Basking Biosciences Announces Positive Topline Phase 1 Data for BB-025, the Reversal Agent for its Acute Ischemic Stroke Thrombolytic Therapy BB-031

BB-025 produced complete, rapid reversal of BB-031 activity within five minutes and was generally safe and well-tolerated across 60 healthy volunteers

RESEARCH TRIANGLE, N.C., Aug. 25, 2026 /PRNewswire/ -- Basking Biosciences (Basking), a clinical-stage biopharmaceutical company developing a first-in-class, targeted, reversible thrombolytic therapy for acute ischemic stroke (AIS), today announced positive topline data from its Phase 1 study of BB-025, an investigational, rapid-acting reversal agent designed to specifically bind to and neutralize BB-031, Basking's lead candidate, within minutes. BB-031 is an investigational RNA aptamer designed to selectively inhibit von Willebrand Factor (vWF) and restore blood flow in patients with AIS. BB-025 is being developed to give clinicians a way to rapidly reverse BB-031 activity if clinically required.

"These results confirm what we designed BB-025 to do: neutralize BB-031 quickly, with a safety profile that supports its use alongside BB-031 in acute care settings," said Shahid Nimjee, MD, PhD, chief scientific officer and stroke clinical lead of Basking Biosciences. "Clinicians need a reversal agent that works quickly and is durable, and these data demonstrate both."

The primary objective of this first-in-human study was to assess the safety and tolerability of single escalating doses of BB-025 administered as intravenous bolus injections in healthy volunteers. To demonstrate BB-025's ability to rapidly reverse the activity of BB-031, the study also evaluated BB-025 administered following a single dose of BB-031.

All 60 healthy adult subjects enrolled in the study received a single administration of BB-025 at doses up to 12 mg/kg, either alone or following a single dose of BB-031, at doses up to 6 mg/kg. When administered following a single dose of BB-031, BB-025 produced a complete, rapid, and stable reversal of BB-031 activity, restoring vWF activity and platelet function within five minutes of administration. This reversal was demonstrated both 30 minutes and five hours after BB-031 administration, supporting a clinically meaningful window for reversal.

BB-025 was generally safe and well-tolerated across all tested doses, with no evidence of a dose-response relationship in the incidence of treatment-emergent adverse events (TEAEs). There were no deaths, life-threatening TEAEs, or serious adverse events during the study, and no TEAEs led to treatment discontinuation. BB-031 was also generally safe and well tolerated at doses up to 6 mg/kg. Adverse events of special interest, including bleeding events and infusion-related reactions, were non-severe and transient.

"Having a reversal agent like BB-025 is a key aspect of BB-031's differentiation from other thrombolytics in development for acute ischemic stroke. BB-031 is the only investigational acute intervention with a clinically validated reversal agent," said Julia C. Owens, Ph.D., chief executive officer of Basking Biosciences. "These data show that the effects of BB-031 can be reversed, and that this can be done quickly. If approved, this could give clinicians a level of flexibility that does not exist with current therapies. It brings us closer to a paired, reversible approach to treating acute ischemic stroke."

Detailed results from the study will be presented at a future medical meeting. Following this Phase 1 study, and pending discussions with FDA, the Company intends to incorporate BB-025 into the BB-031 AIS clinical development program.

About BB-031

BB-031 is an investigational RNA aptamer designed to selectively inhibit von Willebrand Factor (vWF), a central mediator of clot initiation, growth and stabilization. By targeting vWF with high affinity and selectivity, BB-031 is intended to enable potent inhibition of this key element of clot stabilization, resulting in rapid restoration of blood flow that could extend the treatment window and broaden treatment opportunities for patients with acute ischemic stroke (AIS). If clinically required, BB-025 can be administered to neutralize BB-031.

About BB-025

BB-025 is an investigational, rapid-acting oligonucleotide reversal agent that specifically binds to BB-031. Administered as a single intravenous bolus, BB-025 is designed to rapidly and durably reverse BB-031's thrombolytic activity. By delivering immediate, durable neutralization of BB-031, BB-025 is being developed to provide clinicians with a built-in safety mechanism that can reverse BB-031's thrombolytic activity in the event of bleeding or the need for urgent surgical intervention.

About Acute Ischemic Stroke

Acute Ischemic Stroke (AIS) is the leading cause of combined mortality and morbidity worldwide, accounting for 87 percent of all strokes. According to the World Health Organization, 15 million people suffer a stroke each year, resulting in more than 5 million deaths. Currently available therapies, including intravenous thrombolytics and mechanical thrombectomy, reach no more than 20 percent of patients, even in the best stroke centers.

About Basking Biosciences

Basking Biosciences is a clinical-stage biopharmaceutical company dedicated to changing the way potentially life-threatening blood clots are treated. Its novel therapies are designed to significantly improve safety and efficacy, broadening access to many more patients. The company's lead candidate, BB-031, is the first rapid-onset, short-acting thrombolytic therapy with a direct-acting reversal agent, currently in development for the treatment of acute ischemic stroke. By selectively inhibiting von Willebrand Factor (vWF), a central mediator of clot initiation, growth, and stabilization, BB-031 delivers potent, targeted thrombolytic activity that, together with its reversal agent BB-025, could enable more patients to receive timely, life-saving treatment after stroke. For more information, visit www.baskingbiosciences.com and follow us on LinkedIn.

SOURCE Basking Biosciences Inc.