- LP352 Phase 1b/2a PACIFIC Study enrollment completed in August
2023 with topline data on track for January 2024
- LP659 first-in-human Phase 1 single-ascending dose (SAD) study
initiation expected Q4 2023, with topline data expected in the
first half 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, 2023.
“We look forward to PACIFIC Study topline data in January 2024
evaluating LP352 in people living with Developmental and Epileptic
Encephalopathies, or DEEs. We are thrilled with the enthusiasm from
the DEE community about LP352 and our clinical development program
given the significant unmet medical need—both in the syndromes with
specifically approved therapies, as well as the 20-plus syndromes
that have limited or no access to newer, novel therapies. DEE
caregivers and healthcare providers continue to be frustrated with
the lack of new treatment options and remain focused on finding
treatment options that balance safety, efficacy and burden.
“We are also excited to expand our clinical-stage pipeline with
LP659, our oral, centrally acting, highly selective S1P receptor
modulator, moving into the clinic in the coming weeks. We look
forward to Phase 1 SAD data in the first half of 2024,” stated
Kevin R. Lind, Longboard’s President and Chief Executive
Officer.
RECENT AND UPCOMING HIGHLIGHTS
- LP352, an oral, centrally acting, 5-HT2C superagonist in
development for the potential treatment of seizures associated with
DEEs
- In August 2023, we completed enrollment of the PACIFIC Study,
with 52 participants with a broad range of DEEs including
Lennox-Gastaut syndrome (29), Dravet syndrome (4), and other DEEs
(19)
- Topline PACIFIC Study data expected in January 2024
- LP659, an oral, centrally acting, S1P receptor subtypes
1 and 5 (S1P1,5) modulator in development for rare
neuroinflammatory conditions
- Initiating the SAD Phase 1 study in Q4 2023, with topline data
expected in 1H 2024
- Investor & Analyst Event: In October 2023, we hosted
our first Investor & Analyst Event highlighting the DEE
landscape and commercial opportunity for LP352.
- Two thought leaders in the DEE space, Dennis Dlugos, MD, MSCE,
pediatric neurologist at Children's Hospital of Philadelphia, and
Gabrielle Conecker, MPH, Executive Director & Co-Founder of
Decoding Developmental Epilepsies, joined Longboard’s leadership
team to discuss the significant unmet medical need in the DEE
landscape and how LP352 could be an attractive treatment option in
this population.
- An archived recording of the presentation is available
here
- American Epilepsy Society (AES) Annual Meeting: In
December 2023, we are presenting new posters related to LP352 and
the Longboard executive leadership and clinical development teams
are hosting a scientific exhibit featuring these new data as well
as encore presentations.
THIRD QUARTER 2023 FINANCIAL RESULTS:
Balance Sheet Highlights
At September 30, 2023, Longboard’s cash, cash equivalents and
short-term investments were approximately $56.0 million, which
includes net proceeds of $5.8 million from a total of 822,250
shares sold through the Company’s at-the-market (ATM) facility
based on a reverse inquiry from a new, high-quality fund. Cash
runway is expected to support operations into fourth quarter
2024.
Operating Results
Research and development expenses were $10.5 million for the
three months ended September 30, 2023, an increase of $1.1 million,
or 12%, compared to $9.4 million for the three months ended
September 30, 2022. The net increase of $1.1 million is primarily
related to increases of $0.6 million in clinical trial and
preclinical expenses related to LP352 and $0.5 million in
personnel-related expenses.
General and administrative expenses were $3.1 million for the
three months ended September 30, 2023, an increase of $0.6 million,
or 25%, compared to $2.5 million for the three months ended
September 30, 2022. The net increase of $0.6 million is primarily
related to increases of $0.4 million in personnel-related expenses,
$0.3 million in consulting and professional fees and $0.1 million
of miscellaneous expenses, offset by a decrease of $0.2 million in
insurance 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 rare
neuroinflammatory conditions.
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 and tolerability of LP352. The PACIFIC Study will also
evaluate change in seizure frequency over the treatment period. The
study enrolled 52 participants with a variety of treatment
resistant seizures that fall into the category of DEEs 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 planned Phase 3 program for LP352.
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 “on track for”, “January 2024”, “expect”, “Q4 2023”, “first
half 2024”, “focus”, “look forward”, “excited to”, “the coming
weeks”, “potential”, “opportunity”, “could”, “December 2023”,
“fourth quarter 2024”, “working to”, “designed to”, “will”, “plan”,
or the negative, plural or other tenses of these words or other
comparable language, and they may include, without limitation,
statements about the following: Longboard’s clinical and
preclinical product candidates and programs, including their
advancement (including plans for a potential Phase 3 program for
LP352), timing of study initiation, timing of completing
enrollment, timing of topline data, number of study sites, number
and characteristics of study participants, their potential
(including to be transformative, best-in-class, clinically
meaningful or highly selective, the number and type of conditions
they may address and their commercial opportunity), and their
design and characteristics; upcoming presentations; 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 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; PACIFIC Study participants’ diagnoses are as of time
of screening and are subject to change; macroeconomic events
stemming from the COVID-19 pandemic or evolving geopolitical
developments such as the conflicts in Ukraine and the Middle East,
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)
2023
2022
ASSETS
Current assets:
Cash and cash equivalents
$
23,910
$
10,775
Short-term investments
32,106
56,814
Prepaid expenses and other current
assets
2,307
2,249
Total current assets
58,323
69,838
Right-of-use assets
500
736
Property and equipment
5
9
Other long-term assets
36
33
Total assets
$
58,864
$
70,616
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable
$
363
$
1,310
Accrued research and development
expenses
3,652
4,168
Accrued compensation and related
expenses
1,819
2,438
Accrued other expenses
484
490
Right-of-use liabilities, current
portion
394
358
Total current liabilities
6,712
8,764
Right-of-use liabilities, net of current
portion
108
382
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value;
authorized shares - 10,000,000 at September 30, 2023 and December
31, 2022; issued and outstanding shares - none at September 30,
2023 and December 31, 2022
—
—
Voting common stock, $0.0001 par value;
authorized shares - 300,000,000 at September 30, 2023 and December
31, 2022; issued and outstanding shares - 21,426,199 and 13,585,950
at September 30, 2023 and December 31, 2022, respectively
2
1
Non-voting common stock, $0.0001 par
value; authorized shares - 10,000,000 at September 30, 2023 and
December 31, 2022; issued and outstanding shares - 2,420,755 and
3,629,400 at September 30, 2023 and December 31, 2022,
respectively
—
—
Additional paid-in capital
177,754
148,303
Accumulated other comprehensive loss
(181)
(692)
Accumulated deficit
(125,531)
(86,142)
Total stockholders' equity
52,044
61,470
Total liabilities and stockholders'
equity
$
58,864
$
70,616
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)
2023
2022
2023
2022
Operating expenses:
Research and development
$
10,488
$
9,403
$
31,554
$
25,445
General and administrative
3,094
2,481
9,632
7,626
Total operating expenses
13,582
11,884
41,186
33,071
Loss from operations
(13,582)
(11,884)
(41,186)
(33,071)
Interest income, net
662
287
1,838
446
Other income (expense)
(14)
1
(41)
25
Net loss
$
(12,934)
$
(11,596)
$
(39,389)
$
(32,600)
Net loss per share, basic and diluted
$
(0.55)
$
(0.68)
$
(1.77)
$
(1.90)
Weighted-average shares outstanding, basic
and diluted
23,487,457
17,173,838
22,299,998
17,130,573
Comprehensive loss:
Net loss
$
(12,934)
$
(11,596)
$
(39,389)
$
(32,600)
Unrealized gain (loss) on short-term
investments
109
(131)
511
(751)
Comprehensive loss
$
(12,825)
$
(11,727)
$
(38,878)
$
(33,351)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231102233407/en/
Megan E. Knight Head of Investor Relations
IR@longboardpharma.com 858.789.9283
Longboard Pharmaceuticals (NASDAQ:LBPH)
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