Shareholder meeting notes:
First I'll paraphrase several of Dr. Ryan's comments before and during the AGM, followed by my comments/opinions. Others present may have picked up on different emphasis or nuances, but these are from my perspective:
AAIC: General comments: Unlike all previous conferences, there was a significant lack of any buzz about any new Alzheimer's data. A symposia (considered one of the premier events at conferences) on ABeta was canceled; very unusual. Large companies finally looking beyond ABeta to new MOAs. Specific: A lot of big pharma very interested in Dr. Ryan's presentation of our poster on the trial design. We are "in the batter's box", and all eyes will be on the result. Very positive response to our poster/trial because of the target (moderate-to-severe Alzheimer's) and the mechanism.
Status of company: Running a microcap is tough, but this is a good team and committed to succeeding. [Chairman] extremely pleased with the significant hire of Dr. Ryan and recent hire of Dr. Ciraolo. Adds tremendously to the industry contacts, the presentation of the company's work to the industry, and the IP protection. [Bob Weinstein before meeting] Company runs very frugally, uses contractors where appropriate to save money.
Trial: Guidance the same--some time before end of Q3. Trial was well-run. No issues with dropouts or tox. Data still blinded (I think he said except to the DSMB). Currently scrubbing the data (or about to start?).
IP Protection: Before the meeting, Dr. Ryan answered some questions about IP. He talked about his experience at Forrest Labs with Memantine and Lexapro. Worked on cutting deals with 16 generic companies that challenged patents on Namenda [which is common when patents are weaker]. Also his recommendation to Forrest that they fight in court the one generic challenge to Lexapro patent. His opinion was the Lexapro patents should hold up to challenge. During dispute, the CEO was concerned about the court battle (Lexapro was a big money-maker for Forrest) and asked him if he was sleeping well. Dr. Ryan told the CEO, no he wasn't sleeping well, but he felt confident about a good outcome in the trial. Forrest Labs won in court and on appeal. As far as Neurotrope, they are working very hard on IP protection, including Orange Book patent(s) for Bryostatin. I'm no patent expert, but I believe Orange Book patents are the patents that the FDA recognizes when approving a drug, and a generic challenge has to go through these patents. Obviously extremely important patents. With these discussions, I feel very confident that Dr. Ryan and Dr. Ciraolo (also from Forrest Labs IP) are doing everything they can to protect Bryostatin IP with long-life patents.
Dr. Ryan/mgt MO: Laser-focused on getting Bryostatin into the endzone for Alzheimer's. On the road on a regular basis, presenting the company to institutions and retail audiences. He doesn't think scattergun (many trials at once) approach is right for the company at this time [will revisit this after results]. Working as hard as he can right now to get to approval on Alzheimer's. He does not put out a lot of PR that isn't about significant issues [doesn't believe in fluffy PR's].
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My comments/opinions:
I will reiterate, there was no wink or nod or reveal or tell on the trial results. Very professional. No company officer was talking about their predictions, and nobody asked them to weigh in on their prediction.
Obviously, the future of the company hinges on the results due in less than 9 weeks.
If the results are statistically significant, this company WILL become the star in Alzheimer's Disease. Stock price will do extremely well. They have an MOA they can explain, a target population that it works in, on a track to potential FDA approval, potential lucrative deals, and other diseases to start trials in.
If results are mixed, requiring subgroup analysis: If they find a really strong subgroup signal, I think the company will still do well, probably with a partnership, because AAIC revealed that big pharma is moving on to new ideas. The AD research industry is at a low, and IMO a STRONG subgroup would be enough to attract a significant partner on Alzheimer's and start to develop the other indications. If they have a subgroup analysis that is weak, I think it will be an uphill battle for the company.
If results fail (p-value on primary isn't close and no significant subgroup), I didn't get a sense of what the Plan B is for the company. Very focused on Alzheimer's.
