Longboard Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2023 Financial Results
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LP352 Phase 1b/2a PACIFIC Study enrollment completed in
August 2023 with topline data on track forJanuary 2024 - LP659 first-in-human Phase 1 single-ascending dose (SAD) study initiation expected Q4 2023, with topline data expected in the first half 2024
“We look forward to PACIFIC Study topline data in
“We are also excited to expand our clinical-stage pipeline with LP659, our oral, centrally acting, highly selective S1P receptor modulator, moving into the clinic in the coming weeks. We look forward to Phase 1 SAD data in the first half of 2024,” stated
RECENT AND UPCOMING HIGHLIGHTS
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LP352, an oral, centrally acting, 5-HT2C superagonist in development for the potential treatment of seizures associated with DEEs
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In
August 2023 , we completed enrollment of the PACIFIC Study, with 52 participants with a broad range of DEEs including Lennox-Gastaut syndrome (29), Dravet syndrome (4), and other DEEs (19) -
Topline PACIFIC Study data expected in
January 2024
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In
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LP659, an oral, centrally acting, S1P receptor subtypes 1 and 5 (S1P1,5) modulator in development for rare neuroinflammatory conditions
- Initiating the SAD Phase 1 study in Q4 2023, with topline data expected in 1H 2024
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Investor & Analyst Event: In
October 2023 , we hosted our first Investor & Analyst Event highlighting the DEE landscape and commercial opportunity for LP352.-
Two thought leaders in the DEE space,
Dennis Dlugos , MD, MSCE, pediatric neurologist atChildren's Hospital of Philadelphia , and Gabrielle Conecker, MPH, Executive Director & Co-Founder of Decoding Developmental Epilepsies, joined Longboard’s leadership team to discuss the significant unmet medical need in the DEE landscape and how LP352 could be an attractive treatment option in this population. - An archived recording of the presentation is available here
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Two thought leaders in the DEE space,
-
American
Epilepsy Society (AES) Annual Meeting: InDecember 2023 , we are presenting new posters related to LP352 and the Longboard executive leadership and clinical development teams are hosting a scientific exhibit featuring these new data as well as encore presentations.
THIRD QUARTER 2023 FINANCIAL RESULTS:
Balance Sheet Highlights
At
Operating Results
Research and development expenses were
General and administrative expenses were
ABOUT
THE PACIFIC STUDY
The PACIFIC Study is a Phase 1b/2a clinical trial evaluating participants with Developmental and Epileptic Encephalopathies (DEEs). The primary objectives of the study are to assess the safety and tolerability of LP352. The PACIFIC Study will also evaluate change in seizure frequency over the treatment period. The study enrolled 52 participants with a variety of treatment resistant seizures that fall into the category of DEEs across approximately 30 study sites in
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”, “January 2024”, “expect”, “Q4 2023”, “first half 2024”, “focus”, “look forward”, “excited to”, “the coming weeks”, “potential”, “opportunity”, “could”, “December 2023”, “fourth quarter 2024”, “working to”, “designed to”, “will”, “plan”, or the negative, plural or other tenses of these words or other comparable language, and they may include, without limitation, statements about the following: Longboard’s clinical and preclinical product candidates and programs, including their advancement (including plans for a potential Phase 3 program for LP352), timing of study initiation, timing of completing enrollment, timing of topline data, number of study sites, number and characteristics of study participants, their potential (including to be transformative, best-in-class, clinically meaningful or highly selective, the number and type of conditions they may address and their commercial opportunity), and their design and characteristics; upcoming presentations; Longboard’s cash position, expenses and runway to support operations; and Longboard’s focus and work. 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 those stated or implied by Longboard’s 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; PACIFIC Study participants’ diagnoses are as of time of screening and are subject to change; macroeconomic events stemming from the COVID-19 pandemic or evolving geopolitical developments such as the conflicts in
