MNTA: notes from Bio Ceo webcast today. Some comments verbatim, some paraphrased. Admittedly, I have never been more excited about a biotech investment than this one; please factor that into your opinions about my commentary which is positively biased.
Primer: "We have the ability to analyze complex mixtures which others cannot." One of their stated goals is to "remove the black box," via their detailed analysis of what is in these complex compounds. Stated that the initial Sandoz deals gave them an opportunity to fine-tune their toolbox.
M-Enoxaparin: The Enoxaparin "FDA status" portion was essentially minute 11 to 15 for those who care to listen. I thought it was rather upbeat. The situation is "not static." "...As I sit here today, I believe, and I am optimistic, that we will not be asked to do clinical trials to be able to resolve this issue. ...We think this issue is resolvable analytically. ...I think it is still possible, though you shouldn't take this to the bank... that we could still get an approval in 2008. ...I am now signalling to you that I believe that it is within the realm of possibility. So what we are not looking at, at least at where we sit today, is a 2 or 3 year delay which will require us to go out and do new trials."
Patent Appeal: "... We were quite pleased at the judge panel that actually heard the case (a panel that is versed in IP)... we are very positive that we will actually see a good result..." Patent resolution decision remains on track for Mar-Apr timeframe, in Dr. Wheeler's opinion.
Copaxone: They are extremely pleased with the continued sales trajectory of the drug, which "ratifies" their decision to go after the generic version. 50/50 profit split with Sandoz on this generic because MNTA was more mature as a company (characterization-wise?) when the deal struck, as opposed to the Enoxaparin deal. "Expect good news on the generic Copaxone front in the relatively near future." (paraphrased)
M118: "...I couldn't be more pleased." Stated that the M118 molecule is behaving (verbatim) "exactly as we hoped it would behave." Discussed why they went after elective PCI PIIa trial first: Prove that cath lab safety is etched in granite before proceeding to medical management clinical studies.
Partnering discussion again (2008 goal): goal is to have a partner (after PIIa) to fund a broader-based clinical program. "...Looking for a partner with deep and broad capabilities in the clinical development business..."
"...Every day when we see more information on this program, we are becoming more and more bullish on the potential of this compound..."
FoB programs: You really have to listen to minutes 23-26 to grasp the big picture; too much to paraphrase: Getting into a differentiated cell-based "frame-breaking" FoB manufacturing process. Moving from characterization to competitive manufacturing.
Oncology candidate: Compound based on heparin. How it might work in metastatic disease.
Finances: The company has an expected 2008 cash burn of $50-55M and 2 years of cash remaining "now?" The company hopes to end 2008 still possessing 2 years worth of cash. This gives obvious insight as to what Dr. Wheeler thinks about partnering M118 after the PIIa results, at least from the standpoint of receiving upfront cash, and/or Enoxaparin milestones. (I believe he was speaking to M118 only, imo). Unless, of course, he was alluding to less cash burn going forward... I would highly encourage all to listen to his M118 program commentary.
"Illegitimacy is something we should talk about in terms of not having it."
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.