AI
Saturday, November 11, 2006 3:45:14 PM
RPRX
Edited for intelligibility if not elegance.
An I-Hub member sent me a private message asking why I liked RPRX. I spent a significant amount of time writing up the answer, so I'm reposting it here. I would welcome criticism or comments.
Alternatively, you can accuse me of pumping and go back to reading all of the cut n' pasted news articles.
Like any other biotech stock, there's risks and potential reward. I feel that the equation is weighted toward the latter, but what do I know?
The risks:
Proellex fails its primary efficacy end point for uterine fibroids.
Unlikely given previous results as the 25 mg and 50 mg doses appear to provide efficacy equivalent to or a little better than Lupron and asoprisnil (which has been withdrawn). This study is vs placebo.
Proellex fails its efficacy end point for endometriosis.
Again, fairly unlikely--we already know from the interim results that there was 1 day of pain with Proellex vs 19 days of pain with Lupron. This open-label phase II study is vs Lupron.
Key risk for Proellex: endometrial thickening.
The FDA is going to be watching this closely. However, given that the 50 mg dose did not cause thickening, and it is the most efficacious dose, this might not be a huge worry. In addition, the CEO claims endometriosis is manageable through intermittent withdrawal of the drug so that the endometrium can be shed).
Androxal fails its primary efficacy end points.
There are two in the upcoming trial: testosterone levels and libido. Again, I previous trial results indicate we can be pretty confident that the testosterone levels end point will be met as they got P-values vs placebo of .0005 to .0053 in a 40-patient active controlled trial. Note that the change from baseline in testosterone with the 50-mg dose was in between the 5 g and 10 g dosages of Androgel. I think we can be reasonably confident that it will meet the libido end point as well, as long as testosterone has something to do with libido.
Androxal fails the secondary end point of "distress."
Watch the presentation for more info on this. Basically, the FDA is requiring Repros to include a "distress" questionnaire as an end point in the trial. Perhaps the dumbest FDA requirement I've ever heard. I do not understand the rationale. This is the primary risk for Androxal.
Financing
Of course, they're going to need to do a financing in January or February. I don't know how this is going to affect the stock price if the results of the three trials are positive.
Low float
There are only 10 million shares out, so it's going to be an extremely bumpy ride.
In short, I think the risk for Proellex is safety (not efficacy) and the risk for Androxal revolves around a BS end point.
The rewards:
Ridiculously low market cap.
I have no idea where this is going in the intermediate term due to the (hopefully opposing) effects of the trial results and financing. However if the results are positive, the share price should end up multiples of what is today by early to mid 2008.
Demonstrated efficacy in active-controlled trials
Two drugs with demonstrated efficacy in active-controlled phase II trials with good-sized markets. These aren't niche products and would fit quite nicely into the portfolio of, say, Organon.
If Proellex and Androxal hit their target product profile, they also have very significant advantages over existing products. See the presentation below for the spiel.
Management motivated to sell
A management that is motivated to sell. According to the R&R presentation, mid-2008 is their earliest target date.
More information
The October 2006 presentation is here: http://www.reprosrx.com/ppt/Repros%20TherapeuticsPresentationOctober2006.ppt
And if you prefer your presentation with narration by the CEO, who apparently has trained as an auctioneer, go here:
http://www.reprosrx.com/presentations.htm
The latter presentation has information on the endometrial thickness issue, so if you can stand listening to it, I'd recommend it.
Edited for intelligibility if not elegance.
An I-Hub member sent me a private message asking why I liked RPRX. I spent a significant amount of time writing up the answer, so I'm reposting it here. I would welcome criticism or comments.
Alternatively, you can accuse me of pumping and go back to reading all of the cut n' pasted news articles.
Like any other biotech stock, there's risks and potential reward. I feel that the equation is weighted toward the latter, but what do I know?
The risks:
Proellex fails its primary efficacy end point for uterine fibroids.
Unlikely given previous results as the 25 mg and 50 mg doses appear to provide efficacy equivalent to or a little better than Lupron and asoprisnil (which has been withdrawn). This study is vs placebo.
Proellex fails its efficacy end point for endometriosis.
Again, fairly unlikely--we already know from the interim results that there was 1 day of pain with Proellex vs 19 days of pain with Lupron. This open-label phase II study is vs Lupron.
Key risk for Proellex: endometrial thickening.
The FDA is going to be watching this closely. However, given that the 50 mg dose did not cause thickening, and it is the most efficacious dose, this might not be a huge worry. In addition, the CEO claims endometriosis is manageable through intermittent withdrawal of the drug so that the endometrium can be shed).
Androxal fails its primary efficacy end points.
There are two in the upcoming trial: testosterone levels and libido. Again, I previous trial results indicate we can be pretty confident that the testosterone levels end point will be met as they got P-values vs placebo of .0005 to .0053 in a 40-patient active controlled trial. Note that the change from baseline in testosterone with the 50-mg dose was in between the 5 g and 10 g dosages of Androgel. I think we can be reasonably confident that it will meet the libido end point as well, as long as testosterone has something to do with libido.
Androxal fails the secondary end point of "distress."
Watch the presentation for more info on this. Basically, the FDA is requiring Repros to include a "distress" questionnaire as an end point in the trial. Perhaps the dumbest FDA requirement I've ever heard. I do not understand the rationale. This is the primary risk for Androxal.
Financing
Of course, they're going to need to do a financing in January or February. I don't know how this is going to affect the stock price if the results of the three trials are positive.
Low float
There are only 10 million shares out, so it's going to be an extremely bumpy ride.
In short, I think the risk for Proellex is safety (not efficacy) and the risk for Androxal revolves around a BS end point.
The rewards:
Ridiculously low market cap.
I have no idea where this is going in the intermediate term due to the (hopefully opposing) effects of the trial results and financing. However if the results are positive, the share price should end up multiples of what is today by early to mid 2008.
Demonstrated efficacy in active-controlled trials
Two drugs with demonstrated efficacy in active-controlled phase II trials with good-sized markets. These aren't niche products and would fit quite nicely into the portfolio of, say, Organon.
If Proellex and Androxal hit their target product profile, they also have very significant advantages over existing products. See the presentation below for the spiel.
Management motivated to sell
A management that is motivated to sell. According to the R&R presentation, mid-2008 is their earliest target date.
More information
The October 2006 presentation is here: http://www.reprosrx.com/ppt/Repros%20TherapeuticsPresentationOctober2006.ppt
And if you prefer your presentation with narration by the CEO, who apparently has trained as an auctioneer, go here:
http://www.reprosrx.com/presentations.htm
The latter presentation has information on the endometrial thickness issue, so if you can stand listening to it, I'd recommend it.
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