CHAIRMAN’S ADDRESS TO SHAREHOLDERS 2020 MESOBLAST ANNUAL GENERAL...

CHAIRMAN’S ADDRESS TO SHAREHOLDERS 2020 MESOBLAST ANNUAL GENERAL MEETING

This has been an unprecedented year due to the coronavirus pandemic, its impact on human health, and the associated collateral economic damage worldwide. The Mesoblast team has responded with great agility and resilience to this urgent medical challenge, creatively applying our technology platform to develop a potential treatment for ventilated patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. Through a deep understanding of the mechanism of action and by utilizing clinical and regulatory experience, our team was able to apply these learnings to tackle the primary cause of death due to COVID-19.

The rapid pivot of remestemcel-L from steroid-refractory acute graft versus host disease to ARDS has led to an exclusive worldwide license and collaboration agreement with Novartis, a leading global medicines company. This exciting collaboration will leverage the demonstrated ability of Novartis to rapidly move from clinical to commercial scale with cell-based therapies. It will also play a role in the successful development and potential commercialization of remestemcel-L, as will the nearly two decades of experience Novartis has in delivering first-in-class products that address areas of unmet respiratory need.

Even as COVID-19 vaccines become available, patients who have co-morbidities or are older are likely to continue to be at high risk of ARDS and subsequently death. This is why having a potential treatment that reduces mortality in these patients is so important. The loss of life due to the COVID19 pandemic is the driving force behind our shared commitment to make available our transformational cellular therapy to these highest risk patients. We look forward to working with Novartis as they develop remestemcel-L for all-cause ARDS, as well as potentially other respiratory
conditions.

In parallel, we will continue to rigorously pursue an approval pathway for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease, another life-threatening inflammatory condition with no approved therapies for those under 12 years of age. We are seeking accelerated approval from the United States Food and Drug Administration (FDA) with a post-approval requirement to conduct an additional randomized controlled study in patients 12 years and older.

Beyond remestemcel-L, we have a maturing and diverse portfolio of cellular medicines for other serious acute and chronic inflammatory conditions. Upcoming readouts of Phase 3 trials in advanced chronic heart failure and chronic low back pain due to degenerative disc disease will potentially increase our near and mid-term value proposition. On behalf of your Board of Directors, I would like to take this opportunity to express our deep gratitude for your ongoing support and confidence in our technology.