Wise Young, Professor, Chairman and Laboratory Director, Mononuclear Therapeutics

Novel Umbilical Cord Blood Components for Cell Culture, Spinal Cord Injury and other Clinical Indications

Wise Young, Professor, Chairman and Laboratory Director, Mononuclear Therapeutics

[Summary]

Business Overview
Mononuclear Therapeutics Limited (MonoTx) is an internationally accredited research, development and product company focusing on human umbilical cord blood (UCB) mononuclear cell (MNC) therapies for disease and life-saving treatments.
Founded in 2015 by Professor Wise Young and Mr. Ken Giacin, MonoTx creates the world's first UCBMNC bank in Hong Kong (HK) for effective treatment of spinal cord injury (SCI), stroke, age-related macular degeneration (AMD) and neonatal hypoxic-ischemia encephalopathy (HIE).
MonoTx is accredited by the American Association for Blood Bank (AABB) and registered with the U.S. FDA, member of World Marrow Donation Association (WMDA) and working towards Hong Kong Manufacturer License for Advance Therapy Products (ATPs).

Market Analysis
No therapies are currently available to restore function after SCI, stroke, AMD, or severe HIE. Worldwide market sizes for these four indications are as follows:

• Hypoxic Ischemia - 0.3 million babies/year
• Chronic SCI - 3 million
• Chronic Stroke - 80 million
• Macular Degeneration - 200 million

Technology
As technology pioneer in MNC isolation from UCB at cheaper cost and shorter time. MonoTx packages the MNC cells from a single UCB unit into multiple doses to treat more patients.
MonoTx has exclusively licensed technologies developed by Prof Young at Rutgers University to isolate and cryopreserve UCBMNC, T-cells and Muse cells, platelets, platelet depleted plasma (PDP), exosome-rich plasma (ERP), and red cell fraction (RCF).

Business Model
MonoTx established its operations in HK with the objective of translating R&D done at Rutgers University and HKSTP into salable products and therapies for HK and Greater China.
MonoTx is setting up US operations to partner with leading UCB banks around the world. MonoTx is establishing partnerships with three leading US public cord blood banks which have significant FDA approved cord blood units in inventory. These will be key UCB suppliers for clinical trial and future UCBMNC therapies and sales.

MonoTx sales of by-products UCB units to major research institutions as

• PDP - for human cell culture.
• ERP - stimulates cell growth and differentiation with clinical applications, e.g. in-vitro fertilization.
• RCF - contains fetal hemoglobin with high oxygen binding rate and ideal for anemia.

Various usage of UCBMNC in treatment:

• Partner with US UCB bank for investigational new drug (IND) in the US to do Phase I/II clinical trial of chronic SCI to restore walking functions - discussions underway.
• Obtain manufacturer license for ATPs in HK for clinical trials.
• Conduct animal studies that indicate UCBMNC can restore function in chronic stroke, ADM and HIE.
• Working with therapeutics companies in developing UCB Muse cells to treat heart, lung, liver and kidney diseases, UCB T-cells to treat cancer.

Management

• Prof Wise Young (Chairman and Laboratory Director) has over 40 years R&D experience and led the breakthrough clinical trials to obtain regulatory approval of U.S. phase II clinical trials to treat chronic spinal cord injury with UCB MNC.
• Ken Giacin (Chief Executive Officer) has over 40 years of executive experience with Johnson & Johnson and Stemcyte in pharmaceutical and cord blood banking.
• Dr. Wendy Cheng (Chief Operating Office) has 15 years of experience in organizing and running clinical trials and developing cellular products.
• Prof. Chi Kong Li (Medical Director) has over 30 years in pediatric oncology at the Chinese University of Hong Kong. He is one of the most experienced pediatric and transplant physicians in HK.

Major Achievements and Targets
Monotx started as a Hong Kong Company in June 2015 Achievements of MonoTx to date:

• Established a state-of-the-art UCB MNC bank at HK Science Park.
• Obtained accreditation from AABB, registered with the U.S. FDA and member of WMDA.
• Contracted research with the Chinese University of Hong Kong (CUHK) for cord blood collection, neonatal HIE preclinical and clinical study.
• Received a HK$5.86 million project grant from HK Innovation Technology Fund.
• Partnership with US public cord blood banks to secure the UCBMNC for clinical trials and treatments.

Funds and Use of Proceeds

[Profile]
Prof Wise Young (Chairman and Laboratory Director) has dedicated the past 40 years to spinal cord research and led the breakthrough clinical trials to obtain regulatory approval of U.S. phase II clinical trials to treat chronic spinal cord injury with umbilical cord blood mononuclear cells (UCBMNC).