Ann: MSB Q1 Financial Results and Operational Highlights, page-38

During the last conference call at the end of August, Silviu said:

If we can move now to Slide 30. This slide summarizes the unmet need and the potential treatment paradigm for using rexlemestrocel in patients with chronic low back pain due to degenerative disc disease.

This continues to be a major unmet need. And it is important to remember that for patients with this type of chronic severe inflammatory back pain, the only type of therapies beyond conservative nonsteroidal agents are the use of opioids to diminish the pain. And 50% of opioid prescriptions in the U.S. are for the use of opioids in the treatment of chronic low back pain.

Over 7 million patients are estimated to suffer from this disease in each of the U.S. and EU5. And our MPC-06-ID development program targets approximately equal numbers of patients in each of these, the U.S. and the major jurisdictions in Europe.

Next slide, please, Slide 31. The phase 3 trial of rexlemestrocel in these patients was a randomized, placebo-controlled three-arm trial in patients with more than six months of chronic discogenic low back pain, not responsive to conservative measures. The diagnosis of degenerative disease was made by MRI. We excluded non-discogenic causes.

And 404 patients were enrolled randomized to a single intra-discal injection of either saline, cells alone or cells together with a hyaluronic acid carrier. Slide 32 is a summary of the results from this study. We saw substantial and durable reductions in chronic low back pain through 24 months across the entire study population of 391 patients who received either treatment or placebo. The greatest pain reduction observed was in those patients with shorter duration than the study median of 68 months, suggesting that earlier intervention is important in patients with active inflammation.

Significantly greater pain reduction in the prespecified patient subset of opioid users at all time points was seen compared with saline controls. And by 24 months, there was a 40% reduction in opioid use. We concluded that rexlemestrocel may provide a safe, durable, and effective opioid experience therapy for patients with chronic inflammatory back pain due to degenerative disc disease. Based on the above results from this trial, Mesoblast expects to receive feedback in the next quarter from FDA on potential pathways toward approval.