BCRX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-06

• ORLADEYO is an oral, once-daily therapy discovered and developed by us for the prevention of HAE attacks. A capsule formulation of ORLADEYO is approved in the United States and other global markets for the prevention of HAE attacks in adults and pediatric patients 12 years and older. In addition, in…

• On January 23, 2026, we completed the previously announced Merger with Astria (each term as defined below). Pursuant to the Merger, we acquired Astria’s lead product candidate navenibart, an injectable monoclonal antibody designed to inhibit plasma kallikrein for the treatment of HAE. Navenibart is …

• European Commission has granted Orphan Medicinal Product Designation to navenibart for the treatment of HAE. The goal for navenibart is to develop a potentially best-in-class injectable prophylactic therapy with a differentiated every 3- and 6-month administration schedule, which could offer signifi…

• BCX17725 is a potent and selective investigational protein therapeutic KLK5 inhibitor designed to provide best-in-class, potentially disease-modifying, treatment for people with Netherton syndrome. Netherton syndrome is a serious, rare, lifelong genetic disorder causing disruption of the skin barrie…

• Pursuant to the Merger, on the Closing Date, we acquired STAR-0310, which is a monoclonal antibody OX40 antagonist that incorporates YTE half-life extension technology for the treatment of atopic dermatitis (“AD”) and potentially other indications. STAR-0310 was designed as a potentially best-in-cla…

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• ORLADEYO is an oral capsule, once-daily therapy discovered and developed by us for the prevention of HAE attacks. ORLADEYO is approved in the United States and other global markets for the prevention of HAE attacks in adults and pediatric patients 12 years and older. In addition, the ongoing APeX-P …

• BCX17725 is a potent and selective investigational protein therapeutic KLK5 inhibitor designed to provide best-in-class, potentially disease-modifying, treatment for people with Netherton syndrome. Netherton syndrome is a serious, rare, lifelong genetic disorder causing disruption of the skin barrie…

• patients are vulnerable to dehydration and recurrent infections. Currently, there are no approved treatments that target the underlying cause of Netherton syndrome. BCX17725 is designed to replace missing functions of the natural KLK5 inhibitor, which could restore the normal skin barrier and result…

• Avoralstat, an investigational plasma kallikrein inhibitor, is designed to treat patients with diabetic macular edema (“DME”) through delivery of avoralstat to the back of the eye through the suprachoroidal space. DME is an important cause of vision loss in diabetes and is due to leakage of fluid fr…

• On August 4, 2025, we announced that new real-world data from over 350 patients with HAE with normal C1 inhibitor showed substantial reductions in attack rates with ORLADEYO, which we believe reinforces its value for a historically underserved patient segment and provides strong evidence to close ga…

Text added vs the prior filing · source: 10-Q · 2026-05-06

• We are subject to interest rate risk on our investment portfolio and borrowings under our Blackstone Loan Agreement. The Term Loans under the Blackstone Loan Agreement accrue interest each quarter at a rate equal to the three-month Secured Overnight Financing Rate (“SOFR”), which is capped to be no …

• We invest in marketable securities in accordance with our investment policy. The primary objectives of our investment policy are to preserve capital, maintain proper liquidity to meet operating needs and earn a competitive level of return. Our investment policy specifies credit quality standards for…

• Our investment exposure to market risk for changes in interest rates relates to the increase or decrease in the amount of interest income we can earn on our portfolio, changes in the market value due to changes in interest rates and other

• market factors, as well as the increase or decrease in any realized gains and losses. Our investment portfolio includes only marketable securities and instruments with active secondary or resale markets to help ensure portfolio liquidity. A hypothetical 100 basis point increase or decrease in intere…

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• We are subject to interest rate risk on our investment portfolio. We invest in marketable securities in accordance with our investment policy. The primary objectives of our investment policy are to preserve capital, maintain proper liquidity to meet operating needs and earn a competitive level of re…

• Our investment exposure to market risk for changes in interest rates relates to the increase or decrease in the amount of interest income we can earn on our portfolio, changes in the market value due to changes in interest rates and other market factors, as well as the increase or decrease in any re…

• interest rates, or we may suffer losses in principal if forced to sell securities which have declined in market value due to changes in interest rates or other factors, such as changes in credit risk related to the securities’ issuers. To minimize this risk, we schedule our investments to have matur…

Text added vs the prior filing · source: 10-Q · 2026-05-06

• As our programs advance, our costs could increase. Our expenses, revenues and cash utilization rate could vary significantly depending on many factors, including: our ability to effectively manage our product candidate pipeline; our ability to obtain regulatory approvals for our product candidates; …

• Our liquidity needs will largely be determined by the success of operations in regard to the commercialization of our products, particularly ORLADEYO, the progression of our product candidates, including the progress, timeline and ultimate outcome of our development programs (including, but not limi…

• Furthermore, we have exposure to many different industries, financing partners and counterparties, including commercial banks, investment banks and partners (which include investors, licensing partners, distribution partners, and others), which may be unstable or may become unstable in the current e…

• to raise capital in the capital or credit markets, and further could reduce the return available on invested corporate cash, which, if severe and sustained, could have a material and adverse impact on our results of operations and cash flows and limit our ability to continue development and commerci…

• We are in the early stages of integrating Astria into our business, and unknown or unanticipated risks associated with Astria’s business or product candidates could adversely affect us.

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• Our liquidity needs will largely be determined by the success of operations in regard to the commercialization of our products, particularly ORLADEYO, the progression of our product candidates in the future, and our ability to execute our budget plans. Our current plans for managing our liquidity ne…

• The Merger Agreement is subject to a number of conditions which must be fulfilled in order to complete the Merger. If the Merger is not completed for any reason, there may be various adverse consequences and we may experience negative reactions from the financial markets and from our counterparties …

• Additionally, we have incurred and will incur substantial expenses relating to negotiation and completion of the transactions contemplated by the Merger Agreement. If the Merger is not completed, we would have to recognize these expenses without realizing the expected benefits of the Merger.

• We will be subject to business uncertainties, disruptions and contractual restrictions while the Merger is pending.

• Uncertainty about the effect of the Merger on employees, suppliers, vendors and other counterparties may have an adverse effect on our business, financial condition and results of operations. These uncertainties may impair our ability to attract, retain and motivate key personnel and counterparties …

Text added vs the prior filing · source: 10-Q · 2026-05-06

• (1) This trading plan provides for the sale of up to (i) 151,868 shares of common stock underlying stock options and (ii) 64,738 shares of common stock underlying restricted stock units, net of shares withheld to cover taxes.

• (2) This trading plan provides for the sale of up to 800,000 shares of common stock underlying stock options expiring in 2027.

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• (1) This trading plan was originally adopted on December 1, 2022 (the “2022 Barnes Plan”) and provided for the sale of up to (i) 24,710 shares of common stock and (ii) 137,897 shares of common stock underlying stock options through December 29, 2025. The 2022 Barnes Plan was amended on May 15, 2024 …

• (2) This trading plan (the “Sanders Plan”) provides for the sale of up to 9,600 shares of common stock, pursuant to the terms of the Sanders Plan.