Enlivex CEO Issues Letter to Shareholders – Perspectives on Recent Events - Seite 2

We believe that these results have increased the likelihood of Allocetra^TM  to eventually change the lives of millions of people around the world, whether in sepsis or osteoarthritis. We believe that each of these two market segments represents a potential multi-billion dollar commercial opportunity for Enlivex. The Phase II sepsis study also demonstrated the giant leap we made in transforming Allocetra^TM into a completely off-the-shelf drug that can be easily shipped and stored in clinical sites globally and easily administered by physicians, including in complex environments, such as in intensive care units. As we continue to analyze the data from the sepsis study, we will also assess whether collaborators may seek to work with us on a larger sepsis study, which could be in high-risk UTI sepsis patients or across multiple patient populations.

Some asked us recently what the link is between a potential indication of effect in sepsis and the treatment of osteoarthritis.  We note that the basic mechanism of action of Allocetra^TM  is to positively modulate macrophages that are at the core of the particular inflammatory cause. We chose osteoarthritis after careful review of the scientific literature that showed high correlation between inflamed macrophages and osteoarthritis severity and clinical manifestation. Therefore, the potential indication of effect and the favorable safety and tolerability profile of Allocetra^TM  as demonstrated in the sepsis trial are very important, in our opinion, and we expect that these increase the probability of success in osteoarthritis.

We announced earlier this week that the first two patients had been dosed in the Company’s multi-country, randomized, controlled Phase I/II trial evaluating Allocetra^TM in up to 160 patients with moderate to severe knee osteoarthritis. We anticipate two significant milestones relating to osteoarthritis, the first of which being results from the ongoing clinical trial of Allocetra^TM  in patients with end-stage knee osteoarthritis, which we expect in Q3 2024. These patients have been suffering from knee osteoarthritis for many years, and, following various treatments, eventually have reached the stage requiring knee replacement surgery. We are offering them, as a last resort, a single injection of Allocetra^TM to the knee. We started with the first patient approximately seven months ago, and we are continuing to enroll patients. Our second milestone, which we expect in Q3 2025, is top-line results from the Company’s multi-country, randomized, controlled Phase I/II trial evaluating Allocetra^TM in up to 160 patients with moderate to severe knee osteoarthritis.