CONDENSED BALANCE SHEETS (Unaudited) |
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(in thousands, except share and per share data) |
|
2023 |
|
2022 |
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ASSETS |
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|
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Current assets: |
|
|
|
|
||
Cash and cash equivalents |
|
$ |
23,910 |
|
$ |
10,775 |
Short-term investments |
|
|
32,106 |
|
|
56,814 |
Prepaid expenses and other current assets |
|
|
2,307 |
|
|
2,249 |
Total current assets |
|
|
58,323 |
|
|
69,838 |
Right-of-use assets |
|
|
500 |
|
|
736 |
Property and equipment |
|
|
5 |
|
|
9 |
Other long-term assets |
|
|
36 |
|
|
33 |
Total assets |
|
$ |
58,864 |
|
$ |
70,616 |
LIABILITIES AND EQUITY |
|
|
|
|
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Current liabilities: |
|
|
|
|
||
Accounts payable |
|
$ |
363 |
|
$ |
1,310 |
Accrued research and development expenses |
|
|
3,652 |
|
|
4,168 |
Accrued compensation and related expenses |
|
|
1,819 |
|
|
2,438 |
Accrued other expenses |
|
|
484 |
|
|
490 |
Right-of-use liabilities, current portion |
|
|
394 |
|
|
358 |
Total current liabilities |
|
|
6,712 |
|
|
8,764 |
Right-of-use liabilities, net of current portion |
|
|
108 |
|
|
382 |
Commitments and contingencies |
|
|
|
|
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Stockholders' equity: |
|
|
|
|
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Preferred stock, |
|
|
— |
|
|
— |
Voting common stock, |
|
|
2 |
|
|
1 |
Non-voting common stock, |
|
|
— |
|
|
— |
Additional paid-in capital |
|
|
177,754 |
|
|
148,303 |
Accumulated other comprehensive loss |
|
|
(181) |
|
|
(692) |
Accumulated deficit |
|
|
(125,531) |
|
|
(86,142) |
Total stockholders' equity |
|
|
52,044 |
|
|
61,470 |
Total liabilities and stockholders' equity |
|
$ |
58,864 |
|
$ |
70,616 |
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) |
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|
Three Months Ended |
|
Nine Months Ended |
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(in thousands, except share and per share data) |
|
2023 |
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2022 |
|
2023 |
|
2022 |
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Operating expenses: |
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
10,488 |
|
$ |
9,403 |
|
$ |
31,554 |
|
$ |
25,445 |
General and administrative |
|
|
3,094 |
|
|
2,481 |
|
|
9,632 |
|
|
7,626 |
Total operating expenses |
|
|
13,582 |
|
|
11,884 |
|
|
41,186 |
|
|
33,071 |
Loss from operations |
|
|
(13,582) |
|
|
(11,884) |
|
|
(41,186) |
|
|
(33,071) |
Interest income, net |
|
|
662 |
|
|
287 |
|
|
1,838 |
|
|
446 |
Other income (expense) |
|
|
(14) |
|
|
1 |
|
|
(41) |
|
|
25 |
Net loss |
|
$ |
(12,934) |
|
$ |
(11,596) |
|
$ |
(39,389) |
|
$ |
(32,600) |
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|
|
|
|
|
|
|
|
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Net loss per share, basic and diluted |
|
$ |
(0.55) |
|
$ |
(0.68) |
|
$ |
(1.77) |
|
$ |
(1.90) |
|
|
|
|
|
|
|
|
|
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Weighted-average shares outstanding, basic and diluted |
|
|
23,487,457 |
|
|
17,173,838 |
|
|
22,299,998 |
|
|
17,130,573 |
|
|
|
|
|
|
|
|
|
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Comprehensive loss: |
|
|
|
|
|
|
|
|
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Net loss |
|
$ |
(12,934) |
|
$ |
(11,596) |
|
$ |
(39,389) |
|
$ |
(32,600) |
Unrealized gain (loss) on short-term investments |
|
|
109 |
|
|
(131) |
|
|
511 |
|
|
(751) |
Comprehensive loss |
|
$ |
(12,825) |
|
$ |
(11,727) |
|
$ |
(38,878) |
|
$ |
(33,351) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20231102233407/en/
Head of Investor Relations
IR@longboardpharma.com
858.789.9283
Source: