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, 2022.
"In 2022, we are continuing to deliver on key
milestones, including advancing the PACIFIC study and presenting an
extremely robust data set for LP352 at the AAN Annual Meeting in
April. We plan on sharing additional data to illustrate the
intrinsic properties of LP352 and LP659 that we believe will
demonstrate their potentially best-in-class characteristics,"
stated Kevin R. Lind, Longboard’s President and Chief Executive
Officer.
Program Overview:
- LP352, an
oral, highly selective, centrally acting 5-hydroxytryptamine 2c
receptor subtype (5-HT2c) superagonist:
- The Phase
1b/2a PACIFIC Study evaluating approximately 50 participants with
DEEs, such as Dravet syndrome, Lennox-Gastaut syndrome, tuberous
sclerosis complex, CDKL5 deficiency disorder, among others, is
ongoing with expected completion in the second half of 2023.
- Phase 1 data
were presented at the AAN Annual Meeting in April.
- LP659, an oral, selective,
centrally acting S1P receptor modulator targeting multiple
neurological diseases, is currently in IND-enabling studies with
IND application submission to the FDA expected in the fourth
quarter of 2022.
Corporate Update:
- In March 2022, Dr. Randall Kaye
joined the Company as Chief Medical Officer. Dr. Kaye has over 30
years of experience in the medical field, most recently as Chief
Medical Officer of Neurana Pharmaceuticals, a biotechnology company
focused on the treatment of neuromuscular conditions.
First Quarter 2022 Financial
Results:
Balance Sheet Highlights
At March 31, 2022, Longboard’s cash, cash
equivalents and short-term investments were approximately $96.1
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
$7.1 million for the three months ended March 31, 2022, an increase
of $2.7 million, or 62%, compared to $4.4 million for the three
months ended March 31, 2021. The net increase of $2.7 million is
primarily related to an increase of $2.0 million in clinical trial
and preclinical expenses related to LP352 and an increase of $1.1
million in personnel-related expenses, offset by a decrease of $0.6
million in preclinical expenses related to LP659 and LP143.
General and administrative (G&A) expenses
were $2.5 million for the three months ended March 31, 2022, an
increase of $1.2 million, or 92%, compared to $1.3 million for the
three months ended March 31, 2021. The net increase of $1.2 million
is primarily related to an increase of $0.6 million in
personnel-related costs, $0.4 million in insurance expense, $0.1
million in professional services and consulting expenses, and $0.1
million in rent expense.
Net loss was $9.6 million, or $0.56 per share,
for the three months ended March 31, 2022, compared to $5.7
million, or $0.84 per share, for the three months ended March 31,
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 “expected”, “potential”, “plan” and
“focused on”, and include, without limitation, statements about the
following: Longboard’s clinical and preclinical product candidates
and programs, including potential treatments and indications,
clinical trial protocols (for example, number of clinical trial
participants), timing of completion of a clinical trial, additional
data, regulatory applications and their submission timing,
progress, and other plans; our cash position; key milestones; 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 marketing; 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 relate
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.
Financial Tables
FollowLONGBOARD PHARMACEUTICALS,
INC.CONDENSED BALANCE
SHEETS(Unaudited)
|
|
March 31, |
|
|
December 31, |
|
(in thousands, except share and per share
data) |
|
2022 |
|
|
2021 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
35,037 |
|
|
$ |
66,346 |
|
Short-term investments |
|
|
61,087 |
|
|
|
40,379 |
|
Prepaid expenses and other current assets |
|
|
4,035 |
|
|
|
1,659 |
|
Total current assets |
|
|
100,159 |
|
|
|
108,384 |
|
Right-of-use assets |
|
|
438 |
|
|
|
521 |
|
Property and equipment |
|
|
13 |
|
|
|
14 |
|
Other long-term assets |
|
|
33 |
|
|
|
33 |
|
Total assets |
|
$ |
100,643 |
|
|
$ |
108,952 |
|
LIABILITIES AND
EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,357 |
|
|
$ |
1,028 |
|
Accrued research and development
expenses |
|
|
2,998 |
|
|
|
2,245 |
|
Accrued compensation and related
expenses |
|
|
443 |
|
|
|
1,480 |
|
Accrued other expenses |
|
|
1,536 |
|
|
|
352 |
|
Right-of-use liabilities, current
portion |
|
|
350 |
|
|
|
339 |
|
Total current liabilities |
|
|
6,684 |
|
|
|
5,444 |
|
Right-of-use liabilities, net of
current portion |
|
|
94 |
|
|
|
185 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Preferred stock, $0.0001 par value; authorized shares - 10,000,000
at March 31, 2022 and December 31, 2021; issued and outstanding
shares - none at March 31, 2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Voting common stock, $0.0001 par value; authorized shares -
300,000,000 at March 31, 2022 and December 31, 2021; issued and
outstanding shares - 13,484,315 and 13,440,761 at March 31, 2022
and December 31, 2021, respectively, excluding 101,635 and 145,189,
respectively, subject to repurchase |
|
|
1 |
|
|
|
1 |
|
Non-voting common stock, $0.0001 par value; authorized shares -
10,000,000 at March 31, 2022 and December 31, 2021; issued and
outstanding shares - 3,629,400 at March 31, 2022 and December 31,
2021 |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
146,254 |
|
|
|
145,683 |
|
Accumulated other comprehensive loss |
|
|
(596 |
) |
|
|
(164 |
) |
Accumulated deficit |
|
|
(51,794 |
) |
|
|
(42,197 |
) |
Total stockholders' equity |
|
|
93,865 |
|
|
|
103,323 |
|
Total liabilities and stockholders' equity |
|
$ |
100,643 |
|
|
$ |
108,952 |
|
LONGBOARD PHARMACEUTICALS,
INC.CONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(Unaudited)
|
Three Months Ended March 31, |
|
(in thousands, except share and per share
data) |
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
7,121 |
|
|
$ |
4,398 |
|
General and administrative |
|
2,499 |
|
|
|
1,305 |
|
Total operating expenses |
|
9,620 |
|
|
|
5,703 |
|
Loss from operations |
|
(9,620 |
) |
|
|
(5,703 |
) |
Interest income, net |
|
32 |
|
|
|
4 |
|
Other expense |
|
(9 |
) |
|
|
— |
|
Net loss |
$ |
(9,597 |
) |
|
$ |
(5,699 |
) |
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.56 |
) |
|
$ |
(0.84 |
) |
|
|
|
|
|
|
Weighted-average shares outstanding, basic and diluted |
|
17,086,615 |
|
|
|
6,810,407 |
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
Net loss |
$ |
(9,597 |
) |
|
$ |
(5,699 |
) |
Unrealized loss on short-term investments |
|
(432 |
) |
|
|
— |
|
Comprehensive loss |
$ |
(10,029 |
) |
|
$ |
(5,699 |
) |
Corporate Contact:
Megan E. Knight
Head of Investor Relations
mknight@longboardpharma.com
IR@longboardpharma.com
619.592.9775
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