firstwordpharmaJanuary 15, 2019
Tag: Mesoblast , Hercules Capital , Commercialization Programs
Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today announced that it has drawn down a further US$15 million from its US$75 million, non-dilutive, four-year credit facility with Hercules Capital, Inc. The funds will be used primarily to ramp up Mesoblast's product commercialization programs including building out a targeted sales force for its product candidate for acute graft versus host disease (aGVHD).
The additional non-dilutive capital was made available after the success of Mesoblast's product candidate Revascor (MPC-150-IM) in having significantly reduced hospitalization rates from major gastrointestinal bleeding in patients with end-stage heart failure and a left ventricular assist device (LVAD) compared with controls in the 159-patient Phase 2 trial funded by the U.S. National Institutes of Health.
Mesoblast plans to meet with the U.S. FDA during the first half of 2019 to discuss a potential approval pathway for Revascor having met this clinically meaningful outcome in LVAD patients.
Additionally, Mesoblast plans to submit a rolling Biologics License Application with the FDA for use of remestemcel-L in treating aGVHD in children in early 2019 and will execute on the product candidate's market access and commercialization strategy. There are no FDA approved treatments for this disease with high mortality.
Scott Bluestein, Chief Investment Officer of Hercules Capital, said: "We are pleased with the continued clinical and corporate progress of Mesoblast since the original funding of our credit facility. We have made available a US$15 million second advance following Mesoblast's performance in 2018.
"This additional advance once again demonstrates Hercules' unique ability to continue to finance our companies through multiple value inflection points."
An additional draw of US$25 million from the Hercules facility may occur through Q4 2019 subject to certain conditions. There are no warrants associated with this credit facility.
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