PITTSBURGH, PA & FLAGSTAFF, AZ, USA I July 27, 2023 I Carmell Therapeutics Corporation (Nasdaq: CTCX) (“Carmell”), a regenerative medicine company today announced the execution of a definitive agreement and plan of merger (the “Merger Agreement”) with Flagstaff-based Axolotl Biologix, a profitable regenerative medicine company developing products for active soft tissue repair, aesthetics and orthopedic indications (“Axolotl”).
- Axolotl designs, develops and sells human amnion-based allograft products for active soft tissue repair, aesthetics and orthopedic indications.
- Axolotl’s marketed products meet all criteria for regulation under section 361 of the PHS Act and 21 CFR part 1271 as recommended by the FDA Tissue Reference Group (TRG).
- In Q2 2023, two of Axolotl’s products were added to CMS Part B Drug and Biological Average Sales Price pricing files.
- Axolotl is also enrolling a Phase I/II clinical trial for Ankle Osteoarthritis and developing a topical cosmeceutical for skin rejuvenation.
- In Q2 2023, Axolotl became a preferred vendor via a national pricing contract with one of the 3 largest group purchasing organizations, which serves over 1,500 hospitals in the United States.
- As of June 30, 2023, Axolotl achieved approximately $50 million in unaudited trailing 12-month (“TTM”) net revenue and approximately $5 million in unaudited TTM EBITDA from the sales of its products.
- Per the terms of the Merger Agreement, Axolotl’s shareholders will receive $65 million in Initial Equity Value (structured as $8 million in cash and $57 million in CTCX stock at Closing), plus up to $75 million in potential Milestone Equity Payments (structured as 12% cash and 88% in CTCX stock) linked with the achievement of certain revenue and business milestones.
- Shares received by Axolotl’s shareholders in the Merger Agreement will be locked up for 12 months following closing.
- Upon the Closing, Axolotl will operate as wholly owned subsidiary of Carmell.
- Upon the Closing, all full-time employees are expected to remain with Carmell except for Mr. Josh Sandberg, CEO of Axolotl who shall serve as Strategic Advisor to the Executive Chairman of Carmell.
- Transaction Closing is subject to completion of customary approvals and other customary conditions.
- Goodwin Procter LLP acted as legal counsel to Carmell. Doyen Sebesta & Poelma LLP acted as legal counsel to Axolotl. Cabrillo Advisors acted as financial advisor to Carmell.
Said Mr. Sandberg, “I am excited to partner with Rajiv and Carmell to build on our shared vision of offering industry leading products that positively impact patients’ lives. Our teams have worked very diligently, and this transaction creates unlimited possibilities.”
Said Mr. Rajiv Shukla, the Executive Chairman of Carmell, “I look forward to working with Josh and the Axolotl team to accelerate our goal of building Carmell into an Industry-leading regenerative medicine company through a combination of in-house product development, bolt-on acquisitions and business development aimed at aesthetics/soft tissue and orthopedic indications.”
Carmell Therapeutics is a Phase 2 stage regenerative medicine platform company developing allogeneic plasma-based biomaterials that are designed to boost innate regenerative pathways across a variety of bone and soft tissue indications. Carmell received FDA clearance for a Phase 2-stage clinical trial designed to study accelerated healing and reduced infections in open tibia (shinbone) fractures with intramedullary rodding. Carmell expects to initiate a Phase 2 trial for Foot/Ankle Fusion. Pre-clinical development is also underway in Spinal Fusion, Dental Bone Graft Substitute, Androgenetic Alopecia, Active Soft Tissue Repair and Cosmetic Skin Rejuvenation. For more information, visit www.carmellrx.com.
SOURCE: Carmell Therapeutics