8-K
false000183216800018321682022-08-042022-08-04

 

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): August 4, 2022

 

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: (619) 592-9775

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.

 


Item 2.02 Results of Operations and Financial Condition.

 

On August 4, 2022, Longboard Pharmaceuticals, Inc. ("Longboard") issued a press release announcing its financial results for the quarter ended June 30, 2022. 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 August 4, 2022

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.

 

 

 

Longboard Pharmaceuticals, Inc.

 

 

 

 

Date: August 4, 2022

 

By:

/s/ Kevin R. Lind

 

 

 

Kevin R. Lind

 

 

 

President and Chief Executive Officer

 


EX-99.1

Exhibit 99.1

https://cdn.kscope.io/ee9f24ce612e829af99741356346b8b1-img58896055_0.jpg 

 

 

Longboard Pharmaceuticals Provides Corporate Update and

Reports Second Quarter 2022 Financial Results

 

LP352 Phase 1b/2a PACIFIC Study remains on track for completion in the second half of 2023; recently expanded the participant age range to 12-65 years old and added open-label extension study
Initiated a Phase 1 open-label study to assess central nervous system (CNS) pharmacokinetics (PK) and pharmacodynamics (PD) of LP352 in healthy volunteers; data expected around year-end 2022
IND submission for LP659 remains on track for fourth quarter of 2022
Expected cash runway into 2024

SAN DIEGO, Calif., August 4, 2022 – 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 second quarter ended June 30, 2022.

 

“I am pleased with the progress our team has made this quarter. We remain on track to complete the PACIFIC Study in the second half of 2023 by focusing our efforts on site activation and recruitment, including the planned expansion into Australia and the Australian Epilepsy Clinical Trial Network. We have also aligned with regulators to expand the age range of patients to include adolescents, and we have added an open-label extension study which will allow us to offer long-term access of LP352 to eligible study participants. Importantly, the addition of younger patients in the PACIFIC Study will provide the opportunity to evaluate the potential impact of LP352 earlier in the treatment journey. We are encouraged by our interactions with the highly engaged and enthusiastic refractory epilepsy community," stated Kevin R. Lind, Longboard’s President and Chief Executive Officer. "We also continue to make progress on IND-enabling activities for LP659 and we look forward to updating our stakeholders as we advance our promising pipeline.”

 

Program Overview:

LP352, an oral, highly selective, centrally acting 5-hydroxytryptamine 2C receptor subtype (5-HT2C) superagonist:
o
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 completion in the second half of 2023.

o
Multiple clinical and preclinical studies are in process to further elucidate the intrinsic PD/PK properties and support clinical development in a broad range of refractory epilepsies.

 

LP659, an oral, selective, centrally acting S1P receptor modulator targeting multiple neurological diseases, is currently in IND-enabling studies with IND application submission to the FDA expected in the fourth quarter of 2022.

 

Second Quarter 2022 Financial Results:

 

Balance Sheet Highlights

 

At June 30, 2022, Longboard’s cash, cash equivalents and short-term investments were approximately $87.4 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 $8.9 million for the three months ended June 30, 2022, an increase of $4.0 million, or 82%, compared to $4.9 million for the three months ended June 30, 2021. The net increase of $4.0 million is primarily related to increases of $1.7 million in clinical and preclinical trial expenses related to LP352, $1.1 million in personnel-related expenses, and $0.9 million in preclinical expenses related to LP659 and LP143.

 

General and administrative (G&A) expenses were $2.6 million for the three months ended June 30, 2022, an increase of $0.5 million, or 28%, compared to $2.1 million for the three months ended June 30, 2021. The net increase of $0.5 million is primarily related to an increase in personnel-related costs.

 

Net loss was $11.4 million, or $0.67 per share, for the three months ended June 30, 2022 compared to $7.0 million, or $0.41 per share, for the three months ended June 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”, “expected”, “potential”, “plan” and “focused on”, and include, without limitation, statements about the following: Longboard’s clinical and preclinical product candidates and programs, including potential treatments and indications, clinical trials plans and protocols (for example, the planned expansion into Australia), timing of completion of a clinical trial, additional data, regulatory applications and their submission timing; our cash position or expected cash runway; key milestones; the promise of our 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 marketing; 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.

