BHVN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-10-29

• We are targeting to initiate a pivotal study in IgAN in the second half of 2026. The study is a randomized, double blind, placebo-controlled study with 2:1 randomization in approximately 420 adults with IgAN evaluating UPCR, estimated glomerular filtration rate ("eGFR"), and Gd-IgA1 at 52 weeks.

• In October 2026, we entered into a Collaboration and License Agreement (the “Ono License Agreement”) with Ono Pharmaceutical Co., Ltd. (“Ono”). Pursuant to the Ono License Agreement, the Company granted Ono an exclusive, royalty-bearing license, with the right to grant sublicenses subject to the ter…

• retains all rights to the licensed portfolio outside the Ono Licensed Territory, including in the United States, Europe and China. See Note 11, "License, Acquisitions and Other Agreements," to the accompanying condensed consolidated financial statements included in this Form 10-Q for discussion of t…

• In April 2022, we closed the acquisition from Knopp Biosciences LLC (“Knopp”) of Channel Biosciences, LLC ("Channel"), a wholly owned subsidiary of Knopp owning the assets of Knopp’s Kv7 channel targeting platform, pursuant to the Purchase Agreement. The acquisition of the Kv7 channel targeting plat…

• In August 2026, we entered into a License Agreement (the “SKBP License Agreement”) with SK Biopharmaceuticals Co., Ltd. (“SKBP”). Pursuant to the SKBP License Agreement, effective upon the closing of the transactions contemplated thereby, SKBP will have an exclusive, royalty-bearing, worldwide licen…

Text removed vs the prior filing · source: 10-Q · 2026-08-10

• chronic autoimmune disease estimated to affect 1 to 2% of the global population. RA primarily affects the joints, causing pain, swelling, stiffness, and loss of function.

• In the fourth quarter of 2025, we completed a meeting with the FDA to align on a pivotal IgAN study design, which we are targeting to initiate in the second half of 2026. We continue to work with the FDA as we evaluate and finalize potential clinical trial designs, including size and primary and sec…

• In April 2022, we closed the acquisition from Knopp of Channel, a wholly owned subsidiary of Knopp owning the assets of Knopp’s Kv7 channel targeting platform, pursuant to the Purchase Agreement. The acquisition of the Kv7 channel targeting platform added the latest advances in ion-channel modulatio…

• In February 2022, we announced a worldwide license agreement with BMS for the development and commercialization rights to taldefgrobep alfa (also known as BMS-986089 and now referred to as BHV-2000), a novel, Phase 3-ready anti-myostatin adnectin. Myostatin is a natural protein that limits skeletal …

• through the activin receptor type-2B ("ActRIIb"). In patients with neuromuscular diseases, active myostatin can critically limit the growth needed to achieve developmental and functional milestones. Myostatin inhibition is a promising therapeutic strategy for enhancing muscle mass and strength in a …

Text added vs the prior filing · source: 10-Q · 2026-10-29

• As of September 30, 2026, our excess cash balances were invested in short-term money market funds and short-term debt securities issued by the United States government. We seek to diversify our investments and limit the amount of investment concentrations for individual corporate institutions, matur…

• bearing securities are subject to interest rate risk and could decline in value if interest rates fluctuate. Based on the type and duration of securities we hold, we do not believe a change in interest rates would have a material impact on the fair value of our investment portfolio. If interest rate…

Text removed vs the prior filing · source: 10-Q · 2026-08-10

• As of June 30, 2026, our excess cash balances were invested in short-term money market funds and short-term debt securities issued by the United States government. We seek to diversify our investments and limit the amount of investment concentrations for individual corporate institutions, maturities…

Text added vs the prior filing · source: 10-Q · 2026-10-29

• Risks Related to Our Financial Position and Need for Additional Capital

• Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our intellectual property or future revenue streams.

• Until we can generate substantial product revenue, if ever, we expect to finance our operations through a combination of equity offerings, debt financings and license and development agreements in connection with any future collaborations. Other than amounts that may become payable to us under the S…

• Further, if we raise additional capital through collaborations, strategic alliances, or marketing, distribution, licensing or funding arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidat…

• We have entered into, and may in the future enter into, additional collaborations or out-license agreements with third parties to develop and commercialize our product candidates. If these collaborations or out-license agreements are not successful, or if we are not able to establish or maintain the…