Australia-based Mesoblast (ASX: MSB; Nasdaq: MESO) just raised $138 million from investors. The company positions itself as a leader in cellular medicines for inflammatory diseases, placed 43 million shares to existing new institutional investors at a price of A$3.20 per share. This amount equates to a 7% discount to both price at end of closing May 8, 2020 and the five-day volume weighted average price. The company will use a good deal of the capital to set up manufacturing of the company’s lead product remestemcel-L for the treatment of critically ill patients suffering with diseases caused by cytokine release syndromes associated with high mortality, especially COVID-19 acute respiratory distress syndrome (ARDS). The rest of the funds go towards working capital and general corporate purposes. This is an important fund raising as they have been traditionally under pressure for ongoing fund raising.
The company initiated a clinical trial after promising results were observed with remestemcel-L under emergency compassionate use in COVID-19 ARDS, where 9 of 12 (75%) ventilator-dependent patients were able to come off ventilators within a median of 10 days.
Presently the company is conducting a Phase II/III clinical trial with up to 300 patients evaluating whether their investigational regenerative therapy product called remestemcel-L can reduce high mortality in COVID-19 patients with moderate to severe ARDS—the study is now actively enrolling in 30 sites in America. Annetine Gelijn with Mount Sinai is the lead contact for the study.
The Company’s IP
The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast’s Biologics License Application to seek approval of its product candidate RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid refractory acute GVHD. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets.