- 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
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.
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 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.
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 income
(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
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
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241107787183/en/
CORPORATE CONTACT: Megan E. Knight VP, Head of Investor
Relations IR@longboardpharma.com 858.789.9283
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