MEI Pharma: Sell off übertrieben? - 500 Beiträge pro Seite

[DomRuinart]

Klar, die Studienergebnisse waren ein Desaster. Aber 70% Wertverlust halte ich für stark überzogen. Die haben jetzt eine Marktkapitalisierung von 65 Mio $ bei einem Cash-Bestand von 78 Mio $. Wie unten beschrieben, ist Pracinostat noch längst nicht tot. Dazu haben sie mit ME-344 (Phase Ib,) und PWT 143 (Start klinische Test für erstes Halbjahr 2015 angekündigt) noch weitere vielversprechende Produkte in der Pipeline und die entsprechenden „intellectual property“ mit Patenten bis ins Jahr 2028. Selbst wenn ich die Pipeline und die Patente mit nur sehr konservativen 20 Mio $ Bewerte, komme ich auf einen fairen Wert von 3,-$ pro Aktie. Mit dem zu erwartenden News-Flow zu ME-344, PWT 143 und auch Pracinostat halte ich einen ordentlichen Rebound für wahrscheinlich. Ich glaube hier kann man einen kleinen Zock wagen.

MEI Pharma: Upcoming Catalysts Will Drive Stock Rebound

Mar. 24, 2015 10:51 AM ET | About: MEI Pharma, Inc. (MEIP)by: Stock Doctor

Disclosure: The author is long MEIP. (More...)The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it. The author has no business relationship with any company whose stock is mentioned in this article.

Summary
•Secondary endpoints such as overall response rate, progression free survival, leukemic transformation, duration of response need to be analyzed before writing off Pracinostat in front-line MDS.
•Pracinostat efficacy in AML has higher chance of success than MDS due to more advanced disease state and ability to cause complete remission as single agent.
•Several shots on goal with several other Pracinostat indications and 2 other drugs in pipeline.
•Sell off overdone and now selling for less than cash.

Those that follow my biotech investing strategies know I like buying undervalued stocks with good preliminary data heading into specific catalysts. These stocks many times will increase at least 50% as data release approaches. It is always good to ring the cash register when significant gains accrue for small cap biotech stocks as disappointing results will send the stock tumbling. This is especially true, if the upcoming catalyst is not the main reason one is holding the stock. I was able to lock in gains before Cytokinetics (NASDAQ:CYTK) released their ALS data that sent the stock tumbling. As anticipated, in the weeks leading up to the Pracinostat myelodysplastic syndrome (MDS) Phase II results investors drove the stock price up as analysts urged everyone to buy the stock. The ~80% gain in MEI Pharma (NASDAQ:MEIP) in less than 2 months since my article was too much for me to pass up completely as I hedged my bet. Yesterday, MEI Pharma released top-line data from a randomized Phase II study comparing Pracinostat in combination with Azacitidine in treatment naïve intermediate-2 or high-risk MDS patients. The data did not meet the primary endpoint of the number of complete responses. Due to the results, the stock plummeted ~70%, bringing the stock's market cap down almost $15M below their cash on hand to $65M. I've been getting a ton of emails asking my opinion on the stock after the data release. With Pracinostat being tested in numerous indications and other drugs in the pipeline I can assure you the drop is way overdone and I fully anticipate a big upcoming rebound. I am back in following the decline and will await the run-up to the Acute Myeloid Leukemia (AML) Phase II results expected in June.

Don't Give Up On Pracinostat in Front-line MDS Quite Yet

Investors, including myself, were obviously excited about the pilot data showing the effectiveness of the HDAC inhibitor Pracinostat in MDS. The FDA approved hypomethylation agent Azacitidine had achieved a clinical response rate of only 16% by itself in Phase III trials. However, the pilot study conducted at MD Anderson treating MDS patients with a combination of Pracinostat and Azacitidine achieved a complete response rate of 90% (9/10 patients). Therefore, for good reason, I was surprised by the top-line data released yesterday stating that Pracinostat was no more effective in inducing complete responses when combined with Azacitidine than Azacitidine alone. Management picked complete response as the primary endpoint considering the huge response rate observed in the pilot study. However, since Pracinostat is being tested in combination with Azacitidine anyways, I believe the most valuable data will be found in the secondary end-points and may provide a lifeline for Pracinostat in front-line MDS.

