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]

Core Insights - Biohaven Ltd. will host a conference call on September 23, 2024, to discuss topline data from Study BHV4157-206-RWE, which assesses the effectiveness of troriluzole in Spinocerebellar Ataxia [1][2] Group 1: About Troriluzole - Troriluzole is a new chemical entity and third-generation prodrug that modulates glutamate, the most abundant excitatory neurotransmitter in the human body [3] - The primary mode of action of troriluzole is to reduce synaptic levels of glutamate by increasing its uptake from the synapse [3] - Troriluzole has potential applications in various diseases associated with excessive glutamate [3] Group 2: About Biohaven - Biohaven is a biopharmaceutical company focused on discovering, developing, and commercializing treatments in key therapeutic areas such as immunology, neuroscience, and oncology [4] - The company is advancing an innovative portfolio of therapeutics, leveraging proven drug development experience and proprietary drug development platforms [4] - Biohaven's clinical and preclinical programs include treatments for epilepsy, mood disorders, immunological diseases, migraine, neuropathic pain, neuroinflammatory disorders, and neuromuscular diseases [4]

Part I Financial Information This section covers Biohaven Ltd.'s unaudited condensed consolidated financial statements and management's analysis of financial condition and operations [Item 1: Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201:%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents Biohaven Ltd.'s unaudited condensed consolidated financial statements, including balance sheets, income statements, cash flows, and detailed notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of Biohaven's financial position, detailing assets, liabilities, and shareholders' equity at specific dates | Metric | June 30, 2024 (Unaudited) ($ thousands) | December 31, 2023 ($ thousands) | | :-------------------------- | :-------------------------------------- | :------------------------------ | | **Assets** | | | | Total current assets | 511,268 | 442,446 | | Total assets | 582,641 | 513,212 | | **Liabilities** | | | | Total current liabilities | 156,207 | 55,423 | | Total liabilities | 198,901 | 85,237 | | **Shareholders' Equity** | | | | Total shareholders' equity | 383,740 | 427,975 | - Total assets increased by **$69,400 thousand** from December 31, 2023, to June 30, 2024, primarily driven by an increase in marketable securities and prepaid expenses[6](index=6&type=chunk) - Total liabilities significantly increased by **$113,700 thousand**, mainly due to new forward contract and derivative liabilities[6](index=6&type=chunk) - Total shareholders' equity decreased by **$44,200 thousand**[6](index=6&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details Biohaven's financial performance, presenting revenues, expenses, and net loss for the periods ended June 30, 2024 and 2023 | Metric | Three Months Ended June 30, 2024 ($ thousands) | Three Months Ended June 30, 2023 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | Six Months Ended June 30, 2023 ($ thousands) | | :--------------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :------------------------------------------- | :------------------------------------------- | | Research and development | 314,819 | 79,490 | 470,791 | 142,951 | | General and administrative | 18,953 | 14,521 | 46,221 | 28,842 | | Total operating expenses | 333,772 | 94,011 | 517,012 | 171,793 | | Loss from operations | (333,772) | (94,011) | (517,012) | (171,793) | | Other income, net | 14,178 | 5,842 | 18,483 | 14,071 | | Net loss | (319,771) | (90,346) | (499,275) | (160,838) | | Net loss per share — basic and diluted | (3.64) | (1.32) | (5.93) | (2.36) | - Net loss significantly increased for both the three and six months ended June 30, 2024, primarily due to a substantial rise in research and development expenses, which included a one-time non-cash expense of **$171,900 thousand** related to a milestone and royalty buyback for the Kv7 platform[8](index=8&type=chunk)[189](index=189&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section outlines Biohaven's cash flows from operating, investing, and financing activities for the periods ended June 30, 2024 and 2023 | Metric | Six Months Ended June 30, 2024 ($ thousands) | Six Months Ended June 30, 2023 ($ thousands) | | :------------------------------------------------------------------ | :------------------------------------------- | :------------------------------------------- | | Net cash used in operating activities | (270,435) | (122,031) | | Net cash (used in) provided by investing activities | (63,900) | 75,195 | | Net cash provided by financing activities | 324,546 | 6,329 | | Net decrease in cash, cash equivalents, and restricted cash | (9,802) | (40,654) | | Cash, cash equivalents, and restricted cash at end of period | 242,318 | 201,950 | - Net cash used in operating activities increased significantly, primarily due to higher R&D spending[10](index=10&type=chunk)[202](index=202&type=chunk) - Investing activities shifted from providing cash to using cash, driven by increased purchases of marketable securities[10](index=10&type=chunk)[203](index=203&type=chunk) - Financing activities provided a substantial amount of cash, mainly from common share issuances[10](index=10&type=chunk)[204](index=204&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of Biohaven's accounting policies, financial instrument valuations, and key agreements [1. Nature of the Business and Basis of Presentation](index=7&type=section&id=1.%20Nature%20of%20the%20Business%20and%20Basis%20of%20Presentation) This section describes Biohaven's core business as a biopharmaceutical company and the basis for preparing its financial statements - Biohaven Ltd. is a biopharmaceutical company focused on discovery, development, and commercialization of treatments in immunology, neuroscience, and oncology, leveraging proprietary drug development platforms[12](index=12&type=chunk) - The company was spun off from Biohaven Pharmaceutical Holding Company Ltd. on October 3, 2022, becoming an independent, publicly traded entity[14](index=14&type=chunk)[15](index=15&type=chunk) - Biohaven expects its existing cash, cash equivalents, and marketable securities to fund operations for at least one year but anticipates needing additional funding through equity, debt, or collaborations to support its growth strategy and ongoing losses[17](index=17&type=chunk)[18](index=18&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines Biohaven's key accounting principles, including GAAP compliance, equity-linked instruments, and fair value measurements - The unaudited interim condensed consolidated financial statements are prepared in accordance with GAAP, with significant estimates including research and development expense accruals and valuation of forward contract and derivative liabilities[19](index=19&type=chunk)[21](index=21&type=chunk) - The company classifies equity-linked instruments as liabilities or derivatives based on ASC 480-10 and ASC 815-40, with changes in fair value recorded in other income (expense), net[23](index=23&type=chunk)[24](index=24&type=chunk) - Fair value measurements are categorized into Level 1 (quoted prices in active markets), Level 2 (observable inputs), and Level 3 (unobservable inputs), with forward contract liabilities being Level 3 measurements based on Monte Carlo simulations[27](index=27&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) [3. Marketable Securities](index=10&type=section&id=3.%20Marketable%20Securities) This section details Biohaven's marketable securities portfolio, primarily U.S. treasury bills, and related investment income and realized gains/losses | Metric | June 30, 2024 ($ thousands) | December 31, 2023 ($ thousands) | | :------------------------------------ | :-------------------------- | :------------------------------ | | Fair Value of Debt Securities | 234,745 | 167,319 | | - Included in Cash and cash equivalents | 36,944 | 33,902 | | - Included in Marketable securities | 197,801 | 133,417 | | Metric | Three Months Ended June 30, 2024 ($ thousands) | Three Months Ended June 30, 2023 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | Six Months Ended June 30, 2023 ($ thousands) | | :---------------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :------------------------------------------- | :------------------------------------------- | | Net investment income | 5,100 | 4,098 | 9,401 | 8,223 | | Proceeds from sales of debt securities | — | 2,464 | — | 4,920 | | Gross realized capital losses | — | 17 | — | 39 | - The company's marketable securities primarily consist of U.S. treasury bills[31](index=31&type=chunk) - Net investment income increased for both the three and six months ended June 30, 2024, compared to the prior year, while there were no sales of debt securities or realized capital losses in 2024[36](index=36&type=chunk)[37](index=37&type=chunk) [4. Fair Value of Financial Assets and Liabilities](index=13&type=section&id=4.%20Fair%20Value%20of%20Financial%20Assets%20and%20Liabilities) This section categorizes Biohaven's financial assets and liabilities by fair value levels, highlighting Level 3 derivative liabilities from the Knopp Amendment | Balance Sheet Classification | Type of Instrument | Level 1 ($ thousands) | Level 2 ($ thousands) | Level 3 ($ thousands) | Total ($ thousands) | | :---------------------------------------- | :---------------------------------------------------- | :-------------------- | :-------------------- | :-------------------- | :------------------ | | **June 30, 2024 Assets:** | | | | | | | Cash and cash equivalents | Money market funds | 113,379 | — | — | 113,379 | | Cash and cash equivalents | U.S. treasury bills | — | 36,944 | — | 36,944 | | Marketable securities | U.S. treasury bills | 29,701 | 168,100 | — | 197,801 | | Other non-current assets | Money market funds | 2,515 | — | — | 2,515 | | **June 30, 2024 Liabilities:** | | | | | | | Forward contract and derivative liabilities | Forward contract, current and written put option, current | — | — | 81,220 | 81,220 | | Derivative liability, non-current | Written put option, non-current | — | — | 12,180 | 12,180 | - The company's financial assets are primarily classified as Level 1 (money market funds) and Level 2 (U.S. treasury bills)[42](index=42&type=chunk) - New forward contract and derivative liabilities, totaling **$93,400 thousand** as of June 30, 2024, are classified as Level 3 due to unobservable inputs from Monte Carlo simulations, reflecting obligations under the Knopp Amendment[42](index=42&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk) | Unobservable Inputs (Level 3) | As of June 30, 2024 | As of May 1, 2024 | | :---------------------------- | :------------------ | :---------------- | | Time to payment (years) | 0.91 | 1.08 | | Volatility (annual) | 70.0% | 80.0% | | Discount rate | 15.6% | 14.8% | [5. Balance Sheet Components](index=16&type=section&id=5.%20Balance%20Sheet%20Components) This section provides a detailed breakdown of specific balance sheet items, including property and equipment and accrued expenses | Property and Equipment, Net | As of June 30, 2024 ($ thousands) | As of December 31, 2023 ($ thousands) | | :-------------------------- | :-------------------------------- | :------------------------------------ | | Total | 28,597 | 24,916 | | Accumulated depreciation | (10,201) | (8,283) | | Property and equipment, net | 18,665 | 17,191 | | Accrued Expenses and Other Current Liabilities | As of June 30, 2024 ($ thousands) | As of December 31, 2023 ($ thousands) | | :--------------------------------------------- | :-------------------------------- | :------------------------------------ | | Accrued employee compensation and benefits | 10,845 | 837 | | Accrued clinical trial costs | 36,446 | 29,501 | | Total accrued expenses and other current liabilities | 57,728 | 39,846 | - Property and equipment, net, increased by **$1,500 thousand**, primarily due to additions in building and land, and office and lab equipment[52](index=52&type=chunk) - Accrued expenses and other current liabilities rose by **$17,900 thousand**, driven by significant increases in accrued employee compensation and benefits, and accrued clinical trial costs[50](index=50&type=chunk) [6. Shareholders' Equity](index=17&type=section&id=6.%20Shareholders'%20Equity) This section details changes in Biohaven's shareholders' equity, including common share issuances and the impact of net loss | Metric | As of June 30, 2024 ($ thousands) | As of December 31, 2023 ($ thousands) | | :------------------------------------------------------------------ | :-------------------------------- | :------------------------------------ | | Common Shares Amount | 1,298,553 | 887,528 | | Additional Paid-in Capital | 83,832 | 39,804 | | Accumulated Deficit | (998,567) | (499,292) | | Total Shareholders' Equity | 383,740 | 427,975 | - Total shareholders' equity decreased by **$44,200 thousand** from December 31, 2023, to June 30, 2024, primarily due to a net loss of **$499,300 thousand**, partially offset by proceeds from common share issuances totaling **$317,700 thousand** from a public offering and **$69,900 thousand** from an equity distribution agreement[54](index=54&type=chunk)[58](index=58&type=chunk)[61](index=61&type=chunk) - The company issued **1,872,874 common shares** valued at **$66,000 thousand** to Knopp in May 2024 as consideration for the Knopp Amendment, and also issued a warrant to purchase **294,195 common shares**[57](index=57&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk) [7. Accumulated Other Comprehensive (Loss) Income](index=19&type=section&id=7.%20Accumulated%20Other%20Comprehensive%20(Loss)%20Income) This section presents changes in Biohaven's accumulated other comprehensive loss/income for the periods ended June 30, 2024 and 2023 | Metric | Three Months Ended June 30, 2024 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | | :------------------------------------------------------------------ | :--------------------------------------------- | :------------------------------------------- | | Total beginning of period accumulated other comprehensive loss | (106) | (65) | | Total other comprehensive income (loss) | 28 | (13) | | Total end of period accumulated other comprehensive loss | (78) | (78) | | Metric | Three Months Ended June 30, 2023 ($ thousands) | Six Months Ended June 30, 2023 ($ thousands) | | :------------------------------------------------------------------ | :--------------------------------------------- | :------------------------------------------- | | Total beginning of period accumulated other comprehensive income | 166 | 284 | | Total other comprehensive loss | (146) | (264) | | Total end of period accumulated other comprehensive income | 20 | 20 | - Accumulated other comprehensive loss improved from **$(106) thousand** at the beginning of the three-month period to **$(78) thousand** at June 30, 2024, primarily due to other comprehensive income of **$28 thousand**[62](index=62&type=chunk) - For the six months ended June 30, 2024, the accumulated other comprehensive loss was **$(78) thousand**, compared to an income of **$20 thousand** in the prior year[62](index=62&type=chunk)[64](index=64&type=chunk) [8. Non-Cash Share-Based Compensation](index=20&type=section&id=8.%20Non-Cash%20Share-Based%20Compensation) This section details Biohaven's non-cash share-based compensation expenses and unrecognized compensation costs for equity awards | Expense Category | Three Months Ended June 30, 2024 ($ thousands) | Three Months Ended June 30, 2023 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | Six Months Ended June 30, 2023 ($ thousands) | | :---------------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :------------------------------------------- | :------------------------------------------- | | Research and development expenses | 7,071 | 2,457 | 28,362 | 4,698 | | General and administrative expenses | 5,161 | 2,238 | 18,747 | 3,762 | | Total non-cash share-based compensation expense | 12,232 | 4,695 | 47,109 | 8,460 | - Total non-cash share-based compensation expense significantly increased to **$12,200 thousand** for the three months and **$47,100 thousand** for the six months ended June 30, 2024, compared to the prior year, primarily due to annual equity incentive awards granted in late 2023 and early 2024[65](index=65&type=chunk)[190](index=190&type=chunk)[191](index=191&type=chunk)[198](index=198&type=chunk) - As of June 30, 2024, unrecognized compensation cost for unvested share options was **$90,200 thousand**, expected to be recognized over **2.33 years**, and for RSUs was **$9,400 thousand**, expected over **2.53 years**[66](index=66&type=chunk)[68](index=68&type=chunk) [9. Net Loss Per Share](index=22&type=section&id=9.%20Net%20Loss%20Per%20Share) This section presents Biohaven's net loss per share calculations, including basic and diluted figures and excluded potential common shares | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | (319,771) | (90,346) | (499,275) | (160,838) | | Weighted average common shares outstanding | 87,766,069 | 68,248,023 | 84,174,099 | 68,227,564 | | Net loss per share — basic and diluted | (3.64) | (1.32) | (5.93) | (2.36) | - Net loss per share significantly increased to **$(3.64)** for the three months and **$(5.93)** for the six months ended June 30, 2024, compared to the prior year, reflecting the higher net loss and increased weighted average common shares outstanding[71](index=71&type=chunk) | Potential Common Shares Excluded from Diluted EPS | As of June 30, 2024 | As of June 30, 2023 | | :------------------------------------------------ | :------------------ | :------------------ | | Options to purchase common shares | 13,545,016 | 9,639,557 | | Warrants to purchase common shares | 294,195 | — | | Restricted share units | 263,672 | — | | Total | 14,102,883 | 9,639,557 | [10. License, Acquisitions and Other Agreements](index=22&type=section&id=10.%20License,%20Acquisitions%20and%20Other%20Agreements) This section outlines Biohaven's various licensing and acquisition agreements, including potential milestone payments and recent amendments - Biohaven has various license and acquisition agreements with potential future milestone payments totaling approximately **$140,700 thousand** for development, **$642,000 thousand** for regulatory approval, and **$2,150,000 thousand** for commercial milestones[73](index=73&type=chunk) - In May 2024, the Knopp Amendment revised the Kv7 platform acquisition terms, reducing potential future milestone payments by **$867,500 thousand** and replacing scaled royalties with a flat mid-single digit rate[88](index=88&type=chunk)[172](index=172&type=chunk) - Consideration for the Knopp Amendment included issuing **1,872,874 common shares** (valued at **$66,000 thousand**) and a warrant to Knopp[173](index=173&type=chunk)[174](index=174&type=chunk) - The Pyramid acquisition in January 2024 for BHV-1510 involved an upfront payment of **255,794 common shares** and potential success-based payments up to **$75,000 thousand** for developmental, regulatory, and commercial milestones[94](index=94&type=chunk)[95](index=95&type=chunk) [11. Commitments and Contingencies](index=26&type=section&id=11.%20Commitments%20and%20Contingencies) This section details Biohaven's contractual obligations, including lease agreements and research commitments, and potential contingent liabilities - The company entered a new Pittsburgh Centre Avenue Lease in March 2024 for lab space, commencing mid-2025 with a **122-month term** and annual commitments ranging from **$1,860 thousand** to **$2,370 thousand**[98](index=98&type=chunk) - Research commitments with CMOs and CROs had no remaining maximum commitments exceeding one year as of June 30, 2024[99](index=99&type=chunk) - The Moda Agreement was amended in August 2023, making Moda eligible for additional development and regulatory milestone payments up to **$25,200 thousand** and commercial milestone payments up to **$23,000 thousand**[100](index=100&type=chunk)[101](index=101&type=chunk) [12. Income Taxes](index=27&type=section&id=12.%20Income%20Taxes) This section discusses Biohaven's income tax provision and effective tax rate, including the impact of new IRS guidance and valuation allowances | Metric | Three Months Ended June 30, 2024 ($ thousands) | Three Months Ended June 30, 2023 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | Six Months Ended June 30, 2023 ($ thousands) | | :-------------------------- | :--------------------------------------------- | :--------------------------------------------- | :------------------------------------------- | :------------------------------------------- | | Income tax provision | 177 | 2,177 | 746 | 3,116 | | Effective income tax rate | 0.1% | 2.5% | 0.1% | 2.0% | - The income tax provision decreased significantly for both the three and six months ended June 30, 2024, primarily due to the adoption of new IRS guidance allowing immediate deduction of certain U.S. R&D expenditures reimbursed by the foreign parent[103](index=103&type=chunk) - The company maintains a full valuation allowance against its net deferred tax assets, including R&D tax credit and net operating loss carryforwards, as realization is not considered more likely than not[185](index=185&type=chunk) [13. Related Party Transactions](index=28&type=section&id=13.%20Related%20Party%20Transactions) This section describes Biohaven's transactions with related parties, including the Former Parent and agreements involving the CEO - The Former Parent ceased to be a related party after the Separation on October 3, 2022[104](index=104&type=chunk) - The company recorded no material income from transition services to the Former Parent for the three and six months ended June 30, 2024, a decrease from **$1,700 thousand** and **$5,600 thousand** in the prior year periods, respectively[104](index=104&type=chunk) - The company's CEO is entitled to a share of glutamate product-related royalty revenues from the Yale Agreement[104](index=104&type=chunk) - R&D expenses related to Yale Agreements were **$582 thousand** and **$1,030 thousand** for the three and six months ended June 30, 2024, respectively[105](index=105&type=chunk) [Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202:%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Biohaven's financial condition, operational results, clinical milestones, and liquidity [Overview](index=29&type=section&id=Overview) This section introduces Biohaven as a biopharmaceutical company, its strategic focus, diverse pipeline, and independent public company status - Biohaven is a biopharmaceutical company focused on discovering, developing, and commercializing treatments in immunology, neuroscience, and oncology, utilizing proprietary drug development platforms[111](index=111&type=chunk) - The company's pipeline includes programs for Kv7 ion channel modulation (epilepsy, mood disorders), extracellular protein degradation (immunological diseases), TRPM3 antagonism (migraine, neuropathic pain), TYK2/JAK1 inhibition (neuroinflammatory disorders), glutamate modulation (OCD, SCA), myostatin inhibition (SMA, obesity), and antibody-recruiting bispecific molecules/ADCs (cancer)[111](index=111&type=chunk) - Biohaven became an independent, publicly traded company on October 3, 2022, following its spin-off from Biohaven Pharmaceutical Holding Company Ltd[112](index=112&type=chunk) [Clinical-Stage Milestones](index=30&type=section&id=Clinical-Stage%20Milestones) This section highlights Biohaven's progress across its clinical pipeline, detailing key developments for various drug candidates and platforms - Troriluzole (Glutamate Modulation) is in Phase 3 trials for OCD and is being evaluated in GBM AGILE for glioblastoma[114](index=114&type=chunk)[116](index=116&type=chunk) - An NDA for SCA3 was refused by the FDA, but a new real-world evidence protocol (BHV4157-206-RWE) is underway with topline data expected in H2 2024[119](index=119&type=chunk)[120](index=120&type=chunk) - Taldefgrobep Alfa (Myostatin Platform) is in a Phase 3 trial for Spinal Muscular Atrophy (SMA), with topline data expected in H2 2024[124](index=124&type=chunk) - Taldefgrobep Alfa received Fast Track, Orphan Drug, and Rare Pediatric Disease designations for SMA[125](index=125&type=chunk) - A Phase 2 trial for metabolic disease (obesity) is planned for H2 2024 for Taldefgrobep Alfa[129](index=129&type=chunk) - BHV-7000 (Kv7 Ion Channel Platform) is advancing into five Phase 3 trials for refractory focal epilepsy and idiopathic generalized epilepsy, and Phase 2 trials for Major Depressive Disorder (MDD) and bipolar disorder, all initiated in Q1/Q2 2024[134](index=134&type=chunk)[136](index=136&type=chunk)[140](index=140&type=chunk)[144](index=144&type=chunk) - BHV-2100 (TRPM3 Antagonist) reported positive Phase 1 pharmacokinetic and safety data in May 2024, leading to plans for Phase 2 studies in acute migraine and a proof-of-concept study in neuropathic pain in H2 2024[148](index=148&type=chunk) - BHV-8000 (TYK2/JAK1 Inhibitor) showed positive Phase 1 results with CNS target engagement[152](index=152&type=chunk) - Phase 2/3 trials are anticipated in H2 2024 for BHV-8000 in neuroinflammatory conditions like Parkinson's disease and ARIA in Alzheimer's disease[153](index=153&type=chunk) - MoDE Degraders (BHV-1300, BHV-1310, BHV-1400, BHV-1600) are in various stages of preclinical and Phase 1 development, targeting conditions like rheumatoid arthritis, generalized myasthenia gravis, IgA Nephropathy, and dilated cardiomyopathy, with multiple INDs expected in 2024 and 2025[154](index=154&type=chunk)[159](index=159&type=chunk)[161](index=161&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk) - Oncology Platform includes BHV-1100 (CD-38 ARM™) in a Phase 1a/1b trial for multiple myeloma[167](index=167&type=chunk) - BHV-1510 (TROP-2 ADC) commenced a Phase 1/2 trial in Q2 2024 for advanced solid tumors, showing improved preclinical activity and safety[170](index=170&type=chunk)[171](index=171&type=chunk) - BHV-1500 (CD30-directed ADC) IND submission is expected in 2025[172](index=172&type=chunk) [Recent Developments](index=42&type=section&id=Recent%20Developments) This section outlines significant recent events impacting Biohaven, particularly the Knopp Amendment and its financial implications - In May 2024, the Knopp Amendment significantly reduced potential future milestone payments by **$867,500 thousand** and replaced scaled royalties with a flat mid-single digit rate for Kv7 programs[172](index=172&type=chunk) - Consideration for the Knopp Amendment included issuing **1,872,874 common shares** (valued at **$66,000 thousand**) and a warrant to Knopp[173](index=173&type=chunk)[174](index=174&type=chunk) [Components of Our Results of Operations](index=42&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section explains the key drivers of Biohaven's financial performance, including R&D, G&A expenses, other income, and income tax provisions - The company has not generated product sales revenue and does not expect to in the near future, relying on successful clinical development and regulatory approval[175](index=175&type=chunk) - Research and Development (R&D) expenses are expensed as incurred, including costs for CROs/CMOs, manufacturing, personnel, regulatory compliance, and milestone payments[176](index=176&type=chunk)[177](index=177&type=chunk) - R&D expenses are expected to remain significant due to increased personnel, late-stage clinical trials, and regulatory filings[179](index=179&type=chunk) - General and Administrative (G&A) expenses include personnel costs, facilities, and professional services, and are expected to remain significant as the company supports R&D and prepares for potential commercialization as an independent public company[180](index=180&type=chunk) - Other income, net, primarily consists of changes in the fair value of forward contract and derivative liabilities (valued using Monte Carlo simulations) and net investment income[181](index=181&type=chunk)[182](index=182&type=chunk)[183](index=183&type=chunk) - Income tax provisions are primarily for profitable U.S. and Ireland subsidiaries, with a full valuation allowance maintained against net deferred tax assets[185](index=185&type=chunk)[186](index=186&type=chunk) [Results of Operations](index=44&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of Biohaven's financial results for the three and six months ended June 30, 2024 and 2023 | Metric | Three Months Ended June 30, 2024 ($ thousands) | Three Months Ended June 30, 2023 ($ thousands) | Change ($ thousands) | | :--------------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :------------------- | | Research and development | 314,819 | 79,490 | 235,329 | | General and administrative | 18,953 | 14,521 | 4,432 | | Total operating expenses | 333,772 | 94,011 | 239,761 | | Net loss | (319,771) | (90,346) | (229,425) | | Other income, net | 14,178 | 5,842 | 8,336 | | Provision for income taxes | 177 | 2,177 | (2,000) | | Metric | Six Months Ended June 30, 2024 ($ thousands) | Six Months Ended June 30, 2023 ($ thousands) | Change ($ thousands) | | :--------------------------------------- | :------------------------------------------- | :------------------------------------------- | :------------------- | | Research and development | 470,791 | 142,951 | 327,840 | | General and administrative | 46,221 | 28,842 | 17,379 | | Total operating expenses | 517,012 | 171,793 | 345,219 | | Net loss | (499,275) | (160,838) | (338,437) | | Other income, net | 18,483 | 14,071 | 4,412 | | Provision for income taxes | 746 | 3,116 | (2,370) | - R&D expenses for the three months ended June 30, 2024, increased by **$235,300 thousand** to **$314,800 thousand**, largely due to a **$171,900 thousand** non-cash expense for the Kv7 platform milestone and royalty buyback, and advancing multiple clinical programs[189](index=189&type=chunk) - For the six months, R&D increased by **$327,800 thousand** to **$470,800 thousand**, including the Kv7 buyback and **$22,600 thousand** for the Pyramid Acquisition (BHV-1510)[197](index=197&type=chunk) - Other income, net, increased by **$8,300 thousand** for the three months and **$4,400 thousand** for the six months, primarily due to a **$9,200 thousand** gain on settlement of the 2024 Additional Consideration forward contract and increased investment income, partially offset by decreased income from the Transition Services Agreement with the Former Parent[192](index=192&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk) [Liquidity and Capital Resources](index=47&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses Biohaven's financial liquidity, capital resources, cash flow activities, and future funding requirements - As of June 30, 2024, Biohaven had **$239,100 thousand** in cash and cash equivalents and **$197,800 thousand** in marketable securities[201](index=201&type=chunk) - The company expects these resources to fund operations for more than one year[211](index=211&type=chunk) | Cash Flow Activity | Six Months Ended June 30, 2024 ($ thousands) | Six Months Ended June 30, 2023 ($ thousands) | Change ($ thousands) | | :---------------------------------------------------------- | :------------------------------------------- | :------------------------------------------- | :------------------- | | Net cash used in operating activities | (270,435) | (122,031) | (148,404) | | Net cash (used in) provided by investing activities | (63,900) | 75,195 | (139,095) | | Net cash provided by financing activities | 324,546 | 6,329 | 318,217 | - Net cash used in operating activities increased by **$148,400 thousand**, primarily due to higher R&D spending[202](index=202&type=chunk) - Net cash used in investing activities increased by **$139,100 thousand**, driven by increased purchases of marketable securities[203](index=203&type=chunk) - Net cash provided by financing activities increased by **$318,200 thousand**, mainly from a **$247,800 thousand** public offering and **$69,900 thousand** from an equity distribution agreement[204](index=204&type=chunk)[205](index=205&type=chunk)[206](index=206&type=chunk) - The company expects to require additional capital to fund increasing expenses from advancing preclinical and clinical programs, potential commercialization, and acquisitions, planning to raise funds through equity, debt, or strategic alliances[210](index=210&type=chunk)[211](index=211&type=chunk)[212](index=212&type=chunk)[214](index=214&type=chunk) [Item 3: Quantitative and Qualitative Disclosures About Market Risk](index=50&type=section&id=Item%203:%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines Biohaven's exposure to market risks, including foreign currency, interest rate, equity price, and credit risk, without hedging activities - Foreign currency translation exposures are currently immaterial, and the company does not engage in hedging activities[220](index=220&type=chunk) - Interest rate risk exists for marketable securities; a **1.00%** change in interest rates would impact the investment portfolio's fair value by approximately **$400 thousand**, but is not considered material[221](index=221&type=chunk) - No hedging activities are undertaken for interest rate risk[222](index=222&type=chunk) - Equity price risk arises from derivative liabilities related to Knopp Amendment true-up payments, where a decrease in the company's **20-day volume weighted average share price (VWAP)** relative to the Reference Price would increase the fair value of these liabilities[223](index=223&type=chunk)[224](index=224&type=chunk) - Credit risk is managed by investing excess cash in highly rated financial institutions and investment-grade debt instruments, with restrictions on credit ratings, maturities, and concentrations[225](index=225&type=chunk) - No credit losses or allowances for credit losses have been experienced[225](index=225&type=chunk) [Item 4: Controls and Procedures](index=51&type=section&id=Item%204:%20Controls%20and%20Procedures) This section details the evaluation of Biohaven's disclosure controls and internal controls over financial reporting, concluding effectiveness with no material changes - As of June 30, 