SAB Biotherapeutics (SABS) Chardan's 10th Annual Healthcare Conference summary

MAPC therapy and ARDS rationale

• Healios’s MAPCs are end-state cells that do not differentiate; given by IV, they persist for 2–3 days but are intended to dampen acute inflammation and support repair.

• In ARDS, thawed, off-the-shelf allogeneic cells reach the lungs on first pass and act across immune cells and cytokines to shift inflammation toward homeostasis.

• Phase II studies showed faster ventilator removal and reduced mortality, alongside subsiding alveolar edema and improved ability to breathe independently.

Manufacturing and Japan pathway

• Healios inherited Athersys’s large-scale bioreactor process; a 50 L Sartorius process is operating at Minaris in Yokohama, while a 500 L commercial facility is being established in Kobe with a $50 million Japanese government grant.

• The 50 L suite can produce 1,000 doses annually at commercially viable cost; the 500 L facility is designed for 40,000 doses annually, with cost of goods dropping by two-thirds or more versus 50 L.

• Manufacturing at Minaris was described as one-third the cost of Lonza in Singapore; Japanese regulatory support, funding, talent and lower costs support initial commercialization there.

• Japan’s established cell-therapy regulatory pathway supports a conditional ARDS approval route; Healios is also pursuing the U.S. market through a global phase III study.

ARDS filing and global trial milestones

• Manufacturing runs and process characterization are underway to generate filing data; Healios expects to file in the coming months, with approval anticipated nine months after filing under Japan’s orphan-drug pathway.

• Japan has 28,000 ARDS patients annually; the stated plan is to launch after approval and continue advancing commercial manufacturing readiness.

• The pneumonia-induced ARDS phase III study has started in Japan and is planned for about 80 global sites, with substantial U.S. enrollment and sites planned across Europe, Korea, Taiwan and Australia; China sites are under consideration.

• The moderator characterized a potential Japan approval in 2027 as a key anticipated milestone.