Mesoblast Limited, a global pioneer in developing innovative allogeneic cellular medicines for inflammatory diseases, has released its quarterly activity report for the period ending March 31, 2023. With a Nasdaq listing (MESO) and an ASX listing (MSB), Mesoblast continues to deliver cutting-edge treatments to those suffering from chronic inflammatory diseases.
Mesoblast has successfully completed a global private placement, raising approximately US$40 million net of transaction costs, primarily from its existing major US, UK, and Australian shareholders. This placement is a major step forward for the company as it looks to expand its operations.
At the end of the quarter, we had US$48.8 million in cash on hand. After raising funds in April, our pro-forma cash position amounts to US$88.8 million. With certain milestones met, we can access up to an additional US$40 million from our existing financing facilities.
In the quarter ended, our cash usage for operating activities rose by 4% to US$16.2 million compared to the same quarter in the prior year. This was a decrease of US$8.3 million or 34% from the same quarter in the year before.
For the quarter ended March 31, 2023, TEMCELL® HS Inj.1 royalties on sales in Japan grew 4% on a constant currency basis. Our licensee generated US$1.8 million in royalties from sales, up from US$1.9 million in the same period the previous year. This marked an impressive quarter-over-quarter revenue increase of US$2.0 million.
The U.S. Food and Drug Administration (FDA) has been presented with a Biologics License Application (BLA) for approval of remestemcel-L, a potential treatment for children suffering from steroid-refractory acute graft versus host disease (SR-aGVHD). With this application, physicians and researchers are hopeful that remestemcel-L will provide a much-needed relief to those suffering from this life-threatening condition.
Since the receipt of the Complete Response Letter (CRL) in September 2020, we have generated new data and analyses that provide substantial evidence of remestemcel-L’s effectiveness in pediatric SR-aGVHD. This resubmission contains this new information, as well as additional insights that have been developed since then.
The U.S. Food and Drug Administration (FDA) recently accepted Mesoblast’s resubmission for remestemcel-L and set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023, considering the resubmission to be a complete response. This is a major step forward for Mesoblast and a momentous occasion for the medical community.
FDA recently conducted a Pre-License Inspection (PLI) of Mesoblast’s cell therapy manufacturing operations at Lonza Bioscience in Singapore, as part of their ongoing review of the BLA for remestemcel-L. This inspection is a necessary step to ensure that the product meets all safety and efficacy standards before it is approved.
Two ground-breaking studies on the remestemcel-L development program for the treatment of children with SR-aGVHD were selected through rigorous peer review and presented at the 2023 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for Blood and Marrow Transplant Research (CIBMTR). These studies offer hope for children suffering from this life-threatening condition, demonstrating the potential of remestemcel-L to improve their quality of life.
Mesoblast recently resubmitted its remestemcel-L BLA to the FDA to treat children with steroid-refractory acute GVHD, and the data from two clinical studies – “The Immunomodulatory Activity of Remestemcel-L on T Cell Activation in vitro is a Direct Measure of Product Potency and Correlates with Clinical Outcomes in Pediatric Patients with Steroid-Refractory Acute GVHD” and “Long-Term Survival in Children Treated with Remestemcel-L for SR-aGVHD” – formed key components of the submission. The studies showed that remestemcel-L has an immunomodulatory activity on T cell activation and can improve long-term survival in children with SR-aGVHD.
FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to rexlemestrocel-L, a groundbreaking treatment for chronic low back pain (CLBP) associated with disc degeneration. When injected into the lumbar disc in combination with hyaluronic acid (HA), rexlemestrocel-L promises to provide patients with much-needed relief.
FDA has given the green light for Mesoblast’s planned Phase 3 trial for a 12-month reduction in pain, granting the RMAT designation. This means that the company is now one step closer to providing an innovative treatment option for those living with chronic pain.
The results of the randomized, double-blind, controlled DREAM-HF Phase 3 study in 537 patients with chronic heart failure due to reduced ejection fraction (HFrEF) have been published in the prestigious Journal of the American College of Cardiology (JACC).
The results showed that Mesoblast’s mesenchymal precursor cell therapy (MPCs; rexlemestrocel-L) improved heart function, as measured by left ventricular ejection fraction (LVEF) and decreased cardiovascular death, myocardial infarction (MI) or stroke over a mean follow-up of 30 months. These findings are a major breakthrough in the treatment of HFrEF and could potentially improve the quality of life for patients suffering from this condition.
Mesoblast is revolutionizing the medical industry with its advanced allogeneic (off-the-shelf) cellular medicines that can treat severe and life-threatening inflammatory conditions. The Company’s mesenchymal lineage cell therapy technology platform is at the core of its impressive portfolio of late-stage product candidates, which use powerful anti-inflammatory factors to reduce inflammation and the associated damage it can cause. These cutting-edge therapies are transforming the way we approach the treatment of inflammation.
Mesoblast holds a robust and expansive intellectual property portfolio that promises safety and security through to 2041 in major markets. The company’s innovative manufacturing techniques yield industrial-scale, cryopreserved, ready-to-use cell therapies with pre-defined pharmaceutical release criteria. This means that patients around the world will have access to these life-changing therapies as soon as they become available.
Mesoblast is revolutionizing the field of medicine with its innovative remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. These products are being developed for a range of inflammatory diseases in both children and adults, including steroid refractory acute graft versus host disease, biologic-resistant inflammatory bowel disease, and acute respiratory distress syndrome.
Additionally, rexlemestrocel-L is being studied for its potential to treat advanced chronic heart failure and chronic low back pain. To make these treatments more widely accessible, Mesoblast has already established commercial partnerships in Europe and China and two products have already been commercialized in Japan and Europe.
Mesoblast, a global leader in regenerative medicine, is present in three countries – Australia, the United States and Singapore – and is traded on two major exchanges: the Australian Securities Exchange (MSB) and the Nasdaq (MESO). With a presence on two of the world’s most prestigious trading platforms, Mesoblast is well-positioned to provide innovative solutions to improve patient health and quality of life.