July, for RPRX, brings forth the expression “the chickens coming home to roost.” In one month, RPRX PR reveals the true nature and reason of their operation. Consequently, RPRX share price plummeted from $7.19 to $2.53, a 65% decline. The year-to-date decline is 76% ($10.52-$2.53=$7.99) and one-year decline is 72% ($9.00-$2.53=$6.47).
Over the years, RPRX has been able to reap the benefits of raising monies for mismanaged and ill-conceived drug candidates for their own [Podolski] self-serving purpose. The fall of RPRX occurs coincidentally with the removal of Podolski from his power of authority and control. It appears that Podolski fought off wresting his dictatorial rule over RPRX until the very last moment.
This past Fall 2008, RPRX was unable to turn to anyone except Efficay to raise financing. This single act spelled doom for Podolski’s shell game as well as the company. The proverbial “can of worms” was opened when Lammers took the helm. Lappe and Lammers were stuck with the option to continue the shell game. Except they were met with the problem there were so many secrets they could not devise enough shells to keep them all hidden. We have yet to see all of the sleight-of-hand tricks by RPRX. Depending on the timing of RPRX demise, we might never see them all.
However, July PR revel many of the techniques used by RPRX to further their game. The PRs demonstrate the techniques of half-truths, misrepresentation, obfuscation, and much more utilized by RPRX to continue their charade at being a serious biotech. Throughout each PR, RPRX is hard-pressed to be forthcoming and honest. None of the PR actually convey reality, only RPRX fantasy. The following highlights some of these techniques. [Note: Each PR contains the continuing declaration for “investigation of Androxal as a potential treatment for type 2 diabetes.” This is the clear sign RPRX is a joke of a company.]
07/01/2009: Repros Therapeutics Inc. Provides Update for Proellex® Clinical Program
Quote: “The Woodlands, Texas — July 1, 2009, Repros Therapeutics (NasdaqGM:RPRX) announced today that an end of Phase II meeting is scheduled with the Food and Drug Administration (“FDA”) for late September 2009 to discuss a Phase III program investigating the use of Proellex in the treatment of endometriosis.”
Remember the date for EOP2 meeting in late September 2009.
Quote: “At the upcoming end of Phase II meeting, Repros anticipates obtaining direction from the FDA on the objectives and endpoints the Agency would like to see used in the pivotal phase III efficacy and safety studies in endometriosis.”
RPRX barely did one phase 2 trial for Endometriosis. In this one phase 2 trial, RPRX hardly checked for safety. The efficacy is at best a guess since RPRX did not report using accepted statistical analysis. RPRX went on to state, “The study showed no efficacy differences between the 25 mg and 50 mg doses.” What they do not say is the prior (and larger) endometriosis trial with a positive comparator did show a “clear dose dependent” response.
RPRX continually invokes the FDA as instructing them on trial design. This is not the case. But, hey, we are going to have a EOP2 meeting. Translation: We want more money. Do not be concerned that we are unable to move forward on the UF trials.
Quote: “Repros plans to initiate these studies with doses of 12.5 and 25 mg during the fourth quarter of this year and the first quarter 2010, in both the United States and in Europe.”
Here is the first sign of the bad news. The trials will not include the 50 mg dose! Please do not pay attention to what we said in the preceding paragraph about meeting with the FDA at the end of the 3Q09 [late September 2009]. We are miracle workers. RPRX will initiate trials “during the fourth quarter of this year and the first quarter 2010, in both the United States and in Europe.”
Quote: “Furthermore, Repros has decided to discontinue the use of the higher, 50 mg dose in its ongoing studies in women with chronic symptomatic uterine fibroids and anemia associated with this condition due to an observed dose-dependent increase in liver enzymes in a low percentage of women. To date, Repros has dosed over 600 patients, and over 200 patients have completed at least one dosing period followed by an off-drug interval. From completed studies as well as from the ongoing large open label trial, it has been determined that the drug is well tolerated with few women discontinuing treatment due to adverse events.”
Finally, the real meaning of the PR is found buried in the fourth paragraph. There are LFT concerns significant enough to stop the 50 mg dosing. But, RPRX does not elaborate on these problems until a later PR, almost a week later. There is more. In this paragraph, RPRX sets itself up for more contradictions and lies. RPRX states, “[o]ver 200 patients have completed at least one dosing period followed by an off-drug interval.” However, in the immediate following sentence RPRX states, “From completed studies as well as from the ongoing large open label trial . . . .” The ongoing large open trial is not that large since only about “200 patients have completed at least one dosing period followed by an off-drug interval.” In other words, the trials are poorly enrolled. Also, for future reference remember the number 600.
07/07/2009: Repros Therapeutics Inc. Provides Additional Information on Proellex® Clinical Program
RPRX PR in an attempt to quantify the LFT changes lists the number found and significantly that there was resolution of ALL adverse LFT changes. RPRX PR announces LFT 3X > ULN, a significant finding in any clinical trial. RPRX does not announce other chemistry tests, particularly bilirubin, or the details on the LFT elevations. This PR is later shown to be a lie. The LFT changes had not resolved in ALL. Also, interesting, the number of patients included in this list is 470, not the 600 of the July 1 PR. Why? What are the LFT changes in these missing 130 patients?
07/08/2009: Repros Therapeutics Inc. Announces Amendment to NIH License Agreement
In what is a new twist on the NIH license agreement, RPRX must come up with $6 million by September 30, 2009. If they are unsuccessful, nobody really knows the implication but the NIH would not have placed this clause in the 6th Amended Agreement for naught. Yet, we are to believe that RPRX has cash to begin Endometriosis trials. Does RPRX believe that people do not read their PR. RPRX apparently thinks they are not accountable for what they place in separate PR. Each PR stands on its own. RPRX management by pretending to begin multiple clinical trials for huge markets is able to extract monies form the unsuspecting investor. How has a virtual biotech with very limited resources been able to make investors believe they could push their drug candidates to FDA approval? They do not even properly test the drug candidates through phase 2 trials. This company is extremely mismanaged. The RPRX MO is clear. Consistent with this MO, RPRX includes the use of SPRMs for cancer. Is this another huge market to perpetuate the shell game?
07/23/2009: Repros Therapeutics Inc. Provides Clarification on Increased Liver Enzymes at Highest Dose in Proellex® Clinical Program
RPRX PR takes a 180-degree turn by announcing that the LFT changes are not resolved, in a clear contradiction to the July 7 PR, but, further includes the date, June 26, for their letter to the FDA regarding the LFT changes. RPRX knew of the LFT changes before their July 1 PR. It is a sure bet that they knew well before June 26. Since the June 26 FDA letter, RPRX has not held a CC, released another PR, or done anything to explain the lies and contradictions of the July PR. Are we to believe they did not know the LFTs had not resolved? Did RPRX lie to the FDA about the resolution of the LFT changes? It has been over a month since the FDA letter. If RPRX has heard from the FDA, RPRX has a fiduciary responsibility to the shareholders to update them. In this case, doesn’t no news mean bad news?
The above is not a full exhaustive review of the July PR. As can be seen, this review shows RPRX to be anything but a serious biotech company. Initially, I gave RPRX some credibility for their Proellex program. I was skeptical of the Androxal program. After realizing the Androxal program was worthless, which was confirmed by the RPRX Androxal plans for type 2 diabetes, I began researching the Proellex programs. Their is only one conclusion for RPRX. This company has no interest in seriously addressing medical problems. For Efficacy and the other late comers, this will prove to be a disastrous investment.