Note: This is NOT an IPO. This is a NASDAQ Direct Listing. The company sold some stock in a private placement at $4.00 per share on March 25, 2026. H.C. Wainwright is the financial advisor for the NASDAQ Direct Listing.

We are an early-stage biotech company with a limited operating history.

We have developed a next-generation collagen-based platform. We believe that we have achieved a defining milestone in regenerative medicine with the first ever 3D-printed structures made entirely from our patented functional extracellular matrix (ECM) to create 3D printed personalized tissue structures, grafts and implants.  This is a category-creating moment. Conexeu has moved regenerative medicine from “repairing tissue” to “tissue on demand.”

The company is also developing Ten Minute Tissue, a product designed to accelerate the healing of chronic ulcers and burns while reducing scarring and inflammation. 

GLP-1 therapies such as Ozempic^® and Wegovy^®, Mounjaro^® are accelerating demand ¹⁰ for restorative aesthetics, in medical aesthetics with tens of millions of prescriptions expected globally by 2029. ¹¹ Patients frequently report facial hollowing due to tissue loss and skin laxity following rapid weight loss. We are conducting research using CXU^TM as regenerative, volume-restoring injectable, and the potential for use in medical aesthetic applications to address these unmet needs. These concepts are at an early stage, we have not obtained FDA clearance or approval for any injectable use, and the FDA has not determined the classification or regulatory pathway for any such application.

Our first regulatory program focuses on acute wounds and burns, markets where current biologics are costly, inconsistent, and often hard to use. Conexeu’s CXU^TM device candidate is an extra cellular matrix (ECM) scaffold can be applied as a liquid at room temperature, then gels quickly in the body to form tissue a scaffold framework. Early pre-clinical testing suggests ease of application and support for cellular ingrowth and endogenous protein synthesis for long-term structural stability¹⁹ in wound healing.

3D-Printed Tissue Engineering

Looking further ahead, Conexeu sees a significant opportunity in patient-specific scaffolds created through 3D printing. We currently expect that any near-term commercialization activities in the 3D bioprinting market, if pursued, would be limited to RUO applications. Our collagen inks already demonstrate compatibility with leading bioprinters, and near-term sales into research settings may generate early revenue. In the medical arena, we aim to validate constructs that match the shape and function of native tissue. This approach positions Conexeu at the intersection of regenerative medicine and personalized care, while maintaining a device-first regulatory pathway.

Medical Aesthetics

We are conducting a staged, preclinical research program to evaluate potential aesthetic applications of our CXU™ device candidate, initially focusing on small-volume facial indications and, over time, exploring larger-volume applications such as body contouring and volume restoration; this work is expected to progress through animal and other feasibility studies and subsequent regulatory engagement. We have not obtained FDA clearance or approval for any aesthetic indication.

We expect the  CXU™ device candidate to be regulated as a Class II medical device and currently anticipate seeking FDA clearance through the 510(k) premarket notification pathway; however, the FDA has not determined the appropriate classification or regulatory pathway for CXU™, and the FDA may require additional data, including clinical data, may determine that CXU™ is a Class III device subject to a premarket approval (“PMA“) application, may require a De Novo classification request, or may determine that another regulatory pathway applies. 

To date, we have not obtained any regulatory approvals for CXU™ or generated any revenue from product sales relating to CXU™.

Note: Net loss of $1.72 million is for the three-month period that ended Jan. 31, 2026.

Note: The company has not generated any product revenue so far, according to the prospectus.