- 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
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
Longboard Pharmaceuticals (NASDAQ:LBPH)
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