Basking Biosciences Announces First Participants Dosed in Phase 1 Study of BB-025, a Direct-Acting Reversal Agent for Investigational Stroke Therapy BB-031

-First clinical evaluation of BB-025, designed to rapidly and specifically reverse BB-031 activity, advancing Basking's goal to redefine thrombosis treatment-

RESEARCH TRIANGLE, N.C., Nov. 12, 2025 /PRNewswire/ -- Basking Biosciences (Basking), a clinical-stage biopharmaceutical company developing the first reversible thrombolytic therapy for acute ischemic stroke (AIS), today announced that the first participants have been dosed in a Phase 1 clinical study of BB-025. BB-025 is a rapid-acting reversal agent designed to specifically bind to and neutralize BB-031, the company's lead investigational therapy for AIS.

The Phase 1 study, being conducted in Australia, will assess the safety, tolerability, pharmacokinetics and pharmacodynamic activity of BB-025. It will first evaluate BB-025 administered in single ascending-dose cohorts of healthy volunteers randomized to receive BB-025 or placebo. After establishing the safety and tolerability of BB-025 alone, subsequent cohorts of healthy volunteers will receive BB-031 followed by BB-025 to evaluate how rapidly and predictably BB-025 reverses BB-031's activity in humans.

"The ability to reverse treatment represents a paradigm shift in the science of treating stroke," said Shahid M. Nimjee, M.D., Ph.D., co-founder and chief medical officer of Basking Biosciences. "While the majority of patients receiving BB-031 for acute ischemic stroke are unlikely to require reversal, in cases of bleeding or urgent surgery, having that capability adds an important layer of control, safety and flexibility to care."

Following completion of this Phase 1 study, BB-025 will be integrated into the company's ongoing clinical development program for BB-031 for AIS, supporting Basking's goal of advancing targeted, reversible therapies for stroke and beyond.

"This first-in-human study of BB-025 marks an important milestone in our clinical development strategy," said Julia C. Owens, Ph.D., chief executive officer of Basking Biosciences. "It builds on our progress with BB-031 and underscores our aim to enhance safety, flexibility and clinician confidence in stroke treatment."

Multiple nonclinical studies of BB-025 demonstrated rapid and durable reversal of BB-031 activity within minutes of administration, supporting the potential for precise control of thrombolytic effect. These findings provided the foundation for advancing BB-025 into clinical evaluation and reinforce Basking's commitment to advancing reversible thrombolytic therapies that address the limitations of current stroke treatments.

About BB-031
BB-031 is an investigational RNA aptamer designed to inhibit von Willebrand Factor (vWF), a key mediator of platelet adhesion and thrombus formation. By precisely targeting this critical pathway, BB-031 is intended to enable controlled, targeted thrombolysis that could extend the treatment window and broaden treatment opportunities for patients with acute ischemic stroke (AIS). BB-031 is paired with BB-025, a reversal agent that specifically targets BB-031 to create a unique "on-off switch" mechanism. This design aims to enable rapid neutralization of BB-031's antithrombotic activity in the event of bleeding, allowing for potential urgent surgical intervention. Rapid reversal offers a level of safety not available with current therapies, in turn providing greater confidence to physicians treating AIS.

About BB-025
BB-025 is an investigational, rapid-acting reversal agent, designed to specifically bind and neutralize BB-031. Administered as a single intravenous bolus, BB-025 is designed to rapidly and durably reverse BB-031's thrombolytic activity.

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. Incidence is increasing globally with aging populations, and in high-income countries alone, annual direct and indirect stroke-related costs are projected to exceed $826 billion by 2050.

Currently available therapies, including intravenous thrombolytics and mechanical thrombectomy, reach no more than 20 percent of patients, even in the best stroke centers. As a result, 80 percent or more of patients with ischemic stroke receive no acute intervention today, underscoring the urgent need for new approaches.

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 reversal agent, currently in development for the treatment of acute ischemic stroke. By inhibiting von Willebrand Factor (vWF), a key driver in clot formation, BB-031 offers targeted, potent thrombolytic activity that, together with its reversal agent, 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.