LBPH - Longboard Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2022 Financial Results
- LP352 Phase 1b/2a PACIFIC Study in participants with a range of developmental and epileptic encephalopathies (DEEs) ages 12-65 on track for topline data in second half 2023
- Phase 1 open-label study to assess central nervous system (CNS) pharmacokinetics (PK) and pharmacodynamics (PD) of LP352 in healthy volunteers; data on track for fourth quarter 2022
- Pre-investigational new drug (IND) meeting with the FDA to finalize details regarding the clinical development plan for use of LP659 in rare neuroinflammatory indications scheduled in fourth quarter 2022
- Expected cash runway into 2024
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, 2022.
“We remain on track to complete the PACIFIC Study in the second half of 2023, with a hands-on approach to site activation and engagement. Importantly, we continue to support interactions between the experts at the Epilepsy Study Consortium and sites to optimize clinical trial methodology, seizure identification and diagnostic review training in order to facilitate recruitment,” stated Kevin R. Lind, Longboard’s President and Chief Executive Officer. “For LP659, we are excited about the promise of a differentiated, next generation, oral, selective, centrally acting S1P receptor modulator for the treatment of rare neuroinflammatory indications and look forward to our upcoming discussion with regulators.”
Pipeline 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 topline data in the second half of 2023.
- Multiple clinical and preclinical studies are in process to further elucidate the intrinsic PK/PD properties and support clinical development in a broad range of refractory epilepsies.
- LP659, an oral, selective, centrally acting S1P receptor modulator, for which we have a pre-IND meeting scheduled with the FDA in the fourth quarter of 2022.
Third Quarter 2022 Financial Results:
Balance Sheet Highlights
At September 30, 2022, Longboard’s cash, cash equivalents and short-term investments were approximately $77.3 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 $9.4 million for the three months ended September 30, 2022, an increase of $5.3 million compared to $4.1 million for the three months ended September 30, 2021. The net increase of $5.3 million is primarily related to increases of $4.6 million in clinical trial and preclinical expenses related to LP352, $0.9 million in personnel-related expenses, and $0.2 million in preclinical expenses related to LP659 and LP143.
General and administrative (G&A) expenses were $2.5 million for the three months ended September 30, 2022, an increase of $0.2 million compared to $2.3 million for the three months ended September 30, 2021. The net increase of $0.2 million is primarily related to an increase in personnel-related costs.
Net loss was $11.6 million, or $0.68 per share, for the three months ended September 30, 2022 compared to $6.3 million, or $0.38 per share, for the three months ended September 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 for”, “scheduled”, “expected”, “potential”, “plan”, “focused on”, “promise” and “look forward”, and include, without limitation, statements about the following: Longboard’s clinical and preclinical product candidates and programs, including the timing of the completion of clinical trials and availability of data, potential treatments and indications, clinical trials plans and activities, and regulatory meetings and interactions and their timing; our cash position or expected cash runway; the promise of our drug candidates and 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 continuing development or marketing; the regulatory process of the FDA and comparable foreign authorities is lengthy, time consuming and inherently unpredictable; 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.
| LONGBOARD PHARMACEUTICALS, INC. CONDENSED BALANCE SHEETS (Unaudited) |
|
|
|
|
| September 30, |
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| December 31, |
| (in thousands, except share and per share data) |
|
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| 2022 |
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| 2021 |
| ASSETS |
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|
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|
|
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| Current assets: |
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|
|
|
|
|
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| Cash and cash equivalents |
|
|
| $ |
| 18,745 |
|
|
|
|
| $ |
| 66,346 |
|
|
| Short-term investments |
|
|
|
|
| 58,574 |
|
|
|
|
|
|
| 40,379 |
|
|
| Prepaid expenses and other current assets |
|
|
|
|
| 2,473 |
|
|
|
|
|
|
| 1,659 |
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| Total current assets |
|
|
|
|
| 79,792 |
|
|
|
|
|
|
| 108,384 |
|
|
| Right-of-use assets |
|
|
|
|
| 824 |
|
|
|
|
|
|
| 521 |
|
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| Property and equipment |
|
|
|
|
| 10 |
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|
|
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|
|
| 14 |
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| Other long-term assets |
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|
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| 33 |
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|
|
|
|
| 33 |
|
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| Total assets |
|
|
| $ |
| 80,659 |
|
|
|
|
| $ |
| 108,952 |
|
|
| LIABILITIES AND EQUITY |
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|
|
|
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| Current liabilities: |
