jjjorgen's  Instablog

AEterna Zentaris (AEZS) is a company I have owned on and off for years now. I first became aware of the company AEterna Zentaris, through the ownership of Keryx (KERX). Perifosine was slated to be the next great Akt-inhibitor for cancer cell growth, with Phase 3 clinical trials furthest along in colorectal cancer, and secondly a Phase 3 trial encompassing multiple myeloma.

Seeking Alpha and Motley Fool wrote a number of articles on these two companies prior to April 2nd. We also had Adam Feuerstein of "TheStreet" keeping pumpers in check with forecasting the failure of the Perifosine colorectal cancer Phase 3 clinical trial. April 2nd is a day that will live in Infamy for many traders. Dropping from $2.14/share on April 1, and closing on April 2nd @ $.73/share. Unfortunately, Not an April Fool's joke. And now, AEterna is off 80% from $2.14/share.

Keryx, with the failed trial announcement, fell from $4.98/share to close on April 2nd at $1.74/share. Share prices continued to drop to a low of $1.28/share two weeks later, but they have now recovered to $1.75/share. Keryx has relinquished Perifosine rights back to AEterna, and now has one Phase 3 clinical trial continuing with it's kidney medication, Zerenex.

Remember this SA Article? Well that sure didn't work out as forecasted. Oh, how I would like to see $1/share again. People now need to consider today's position. AEterna currently holds $46 million in cash, and receives approximately $7.5 million a quarter in Cetrotide royalties. The pipeline is promising, and here's what currently is happening: (Updates provided to me by Paul Burroughs)

Management made it clear during their May 9 analyst conference call that they had not been sitting on their hands since the April 2 announcement on Perifosine in CRC. They are working hard to move their main products through the pipeline as quickly as possible and at the most reasonable costs. Dr. Engel mentioned that there is interest from Biopharma for some of their products and potential partnerships are part of AEterna's strategy, but no names can be mentioned. Management was clear on why and how they will be moving forward with their lead compounds:

Perifosine- a decision has been made to continue their Phase 3 trial in multiple myeloma based on the following factors: 1) Existing preclinical and clinical data 2) Support among key opinion leaders in this field. 3) Market opportunity 4) Examples of other drugs (Avastin, Iressa, Sutent) enjoying success after facing setbacks 5) Reasonable investment (about $2.5M) up to interim analysis in Q1 2013. At this point a decision will be made whether to continue.

Perifosine in Japan~ Yakult trial in colorectal cancer: A meeting was held in the third week of May to discuss development plans in this indication.

And lastly for Perifosine, Johanna Bendell, MD, Director of Gastrointestinal Cancer Research and Associate Director of Drug Development at the Sarah Cannon Research Institute in Nashville, Tennessee, presented Phase 3 results for Perifosine in refractory colorectal cancer at the American Society of Clinical Oncology (ASCO) Annual Meeting. Dr. Bendell was the lead investigator of the trial. Data showed no benefit in overall survival when adding Perifosine to capecitabine in the refractory colorectal cancer setting, confirming top line results previously disclosed by the Company on April 2, 2012.

AEZS-108~ why Phase 3 trial in endometrial cancer has not yet been initiated: 1) Doxil, which was supposed to be used in this trial and is no longer available following an FDA decision 2) FDA recommended waiting for Ventana companion diagnostic before starting the trial in order to better screen LHRH positive patients.

AEZS-130~ A meeting with the FDA was held during the last week of May to get an update on this diagnostic test. Why has the NDA as diagnostic test for AGHD not yet been filed? 1) the FDA has been coming up with many questions on AEterna's document and they have decided to answer all FDA questions before submitting an NDA, thus increasing the chances of presenting a document suited to meet FDA requirements.

So, on June 12th, we saw AEterna share price per share drop below $.40/share. It is hard to believe AEterna dropped below cash value, with no value given to AEterna's pipeline and prospects. Look on AEterna Zentaris's website, and view their pipeline.

By all means, I have not brought up everything that is currently happening within AEterna Zentaris. Shares of AEZS are almost exclusively held by retail investors, a very fickle group. Share price is highly dependent on current news being provided, and patience does not sit well. And now, the typical frivolous lawsuits begin to appear. As for me, I've been accumulating shares at these levels. My belief and opinion is that trading groups are now slowly acquiring shares, and may soon begin a pumping effort to raise the price per share. AEterna has also currently began to give investors some press releases for current trials.

So, I'll hold my shares and see what happens. What will YOU do?

Disclosure: I am long AEZS.

I'll start off by saying I own a large number of shares. AEterna Zentaris (AEZS) is a company I've owned on and off for years now. I first came aware of AEterna Zentaris, through ownership of Keryx (KERX). It seems like a distant memory now (bad memories). I actually made some money trading both Keryx and AEterna. The good old days. So, who would have imagined that Perifosine would fail. Why, my old friend Adam Feurstein. Boy, he nailed this one on the head. Remember how he duked it out online with Feurstein. So, over $3/shr?? seekingalpha.com/article/463691-aeterna-..., That didn't work out. Oh, how I would like to see $1/shr again. The promises are great, and what we are currently waiting for: I think that management made it clear during the May 9 analyst conference call that they had not been sitting on their hands since the April 2 announcement on perifosine in CRC. They are working hard to move our main products through the pipeline as quickly as possible, and at the most reasonable costs. Dr. Engel mentioned that there is interest from pharma for some of our products and potential partnerships are part of our strategy, but you can well understand that we cannot name names. Management was clear on why and how we will be moving forward with our lead compounds: Perifosine: decision to pursue Phase 3 trial in multiple myeloma is based on the following factors: o Existing preclinical and clinical data o Support among key opinion leaders in this field o Market opportunity o Examples of other drugs (Avastin, Iressa, Sutent) enjoying success after facing setbacks o Reasonable investment (about $2.5M) up to interim analysis in Q1 2013 Perifosine: Yakult trial in colorectal cancer o Meeting planned in third week of May to discuss development plans in this indication in Japan o Results from the Phase 3 trial in CRC presented by investigator at ASCO in early June will yield valuable information on perifosine . AEZS-108 : why Phase 3 trial in endometrial cancer has not yet been initiated: o Doxil which was supposed to be used in this trial is no longer available following FDA decision o FDA recommended waiting for Ventana companion diagnostic before starting the trial in order to better screen LHRH positive patients o Meeting with Ventana this week to get update on diagnostic test AEZS-130: why NDA as diagnostic test for AGHD not yet filed o FDA has been coming up with many questions on our document / we have decided to answer all FDA questions before submitting our NDA, thus increasing our chances of presenting a document suited to FDA's requests o Meeting planned with the FDA at end of May to discuss this topic Regards, Paul Burroughs This is an email I received from Mr. Burroughs. So, today we closed again @ $.45/shr. That's pretty much book value. Look on AEterna Zentaris's website, and view their pipeline. With close to $50 million currently in the bank, that pipeline is free. Hard to explain, isn't it? So, I'll hold my shares and see what happens. What will YOU do?

Disclosure: I am long AEZS.

I can't believe we have fell to $.445/shr. Anyone else? No news and low volume have a great deal to do with it. Retail Investors are the majority ownership, and we know what a fickle group retail investors are. AEZS does have a presentation forthcoming at ASCO on AEZS-108, but I'm not sure if anyone cares on this one:

http://abstract.asco.org/AbstView_114_97143.html

OK, so how do we bring this pps back to reality? We're currently close to book value, with a great pipeline. Who has a great idea for AEterna Zentaris?

Disclosure: I am long AEZS.