- LP352 Phase 1b/2a PACIFIC Study enrollment completion expected
this summer with topline data expected around year-end 2023
- Ended second quarter 2023 with $63.0 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 second
quarter ended June 30, 2023.
“We have made great progress in the first half of 2023 and look
forward to completing enrollment for the PACIFIC Study in the
coming weeks resulting in topline data around the end of this year.
We believe LP352’s best-in-class 5-HT2C superagonist
characteristics provide us with the opportunity to deliver a
clinically meaningful treatment for those living with a range of
developmental and epileptic encephalopathies,” stated Kevin R.
Lind, Longboard’s President and Chief Executive Officer. “We also
look forward to making advances on LP659, our centrally acting, S1P
receptor subtypes 1 and 5 modulator.”
SECOND QUARTER 2023 FINANCIAL RESULTS:
Balance Sheet Highlights
At June 30, 2023, Longboard’s cash, cash equivalents and
short-term investments were approximately $63.0 million.
Operating Results
Research and development expenses were $12.5 million for the
three months ended June 30, 2023, an increase of $3.6 million, or
41%, compared to $8.9 million for the three months ended June 30,
2022. The net increase of $3.6 million is primarily related to
increases of $3.1 million in clinical trial and preclinical
expenses related to LP352, $0.4 million in personnel-related
expenses and $0.1 million in expenses related to preclinical
programs.
General and administrative expenses were $3.1 million for the
three months ended June 30, 2023, an increase of $0.5 million, or
17%, compared to $2.6 million for the three months ended June 30,
2022. The net increase of $0.5 million is primarily related to a
$0.4 million increase in personnel-related 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, an oral, 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 trial 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 will also
evaluate change in seizure frequency over the treatment period. The
study is expected to enroll approximately 50 participants with a
variety of treatment resistant seizures that fall into the category
of DEE across approximately 30 study sites in the United States and
Australia. The PACIFIC Study data are expected to inform the design
and characteristics of the Phase 3 program. Participants who
complete the PACIFIC Study are eligible to roll over into the
ongoing open-label extension (OLE) trial should they choose to do
so. The OLE is a Phase 2 multicenter, open-label, multiple-dose,
long-term extension clinical trial designed to evaluate long-term
safety of LP352 in participants with DEEs who have completed the
PACIFIC Study.
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 “expect”, “focus”, “look forward”, “plan”, “opportunity”,
“potential”, “believe”, “working to”, “designed to”, 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 their advancement, timing of completing
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,
best-in-class, clinically meaningful or highly selective and the
number and type of conditions they may address), their design and
characteristics, plans to conduct and share market research,
Longboard’s positioning to deliver a potential treatment to
patients, and plans for a potential Phase 3 program informed by
data from the PACIFIC Study; Longboard’s cash position, expenses
and runway to support operations; and Longboard’s 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)
June 30,
December 31,
(in thousands, except share and per
share data)
2023
2022
ASSETS
Current assets:
Cash and cash equivalents
$
19,504
$
10,775
Short-term investments
43,543
56,814
Prepaid expenses and other current
assets
2,545
2,249
Total current assets
65,592
69,838
Right-of-use assets
589
736
Property and equipment
7
9
Other long-term assets
35
33
Total assets
$
66,223
$
70,616
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable
$
1,939
$
1,310
Accrued research and development
expenses
3,790
4,168
Accrued compensation and related
expenses
1,238
2,438
Accrued other expenses
559
490
Right-of-use liabilities, current
portion
375
358
Total current liabilities
7,901
8,764
Right-of-use liabilities, net of current
portion
214
382
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value;
authorized shares - 10,000,000 at June 30, 2023 and December 31,
2022; issued and outstanding shares - none at June 30, 2023 and
December 31, 2022
—
—
Voting common stock, $0.0001 par value;
authorized shares - 300,000,000 at June 30, 2023 and December 31,
2022; issued and outstanding shares - 20,554,609 and 13,585,950 at
June 30, 2023 and December 31, 2022, respectively
2
1
Non-voting common stock, $0.0001 par
value; authorized shares - 10,000,000 at June 30, 2023 and December
31, 2022; issued and outstanding shares - 2,420,755 and 3,629,400
at June 30, 2023 and December 31, 2022, respectively
—
—
Additional paid-in capital
170,993
148,303
Accumulated other comprehensive loss
(290
)
(692
)
Accumulated deficit
(112,597
)
(86,142
)
Total stockholders' equity
58,108
61,470
Total liabilities and stockholders'
equity
$
66,223
$
70,616
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)
2023
2022
2023
2022
Operating expenses:
Research and development
$
12,536
$
8,921
$
21,066
$
16,042
General and administrative
3,106
2,646
6,538
5,145
Total operating expenses
15,642
11,567
27,604
21,187
Loss from operations
(15,642
)
(11,567
)
(27,604
)
(21,187
)
Interest income, net
660
127
1,176
159
Other income (expense)
(17
)
33
(27
)
24
Net loss
$
(14,999
)
$
(11,407
)
$
(26,455
)
$
(21,004
)
Net loss per share, basic and diluted
$
(0.65
)
$
(0.67
)
$
(1.22
)
$
(1.23
)
Weighted-average shares outstanding, basic
and diluted
22,968,920
17,130,307
21,696,427
17,108,582
Comprehensive loss:
Net loss
$
(14,999
)
$
(11,407
)
$
(26,455
)
$
(21,004
)
Unrealized gain (loss) on short-term
investments
131
(188
)
402
(620
)
Comprehensive loss
$
(14,868
)
$
(11,595
)
$
(26,053
)
$
(21,624
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230803465148/en/
Megan E. Knight Head of Investor Relations
IR@longboardpharma.com 858.789.9283
Longboard Pharmaceuticals (NASDAQ:LBPH)
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