Repros Therapeutics, Inc. (RPRX)

[hptaxis]

Can anyone stop the bleeding?

It is ironic; CDB-4124 (Proellex) is unable to stop the bleeding. I would say it is a foretelling of things to come.

It sounds like a bloodbath, it acts like a bloodbath, and it looks like a bloodbath.

It is a bloodbath!


The financial numbers are the same. RPRX has enough liquidity to make it to November 2008, not much farther. RPRX has about 2.5 million shares to sell to raise more cash. Assuming (and this is a big assumption) the share price does not travel south; at current market prices they might raise about $15+ million. If RPRX does not expand their current R&D, to the detriment of any possible FDA approval, these monies will run out after little more than two quarters. RPRX will need to go back to the trough, again.

At this time, RPRX will have little to show for their continued “anemic” efforts to raise more cash. And the efforts they will have in the most hoped for R&D, CDB-4124 (Proellex) and perioperative anemia, will be for naught due to poor clinical trial design.

For those of you not so completely invested emotionally, I spoke of the danger in using a surrogate endpoint. I went so far as to quote from FDA guidance on surrogate endpoints. Importantly, the post includes the use of a surrogate endpoint with erythropoietin. In this case, the FDA specifically states that avoidance of allogeneic blood transfusion is an acceptable endpoint in the treatment of perioperative hemoglobin. This is precisely the case for CDB-4124 (Proellex).

Erythropoietin raises the hemoglobin by increased synthesis, while CDB-4124 (Proellex) raises the hemoglobin by decreased destruction (bleeding). In both cases, a drug acts to raise the perioperative hemoglobin level. Take a minute to read the package insert for EPOGEN® (http://www.epogen.com/pdf/epogen_pi.pdf): “Reduction of Allogeneic Blood Transfusion in Surgery Patients EPOGEN® is indicated for the treatment of anemic patients (hemoglobin > 10 to ≤ 13 g/dL) who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.”

If RPRX does not modify its anemia trial design, there will be no FDA approval forthcoming. An unnecessary delay in what might be the most promising path for FDA approval. Resources, time, and money wasted. The downside is no cash revenues! The result is a continued need to raise cash.

Ronald Wiehle, Vice President-Research & Development, and Andre van As, Chief Medical Officer, would seem to be well-positioned to know and take advantage of their great pipeline. But, neither has bought shares on the open market for a very long time. Similarly, the other officers would seem to be excited about accumulating shares at these prices, but, again, no action.

What could be the possible reason to delay funding? A decreasing share price surely does not make RPRX more attractive. A decreasing share price reduces the cash through a stock offering. What are the options available to RPRX? The white knight(s) that come forward to inject cash in whatever form are entailing a high degree of risk. My bet is that RPRX will find the additional cash, if for nothing else than to continue their largesse. It would seem that there must be a trade-off that will include something more than just RPRX shares.

There is that voice that keeps shouting. I can hear it, can you? FIRE!

Have A Great Day!