2024, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[228](index=228&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2024[228](index=228&type=chunk) Part II Other Information This section provides additional information on Biohaven's legal proceedings, risk factors, equity sales, other disclosures, and exhibits [Item 1: Legal Proceedings](index=52&type=section&id=Item%201:%20Legal%20Proceedings) Biohaven is not currently involved in any material legal proceedings that would significantly impact its business, operating results, or financial condition - The company is not currently involved in any material legal proceedings and is unaware of any pending or threatened legal actions that could have a material adverse effect on its financial condition or operations[229](index=229&type=chunk) [Item 1A: Risk Factors](index=52&type=section&id=Item%201A:%20Risk%20Factors) Biohaven's risk factors have not materially changed from those described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2023 - No material changes to the company's risk factors have occurred since the Annual Report on Form 10-K for the fiscal year ended December 31, 2023[230](index=230&type=chunk) [Item 2: Unregistered Sales of Equity Securities and Use of Proceeds](index=52&type=section&id=Item%202:%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details Biohaven's unregistered sales of equity securities, including common shares issued for the Pyramid acquisition and Knopp Amendment - In January 2024, Biohaven issued **255,794 common shares** (253,410 issued by June 30, 2024) as an upfront payment for the Pyramid acquisition, and an additional **98,129 common shares** (97,233 issued by June 30, 2024) for a developmental milestone[230](index=230&type=chunk) - In May 2024, in connection with the Knopp Amendment, the company issued **1,872,874 common shares** (valued at approximately **$75,000 thousand**) as 2024 Additional Consideration and a warrant to purchase **294,195 common shares**[232](index=232&type=chunk) - All these issuances were unregistered under the Securities Act, relying on the private offering exemption under Section 4(a)(2)[230](index=230&type=chunk)[233](index=233&type=chunk) [Item 5. Other Information](index=52&type=section&id=Item%205.%20Other%20Information) This section states that no directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended June 30, 2024 - No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended June 30, 2024[234](index=234&type=chunk) [Item 6: Exhibits](index=53&type=section&id=Item%206:%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including amendments to agreements, warrants, certifications, and iXBRL financial data - Exhibits include the Amendment to Membership Interest Purchase Agreement with Knopp, the Warrant issued to Knopp, Section 302 and 906 certifications, and iXBRL formatted financial statements[235](index=235&type=chunk) [Signatures](index=54&type=section&id=Signatures) This section contains the official signatures of Biohaven Ltd.'s Chief Executive Officer and Chief Financial Officer, certifying the report pursuant to the Securities Exchange Act of 1934 - The report is duly signed by Vlad Coric, M.D., Chief Executive Officer, and Matthew Buten, Chief Financial Officer, on behalf of Biohaven Ltd. on August 9, 2024[237](index=237&type=chunk)

[Key Business Highlights & Pipeline Update](index=1&type=section&id=Second%20Quarter%202024%20and%20Recent%20Business%20Highlights) Biohaven reported significant progress across its diverse pipeline in Q2 2024, advancing multiple candidates and achieving positive clinical and preclinical data [MoDE™ Platform (BHV-1300, BHV-1600)](index=1&type=section&id=MoDE%20Platform) The MoDE™ platform's lead candidate BHV-1300 showed positive Phase 1 data with a promising subcutaneous formulation, and the platform is expanding with new INDs planned - Reported positive interim Phase 1 data for BHV-1300, demonstrating **dose-dependent and rapid IgG reductions** with no serious adverse events[1](index=1&type=chunk) - An optimized subcutaneous formulation of BHV-1300 showed approximately **44% higher exposure** than the IV dose, supporting self-administration[1](index=1&type=chunk)[4](index=4&type=chunk) - The company expects to submit **3 new INDs** for MoDE programs by year-end and has an FDA INTERACT meeting for BHV-1600 in 2H 2024[1](index=1&type=chunk)[6](index=6&type=chunk) [Ion Channel Platform (BHV-7000, BHV-2100)](index=1&type=section&id=Ion%20Channel%20Platform) The ion channel platform is rapidly advancing with five Phase 2/3 trials for BHV-7000 and planned Phase 2 studies for BHV-2100 following positive Phase 1 data - **Five Phase 2/3 trials** for Kv7 activator BHV-7000 are underway, targeting epilepsy and mood disorders[1](index=1&type=chunk)[4](index=4&type=chunk) - TRPM3 antagonist BHV-2100 showed positive Phase 1 data, achieving target drug concentrations and a well-tolerated profile, with Phase 2 studies planned for 2H 2024[1](index=1&type=chunk)[4](index=4&type=chunk) [Myostatin Platform (Taldefgrobep alfa)](index=1&type=section&id=Myostatin%20Platform) Taldefgrobep alfa is advancing with Phase 3 data in SMA and a Phase 2 obesity trial expected in 2H 2024, supported by preclinical data showing dual fat reduction and muscle increase - Topline Phase 3 data for taldefgrobep alfa in SMA and initiation of a Phase 2 trial in obesity are both expected in **2H 2024**[1](index=1&type=chunk)[5](index=5&type=chunk) - Preclinical data showed taldefgrobep alfa directly reduces adipose tissue and, combined with a GLP-1 agonist, significantly reduced fat and total body weight while increasing lean muscle[1](index=1&type=chunk)[4](index=4&type=chunk) [Neuroinflammation Platform (BHV-8000)](index=1&type=section&id=Neuroinflammation%20Platform) The selective TYK2/JAK1 inhibitor BHV-8000 completed Phase 1, confirming CNS penetration and biomarker engagement, with registrational programs advancing for Parkinson's disease and ARIA prevention - BHV-8000 completed Phase 1, confirming **biomarker target engagement** and CNS penetration with CSF target exposures[1](index=1&type=chunk)[4](index=4&type=chunk) - Registrational programs for Parkinson's disease and ARIA prevention are advancing following favorable FDA feedback[1](index=1&type=chunk)[4](index=4&type=chunk) [Glutamate Platform (Troriluzole)](index=1&type=section&id=Glutamate%20Platform) The glutamate modulator troriluzole is advancing in OCD and SCA, with interim Phase 3 OCD data and RWE results for SCA expected in 2H 2024 - Interim data analysis from the second Phase 3 OCD trial is expected in **2H 2024**, with topline data from the first trial in **1H 2025**[1](index=1&type=chunk)[5](index=5&type=chunk) - A new real-world evidence protocol for troriluzole in SCA is expected to deliver topline results in **2H 2024**, incorporating FDA feedback[1](index=1&type=chunk)[5](index=5&type=chunk) [Oncology Platform (ADC - BHV-1510)](index=1&type=section&id=Oncology%20Platform) Biohaven's