Longboard Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
Longboard Pharmaceuticals (Nasdaq: LBPH) reported Q3 2024 financial results and corporate updates. Key highlights include the initiation of Phase 3 DEEp SEA Study for bexicaserin in Dravet syndrome, and a positive EMA PDCO opinion for pediatric investigation. The company reported cash and investments of $288.4 million as of September 30, 2024. R&D expenses increased 105% to $21.5 million, while G&A expenses rose 116% to $6.7 million compared to Q3 2023. In October, H. Lundbeck A/S agreed to acquire Longboard in a strategic deal.
Longboard Pharmaceuticals (Nasdaq: LBPH) ha riportato i risultati finanziari e gli aggiornamenti aziendali del terzo trimestre 2024. Tra i punti salienti, l'inizio dello studio di Fase 3 DEEp SEA Study per la bexicaserina nella sindrome di Dravet e un parere positivo dell'EMA PDCO per l'indagine pediatrica. L'azienda ha riportato disponibilità liquide e investimenti pari a $288,4 milioni al 30 settembre 2024. Le spese per ricerca e sviluppo sono aumentate del 105% raggiungendo $21,5 milioni, mentre le spese generali e amministrative sono aumentate del 116% a $6,7 milioni rispetto al terzo trimestre 2023. In ottobre, H. Lundbeck A/S ha concordato di acquisire Longboard in un accordo strategico.
Longboard Pharmaceuticals (Nasdaq: LBPH) reportó los resultados financieros y las actualizaciones corporativas del tercer trimestre de 2024. Los puntos clave incluyen el inicio del estudio de Fase 3 DEEp SEA Study para la bexicaserina en el síndrome de Dravet y una opinión positiva de la EMA PDCO para la investigación pediátrica. La empresa reportó efectivo e inversiones por un total de $288.4 millones a fecha del 30 de septiembre de 2024. Los gastos de I+D aumentaron un 105% a $21.5 millones, mientras que los gastos generales y administrativos aumentaron un 116% a $6.7 millones en comparación con el tercer trimestre de 2023. En octubre, H. Lundbeck A/S acordó adquirir Longboard en un acuerdo estratégico.
롱보드 제약 (Nasdaq: LBPH)이 2024년 3분기 재무 결과 및 기업 업데이트를 보고했습니다. 주요 내용으로는 드라베 증후군에 대한 벡시카세린의 3상 DEEp SEA Study 시작과 소아 임상 조사를 위한 EMA PDCO의 긍정적인 의견이 있습니다. 이 회사는 2024년 9월 30일 기준으로 $288.4 백만의 현금 및 투자를 보고했습니다. 연구개발 비용은 105% 증가하여 $21.5 백만에 도달했으며, 일반 관리 비용은 2023년 3분기 대비 116% 증가한 $6.7 백만으로 나타났습니다. 10월에 H. Lundbeck A/S는 전략적 거래로 롱보드를 인수하기로 합의했습니다.
Longboard Pharmaceuticals (Nasdaq: LBPH) a rapporté les résultats financiers et les mises à jour de l'entreprise pour le troisième trimestre 2024. Les points clés comprennent le lancement de l'étude de phase 3 DEEp SEA Study pour la bexicasérine dans le syndrome de Dravet et un avis positif de l'EMA PDCO concernant l'investigation pédiatrique. L'entreprise a déclaré des liquidités et des investissements de $288,4 millions au 30 septembre 2024. Les dépenses de R&D ont augmenté de 105 % pour atteindre $21,5 millions, tandis que les dépenses générales et administratives ont augmenté de 116 % pour atteindre $6,7 millions par rapport au troisième trimestre 2023. En octobre, H. Lundbeck A/S a accepté d'acquérir Longboard dans le cadre d'un accord stratégique.
Longboard Pharmaceuticals (Nasdaq: LBPH) hat die finanziellen Ergebnisse und Unternehmensaktualisierungen für das dritte Quartal 2024 bekannt gegeben. Zu den wichtigsten Punkten gehört der Beginn der Phase-3-Studie DEEp SEA Study für Bexicaserin bei Dravet-Syndrom und eine positive EMA-PDCO-Stellungnahme zur pädiatrischen Untersuchung. Das Unternehmen berichtete zum 30. September 2024 über liquiden Mittel und Investitionen in Höhe von $288,4 Millionen. Die F&E-Ausgaben stiegen um 105% auf $21,5 Millionen, während die allgemeinen Verwaltungs- und Betriebskosten um 116% auf $6,7 Millionen im Vergleich zum 3. Quartal 2023 anstiegen. Im Oktober stimmte H. Lundbeck A/S einem strategischen Deal zur Übernahme von Longboard zu.
