Mesoblast Limited (ASX:MSB) Head, Business Development and Licensing, David Oxley, discusses the company's Phase 3 trials, its agreement with Tasly China and the near-term potential of stem cell medicines.
Rachael Jones: Hello, I'm Rachael Jones for the Finance News Network. Joining me today from Mesoblast is head of business and licensing, David Oxley. David, welcome to FNN.
David Oxley: Thank you, Rachael, it's good to be here.
Rachael Jones: So first up, can you talk us through the business?
David Oxley: Sure. Mesoblast is the premier cellular medicines company. What does that mean? It means we have developed technology that treats life-threatening injury and illness and unmet medical conditions around the world, that's underpinned by a technology that has been borne out through clinical trials. We have robust manufacturing in place, and have commercial partners on the ground in major geographies.
Rachael Jones: Thanks, David. Now, before we discuss your product portfolio, could we talk about how important stem cells are and how the technology has progressed?
David Oxley: Stem cells today we can think of as an injury and our body's ability to heal that injury, except for things that are significant, such as a heart attack or chronic kidney disease, where the body does not have that ability. Stem cell therapy today exists in technology developed by Mesoblast that has been borne out in clinical trials in the United States and in other jurisdictions that enables us in medicine to treat major unmet medical conditions with cellular medicine.
Rachael Jones: Now to your portfolio, David. Can you tell us about your Phase 3 product candidates?
David Oxley: We're really excited, Rachael. We are at the end of a set of Phase 3 programs for three major products. The first is to address a major unmet medical condition in bone marrow transplantation called "graft versus host disease" in children. We have that program that has completed important primary endpoints and its secondary endpoint is pending anytime. And on the conclusion of that secondary endpoint, we will be working with US FDA to pursue an application for approval.
The second program is in the area of cardiology, very specifically in the area of chronic heart failure. There we have two major programs that are going to address multi-billion dollar market opportunities. The first is to address what's called ‘end-stage heart failure’ or US class IV stage of the disease. We anticipate later this year a read out of that program which will be the basis of an accelerated FDA approval pathway in the United States.
And the second program in cardiology is to address chronic heart failure or advanced heart failure of the disease. And we anticipate that program will complete enrolment later this year and we'll be looking in 2019 at a pathway for regulatory approval in the United States.
The last and perhaps most important of these programs is completed enrolment in the area of chronic low back pain, an area important for the opioid epidemic that is taking place in the United States we've all read about, and the lack of intervention that is accessible to patients and providers where our program has demonstrated durability to treat that chronic low back pain and that degenerative disease with a durability effect of greater than three years.
Rachael Jones: That all sounds very encouraging. Now, could you talk me through the collaboration with Tasly of China? What does that involve?
David Oxley: We were very pleased, Rachael, to announce our partnership with Tasly. Tasly Pharmaceuticals represents to Mesoblast three strategic contributions. The first is validation of our technology in their due diligence that confirmed for them the contribution of our product candidates that will address chronic heart failure in China.
Number two, Tasly represented a very strategic interest in Mesoblast's corporate strategy to launch our products in the second-largest medical market in the world today, likely to be the largest medical market in years ahead.
And three, and perhaps most importantly, Tasly represents a strategic investment in Mesoblast today.
Rachael Jones: And now to your finances and the share price. How is business tracking?
David Oxley: Rachael, we were very pleased to announce recently two very significant, strategic, non-dilutive financings, the first with Hercules and the second with Novaquest. The combined give us access to about 18 months of working capital. Why does that matter? Because it represents enough capital for us to get to major inflection points for Mesoblast and most notably the first US FDA approved product we anticipate launching in the United States for graft versus host disease, mentioned earlier.
As to our share price, I can only share by observation the management could not be more confident right now. We have three blockbuster potential indications we intend to prosecute in the years ahead in the United States market. We have a robust manufacturing mechanism in place to supply those markets. And we have three major commercial partners, one in Japan, one in China, and one in Europe, validating the technology, validating our thesis of cellular medicine and its importance in these major unmet needs, and validating the investments they've made in Mesoblast.
Rachael Jones: David Oxley, thanks for the update.
David Oxley: Thank you, Rachael. It was nice to be here.