BHVN

First extracellular protein degraders in the clinic demonstrate rapid and robust pharmacodynamic effects and compelling safety in nearly 200 individuals dosed, Phase 3 trial underway Ongoing clinical progress with opakalim across multiple epilepsy types; pivotal readout on track for 2H 2026 New clinical data with BHV-1530, an FGFR3-directed ADC using a novel TopoIx payload, being presented at ESMO in October 2026; new Phase 1 data will provide clinically meaningful update to early Phase 1 data initially disclosed at R&D Day in May 2026 and will include signals of clinical activity demonstrated in ongoing Phase 1, open-label, dose-escalation study in patients with advanced solid tumors. Progress continues across broader pipeline: NEW HAVEN, Conn., August 10, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), 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 reported financial results for the second quarter ended June 30, 2026, and provided a review of recent accomplishments and anticipated upcoming developments. Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "What excites me most about Biohaven today is that we're no longer talking about scientific promise—we're watching new therapeutic approaches begin to work in patients. This year we've crossed important milestones across our portfolio, including advancing BHV-1300 into pivotal development for Graves' disease and generating compelling patient data from both our Graves' disease and IgA nephropathy programs. We believe our MoDE and TRAP platforms are doing something fundamentally different: selectively removing the proteins that drive disease while preserving normal immune function. If these data continue to translate into larger studies, extracellular protein degradation has the potential to reshape how autoimmune diseases are treated." Dr. Coric continued, "Opakalim represents another example of our commitment to solving difficult biological problems with precision. For decades, patients with epilepsy have often had to choose between seizure control and living with burdensome central nervous system side effects like somnolence, dizziness, and cognitive impairment. Our goal is to change that equation. Across studies to date, opakalim has consistently demonstrated the potential to deliver meaningful seizure reduction with a differentiated tolerability profile from existing therapies. As we approach our pivotal readout later this year, we believe we have the opportunity to introduce an important new treatment option for patients who deserve both seizure control and the ability to fully participate in their everyday lives." Second Quarter 2026 and Recent Business Highlights Presented new patient data from the MoDE platform in Graves' disease; initiated pivotal study: In May 2026, the Company presented new clinical data from an ongoing Phase 1b study of BHV-1300 in patients with Graves' disease. In the study, weekly administration of BHV-1300 1000 mg subcutaneously achieved mean reductions of pathogenic TSHR-IgG1 autoantibodies of greater than 80% by week 12 in patients with Graves' hyperthyroidism. Among participants with elevated thyroid hormones despite concurrent anti-thyroid drug therapy, normalization of free T4 occurred at a median of 3 weeks, and normalization of free T3 occurred at a median of 5 weeks after the first administration of BHV-1300. To date, BHV-1300 has been safe and well-tolerated through 12 weeks of dosing, with most AEs mild and self-resolving, no SAEs, no clinically significant increases in cholesterol or ALT/AST/bilirubin, no clinically significant reductions in albumin, and no clinically significant reductions in IgG3, IgA, IgE, or IgM relative to baseline. Based upon these Phase 1b results, we have initiated a pivotal trial of BHV-1300 in Graves' disease and expect to pursue additional follow-on studies in other autoimmune diseases. The Phase 3 study is designed to evaluate the ability of BHV-1300 to rapidly and selectively eliminate disease-causing autoantibodies while preserving the remainder of the immune system. Presented additional patient data supporting the TRAP degrader platform in IgA nephropathy: In May 2026, the Company reported updated Phase 1b data from our ongoing study of BHV-1400 in patients with IgAN. BHV-1400 administered subcutaneously achieved mean reductions of pathogenic Gd-IgA1 of greater than 60% within 48 hours and approximately 70% within the first month of dosing. These reductions were deeper than those reported for BAFF/APRIL inhibitors, APRIL inhibitors, and CD38 inhibitors at comparable early time points. Reductions in Gd-IgA1 were associated with increases in eGFR, decreases in spot UPCR, and resolution of hematuria. Effects were selective, with no clinically significant reductions in other immunoglobulins (IgA, IgG, IgE, or IgM). To date, BHV-1400 has been safe and well-tolerated throughout one month of dosing, with most AEs mild and self-resolving, no SAEs, and no clinically significant increases in ALT, AST, or bilirubin. A pivotal study is expected to initiate in 2H 2026. Continued advancement of Biohaven's extracellular degrader pipeline: Biohaven continues to expand its leadership in extracellular targeted protein degradation with multiple MoDE and TRAP programs advancing across autoimmune diseases. In addition to ongoing development of BHV-1300 in Graves' disease and BHV-1400 in IgA nephropathy, the Company continues advancing additional degrader candidates targeting IgG4-mediated disease, PLA2R autoantibodies, pro-insulin autoantibodies and other pathogenic extracellular proteins, broadening the potential impact of its proprietary platform. Presented clinical data update with opakalim (BHV-7000) across multiple epilepsy types: In May 2026 at the Company's annual R&D Day, the Company reported new clinical data for opakalim, a selective Kv7 activator, demonstrating durable seizure control and a differentiated tolerability profile across multiple epilepsy populations. In a proof-of-concept study in idiopathic generalized epilepsy (IGE), with a time-to-event design, the median time to the second generalized tonic-clonic seizure was 141 days with opakalim versus 47 days with placebo, with 33% of treated participants completing the 24-week double-blind period without a second seizure. Updated data from the ongoing open-label extension study in focal epilepsy showed that 54% of participants achieved a ≥50% reduction in seizure frequency over any consecutive six-month treatment period (n>100), while opakalim continued to demonstrate a favorable safety profile with a low incidence of CNS adverse events. Topline results from the Phase 2/3 RISE3 trial in focal epilepsy are expected during 2H 2026. Continued advancement of Biohaven's oncology portfolio: In July 2026, the Company announced that new data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC) using a novel topoisomerase I (TopoIx) payload, will be presented at the ESMO Congress 2026. The new Phase 1 data will provide a clinically meaningful update to the early Phase 1 data initially disclosed at Biohaven's R&D Day in May 2026 and will include signals of clinical activity demonstrated in the ongoing Phase 1, open-label, dose-escalation study of BHV-1530 in patients with advanced solid tumors. The data from May 27, 2026, showed early signs of antitumor activity in patients with both FGFR3-altered and wild-type overexpressing tumors, and across multiple tumor types. The Company also announced a new clinical supply agreement with Regeneron to evaluate BHV-1530 in combination with Libtayo. This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven's oncology pipeline. Completed enrollment in Phase 2 obesity study with taldefgrobep alfa: Taldefgrobep alfa targets the myostatin/activin pathway with the goal of producing high-quality weight loss while preserving lean muscle mass. Unlike therapies designed primarily to maximize weight reduction, Biohaven believes preservation of skeletal muscle may translate into greater metabolic health, improved physical function, and more durable long-term treatment outcomes. Reported first-in-human (FIH) dosing of oral PKM2 modulator, BHV-8100, targeting metabolic restoration and immunomodulation: In June 2026, the Company announced the initiation of FIH dosing for BHV-8100, its oral, brain-penetrant pyruvate kinase M2 isoform (PKM2) modulator. PKM2 modulation offers a potential new paradigm for treating large, underserved, and high-value indications in neurology, ophthalmology, and immunology and exhibits robust beneficial effects across a spectrum of preclinical models of Alzheimer's, and multiple sclerosis, specifically by restoring metabolic deficits, reducing inflammation and neurodegeneration, and enhancing remyelination. Advanced Parkinson's disease program with BHV-8000: Enrollment continues in the Company's global pivotal Phase 2/3 study evaluating BHV-8000, its orally administered, brain-penetrant, highly selective TYK2/JAK1 inhibitor for early Parkinson's disease. BHV-8000 is designed to modulate neuroinflammation, a central driver of disease progression, and peripheral immune dysregulation. Expected Upcoming Milestones: We believe Biohaven is well positioned to achieve significant milestones in the second half of 2026 across numerous programs: Selective Kv7 Ion Channel Activator (Opakalim): Continue two Phase 2/3 studies in focal epilepsy; topline results for the first study expected in 2H 2026. Myostatin-Activin Pathway Inhibitor (Taldefgrobep alfa): Completed enrollment in Phase 2 study in obesity in 1Q 2026. Lead TRAP and MoDE Extracellular Protein Degraders (BHV-1400 and BHV-1300) BHV-1300: Continue enrolling patients in ongoing Phase 3 study in Graves' disease following June 2026 study initiation. The study is a randomized, double-blind, placebo-controlled study in approximately 300 adults with Graves' hyperthyroidism evaluating normalization of T3, T4, and TSH at 26 weeks absent an antithyroid drug. BHV-1400: Pivotal study initiation in IgAN study targeted for 2H 2026. Capital Position: Cash, cash equivalents, marketable securities and restricted cash as of June 30, 2026, totaled approximately $270.5 million. Second Quarter 2026 Financial Highlights: Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $100.8 million for the three months ended June 30, 2026, compared to $184.4 million for the three months ended June 30, 2025. The decrease of $83.6 million was primarily due to decreases in direct program spend and preclinical spend in 2026 as compared to the same period in the prior year. The decrease in direct program spend was largely due to our strategic reprioritization of programs, which was implemented in the fourth quarter of 2025, as well as one-time developmental milestones recorded during the three months ended June 30, 2025 of $15.0 million and $10.0 million for our BHV-8000 and BHV-1530 programs, respectively. Non-cash share-based compensation expense was $12.0 million for the three months ended June 30, 2026, a decrease of $1.1 million as compared to the same period in 2025. General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $24.1 million for the three months ended June 30, 2026, compared to $27.3 million for the three months ended June 30, 2025. The decrease of $3.2 million was primarily due to decreased legal costs and employee costs, including non-cash share based compensation expense. Non-cash share-based compensation expense was $7.2 million for the three months ended June 30, 2026, a decrease of $0.5 million as compared to the same period in 2025. Other (Expense) Income, Net: Other (expense) income, net was other expense, net of $12.0 million for the three months ended June 30, 2026, compared to other income, net of $13.8 million for the three months ended June 30, 2025. The decrease of $25.8 million was primarily due to increased non-cash losses during the three months ended June 30, 2026 related to changes in fair value of our notes payable liability under the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the NPA), and gains recorded during the three months ended June 30, 2025 for the non-cash changes in fair value of our forward contracts and derivative liabilities recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment). Net Loss: Biohaven reported a net loss for the three months ended June 30, 2026 of $137.3 million, or $0.91 per share, compared to $198.1 million, or $1.94 per share, for the same period in 2025. Non-GAAP adjusted net loss for the three months ended June 30, 2026 was $118.1 million, or $0.78 per share, compared to $166.4 million, or $1.63 per share, for the same period in 2025. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below. Non-GAAP Financial MeasuresThis news release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted net loss and adjusted net loss per share, which are adjusted to exclude non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares, and changes in the fair value of derivative liabilities, which do not correlate to actual cash payment obligations in the relevant periods. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Biohaven believes the presentation of non-GAAP adjusted net loss and adjusted net loss per share, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance and can assist investors in comparing Biohaven's performance between periods. In addition, these non-GAAP financial measures are among those indicators Biohaven uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this news release. About BiohavenBiohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, obesity, neuroscience, and oncology. The Company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity. Forward-looking StatementsThis news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and amounts of funding under the NPA. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates and regarding reduction in annual direct R&D spend, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; the effectiveness of restructuring of business priorities; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd. Investor Contact:Jennifer PorcelliVice President, Investor [email protected] +1 (201) 248-0741 Media Contact:Christy CurranSam Brown [email protected] 615-414-8668 View original content to download multimedia:https://www.prnewswire.com/news-releases/biohaven-reports-recent-business-developments-and-second-quarter-2026-financial-results-302847335.html

It has been about a month since the last earnings report for TG Therapeutics (TGTX). Shares have lost about 5.7% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is TG Therapeutics due for a breakout? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent drivers for TG Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late. TG Therapeutics reported earnings of 17 cents per share (excluding the loss on extinguishment of debt) for the first quarter of 2026, missing the Zacks Consensus Estimate of 23 cents. The company had reported earnings of 3 cents per share in the year-ago quarter. Total revenues in the first quarter were $204.9 million, up almost 69.5% year over year, driven by strong demand for Briumvi. The figure beat the Zacks Consensus Estimate of $199 million. The top line comprised product sales from Briumvi and license, royalty and other revenues. Total product revenues were $201.3 million in the first quarter, reflecting 68.2% year-over-year increase. Briumvi’s net product sales in the United States were $194.8 million in the first quarter, up 63% year over year. Sales of the drug came in ahead of management’s guided range of $185-$190 million. Sales of Briumvi to Neuraxpharm were $6.5 million in the quarter and included in total product revenues. License, milestone, royalty and other revenues were $3.6 million in the first quarter, compared with $1.2 million reported in the year-ago quarter. Research and development (R&D) expenses (excluding non-cash compensation) rose around 1.2% year over year to $43.5 million due to higher expenses related to ongoing clinical studies. Selling, general and administrative (SG&A) expenses (excluding non-cash compensation) totaled $73.1 million, up almost 88.9% from the year-ago quarter’s level, due to higher commercialization costs for Briumvi as well as other personnel costs. As of March 31, 2026, TG Therapeutics had cash, cash equivalents and investments worth $572.8 million compared with $199.5 million as of Dec. 31, 2025. TG Therapeutics raised its total revenue guidance. The company now expects worldwide total revenues of around $925 million in 2026, including net product revenues of $885-$900 million from Briumvi sales in the United States. Previously, the company expected total revenues in the range of $875 million to $900 million in 2026, including net product revenues of $825-$850 million from Briumvi sales in the United States. In the second quarter of 2026, net product revenues from Briumvi sales in the United States are expected to be $220 million. Excluding non-cash compensation, total operating expenses, defined as R&D and SG&A, are expected to be around $350 million in 2026, unchanged from the previous expectation. Since the earnings release, investors have witnessed a upward trend in estimates revision. The consensus estimate has shifted 58.48% due to these changes. At this time, TG Therapeutics has a subpar Growth Score of D, however its Momentum Score is doing a lot better with a B. However, the stock was allocated a grade of D on the value side, putting it in the bottom 40% for this investment strategy. Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been trending upward for the stock, and the magnitude of these revisions looks promising. Interestingly, TG Therapeutics has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. TG Therapeutics belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Biohaven Ltd. (BHVN), has gained 17% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026. Biohaven Ltd. reported revenues of $0 million in the last reported quarter, representing a year-over-year change of 0%. EPS of -$0.88 for the same period compares with -$2.17 a year ago. For the current quarter, Biohaven Ltd. is expected to post a loss of $0.77 per share, indicating a change of +60.3% from the year-ago quarter. The Zacks Consensus Estimate has changed +2.4% over the last 30 days. Biohaven Ltd. has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of D. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report TG Therapeutics, Inc. (TGTX) : Free Stock Analysis Report Biohaven Ltd. (BHVN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

A month has gone by since the last earnings report for Myriad Genetics (MYGN). Shares have added about 7.1% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Myriad due for a pullback? Well, first let's take a quick look at the latest earnings report in order to get a better handle on the recent drivers for Myriad Genetics, Inc. before we dive into how investors and analysts have reacted as of late. Myriad Genetics, Inc. reported first-quarter 2026 adjusted loss of 9 cents per share, compared with the Zacks Consensus Estimate of 6 cents. The reported figure came wider than the year-ago period’s loss of 3 cents per share. Adjusted earnings exclude amortization expenses from acquired intangible assets, equity compensation and real estate optimization. GAAP loss per share came in at 36 cents in the quarter compared with the prior-year quarter’s flat earnings. MYGN’s Revenues Total revenues rose 2% year over year to $200.4 million but missed the Zacks Consensus Estimate by 1.09%. Testing volumes remained stable in the quarter. Detailed Breakdown of MYGN’s Q1 Revenues The Cancer Care Continuum business delivered $120.2 million in revenues in the first quarter of 2026, up 4% year over year.  Within this, hereditary cancer testing revenue increased 5%, driven by a 14% increase in volume. Prolaris testing revenue grew 3% year over year. The Prenatal Health business revenues dropped 15% year over year to $41.9 million. This was due to a 12% decline in volume decreased, reflecting a difficult prior year comparison as the company continues to engage with customers and address the disruption caused by the 2025 second-quarter implementation of its new order management system. Meanwhile, the GeneSight test revenues within Mental Health grew 24% year over year, reflecting 7% volume growth, and overall improved reimbursement trends. MYGN’s Q1 Margin Performance The gross margin rose 16 basis points (bps) to 68.7% due to a 1.8% increase in the cost of revenues. Research and development expenses dropped 1.5% year over year to $27.1 million. Sales and marketing expenses rose 6.4% to $74 million in the reported quarter. General and administration expenses were $62.2 million, down 6.5% year over year. The adjusted operating loss was $25.3 million compared with a loss of $29 million in the year-ago quarter. MYGN’s Financial Position Myriad Genetics exited the first quarter of 2026 with cash and cash equivalents of $124.4 million compared with $149.6 million at the end of 2025. Long-term debt amounted to $120.3 million, compared with $119.9 million at the 2025-end. The cumulative net cash outflow from operating activities at the end of the reported quarter was $15.7 million compared with an outflow of $16.3 million in the year-ago period. Myriad Genetics’ 2026 Guidance Myriad Genetics continues to project full-year 2026 revenues to be $860 - $880 million. The Zacks Consensus Estimate is pegged at $861.9 million. Full-year adjusted gross margin is expected to be in the 68%-69% range. Adjusted EBITDA is forecasted in the $37-$49 million band. Investors have witnessed a downward trend in estimates review over the past two months. The consensus estimate has shifted 11.11% due to these changes. Currently, Myriad has a great Growth Score of A, though it is lagging a bit on the Momentum Score front with a B. Charting a somewhat similar path, the stock has a grade of C on the value side, putting it in the middle 20% for value investors. Overall, the stock has an aggregate VGM Score of A. If you aren't focused on one strategy, this score is the one you should be interested in. Myriad has a Zacks Rank #2 (Buy). We expect an above average return from the stock in the next few months. Myriad belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Biohaven Ltd. (BHVN), has gained 7.7% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026. Biohaven Ltd. reported revenues of $0 million in the last reported quarter, representing a year-over-year change of 0%. EPS of -$0.88 for the same period compares with -$2.17 a year ago. For the current quarter, Biohaven Ltd. is expected to post a loss of $0.77 per share, indicating a change of +60.3% from the year-ago quarter. The Zacks Consensus Estimate has changed +4% over the last 30 days. Biohaven Ltd. has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of C. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Myriad Genetics, Inc. (MYGN) : Free Stock Analysis Report Biohaven Ltd. (BHVN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Biohaven to update clinical, regulatory, and operational progress at annual R&D Day at the upcoming Yale Innovation Summit on May 27, 2026. Advancement of high-value, late-stage priority programs: Pivotal epilepsy program with selective Kv7 ion channel activator, opakalim, with expected topline results in 2H 2026. Phase 2 obesity study with myostatin-activin pathway inhibitor, taldefgrobep alfa, completed enrollment and topline data expected in 2H 2026. TRAP™ and MoDE™ Degraders Advancing to Pivotal Trials Pivotal trials in both IgA nephropathy (IgAN) with Gd-IgA1 TRAP degrader, BHV-1400, and Graves' disease with IgG MoDE degrader, BHV-1300, expected to initiate by mid-year. Sustained progress across development pipeline: Enrollment in Phase 2 early Parkinson's disease trial with brain-penetrant TYK2/JAK1 inhibitor, BHV-8000, continues to advance. Enrollment advances in advanced endometrial cancer expansion cohort with the next-generation TROP-2 directed ADC BHV-1510 in combination with Libtayo®. Dose escalation advances with BHV-1530, a first-in-class FGFR3-directed antibody-drug conjugate (ADC). No dose-limiting toxicities observed to date. A total of 5 abstracts, including 1 oral presentation and 4 posters, featured at the American Academy of Neurology ("AAN") Annual Meeting Highlight's Biohaven leadership, innovative science, and development programs evaluating novel therapies to treat neurological and immunological diseases, including Kv7 ion channel activation, extracellular protein degradation, and TYK2/JAK1 inhibition. NEW HAVEN, Conn., May 4, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), 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 reported financial results for the first quarter ended March 31, 2026, and provided a review of recent accomplishments and anticipated upcoming developments. Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "We are planning for a transformative year ahead at Biohaven, with multiple potential value-driving milestones on the horizon. In the coming several weeks, we expect the initiation of our pivotal clinical trials to advance our novel MoDE and TRAP extracellular protein degradation platform into two pivotal studies, BHV-1300 for Graves' disease and BHV-1400 for IgA nephropathy. These pivotal trials represent a key milestone for the degrader platform and further extends the clinical validation of our strategy to selectively degrade disease-causing proteins with our precision immunology technology. In the second half of 2026, we expect to report pivotal data from our epilepsy program and topline results from our obesity program." Dr. Coric continued, "Additionally, our first-in-class FGFR3-directed ADC, BHV-1530, continues dose escalation with no dose-limiting toxicities observed to date, and we have begun an expansion cohort in advanced endometrial cancer with our next-generation TROP-2 directed ADC BHV-1510 in combination with Libtayo. We are also excited about progress with our TYK2/JAK1 inhibitor for early Parkinson's disease and continue to advance enrollment in this trial. Finally, our thought leadership in neurology was on display last month at AAN, where we notably delivered a total of 5 oral presentations and posters highlighting our differentiated neuroscience and immunoscience portfolio. Though our approach has been marked by a disciplined and careful management of resources, we are pleased with progress achieved in recent months and look forward to sharing more detailed and robust updates across our portfolio at our annual R&D Day at the Yale Innovation Summit on May 27, 2026 in New Haven, Connecticut." First Quarter and Recent Business Updates First Quarter 2026 and Recent Business Highlights Completed Enrollment in Phase 2 Obesity Study with Taldefgrobep Alfa – Taldefgrobep alfa, a myostatin-activin pathway inhibitor, offers the potential to achieve high-quality weight loss in people living with obesity. Biohaven initiated a taldefgrobep Phase 2 proof-of-concept study in obesity in 4Q 2025. This randomized, placebo-controlled dose-ranging study is evaluating the efficacy and tolerability of once-weekly and once-monthly taldefgrobep as monotherapy, via self-administered autoinjector, in adults living with overweight and obesity. Topline data from the study are expected in 2H 2026. Oral and poster presentations at AAN underpinned breadth of development work across core programs - In April 2026, the Company delivered 1 oral presentation and 4 posters at the AAN Annual Meeting, showcasing development programs including Kv7 ion channel activation, extracellular protein degraders, and TYK2/JAK1 inhibition. Expected Upcoming Milestones: We believe Biohaven is well positioned to achieve significant, value-creating milestones in 2026 across numerous programs: Selective Kv7 Ion Channel Activator (Opakalim): Continue two Phase 2/3 studies in focal epilepsy; initial topline results for the first study expected in 2H 2026. Myostatin-Activin Pathway Inhibitor (Taldefgrobep alfa): Completed enrollment in Phase 2 study in obesity in 1Q 2026; topline results expected in 2H 2026. Lead TRAP and MoDE Extracellular Protein Degraders (BHV-1400 and BHV-1300) BHV-1400: Pivotal study initiation in IgAN study expected mid-year 2026 BHV-1300: Pivotal study initiation in Graves' disease expected mid-year 2026. Capital Position: Cash, cash equivalents, marketable securities and restricted cash as of March 31, 2026, totaled approximately $351.8 million. First Quarter 2025 Financial Highlights: Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $103.8 million for the three months ended March 31, 2026, compared to $187.6 million for the three months ended March 31, 2025. The decrease of $83.8 million was primarily due to decreases in direct program and preclinical spend, and non-cash share-based compensation expense in 2026 as compared to the same period in the prior year. The decrease in direct program spend was largely due to our strategic reprioritization of programs which was implemented in the fourth quarter of 2025. The decrease in R&D expense included a $17.0 million decrease in preclinical research programs, which was primarily due to an upfront share payment valued at $4.9 million and an accrual for an upfront cash payment of $5.0 million related to agreements entered into during the three months ended March 31, 2025. General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $26.6 million for the three months ended March 31, 2026, compared to $34.0 million for the three months ended March 31, 2025. The decrease of $7.4 million was primarily due to decreased non-cash share-based compensation expense. Non-cash share-based compensation expense was $9.8 million for the three months ended March 31, 2026, a decrease of $8.0 million as compared to the same period in 2025. Non-cash share-based compensation expense was lower in 2026 primarily due to our annual equity incentive awards granted in the first quarter of 2026, which had a lower grant date fair value per share than the annual awards granted in the first quarter of 2025. Other (Expense) Income, Net: Other (expense) income, net was other expense, net of $0.2 million for the three months ended March 31, 2026, compared to other income, net of $0.5 million for the three months ended March 31, 2025. The decrease of $0.3 million was primarily due to non-cash losses related to changes in fair value of our notes payable liability under the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the NPA), and decreased investment income during the three months ended March 31, 2026, which was partially offset by losses recorded for the non-cash changes in the fair value of our forward contracts and derivative liabilities in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment) during the three months ended March 31, 2025. Net Loss: Biohaven reported a net loss for the three months ended March 31, 2026 of $130.5 million, or $0.88 per share, compared to $221.7 million, or $2.17 per share, for the same period in 2025. Non-GAAP adjusted net loss for the three months ended March 31, 2026 was $102.2 million, or $0.69 per share, compared to $166.8 million, or $1.64 per share, for the same period in 2025. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below. Non-GAAP Financial Measures This news release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted net loss and adjusted net loss per share, which are adjusted to exclude non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares, and changes in the fair value of derivative liabilities, which do not correlate to actual cash payment obligations in the relevant periods. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Biohaven believes the presentation of non-GAAP adjusted net loss and adjusted net loss per share, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance and can assist investors in comparing Biohaven's performance between periods. In addition, these non-GAAP financial measures are among those indicators Biohaven uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this news release. About Biohaven Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The Company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity. Forward-looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and amounts of funding under the NPA. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates and regarding reduction in annual direct R&D spend, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; the effectiveness of restructuring of business priorities; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd. Libtayo is a registered trademark of Regeneron Pharmaceuticals, Inc. Investor Contact: Jennifer Porcelli Vice President, Investor Relations [email protected] +1 (201) 248-0741 Media Contact: Christy Curran Sam Brown Inc. 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Prioritizing three key, late-stage clinical programs including Molecular Degrader of Extracellular Proteins (MoDETM) and Targeted Removal of Aberrant Protein (TRAPTM) extracellular protein degradation for immunological diseases, Kv7 ion channel modulation for epilepsy; and myostatin-activin pathway targeting obesity: Inflammation and Immunology: Graves' Disease: First-in-patient clinical experience with IgG MoDE degrader BHV-1300 resulted in complete suppression of disease-causing TSH receptor-stimulating antibodies, normalization of previously elevated thyroid hormones within weeks after dosing a patient with Graves' disease. BHV-1300 has shown the potential for best-in-class reductions of IgG, with maximum reductions of up to an 87% decrease from baseline within weeks of dosing in a study conducted in healthy volunteers. The Company intends to initiate a pivotal study with BHV-1300 in Graves' disease in the second half of 2026. IgA Nephropathy (IgAN): First dosing of BHV-1400 TRAP degrader in IgAN patients achieved early observations of both biomarker and clinical responses. BHV-1400 previously achieved rapid lowering of Gd-IgA1 with a mean reduction of >60% within hours and maximum reduction exceeding 80% in a study conducted in healthy volunteers. A pivotal study is set to initiate in the first quarter of 2026. Ion Channel: Epilepsy: In an ongoing open-label extension study of Biohaven's selective Kv7 channel activator, the majority of participants who completed at least 6 months of open-label extension (OLE) treatment with opakalim 75 mg once daily showed ≥50% reductions in seizure frequency compared to pretreatment baseline. Opakalim was well-tolerated in the OLE with a low incidence of central nervous system adverse events, representing a potential paradigm-shift for patients with a highly favorable and differentiated safety profile compared to other approved or investigational antiseizure medicines. Pivotal results for opakalim in the treatment of focal epilepsy are expected in the second half of 2026. Myostatin-Activin: Obesity: In 4Q 2025, Biohaven initiated a Phase 2 study in people living with overweight and obesity, with topline results expected in the second half of 2026. The study is evaluating the ability of taldefgrobep, administered once-weekly or once-monthly via autoinjector, to achieve high quality weight loss including reducing fat mass and total body weight while also increasing lean muscle mass. Disciplined approach to balance sheet management and capital preservation in place, as we continue positioning the portfolio for future value creation, including ongoing evaluation of potential strategic opportunities with non-priority programs: Broader Degrader Portfolio: With clinical proof-of-concept now established, Biohaven is positioned to advance multiple next-generation extracellular protein degraders targeting high value immune-mediated disease indications and explore strategic partnerships to advance the breadth of this platform technology. Potential applications include BHV-1420 in membranous nephropathy, BHV-1450 in pemphigus vulgaris, myasthenia gravis, and encephalitis, BHV-1440 in Graves' disease and thyroid eye disease, BHV-6500 in type 1 diabetes, BHV-1490 in cryoglobulinemia, Waldenstrom's macroglobulinemia and IgM neuropathy, BHV-1310 for management of rare IgG-mediated indications, and various additional undisclosed degraders. Highly differentiated, next-generation antibody drug conjugate (ADC) portfolio: Phase 1/2 study evaluating BHV-1510 (Trop2 ADC) as monotherapy and in combination with Regeneron's anti-PD-1 monoclonal antibody cemiplimab shows continued clinical activity with confirmed responses in non-small cell lung cancer, endometrial cancer, and urothelial cancer with a differentiated safety profile in the ongoing study. BHV-1510 is the first and only Trop2 ADC in clinic with potential subcutaneous route of administration. Additionally, first-in-class FGFR3 directed ADC, BHV-1530, continues with dose escalation and no dose limiting toxicities to date. TYK2/JAK1 inhibition: Pivotal clinical trial evaluating Biohaven's brain-penetrant TYK2/JAK1 inhibitor for the treatment of early Parkinson's disease continues to advance enrollment. Cash, cash equivalents, marketable securities and restricted cash as of December 31, 2025, totaled approximately $322.0 million. Subsequent to December 31, 2025, the Company issued and sold an additional 17.2 million common shares for net proceeds of $178.9 million, including a directed common share sale to Janus Henderson Investors as a block transaction under the Company's "at-the-market" offering program. NEW HAVEN, Conn., March 2, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), 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 reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a review of recent accomplishments and anticipated upcoming developments. Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "We made significant progress over the past year in advancing our pipeline of innovative therapies, particularly with our revolutionary degrader platform, the central pillar of our long-term strategic focus in immunology and inflammation. Biohaven is a leader in the field of targeted extracellular protein degradation with our MoDE and TRAP degraders, with a technology borne out of ground-breaking science exclusively licensed from Yale and developed internally by our impressive discovery engine. MoDE and TRAP degraders have demonstrated the ability to rapidly, profoundly, and selectively target the root causes of disease without compromising patients' healthy immune functions. To date, we have established strong IP across multiple disease targets, advanced next-generation drug candidates, developed easy-to-use autoinjectors, and, most critically, provided proof of concept with a robust body of evidence in non-clinical studies as well as in healthy volunteers and patients. Our degrader portfolio possesses the potential to address an array of well-validated targets with highly differentiated mechanisms of action, reinforcing our confidence in this platform as a meaningful driver of future value creation, and we have the unique opportunity to be the first to market with this innovative technology." "In parallel, we advanced other key programs that underscore the breadth and balance of our pipeline. Our selective Kv7 program is an extremely promising approach for treating focal epilepsy, which has the potential to address the significant unmet medical need for a novel efficacious antiseizure medicine that is easy-to-use, does not burden patients with central nervous system (CNS) side effects like dizziness and somnolence, and does not make their comorbidities worse. In fact, we were very excited to report preliminary data demonstrating strong signals of efficacy from our ongoing open label extension (OLE) trial of opakalim, including improvements in seizure frequency greater than or equal to 50% in the majority of participants treated with opakalim 75 mg once daily for at least six months in the OLE, coupled with an exceptional tolerability profile. We are on track to deliver pivotal topline data from this program this year. Shifting to our third and final key strategic focus area, with our myostatin-activin pathway inhibitor, taldefgrobep alfa, we are now exploring the opportunity to address critical gaps in the treatment of obesity. Specifically, taldefgrobep is designed to directly target fat, build muscle and increase bone density while avoiding the intolerable adverse effects that occur with other myostatin-activin inhibitors. We look forward to reporting topline data with this exciting program this year. Together, these assets reflect our focus on pursuing scientifically rigorous programs with the potential to deliver impactful therapies to patients, and critical milestones are on the horizon this year for all three of these core programs." Matt Buten, Biohaven's Chief Financial Officer, added, "Though progress across our portfolio was demonstrable, we redoubled efforts to execute with a renewed emphasis on financial discipline. During the final quarter of 2025, we initiated strategic portfolio and cost-optimization measures, carefully prioritized investments, aligned spending with clear development milestones, and maintained a prudent approach to capital allocation. This disciplined approach positions Biohaven to advance these three key programs with the highest probability of generating near term value efficiently while preserving flexibility to opportunistically support sustained innovation in our oncology portfolio and with other emerging targets." Full Year and Recent Business Updates Corporate updates: Initiated strategic cost optimization efforts across portfolio in 4Q 2025 to focus forward-looking spend on three value-driving, late-stage clinical programs that will prioritize resources: Lead TRAP and MoDE extracellular degraders, for IgA nephropathy (BHV-1400) and Graves' disease (BHV-1300); Opakalim, selective Kv7 ion channel activator, in pivotal studies for focal epilepsy; and Taldefgrobep alfa, myostatin-activin pathway inhibitor, in Phase 2 for obesity. In November 2025, we announced a restructuring of business priorities and an optimization of resource allocation, expected to achieve an approximately 60% reduction in annual direct R&D spend (which excludes personnel and share-based compensation). The fourth quarter results that we are releasing today reflect the commencement of those restructuring and optimization efforts. Subsequently, in 2026, we have reported positive early clinical experience from clinically validated, extracellular protein degraders using our proprietary MoDE and next-generation, highly selective TRAP degraders. In addition, subsequent to December 31, 2025, the Company issued and sold an additional 17.2 million common shares for net proceeds of $178.9 million, including a directed common share sale to Janus Henderson Investors as a block transaction under the Company's "at-the-market" offering program. As reported today, we are accelerating pivotal degrader trials using our proprietary MoDE and next-generation, highly selective TRAP degraders. We continue to expect that the restructuring and optimization efforts that we commenced in the fourth quarter of 2025 will lead to a reduction in annual direct R&D spend, although the acceleration of these trials is expected to reduce the level of that reduction. Continued pipeline advancement and ongoing business activities through capital raising initiatives: In 2026, the Company issued and sold 17.2 million common shares for net proceeds of $178.9 million, including a $125 million in gross proceeds directed common share sale to Janus Henderson Investors as a block transaction under the Company's "at-the-market" offering program. In November 2025, the Company generated gross proceeds of approximately $200 million in an upsized public offering of common shares. In April 2025, the Company announced an investment of up to $600 million by Oberland Capital, comprised of $250 million funded at closing, $150 million available at the Company's option upon the achievement of regulatory milestones related to troriluzole, and up to $200 million available at the mutual agreement of the parties for permitted strategic acquisitions and related costs and expenses. Entered into MoU with KAUST: In January 2026, Biohaven entered into a memorandum of understanding (MoU) with the King Abdullah University of Science and Technology (KAUST) to collaborate on discovery efforts and leverage the University's technology capabilities including strengths in its Smart Health initiatives, generative AI, and supercomputing. The agreement was established as part of an initiative to further advance and accelerate next-generation degrader development. Key program updates: Gd-IgA1 TRAP Degrader (BHV-1400) and IgG MoDE Degrader (BHV-1300) Biohaven MoDE and TRAP extracellular protein degraders harness selectivity, rapidity and patient-friendly self-administration to remove disease-causing proteins from the body to potentially treat a range of diseases. Each MoDE or TRAP degrader is a novel bispecific molecule that targets a specific form of disease-causing circulating protein and directs it to the liver for degradation by the endosomal/lysosomal pathway. IgAN Program: In January 2026, first dosing of TRAP degrader BHV-1400 in IgAN patients achieved early observations of both biomarker and clinical responses including: selective lowering of only the disease-causing galactose-deficient IgA1 (Gd-IgA1) while sparing off-target effects on healthy antibodies (IgA, IgM, IgE, IgG), resolution of blood in the urine (hematuria), deep reductions in proteinuria, and improvement in fatigue and kidney function (eGFR) within weeks. In May 2025, the Company shared results from the ongoing Phase 1 study in healthy volunteers, in which a single dose of BHV-1400 was subcutaneously administered at a dose of 500 mg and achieved rapid, deep and sustained reductions in Gd-IgA1 of up to 81%, with a median reduction of 66%. Reductions occurred within hours of each dose, were progressive, and were sustained for weeks after a single dose administration. Effects were selective, with no significant reductions observed in other immunoglobulins: IgA, IgG, IgE, or IgM. The pivotal IgAN study is expected to initiate in the first quarter of 2026. Graves' Disease Program: In January 2026, the Company announced first-in-patient clinical experience with IgG MoDE degrader BHV-1300 resulted in a complete suppression of disease-causing TSH receptor-stimulating antibodies with accompanying normalization of previously elevated thyroid hormones within weeks after dosing a patient with Graves' disease. In May 2025, the Company released positive data from its Phase 1 multiple-dose study in healthy volunteers, whereby SC administered BHV-1300 achieved IgG reductions up to 87%. Median maximum reductions of 83% were achieved within 18 days. Biohaven is planning a pivotal study of BHV-1300 in Graves' disease in the second half of 2026. Broad Degrader Portfolio: With clinical proof-of-concept now established, Biohaven is positioned to advance multiple next-generation degraders targeting high value immune-mediated disease indications and explore strategic partnerships to advance the breadth of this platform technology, including: BHV-1420, a PLA2R autoantibody specific TRAP degrader, for membranous nephropathy; BHV-1450, an IgG4 specific MoDE degrader, for potential indications including pemphigus vulgaris and myasthenia gravis with anti-MuSK antibodies; BHV-1440, a TSHR autoantibody specific TRAP degrader, as the next-generation of immune therapy for Graves' disease and thyroid eye disease; BHV-6500, a proinsulin and insulin autoantibody TRAP degrader, for type 1 diabetes; BHV-1490, an IgM MoDE degrader for cryoglobulinemia, Waldenstrom's macroglobulinemia and IgM neuropathy; BHV-1310, a next generation IgG MoDE degrader, for management of rare IgG-mediated indications; BHV-1600, a beta-1 adrenergic receptor autoantibody degrader, for cardiomyopathy; and, Multiple undisclosed degrader targets in early discovery development. Opakalim Next-generation, selective Kv7 activator, targeting a clinically validated mechanism of action for the treatment of epilepsy. Focal Epilepsy Program: In January 2026, the Company announced preliminary data from the ongoing OLE study in focal epilepsy, demonstrating clinically meaningful reductions in seizure frequency compared to pretreatment baseline. Specifically, the majority of participants treated with opakalim 75 mg once daily who completed at least six months of OLE treatment showed ≥50% reductions in seizure frequency compared to pretreatment baseline. Opakalim was well-tolerated in the OLE with a low incidence of CNS adverse events, representing a potential paradigm-shift for patients with a highly favorable and differentiated safety profile compared to other approved or investigational antiseizure medicines. Top‑line results from the first of two pivotal studies of opakalim in the treatment of focal epilepsy are expected in the second half of 2026. Taldefgrobep alfa Novel inhibitor of the myostatin-activin signaling pathway with the potential to achieve high quality weight loss in people living with obesity. Obesity Program: Biohaven initiated a taldefgrobep Phase 2 proof-of-concept study in obesity in 4Q 2025; topline results are expected in the second half of 2026. This randomized, double-blind, placebo-controlled, 24-week, dose-ranging study is evaluating the efficacy and tolerability of once-weekly and once-monthly taldefgrobep as monotherapy, via self-administered autoinjector, in adults living with overweight and obesity. Taldefgrobep's differentiated mode of action targets fat reduction, building muscle, and increasing bone density. In a Phase 1 study, taldefgrobep has demonstrated beneficial changes in fat mass and lean mass in non-obese populations, including healthy adult participants. Participants who received taldefgrobep once-weekly realized significant reductions in total body fat mass (>6%) and increases in lean muscle mass (up to 4%) after one month of dosing. These body composition parameters continued to demonstrate additional improvements after cessation of dosing associated with the persistence of the pharmacologically active taldefgrobep-myostatin complex, suggesting the drug may support extended dosing intervals. Nonclinical data demonstrated that the complex can also potently inhibit the Activin E-ALK7 signaling axis within adipocytes, further underpinning the complementary mechanistic advantages of taldefgrobep in both growing muscle and reducing fat. Taldefgrobep has demonstrated a highly favorable safety and tolerability profile in >700 clinical trial participants studied to date. Other pipeline updates: As previously disclosed in 4Q 2025, development of programs outside of the key prioritized programs outlined above may be substantially downsized, paused or delayed as a result of the Company's strategic reprioritization. Antibody Drug Conjugates (ADCs) BHV-1510 is a next-generation ADC targeting TROP2-expressing carcinomas, or malignant neoplasms of epithelial origin. BHV-1530 is an FGFR3-directed ADC with potential indications in urothelial cancers and other solid tumors. BHV-1510: In December 2025, the Company presented data from the ongoing BHV1510-101 trial at the ESMO Immuno-Oncology Congress. BHV-1510, demonstrated encouraging early clinical activity and differentiated safety profile in a Phase 1 study in combination with the anti-PD-1 cemiplimab: In a pretreated population of participants with advanced/metastatic cancer and the majority with prior PD-(L)1 treatment, BHV-1510 2.5 mg/kg Q3W plus cemiplimab resulted in confirmed objective response rates 3/5 (60%) in non-small cell lung cancer (NSCLC), 4/4 (100%) in endometrial cancer, and 1/2 (50%) in urothelial cancer. There were low rates of adverse events attributed to unconjugated payload such as hematological toxicities and diarrhea, and there were no cases of interstitial lung disease, showing a differentiated safety profile of BHV-1510 from other Trop2 ADCs. The most frequent toxicity observed was oral mucositis/stomatitis. This is a well-known class effect which is manageable. The pharmacokinetic profile for BHV-1510 was favorable, the unconjugated payload concentration is low, indicating a highly stable ADC in the circulation. In January 2026, the Company announced the initiation of subcutaneous administration with BHV-1510, the first and only Trop2 ADC in clinic with the potential for subcutaneous delivery. BHV-1530: In December 2025, the Company noted that dose escalation continues in the ongoing Phase 1 study; no dose limiting toxicities have been observed to date. The study is evaluating BHV-1530 in patients with advanced solid tumors, including patients whose cancers have progressed on or are intolerant to standard therapy. TYK2/JAK1 Inhibition BHV-8000 is an oral, brain-penetrant, selective TYK2/JAK1 inhibitor with broad potential for neuroinflammatory and neurodegenerative disorders. Parkinson's disease (PD): Aligned with our current portfolio prioritization, a more focused execution plan concentrating on a select number of sites in the US has been implemented for the ongoing Phase 2/3 clinical trial in early Parkinson's disease to optimize efficiency and resource allocation. Biohaven Discovery Engine: Discovery has advanced multiple novel development candidates for future clinical development. Beyond the degrader platform, these include: BHV-1955 targeting the oxytocin receptor centrally for the treatment of tinnitus; BHV-2120, a brain-penetrant, oral, small molecule TRPM3 inhibitor for epilepsy; BHV-8555, a brain-penetrant, oral, small molecule preventing alpha-synuclein aggregation in Parkinson's disease; and, BHV-8100, a brain-penetrant, oral, small molecule activating the M2 isoform of pyruvate kinase (PKM2) for neurodegenerative disorders and aging. Expected Upcoming Milestones: We believe Biohaven is well positioned to achieve significant, value-creating milestones in 2026 across numerous programs: Lead TRAP and MoDE Extracellular Protein Degraders (BHV-1400 and BHV-1300) BHV-1400: Completed 4Q25 meeting with the U.S. Food and Drug Administration (FDA) to align on pivotal IgAN study design; study to initiate in 1Q 2026 BHV-1300: Pivotal study initiation in Graves' disease expected in 2H 2026. Kv7 Activator (Opakalim): Continue two Phase 2/3 studies in focal epilepsy; initial topline results expected in the second half of 2026. Myostatin-Activin Pathway Inhibitor (Taldefgrobep alfa): Initiated Phase 2 study in obesity in 4Q 2025; topline results expected in the second half of 2026 Capital Position: Cash, cash equivalents, marketable securities and restricted cash as of December 31, 2025, totaled approximately $322.0 million. Subsequent to December 31, 2025, the Company issued and sold an additional 17.2 million common shares for net proceeds of $178.9 million and made a $42.7 million payment to Knopp Biosciences LLC (Knopp) to settle the 2025 Additional Consideration True-Up liability recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp in May 2024 (the Knopp Amendment). Fourth Quarter 2025 Financial Highlights: Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $121.9 million for the three months ended December 31, 2025, compared to $167.5 million for the three months ended December 31, 2024. The decrease of $45.5 million was primarily due to decreases in direct program spend, largely related to BHV-2100, opakalim and BHV-1530, which were partially offset by a $12.0 milestone payment for BHV-1510 during the fourth quarter of 2025 as well as increased program spend for our lead degraders, BHV-1300 and BHV-1400. The decrease in direct spend for BHV-1530 was primarily due to a one-time upfront payment of $6.0 million cash and non-cash issuance of common shares valued at $8.6 million for a development and license agreement entered into in the fourth quarter of 2024. Non-cash share-based compensation expense was $10.5 million for the three months ended December 31, 2025, an increase of $3.4 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025. General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $20.8 million for the three months ended December 31, 2025, compared to $22.5 million for the three months ended December 31, 2024. The decrease of $1.7 million was primarily due decreased personnel costs, excluding non-cash share based compensation. Non-cash share-based compensation expense was $6.5 million for the three months ended December 31, 2025, an increase of $0.8 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025. Other (Expense) Income, Net: Other (expense) income, net was other expense, net of $2.5 million for the three months ended December 31, 2025, compared to other income, net of $3.1 million for the three months ended December 31, 2024. The decrease of $5.6 million was primarily due to an increase in losses recorded for the change in the fair value the 2025 Additional Consideration True-Up derivative liability, decreased investment income, and a loss recognized on the impairment of a purchased loan commitment asset recorded in connection with the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the NPA). These decreases were partially offset by an increase in gains related to changes in fair value of our notes payable liability under the NPA. Net Loss: Biohaven reported a net loss for the three months ended December 31, 2025 of $145.6 million, or $1.21 per share, compared to $186.8 million, or $1.85 per share, for the same period in 2024. Non-GAAP adjusted net loss for the three months ended December 31, 2025 was $107.9 million, or $0.90 per share, compared to $173.3 million, or $1.71 per share, for the same period in 2024. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below. Full Year 2025 Financial Highlights R&D Expenses: R&D expenses, including non-cash share-based compensation, were $635.1 million for the year ended December 31, 2025, compared to $795.9 million for the year ended December 31, 2024. The decrease was primarily due to a one-time non-cash expense during the year ended December 31, 2024 of $171.9 million paid in connection with the Knopp Amendment (the Knopp Amendment reduced our potential future milestone payments by $867.5 million and replaced the scaled high single digit to low teens royalty payment obligations with a flat royalty payment in the mid-single digits for the Kv7 programs). The decrease was also due to decreased program expense for BHV-2000, troriluzole, and opakalim. These decreases were partially offset by increased direct program spend for advancing clinical trials and preclinical research programs in 2025, including one-time developmental milestone payments of $15.0 million, $12.0 million, and $10.0 million for our BHV-8000, BHV-1510 and BHV-1530 programs, respectively, as well as increased non-cash share-based compensation expense. Non-cash share-based compensation expense was $72.8 million for the year ended December 31, 2025, an increase of $30.2 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025. G&A Expenses: G&A expenses, including non-cash share-based compensation costs, were $110.3 million for the year ended December 31, 2025, compared to $89.2 million for the year ended December 31, 2024. The increase of $21.1 million was primarily due to increased non-cash share-based compensation expense and increased expenses related to fees incurred in connection with the NPA and other legal costs. Non-cash share-based compensation expense was $39.6 million for the year ended December 31, 2025, an increase of $10.2 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025. Other Income (Expense), Net: Other income, net was other income of $8.0 million for the year ended December 31, 2025, compared to other income of $39.4 million for the year ended December 31, 2024. The decrease of $31.4 million was primarily due to an increase in losses recorded for the non-cash changes in the fair value of our forward contracts and derivative liabilities recorded in connection with the Knopp Amendment, decreased investment income, and other expense recognized to write-off an impaired asset related to the NPA during the year ended December 31, 2025. This was partially offset by an increase in non-cash gains related to changes in fair value of our notes payable liability under the NPA. Net Loss: The Company reported a net loss attributable to common shareholders for the year ended December 31, 2025 of $738.8 million, or $6.86 per share, compared to $846.4 million, or $9.28 per share for the same period in 2024. Non-GAAP adjusted net loss for the year ended December 31, 2025 was $597.0 million, or $5.55 per share, compared to $790.6 million, or $8.67 per share for the same period in 2024. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below. Non-GAAP Financial Measures This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted net loss and adjusted net loss per share, which are adjusted to exclude non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares, and changes in the fair value of derivative liabilities, which do not correlate to actual cash payment obligations in the relevant periods. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Biohaven believes the presentation of non-GAAP adjusted net loss and adjusted net loss per share, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance and can assist investors in comparing Biohaven's performance between periods. In addition, these non-GAAP financial measures are among those indicators Biohaven uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this news release. About Biohaven Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity. Forward-looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and amounts of funding under the NPA. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates and regarding reduction in annual direct R&D spend, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; the effectiveness of restructuring of business priorities; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd. Investor Contact: Jennifer Porcelli Vice President, Investor Relations [email protected] +1 (201) 248-0741 Media Contact: Mike Beyer Sam Brown Inc. [email protected] +1 (312) 961-2502 View original content to download multimedia:https://www.prnewswire.com/news-releases/biohaven-reports-recent-business-developments-and-fourth-quarter-and-full-year-2025-financial-results-302701521.html

