- LP352 Phase 1b/2a PACIFIC Study topline data expected in fourth
quarter 2023
- LP659 IND submitted to FDA after incorporating input from a
pre-IND meeting; Phase 1 initiation of first in-human clinical
study on track for second quarter 2023, with Phase 1 topline
single-ascending dose data expected in fourth quarter 2023
- Ended first quarter 2023 with $76.1 million in cash, cash
equivalents and investments; cash runway is expected to support
operations into mid-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 first
quarter ended March 31, 2023.
“We are pleased with the excitement for the PACIFIC Study as we
progress towards full enrollment and prepare for topline Phase
1b/2a data for LP352 in the fourth quarter of 2023. Sites are
embracing our unique approach to addressing a broad range of rare,
treatment-refractory epilepsies, and we truly appreciate the
support and collaborative spirit from the community,” stated Kevin
R. Lind, Longboard’s President and Chief Executive Officer. “For
LP659, we look forward to initiating our first in-human study in
the coming months and sharing data from the single-ascending dose
trial later this year. We are enthusiastic about moving LP659 into
clinical studies as we believe that it could be transformative in a
number of neuroinflammatory conditions.”
FIRST QUARTER 2023 FINANCIAL RESULTS:
Balance Sheet Highlights
At March 31, 2023, Longboard’s cash, cash equivalents and
short-term investments were approximately $76.1 million.
Operating Results
Research and development expenses were $8.5 million for the
three months ended March 31, 2023, an increase of $1.4 million, or
20%, compared to $7.1 million for the three months ended March 31,
2022. The net increase of $1.4 million is primarily related to
increases of $0.9 million in personnel-related expenses and $0.5
million in clinical trial and preclinical expenses related to
LP352.
General and administrative expenses were $3.4 million for the
three months ended March 31, 2023, an increase of $0.9 million, or
37%, compared to $2.5 million for the three months ended March 31,
2022. The net increase of $0.9 million is primarily related to
increases of $0.6 million in consulting and professional fees, $0.2
million in personnel-related costs and $0.1 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 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 no
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,
which is in development for the potential treatment of multiple
neurological diseases.
THE PACIFIC STUDY
The PACIFIC Study is a Phase 1b/2a clinical study evaluating
participants with developmental and epileptic encephalopathies
(DEEs). The primary objectives of the study are to assess the
safety & tolerability of LP352. The PACIFIC Study is also
designed to examine change in seizure frequency over the 90-day
treatment period. The study plans to enroll approximately 50
participants with a variety of treatment resistant seizures that
fall into the category of DEEs. Approximately 30 study sites in the
United States and Australia are participating. The PACIFIC Study
data are expected to inform the design and characteristics of our
Phase 3 program.
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”, “expect”, “progress towards”, “potential”,
“opportunity”, “intend”, “look forward”, “excited to”, “plan”,
“focus”, “will”, “may”, “could”, “goal”, “working to build”, or the
negative, plural or other tenses of these words or other comparable
language, and include, without limitation, statements about the
following: Longboard’s clinical and preclinical product candidates
and programs, including timing of full enrollment, timing of
topline data, timing of study initiation, number of study sites,
number and characteristics of study participants, their potential
(including to be transformative and the number and type of
conditions they may address), their design and characteristics, and
Longboard’s other plans and expectations, including for a potential
Phase 3 program informed by data from the PACIFIC Study;
Longboard’s cash position, expenses and runway to support
operations; Longboard’s team; and Longboard’s goals and 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 those stated
or implied by Longboard’s 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; macroeconomic events stemming from the COVID-19
pandemic or evolving geopolitical developments such as the conflict
in Ukraine, 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)
March 31,
December 31,
(in thousands, except share and per
share data)
2023
2022
ASSETS
Current assets:
Cash and cash equivalents
$
25,121
$
10,775
Short-term investments
51,005
56,814
Prepaid expenses and other current
assets
2,834
2,249
Total current assets
78,960
69,838
Right-of-use assets
681
736
Property and equipment
8
9
Other long-term assets
35
33
Total assets
$
79,684
$
70,616
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable
$
283
$
1,310
Accrued research and development
expenses
4,813
4,168
Accrued compensation and related
expenses
704
2,438
Accrued other expenses
1,068
490
Right-of-use liabilities, current
portion
371
358
Total current liabilities
7,239
8,764
Right-of-use liabilities, net of current
portion
312
382
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value;
authorized shares - 10,000,000 at March 31, 2023 and December 31,
2022; issued and outstanding shares - none at March 31, 2023 and
December 31, 2022
—
—
Voting common stock, $0.0001 par value;
authorized shares - 300,000,000 at March 31, 2023 and December 31,
2022; issued and outstanding shares - 20,544,595 and 13,585,950 at
March 31, 2023 and December 31, 2022, respectively
2
1
Non-voting common stock, $0.0001 par
value; authorized shares - 10,000,000 at March 31, 2023 and
December 31, 2022; issued and outstanding shares - 2,420,755 and
3,629,400 at March 31, 2023 and December 31, 2022, respectively
—
—
Additional paid-in capital
170,150
148,303
Accumulated other comprehensive loss
(421
)
(692
)
Accumulated deficit
(97,598
)
(86,142
)
Total stockholders' equity
72,133
61,470
Total liabilities and stockholders'
equity
$
79,684
$
70,616
LONGBOARD PHARMACEUTICALS,
INC.
CONDENSED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Three Months Ended March
31,
(in thousands, except share and per
share data)
2023
2022
Operating expenses:
Research and development
$
8,530
$
7,121
General and administrative
3,432
2,499
Total operating expenses
11,962
9,620
Loss from operations
(11,962
)
(9,620
)
Interest income, net
516
32
Other expense
(10
)
(9
)
Net loss
$
(11,456
)
$
(9,597
)
Net loss per share, basic and diluted
$
(0.56
)
$
(0.56
)
Weighted-average shares outstanding, basic
and diluted
20,409,794
17,086,615
Comprehensive loss:
Net loss
$
(11,456
)
$
(9,597
)
Unrealized gain (loss) on short-term
investments
271
(432
)
Comprehensive loss
$
(11,185
)
$
(10,029
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230509006142/en/
CORPORATE CONTACT: Megan E. Knight Head of Investor
Relations IR@longboardpharma.com 858.789.9283
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