Longboard Pharmaceuticals(LBPH)
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Longboard Pharmaceuticals(LBPH) - 2024 Q2 - Earnings Call Transcript
2024-08-04 17:39
Financial Data and Key Metrics Changes - The company ended Q2 2024 with approximately $305 million in cash and investments, reflecting a cash burn of about $19 million for the quarter [21] - Q2 expenses were higher than Q1 due to increased R&D activities primarily related to Bexicaserincaserin and a smaller amount for LP659 [21][22] Business Line Data and Key Metrics Changes - Bexicaserincaserin achieved a median reduction of countable motor seizures of approximately 60% in highly refractory participants [5] - The PACIFIC study demonstrated a sustained response over an approximate six-month period with continued favorable safety and tolerability [6][7] Market Data and Key Metrics Changes - The market for S1P receptor modulators is substantial, with existing treatments generating significant revenue in CNS applications, primarily in multiple sclerosis [9] - The company is preparing to initiate its Phase 3 program for Bexicaserincaserin, which will include pivotal studies for Dravet syndrome and other DEEs [7] Company Strategy and Development Direction - The company is committed to addressing the unmet medical needs for patients with DEEs and is moving forward with a global Phase 3 program [6][7] - LP659 is positioned as a next-generation S1P receptor modulator targeting CNS-related diseases with greater precision [14] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the breakthrough therapy designation for Bexicaserincaserin, indicating a significant opportunity to address a large patient population [5][6] - The company plans to continue building its organization and infrastructure to support the global Phase 3 program for Bexicaserincaserin [22] Other Important Information - The Phase 1 SAD trial for LP659 demonstrated a favorable safety profile, with no serious adverse events reported [17] - The company is evaluating the risk-reward of additional studies for both programs to ensure efficient use of resources [23] Q&A Session Summary Question: Can you expand on the sizing of the Bexicaserincaserin pivotal programs? - Management indicated that they will provide a full disclosure of the plans during the R&D day scheduled for September 16 [25] Question: What is the market opportunity for DEEs? - Management believes the market is very large and is excited about the opportunity to address patients who lack access to the latest clinical trials and standard of care [27] Question: What formulations will be tested in the MAD study for LP659? - Management confirmed that formulation two is the path forward for the MAD study, as it shows better plasma absorption and less variability [28] Question: What is the status of discussions with global regulators regarding DEE? - Management stated that discussions with global regulatory authorities have been initiated and are expected to proceed positively [31] Question: What is the overall safety profile of LP659 compared to other S1P molecules? - Management noted that no abnormalities were observed in other organ systems typically seen with S1P modulators, but monitoring will continue [42]
Longboard Pharmaceuticals(LBPH) - 2024 Q2 - Quarterly Report
2024-08-01 20:20
Financial Performance - The company reported net losses of $21.8 million for Q2 2024, compared to $15.0 million for Q2 2023, reflecting a 45% increase in losses year-over-year[77]. - The total operating expenses for Q2 2024 were $25.6 million, up from $15.6 million in Q2 2023, marking a 64% increase[88]. - The company has incurred an accumulated deficit of $177.3 million as of June 30, 2024, indicating ongoing financial challenges[77]. - The company anticipates continuing to incur net losses for the foreseeable future, with existing cash expected to fund operations for at least the next 12 months[97]. Research and Development - Research and development expenses for Q2 2024 were $20.4 million, a 63% increase from $12.5 million in Q2 2023, primarily due to increased clinical trial costs for bexicaserin and LP659[89]. - Research and development expenses for the first half of 2024 totaled $33.6 million, a 60% increase from $21.1 million in the same period of 2023[90]. - Bexicaserin (LP352) is in the planning stages for a global Phase 3 program, expected to initiate later in 2024, following positive Phase 1b/2a trial results[75]. - As of June 30, 2024, a hypothetical 10.0 percent increase in accrued research and development expenses would have resulted in an increase to the net loss of approximately $0.9 million[111]. Cash and Financing - The company had cash, cash equivalents, and short-term investments of $304.9 million as of June 30, 2024, sufficient to fund operations for at least the next 12 months[76]. - The company raised approximately $241.5 million from a follow-on public offering in January 2024, contributing to its financial resources[76]. - The company raised $241.5 million in a follow-on public offering in January 2024, issuing 11,500,000 shares at a public offering price of $21.00 per share, resulting in net proceeds of $226.5 million after expenses[94]. - Net cash used in operating activities for the six months ended June 30, 2024, was $34.3 million, compared to $26.6 million for the same period in 2023, primarily due to a net loss of $36.8 million[103]. - Net cash used in investing activities was $251.6 million for the six months ended June 30, 2024, primarily due to $354.0 million in short-term investment purchases[104]. - Net cash provided by financing activities was $286.4 million for the six months ended June 30, 2024, significantly higher than $21.2 million for the same period in 2023[105]. - The company has incurred negative cash flows from operations since inception and may need substantial additional financing to support ongoing operations and product development[100]. Company Classification - The company will cease to be an emerging growth company effective December 31, 2024, as the market value of its common stock held by non-affiliates exceeded $700.0 million[114]. - The company is classified as a smaller reporting company and is not required to provide the information required by this item[116]. Administrative Expenses - General and administrative expenses rose to $5.2 million in Q2 2024, a 67% increase compared to $3.1 million in Q2 2023, driven by higher personnel-related costs[91].
Longboard Pharmaceuticals (LBPH) Is a Great Choice for 'Trend' Investors, Here's Why
ZACKS· 2024-07-25 13:50
Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it. The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock alive. Inv ...
Longboard Pharmaceuticals (LBPH) is on the Move, Here's Why the Trend Could be Sustainable
ZACKS· 2024-07-09 13:51
When it comes to short-term investing or trading, they say "the trend is your friend." And there's no denying that this is the most profitable strategy. But making sure of the sustainability of a trend to profit from it is easier said than done. Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate re ...
Longboard (LBPH) Up 14% as Epilepsy Drug Gets Breakthrough Tag
ZACKS· 2024-07-02 14:26
Longboard Pharmaceuticals (LBPH) gained 14.4% on Jul 1 after it announced that the FDA has granted Breakthrough Therapy designation for its investigational drug, bexicaserin, to treat seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients aged two years or older. The FDA's Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence sugge ...
Longboard Pharmaceuticals(LBPH) - 2024 Q1 - Quarterly Report
2024-05-02 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to ___________ Commission File Number: 001-40192 Longboard Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware ...
Longboard Pharmaceuticals(LBPH) - 2024 Q1 - Quarterly Results
2024-05-02 20:10
"I am extremely encouraged by the totality of the bexicaserin data generated to date. The recently presented late-breaking data from the PACIFIC Study at AAN continues to support the potential of bexicaserin as a best- in-class and differentiated 5-HT2C agonist across a range of DEEs," stated Kevin R. Lind, Longboard's President and Chief Executive Officer. "We are pleased to have this compelling data set for our End of Phase 2 meeting with FDA and we look forward to initiating our global Phase 3 program be ...
Longboard Pharmaceuticals(LBPH) - 2023 Q4 - Annual Report
2024-03-12 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40192 4275 Executive Square, Suite 950 La Jolla, CA 92037 (Address of principal executive offices) (Zip Code) Identification No.) Reg ...
Longboard Pharmaceuticals(LBPH) - 2023 Q4 - Annual Results
2024-03-12 20:10
Exhibit 99.1 Longboard Pharmaceuticals Reports Full Year 2023 Financial Results and Provides Corporate Updates LA JOLLA, Calif., March 12, 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 full year 2023 financial results. "I am extremely proud of what our team has accomplished starting with the immense effort that went into the PACIF ...
Longboard Pharmaceuticals(LBPH) - 2023 Q3 - Quarterly Report
2023-11-02 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to ___________ Commission File Number: 001-40192 Longboard Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaw ...