Core Viewpoint - U.S. stock futures are up, with Dow futures increasing by over 300 points, while shares of Cassava Sciences fell sharply after disappointing Phase 3 study results for Simufilam in Alzheimer's patients [1]. Company Summaries - Cassava Sciences, Inc. experienced a significant decline in share price, dropping 85.6% to $3.82 in pre-market trading following the announcement that Simufilam did not show a significant reduction in cognitive decline compared to placebo in the ReThink-ALZ Phase 3 study [2][1]. - Centessa Pharmaceuticals PLC saw its shares tumble 12% to $15.00 in pre-market trading after reporting a quarterly loss of $0.37 per share [4]. - Biohaven Ltd. shares fell 11% to $40.60 after the treatment arm of the RESILIENT SMA study did not statistically separate from the placebo group at Week 48 [4]. - ZIM Integrated Shipping Services Ltd. shares dipped 6.9% to $22.15 despite reporting better-than-expected third-quarter financial results and raising FY24 adjusted EBIT and EBITDA guidance [4]. - i3 Verticals, Inc. shares declined 6.6% to $22.11 after posting disappointing quarterly results [4]. - ChromaDex Corporation shares fell 5.9% to $7.00 in pre-market trading [4]. - Fitell Corporation shares declined 4.9% to $24.00 after gaining around 6% on the previous trading day [4]. - Logility Supply Chain Solutions, Inc. shares fell 4.4% to $9.31 after reporting worse-than-expected second-quarter revenue results and issuing FY25 revenue guidance below estimates [4]. - Kingsoft Cloud Holdings Limited shares fell 4.3% to $6.90 after a significant jump of around 25% on the previous trading day, despite reporting a fiscal third-quarter 2024 revenue of 1.89 billion Chinese yuan ($268.7 million), which was up 16.0% year-on-year and exceeded analyst expectations [4].

Financial Performance - The company reported a net loss of $160.3 million, or $1.70 per share, for Q3 2024, compared to a net loss of $102.6 million, or $1.50 per share, for the same period in 2023[12]. - Total operating expenses for Q3 2024 were $178,168,000, a 61.2% increase from $110,547,000 in Q3 2023[17]. - Non-GAAP adjusted net loss for Q3 2024 was $164,134,000, compared to $98,118,000 in Q3 2023, indicating a 67.1% increase[21]. - The company reported a non-GAAP adjusted net loss per share of $1.74 for Q3 2024, compared to $1.44 for Q3 2023[21]. - The net loss for Q3 2024 was $160,304,000, compared to a net loss of $102,574,000 in Q3 2023, representing a 56.3% increase in losses[17]. Cash and Assets - As of October 2, 2024, the company reported cash, cash equivalents, marketable securities, and restricted cash totaling approximately $642 million[1]. - Cash and cash equivalents decreased to $84,390,000 as of September 30, 2024, down from $248,402,000 at the end of 2023[18]. - Total assets as of September 30, 2024, were $510,523,000, slightly down from $513,212,000 at the end of 2023[19]. - The accumulated deficit grew to $1,158,871,000 as of September 30, 2024, up from $499,292,000 at the end of 2023[20]. - Current liabilities increased significantly to $152,294,000 in Q3 2024, compared to $55,423,000 at the end of 2023[19]. - The number of outstanding shares increased to 1,381,699 as of September 30, 2024, from 887,528 at the end of 2023[20]. Research and Development - Research and Development (R&D) expenses for Q3 2024 were $157.6 million, an increase of $62.1 million compared to $95.5 million in Q3 2023, driven by advancing clinical trials[9]. - Research and development expenses rose to $157,607,000 in Q3 2024, compared to $95,517,000 in Q3 2023, reflecting a 65% increase[17]. - The company anticipates submitting a total of 4 Investigational New Drug (IND) applications in 2024 as part of its MoDE™ platform[8]. - The pivotal trial for troriluzole in spinocerebellar ataxia (SCA) achieved positive topline results, demonstrating a 50-70% slowing of disease progression, equating to a delay of 1.5-2.2 years over the 3-year study period[4]. - The company plans to submit a New Drug Application (NDA) for troriluzole to the FDA in 4Q 2024, following the positive trial results[4]. - The company initiated a Phase 2 trial for BHV-2100 in the acute treatment of migraine, with an expected enrollment of approximately 575 patients across 60 sites in the U.S.[5]. - Upcoming milestones include topline data from the Phase 3 trial of taldefgrobep alfa in spinal muscular atrophy (SMA) expected in 4Q 2024[7]. Expenses - General and Administrative (G&A) expenses for Q3 2024 were $20.6 million, up from $15.0 million in Q3 2023, reflecting increased non-cash share-based compensation[10].

