The Interview

think beyond current practices and develop long-term solutions to the unique challenges of cell therapy manufacturing. The Center accelerates the use of automation, integration, closed processing and other strategies to address scale up, cost of goods, quality control and robustness of client manufacturing process.

You recently acquired California Stem Cell (CSC); what more can you tell us about this acquisition?

With the acquisition of CSC in May 2014, we added Targeted Immunotherapy to our

development

pipeline. In choosing to make the acquisition, we seized upon the strength of our already strong clinical programs and PCT’s expertise in the manufacturing of cancer immunotherapies.

As NeoStem was built upon a series of strategic transactions, the acquisition of CSC was entirely in keeping with the opportunistic growth strategy that is at the core of our corporate philosophy. When the opportunity arose to apply our specific and extensive expertise to a technology platform for the treatment of cancer, which included a Phase 3 ready asset with Special Protocol Assessment, Fast Track designation, Orphan Drug designation, and compelling Phase 2 data, we felt we had to take it.

Speaking of the Phase 3 trial, can you talk about your Targeted Immunotherapy program and your proprietary cell technology to treat cancer?

The American Cancer Society estimates that there are about 76,100 new cases of melanoma in the U.S. each year, and about 9,710 deaths from melanoma. Skin cancer is the most common of all cancers. While melanoma accounts for less than 5% of skin cancers, it causes most skin cancer deaths. The number of new cases of melanoma in the U.S. has been increasing for at least 30 years.

Our lead product candidate, Melapuldencel-T, focuses on Stage IV and recurrent Stage III metastatic melanoma. We expect to initiate a pivotal Phase 3 trial of Melapuldencel-T later this year. The goal of the therapy is to eliminate or neutralize the tumor cells that are responsible for recurrence after medically induced tumor regression after a patient has already had undergone other treatments which may have reduced tumor size, but failed to entirely eliminate the cancer.

Melapuldencel–T has been the subject of compelling clinical trial results for the treatment of metastatic melanoma. Also, the platform on which Melapuldencel-T is created is being investigated for other indications including hepatocellular carcinoma and other immune responsive tumor types. We are really excited about the potential of this novel cancer immunotherapy.

What is NeoStem looking forward to in the coming months?

On the clinical front, our collaborator, University of California, San Francisco, recently announced the data results from a Phase 1 clinical trial that studied the effect of a T regulatory cell (Treg) immunotherapy for type 1 diabetes, and we are planning to launch a Phase 2 trial for this Treg product candidate in Q3 2014. Also, later this year we will be announcing data from our Phase 2 PreSERVE trial testing our CD34 Cell Program’s lead product candidate AMR-001 for heart attack patients, and, as I mentioned before, we expect to initiate a Phase 3 trial of Melapuldencel-T for malignant melanoma later this year.

What do you see for the future of this young industry?

According to Robin R. Young’s Stem Cell Summit FINANCEMONTHLY 35

Executive Summary-Analysis and Market Forecasts 2014-2024, the U.S. stem cell therapy market is estimated to grow from an estimated $237 million in 2013 to more than $5.7 billion in 2020.

With approved cell therapy products currently being sold in the U.S. and abroad, and an increasing number of Phase 2 and Phase 3 trials with cell therapies underway, we believe the “promise” of cell therapy is becoming more and more clear. Cell therapies, if approved, should cut health care costs as they aim to facilitate functional restoration of damaged tissues and not just abate or moderate symptoms. Safe and efficacious cell therapies for chronic diseases could capture an increasing portion of future healthcare spending in the U.S., driven both by favorable demographics and meaningful pharmacoeconomic benefit.

Is NeoStem looking for partnership opportunities?

Yes, we are laying foundations now in all of our programs to support partnering and collaborative activities as we hit significant milestones in our development. Anyone interested in partnering with NeoStem, should contact me at rsmith@neostem.com or 212 584 4174.

CONTACT:

Dr. Robin L. Smith Tel: 212 584 4174

Email: rsmith@neostem.com Web: www.neostem.com