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, 2021.
"This quarter we successfully completed the MAD
portion of our Phase 1 clinical trial for our lead asset, LP352,
and we look forward to initiating our first clinical trial in
patients with severe and refractory epilepsies next quarter. We are
collaborating with a world-class CRO and have commenced key
activities for trial readiness and site activation. We continue to
engage with thought leaders, advocacy groups and caregivers in
order to prioritize enrollment optimization, and most importantly,
the best outcome for patients living with these devastating
diseases," stated Kevin R. Lind, Longboard’s President and Chief
Executive Officer. "For LP143 and LP659 we look forward to sharing
additional preclinical data that support the scientific rationale
for our initial areas of focus as we approach IND submissions for
each program in 2022."
Program Overview:
- LP352, an oral, highly selective,
centrally acting 5-hydroxytryptamine 2c receptor subtype (5-HT2c)
superagonist, has successfully completed the SAD/MAD portions of a
Phase 1 clinical trial, informing the optimal expected dose range
for the next phase of development. We plan to initiate a Phase
1b/2a clinical trial in participants with DEEs, such as Dravet
syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex,
CDKL5 deficiency disorder, among others, in the first quarter of
2022.
- LP143, an oral, centrally acting
full agonist to the cannabinoid type 2 (CB2) receptor targeting a
broad range of neurodegenerative diseases, with an initial focus in
amyotrophic lateral sclerosis (ALS), is currently in
Investigational New Drug (IND)-enabling studies and we anticipate
submitting an IND application to the United States Food and Drug
Administration (FDA) in the first quarter of 2022.
- LP659, an oral, selective,
centrally acting sphingosine-1-phosphate (S1P) receptor modulator
targeting a range of central nervous system neuroinflammatory
diseases, is currently in IND-enabling studies and we anticipate
submitting an IND application to the FDA in the second half of
2022.
Leadership Update:
- In October 2021, Steven W. Spector,
J.D., joined the Company as general counsel. Most recently, Mr.
Spector served as part-time general counsel for several public
companies, including Longboard, Dynavax Technologies and Galecto,
Inc. Prior to this, he served as general counsel of Arena
Pharmaceuticals, Inc. for nearly twenty years, from October 2001 to
March 2020.
Third Quarter 2021 Financial
Results:
Balance Sheet Highlights
At September 30, 2021, Longboard’s cash, cash
equivalents and short-term investments were approximately $112.6
million and approximately 16.9 million shares of Longboard voting
and non-voting common stock were outstanding.
Operating Results
Research and development (R&D) expenses were
$4.1 million for the three months ended September 30, 2021 compared
to $1.6 million for the three months ended September 30, 2020.
R&D expenses for the three months ended September 30, 2021
included $1.3 million in preclinical and clinical trial expenses
related to LP352, $1.3 million in preclinical expenses related to
advancing LP143 and LP659 and $1.3 million in personnel-related
expenses. R&D expenses for the three months ended September 30,
2020 included $0.3 million in preclinical and clinical trial
expenses related to LP352, $0.8 million related to preclinical
expenses for LP143 and LP659 and $0.5 million in personnel-related
expenses.
General and administrative (G&A) expenses
were $2.3 million for the three months ended September 30, 2021
compared to $0.9 million for the three months ended September 30,
2020. G&A expenses for the three months ended September 30,
2021 included $1.0 million of personnel-related costs, $0.5 million
of professional services and consulting expenses and $0.5 million
of insurance expense. G&A expenses for the three months ended
September 30, 2020 included $0.6 million of personnel-related costs
and $0.3 million in professional services and consulting
expenses.
Net loss was $6.3 million, or $0.38 per share,
for the three months ended September 30, 2021 compared to $2.6
million, or $0.66 per share, for the three months ended September
30, 2020.
