BMTI reported a net loss of $7.8M, or $0.29 per diluted share.
For Q3/10, BMTI reported revenues of $0.4M consisting of royalty income, sublicense fee income and a training grant. R&D expenses totaled $4.4M which include outside professional services expenses, as well as salaries, wages and related benefits, payroll taxes and stock compensation expense and result primarily from clinical trials of the orthopedic product candidates in the US, Canada and the EU as well as continuing expenses associated with new and ongoing pre-clinical studies and regulatory filings. G&A expenses totaled $2.9M. At the end of Q3/10, BMTI had approximately $16M in cash and cash equivalents and $83.4M of GSE securities investment.
- In 11/10, BMTI was awarded 2 cash grants totaling $488,959 under the QTDP program;
- For the 9 months ended 9/30/10, BMTI reported a net loss of $23.9M, or $1.02 per diluted share;
- Forecasting timing and costs of clinical trials and other product development programs, BMTI anticipates its 2010 year-end balance of cash, cash equivalents and investments to range from $84 to $91M, and anticipates its net cash inflow will be between $9 and $16M;
- Net loss for FY10 is forecasted to be in the range of $34 to $41M.
- BMTI completed its 100-day Premarket Approval (NYSEARCA:PMA) application meeting with the FDA regarding the review of Augment for the treatment of foot and ankle fusions in the US;
- To date, the FDA has raised no unexpected issues that would impact the timing for an upcoming Orthopedic Advisory Panel meeting or potential approval of Augment. BMTI anticipates that the panel meeting will be held in early 2011. If the panel determines the product to be safe and effective and if the FDA finds the PMA information satisfactory, the Company expects approval of Augment will occur within six months after the panel meeting;
- Received a determination letter from the FDA regarding its request for designation (RFD) for Augment Injectable Bone Graft, the 2nd generation bone grafting product. The letter indicated that Augment Injectable review will follow a medical device pathway, and the previously filed Investigational Device Exemptions (NYSE:IDE) for the use of Augment Injectible in treating foot and ankle fusions. BMTI expects to initiate patient enrollment in a US pivotal trial shortly after the anticipated FDA approval of the IDE. IDE approval is expected to occur around year-end 2010;
- Remains on track to initiate a phase I/II clinical trial of its Augment Rotator Cuff product candidate around year-end 2010. This study will occur in Canada where the product is regulated as a medical device since the previously announced that the FDA concluded that its rotator cuff product candidate should be reviewed as a drug rather than a device;
- Received orphan drug designation from the FDA for rhPDGF-BB to be used in conjunction with autograft and/or commercially available osteochondral allograft for the treatment of osteochondritis dissecans (OCD) of the knee, elbow or ankle;
- The expansion of its patent portfolio in both the US and EU with the addition of 2 new patents.