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 2021.
"I am very proud of the work our team
accomplished over the past year, particularly advancing LP352 into
our first clinical trial in patients with DEEs. It is great to see
the enthusiasm from physicians, caretakers and advocacy groups for
the PACIFIC Study. Enrollment and study conduct will continue to be
our number one priority until study completion which is expected in
the second half of 2023. We continue to see a high unmet commercial
need for a safe and efficacious seizure treatment, and believe that
LP352 has the potential to be the first highly-selective 5-HT2c
receptor superagonist optimized and designed specifically for this
patient population," stated Kevin R. Lind, Longboard’s President
and Chief Executive Officer. "For LP659, we are enthusiastic about
the potential for this program, especially given the recent
proposed acquisition of Arena Pharmaceuticals, further validating
the quality of the compounds that have been developed and optimized
within its world-class discovery engine. We look forward to
meaningful pipeline progress in 2022 and updating shareholders
along the way."
Program Overview:
- LP352, an oral, highly selective, centrally acting 5-HT2c
superagonist
- We initiated the PACIFIC Study in the first quarter of 2022. We
plan to evaluate approximately 50 participants with DEEs, such as
Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis
complex, CDKL5 deficiency disorder, among others, and expect to
complete the study in the second half of 2023.
- LP352 demonstrated statistically significant reductions in both
epileptiform event frequency and duration - reducing the frequency
of epileptiform events by 85% and cumulative duration of
epileptiform events by 84% in the scn1lab zebrafish model of Dravet
syndrome.
- 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 second half of 2022.
- LP143, an oral, centrally acting full agonist to the CB2
receptor targeting CNS diseases and disorders, for which
IND-enabling studies have been completed; we are continuing to
conduct additional preclinical work before determining whether to
advance LP143 into clinical studies.
Corporate Update:
- We expanded our Board of Directors to seven members with the
appointment of Dr. Jane Tiller in November 2021. Dr. Tiller
currently serves as Chief Medical Officer of Neumora Therapeutics,
a clinical-stage neurology focused biopharmaceutical company.
- Since inception, we have been working to build a world-class
neurology team to support our programs. We grew from three
employees at the end of 2020 to 25 employees currently, enabling
the successful separation from Arena Pharmaceuticals and creating
functional neurological expertise at Longboard.
Full Year Financial
Results:
Balance Sheet Highlights
At December 31, 2021, Longboard’s cash, cash
equivalents and short-term investments were approximately $106.7
million. Our cash position is expected to support operations into
2024 based on our current business plan.
Operating Results
R&D expenses were $19.8 million for the full
year ended December 31, 2021. R&D expenses for the full year
2021 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. R&D expenses for the period from
January 3, 2020 (inception) through December 31, 2020 were $4.6
million, including $1.3 million in preclinical and clinical trial
expenses related to LP352, $2.5 million related to preclinical
expenses for LP659 and LP143 and $0.7 million in personnel-related
expenses.
G&A expenses were $8.1 million for the full
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.
G&A expenses for the period from January 3, 2020 (inception)
through December 31, 2020 were $9.8 million, with $7.4 million
related to a one-time stock-based compensation expense related to
Arena equity awards, $1.6 million of personnel-related costs, and
$0.8 million of professional services and legal related fees.
Net loss was $27.8 million, or $1.93 per share,
for the full year 2021 compared to $14.4 million, or $3.78 per
share, for the period from January 3, 2020 (inception) through
December 31, 2020, respectively.