- Strong cash position of $288.4 million
- FDA granted Orphan Drug and Rare Pediatric Disease designations for bexicaserin
- Positive EMA PDCO opinion for pediatric investigation
- Strategic acquisition agreement with H. Lundbeck A/S
- R&D expenses increased 105% to $21.5 million year-over-year
- G&A expenses increased 116% to $6.7 million year-over-year
Insights
The Q3 2024 financial report reveals significant developments at Longboard Pharmaceuticals. The company maintains a strong cash position of
The pending acquisition by H. Lundbeck A/S marks a strategic shift and could provide additional resources for drug development. The increased spending reflects an aggressive push in clinical development, particularly for bexicaserin in Dravet syndrome. The regulatory milestones achieved, including FDA Orphan Drug designation and positive EMA PDCO opinion, enhance the drug's market potential.
The advancement of bexicaserin, a 5-HT2C superagonist, into Phase 3 trials for Dravet syndrome represents a significant milestone. The PACIFIC open-label extension study's interim results showing sustained seizure reduction and favorable safety profile over 9 months are particularly encouraging. The expansion of the treatment age range from 2-65 years, supported by the EMA's positive opinion, substantially broadens the potential patient population.
The dual regulatory designations (Orphan Drug and Rare Pediatric Disease) provide market exclusivity benefits and potential priority review voucher eligibility. These developments, combined with the positive safety profile, position bexicaserin as a promising candidate in the underserved DEE market.
- Positive opinion of Paediatric Investigation Plan for bexicaserin issued by European Medicines Agency (EMA) Paediatric Committee (PDCO) for children down to the age of 2 years
- Recently initiated Phase 3 global clinical trial (the DEEp SEA Study) to evaluate bexicaserin in Dravet syndrome for participants ages 2-65 years
RECENT UPDATES:
- In October, announced an agreement for H. Lundbeck A/S (Lundbeck) to acquire Longboard in a strategic deal
Bexicaserin (LP352), an oral, centrally acting, 5-HT2C superagonist in development for the potential treatment of seizures associated with DEEs
- Initiated Phase 3 global DEEp SEA Study in Dravet syndrome evaluating participants ages 2-65 years
- PACIFIC open-label extension (OLE) interim analysis results continued to demonstrate a sustained, durable response in seizure reduction and a favorable safety and tolerability profile across a broad range of DEEs over an approximate 9-month treatment period
-
U.S. Food and Drug Administration (FDA) granted Orphan Drug designation and Rare Pediatric Disease designation for bexicaserin for the treatment of Dravet syndrome - European Medicines Agency (EMA) Paediatric Committee (PDCO) issued positive opinion of Paediatric Investigation Plan for children down to the age of 2 years
THIRD QUARTER 2024 FINANCIAL RESULTS:
Balance Sheet Highlights
At September 30, 2024, Longboard’s cash, cash equivalents and short-term investments were approximately
Operating Results
Research and development expenses were
General and administrative expenses were
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 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. Bexicaserin (LP352), an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, with no observed impact on 5-HT2B and 5-HT2A receptor subtypes, is being evaluated in a global Phase 3 clinical program (the DEEp Program). The FDA has granted Breakthrough Therapy designation for bexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age and older.
Bexicaserin is an investigational compound that is not approved for marketing by the FDA or any other regulatory authority.
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 “plan”, “focused on”, “potential”, “working to”, “designed to”, the negative, plural or other tenses of these words, references to future dates or time periods, or other comparable language, and they may include, without limitation, statements about the following: the pending acquisition of Longboard by Lundbeck; Longboard’s clinical and preclinical product candidates, including plans, study design, enrollment and timing of study initiation of the global Phase 3 program for bexicaserin, bexicaserin’s potential, design and characteristics; 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 the satisfaction or waiver of the conditions to closing the proposed acquisition of Longboard by Lundbeck (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including the possibility that the proposed acquisition does not close; 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; the standard for Breakthrough Therapy designation is not the same as the standard for drug approval, the clinical evidence supporting Breakthrough Therapy designation is preliminary, and not all drugs designated as Breakthrough Therapies ultimately will be shown to have substantial improvement over available therapies; the FDA may later decide to rescind a Breakthrough Therapy designation if it determines the designation is no longer supported by subsequent data; Longboard’s product candidates are in a lengthy research and development process, the timing, manner and outcome of research, development and regulatory review is uncertain, and Longboard’s product candidates, including bexicaserin, may not advance in research or development or be approved for marketing; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; topline or interim data may not accurately reflect the complete results of a particular study or trial and remain subject to audit, and final data may differ materially from topline or interim data; risks related to the development and commercialization of Longboard’s product candidates; enrolling participants in clinical trials is competitive and challenging; 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; 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.