It has been noted numerous times by Dr. Garcia-Manero of MD Anderson that the responses seen with the combo treatment were deep responses. It is possible that the overall response rate, the duration of response, progression free survival or rate of AML transformation is affected positively. Investors always want examples in which this is true. How can a drug improve these secondary endpoints but not have a significant impact on response rate? Novartis (NYSE:NVS) recently received FDA approval for its HDAC inhibitor Farydak in multiple myeloma patients who had received two prior treatment regimens. The overall response rate in the study was not statistically significant although there was a progression free survival advantage of 3.9 months resulting in approval…

Quelle: Seeking Alpha

[DomRuinart]

7$ wären ja mal nicht schlecht:

Cantor Is Slashing Its MEI Pharma Price Target

Monica Gerson , Benzinga Staff Writer

March 24, 2015 5:12pm

In a report published Tuesday, Cantor Fitzgerald analyst Daniel Brims maintained a Buy rating on MEI Pharma, Inc
, while reducing the price target from $14 to $7, after reassessing the risk profile of Pracinostat.

Further clinical development in MDS has increased the risk profile of Pracinostat. "We believe the lack of tolerability which resulted in the failure of the phase 2 trial to meet the primary end point of complete response has substantially increased the risk associated with this clinical program (currently 20% risk adjustment from 70% adjustment previously)," Brims said.

"We believe the duration endpoints of overall survival and progression-free survival are better indicators of clinical benefit, and, though these endpoints are not powered for statistical significance, we believe numerically superior results will justify continued development, given a more tolerant dosing regimen," the analyst explained.

Since there are fewer treatment options for AML patients, doctors may have become increasingly tolerant of a higher adverse event profile. There has been a delay in the Phase III front line AML study in order to evaluate optimized dosing regimens, although "this study can proceed as currently designed," Brims commented.

The analyst believes that the single-arm Phase II trial data demonstrates the efficacy of Pracinostat and there could be a continued robust response rate during the Phase III trial.

"Our peak sales expectation of >$375M is based on conservative penetration rates of 15% in front-line MDS, 30% in second-line MDS, and 35% in AML and risk adjustments of 20% in MDS as well as 70% in frontline AML," Brims added.

Quelle: Benzinga

[DomRuinart]

Duplicando ante portas:

Here’s Why MEI Pharma Is Undervalued By At Least Half And Will Recover

March 31, 2015 5:04 PM EDT

Written by Scott Matusow.

Sometimes in biotech, things do not go as expected. In the case of MEI Pharma Inc (NASDAQ:MEIP), this was definitely one of those times when the company's cancer drug failed to meet the main goal in a mid-stage study. In December of last year, the company engaged in an offering along with reporting some very promising early data for its lead investigational drug, Pracinostat. Based on the early data, institutions piled in, bringing the company's institutional ownership up over 70%, quite a feat for a stock that was selling under $5/share at the time.

These institutions, along with us did not expect the company announcing on March 25, 2015, that the combination of Pracinostat and azacitidine showed no difference compared to patients being treated with azacitidine alone.

After all, the company's pilot data for patients with MDS was very positive, with 10 patients who were treated with a combination of Pracinostat and azacitidine showing an overall response rate (ORR) of 89% including one additional responder, bringing the response rate to 90%. The ORR was defined by either a CR or a complete remission with incomplete blood count recovery (CRI).

So what happened in the latest trial of Procinostat in the same combination with azacitidine that lead to the trial failing to produce positive CR/CRI over placebo?

One part of the answer is likely the fact that in the pilot study, seven patients had received prior treatment for their MDS with three patients failing to show any benefit whatsoever from prior therapy. So, these patients were refractory (hard to treat, resistant to first line/prior therapy).

From the pilot study PDF;

Seven (78%) patients had therapy related MDS with history of prior chemotherapy/radiotherapy exposure (3 breast cancer, 2 non-Hodgkin's lymphoma, 1 breast and ovarian cancer, and 1 melanoma). Three patients had failed prior therapy.

Another part of the answer may lie in the actions of the investigators in the trial itself. In the trial, the patients were randomized to receive azacitidine alone and Pracinostat in combination with azacitidine (the combination being studied for a positive result).

In the trial, there was a high dropout rate as trial investigators discontinued administering Pracinostat and azacitidine to many patients. Pracinostat is an HDAC inhibitor which are known to cause worsening conditions at first, including blocked maturation of red blood cells, platelets, and neutrophils (myelosuppression). However, once these adverse conditions subside, the patients should then see a benefit (similar to chemotherapy).

Also, HDAC's are known to work best in actively replicating cancer cells. MDS is a pre-malignant condition and the cells are generally not actively replicating unless they are in the blast phase. (This is not the case in AML, which will be covered later in this article).

We wonder if the investigators here were too quick to discontinue patients on the Pracinostat/azacitidine combination. It's probably easier to convince patients to 'stick it out' in a smaller trial like the ones MEI have ran before, but in a larger trial it's much more impersonal, so it's easier to simply discontinue patients who report adverse effects in mass.

We also wonder if the investigators understood clearly the set timeframe of recovery from myelosuppression as in the pilot study, or did they just "panic" and were not aware of HDAC's causing myelosuppression in MDS patients, thinking it was an unknown hematological event, and remove patients from the combination drug arm on the first sign of this?

Considering these, we might get a better understanding as Daniel P. Gold, Ph.D., President and Chief Executive Officer (CEO) of MEI commented:

While we are disappointed with these top-line response data, we are diligently analyzing the entire data set as well as subsets from this study.Specifically, we are trying to fully assess the impacts of discontinuations on clinically important efficacy outcomes,including duration of response, event and progression free survival and overall survival. These findings will be important to inform the future development path for Pracinostat.

Investigators have made errors before. Whether trial design or simply being unaware of various preconditions that certain drug agents cause.

A good example of this was with Amicus (FOLD). Many biotech analysts (including us) were expecting the company to present positive Phase III data in late 2012 (as in the current case of MEI). However, the company surprisingly disappointed investors and announced the study did not meet primary endpoints. Later, partner GlaxoSmithKline (NYSE:GSK) gave up co-commercialization and co-development rights on the drug.

We wrote in July 2014 concerning Amicus;

In the [company’s] original study, about half of the patients enrolled had a mild case of Fabry's Disease, while the other half had a severe case. The study was constructed for patients that had a severe case of the disease. Thus, when Amicus announced Phase III trial results, the patients with a mild case of the disease "diluted" the trial results.

The study was not setup [powered] to have both types of patients and, in a sense, missed primary endpoints by a formality. Patients with a mild case of the disease were treated with the drug or placebo. Of the patients treated with the drug, 32% were responders. Conversely, of the patients treated with placebo, 44% were responders. The mild case of Fabry's Disease is difficult to measure and this is what most likely caused the trial to miss primary endpoints.

We can clearly see in Amicus's case, the trial design was faulty in the sense that the designers simply overlooked an important element. We think a similar case is going on here with MEI, but in this case, the investigators did not seem to take into account myelosuppression, and allowed patients to discontinue in the combination drug arm.

Amicus stock plummeted on the 'failed Phase III data,' dropping in time to the low $2 range. Afterwards, Amicus correctly designed the retrial of its Fabry's disease drug, and reported positive results in 2014. Subsequently, the stock has multiplied 5x to its current trading level of $11 a share.

Another case of a trial that first failed, then succeeded happened with ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) Nuplazid (formerly called pimavanserin)

Nuplazid's first Phase III study was a failure in 2009. Many believed at the time that the trial simply did not administer the higher placebo doses to the placebo group, as they stopped at an earlier dosage when with comparison to the drug arms did not show any benefit. 10mg and 20mg of Nuplazid showed no benefit to 10/20mg of placebo. But, the trial seemed to have stopped the comparison with placebo at 20mg, without comparing both groups at 40mg.

In the retrial, it appears Acadia upped both arm's dosage until Nuplazid was shown to have a clear benefit over placebo. On a side note, it's worth mentioning that for some odd reason, Acadia has still yet to file a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nuplazid.

When the company carefully assesses all the data, we are confident it will come to the right understanding of what went wrong here if it has not done so already. We think a new trial for Praconistat should be focused on treating Refractory MDS patients — a 2nd line treatment setting.

With regards to MEI Pharma, the Pracinostat/azacitidine combination has shown a very good trend in treating elderly patients with AML in a first line setting. AML is often a result of untreated MDS. Elderly patients with AML are very hard to treat in comparison to younger patients (it's rare for younger patients to have AML). In December of last year, MEI reported that;

45% of patients (15 out of 33) evaluable for efficacy achieved the primary endpoint in the study, including nine who achieved a CR, four who achieved a CRi and two who achieved a morphologic leukemia-free state (MLFS). No patient who achieved a response has progressed.

The above seems promising. HDAC inhibitors like Pracinostat are known to work best in actively replicating cancer cells. MDS is a pre-malignant condition and the cells are generally not actively replicating unless they are in the blast phase, so there should be clearer path to designing a first line Phase III trial for the AML indication.

Currently, MEI has a market cap of around $60M and has simply become grossly oversold. One would think that since the company is trading for less than its cash on hand, that the Phase II data failure is a death blow for the company. This simply is not the case. At the very least, Pracinostat can be used to treat refractory MDS (2nd line treatment), and we think the company has gained the correct understanding of this and will redesign future trials accordingly.

However, running a redesigned Phase III trial in an attempt to get Praconistat approved as first line treatment could be successful, but ultimately too risky to attempt in our estimation. The likeliness of success is high if MEI runs a Phase III trial to get Praconistat approved as a 2nd line refractory MDS treatment.

Additionally, MEIP has two other drugs in its clinical pipeline, with one that has completed initial human trials, ME-344. According to the company;

Results from our first-in-human Phase I clinical study of intravenous ME-344 in patients with refractory solid tumors were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October 2013. Data from the single-agent study indicated that eight of 21 evaluable patients treated with ME-344 achieved stable disease or better, including five who experienced progression-free survival that was at least twice the duration of their last prior treatment before entry into the study.

ME-344 is designed for the treatment of tumor cells and is showing promise, although it's very early. The other drug is in pre-clinical, so we won't go into that one as no value can be assigned to it until it's tested in humans.

So, why did the stock drop so much after the latest setback, are the institutions not understanding the situation? In our opinion, this is hardly the case.

The data failure here happened right near the end of Q1. It's very common for institutions to cut their losing positions to receive a tax loss to counter gains from their successful positions and vice a versa. This is commonly called on the street, "window dressing."

Also, MEI has/had a large institutional ownership of over 70%, with a lower than average short position of around 7%. Institutions seemed so sure of trial success here, that it appears they did not hedge properly. In our estimation, these factors have lead the stock dropping at least two dollars more than it should have, notwithstanding that the company's language in its press release have led many to think that Pracinostat trials could be discontinued.

From our point of view, this will not be the case. Rather, we see management not trying to spin results and acting responsibly, unlike many developmental biotech's who spin results for their own self-interests.

We think many institutions that sold to show a tax loss for the quarter will begin to buy back in now that we have just started the new quarter. Also, with two investor conferences coming up in April, and full data points in June, we feel that MEI will rebound sharply. Therefore, we feel that MEI at the very least should make for an excellent long swing trade opportunity.

However, as much as we do not think Pracinostat will be discontinued and this will be resolved in a positive manner similar to the Acadia and Amicus situations, there is no guarantee that it will be. We are not insiders, so we can only give our best reasoning why we believe this and go from there as developmental biotechs are very speculative.

It's our estimation that MEI should valuate at twice the current market cap. We think over the next three months it has a good chance to make it there.

Quelle: Smarter Analyst

[MasterbrokerUSA]

Hier sollte nach dem Absturz,einiges noch möglich sein.RSI Überverkauft.Und alleine die Cash bestände rechtfertigen keine Kurse unter 3 $.Also rauf mit Meip

[MasterbrokerUSA]

Antwort auf Beitrag Nr.: 49.697.550 von MasterbrokerUSA am 03.05.15 14:29:35

Also

immer noch ist der Kurs Unterbewertet.3$ sehe ich als Fair an.Schon merkwürdig dieses Bashen des Kurses dir die Shorter.Für die ist dies nicht wirklich mehr sinnvoll zu diesen Werten zu horten.Auf Steigende Kurse.