- LP352 Phase 1b/2a PACIFIC Study remains on track to complete
enrollment in the first half of 2023, with topline data expected in
the second half of 2023
- LP659 Phase 1 initiation of first in-human clinical study on
track for first half of 2023, with Phase 1 topline single-ascending
dose (SAD) data expected in the second half of 2023
- Ended 2022 with $67.6 million in cash, cash equivalents and
investments; cash runway is expected to support operations into
mid-2024
- Further strengthened institutional shareholder base by
completing a follow-on public offering of common stock in February
2023 with gross proceeds of $23.0 million
- Longboard to host conference call and webcast today at 4:30 PM
ET
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 full year
2022.
"I am very proud of the team for the progress that we made in
2022, including the strong engagement and excitement we have
generated around the PACIFIC Study, which remains on track to
deliver topline data in the second half of this year. We continue
to think strategically on ways to truly differentiate LP352 in the
clinic as a potential best-in-class treatment option for
individuals living with DEEs. For LP659, we plan to initiate our
first in-human study in the coming months, and anticipate topline
SAD data in the second half of the year," stated Kevin R. Lind,
Longboard’s President and Chief Executive Officer.
2022 PROGRAM HIGHLIGHTS AND ANTICIPATED 2023
MILESTONES
LP352 Highlights:
LP352 is an oral, highly selective, centrally acting
5-hydroxytryptamine 2C receptor subtype (5-HT2C) superagonist.
LP352 is the only 5-HT2C receptor agonist being dose optimized for
developmental and epileptic encephalopathies (DEEs). We believe
LP352 could be a treatment for individuals with DEEs where no
options are available and a potentially safer, more efficacious,
easy to add-on treatment option for individuals with syndromes
where current therapies are inadequate.
The PACIFIC Study
The PACIFIC Study is an ongoing Phase 1b/2a basket clinical
trial of LP352. We plan to evaluate 50 participants ages 12 to 65
years old with DEEs. We are utilizing approximately 30 study sites
across the United States and Australia in the trial.
- Full enrollment expected in the first half of 2023
- Topline data expected in the second half of 2023
- PACIFIC Study data is expected to inform the design and
characteristics of our Phase 3 program
The 102 Phase 1 Central Nervous System (CNS) Pharmacokinetics
(PK) and Pharmacodynamics (PD) Study
In December 2022, we reported positive topline data from cohorts
1 and 2 of an ongoing Phase 1 clinical study evaluating the CNS PK
and PD of LP352 in healthy volunteers.
- LP352 exhibited a strong correlation between plasma and
cerebrospinal fluid PK concentration, which increased in a
dose-dependent and consistent manner
- LP352 demonstrated early quantitative electroencephalogram
(qEEG) changes, and sustained effects on qEEG activity after
continuous dosing in a dose-dependent manner indicating receptor
engagement
- Favorable safety and tolerability results were observed, with
adverse events generally consistent with previous clinical
studies
Presented and hosted a Scientific Exhibit at the American
Epilepsy Society (AES) Annual Meeting
- New posters included the following:
- Searching for Safer and More Effective Medications in the
Management of Seizure Disorders: A 5-HT2C Superagonist
- Evaluation of Prolactin as a Useful Pharmacodynamic Tool to
Assess Engagement of Central 5-HT2C Receptors by LP352, a Potent
and Selective 5-HT2C Agonist
- Presentation materials from AES and other medical meetings can
be found on the “Our Approach” section of our website here
LP659 Highlights:
LP659 is a centrally acting, S1P1,5 receptor modulator. LP659
was designed for optimized pharmacology, PK and engagement of
S1P1,5, which may lead to improved efficacy and safety. We believe
LP659 could have potential in a number of inflammatory neurological
conditions.
Initiating First In-Human (FIH) Clinical Trial of LP659 in
Healthy Volunteers
- Expect to initiate clinical trial in the first half of
2023
- Phase 1 topline SAD data expected in the second half of
2023
CORPORATE AND FINANCIAL UPDATES
Continued to add key expertise across the company with the
goal of cultivating a world-class neuroscience team to advance our
programs in a strategic manner
- Expanded our team from 22 to 33 employees during 2022
- Added key leaders to our team with extensive experience in the
epilepsy space, including commercial strategy, clinical development
and medical affairs
Completed a $23.0 million public offering of common
shares
- We further strengthened our institutional shareholder base by
completing a follow-on public offering of 5,750,000 shares of our
voting common stock in February 2023. Gross proceeds were $23.0
million.
FULL YEAR 2022 FINANCIAL RESULTS:
Balance Sheet Highlights
At December 31, 2022, Longboard’s cash, cash equivalents and
short-term investments were approximately $67.6 million. We added
net proceeds of approximately $21.2 million to our balance sheet
after the completion of our follow-on public offering in February
2023. Our cash position is expected to support operations into
mid-2024 based on our current business plan.
Operating Results
Research and development expenses were $34.6 million for the
year ended December 31, 2022. These expenses include $19.4 million
in preclinical and clinical trial expenses related to LP352, $5.6
million in preclinical expenses primarily related to advancing
LP659 and $8.4 million in personnel-related expenses. Research and
development expenses were $19.8 million for the year ended December
31, 2021. These expenses include $8.2 million in preclinical and
clinical trial expenses related to LP352, $6.2 million in
preclinical expenses related to advancing LP659 and LP143 and $4.5
million in personnel-related expenses.
General and administrative expenses were $10.2 million for the
year ended December 31, 2022. These expenses include $5.3 million
of personnel-related costs, $2.0 million of professional services
and consulting expenses and $1.6 million of insurance expense.
General and administrative expenses were $8.1 million for the year
ended December 31, 2021. These expenses include $4.0 million of
personnel-related costs, $1.7 million of professional services and
consulting expenses and $1.5 million of insurance expense.
Net loss was $43.9 million, or $2.56 per share, for the full
year 2022 compared to $27.8 million, or $1.93 per share, for the
full year 2021.
We are currently estimating 2023 operating expenses in the $57.0
to $63.0 million range, excluding share-based compensation.
CONFERENCE CALL DETAILS
Longboard will host a conference call today at 4:30 p.m. ET to
discuss 2022 financial results and provide a corporate update.
To join the live call by phone, please register via this link,
complete the brief online registration form, and select your
preferred method for joining the call. Upon registering you will
receive the dial-in info and a unique PIN to join the call, as well
as an email confirmation with the details. Please register at least
10 minutes prior to the event to ensure timely access.
To access a live or archived webcast of the event, please visit
the “Events & Presentations” page within the Investors
Relations section of Longboard’s website at
https://ir.longboardpharma.com/. An archived webcast of the call
will be available shortly after the event concludes and archived on
the website for at least 30 days following the event.
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.
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”, “potential”, “look forward”, “plan”,
“anticipate”, “focus”, “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 completing enrollment, timing of
topline data, timing of study initiation, their potential
(including to be a best-in-class treatment option, a safer, more
efficacious treatment, and the number and type of conditions they
may address), their design and characteristics, clinical trial
protocols (for example, dose optimizing, clinical trial
participants, indications and treatments), and our other plans; our
cash position, expenses and runway to support operations; our team;
and our 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 the 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.
BALANCE SHEETS
December 31,
December 31,
(in thousands, except share and per
share data)
2022
2021
ASSETS
Current assets:
Cash and cash equivalents
$
10,775
$
66,346
Short-term investments
56,814
40,379
Prepaid expenses and other current
assets
2,249
1,659
Total current assets
69,838
108,384
Right-of-use assets
736
521
Property and equipment
9
14
Other long-term assets
33
33
Total assets
$
70,616
$
108,952
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable
$
1,310
$
1,028
Accrued research and development
expenses
4,168
2,245
Accrued compensation and related
expenses
2,438
1,480
Accrued other expenses
490
352
Right-of-use liabilities, current
portion
358
339
Total current liabilities
8,764
5,444
Right-of-use liabilities, net of current
portion
382
185
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value;
authorized shares - 10,000,000 at December 31, 2022 and 2021,
respectively; issued and outstanding shares - none at December 31,
2022 and 2021
—
—
Voting common stock, $0.0001 par value;
authorized shares - 300,000,000 at December 31, 2022 and 2021,
respectively; issued and outstanding shares - 13,585,950 and
13,440,761 at December 31, 2022 and 2021, respectively, excluding 0
and 145,189 shares, respectively, subject to repurchase
1
1
Non-voting common stock, $0.0001 par
value; authorized shares - 10,000,000 at December 31, 2022 and
2021, respectively; issued and outstanding shares - 3,629,400 at
December 31, 2022 and 2021, respectively
—
—
Additional paid-in capital
148,303
145,683
Accumulated other comprehensive loss
(692
)
(164
)
Accumulated deficit
(86,142
)
(42,197
)
Total stockholders' equity
61,470
103,323
Total liabilities and stockholders'
equity
$
70,616
$
108,952
LONGBOARD PHARMACEUTICALS,
INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
Year Ended December
31,
(in thousands, except share and per
share data)
2022
2021
Operating expenses:
Research and development
$
34,638
$
19,774
General and administrative
10,160
8,065
Total operating expenses
44,798
27,839
Loss from operations
(44,798
)
(27,839
)
Interest income, net
837
64
Other income (expense)
16
(22
)
Net loss
$
(43,945
)
$
(27,797
)
Net loss per share, basic and diluted
$
(2.56
)
$
(1.93
)
Weighted-average shares outstanding, basic
and diluted
17,150,907
14,410,502
Comprehensive loss:
Net loss
$
(43,945
)
$
(27,797
)
Unrealized loss on short-term
investments
(528
)
(164
)
Comprehensive loss
$
(44,473
)
$
(27,961
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230302005771/en/
CORPORATE CONTACT: Megan E. Knight Head of Investor
Relations mknight@longboardpharma.com IR@longboardpharma.com
619.592.9775
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