Dear Fellow Shareholders,
Today we announce Pluristem’s update for the second quarter of fiscal 2020, including recent achievements and our next short-term milestones. Recently, Pluristem’s management attended the annual J.P. Morgan Healthcare Conference in San Francisco, and this year it was clear more than ever that the pharmaceutical industry is significantly increasing its interest in cell and gene therapy. Many of the discussions and conversations about cell and gene therapy focus on the technological gaps and the lack of manufacturing platforms. As you know, Pluristem considers its manufacturing capabilities to be one of its key competitive advantages. There is significant interest in our platform technology and in the fact that we have strong industrial manufacturing capabilities and high batch to batch consistency, while maintaining a strong pipeline aimed for valuable markets with unmet medical needs. The discussions during this week confirmed that we hold a leading position in the field of advanced therapies. My goal is to materialize this advantage to also benefit our shareholders.
During this past quarter, we were very focused on completing our pivotal Phase III clinical studies. We made significant advancements in both of our Phase III studies for PLX-PAD, including achieving the 75% enrollment milestone in our multinational Phase III Critical Limb Ischemia (CLI) study and the 50% enrollment milestone in our multinational Phase III study in muscle regeneration following hip fracture. I am very pleased with the fact that we have kept enrollment rates high. We have strong cooperation from our clinical sites, and we are pushing forward to complete our mission to be the first company in U.S. and Europe with approved treatments for unmet medical needs such as CLI and muscle regeneration.
As recently announced, we have also concluded a thorough market analysis of the U.S. CLI market. This market access study, which included interviews with dozens of U.S. payers and key opinion leaders, demonstrated what we believe is a significant need with a potential addressable market estimated between $2 and $6 billion for PLX-PAD in the United States. During this past quarter we also made important progress with our preparation for commercialization of CLI and advanced our relationships and discussions with potential collaborators and other stakeholders. We have established a wholly owned subsidiary, based in Berlin, Germany, understanding the importance of a physical presence in our strategic markets, and advancing research and development activities with our long-term partner, the Charité and BCRT (BIH Center for Regenerative Therapies) of Berlin.
As we previously reported, Pluristem submitted a proposal to the U.S. Biomedical Advanced Research and Development Authority (BARDA) for a project designed to demonstrate the superiority of our PLX-R18 therapy versus current standards of care in the treatment of Acute Radiation Syndrome (ARS). We were recently notified by BARDA that the proposal is still being evaluated and a final answer should be provided soon. We recognize BARDA’s near-term focus may have shifted to the coronavirus threat over the past few weeks and believe that a decision made regarding PLX-R18 will be made within the context of the agency’s broader current and future needs. Once we receive a response to our proposal from BARDA, we will announce it.
As of December 31, 2020, Pluristem had approximately $17.5 million in cash and cash equivalents, bank deposits and restricted deposits. We strengthened our cash position in January by an additional approximately $4 million that was raised through our Open Market Sales Agreement with Jefferies LLC from several family offices and institutional investors that have shown long term interest in Pluristem.
The coming quarters are extremely important to us all, as Pluristem is well positioned to successfully meet milestones and become a global leading regenerative medicine company.
Chief Executive Officer and President