Longboard Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2022 Financial Results
August 04 2022 - 4:05PM
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, 2022.
“I am pleased with the progress our team has
made this quarter. We remain on track to complete the PACIFIC Study
in the second half of 2023 by focusing our efforts on site
activation and recruitment, including the planned expansion into
Australia and the Australian Epilepsy Clinical Trial Network. We
have also aligned with regulators to expand the age range of
patients to include adolescents, and we have added an open-label
extension study which will allow us to offer long-term access of
LP352 to eligible study participants. Importantly, the addition of
younger patients in the PACIFIC Study will provide the opportunity
to evaluate the potential impact of LP352 earlier in the treatment
journey. We are encouraged by our interactions with the highly
engaged and enthusiastic refractory epilepsy community," stated
Kevin R. Lind, Longboard’s President and Chief Executive Officer.
"We also continue to make progress on IND-enabling activities for
LP659 and we look forward to updating our stakeholders as we
advance our promising pipeline.”
Program Overview:
- LP352, an
oral, highly selective, centrally acting 5-hydroxytryptamine 2C
receptor subtype (5-HT2C) superagonist:
-
The PACIFIC Study, a Phase 1b/2a basket trial, evaluating
approximately 50 participants ages 12 to 65 years old with
developmental and epileptic encephalopathies or DEEs, such as
Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis
complex, CDKL5 deficiency disorder, SCN2A-related disorders, among
others, is ongoing with expected completion in the second half of
2023.
-
Multiple clinical and preclinical studies are in process to further
elucidate the intrinsic PD/PK properties and support clinical
development in a broad range of refractory epilepsies.
- 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.
Second Quarter 2022 Financial
Results:
Balance Sheet Highlights
At June 30, 2022, Longboard’s cash, cash
equivalents and short-term investments were approximately $87.4
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
$8.9 million for the three months ended June 30, 2022, an increase
of $4.0 million, or 82%, compared to $4.9 million for the three
months ended June 30, 2021. The net increase of $4.0 million is
primarily related to increases of $1.7 million in clinical and
preclinical trial expenses related to LP352, $1.1 million in
personnel-related expenses, and $0.9 million in preclinical
expenses related to LP659 and LP143.
General and administrative (G&A) expenses
were $2.6 million for the three months ended June 30, 2022, an
increase of $0.5 million, or 28%, compared to $2.1 million for the
three months ended June 30, 2021. The net increase of $0.5 million
is primarily related to an increase in personnel-related costs.
Net loss was $11.4 million, or $0.67 per share,
for the three months ended June 30, 2022 compared to $7.0 million,
or $0.41 per share, for the three months ended June 30, 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 “on track”, “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 trials plans and protocols
(for example, the planned expansion into Australia), timing of
completion of a clinical trial, additional data, regulatory
applications and their submission timing; our cash position or
expected cash runway; key milestones; the promise of our pipeline;
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 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.
Financial Tables
FollowLONGBOARD PHARMACEUTICALS,
INC.CONDENSED BALANCE
SHEETS(Unaudited)
|
|
June 30, |
|
|
December 31, |
|
(in thousands, except share and per share
data) |
|
2022 |
|
|
2021 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
27,716 |
|
|
$ |
66,346 |
|
Short-term investments |
|
|
59,702 |
|
|
|
40,379 |
|
Prepaid expenses and other
current assets |
|
|
2,728 |
|
|
|
1,659 |
|
Total current assets |
|
|
90,146 |
|
|
|
108,384 |
|
Right-of-use assets |
|
|
355 |
|
|
|
521 |
|
Property and equipment |
|
|
12 |
|
|
|
14 |
|
Other long-term assets |
|
|
— |
|
|
|
33 |
|
Total assets |
|
$ |
90,513 |
|
|
$ |
108,952 |
|
LIABILITIES AND
EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
602 |
|
|
$ |
1,028 |
|
Accrued research and development
expenses |
|
|
4,215 |
|
|
|
2,245 |
|
Accrued compensation and related
expenses |
|
|
1,019 |
|
|
|
1,480 |
|
Accrued other expenses |
|
|
1,345 |
|
|
|
352 |
|
Right-of-use liabilities, current
portion |
|
|
363 |
|
|
|
339 |
|
Total current liabilities |
|
|
7,544 |
|
|
|
5,444 |
|
Right-of-use liabilities, net of
current portion |
|
|
— |
|
|
|
185 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Preferred stock, $0.0001 par value; authorized shares - 10,000,000
at June 30, 2022 and December 31, 2021; issued and outstanding
shares - none at June 30, 2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Voting common stock, $0.0001 par value; authorized shares -
300,000,000 at June 30, 2022 and December 31, 2021; issued and
outstanding shares - 13,527,869 and 13,440,761 at June 30, 2022 and
December 31, 2021, respectively, excluding 58,081 and 145,189,
respectively, subject to repurchase |
|
|
1 |
|
|
|
1 |
|
Non-voting common stock, $0.0001 par value; authorized shares -
10,000,000 at June 30, 2022 and December 31, 2021; issued and
outstanding shares - 3,629,400 at June 30, 2022 and December 31,
2021 |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
146,953 |
|
|
|
145,683 |
|
Accumulated other comprehensive loss |
|
|
(784 |
) |
|
|
(164 |
) |
Accumulated deficit |
|
|
(63,201 |
) |
|
|
(42,197 |
) |
Total stockholders' equity |
|
|
82,969 |
|
|
|
103,323 |
|
Total liabilities and stockholders' equity |
|
$ |
90,513 |
|
|
$ |
108,952 |
|
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) |
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
8,921 |
|
|
$ |
4,915 |
|
|
$ |
16,042 |
|
|
$ |
9,313 |
|
General and administrative |
|
2,646 |
|
|
|
2,072 |
|
|
|
5,145 |
|
|
|
3,377 |
|
Total operating expenses |
|
11,567 |
|
|
|
6,987 |
|
|
|
21,187 |
|
|
|
12,690 |
|
Loss from operations |
|
(11,567 |
) |
|
|
(6,987 |
) |
|
|
(21,187 |
) |
|
|
(12,690 |
) |
Interest income, net |
|
127 |
|
|
|
13 |
|
|
|
159 |
|
|
|
17 |
|
Other income (expense) |
|
33 |
|
|
|
(6 |
) |
|
|
24 |
|
|
|
(6 |
) |
Net loss |
$ |
(11,407 |
) |
|
$ |
(6,980 |
) |
|
$ |
(21,004 |
) |
|
$ |
(12,679 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.67 |
) |
|
$ |
(0.41 |
) |
|
$ |
(1.23 |
) |
|
$ |
(1.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding, basic and diluted |
|
17,130,307 |
|
|
|
16,827,556 |
|
|
|
17,108,582 |
|
|
|
11,846,653 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(11,407 |
) |
|
$ |
(6,980 |
) |
|
$ |
(21,004 |
) |
|
$ |
(12,679 |
) |
Unrealized loss on short-term investments |
|
(188 |
) |
|
|
(34 |
) |
|
|
(620 |
) |
|
|
(34 |
) |
Comprehensive loss |
$ |
(11,595 |
) |
|
$ |
(7,014 |
) |
|
$ |
(21,624 |
) |
|
$ |
(12,713 |
) |
Corporate Contact:
Megan E. Knight
Head of Investor Relations
mknight@longboardpharma.com
IR@longboardpharma.com
619.592.9775
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