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|
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| Accounts payable |
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| $ |
| 575 |
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|
|
|
| $ |
| 1,028 |
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|
| Accrued research and development expenses |
|
|
|
|
| 4,800 |
|
|
|
|
|
|
| 2,245 |
|
|
| Accrued compensation and related expenses |
|
|
|
|
| 1,589 |
|
|
|
|
|
|
| 1,480 |
|
|
| Accrued other expenses |
|
|
|
|
| 829 |
|
|
|
|
|
|
| 352 |
|
|
| Right-of-use liabilities, current portion |
|
|
|
|
| 360 |
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|
|
|
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| 339 |
|
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| Total current liabilities |
|
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|
|
| 8,153 |
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|
|
|
|
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| 5,444 |
|
|
| Right-of-use liabilities, net of current portion |
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|
|
| 469 |
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|
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|
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| 185 |
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| Commitments and contingencies |
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| Stockholders' equity: |
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| Preferred stock, $0.0001 par value; authorized shares - 10,000,000 at September 30, 2022 and December 31, 2021; issued and outstanding shares - none at September 30, 2022 and December 31, 2021 |
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|
|
| — |
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|
|
|
|
|
| — |
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| Voting common stock, $0.0001 par value; authorized shares - 300,000,000 at September 30, 2022 and December 31, 2021; issued and outstanding shares - 13,571,423 and 13,440,761 at September 30, 2022 and December 31, 2021, respectively, excluding 14,527 and 145,189, respectively, subject to repurchase |
|
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|
|
| 1 |
|
|
|
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|
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| 1 |
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| Non-voting common stock, $0.0001 par value; authorized shares - 10,000,000 at September 30, 2022 and December 31, 2021; issued and outstanding shares - 3,629,400 at September 30, 2022 and December 31, 2021 |
|
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|
|
| — |
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|
|
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|
|
| — |
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| Additional paid-in capital |
|
|
|
|
| 147,748 |
|
|
|
|
|
|
| 145,683 |
|
|
| Accumulated other comprehensive loss |
|
|
|
|
| (915 |
| ) |
|
|
|
|
| (164 |
| ) |
| Accumulated deficit |
|
|
|
|
| (74,797 |
| ) |
|
|
|
|
| (42,197 |
| ) |
| Total stockholders' equity |
|
|
|
|
| 72,037 |
|
|
|
|
|
|
| 103,323 |
|
|
| Total liabilities and stockholders' equity |
|
|
| $ |
| 80,659 |
|
|
|
|
| $ |
| 108,952 |
|
|
| LONGBOARD PHARMACEUTICALS, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) |
|
|
| Three Months Ended September 30, |
|
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| Nine Months Ended September 30, |
| (in thousands, except share and per share data) |
| 2022 |
|
|
| 2021 |
|
|
| 2022 |
|
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| 2021 |
| Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Research and development |
| $ |
| 9,403 |
|
|
|
|
| $ |
| 4,093 |
|
|
|
|
| $ |
| 25,445 |
|
|
|
|
| $ |
| 13,406 |
|
|
| General and administrative |
|
|
| 2,481 |
|
|
|
|
|
|
| 2,262 |
|
|
|
|
|
|
| 7,626 |
|
|
|
|
|
|
| 5,639 |
|
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| Total operating expenses |
|
|
| 11,884 |
|
|
|
|
|
|
| 6,355 |
|
|
|
|
|
|
| 33,071 |
|
|
|
|
|
|
| 19,045 |
|
|
| Loss from operations |
|
|
| (11,884 |
| ) |
|
|
|
|
| (6,355 |
| ) |
|
|
|
|
| (33,071 |
| ) |
|
|
|
|
| (19,045 |
| ) |
| Interest income, net |
|
|
| 287 |
|
|
|
|
|
|
| 23 |
|
|
|
|
|
|
| 446 |
|
|
|
|
|
|
| 40 |
|
|
| Other income (expense) |
|
|
| 1 |
|
|
|
|
|
|
| (13 |
| ) |
|
|
|
|
| 25 |
|
|
|
|
|
|
| (19 |
| ) |
| Net loss |
| $ |
| (11,596 |
| ) |
|
|
| $ |
| (6,345 |
| ) |
|
|
| $ |
| (32,600 |
| ) |
|
|
| $ |
| (19,024 |
| ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net loss per share, basic and diluted |
| $ |
| (0.68 |
| ) |
|
|
| $ |
| (0.38 |
| ) |
|
|
| $ |
| (1.90 |
| ) |
|
|
| $ |
| (1.41 |
| ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted-average shares outstanding, basic and diluted |
|
|
| 17,173,838 |
|
|
|
|
|
|
| 16,866,900 |
|
|
|
|
|
|
| 17,130,573 |
|
|
|
|
|
|
| 13,538,458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net loss |
| $ |
| (11,596 |
| ) |
|
|
| $ |
| (6,345 |
| ) |
|
|
| $ |
| (32,600 |
| ) |
|
|
| $ |
| (19,024 |
| ) |
| Unrealized (loss) gain on short-term investments |
|
|
| (131 |
| ) |
|
|
|
|
| 10 |
|
|
|
|
|
|
| (751 |
| ) |
|
|
|
|
| (24 |
| ) |
| Comprehensive loss |
| $ |
| (11,727 |
| ) |
|
|
| $ |
| (6,335 |
| ) |
|
|
| $ |
| (33,351 |
| ) |
|
|
| $ |
| (19,048 |
| ) |
|
|
|
|
|
|
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|
View source version on businesswire.com: https://www.businesswire.com/news/home/20221103005447/en/
Megan E. Knight
Head of Investor Relations
IR@longboardpharma.com
619.592.9775