Our fundamental goals are to create safer and more effective new medicines that can address significant unmet medical needs, and to generate substantial value for our shareholders in the process.
Our business strategy is to: (1) develop a portfolio of therapeutic products and programs in a highly cost effective manner (as opposed to developing a single opportunity); (2) develop “best-in-class products” that have the potential to be safer and more effective than current standard of care, and that can address substantial unmet medical needs (as opposed to developing “me too” products); (3) partner with other groups, including leading research centers, clinical institutions, and commercial partners to accelerate and enhance our development efforts, and enable us to do things more cost effectively (as opposed to trying to do everything ourselves), and; (4) to apply knowledge and experience from other programs, as well as innovative approaches we have developed to reduce development risk, time, and cost.
We are committed to developing a portfolio of product development opportunities that we believe have the potential to be safer, more effective products than the current standard of care or other products in development, and that may have other advantages, such as superior scalability or ease of administration. By applying our distinctive technologies and capabilities, and by utilizing certain approaches to minimize development risk and costs, we believe that we can create substantial value while also being very cost effective.
We are developing the MultiStem® product platform for multiple disease indications in parallel, including indications in the cardiovascular, neurological, inflammatory and immune disease areas. The opportunities in these areas are very broad, which for a small company, can pose significant challenges. However, we are using several approaches that we believe are enabling us to cost effectively explore and develop a high quality portfolio of opportunities.
First, over the past few years we have established a very broad network of collaborations with leading researchers and clinical investigators at institutions across the United States and Europe. This network has enabled us to efficiently evaluate the potential relevance of MultiStem across multiple indications in the cardiovascular, neurological, inflammatory and immune disease areas, without having to build enormous infrastructure. As these independent investigators generate data and results, they are encouraged to present them at leading scientific conferences and publish their findings in qualified scientific journals. This approach enables us to cost effectively explore a broad range of potential applications for our technologies, accelerate development efforts, minimize infrastructure and reduce costs.
Second, we are utilizing a common platform to achieve consistency in product manufacturing, characterization, and validation, and to pursue multiple distinct pre-clinical and clinical development programs in parallel. By using this approach, we are able to advance multiple MultiStem programs in parallel in a cost effective and efficient manner, and leverage safety from some programs to accelerate and support development in other programs. This saves us time and valuable resources.
Third, we have selected specific lead indications in the cardiovascular, neurological, inflammatory and immune disease areas to advance into initial “proof of concept” clinical studies, while we continue to explore and advance opportunities in related disease indications in parallel. We believe that success in one or more of these initial indications will enable us (and our partners) to advance these programs into later stage clinical development, and will also facilitate the accelerated advancement of other programs in related areas. We believe that this approach will also maximize the portfolio value in each area, which is important from a partnering and long term value creation standpoint.
Finally, in our portfolio of programs we are learning from the prior experience of others, and incorporating that knowledge into our development approach. By closely examining where and why other programs have to meet appropriate regulatory requirements failed (e.g. trial design failure, specific safety issues, efficacy endpoints), and incorporating that knowledge into our development approach in an efficient and timely manner, we believe we can better avoid the mistakes of others, and increase the probability of establishing best in class products. This approach also allows us to stage investment and development risk, as we seek to maximize long term value for our shareholders. |