8-K
0001832168false00018321682021-11-042021-11-04

 

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): November 4, 2021

 

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 November 4, 2021, Longboard Pharmaceuticals, Inc. ("Longboard") issued a press release announcing its financial results for the fiscal quarter ended September 30, 2021. 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

Number

 

Description

99.1

 

Press release dated November 4, 2021

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: November 4, 2021

 

By:

/s/ Kevin R. Lind

 

 

 

Kevin R. Lind

 

 

 

President and Chief Executive Officer

 


EX-99.1

 

Exhibit 99.1

 

https://cdn.kscope.io/f97e8c8b170e659ccc5cd4730ddffe3e-img58896055_0.jpg 

 

Longboard Pharmaceuticals Provides Corporate Update and

Reports Third Quarter 2021 Financial Results

Successfully completed multiple ascending dose (MAD) portion of a Phase 1 clinical trial for LP352, a potential treatment for seizures associated with a broad range of severe epilepsies
Initiating a Phase 1b/2a clinical trial evaluating LP352 in approximately 50 participants with developmental and epileptic encephalopathies (DEEs) in Q1 2022
IND-enabling preclinical studies for LP143 and LP659 ongoing
Continuing to strengthen key expertise and leadership

 

SAN DIEGO, Calif., November 4, 2021 – 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, 2021.

 

"This quarter we successfully completed the MAD portion of our Phase 1 clinical trial for our lead asset, LP352, and we look forward to initiating our first clinical trial in patients with severe and refractory epilepsies next quarter. We are collaborating with a world-class CRO and have commenced key activities for trial readiness and site activation. We continue to engage with thought leaders, advocacy groups and caregivers in order to prioritize enrollment optimization, and most importantly, the best outcome for patients living with these devastating diseases," stated Kevin R. Lind, Longboard’s President and Chief Executive Officer. "For LP143 and LP659 we look forward to sharing additional preclinical data that support the scientific rationale for our initial areas of focus as we approach IND submissions for each program in 2022."

 

Program Overview:

LP352, an oral, highly selective, centrally acting 5-hydroxytryptamine 2c receptor subtype (5-HT2c) superagonist, has successfully completed the SAD/MAD portions of a Phase 1 clinical trial, informing the optimal expected dose range for the next phase of development. We plan to initiate a Phase 1b/2a clinical trial in participants with DEEs, such as Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, CDKL5 deficiency disorder, among others, in the first quarter of 2022.
LP143, an oral, centrally acting full agonist to the cannabinoid type 2 (CB2) receptor targeting a broad range of neurodegenerative diseases, with an initial focus in amyotrophic lateral sclerosis (ALS), is currently in Investigational New Drug (IND)-enabling studies and we anticipate submitting an IND application to the United States Food and Drug Administration (FDA) in the first quarter of 2022.

 


 

LP659, an oral, selective, centrally acting sphingosine-1-phosphate (S1P) receptor modulator targeting a range of central nervous system neuroinflammatory diseases, is currently in IND-enabling studies and we anticipate submitting an IND application to the FDA in the second half of 2022.

 

Leadership Update:

 

In October 2021, Steven W. Spector, J.D., joined the Company as general counsel. Most recently, Mr. Spector served as part-time general counsel for several public companies, including Longboard, Dynavax Technologies and Galecto, Inc. Prior to this, he served as general counsel of Arena Pharmaceuticals, Inc. for nearly twenty years, from October 2001 to March 2020.

 

Third Quarter 2021 Financial Results:

 

Balance Sheet Highlights

 

At September 30, 2021, Longboard’s cash, cash equivalents and short-term investments were approximately $112.6 million and approximately 16.9 million shares of Longboard voting and non-voting common stock were outstanding.

 

Operating Results

 

Research and development (R&D) expenses were $4.1 million for the three months ended September 30, 2021 compared to $1.6 million for the three months ended September 30, 2020. R&D expenses for the three months ended September 30, 2021 included $1.3 million in preclinical and clinical trial expenses related to LP352, $1.3 million in preclinical expenses related to advancing LP143 and LP659 and $1.3 million in personnel-related expenses. R&D expenses for the three months ended September 30, 2020 included $0.3 million in preclinical and clinical trial expenses related to LP352, $0.8 million related to preclinical expenses for LP143 and LP659 and $0.5 million in personnel-related expenses.

 

General and administrative (G&A) expenses were $2.3 million for the three months ended September 30, 2021 compared to $0.9 million for the three months ended September 30, 2020. G&A expenses for the three months ended September 30, 2021 included $1.0 million of personnel-related costs, $0.5 million of professional services and consulting expenses and $0.5 million of insurance expense. G&A expenses for the three months ended September 30, 2020 included $0.6 million of personnel-related costs and $0.3 million in professional services and consulting expenses.

 

Net loss was $6.3 million, or $0.38 per share, for the three months ended September 30, 2021 compared to $2.6 million, or $0.66 per share, for the three months ended September 30, 2020.

 

 

 


 

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 receptor superagonist, with negligible observed impact on 5-HT2b and 5-HT2a receptor subtypes, in development for the potential treatment of seizures associated with developmental and epileptic encephalopathies. Longboard is also evaluating LP143, a centrally acting, full cannabinoid type 2 receptor agonist, in development for the potential treatment of neurodegenerative diseases associated with neuroinflammation caused by microglial activation, and LP659, a centrally acting, sphingosine-1-phosphate receptor subtypes 1 and 5 modulator, in development for the potential treatment of central nervous system neuroinflammatory diseases.

