Mr. Bowman: NeoRx is a development-stage biotechnology company. We'll be preparing to enter into the pivotal clinical program for our lead product candidate over the next several months. That product, STR, which stands for Skeletal Targeted Radiotherapy, is initially being tested in the treatment of multiple myeloma, which is a cancer of the bone marrow. At the FDA's request, we submitted to them a proposed pivotal clinical program on June 30. We expect to get their reaction in a month or so to that proposed plan. The reason we are so interested in this, and our investors are as well, is because our Phase I/II trials for STR showed excellent efficacy, a far higher percent of complete responses than any approved product for multiple myeloma. In fact, overall we had about a 35% complete response rate, which compares to about a 5% complete response rate with other products used in the treatment of multiple myeloma. Complete response rate correlates with survival so it's a very important factor. Complete response is the primary end-point in our proposed pivotal program. So as soon as the FDA and we agree on the program, then we'll be in a position to start gearing up manufacturing for clinical trial supplies and contracting of clinical trial sites. The critical path for actually starting to treat patients in this program will be the speed at which the investigators can get their Institutional Review Board approvals. This is a rather slow bureaucratic process so, assuming we receive FDA approval to begin our pivotol program, it may be early next year before we even start treating patients. So we are a development stage biotechnology company. We are in pretty good shape right now. We are in good shape competitively with STR. And we have enough cash on hand to make a good start on the proposed pivotal program. We have a little less than 20 million in cash right now. Our burn rate is a little over 1 million a month. We'll need to raise some more money before next year to continue the clinical trials and we will probably do that through a combination of selling equity and partnering with a larger company.
Tickers included in this excerpt: NERX
For more information call (212) 952 7433. The Wall Street Transcript does not endorse any of the comments made by interviewees, and does not make stock recommendations.