NEW HAVEN, Conn., Nov. 10, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), 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 reported financial results for the third quarter ended September 30, 2025, and provided a review of recent accomplishments and anticipated upcoming developments. Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "Biohaven remains energized and focused on our mission to advance innovative medicines to patients who are waiting every day for new treatments. Our pipeline consists of multiple novel approaches for unmet medical needs and has the potential to deliver paradigm shifting treatments for conditions such as epilepsy, autoimmune disease, obesity, depression and cancer. We are particularly excited about the continued progress across our key programs and clinical-stage assets including: MoDE™ and TRAP™ degrader programs, where our two lead assets, BHV-1300 and BHV-1400, show compelling evidence to change the treatment paradigm in immune-mediated diseases; opakalim, a novel Kv7 ion channel activator, for the treatment of epilepsy and depression; and taldefgrobep alfa, myostatin-activin targeting therapy for obesity and SMA." Dr. Coric continued, "Our late-stage clinical programs are poised to transform their respective treatment paradigms, given their novel mechanistic foundations and the body of clinical and non-clinical data generated to date. Our redirected approach to 'right-sizing' innovation is an important step we have undertaken to ultimately drive growth and resources to the most critical areas of our business. With this thoughtful approach to rebalancing our portfolio, we believe Biohaven remains well-positioned to execute on our commitment to transforming the treatment landscape for patients with serious and underserved diseases and we remain unwaveringly committed to delivering on our promise to advance our programs for patients, families, and shareholders in the balance of the year and in the years ahead. We will also continue to provide updates on any progress determining a path forward in SCA." Third Quarter 2025 and Recent Business Updates Initiated strategic cost optimization efforts across portfolio to focus forward-looking spend on three value-driving, late-stage clinical programs that will prioritize resources: Opakalim, Kv7 ion channel activator, in pivotal studies for focal epilepsy and depression; Lead TRAP and MoDE extracellular degraders for IgA nephropathy (BHV-1400) and Graves' disease (BHV-1300); Taldefgrobep alfa, myostatin-activin pathway inhibitor, for obesity and spinal muscular atrophy. Restructuring of business priorities and optimizing resource allocation may result in either pause, delay or halting of non-priority programs. The cost optimization efforts are expected to achieve an approximately 60% reduction in annual direct R&D spend (which excludes personnel and share-based compensation). Expected Upcoming Milestones: We believe Biohaven is well positioned to achieve significant, value-creating milestones in 2025 and 2026 across numerous programs: Kv7 Activator (Opakalim): Deliver top-line results from Phase 2 study in major depressive disorder study in 4Q 2025. Continue two Phase 2/3 studies in focal epilepsy with initial top-line results expected in 1H 2026. Lead TRAP and MoDE Extracellular Degraders (BHV-1400 and BHV-1300) Continue enrollment of patients with IgAN and Graves's disease in expanded Phase 1b and advance to pivotal studies in IgAN and Graves' disease. Myostatin-Activin Pathway Inhibitor (Taldefgrobep alfa): Initiate Phase 2 clinical trial in obesity in 4Q 2025.Continue ongoing Health Authority interactions to discuss SMA registrational path in the US and Europe. Glutamate Modulator (VYGLXIA): We requested a Type A meeting with FDA as part of initiating an appeal process for the SCA CRL and plan to meet with the FDA to discuss potential next steps. Capital Position: Cash, cash equivalents, marketable securities and restricted cash as of September 30, 2025, totaled approximately $263.8 million. Third Quarter 2024 Financial Highlights: Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $141.2 million for the three months ended September 30, 2025, compared to $157.6 million for the three months ended September 30, 2024. The decrease of $16.4 million was primarily due to decreases in direct program spend, largely related to BHV-2000 and opakalim, which were partially offset by increased personnel costs including non-cash share-based compensation, as compared to the same period in the prior year. Non-cash share-based compensation expense was $13.9 million for the three months ended September 30, 2025, an increase of $6.8 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025. General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $28.2 million for the three months ended September 30, 2025, compared to $20.6 million for the three months ended September 30, 2024. The increase of $7.7 million was primarily due to increased non-cash share-based compensation expense and increased legal costs. Non-cash share-based compensation expense was $7.6 million for the three months ended September 30, 2025, an increase of $2.6 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025. Other (Expense) Income, Net: Other (expense) income, net was other expense, net of $3.8 million for the three months ended September 30, 2025, compared to other income, net of $17.8 million for the three months ended September 30, 2024. The decrease of $21.6 million was primarily due to an increase in non-cash losses related to changes in fair value of our notes payable liability under the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the Note Purchase Agreement), a decrease in gains recorded for the non-cash changes in the fair value of our forward contracts and derivative liabilities recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment), and decreased investment income. Net Loss: Biohaven reported a net loss for the three months ended September 30, 2025 of $173.4 million, or $1.64 per share, compared to $160.3 million, or $1.70 per share, for the same period in 2024. Non-GAAP adjusted net loss for the three months ended September 30, 2025 was $155.9 million, or $1.47 per share, compared to $164.1 million, or $1.74 per share, for the same period in 2024. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below. Non-GAAP Financial Measures This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted net loss and adjusted net loss per share, which are adjusted to exclude non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares, and changes in the fair value of derivative liabilities, which do not correlate to actual cash payment obligations in the relevant periods. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Biohaven believes the presentation of non-GAAP adjusted net loss and adjusted net loss per share, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance and can assist investors in comparing Biohaven's performance between periods. In addition, these non-GAAP financial measures are among those indicators Biohaven uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this news release. About Biohaven Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity. Forward-looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and amounts of funding under the NPA. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates and regarding reduction in annual direct R&D spend, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; the effectiveness of restructuring of business priorities; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. VYGLXIA is a registered trademark, and MoDE and TRAP are trademarks, of Biohaven Therapeutics Ltd. Investor Contact: Jennifer Porcelli Vice President, Investor Relations [email protected] +1 (201) 248-0741 Media Contact: Mike Beyer Sam Brown Inc. [email protected] +1 (312) 961-2502 View original content to download multimedia:https://www.prnewswire.com/news-releases/biohaven-reports-third-quarter-2025-financial-results-and-recent-business-developments-302609810.html

Cash, cash equivalents, marketable securities and restricted cash as of June 30, 2025, totaled approximately $408.2 million VYGLXIA NDA for spinocerebellar ataxia (SCA) PDUFA date 4Q2025, completed clinical trial inspections by FDA without observations or findings, and filing review remains ongoing MoDE and TRAP degrader platforms advance in clinical development, IgG reductions of up to 87% observed with MoDE degrader BHV-1300 in Phase 1 with the potential to address IgG-mediated diseases including Graves' disease and rheumatoid arthritis; sustained and deep Gd-IgA1 reductions over 80% reported with TRAP degrader BHV-1400 highlight its potential for treating IgA Nephropathy Next -generation Trop2 Antibody Drug Conjugate (ADC) BHV-1510 demonstrated early clinical activity, favorable PK and differentiated safety profile in a Phase 1/2 study as a monotherapy and in combination with Regeneron's anti-PD-1 cemiplimab (Libtayo®); Tumor reduction was observed in first 6 out of 6 patients treated with BHV-1510 plus cemiplimab including confirmed partial responses Commenced dosing with BHV-1530, a novel FGFR3-directed ADC with potential application in urothelial cancers and other FGFR3-expressing solid tumors Compassionate use of opakalim (BHV-7000) in a child with intractable epilepsy due to Kv7 gene mutation (KCNQ2 Developmental and Epileptic Encephalopathy [KCNQ2-DEE]) provides early evidence of potential clinical benefit associated with Biohaven's next-generation Kv7 activator Enrolled first patient in pivotal Phase 2/3 study in Parkinson's disease (PD) with BHV-8000, a highly selective, brain-penetrant TYK2/JAK1 inhibitor with the potential to modulate critical inflammatory pathways that underpin the widespread immune dysregulation and neurodegeneration that drive functional decline in people with PD NEW HAVEN, Conn., Aug. 11, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), 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 reported financial results for the second quarter ended June 30, 2025, and provided a review of recent accomplishments and anticipated upcoming developments. Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "As we eagerly await a regulatory decision on the VYGLXIA® (troriluzole) NDA for spinocerebellar ataxia, Biohaven has made important progress on multiple clinical stage assets this quarter, highlighted by the momentum we showcased at our recent R&D Day, where we unveiled advancements across our innovative therapeutic platforms." Dr. Coric added, "We are excited about the prospects of launching the first treatment for SCA if VYGLXIA is approved by the FDA and our commercial team is taking the appropriate steps to ensure an efficient launch to meet this high unmet need. We are also enthusiastic about the progress made across our Inflammation and Immunology (I&I) platform where we have observed compelling evidence of targeted protein degradation with our MoDE and TRAP degraders, BHV-1300 and BHV-1400. The body of evidence we have presented to date, combined with the safety profiles observed and convenient subcutaneous administration, continues to support our belief in our degrader platform's ultimate potential in addressing a range of immune-mediated diseases. We are also very pleased with the advancement of another key pillar of our I&I platform -- the brain-penetrant, TYK2/JAK1 inhibitor, BHV-8000, which has the potential to revolutionize the treatment of neuroinflammatory and neurodegenerative diseases. We initiated a pivotal Phase 2/3 study in Parkinson's disease, an unrelenting illness for which there is an urgent need for novel therapies to halt the progression of the disease." Dr. Coric continued, "We also continue to take bold steps in other therapeutic areas to address important unmet medical needs for patients including in our Ion Channel and Oncology platforms. Our Kv7 platform continues to advance clinical programs toward completion in epilepsy and depression, and we are pleased to hear the promising early observations of a DEE pediatric patient successfully transitioned from ezogabine to opakalim. Finally, our Oncology platform is also generating early promising clinical data, demonstrating tumor reduction in the first 6 out of 6 patients treated with BHV-1510 plus cemiplimab. Our oncology team has also been the first to advance an FGFR3-directed ADC with potential application in urothelial cancers into clinical testing." "Biohaven is committed to following cutting edge science to attempt to help patients across multiple areas of high unmet need. For the balance of the year, we expect to deliver continued excellence in study execution and patient enrollment across key trials in our portfolio, as well as prepare for the potential commercialization of VYGLXIA in SCA if approved. We believe the SCA data supports approval in this rare, progressive and fatal indication for which no other treatments are available. Biohaven is well-positioned to execute on our commitment to transforming the treatment landscape for patients with serious and underserved diseases and we are excited to deliver on our promise to advance our programs for patients, caregivers, and shareholders in the balance of the year." Second Quarter 2025 and Recent Business Highlights Released new data with MoDE (Molecular Degrader of Extracellular Proteins) program: In May 2025, the Company released new positive data from the Phase 1 study of BHV-1300, a MoDE initially being developed for the treatment of common immune-mediated diseases, such as Graves' disease and rheumatoid arthritis. In the Phase 1 multiple-dose study, subcutaneous administered BHV-1300 achieved IgG reductions up to 87%. Median maximum reductions of 83% were achieved within 18 days. The range of IgG lowering enabled by different dose levels of BHV-1300 potentially offers tunability and flexibility in dosing paradigm, with higher doses planned for management of acute conditions, and lower, less frequent dosing planned for the management of chronic disease. Released new data with TRAP (Targeted Removal of Aberrant Protein) degrader program: In May 2025, the Company announced further data from the Phase 1 study of BHV-1400, a TRAP degrader initially being developed to target Gd-IgA1, the aberrant immunoglobulin that drives IgA Nephropathy. In the Phase 1 study, a single dose of BHV-1400 was subcutaneously administered at a dose of 500 mg and achieved rapid, deep and sustained reductions in Gd-IgA1 of up to 81%, with a median reduction of 66%. Reductions occurred within hours of each dose, were progressive, and were sustained for weeks after a single dose administration. Effects were selective, with no significant reductions observed in other immunoglobulins (IgA, IgG, IgE, or IgM). Demonstrated early clinical activity and favorable PK profile with BHV-1510: In May 2025, the Company announced early clinical results from a Phase 1 study of BHV-1510, a next-generation Trop2-directed ADC incorporating the proprietary TopoIx payload. The data demonstrated early signs of clinical activity and a differentiated, manageable safety profile, both as monotherapy and in combination with Regeneron's anti-PD-1, cemiplimab. Partial responses were observed across multiple tumor types with BHV-1510 monotherapy, accompanied by low rates of payload-related toxicities. The most common adverse event was stomatitis, an anticipated and manageable class effect associated with Trop2-targeted therapies. Notably, tumor reduction was seen in all six of the first patients treated with the BHV-1510 and cemiplimab combination, including confirmed partial responses. The combination regimen was well tolerated, with no dose-limiting toxicities or cases of interstitial lung disease reported in these initial cohorts. These encouraging early clinical data, along with the favorable pharmacokinetic profile and proprietary stable linker technology, support continued investigation of BHV-1510 as monotherapy and in combination with cemiplimab in difficult-to-treat tumor types, including potential evaluation in earlier lines of therapy for patients with advanced or metastatic disease. First patient dosed with Biohaven's TopoIx ADC, BHV-1530: In May 2025, the Company commenced dosing with BHV-1530, a potential first-in-class fibroblast growth factor receptor 3 (FGFR3)-directed ADC which utilizes the proprietary Topolx payload. BHV-1530 has potential in cancer indications driven by FGFR3 alterations and/or upregulated FGFR3 protein expression, including urothelial cancers and other solid tumors. Phase 2/3 PD trial initiated: In May 2025, the Company commenced enrollment in a global, pivotal, Phase 2/3 study of the first-in-clinic, orally-administered, brain-penetrant, and highly selective TYK2/JAK1 inhibitor, BHV-8000, for the treatment of early Parkinson's disease (PD). Compassionate use of opakalim (BHV-7000) in a child with intractable epilepsy due to Kv7 gene mutation (KCNQ2 Developmental and Epileptic Encephalopathy [KCNQ2-DEE]) provides early evidence of potential clinical benefit. A child with KCNQ2-DEE and a history of intractable epilepsy who was previously maintained on ezogabine, as well as other antiepileptics, was successfully transitioned to treatment with opakalim, Biohaven's next-generation Kv7 activator. Opakalim was administered after receiving a compassionate use request, under a single patient IND approved by the FDA, as the child was being withdrawn from ezogabine treatment. The child had multiple unsuccessful attempts in the past to taper ezogabine, leading to severe seizure exacerbations requiring admission to the hospital intensive care unit. Dosing of opakalim in this pediatric patient was selected to achieve comparable exposures as the 75mg dose being investigated in ongoing Phase 2/3 clinical trials. Following the transition, the patient demonstrated signs of therapeutic benefit as assessed by initial seizure control and a favorable side effect profile. Although generalizability of these observations is limited, given it represents a single case report of treating a KCNQ2-DEE patient and a short initial follow-up period after transition from ezogabine, the early clinical experience after initiation of opakalim, a selective Kv7 activator, is promising for its observed antiseizure effects and favorable tolerability. Phase 3 trial in OCD with troriluzole was completed with no efficacy signal detected. The OCD development program is being ended to allow resources to be applied to other development programs. Study results will be presented at an upcoming academic meeting. Expected Upcoming Milestones: We believe Biohaven is well positioned to achieve significant milestones in 2025 and 2026 across numerous programs: MoDE Platform IgG MoDE Degraders (1300/1310): Initiated Phase 1b study in Graves' disease in 2H 2025, with potentially registrational study expected to initiate in 2H 2025. Phase 1 studies in healthy volunteers with BHV-1400 and BHV-1600 concluding, with BHV-1400 Phase 1 studies expanding to include patients with IgA nephropathy. BHV-1400 potentially registrational study expected to initiate in 2026. Four additional degrader molecules advancing, including: IgG4 degrader, PLA2R autoantibody degrader, pro-insulin autoantibody degrader, and TSH receptor autoantibody degrader. Kv7 Activator (BHV-7000): Pivotal major depressive disorder topline results expected in 2H 2025. Focal epilepsy study pivotal topline results expected in 1H 2026. Glutamate Modulator (VYGLXIA): Priority Review of SCA NDA ongoing, with PDUFA expected in 4Q 2025. Preparing for potential commercial launch in all-genotype SCA if approved by FDA. Myostatin (Taldefgrobep alfa): Continue ongoing Health Authority interactions to discuss Spinal Muscular Atrophy ("SMA") registrational path in the U.S. and Europe. Expect to initiate Phase 2 study in obesity in 2H 2025. TYK2/JAK1 Inhibitor (BHV-8000): Continue advancing enrollment in Phase 2/3 study in Parkinson's disease. Advance Alzheimer's disease, multiple sclerosis ("MS") and amyloid-related imaging abnormalities ("ARIA") programs. Next Generation ADC Platform: Continue advancing Phase 1/2 study with BHV-1510 as monotherapy and combination therapy with cemiplimab in epithelial tumors in 2025. Continue advancing Phase 1 study with BHV-1530, FGFR3-directed ADC utilizing proprietary Topolx payload with potential applications in urothelial cancers and other solid tumors. Advance additional preclinical ADCs, including Merus and GeneQuantum collaborations (undisclosed targets) in 2025. Capital Position: Cash, cash equivalents, marketable securities and restricted cash as of June 30, 2025 totaled approximately $408.2 million. Second Quarter 2024 Financial Highlights: Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $184.4 million for the three months ended June 30, 2025, compared to $314.8 million for the three months ended June 30, 2024. The decrease of $130.5 million was primarily due to a one-time non-cash expense during the three months ended June 30, 2024, paid to Knopp for a milestone and royalty buyback related to the BHV-7000 and broader Kv7 platform. The decrease was partially offset by increased direct program costs for advancing clinical trials and preclinical research programs in 2025, including one-time developmental milestone payments of $15.0 million and $10.0 million for our BHV-8000 and BHV-1530 programs, respectively, as well as increased non-cash share-based compensation expense. Non-cash share-based compensation expense was $13.1 million for the three months ended June 30, 2025, an increase of $6.0 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025. General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $27.3 million for the three months ended June 30, 2025, compared to $19.0 million for the three months ended June 30, 2024. The increase of $8.4 million was primarily due to increased non-cash share-based compensation expense and increased expenses related to fees incurred in connection with the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the Note Purchase Agreement) and other legal costs. Non-cash share-based compensation expense was $7.7 million for the three months ended June 30, 2025, an increase of $2.5 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025. Other Income, Net: Other income, net was $13.8 million for the three months ended June 30, 2025, compared to other income, net of $14.2 million for the three months ended June 30, 2024. The decrease of $0.4 million was primarily due to decreased investment income and an increase in non-cash losses related to changes in fair value of our notes payable liability under the Note Purchase Agreement during the second quarter of 2025, partially offset by an increase in gains recorded for the non-cash changes in the fair value of our forward contract and derivative liability recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment). Net Loss: Biohaven reported a net loss for the three months ended June 30, 2025 of $198.1 million, or $1.94 per share, compared to $319.8 million, or $3.64 per share, for the same period in 2024. Non-GAAP adjusted net loss for the three months ended June 30, 2025 was $166.4 million, or $1.63 per share, compared to $308.6 million, or $3.52 per share, for the same period in 2024. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below. Non-GAAP Financial Measures This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted net loss and adjusted net loss per share, which are adjusted to exclude non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares, and changes in the fair value of derivative liabilities, which do not correlate to actual cash payment obligations in the relevant periods. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Biohaven believes the presentation of non-GAAP adjusted net loss and adjusted net loss per share, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance and can assist investors in comparing Biohaven's performance between periods. In addition, these non-GAAP financial measures are among those indicators Biohaven uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this news release. About Biohaven Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; TRPM3 antagonism for neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for SCA; myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules; and antibody drug conjugates for cancer. Forward-looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and amounts of funding under the NPA. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. VYGLXIA is a registered trademark, and MoDE and TRAP are trademarks, of Biohaven Therapeutics Ltd. Libtayo is a registered trademark of Regeneron Pharmaceuticals, Inc. Investor Contact: Jennifer Porcelli Vice President, Investor Relations [email protected] +1 (201) 248-0741 Media Contact: Mike Beyer Sam Brown Inc. [email protected] +1 (312) 961-2502 View original content to download multimedia:https://www.prnewswire.com/news-releases/biohaven-reports-second-quarter-2025-financial-results-and-recent-business-developments-302526204.html SOURCE Biohaven Ltd.

Cash, cash equivalents, marketable securities and restricted cash as of April 30, 2025 totaled approximately $518 million. Announced up to $600 million non-dilutive capital agreement with Oberland Capital Management LLC ("Oberland Capital"), with $250 million in gross proceeds received on closing on April 30, 2025, expected to support commercial launch planning in spinocerebellar ataxia ("SCA"), clinical development activities, and ongoing business operations. Completed U.S. Food and Drug Administration ("FDA") mid-cycle review meeting and regulatory inspections of Biohaven and key clinical research sites for troriluzole new drug application ("NDA") for the treatment of SCA (all genotypes); continuity of the review process and timelines maintained throughout troriluzole's review. Presented 13 abstracts, including 3 oral presentations and 10 posters, featured at the American Academy of Neurology ("AAN") Annual Meeting; breadth of presentations highlights Biohaven's leadership in neuroscience and immunoscience, as well as extensive development programs evaluating novel therapies to treat neurological and immunological diseases, with abstracts covering programs including Kv7 ion channel modulation, extracellular protein degradation, TYK2/JAK1 inhibition, glutamate modulation, and TRPM3 antagonism. Company to expound on clinical, regulatory, and operational progress across five platforms, including more than 10 assets in 6 therapeutic areas spanning immunology & inflammation, neuroscience, and oncology, at annual R&D Day at the Yale Innovation Summit on May 28, 2025. NEW HAVEN, Conn., May 12, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), 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 reported financial results for the first quarter ended March 31, 2025, and provided a review of recent accomplishments and anticipated upcoming developments. Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "In spite of a challenging macroeconomic climate and economic uncertainty, our team has remained more focused than ever on strategic execution and creating a strong financial balance sheet to create value across our broad portfolio of innovative product candidates. Enthusiasm for our rare disease and degrader programs has grown, as we eagerly await the completion of the NDA review for troriluzole and continued advancement of our MoDE™ and TRAP™ degraders into the clinic. We expect to complete three separate Phase 1 studies in 1H 2025 with three innovative compounds, including BHV-1300 (IgG degrader targeting with first target indication in Graves' disease), BHV-1400 (Gd-IgA1 degrader for IgA nephropathy), and BHV-1600 (β1AR AAb degrader targeting PPCM), and are advancing four additional degrader molecules in parallel. We also look forward to delivering key clinical readouts, including pivotal topline data with troriluzole in obsessive compulsive disorder in 1H 2025 and with our selective Kv7 activator BHV-7000 in major depressive disorder ("MDD") in 2H 2025. In oncology, interim Phase 1 data remain on track for 2025 with our lead clinical Trop-2 antibody drug conjugate ("ADC") program, BHV-1510, and initiation of a Phase 1 study with the field's first FGFR3 ADC, BHV-1530, for patients with urothelial cancer & other tumors. With taldefgrobep alfa, our anti-myostatin agent, we continue to pursue a potential path forward in spinal muscular atrophy, while we hasten to initiate our Phase 2 study in obesity; we are also extremely excited about BHV-8000, our TYK2/JAK1 inhibitor, and eagerly anticipate initiating our Phase 2/3 study in Parkinson's disease in 1H 2025." Dr. Coric continued, "Importantly, we remain steadfastly committed to the SCA community as we continue unwaveringly pursuing an approval in this indication and are now past the mid-cycle review. In addition, our recent $600 million financing agreement with Oberland Capital will provide financial flexibility to advance our troriluzole commercialization plans, accelerate clinical development and operational execution across our five platforms, and be ready to execute on strategic opportunities as they arise. We look forward to sharing further progress from all of our innovative discovery and clinical programs and future development plans at our annual R&D Day at the Yale Innovation Summit on May 28, 2025 in New Haven, CT." First Quarter 2025 and Recent Business Highlights Announced up to $600 Million non-dilutive capital agreement with Oberland Capital — In April 2025, the Company entered into an agreement with Oberland Capital for an investment of up to $600 million in the Company, with the first tranche of $250 million of gross proceeds being funded at closing on April 30, 2025. The investment from Oberland Capital takes the form of a Note Purchase Agreement ("NPA") that is non-dilutive to current investors under which Oberland may purchase up to $600 million of Biohaven's senior secured notes. The second tranche of up to $150 million can be funded at the Company's option contingent upon FDA approval of troriluzole, and subject to the satisfaction of certain additional conditions, and the third tranche of up to $200 million can be funded upon the mutual agreement of the parties for permitted strategic acquisitions and related costs and expenses. The purchases of the senior notes are subject to other terms and conditions as set forth in the NPA. Under the terms of the NPA, Oberland Capital will have a right to receive a regulatory approval milestone payment of 35% of the amount funded, payable quarterly through December 31, 2030, and for the first tranche, single-digit royalty payments on global net sales of troriluzole for up to a maximum of 10 years from the closing date. These payments are capped at a multiple of amounts funded by Oberland Capital. Troriluzole NDA mid-cycle review meeting with FDA completed — The Company completed a mid-cycle review meeting with the FDA of the NDA for troriluzole for the treatment of SCA. The FDA has not conveyed any intention of holding an Advisory Committee Meeting. The NDA had previously been accepted and granted priority review by the FDA with a Prescription Drug User Fee Act ("PDUFA") date expected in the third quarter of 2025. Oral and poster presentations at AAN showcased breadth of development work across the platform — In April 2025, the Company delivered 3 oral presentations and 10 posters at the AAN Annual Meeting, showcasing development programs including Kv7 ion channel modulation, MoDEs, TRPM3 antagonism, TYK2/JAK1 inhibition, and glutamate modulation. Biohaven's selective, brain-penetrant TYK2/JAK1 inhibitor, BHV-8000, was selected for an oral presentation at AAN, highlighting the efficacy demonstrated in a human alpha-synuclein overexpressing Parkinson's disease mouse model. Other oral presentations covered the safety, tolerability, and pharmacokinetics of BHV-2100, a first-in-class TRPM3 antagonist for pain and migraine, as well as the rapid, robust, and selective IgG reduction observed in preclinical models of BHV-1310, Biohaven's novel IgG degrader. Expected Upcoming Milestones: We believe Biohaven is well positioned to achieve significant milestones in 2025 and 2026 across numerous programs: MoDE Platform IgG MoDE Degraders (1300/1310): BHV-1300 Phase 1 with the optimized subcutaneous formulation completing in 1H 2025. Expect to initiate Phase 1b study in Graves' disease in mid-2025, and additional programs in rheumatoid arthritis and myasthenia gravis continue to be pursued. Phase 1 studies with BHV-1400 and BHV-1600 expected to be completed in 1H 2025. Four additional degrader molecules advancing including: IgG4 degrader, PLA2R autoantibody degrader, pro-insulin autoantibody degrader, and TSH receptor autoantibody degrader. Kv7 Activator (BHV-7000): Pivotal major depressive disorder topline results expected in 2H 2025. Focal epilepsy study pivotal topline results expected in 1H 2026. Glutamate Modulator (Troriluzole): Preparing for commercial launch in all-genotype SCA in 2025, following NDA acceptance with Priority Review and 3Q 2025 PDUFA date. Pivotal topline data from two Phase 3 OCD trials expected in 1H 2025 and 2H 2025, respectively. Myostatin (Taldefgrobep alfa): FDA interaction to discuss Spinal Muscular Atrophy ("SMA") registrational path planned in 1H 2025. Initiate taldefgrobep Phase 2 study in obesity in 1H 2025. TRPM3 Antagonist (BHV-2100): Expect data from proof-of-concept trial with BHV-2100 in acute migraine in 1H 2025. TYK2/JAK1 Inhibitor (BHV-8000): Initiate BHV-8000 Phase 2/3 study in Parkinson's disease in 1H 2025. Advance Alzheimer's disease, multiple sclerosis ("MS") and amyloid-related imaging abnormalities ("ARIA") programs. Next Generation ADC Platform: Preliminary Phase 1 data with BHV-1510 and dose optimization as monotherapy and combination therapy with Libtayo® in epithelial tumors in 2025. Initiate Phase 1 trial of BHV-1530 in 1H 2025. Advance additional preclinical ADCs, including Merus and GeneQuantum collaborations (undisclosed targets) in 2025. Capital Position: Cash, cash equivalents, marketable securities and restricted cash as of March 31, 2025 totaled approximately $327 million.  In addition, the Company received $250 million in gross proceeds in April 2025 from Oberland Capital under the NPA discussed above. First Quarter 2024 Financial Highlights: Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $187.6 million for the three months ended March 31, 2025, compared to $156.0 million for the three months ended March 31, 2024. The increase of $31.6 million was due to increased non-cash share-based compensation expense in 2025, as well as increased direct program spend for advancing clinical trials and preclinical research programs in 2025, as compared to the same period in the prior year.  Preclinical research expense for the three months ended March 31, 2025 included an upfront share payment valued at $4.9 million and an accrual for an upfront cash payment of $5.0 million related to agreements entered into during the three months ended March 31, 2025. These increases were partially offset by decreased program expense for BHV-1510, primarily related to the acquisition of Pyramid Biosciences, Inc., which resulted in a $10.9 million non-cash upfront payment and $7.2 million in milestones which became due during the three months ended March 31, 2024. Non-cash share-based compensation expense was $35.2 million for the three months ended March 31, 2025, an increase of $13.9 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025. General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $34.0 million for the three months ended March 31, 2025, compared to $27.3 million for the three months ended March 31, 2024. The increase of $6.7 million was primarily due to increased non-cash share-based compensation expense and increased legal costs. Non-cash share-based compensation expense was $17.8 million for the three months ended March 31, 2025, an increase of $4.2 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025. Other Income, Net: Other income, net was $0.5 million for the three months ended March 31, 2025, compared to other income, net of $4.3 million for the three months ended March 31, 2024. The decrease of $3.8 million was primarily due to non-cash changes in the fair value of our forward contract and derivative liability recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment). Net Loss: Biohaven reported a net loss for the three months ended March 31, 2025 of $221.7 million, or $2.17 per share, compared to $179.5 million, or $2.20 per share, for the same period in 2024. Non-GAAP adjusted net loss for the three months ended March 31, 2025 was $166.8 million, or $1.64 per share, compared to $144.6 million, or $1.77 per share for the same period in 2024. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below. Non-GAAP Financial MeasuresThis press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted net loss and adjusted net loss per share, which are adjusted to exclude non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares, and changes in the fair value of derivative liabilities, which do not correlate to actual cash payment obligations in the relevant periods. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Biohaven believes the presentation of non-GAAP adjusted net loss and adjusted net loss per share, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance and can assist investors in comparing Biohaven's performance between periods. In addition, these non-GAAP financial measures are among those indicators Biohaven uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this news release. About BiohavenBiohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA; myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules; and antibody drug conjugates for cancer. Forward-looking StatementsThis news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and amounts of funding under the NPA. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.     MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd.Libtayo is a registered trademark of Regeneron Pharmaceuticals, Inc. Investor Contact: Jennifer PorcelliVice President, Investor [email protected] +1 (201) 248-0741 Media Contact: Mike BeyerSam Brown [email protected] +1 (312) 961-2502   View original content to download multimedia:https://www.prnewswire.com/news-releases/biohaven-reports-first-quarter-2025-financial-results-and-recent-business-developments-302452555.html SOURCE Biohaven Ltd.