 

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 “expected”, “potential”, “plan”, “anticipate”, “focused on”, “look forward” and “build out”, and include, without limitation, statements about the following: Longboard’s clinical and preclinical product candidates and programs, including clinical trial protocols (for example, clinical trial participants, indications and treatments), timing of initiation of clinical trials, data supporting the scientific rationale for our focus, regulatory applications and their submission timing, progress, and other plans; our team; 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 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 relate 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)

 

 

 

September 30,

 

 

December 31,

 

(in thousands, except share and per share data)

 

2021

 

 

2020

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

75,461

 

 

$

55,316

 

Short-term investments

 

 

37,098

 

 

 

 

Prepaid expenses and other current assets

 

 

2,740

 

 

 

46

 

Total current assets

 

 

115,299

 

 

 

55,362

 

Right-of-use assets

 

 

600

 

 

 

 

Property and equipment

 

 

16

 

 

 

 

Other long-term assets

 

 

33

 

 

 

 

Deferred financing costs

 

 

 

 

 

876

 

Total assets

 

$

115,948

 

 

$

56,238

 

LIABILITIES AND EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

891

 

 

$

1,213

 

Accrued research and development expenses

 

 

1,653

 

 

 

916

 

Accrued other expenses

 

 

231

 

 

 

845

 

Accrued compensation and related expenses

 

 

918

 

 

 

161

 

Right-of-use liabilities, current portion

 

 

328

 

 

 

 

Total current liabilities

 

 

4,021

 

 

 

3,135

 

Right-of-use liabilities, net of current portion

 

 

275

 

 

 

 

Commitments and contingencies (see Note 9)

 

 

 

 

 

 

Convertible preferred stock:

 

 

 

 

 

 

Series A convertible preferred stock $0.0001 par value; authorized shares - none and 5,600,000 at September 30, 2021 and December 31, 2020, respectively; issued and outstanding shares - none and 5,600,000 at September 30, 2021 and December 31, 2020, respectively; aggregate liquidation preference – none and $56,000 at September 30, 2021 and December 31, 2020, respectively

 

 

 

 

 

55,795

 

Stockholders' equity (deficit):

 

 

 

 

 

 

Preferred stock, $0.0001 par value; authorized shares - 10,000,000 and none at September 30, 2021 and December 31, 2020, respectively; issued and outstanding shares - none at September 30, 2021 and December 31, 2020

 

 

 

 

 

 

Voting common stock, $0.0001 par value; authorized shares - 300,000,000 and 10,500,000 at September 30, 2021 and December 31, 2020, respectively; issued and outstanding shares - 13,237,500 and 3,840,540 at September 30, 2021 and December 31, 2020, respectively, both excluding 348,450 shares subject to repurchase

 

 

1

 

 

 

 

Non-voting common stock, $0.0001 par value; authorized shares - 10,000,000 and none at September 30, 2021 and December 31, 2020, respectively; issued and outstanding shares - 3,629,400 and none at September 30, 2021 and December 31, 2020, respectively

 

 

 

 

 

 

Additional paid-in capital

 

 

145,099

 

 

 

11,708

 

Accumulated other comprehensive loss

 

 

(24

)

 

 

 

Accumulated deficit

 

 

(33,424

)

 

 

(14,400

)

Total stockholders' equity (deficit)

 

 

111,652

 

 

 

(2,692

)

Total liabilities, convertible preferred stock and stockholders' equity (deficit)

 

$

115,948

 

 

$

56,238

 

 

 

 

 


 

LONGBOARD PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

Three Months Ended September 30,

 

 

Nine Months Ended
September 30,

 

 

Period from
January 3, 2020
 (Inception) through
 September 30,

 

(in thousands, except share and per share data)

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

4,093

 

 

$

1,603

 

 

$

13,406

 

 

$

2,462

 

General and administrative

 

2,262

 

 

 

947

 

 

 

5,639

 

 

 

1,829

 

Total operating expenses

 

6,355

 

 

 

2,550

 

 

 

19,045

 

 

 

4,291

 

Loss from operations

 

(6,355

)

 

 

(2,550

)

 

 

(19,045

)

 

 

(4,291

)

Interest income, net

 

23

 

 

 

 

 

 

40

 

 

 

 

Other expense

 

(13

)

 

 

 

 

 

(19

)

 

 

 

Net loss

$

(6,345

)

 

$

(2,550

)

 

$

(19,024

)

 

$

(4,291

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

$

(0.38

)

 

$

(0.66

)

 

$

(1.41

)

 

$

(1.13

)

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding, basic and diluted

 

16,866,900

 

 

 

3,840,540

 

 

 

13,538,458

 

 

 

3,798,025

 

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(6,345

)

 

$

(2,550

)

 

$

(19,024

)

 

$

(4,291

)

  Unrealized loss on short-term investments, net

 

10

 

 

 

 

 

 

(24

)

 

 

 

Comprehensive loss

$

(6,335

)

 

$

(2,550

)

 

$

(19,048

)

 

$

(4,291

)