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 for”, “expected” or “expect”,
“potential”, “look forward”, “plan”, “focused on”, and “working to
build”, and include, without limitation, statements about the
following: Longboard’s clinical and preclinical product candidates
and programs, including clinical trial protocols (for example,
clinical trial participants, indications and treatments), timing of
IND submission, timing of study completion, data supporting the
scientific rationale for our focus and IND filing, and other plans;
our cash position; our team; 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 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.BALANCE SHEETS
|
|
December 31, |
|
|
December 31, |
|
(in thousands, except share and per share
data) |
|
2021 |
|
|
2020 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
66,346 |
|
|
$ |
55,316 |
|
Short-term investments |
|
|
40,379 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
1,659 |
|
|
|
46 |
|
Total current assets |
|
|
108,384 |
|
|
|
55,362 |
|
Right-of-use assets |
|
|
521 |
|
|
|
— |
|
Property and equipment |
|
|
14 |
|
|
|
— |
|
Other long-term assets |
|
|
33 |
|
|
|
— |
|
Deferred financing costs |
|
|
— |
|
|
|
876 |
|
Total assets |
|
$ |
108,952 |
|
|
$ |
56,238 |
|
LIABILITIES AND
EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,028 |
|
|
$ |
1,213 |
|
Accrued research and development expenses |
|
|
2,245 |
|
|
|
916 |
|
Accrued compensation and related expenses |
|
|
1,480 |
|
|
|
161 |
|
Accrued other expenses |
|
|
352 |
|
|
|
845 |
|
Right-of-use liabilities, current portion |
|
|
339 |
|
|
|
— |
|
Total current liabilities |
|
|
5,444 |
|
|
|
3,135 |
|
Right-of-use liabilities, net of current portion |
|
|
185 |
|
|
|
— |
|
Commitments and contingencies |
|
|
|
|
|
|
Convertible preferred stock: |
|
|
|
|
|
|
Series A convertible preferred stock $0.0001 par value; authorized
shares - none and 5,600,000 at December 31, 2021 and 2020,
respectively; issued and outstanding shares - none and 5,600,000 at
December 31, 2021 and 2020, respectively; aggregate liquidation
preference – none and $56,000 at December 31, 2021 and 2020,
respectively |
|
|
— |
|
|
|
55,795 |
|
Stockholders' equity
(deficit): |
|
|
|
|
|
|
Preferred stock, $0.0001 par value; authorized shares - 10,000,000
and none at December 31, 2021 and 2020, respectively; issued and
outstanding shares - none at December 31, 2021 and 2020 |
|
|
— |
|
|
|
— |
|
Voting common stock, $0.0001 par value; authorized shares -
300,000,000 and 10,500,000 at December 31, 2021 and 2020,
respectively; issued and outstanding shares - 13,440,761 and
3,840,540 at December 31, 2021 and 2020, respectively, excluding
145,189 and 348,450 shares, respectively, subject to
repurchase |
|
|
1 |
|
|
|
— |
|
Non-voting common stock, $0.0001 par value; authorized shares -
10,000,000 and none at December 31, 2021 and 2020, respectively;
issued and outstanding shares - 3,629,400 and none at December 31,
2021 and 2020, respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
145,683 |
|
|
|
11,708 |
|
Accumulated other comprehensive loss |
|
|
(164 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(42,197 |
) |
|
|
(14,400 |
) |
Total stockholders' equity (deficit) |
|
|
103,323 |
|
|
|
(2,692 |
) |
Total liabilities, convertible preferred stock and stockholders'
equity (deficit) |
|
$ |
108,952 |
|
|
$ |
56,238 |
|
|
|
|
|
|
|
|
|
|
LONGBOARD PHARMACEUTICALS,
INC.STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
|
Year Ended December 31, |
|
|
Period from January 3, 2020
(Inception) throughDecember
31, |
|
(in thousands, except share and per share
data) |
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
19,774 |
|
|
$ |
4,633 |
|
General and administrative |
|
8,065 |
|
|
|
9,767 |
|
Total operating expenses |
|
27,839 |
|
|
|
14,400 |
|
Loss from operations |
|
(27,839 |
) |
|
|
(14,400 |
) |
Interest income, net |
|
64 |
|
|
|
— |
|
Other expense |
|
(22 |
) |
|
|
— |
|
Net loss |
$ |
(27,797 |
) |
|
$ |
(14,400 |
) |
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(1.93 |
) |
|
$ |
(3.78 |
) |
|
|
|
|
|
|
Weighted-average shares outstanding, basic and diluted |
|
14,410,502 |
|
|
|
3,808,887 |
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
Net loss |
$ |
(27,797 |
) |
|
$ |
(14,400 |
) |
Unrealized loss on short-term investments |
|
(164 |
) |
|
|
— |
|
Comprehensive loss |
$ |
(27,961 |
) |
|
$ |
(14,400 |
) |
|
|
|
|
|
|
|
|
Corporate Contact:
Megan E. Knight
Head of Investor Relations
mknight@longboardpharma.com
IR@longboardpharma.com
619.592.9775
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