 

 


Corporate Contact:

Megan E. Knight
Head of Investor Relations
mknight@longboardpharma.com 

IR@longboardpharma.com

619.592.9775

 

###

 

 

 

Financial Tables Follow

 


LONGBOARD PHARMACEUTICALS, INC.

CONDENSED BALANCE SHEETS

(Unaudited)

 

 

 

June 30,

 

 

December 31,

 

(in thousands, except share and per share data)

 

2022

 

 

2021

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

27,716

 

 

$

66,346

 

Short-term investments

 

 

59,702

 

 

 

40,379

 

Prepaid expenses and other current assets

 

 

2,728

 

 

 

1,659

 

Total current assets

 

 

90,146

 

 

 

108,384

 

Right-of-use assets

 

 

355

 

 

 

521

 

Property and equipment

 

 

12

 

 

 

14

 

Other long-term assets

 

 

 

 

 

33

 

Total assets

 

$

90,513

 

 

$

108,952

 

LIABILITIES AND EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

602

 

 

$

1,028

 

Accrued research and development expenses

 

 

4,215

 

 

 

2,245

 

Accrued compensation and related expenses

 

 

1,019

 

 

 

1,480

 

Accrued other expenses

 

 

1,345

 

 

 

352

 

Right-of-use liabilities, current portion

 

 

363

 

 

 

339

 

Total current liabilities

 

 

7,544

 

 

 

5,444

 

Right-of-use liabilities, net of current portion

 

 

 

 

 

185

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; authorized shares - 10,000,000 at June 30, 2022 and December 31, 2021; issued and outstanding shares - none at June 30, 2022 and December 31, 2021

 

 

 

 

 

 

Voting common stock, $0.0001 par value; authorized shares - 300,000,000 at June 30, 2022 and December 31, 2021; issued and outstanding shares - 13,527,869 and 13,440,761 at June 30, 2022 and December 31, 2021, respectively, excluding 58,081 and 145,189, respectively, subject to repurchase

 

 

1

 

 

 

1

 

Non-voting common stock, $0.0001 par value; authorized shares - 10,000,000 at June 30, 2022 and December 31, 2021; issued and outstanding shares - 3,629,400 at June 30, 2022 and December 31, 2021

 

 

 

 

 

 

Additional paid-in capital

 

 

146,953

 

 

 

145,683

 

Accumulated other comprehensive loss

 

 

(784

)

 

 

(164

)

Accumulated deficit

 

 

(63,201

)

 

 

(42,197

)

Total stockholders' equity

 

 

82,969

 

 

 

103,323

 

Total liabilities and stockholders' equity

 

$

90,513

 

 

$

108,952

 

 

 

 

 

 

 

 

 

 

 

 


LONGBOARD PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(in thousands, except share and per share data)

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

8,921

 

 

$

4,915

 

 

$

16,042

 

 

$

9,313

 

General and administrative

 

2,646

 

 

 

2,072

 

 

 

5,145

 

 

 

3,377

 

Total operating expenses

 

11,567

 

 

 

6,987

 

 

 

21,187

 

 

 

12,690

 

Loss from operations

 

(11,567

)

 

 

(6,987

)

 

 

(21,187

)

 

 

(12,690

)

Interest income, net

 

127

 

 

 

13

 

 

 

159

 

 

 

17

 

    Other income (expense)

 

33

 

 

 

(6

)

 

 

24

 

 

 

(6

)

Net loss

$

(11,407

)

 

$

(6,980

)

 

$

(21,004

)

 

$

(12,679

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

$

(0.67

)

 

$

(0.41

)

 

$

(1.23

)

 

$

(1.07

)

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding, basic and diluted

 

17,130,307

 

 

 

16,827,556

 

 

 

17,108,582

 

 

 

11,846,653

 

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(11,407

)

 

$

(6,980

)

 

$

(21,004

)

 

$

(12,679

)

Unrealized loss on short-term investments

 

(188

)

 

 

(34

)

 

 

(620

)

 

 

(34

)

Comprehensive loss

$

(11,595

)

 

$

(7,014

)

 

$

(21,624

)

 

$

(12,713

)