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 receptor superagonist, with
negligible observed impact on 5-HT2b and 5-HT2a receptor subtypes,
in development for the potential treatment of seizures associated
with developmental and epileptic encephalopathies. Longboard is
also evaluating LP143, a centrally acting, full cannabinoid type 2
receptor agonist, in development for the potential treatment of
neurodegenerative diseases associated with neuroinflammation caused
by microglial activation, and LP659, a centrally acting,
sphingosine-1-phosphate receptor subtypes 1 and 5 modulator, in
development for the potential treatment of central nervous system
neuroinflammatory 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 “expected”, “potential”, “plan”,
“anticipate”, “focused on”, “look forward” and “build out”, 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
initiation of clinical trials, data supporting the scientific
rationale for our focus, regulatory applications and their
submission timing, progress, and other plans; 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.CONDENSED BALANCE
SHEETS(Unaudited)
|
|
September 30, |
December 31, |
(in thousands, except share and per share
data) |
|
|
2021 |
|
|
|
2020 |
|
ASSETS |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
75,461 |
|
|
$ |
55,316 |
|
Short-term investments |
|
|
37,098 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
2,740 |
|
|
|
46 |
|
Total current assets |
|
|
115,299 |
|
|
|
55,362 |
|
Right-of-use
assets |
|
|
600 |
|
|
|
— |
|
Property and
equipment |
|
|
16 |
|
|
|
— |
|
Other long-term
assets |
|
|
33 |
|
|
|
— |
|
Deferred financing
costs |
|
|
— |
|
|
|
876 |
|
Total assets |
|
$ |
115,948 |
|
|
$ |
56,238 |
|
LIABILITIES AND EQUITY |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
|
$ |
891 |
|
|
$ |
1,213 |
|
Accrued research and development expenses |
|
|
1,653 |
|
|
|
916 |
|
Accrued other expenses |
|
|
231 |
|
|
|
845 |
|
Accrued compensation and related expenses |
|
|
918 |
|
|
|
161 |
|
Right-of-use liabilities, current portion |
|
|
328 |
|
|
|
— |
|
Total current liabilities |
|
|
4,021 |
|
|
|
3,135 |
|
Right-of-use liabilities, net of current portion |
|
|
275 |
|
|
|
— |
|
Commitments and contingencies (see Note 9) |
|
|
|
|
Convertible preferred stock: |
|
|
|
|
Series A convertible preferred stock $0.0001 par value; authorized
shares - none and 5,600,000 at Sept. 30, 2021 and Dec. 31, 2020,
respectively; issued and outstanding shares - none and 5,600,000 at
Sept. 30, 2021 and Dec. 31, 2020, respectively; aggregate
liquidation preference – none and $56,000 at Sept. 30, 2021 and
Dec. 31, 2020, respectively |
|
|
— |
|
|
|
55,795 |
|
Stockholders' equity (deficit): |
|
|
— |
|
|
|
Preferred stock, $0.0001 par value; authorized shares - 10,000,000
and none at Sept. 30, 2021 and Dec. 31, 2020, respectively; issued
and outstanding shares - none at Sept. 30, 2021 and Dec. 31,
2020 |
|
|
— |
|
|
|
— |
|
Voting common stock, $0.0001 par value; authorized shares -
300,000,000 and 10,500,000 at Sept. 30, 2021 and Dec. 31, 2020,
respectively; issued and outstanding shares - 13,237,500 and
3,840,540 at Sept. 30, 2021 and Dec. 31, 2020, respectively, both
excluding 348,450 shares subject to repurchase |
|
|
1 |
|
|
|
— |
|
Non-voting common stock, $0.0001 par value; authorized shares -
10,000,000 and none at Sept. 30, 2021 and Dec. 31, 2020,
respectively; issued and outstanding shares - 3,629,400 and none at
Sept. 30, 2021 and Dec. 31, 2020, respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
145,099 |
|
|
|
11,708 |
|
Accumulated other comprehensive loss |
|
|
(24 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(33,424 |
) |
|
|
(14,400 |
) |
Total stockholders' equity (deficit) |
|
|
111,652 |
|
|
|
(2,692 |
) |
Total liabilities, convertible preferred stock and stockholders'
equity (deficit) |
|
$ |
115,948 |
|
|
$ |
56,238 |
|
LONGBOARD PHARMACEUTICALS,
INC.CONDENSED STATEMENTS OF
OPERATIONS(Unaudited)
|
Three Months Ended September 30, |
|
Nine Months Ended |
|
Period fromJanuary 3, 2020 (Inception)
through |
(in thousands, except share and per share
data) |
|
2021 |
|
|
|
2020 |
|
|
September 30, 2021 |
|
September 30, 2020 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
4,093 |
|
|
$ |
1,603 |
|
|
$ |
13,406 |
|
|
$ |
2,462 |
|
General and administrative |
|
2,262 |
|
|
|
947 |
|
|
|
5,639 |
|
|
|
1,829 |
|
Total
operating expenses |
|
6,355 |
|
|
|
2,550 |
|
|
|
19,045 |
|
|
|
4,291 |
|
Loss
from operations |
|
(6,355 |
) |
|
|
(2,550 |
) |
|
|
(19,045 |
) |
|
|
(4,291 |
) |
Interest income, net |
|
23 |
|
|
|
— |
|
|
|
40 |
|
|
|
— |
|
Other expense |
|
(13 |
) |
|
|
— |
|
|
|
(19 |
) |
|
|
— |
|
Net
loss |
$ |
(6,345 |
) |
|
$ |
(2,550 |
) |
|
$ |
(19,024 |
) |
|
$ |
(4,291 |
) |
|
|
|
|
|
|
|
|
Net loss
per share, basic and diluted |
$ |
(0.38 |
) |
|
$ |
(0.66 |
) |
|
$ |
(1.41 |
) |
|
$ |
(1.13 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares outstanding, basic and diluted |
|
16,866,900 |
|
|
|
3,840,540 |
|
|
|
13,538,458 |
|
|
|
3,798,025 |
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
Net
loss |
$ |
(6,345 |
) |
|
$ |
(2,550 |
) |
|
$ |
(19,024 |
) |
|
$ |
(4,291 |
) |
Unrealized gain (loss) on short-term investments, net |
|
10 |
|
|
|
— |
|
|
|
(24 |
) |
|
|
— |
|
Comprehensive loss |
$ |
(6,335 |
) |
|
$ |
(2,550 |
) |
|
$ |
(19,048 |
) |
|
$ |
(4,291 |
) |
Corporate Contact:
Megan E. Knight
Head of Investor Relations
mknight@longboardpharma.com
IR@longboardpharma.com
619.592.9775
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