Longeveron LLC is a regenerative medicine company developing cellular solutions for aging-related diseases. The company is focused on the development of allogeneic (donor-derived) human mesenchymal stem cells (MSCs) that are harvested and grown at its manufacturing facility in Miami, Florida.

Longeveron’s MSC (LMSC) product is derived from the bone marrow of young, healthy adult donors.

In addition to manufacturing its own cells in this cGMP facility, Longeveron is conducting clinical trials and manufacturing cells for other parties through its cell therapy CMO business. A contract manufacturing organization (CMO) is a company that provides manufacturing services to cell and gene therapy companies on a contract basis.

Longeveron’s Clinical Trial Activity

In 2017, Longeveron published positive Phase I and Phase 2 clinical studies in the Journals of Gerontology that evaluated the safety and efficacy of its Mesenchymal Stem Cells in patients with Aging Frailty.

The company is now recruiting for an expanded Phase 2b Aging Frailty study that will enroll 120 participants. The trial will test three different doses of a single peripheral intravenous (IV) infusion of Longeveron Mesenchymal Stem Cells (LMSCs) against a single peripheral IV infusion of placebo. The trial is anticipated to be competed in September 2019.

Other clinical trials that Longeveron is pursuing include:

• Allogeneic Human Mesenchymal Stem Cell Infusion Versus Placebo in Patients With Alzheimer’s Disease (NCT02600130)
• Human Mesenchymal Stem Cells (LMSCs) on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (NCT02982915)
• Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial (NCT02587572)
• Longeveron Mesenchymal Stem Cells (LMSCs) Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (NCT03525418)

Longeveron Funding Achievements

Importantly, Longeveron has achieved a number of recent funding successes, including:

• A $3.8 million Small Business Innovation Research (SBIR) grant from the National Institute of Health (NIH) for its research to develop stem cell therapies for Aging Frailty. The award was announced by Longeveron on October 18, 2018.
• A $1.15 million Small Business Technology Transfer grant under the NIH Fast Track program to support the development of therapeutics to combat metabolic syndrome. The grant was awarded to Longeveron on January 9, 2018.
• A $750,000 grant from the Maryland Technology Development Corporation (TEDCO)announced May 22, 2018. The grant supports previous financial support from the Alzheimer’s Association and TEDCO for clinical trials related to Alzheimer’s disease and hypoplastic left heart syndrome (HLHS), respectively.
• A $1 million “Part the Cloud Challenge on Neuroinflammation” grant from theAlzheimer’s Association.

In total, the company has been the recipient of more than $6.7 million in grant funding to support the development of its unique Longeveron Mesechymal Stem Cell (LMSC) technology platform.

Longeveron and TEDCO

In addition to receiving $750,000 in financial support from the Maryland Technology Development Corporation (TEDCO), Longeveron’s alignment with the group provides other critical support as well. TEDCO has been instrumental in providing visibility to company, as well as connecting it with other technology groups with Maryland and country-wide.

Most recently, Longeveron announced that Dr. Joshua Hare will be a speaker at the 2018 TEDCO Entrepreneur Expo & Stem Cell Symposium, to be held October 30 at the Hotel at the University of Maryland. Longeveron is also an event sponsor.

Having a well-capitalized champion at the state level to support stem cell therapy development within Maryland provides critical support to Longeveron at a time during which it is rapidly expanding, as well as concurrently pursuing five clinical trials across various age-related indications.

To learn more about Longeveron, visit the company at: http://longeveron.com/