Prima BioMed files for NASDAQ listing (ASX: PRR)

Just a quick heads up that Australian biotech company Prima BioMed (ASX: PRR) has filed for a NASDAQ listing of American Depositary Receipts (ADR). Once the listing is complete the company will have a dual listings of its securities on both the Australian Securities Exchange (ASX) and NASDAQ. Every one ADR will represent 30 common shares, so Prima at $0.17 cents would trade at $5.10 and a market cap of >$160 mln.

Prima’s proposed NASDAQ listing will be a Level II ADR compliance listing, and is being managed by Bank of New York Mellon and US broking houses Deutsche Bank AG, Noble Financial and Aegis. Prima did say that they are currently unable to say precisely when the shares will actually list and trade but we expect it will be soon.

Here the big question: Is this a blessing or a Curse ?

Prima is listing on the NASDAQ for better exposure and most importantly access to U.S. capital markets. The company is now beginning a Phase III trial in ovarian cancer using a dendritic cell based vaccine (in the U.S., Progenitor Cell Therapy (NeoStem-NBS) is doing the manufacturing, recall that PCT did the clinical work for Dendreon's Provenge and is also working for Coronado (CNDO) and Immunocellular (IMUC). If anyone can make sure that the "manufacturing goes off with-out a hitch” its PCT-NBS. 

So the next big question, is does it work ? Ovarian is a very tough indication and the life expectancy of Ovarian cancer varies a great deal. Prima's Phase II data was not double blinded cross-over so the results are not definitive. No way to say what the results of the current global PIII trial will be yet. We do know Prima will likely need to raise capital at some point ahead (thus the U.S. listing).

Perhaps the most important event that investors will watch will be not Prima at all, but Merck KG who is running the StimuVax trial which like Prima's product (C-Vac) targets the MUC-1 antigen (over-expressed in ovarian cancer).

If StimuVax works, Prima could rock, if not, it could flop as it validates one way or another the MUC-1 antigen as a target.

Let’s watch Prima and see how the company does as they work to build a U.S. institutional presence and present their data to the scrutiny of US investors.

Dendrion ($DNDN): Its Complex but Gold is Gone so is Platinium Ahead ?

A very significant event in the world of cell therapy occurred this week when news came that Mitch Gold, CEO of Dendreon (NASDAQ: DNDN) has left the company. Wall Street analysts reacted positively and the stock was up modestly on the news and has since settled back. Dendreon has been the shining example of what's possible in the cell therapy space until the company seemed to over-inflate expectations, and over-ramped manufacturing. When sales numbers failed to meet high expectations the stock corrected sharply (this past summer DNDN was >$40) and fell back to the $7 range. Savy investors who bought the over-sold stock at $7 have been rewarded as it bounced back to $14 (range). 

The key question now is what should we expect going forward ?

Dendreon remains a solid example of the utility a cell based immunological cancer therapy can have in the marketplace. We see Immunocellular (IMUC) as a very viable and cheaper play but granted earlier stage. PrimaBioMed (AUX: PRR) also falls into this space, chasing Ovarian cancer. Stay tuned for the results of Stimuvax, which would validate the MUC-1 antigen for Ovarian. As for Dendreon we believe a slow and steady climb back is likely as the company smooth’s out its commercialization and manufacturing ramp associated with Provenge.

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Which Cell Therapy companies present the best value?

Which Cell Therapy companies present the best value?

We developed an analysis using public filings and annualizing the most recent quarters as of 12/31/11. As such, the accuracy is subjective to our proprietary algorithm, and this list is not mean to be all comprehensive.

We conclude that ex leaders Dendreon and MesoBlast make the space very inexpensive. The sample below represents just over $500 million in market cap for eight of the selected public companies (ex DNDN and MSB). These companies have 3 - PIII trials, 5 PII trials and several P1 trials (based on these crude metrics).

We conclude that is worth investors time to understand among these companies in terms of what they are doing and the associated probabilities of success of their trials. Recent data peaks from the Cardiology space suggests that Baxter (BAX) and their CD34 cell type may be very viable. NeoStem has a very similar approach. The retrenchment in MesoBlast shares since that company presented data at AHA in November is of concern. Cytori, Aastrom, Athersys all have active programs in cardiology while Athersys lead program is partnered with Pfizer for Ulcerative Colitis and Aastrom is entering a Phase 3 trial in CLI.

By price ($), Osiris, MesoBlast, and Dendreon are the highest $ priced stocks:

But that starts to change as we migrate to market cap:

And if we eliminate Mesoblast and Dendreon we get a better picture of the rest of the field:

And that picture changes as we adjust for debt and cash: (enterprise value). In all fairness here, we know that NeoStem with $20-$30 million in value from their China generic company, could be the cheapest name and others are / will raise capital but ex China, Athersys is the “cheapest name”.

Looking at R&D spending: IMUC, Prima and NeoStem are among the most efficient but in fairness one must adjust for the fact that Aastrom is embarking on a pivotal trial versus Prima just starting their P3 and NeoStem their P2.

Revenues: Here we have excluded NeoStem’s $65 million from China which means PCT (Cell Therapy CMO) is running at close to $10 million in annual revenues (currently).

Immunocellular (IMUC) - Update(s) Phase II trial of ICT-107 for Glioblastoma

ImmunoCellular (OTCBB: IMUC) provided an update on the site and patient enrollment for ICT-107, currently in a Phase II trial for Brain Cancer. Recall that this is a dendritic cell based cancer vaccine targeting multiple tumor antigens for the treatment of glioblastoma multiforme (GBM or brain cancer).

• The company initiated the trial in 23 centers to enroll up to 160-200 patients, (100 with the HLA-A1/A2 immunological subtypes). 115 patients are enrolled in the study to date, ahead of schedule.
• Enrollment for the trial is expected to be completed by Q2 of 2012 and an interim analysis is expected when 50% of events (32 deaths) have been observed.
• NeoStem's, Progenitor Cell Therapy (PCT) is working with Immunocellular on the "manufacturing".

Conclusion: We discussed IMUC last week and we believe that this dendritic approach is showing compelling data in this unmet medical need. PCT (NeoStem) eliminates any manufacturing concerns, (PCT did most of the clinical manufacturing for Dendreon's Provenge). IMUC looks like an attractive play, and the company is financed through to proof of concept, given that capital was raised earlier in January 2012.

See all Daily Dose articles on IMUC.

ImmonoCellular (IMUC) - All Systems are Go !

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC) presented at the Noble conference in Florida last week, and we attended their presentation. Think of IMUC as Dendrion but this time targeting brain cancer (GlioBlastoma), the same cancer that killed Ted Kennedy. This is absolutely an unmet medical need. A few points to be excited about IMUC:

1. The company has now raised capital, has a modest burn rate and as such is solidly financed to the next data point.
2. Lead product is ICT-107 (dendritic cell for glioblastoma - GBM, or Brain Cancer), and the Phase II trial has started.
3. The Phase 1 data looks pretty remarkable. Average survival in these patients is typically about 15 months. In the Phase 1 trial IMUC has reported a median over-all survival of 38.4 months.
4. Attractive valuation: $45 mln market cap, plenty of cash, Phase II trials underway, and proof of concept data in the P1 trial as well as the therapeutic area (dendritic cell approach, aka :Dendrion).

See all Daily Dose articles on IMUC.

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ARM Panel shines light on the Cell Therapy Cardiovascular Space

This morning in SanFransico the ARM panel on cardiovascular medicine is taking place. NeoStem (Amorcyte), MesoBlast (MSB), Athersys (ATHX) and Cytori (CYTX) are presenting their cell therapy approaches. We will follow up with comments from this panel and the panels that follow throughout the day. In other news NeoStem announced the expansion of their IP for AMR-001 (their CD34+ cell therapy product) beyond STEMI (heart attacks) and to all ischemic (vascular insufficiency) diseases. We looked at the patent and we see this as a landmark expansion in the space. Immunocelluar (IMUC) also had news today, raising capital (aprox $9.4 mln) which will be used to fund the development of their dendritic approach to brain cancer (glioblastoma). We note that IMUC is working with NeoStem's CMO subsidiary, Progenitor Cell Therapy (PCT).

The TurnAround in Dendrion ? DNDN Presents at JP Morgan in SFO

Last week Dendreon NASDAQ: DNDN reported stronger than expected sales for Provenge sales at $82 Million generally above "street" consensus expectations. The company has a strong cash balance (approx. $600M) to fund the Provenge launch through to profitability. The stock rallied sharply starting the week at $8 and closing north of $12. This sets the stage for continued expansion for Dendrion and is welcome news for earlier stage cancer immune based therapies in development.

This week the JP Morgan Healthcare Conference begins in San Fransico, Monday through Thursday. Healthcare companies from all over the world converge for a week in meetings with sell side analysts, bankers and institutional portfolio managers.

We have been highlighting the Alliance for Regenerative Medicine (ARM) efforts as an industry group to highlight the progress that cell based companies have made over the past decade. To this end, ARM has organized a two day mini-conference (we have previously posted the schedule). What's special about the ARM event is that the companies will all present in a panels style format.

Industry leaders like Dendrion (presenting on a panel Wed) will be alongside other earlier stage companies in their market niche such as Immunocellular (IMUC), Coronado (CNDO), PrimaBioMed (PRR.AX) as well as other players in the space. We believe this will be a great venue for investors to learn not only about where Dendrion may be going as a stock, but what's next in the cancer-immunotherapy space.

We will be present throughout the day and blogging on the various panels as we go through the motions of comparing and contrasting the various approaches of the companies. For example we are keenly focused to listen to the cardiology panel where industry leader MesoBlast (MSB) will present alongside NeoStem (Amorcyte-NBS), Athersys (ATHX) and Cytori (CYTX).  Baxter (BAX) will not be present for the panel but investors should take note of their progress (P3 trial in cardiac ischemia).

We believe the next major breakthroughs on the regen side will likely be found in the cardiology space.

Immunocellular ($IMUC) - Moving forward in Brain Cancer

IMUC is developing ICT-107, an autologous, dendritic cell-based vaccine (like Dendrion's Provenge) that works by activating a patient's immune system against specific tumor-associated antigens. This is accomplished by extracting dendritic cells from a patient, loading them with the antigens, and reintroducing them to the patient's body to trigger an immune response. It is still early days, but IMUC is targeting glioblastoma multiforme (aggressive brain cancer) with this product. Data from Phase 1 trials has been encouraging and the company is embarking on a P2 program. The company is also developing ICT-140: Dendritic cell-based vaccine for the treatment of ovarian cancer. This product will target multiple antigens present on cancer stem cells and daughter cells. Interesting because we have discussed Prima BioMed's dendritic approach in ovarian cancer too.

This is not new news, but its worthy of mention, according to a blurb we saw in Bio Century, IMUC announced in early December the company’s plans to raise capital in a follow-on offering with a goal to raise up to $13.8 million in cash (10 million at $1.40) with 1:1 share – warrant coverage.