MSB 0.21% $1.17 mesoblast limited

Ann: MSB Enters Into $75 Million Non-Dilutive Credit Facility, page-77

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    … “ This removes a potential "capital overhang" and as such, we see it as "smart" ” …

    Jason Kolbert makes a valid point … IMO great news for all stakeholders ( shareholders; hospitals; patients ect)


    Maxim Group Update: 7 March 2018


    Column 1
    0 Summary:
    1
    • Mesoblast shares are up today on the announcement of a $75M non-dilutive 4-year credit facility with Hercules Capital. The first tranche of $35M was withdrawn upon closing. Mesoblast recently reported a December 31st cash position of $47M. Based on a quarterly cash burn of ~$15M, we estimate that the company now has ~$70M on the balance sheet, extending its runway into 2019. The terms of the facility include the option to withdraw an additional $15M by 4Q18 and $25M by 3Q19. Interest will accrue on the funds at an annual rate of 9.45%.
    • Recall that top line data for Remestemcel-L (GvHD) trial was just recently announced. The trial met its primary endpoint, an overall response rate (ORR) at day 28 of 69% vs. 45% for historical controls (p=0.0003). In 50 evaluable patients with 100 days of follow-up, the survival rate was 78%, suggesting that the complete data release for 100 day survival (expected in 2Q18) should be positive too. Mesoblast is seeking an accelerated approval in the U.S. and as such, hopes to file by year-end / early 2019. Remestemcel-L has Fast Track designation in the U.S. to treat children with acute GvHD. After pediatric aGvHD, Mesoblast intends to pursue label expansion to high-risk adult aGvHD based on positive subgroup analyses of this population as well as lifecycle potential in chronic GvHD.
    • Conclusion: The decision to go with Hercules Capital extends the capital runway well beyond catalysts ahead in HF and DD, as well as GvHD and RA. This removes a potential "capital overhang" and as such, we see it as "smart".
    2 Details:
    3
    • Other catalysts coming next:
      • Heart failure (HF), MPC-150-IM: The P3 study in class II-III HF has enrolled over 400 patients and is on track to complete enrollment (N=600) in 2H18. The P2b study in end-stage HF (Class IV) completed enrollment (N=159) in 3Q17 with data expected in 3Q18 (a 6-month readout was expected in 1H18. However, the NIH felt it could potentially bias the 12-month readout).
      • Disc Degeneration (DD), MPC-06-ID: The P3 (N=360) study is expected to complete enrollment in early 1Q18. The study is evaluating durable pain reduction and functional improvement (aiming for similar results observed in the N=100 P2 study).
      • Rheumatoid Arthritis (RA), MPC-300-IV: Data in the P2 study demonstrated durable efficacy in anti-TNF refractory patients going out to 52 weeks. The totality of the data will be used to design a P3 program.


    Exciting times ahead for the Blaster and MSB nation.
    GLTAH.
 
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