• GLP toxicology study demonstrates tolerability of single and repeat epidural dosing at highest dose tested
• Data support advancement of C-1101into first-in-human clinical trial for chronic sciatica

BURLINGTON, MA — November 21, 2025 — Consano Bio, a clinical-stage biotechnology company advancing novel therapeutics designed to address serious pain conditions, today announced positive data from its nonclinical safety and toxicology program for C-1101, supporting initiation of a Phase 1 clinical trial in patients with chronic painful lumbosacral radiculopathy (LSR), or chronic sciatica. The results were presented in a poster at the American College of Toxicology (ACT) 46th Annual Meeting in Phoenix, AZ.

The poster presentation titled, “Nonclinical Safety Assessment of C-1101, an Allogeneic Platelet- and Plasma-Derived Therapeutic for Epidural Injection,” detailed the nonclinical safety program to support the initial clinical study for C-1101. The nonclinical program was designed to evaluate the potential toxicity of C-1101 while utilizing a single species and a new approach method (NAM) to evaluate potential immunogenicity. This nonclinical program provides a robust evaluation of the safety of C-1101, while following the principles of reducing and replacing animal use in pharmaceutical development.

In the 28-day GLP toxicology study conducted in rats, C-1101 was well tolerated after single and repeat epidural administration of C-1101 at all dose levels tested. Immunogenicity potential was evaluated using a nonanimal method in vitro human peripheral blood mononuclear cell assay. Results showed minimal CD4+ T-cell activation, comparable to commercially available intravenous immunoglobulin (IVIg), indicating a low immunogenicity risk consistent with other approved blood-derived products.

“These nonclinical safety data represent a critical milestone for Consano Bio and provide strong support for advancing C-1101 into clinical testing,” said Andrew Hall, Chief Executive Officer of Consano Bio.

Consano Bio plans to initiate a Phase 1 clinical trial (NCT07264270) in patients with chronic painful LSR.

About Chronic Lumbosacral Radiculopathy (LSR)
Chronic painful LSR, or sciatica, is a chronic lower back pain condition caused by damage or irritation of spinal nerve roots, leading to radiating pain, numbness, and weakness from the spine into the leg. There are no FDA-approved pharmaceutical treatments for chronic sciatica despite its prevalence and widespread societal and economic impact.

About C-1101
C-1101 is Consano Bio’s lead investigational clinical candidate and the first pharmaceutical therapy of its kind: a novel, platelet-derived multi-protein biologic therapeutic. It is designed to treat chronic painful lumbosacral radiculopathy (LSR), or chronic sciatica, by modulating inflammation and stimulating and enhancing cellular repair at the site of injury. C-1101 is a purified, multi-protein solution derived from human platelets in plasma collected from healthy donors. The product contains consistent concentrations of cytokines, growth factors, and matrix proteins to help trigger the body’s natural healing response. Delivered via an epidural injection, C-1101 provides supraphysiologic concentrations of these proteins directly to the site of nerve injury.

About Consano Bio
Consano Bio is a clinical-stage biotechnology company dedicated to transforming the treatment of painful and debilitating orthopedic conditions through a new class of multi-protein therapeutics. Founded in 2023 and headquartered in the Greater Boston area, the company is developing C-1101, the first potential pharmaceutical therapy for chronic painful lumbosacral radiculopathy (LSR), or chronic sciatica. The therapy is designed to deliver a high concentration of these proteins from human platelets directly to the site of injury to modulate inflammation and promote localized tissue repair. For more information, visit www.consanobio.com.