Biohaven Reports Second Quarter 2025 Financial Results and Recent Business Developments
Rhea-AI Summary
Biohaven (NYSE: BHVN) reported Q2 2025 financial results and business developments, highlighting a cash position of $408.2 million as of June 30, 2025. Key developments include promising clinical results across multiple platforms: MoDE degrader BHV-1300 achieved up to 87% IgG reduction, while TRAP degrader BHV-1400 demonstrated over 80% Gd-IgA1 reductions.
The company's oncology program showed early success with BHV-1510, their Trop2 ADC, achieving tumor reduction in all initial 6 patients when combined with cemiplimab. Additionally, Biohaven initiated a pivotal Phase 2/3 study for BHV-8000 in Parkinson's disease and awaits FDA decision on VYGLXIA for spinocerebellar ataxia in Q4 2025.
Financial results showed R&D expenses of $184.4 million, down from $314.8 million in Q2 2024, with a net loss of $198.1 million ($1.94 per share) compared to $319.8 million ($3.64 per share) in the prior year.
Positive
- Strong cash position of $408.2 million as of June 30, 2025
- BHV-1300 achieved significant IgG reductions up to 87% in Phase 1 study
- BHV-1510 demonstrated 100% tumor reduction rate in initial combination therapy cohort
- R&D expenses decreased by $130.5 million year-over-year
- Multiple promising clinical developments across oncology and neurology platforms
- VYGLXIA regulatory review for SCA progressing with PDUFA in Q4 2025
Negative
- Net loss of $198.1 million in Q2 2025
- Phase 3 trial in OCD with troriluzole failed to show efficacy
- Increased G&A expenses by $8.4 million year-over-year
- Development program for OCD being discontinued
News Market Reaction 22 Alerts
On the day this news was published, BHVN declined 9.02%, reflecting a notable negative market reaction. Our momentum scanner triggered 22 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $149M from the company's valuation, bringing the market cap to $1.51B at that time.
Data tracked by StockTitan Argus on the day of publication.
- 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 over80% 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
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 of83% 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 of66% . 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. andEurope . - 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
Second Quarter 2024 Financial Highlights:
Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were
General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were
Other Income, Net: Other income, net was
Net Loss: Biohaven reported a net loss for the three months ended June 30, 2025 of
Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in
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
BIOHAVEN LTD. CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands, except share and per share amounts) (Unaudited)
| ||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||
2025 | 2024 | 2025 | 2024 | |||||
Operating expenses: | ||||||||
Research and development | $ 184,367 | $ 314,819 | $ 371,951 | $ 470,791 | ||||
General and administrative | 27,334 | 18,953 | 61,311 | 46,221 | ||||
Total operating expenses | 211,701 | 333,772 | 433,262 | 517,012 | ||||
Loss from operations | (211,701) | (333,772) | (433,262) | (517,012) | ||||
Other income, net | 13,815 | 14,178 | 14,308 | 18,483 | ||||
Loss before provision for income taxes | (197,886) | (319,594) | (418,954) | (498,529) | ||||
Provision for income taxes | 261 | 177 | 870 | 746 | ||||
Net loss | $ (198,147) | $ (319,771) | $ (419,824) | $ (499,275) | ||||
Net loss per share — basic and diluted | $ (1.94) | $ (3.64) | $ (4.11) | $ (5.93) | ||||
Weighted average common shares outstanding— basic and diluted | 102,372,820 | 87,766,069 | 102,159,294 | 84,174,099 | ||||
BIOHAVEN LTD. CONSOLIDATED BALANCE SHEETS (Amounts in thousands, except share amounts)
| ||||
June 30, 2025 | December 31, 2024 | |||
(Unaudited) | ||||
Assets | ||||
Current assets: | ||||
Cash and cash equivalents | $ 165,797 | $ 99,134 | ||
Marketable securities | 239,183 | 386,857 | ||
Prepaid expenses | 61,489 | 49,376 | ||
Other current assets | 8,358 | 3,105 | ||
Total current assets | 474,827 | 538,472 | ||
Property and equipment, net | 18,593 | 17,320 | ||
Intangible assets | 18,400 | 18,400 | ||
Goodwill | 1,390 | 1,390 | ||
Other non-current assets | 37,205 | 39,525 | ||
Total assets | $ 550,415 | $ 615,107 | ||
Liabilities and Shareholders' Equity | ||||
Current liabilities: | ||||
Accounts payable | $ 19,628 | $ 18,029 | ||
Accrued expenses and other current liabilities | 78,726 | 51,487 | ||
Forward contract and derivative liability | 25,970 | 84,710 | ||
Total current liabilities | 124,324 | 154,226 | ||
Non-current operating lease liability | 29,797 | 32,782 | ||
Notes payable | 257,070 | — | ||
Other non-current liabilities | 4,637 | 4,663 | ||
Total liabilities | 415,828 | 191,671 | ||
Shareholders' Equity: | ||||
Preferred shares, no par value; 10,000,000 shares authorized, no shares issued | — | — | ||
Common shares, no par value; 200,000,000 shares authorized as of June 30, 2 | 1,743,109 | 1,656,702 | ||
Additional paid-in capital | 157,019 | 112,369 | ||
Accumulated deficit | (1,765,538) | (1,345,714) | ||
Accumulated other comprehensive (loss) income | (3) | 79 | ||
Total shareholders' equity | 134,587 | 423,436 | ||
Total liabilities and shareholders' equity | $ 550,415 | $ 615,107 | ||
BIOHAVEN LTD. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES (Amounts in thousands, except share and per share amounts) (Unaudited)
| ||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||
2025 | 2024 | 2025 | 2024 | |||||
Reconciliation of GAAP to Non-GAAP adjusted net loss: | ||||||||
GAAP net loss | $ (198,147) | $ (319,771) | $ (419,824) | $ (499,275) | ||||
Add: non-cash share-based compensation expense | 20,812 | 12,232 | 73,874 | 47,109 | ||||
Add: loss from change in fair value of derivatives | 10,970 | (1,040) | 12,760 | (1,040) | ||||
Non-GAAP adjusted net loss | $ (166,365) | $ (308,579) | $ (333,190) | $ (453,206) | ||||
Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted: | ||||||||
GAAP net loss per share — basic and diluted | $ (1.94) | $ (3.64) | $ (4.11) | $ (5.93) | ||||
Add: non-cash share-based compensation expense | 0.20 | 0.14 | 0.72 | 0.56 | ||||
Add: loss from change in fair value of derivatives | 0.11 | (0.01) | 0.12 | (0.01) | ||||
Non-GAAP adjusted net loss per share — basic and diluted | $ (1.63) | $ (3.52) | $ (3.26) | $ (5.38) | ||||
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
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741
Media Contact:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502
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SOURCE Biohaven Ltd.
FAQ
What were Biohaven's (BHVN) key financial results for Q2 2025?
What results did Biohaven report for BHV-1300 in Q2 2025?
When is the PDUFA date for Biohaven's VYGLXIA for spinocerebellar ataxia?
What were the clinical results for Biohaven's BHV-1510 cancer treatment?
Which Biohaven clinical programs were discontinued in Q2 2025?
What are Biohaven's major upcoming milestones for 2025-2026?
