2024.

Negative

• Net loss increased to $11.6 million, up from $6.3 million year-over-year.
• R&D expenses rose significantly, indicating increased financial strain.

• LP352 Phase 1b/2a PACIFIC Study in participants with a range of developmental and epileptic encephalopathies (DEEs) ages 12-65 on track for topline data in second half 2023
• Phase 1 open-label study to assess central nervous system (CNS) pharmacokinetics (PK) and pharmacodynamics (PD) of LP352 in healthy volunteers; data on track for fourth quarter 2022
• Pre-investigational new drug (IND) meeting with the FDA to finalize details regarding the clinical development plan for use of LP659 in rare neuroinflammatory indications scheduled in fourth quarter 2022
• Expected cash runway into 2024

LA JOLLA, Calif.--(BUSINESS WIRE)-- 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 financial results for the third quarter ended September 30, 2022.

“We remain on track to complete the PACIFIC Study in the second half of 2023, with a hands-on approach to site activation and engagement. Importantly, we continue to support interactions between the experts at the Epilepsy Study Consortium and sites to optimize clinical trial methodology, seizure identification and diagnostic review training in order to facilitate recruitment,” stated Kevin R. Lind, Longboard’s President and Chief Executive Officer. “For LP659, we are excited about the promise of a differentiated, next generation, oral, selective, centrally acting S1P receptor modulator for the treatment of rare neuroinflammatory indications and look forward to our upcoming discussion with regulators.”

Pipeline Overview:

• LP352, an oral, highly selective, centrally acting 5-hydroxytryptamine 2C receptor subtype (5-HT2C) superagonist:
  • The PACIFIC Study, a Phase 1b/2a basket trial, evaluating approximately 50 participants ages 12 to 65 years old with developmental and epileptic encephalopathies or DEEs, such as Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, CDKL5 deficiency disorder, SCN2A-related disorders, among others, is ongoing with expected topline data in the second half of 2023.
  • Multiple clinical and preclinical studies are in process to further elucidate the intrinsic PK/PD properties and support clinical development in a broad range of refractory epilepsies.

• LP659, an oral, selective, centrally acting S1P receptor modulator, for which we have a pre-IND meeting scheduled with the FDA in the fourth quarter of 2022.

Third Quarter 2022 Financial Results:

Balance Sheet Highlights

At September 30, 2022, Longboard’s cash, cash equivalents and short-term investments were approximately $77.3 million. Our cash position is expected to support operations into 2024 based on our current business plan.

Operating Results

Research and development (R&D) expenses were $9.4 million for the three months ended September 30, 2022, an increase of $5.3 million compared to $4.1 million for the three months ended September 30, 2021. The net increase of $5.3 million is primarily related to increases of $4.6 million in clinical trial and preclinical expenses related to LP352, $0.9 million in personnel-related expenses, and $0.2 million in preclinical expenses related to LP659 and LP143.

General and administrative (G&A) expenses were $2.5 million for the three months ended September 30, 2022, an increase of $0.2 million compared to $2.3 million for the three months ended September 30, 2021. The net increase of $0.2 million is primarily related to an increase in personnel-related costs.

Net loss was $11.6 million, or $0.68 per share, for the three months ended September 30, 2022 compared to $6.3 million, or $0.38 per share, for the three months ended September 30, 2021.

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 a portfolio of 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. Longboard is evaluating LP352, an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, with negligible observed impact on 5-HT2B and 5-HT2A receptor subtypes, in development for the potential treatment of seizures associated with a broad range of developmental and epileptic encephalopathies. Longboard is also evaluating LP659, a centrally acting, sphingosine-1-phosphate (S1P) receptor subtypes 1 and 5 modulator, in development for the potential treatment of multiple neurological diseases, and LP143, a centrally acting, full cannabinoid type 2 receptor (CB2) agonist, in development for the potential treatment of central nervous system (CNS) diseases and disorders.

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 “on track for”, “scheduled”, “expected”, “potential”, “plan”, “focused on”, “promise” and “look forward”, and include, without limitation, statements about the following: Longboard’s clinical and preclinical product candidates and programs, including the timing of the completion of clinical trials and availability of data, potential treatments and indications, clinical trials plans and activities, and regulatory meetings and interactions and their timing; our cash position or expected cash runway; the promise of our drug candidates and pipeline; and our focus. 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 the forward-looking statements include, but are not limited to, the following: Risks related to Arena’s acquisition by Pfizer; 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; risks related to the development and commercialization of Longboard’s product candidates; Longboard’s product candidates are in the early phase of a lengthy research and development process, the timing, manner and outcome of research, development and regulatory review is uncertain, and Longboard’s product candidates may not advance in research or development or be approved for continuing development or marketing; the regulatory process of the FDA and comparable foreign authorities is lengthy, time consuming and inherently unpredictable; enrolling participants in Longboard’s ongoing and intended clinical trials is competitive and challenging; the duration and severity of the coronavirus disease (COVID-19) outbreak, including but not limited to the impact on Longboard’s clinical trials and operations, the operations of Longboard’s suppliers, partners, collaborators, and licensees, and capital markets, which in each case remains uncertain; 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; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; topline data may not accurately reflect the complete results of a particular study or trial; 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.

LONGBOARD PHARMACEUTICALS, INC. CONDENSED BALANCE SHEETS (Unaudited)
		September 30,				December 31,
(in thousands, except share and per share data)		2022				2021
ASSETS
Current assets:
Cash and cash equivalents		$	18,745			$	66,346
Short-term investments			58,574				40,379
Prepaid expenses and other current assets			2,473				1,659
Total current assets			79,792				108,384
Right-of-use assets			824				521
Property and equipment			10				14
Other long-term assets			33				33
Total assets		$	80,659			$	108,952
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable		$	575			$	1,028
Accrued research and development expenses			4,800				2,245
Accrued compensation and related expenses			1,589				1,480
Accrued other expenses			829				352
Right-of-use liabilities, current portion			360				339
Total current liabilities			8,153				5,444
Right-of-use liabilities, net of current portion			469				185
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value; authorized shares - 10,000,000 at September 30, 2022 and December 31, 2021; issued and outstanding shares - none at September 30, 2022 and December 31, 2021			—				—
Voting common stock, $0.0001 par value; authorized shares - 300,000,000 at September 30, 2022 and December 31, 2021; issued and outstanding shares - 13,571,423 and 13,440,761 at September 30, 2022 and December 31, 2021, respectively, excluding 14,527 and 145,189, respectively, subject to repurchase			1				1
Non-voting common stock, $0.0001 par value; authorized shares - 10,000,000 at September 30, 2022 and December 31, 2021; issued and outstanding shares - 3,629,400 at September 30, 2022 and December 31, 2021			—				—
Additional paid-in capital			147,748				145,683
Accumulated other comprehensive loss			(915	)			(164	)
Accumulated deficit			(74,797	)			(42,197	)
Total stockholders' equity			72,037				103,323
Total liabilities and stockholders' equity		$	80,659			$	108,952

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)	2022				2021				2022				2021
Operating expenses:
Research and development	$	9,403			$	4,093			$	25,445			$	13,406
General and administrative		2,481				2,262				7,626				5,639
Total operating expenses		11,884				6,355				33,071				19,045
Loss from operations		(11,884	)			(6,355	)			(33,071	)			(19,045	)
Interest income, net		287				23				446				40
Other income (expense)		1				(13	)			25				(19	)
Net loss	$	(11,596	)		$	(6,345	)		$	(32,600	)		$	(19,024	)
Net loss per share, basic and diluted	$	(0.68	)		$	(0.38	)		$	(1.90	)		$	(1.41	)
Weighted-average shares outstanding, basic and diluted		17,173,838				16,866,900				17,130,573				13,538,458
Comprehensive loss:
Net loss	$	(11,596	)		$	(6,345	)		$	(32,600	)		$	(19,024	)
Unrealized (loss) gain on short-term investments		(131	)			10				(751	)			(24	)
Comprehensive loss	$	(11,727	)		$	(6,335	)		$	(33,351	)		$	(19,048	)

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20221103005447/en/

Megan E. Knight

Head of Investor Relations

IR@longboardpharma.com

619.592.9775

Source: Longboard Pharmaceuticals, Inc.

FAQ

What is the status of Longboard Pharmaceuticals' LP352 study?

The PACIFIC Study for LP352 is ongoing and expected to provide topline data in the second half of 2023.

What were Longboard Pharmaceuticals' Q3 2022 financial results?

For Q3 2022, Longboard reported a net loss of $11.6 million, or $0.68 per share, compared to a loss of $6.3 million, or $0.38 per share, in Q3 2021.

How much cash does Longboard Pharmaceuticals have as of Q3 2022?

As of September 30, 2022, Longboard had approximately $77.3 million in cash and short-term investments.

When is the pre-IND meeting for LP659 scheduled?

The pre-IND meeting with the FDA for LP659 is scheduled for the fourth quarter of 2022.