LONGBOARD PHARMACEUTICALS, INC. CONDENSED BALANCE SHEETS (unaudited) |
||||||||
|
|
September 30, |
|
|
December 31, |
|
||
(in thousands, except share and per share data) |
|
2024 |
|
|
2023 |
|
||
ASSETS |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
27,610 |
|
|
$ |
14,331 |
|
Short-term investments |
|
|
260,836 |
|
|
|
34,167 |
|
Prepaid expenses and other current assets |
|
|
4,584 |
|
|
|
1,723 |
|
Total current assets |
|
|
293,030 |
|
|
|
50,221 |
|
Right-of-use assets |
|
|
3,731 |
|
|
|
472 |
|
Property and equipment |
|
|
— |
|
|
|
4 |
|
Other long-term assets |
|
|
244 |
|
|
|
— |
|
Total assets |
|
$ |
297,005 |
|
|
$ |
50,697 |
|
LIABILITIES AND EQUITY |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
1,132 |
|
|
$ |
1,001 |
|
Accrued research and development expenses |
|
|
10,896 |
|
|
|
4,556 |
|
Accrued compensation and related expenses |
|
|
4,163 |
|
|
|
3,374 |
|
Accrued other expenses |
|
|
1,894 |
|
|
|
368 |
|
Right-of-use liabilities, current portion |
|
|
267 |
|
|
|
475 |
|
Total current liabilities |
|
|
18,352 |
|
|
|
9,774 |
|
Right-of-use liabilities, net of current portion |
|
|
3,467 |
|
|
|
— |
|
Commitments and contingencies |
|
|
|
|
|
|
||
Stockholders' equity: |
|
|
|
|
|
|
||
Preferred stock, |
|
|
— |
|
|
|
— |
|
Voting common stock, |
|
|
3 |
|
|
|
2 |
|
Non-voting common stock, |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
476,358 |
|
|
|
181,563 |
|
Accumulated other comprehensive income (loss) |
|
|
700 |
|
|
|
(78 |
) |
Accumulated deficit |
|
|
(201,875 |
) |
|
|
(140,564 |
) |
Total stockholders' equity |
|
|
275,186 |
|
|
|
40,923 |
|
Total liabilities and stockholders' equity |
|
$ |
297,005 |
|
|
$ |
50,697 |
|
LONGBOARD PHARMACEUTICALS, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) |
||||||||||||||||
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||||||
(in thousands, except share and per share data) |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||||||
Operating expenses: |
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
$ |
21,450 |
|
|
$ |
10,488 |
|
|
$ |
55,065 |
|
|
$ |
31,554 |
|
General and administrative |
|
|
6,674 |
|
|
|
3,094 |
|
|
|
16,812 |
|
|
|
9,632 |
|
Total operating expenses |
|
|
28,124 |
|
|
|
13,582 |
|
|
|
71,877 |
|
|
|
41,186 |
|
Loss from operations |
|
|
(28,124 |
) |
|
|
(13,582 |
) |
|
|
(71,877 |
) |
|
|
(41,186 |
) |
Interest income, net |
|
|
3,655 |
|
|
|
662 |
|
|
|
10,693 |
|
|
|
1,838 |
|
Other expense |
|
|
(71 |
) |
|
|
(14 |
) |
|
|
(127 |
) |
|
|
(41 |
) |
Net loss |
|
$ |
(24,540 |
) |
|
$ |
(12,934 |
) |
|
$ |
(61,311 |
) |
|
$ |
(39,389 |
) |
|
|
|
|
|
|
|
|
|
||||||||
Net loss per share, basic and diluted |
|
$ |
(0.63 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.63 |
) |
|
$ |
(1.77 |
) |
|
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares outstanding, basic and diluted |
|
|
38,957,524 |
|
|
|
23,487,457 |
|
|
|
37,724,402 |
|
|
|
22,299,998 |
|
|
|
|
|
|
|
|
|
|
||||||||
Comprehensive loss: |
|
|
|
|
|
|
|
|
||||||||
Net loss |
|
$ |
(24,540 |
) |
|
$ |
(12,934 |
) |
|
$ |
(61,311 |
) |
|
$ |
(39,389 |
) |
Unrealized gain on short-term investments |
|
|
1,175 |
|
|
|
109 |
|
|
|
778 |
|
|
|
511 |
|
Comprehensive loss |
|
$ |
(23,365 |
) |
|
$ |
(12,825 |
) |
|
$ |
(60,533 |
) |
|
$ |
(38,878 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241107787183/en/
CORPORATE CONTACT:
Megan E. Knight
VP, Head of Investor Relations
IR@longboardpharma.com
858.789.9283
Source: Longboard Pharmaceuticals, Inc.
FAQ
What was LBPH's cash position in Q3 2024?
How much did LBPH's R&D expenses increase in Q3 2024?
What regulatory designations did bexicaserin receive for Dravet syndrome?