Cyclo Therapeutics and Applied Molecular Transport Agree to Merge

Rare Daily Staff

Cyclo Therapeutics, a clinical stage company focused on developing therapies for rare and neurological diseases with limited treatment options, and Applied Molecular Transport have entered into a definitive agreement in which AMT will merge with Cyclo in an all-stock transaction.

The combined company will operate under the name “Cyclo Therapeutics, Inc.” and will continue trading on The Nasdaq Capital Market under the ticker symbol CYTH. The combined company will focus on advancing Cyclo Therapeutics’ pivotal phase 3 global study evaluating Trappsol Cyclo for Niemann-Pick disease Type C1 (NPC1).

“This transaction bolsters our cash position to complete our phase 3 study and support operations through the regulatory submission process, assuming a successful outcome in our pivotal study,” said N. Scott Fine, CEO of Cyclo Therapeutics. “We remain dedicated to bringing our NPC global pivotal program, which is on track to complete enrollment by the end of 2023, across the finish line towards approval.”

Cyclo’s investigational Trappsol Cyclo has orphan drug status in the United States and Europe, and is the subject of four formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease. The company is also conducting a phase 2b clinical trial using Trappsol Cyclo intravenously in early Alzheimer’s disease based on encouraging data from an Expanded Access program for Alzheimer’s disease.

“Following an extensive and thorough strategic review process, we view this merger with Cyclo Therapeutics as the best path forward for AMT shareholders given the promise and potential of its late-stage program in NPC1,” said Shawn Cross, CEO of AMT.

Under the terms of the merger agreement, AMT stockholders will receive approximately 0.174 shares of Cyclo Therapeutics in exchange for each of their shares in AMT (subject to adjustment based on AMT’s net cash at closing). Cyclo Therapeutics expects to issue approximately 7.624 million shares of Cyclo Therapeutics’ common stock to AMT shareholders, equating to approximately 25 percent of the combined company on a fully diluted basis. At closing, which is expected in the fourth quarter of 2023, the combined company will have approximately $13.7 million cash on hand to fund operations into the second half of 2024.

Cyclo Therapeutics’ existing management team will lead the combined company. It will be headquartered in Gainesville, Florida. Subsequent to the closing of the transaction, Shawn Cross, CEO and chairman of AMT will be appointed to the Cyclo Therapeutics Board of Directors.

The boards of directors of each company approved the merger and it is expected to close in the fourth quarter of 2023, subject to the satisfaction or waiver of customary conditions.

Photo: Shawn Cross, CEO and chairman of AMT