Financial Performance - Total operating expenses for Q3 2024 were $178.168 million, a 61.3% increase from $110.547 million in Q3 2023[11]. - Research and development expenses increased to $157.607 million in Q3 2024, compared to $95.517 million in Q3 2023, reflecting a 65% rise[11]. - Net loss for Q3 2024 was $160.304 million, compared to a net loss of $102.574 million in Q3 2023, representing a 56.3% increase[11]. - Cash used in operating activities for the nine months ended September 30, 2024, was $411.711 million, compared to $216.844 million for the same period in 2023, a 90% increase[14]. - The company expects to continue generating operating losses for the foreseeable future, indicating ongoing financial challenges[22]. Shareholder Equity and Shares - The weighted average common shares outstanding increased to 94,372,159 in Q3 2024 from 68,320,125 in Q3 2023, indicating a 38.2% increase[11]. - As of September 30, 2024, total shareholders' equity was $316,006, a decrease from $427,975 as of December 31, 2023, reflecting a net loss of $179,504 for the three months ended September 30, 2024[75]. - The company raised approximately $247,830 from a public offering of 6,451,220 common shares at $41.00 per share on April 22, 2024, and approximately $269,935 from another offering of 6,052,631 shares at $47.50 per share on October 2, 2024[82][83]. - The company issued 1,872,874 shares to Knopp, valued at approximately $65,981, as part of the Knopp Amendment in May 2024[79]. - As of September 30, 2024, the company had issued 4,248,588 common shares under the amended Equity Distribution Agreement, generating total net proceeds of approximately $146,250[85]. Cash and Investments - Cash, cash equivalents, and restricted cash at the end of Q3 2024 were $88.019 million, down from $125.990 million at the end of Q3 2023, a decrease of 30%[14]. - The company held $294,211 in U.S. treasury bills with a fair value of $294,426 as of September 30, 2024, reflecting a gross unrealized gain of $215[44]. - The company’s total cash and cash equivalents decreased by 24.5% from $111,697 as of September 30, 2023[32]. - The company reported no proceeds from the sale of available-for-sale debt securities for the nine months ended September 30, 2024, compared to $4,920,000 in 2023[52]. Research and Development - Biohaven is focused on developing therapeutics in key areas such as immunology, neuroscience, and oncology, leveraging proprietary drug development platforms[16]. - The company is advancing its innovative portfolio in key therapeutic areas, including immunology, neuroscience, and oncology, with multiple proprietary drug development platforms[152]. - Troriluzole, the most advanced product candidate, is in two Phase 3 trials for OCD and plans to submit an NDA for Spinocerebellar Ataxia (SCA) to the FDA[156]. - The pivotal Study BHV4157-206-RWE demonstrated a 50-70% slower rate of decline in SCA patients treated with troriluzole compared to untreated patients, translating to a 1.5-2.2 years delay in disease progression over three years[163]. - The company announced a worldwide license agreement with BMS for taldefgrobep alfa (BHV-2000), a Phase 3-ready anti-myostatin adnectin, to enhance muscle mass and strength in neuromuscular conditions[174]. Future Plans and Milestones - The company plans to submit an NDA to the FDA in Q4 2024 for troriluzole, with potential commercialization in the U.S. in 2025 if approved[167]. - The Phase 3 program for OCD has an estimated total enrollment of up to 700 participants, with topline data expected in the first half of 2025[171]. - A Phase 2 clinical trial for taldefgrobep in metabolic disease is planned for Q4 2024 or early 2025[183]. - The company has potential future milestone payments under its licensing agreements of up to approximately $140,650,000, $641,975,000, and $2,150,450,000 for developmental, regulatory, and commercial milestones, respectively[100]. Accounting and Financial Reporting - The company is currently evaluating the impact of recently issued accounting standards on its consolidated financial statements[42]. - The company’s assessment of its ability to continue as a going concern involves estimating future cash inflows and outflows[28]. - The fair value of forward contract liabilities is determined based on significant inputs not observable in the market, representing a Level 3 measurement within the fair value hierarchy[41]. Non-Cash Expenses - The company recorded a non-cash share-based compensation expense of $34,877 for the three months ended September 30, 2024[75]. - The company reported total non-cash share-based compensation expense of $12,160,000 for the three months ended September 30, 2024, compared to $4,456,000 in 2023[91]. - The total unrecognized compensation cost related to unvested share options was $78,570,000, expected to be recognized over a weighted average period of 2.13 years[94].

Core Viewpoint - Biohaven Ltd. has successfully closed its underwritten public offering of 6,052,631 common shares at a price of $47.50 per share, raising approximately $287.5 million in gross proceeds before expenses [1]. Group 1: Offering Details - The offering included the full exercise of the underwriters' option to purchase an additional 789,473 common shares [1]. - The net proceeds from the offering will be used for general corporate purposes [1]. Group 2: Underwriters - J.P. Morgan, Morgan Stanley, Jefferies, and TD Cowen are acting as the joint lead book-running managers for the offering [2]. Group 3: Regulatory Information - The shares were issued under an effective shelf registration statement on Form S-3 [4].

Group 1 - Biohaven Ltd. announced the pricing of its public offering of 5,263,158 common shares at $47.50 per share, with expected gross proceeds of approximately $250 million [1] - The offering includes a 30-day option for underwriters to purchase an additional 789,473 common shares at the public offering price [1] - The offering is expected to close on October 2, 2024, subject to customary closing conditions [1] Group 2 - J.P. Morgan, Morgan Stanley, Jefferies, and TD Cowen are acting as the joint lead book-running managers for the offering [2] - The shares will be issued under an effective shelf registration statement on Form S-3 [4]

NEW HAVEN, Conn., Sept. 30, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced that it has commenced an underwritten public offering of $250 million of its common shares. All of the common shares to be sold in the offering will be offered by Biohaven. In addition, Biohaven expects to grant the underwriter a ...

Shares of Biohaven Ltd. (BHVN) were up 13.7% on Sept. 23 after the company announced positive top-line data from the pivotal BHV4157-206-RWE study, which evaluated its pipeline candidate, troriluzole, for the treatment of spinocerebellar ataxia (SCA), a rare and debilitating neurodegenerative disease. Currently, there are no FDA-approved therapy for the given indication. The study showed the efficacy of troriluzole on the mean change from baseline in the modified functional Scale for the Assessment and Rati ...

Biohaven Today BHVN Biohaven $45.03 -0.91 (-1.98%) 52-Week Range $16.48 ▼ $62.21 Price Target $59.00 Add to Watchlist Biohaven Ltd. NYSE: BHVN has taken center stage in the biopharmaceutical sector after releasing positive results from its Phase 3 clinical trial for troriluzole, a drug being developed to treat spinocerebellar ataxia (SCA). This rare and debilitating neurodegenerative disease currently lacks FDA-approved treatments. The news sent Biohaven shares soaring as high as 20% on Monday, marking a si ...

Key Takeaways Biohaven said its experimental treatment for a rare neurological condition showed "a robust and clinically meaningful" slowing of the disease. The study of the drug troriluzole found a 50% to 70% slower rate of decline over three years for patients with spinocerebellar ataxia (SCA). The news sent Biohaven shares soaring 15% and moving into positive territory for the year. Biohaven (BHVN) shares soared 15% Monday after the biotech firm announced positive results from a study of its experimental ...

Core Insights - Biohaven Ltd. announced positive topline results from pivotal Study BHV4157-206-RWE, demonstrating the efficacy of troriluzole in treating Spinocerebellar Ataxia (SCA) over three years [1][3] - The study achieved its primary endpoint, showing statistically significant improvements in the f-SARA scale at years 1 and 2, indicating a robust treatment effect [1][3] - SCA is a rare neurodegenerative disease affecting approximately 15,000 individuals in the U.S. and 24,000 in Europe and the U.K. [1] Treatment Efficacy - Data from multiple analyses indicate a clinically meaningful slowing of disease progression in SCA patients treated with troriluzole, translating to a 50-70% slower rate of decline compared to untreated patients [2] - The treatment represents a delay in disease progression of 1.5-2.2 years over the three-year study period [2] - The odds ratio for disease progression in untreated patients compared to those treated with troriluzole was 4.1, highlighting the treatment's effectiveness [3] Regulatory and Commercial Plans - Biohaven plans to submit a New Drug Application (NDA) to the FDA in Q4 2024, aiming for commercialization of SCA treatment in the U.S. by 2025, contingent on approval [3][4] - The troriluzole development program has generated the largest clinical trial dataset in SCA, with some patients followed for over five years [4] Market Reaction - Following the announcement, Biohaven's stock rose by 12%, reaching $45.20 in premarket trading [4]