oncology platform is now clinical-stage, with lead ADC BHV-1510 dosing patients in a Phase 1/2 study and combination dosing with Libtayo® expected by Q4 2024 - The lead ADC, BHV-1510 (Trop-2 directed), is currently **dosing cancer patients** in a Phase 1/2 study[1](index=1&type=chunk)[4](index=4&type=chunk) - A combination study of BHV-1510 with Regeneron's Libtayo® is expected to begin by **Q4 2024**[1](index=1&type=chunk)[4](index=4&type=chunk) [Expected Upcoming Milestones](index=3&type=section&id=Expected%20Upcoming%20Milestones) Biohaven anticipates significant pipeline milestones in 2H 2024 and 2025, including topline data, interim analyses, and multiple Phase 2 trial initiations - **Troriluzole:** - Topline results from a new RWE protocol in SCA (**2H 2024**)[5](index=5&type=chunk) - Interim analysis of the second Phase 3 OCD trial (**2H 2024**)[5](index=5&type=chunk) - Topline data from the first Phase 3 OCD trial (**1H 2025**)[5](index=5&type=chunk) - **Taldefgrobep alfa:** - Initiate Phase 2 trial in obesity (**2H 2024**)[5](index=5&type=chunk) - Report topline data from Phase 3 trial in SMA (**2H 2024**)[5](index=5&type=chunk) - **BHV-2100 (TRPM3 Antagonist):** - Initiate Phase 2 trial in acute migraine (**2H 2024**)[5](index=5&type=chunk) - Initiate POC study for pain (**2H 2024**)[5](index=5&type=chunk) - **MoDE™ Platform:** - Submit a total of **4 INDs** in **2024**[6](index=6&type=chunk) - Provide a further update from Phase 1 SAD/MAD studies with BHV-1300 (**2H 2024**)[6](index=6&type=chunk) [Second Quarter 2024 Financial Results](index=1&type=section&id=Second%20Quarter%202024%20Financial%20Highlights) Biohaven reported a net loss of **$319.8 million** in Q2 2024, primarily due to increased R&D expenses including a **$171.9 million** non-cash charge, while maintaining a strong capital position of approximately **$440 million** [Capital Position](index=1&type=section&id=Capital%20Position) As of June 30, 2024, Biohaven maintained a strong financial position with approximately **$440 million** in cash and equivalents - Cash, cash equivalents, marketable securities, and restricted cash totaled approximately **$440 million** on June 30, 2024[1](index=1&type=chunk)[6](index=6&type=chunk) [R&D Expenses](index=4&type=section&id=R%26D%20Expenses) R&D expenses significantly increased to **$314.8 million** in Q2 2024, primarily due to a **$171.9 million** non-cash milestone and royalty buyback and increased clinical program spending R&D Expenses (Millions USD) | Expense Category | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Research and Development (R&D) | $314.8 | $79.5 | - The increase was primarily due to a one-time, non-cash expense of **$171.9 million** for a milestone and royalty buyback related to the BHV-7000 and Kv7 platform[7](index=7&type=chunk) [G&A Expenses](index=4&type=section&id=G%26A%20Expenses) General and Administrative expenses increased to **$19.0 million** in Q2 2024, primarily driven by higher non-cash share-based compensation expense G&A Expenses (Millions USD) | Expense Category | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | General and Administrative (G&A) | $19.0 | $14.5 | [Net Loss & EPS](index=4&type=section&id=Net%20Loss%20%26%20EPS) Biohaven reported a GAAP net loss of **$319.8 million** ($3.64 per share) for Q2 2024, with a Non-GAAP adjusted net loss of **$307.4 million** ($3.50 per share) Net Loss & EPS (Millions USD, except per share data) | Metric | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | **GAAP Net Loss** | $319.8 | $90.3 | | **GAAP Net Loss Per Share** | $3.64 | $1.32 | | **Non-GAAP Adjusted Net Loss** | $307.4 | $85.7 | | **Non-GAAP Adj. Net Loss Per Share** | $3.50 | $1.25 | [Non-GAAP Financial Measures](index=4&type=section&id=Non-GAAP%20Financial%20Measures) Non-GAAP financial measures are provided to offer a clearer view of ongoing operating performance by excluding non-cash share-based compensation and derivative fair value changes - Non-GAAP financial measures exclude non-cash share-based compensation and changes in derivative fair value for a clearer understanding of ongoing operating performance[11](index=11&type=chunk) [Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for Q2 2024 show a significant increase in operating expenses and net loss, alongside an increase in total assets and liabilities [Consolidated Statements of Operations](index=6&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For Q2 2024, total operating expenses were **$333.8 million**, resulting in a net loss of **$319.8 million**, significantly higher than the prior-year period Statement of Operations Summary (Three Months Ended June 30, In Thousands USD) | (In thousands) | 2024 | 2023 | | :--- | :--- | :--- | | Research and development | $314,819 | $79,490 | | General and administrative | $18,953 | $14,521 | | **Total operating expenses** | **$333,772** | **$94,011** | | Loss from operations | ($333,772) | ($94,011) | | Other income, net | $14,178 | $5,842 | | **Net loss** | **($319,771)** | **($90,346)** | [Consolidated Balance Sheets](index=7&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2024, total assets increased to **$582.6 million**, total liabilities rose to **$198.9 million** due to new derivative liabilities, and total shareholders' equity was **$383.7 million** Balance Sheet Summary (In Thousands USD) | (In thousands) | June 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Total current assets** | **$511,268** | **$442,446** | | **Total assets** | **$582,641** | **$513,212** | | **Total current liabilities** | **$156,207** | **$55,423** | | **Total liabilities** | **$198,901** | **$85,237** | | **Total shareholders' equity** | **$383,740** | **$427,975** | [Reconciliation of GAAP to Non-GAAP Financial Measures](index=8&type=section&id=RECONCILIATION%20OF%20GAAP%20TO%20NON-GAAP%20FINANCIAL%20MEASURES) For Q2 2024, the GAAP net loss of **$319.8 million** was adjusted to a Non-GAAP net loss of **$307.4 million** by excluding non-cash compensation and derivative fair value changes GAAP to Non-GAAP Reconciliation (Three Months Ended June 30, 2024, In Thousands USD) | (In thousands) | Amount | | :--- | :--- | | GAAP net loss | ($319,771) | | Add: non-cash share-based compensation | $12,232 | | Add: loss from change in fair value of derivatives | $110 | | **Non-GAAP adjusted net loss** | **($307,429)** |

The clinical progress, regulatory updates and pipeline developments at Biohaven's R&D Day include: Molecular Degrader of Extracellular Proteins (MoDE) Platform: Harnessing a New Modality with Transformational Potential for the Treatment of Immunological and Inflammatory Disorders The Company unveiled new positive data from its ongoing Phase 1 single ascending dose (SAD) study with BHV-1300, a first-in-human IgG degrader that uses an ASGPR-bispecific from its MoDE platform. Emerging results in healthy subjec ...

Core Insights - Biohaven Ltd. has initiated a Phase 1/2 clinical trial for BHV-1510, a novel antibody drug conjugate (ADC) targeting Trophoblast Cell Surface Antigen-2 (Trop-2), which has shown promising preclinical efficacy and safety profiles [1][3][4] - The trial will explore BHV-1510 as a monotherapy and in combination with Regeneron's anti-PD-1 therapy, Libtayo® [1][4] - The advanced forms of epithelial tissue malignancies represent a significant unmet medical need, highlighting the importance of this clinical trial [1] Company Overview - Biohaven is a global clinical-stage biopharmaceutical company focused on developing therapies for a range of diseases, including oncology [1][7] - The company is advancing a portfolio of differentiated ADCs, leveraging proprietary technologies to enhance therapeutic margins and efficacy [6][7] - Biohaven's ADC technology aims to differentiate from existing market options by utilizing advanced payloads and conjugation methods [5][6] Clinical Trial Details - The Phase 1/2 study is a multicenter, open-label trial targeting advanced or metastatic epithelial cell tumors, consisting of a dose-escalation phase followed by a multicohort expansion phase [2] - The trial is registered under NCT06384807, and additional details can be found on clinical trial registries [2] Collaboration and Development - Biohaven has entered into a clinical supply agreement with Regeneron, where Biohaven will fund the trial while Regeneron provides Libtayo [4] - The collaboration aims to efficiently explore the potential of BHV-1510 in combination with Libtayo across various tumor types [3][4] Technology and Innovation - BHV-1510 is characterized by a homogeneous drug-antibody ratio (DAR) of 4 and utilizes a unique site-specific conjugation methodology, enhancing its stability and efficacy [3][5] - The proprietary MATE™ platform technology focuses on novel conjugation chemistry, which may offer advantages over traditional methods used in the industry [6]

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Biohaven Ltd. (BHVN) has been on a downward spiral lately with significant selling pressure. After declining 32.8% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.How to Determine if a Stock is OversoldWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a s ...

Financial Performance - Biohaven reported a net loss of $179.5 million, or $2.20 per share, for Q1 2024, compared to a net loss of $70.5 million, or $1.03 per share, for the same period in 2023[11]. - Total operating expenses for Q1 2024 were $183,240,000, a significant increase of 135% compared to $77,782,000 in Q1 2023[17]. - Net loss for Q1 2024 was $179,504,000, compared to a net loss of $70,492,000 in Q1 2023, representing an increase of 154%[17]. - Basic and diluted net loss per share for Q1 2024 was $(2.20), compared to $(1.03) in Q1 2023, reflecting a 113% increase in loss per share[17]. - Non-GAAP adjusted net loss for Q1 2024 was $144,627,000, compared to $66,727,000 in Q1 2023, indicating a 116% increase[26]. - Non-GAAP adjusted net loss per share for Q1 2024 was $(1.77), compared to $(0.98) in Q1 2023, reflecting an increase of 80.6%[26]. Cash and Assets - As of March 31, 2024, cash, cash equivalents, marketable securities, and restricted cash totaled approximately $287.6 million, excluding net proceeds of approximately $247.8 million from a public offering completed on April 22, 2024[7]. - Cash and cash equivalents decreased to $182,705,000 as of March 31, 2024, down from $248,402,000 at the end of 2023[23]. - Total assets decreased to $418,532,000 as of March 31, 2024, compared to $513,212,000 at the end of 2023, a decline of 18.5%[23]. - Total liabilities increased to $117,085,000 as of March 31, 2024, up from $85,237,000 at the end of 2023, marking a rise of 37.4%[23]. Research and Development - Research and Development (R&D) expenses for Q1 2024 were $156.0 million, a significant increase of $92.5 million compared to $63.5 million in Q1 2023, primarily due to increased spending on clinical trials and preclinical research[8]. - Research and development expenses rose to $155,972,000 in Q1 2024, up 145% from $63,461,000 in the same period last year[17]. - The company initiated Phase 2 and 3 programs for BHV-7000 in epilepsy, major depressive disorder (MDD), and bipolar disorder, with ongoing late-stage pivotal trials for taldefgrobep alfa in SMA and troriluzole in obsessive-compulsive disorder (OCD)[2]. - Preliminary data from the ongoing single ascending dose study of BHV-1300 indicated safety and target engagement, with no serious adverse events reported[3]. - The company plans to accelerate development across additional autoantibody-mediated targets based on initial findings from the BHV-1300 study[4]. - Upcoming milestones include the initiation of multiple Phase 2 studies in obesity and acute migraine, as well as the advancement of the BHV-8000 TYK2/JAK1 inhibitor to Phase 2 in the second half of 2024[6]. Offerings and Designations - Biohaven completed a public offering of 6,451,220 common shares at a price of $41.00 per share, raising approximately $247.8 million in net proceeds[4]. - The FDA granted rare pediatric disease designation for taldefgrobep alfa, which may provide a priority review voucher if approved for spinal muscular atrophy (SMA)[4].