#United States #Biohaven #New Haven #Troriluzole #Oberland Capital

Biohaven's Financial Report and Business Developments for Q1 2025

Biohaven Ltd. (NYSE: BHVN) has released its financial results for the first quarter of 2025, showcasing substantial progress in its ongoing business operations despite facing a challenging macroeconomic environment. As of April 30, 2025, the company reported a solid financial position, with cash, cash equivalents, marketable securities, and restricted cash totaling approximately $518 million. The biopharmaceutical company recently announced a $600 million non-dilutive capital agreement with Oberland Capital Management LLC, which received $250 million in gross proceeds that was finalized on the same date. This funding will support Biohaven's planning for the commercial launch of its promising treatment for spinocerebellar ataxia (SCA) and bolster various clinical development activities.

In addition to the funding news, Biohaven has successfully completed a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) concerning troriluzole, aimed at treating all genotypes of SCA. This keystone drug's NDA has been granted priority review with a PDUFA date slated for the third quarter of 2025, keeping the review process on track.

The recent American Academy of Neurology (AAN) Annual Meeting also highlighted Biohaven’s continued leadership in neuroscience and immunoscience, with the company presenting 13 abstracts, including three oral presentations and ten posters. These presentations showcased innovative research and development work, announcing ongoing endeavors into various novel therapies targeting neurological and immunological diseases. Notable projects covered during the meeting included Kv7 ion channel modulation and groundbreaking approaches to extracellular protein degradation.

In his comments, Dr. Vlad Coric, Biohaven's Chairman and CEO, expressed enthusiasm for the company’s portfolio of rare disease treatments and degrader programs while emphasizing their commitment to financial prudence. The company anticipates key clinical readouts within 2025, including pivotal topline data from two Phase 3 trials for OCD and ongoing clinical trials for their innovative BHV-7000 selective Kv7 activator, aiming to address major depressive disorder (MDD).

Dr. Coric continued to highlight the momentum generated by Biohaven’s pipeline, which showcases over ten assets across six therapeutic areas, including oncological and neuroinflammatory disorders. These programs could potentially provide significant benefits to patients suffering from various chronic conditions.

As Biohaven moves forward with its plans, several upcoming milestones include:

• - Initiating Phase 1 clinical trials for BHV-1300 and BHV-1400 in Graves’ disease and IgA nephropathy, respectively.
• - Launching pivotal topline results for major depressive disorder in the second half of 2025.
• - Expecting positive interim data insights from their leading clinical programs, actively working toward enhancing treatment modalities within oncology and rare disease landscapes.

Financial Overview

During the first quarter of 2025, Biohaven reported total research and development expenses amounting to approximately $187.6 million, reflecting an increase owing to direct program spending on clinical trials and share-based compensation. General and administrative expenses rose to around $34 million, comparatively up from $27.3 million year-over-year, driven by legal costs and share-based compensation expenses.

For the three months ended March 31, 2025, Biohaven recorded a net loss of $221.7 million, or $2.17 per share, representing a slight reduction from a loss of $179.5 million or $2.20 per share in 2024. This financial snapshot bolsters the case for investors to consider Biohaven's ongoing initiatives and rapid-paced innovation in drug development.

As Biohaven concludes its report for Q1 2025, it looks ahead with optimism to sharing further advancements during its annual RD Day at the Yale Innovation Summit scheduled for May 28, 2025. This event will provide stakeholders an opportunity to gain insight into continued clinical progress and the next significant steps for the company’s robust pipeline.