YM BioSciences (AMEX:
) (TSE:YM) (US$0.58) currently trades at a negative enterprise value of about $10 million (M), which includes $43M in cash, zero debt, and a trailing 12-month cash burn rate of about $18M. YMI has about 58.5M shares outstanding and 65M shares of common stock on a fully diluted basis, which equates to a market cap of about US$34M and US$38M, respectively.
Nimotuzumab (nimo) (an IgG1, humanized epidermal growth factor or EGFR targeting monoclonal antibody or MAb) is currently being evaluated in 11 Phase 2 and 3 international trials, including three by YMI and eight by its licensees. The Company is making progress on its lead cancer drug nimotuzumab, which is in the same class as Erbitux (cetuximab), but has a better safety profile since it does not cause the severe (Grade 3 or 4) skin rash associated with these types of treatments. The lack of severe skin rash would otherwise be a clear advantage, but in this case the clinical effectiveness of EGFR inhibitors is thought to be linked with the occurrence of this side effect (see the Company's corporate presentation for more details and images of Grade 3 or 4 rash).
In April 2009, YMI presented data at AACR that demonstrated bivalent binding by nimo results in differential recognition of EGFR over-expressing cancer cells and normal cells, which is in contrast to observations with Erbitux, whose high affinity monovalent interaction prevents it from discriminating between the cells. Whereas the activity of high-affinity anti-EGFR MAbs such as Erbitux is dispersed across all tissues (resulting in toxicities such as severe skin rash), the activity of nimo is concentrated at the site of the tumor, thus sparing health tissues such as the skin.
YMI is able to leverage Phase 3 data for nimo from less-regulated markets where the drug is already used such as India, Argentina, and Colombia (nimo is already approved for marketing in 18 countries with potential for approval in a large market such as Europe, Japan, and/or U.S. during 2010-2011). As of late 2007, a consortium of licensees was also formed to share late-stage clinical trials in order to rapidly recruit patients in numerous countries and familiarize oncologists with the drug as part of the clinical development process for nimo in developed markets. Nimo is approved for use in India and is marketed by licensee Biocon (BOM:532523) and the drug is also available in Singapore, Malaysia, Indonesia, and several European countries on a special-access, compassionate use basis.
