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I notice that Cassava issued a PR today noting that at week 40 of a Phase 3 clinical trial of simufilam interim MRI data showed the drug is not associated with any ARIA effects such as edema or brain bleeds. Not that I would have expected a different result, but the company is obviously trying to distinguish its treatment from the monoclonal antibodies directed against beta amyloid (e.g., LEQEMBI). One thing they didn't address is whether the MRI revealed any significant reduction in brain loss volume compared to placebo, as occurred in the Anavex trial of blarcamesine. I suspect Cassava would not have held that back were it observed in the MRI analysis.
Not only that, Steady, but if either the company or the CEO bought stock, the market would know for sure that no major data release, Rett or AD, was imminent (or that the Rett data had even been received by the company). If positive news was released not too long thereafter and the stock rose appreciably, lawsuits would be initiated on behalf of the aggrieved shareholders who sold to the company or an officer.
Crescent, you are smart enough to know that the XBI is made up of a lot of biotechs in different stages of their life cycle. Pre-revenue (and, even more so, pre-approval) companies within that index are much more volatile than the index as a whole. Since you own it as well, it shouldn't surprise you that SAVA is down an identical 61% from its 52 week high.
What is he having for lunch, if I may ask?
Indeed there was none despite the fact that Biogen/Eisai diligently culled out 80% of the trial applicants who did not fit their amyloid plaque starting points (in terms of level and ratio, if I am not mistaken). That too is a “narrow subgroup.”
Just to put it in some perspective, can you tell us what the AD subgroup labelling is for Lecanemab (aka LEQEMBI)?
Always good to remember that even Herr Doktor Missling and our "Doc" have something in common.
Bourbon, I don't call beating the results of Acadia's DAYBUE (trofinitide) "heroic." It is an extremely low bar to step over in terms of both efficacy and tolerability.
Joseph, I think that despite the fact that it received relatively few recs - no doubt because it came in the evening hours - this has to be one of the better posts of the week. People on this board are always consumed by every nuance of FDA trial procedures, statistical variances, comparable approvals and new precedence, all of which can be critical, but it is rarely if ever mentioned that there is also a court of public opinion which can somewhat color the FDA approval process. You rightly point out that Sabbagh, while tied to Biogen/Eisai's effort with lecanemab, was very much intrigued with the Anavex presentation on blarcamesine at CTAD 2022. He now comes in as Chairman of the SAB at AVXL with, as you point out, broad experience and connections in the industry and as a recognizable and respected source for the media in their efforts to analyze and present information related to developments in Alzheimer's research. You note in jest that "he could qualify as Anavex's head of PR." Well, Anavex will be in a war to grab media attention if the Alzheimer's 2b/3 data is as good as Herr Doktor Missling suggests, and his input (to both the company and the media) could be even more important to the success of approval than the company's head of PR, whoever that is.
Well, if Anavex has P3 OLE data for a substantial chunk of the patients, one might imagine it to quite positive if Missling is suggesting that the OLE could be used as the confirmatory trial…
Incorrect, Investor. The whole 96 week OLE is over in July 2024.
Yes, treden, that comment about building inventory for "potential market supply" didn't escape me either. I would still suggest that the bigger "tell" was Missling's assertion that they were seriously considering proposing the ongoing OLE as the confirmatory trial for AD as a follow-up to the P2b/3 trial when presumably seeking Accelerated Approval. It would take a lot of balls to suggest that seemingly rather novel approach unless the OLE - with far fewer participants than a typical "confirmatory trial" - was generating very impressive data and unless Dr. Kun Jin had signed off on that concept.
Excellent analysis, as always, Clark. Agree on all three points. Allow me to add a thought or two for each.
1) In the past Missling has alluded to ongoing conversations about partnerships/licensing. Here, I believe, it specifically came up in relation to RETT. The latter is new, since heretofore RETT was categorized as DIY, as opposed to AD or PD. While I always imagined that he meant primarily meant the English speaking countries, today’s commentary is interesting not only for the word “unsolicited” that you highlight, but also for allowing that the partnerships and/or licensing on RETT might be broader than I previously thought.
2) I think that Kun Jin was already helpful in steering Missling toward watching the Lecanemab process and then waiting for the various biomarker results, resulting in the serious consideration of AA. And, yes, Missling would not likely to have been bold enough to publicly suggest that he might be able to use the OLE as a confirmatory trial without a confirmatory nod from Kun Jin. (I’m sure Missling is also using him as a critical touchstone in deciding if RETT is to precede AD in data release and/or filing for approval.)
3. Getting down to individual words employed, I also believe that surprise is good for the reason you suggest and that it conveniently has two meanings here. I might even suggest that Herr Doktor Missling had the German word “überraschen“ rolling around in his head before “surprise” came out. Google translates it as “surprise, astonish, astound, overtake, and take aback.” As a final note, and not to be picky, Missling actually said at the ASM that we would really “enjoy” the results. Of the many things I like, only a few do I really enjoy!
George, not only might Red Barber suggest that we were "sittin' in the catbird seat," but similarly that we were "walkin' in high cotton."
Joseph, I too receive the company's press releases, having signed up online about two years ago. That said, I would echo Hoskuld's observation that IR is not a forte of of Anavex.
treden, according to Mayo the AAIC materials will be provided as an update to the SOTC site by Sunday.
Hoskuld, if one of those interested companies is Anavex, I would advise doing a stock deal rather than cash.
And exactly what "Business Director" was that?
Indeed, Hoskuld, the efficacy of the placebo is remarkable - so much so that one wonders if the FDA will approve it as well as donanemab - slightly less efficacious, but far lesser concern over side effects. Surely cheaper to produce. If the manufacturer is a publicly traded company perhaps we should go long...
Power, the article said that that the 60% number applied to those at the earliest stages of Alzheimer's. The numbers in May for the overall group were around 30%. Note also that the article said that brain bleeding occurred in 31% of the patients treated with donanemab
That is helpful chrismiss when someone at a bar might ask what I do. Saying that I invest in pluripotent Renaissance Octopii that will protect and soothe your central nervous system should certainly be a good line to open up conversation.
Yes, abe, particularly since blarcamesine satisfies that MOA (i.e., reduction of inflammation), as Missling indicates will be demonstrated in the upcoming release of the full Ph 2b/3 trial data.
Just to follow up on the rough earnings model for AVXL on Rett alone discussed yesterday, should blarcamesine receive approval from the FDA, as many of us here (including myself) expect, I looked up the Federal operating tax loss carryforward for Anavex. As of the last 10-K for fiscal year ending September 2022, the company had a carryforward of $123.4 million. By now I suspect the number is closer to $140 million, or about $1.75 per share. That should cover a very decent chunk of Rett earnings in the first year or two. Cash and cash equivalents totaled about $154 million, or just shy of $2.00 per share. For an $8 stock I would say that puts AVXL in a pretty good position as it transitions into a commercialization phase, as Missling expects.
First of all, the word you mean to use is "jibe" (not "jive"). More importantly, you did not read the title of the bottom section of the form. It relates to "Derivative Securities," not Common Stock. Yes, he disposed of all the Options in question, 500,000 in total, by exercising them. 268,000 shares of common were sold to fund the acquisition and pay the taxes (shown as first acquired, then sold, in the top box).. 232,000 shares of common were retained, as also shown in the top box.
I agree, crescent, that the market share assumption in his model seems way too low. The community of Rett parents is small, relatively well informed, and relatively well connected, and Trofinetide (Daybue) has nasty side effects that should allow Blarcamesine to be the dominant drug of choice. Furthermore, Dr. Missling ought to give back his MBA if he can't generate a higher post tax profit margin than 20%, given the projected price of the drug compared to the very modest cost of producing it (not to mention the company's existing tax loss carryforwards).
This is an interesting take, mrplmer. Do you care to expand a bit on this theory?
Excellent!
Piper Sandler increased the target on BIIB from $346 to $360 today (while maintaining "Overweight" opinion). Some of the juice today also came from Medicare elaborating on its intentions to broaden the coverage of the new Alzheimer's drugs from BIIB and LLY, although that was probably expected to some degree. If the drugs receive full approval, the agency will provide coverage for anyone with Medicare Part B coverage who meets the criteria and who is enrolled in a national data registry,
Gute Frage, Josef! I asked Herr Doktor Missling that very question at the ASM. He said that apparently there was no such screening limit for whom the drug was approved, at least so far. As I recall he added a bit of a quizzical comment thereafter. He seemed rather animated when I followed up with this question after he commented on his observation that the mabs were only relevant to 20% of the AD market (of 6.5 million, as I remember). I think this issue will be brought up when Anavex goes to the FDA for approval.
Kunð, for less than $10 you could have bought a share and come to the show yourself (or even walked in like a big swinging d**k with a round lot of 100 under your belt). I am afraid I will be too busy noshing on those bagels that BIOCheeks promised (hopefully from Ess-a-Bagel) to provide a play-by-play. As a concession to you for all your contributions to the board, however, I might subsequently reveal what designer outfit was worn by the spokesmodel that you seem to be obsessed with.
Pfizer emulates Anavex. I noticed with some amusement this morning a story on the CNBC feed about Pfizer's candidate in the weight loss drug frenzy, danuglipron. It seems as if they presented some top line results of a (Phase 2) study at an industry conference last fall, and only now has the full study come out in a peer reviewed paper. (If the Pfizer shareholders were anything like the Anavex shareholders here, the Pfizer CEO would be lucky to still have his job!) The Pfizer entry into the battle with the current contenders, Ozempic and Wegovy, is a pill versus injection and is as effective as the others in a shorter period of time. The story headline reads, "Pfizer oral weightless drug may be as effective as, quicker than injection by Novo Nordisk." I would expect something similar (but better) when the full Blarcamesine results are presented in 2H this year, "Anavex oral Alzheimer's drug is more effective, quicker than Leqembi infusion by Eisai/Biogen and without its serious side effects."
FWIW, I think that most of the downward pressure on AVLX today, like the XBI (and, for that matter, SAVA) is the result of the FTC moving to block the acquisition of Horizon Therapeutics by Amgen. It seems to be a fairly aggressive move by the FTC since it seems to violate neither overall industry concentration nor any meaningful overlap of disease treatment by the two companies. The market sees it as a threat to M&A in the overall industry.
LOL, thanks. If sorrows need to be drowned under that saint's spiritual patronage, I will have to wait until the market closes and meander down rather than powerwalking.
May 23rd. 10:00AM EDT.
Fine. I will no doubt pick you out at the meeting. (I am a half foot shorter with more salt than pepper.) Being actually more optimistic about the tone of the meeting, I doubt the pilgrimage to St. Dymphna’s will be necessary, and might suggest more Gemütlichkeit and convenience at a place like Koloman on 19th St.
Yes, I thought I would stroll over and meet Herr Doktor Missling.
There is a small Irish pub down in Alphabet City named St. Dymphna's. If the shareholders meeting doesn't go well, I may head down there for consolation and to expunge the demons. Hopefully, I will hear better tidings and that pilgrimage downtown won't be necessary. Either way, you are welcome to join, Hoskuld.
william, I think you are misreading a bit what Pazzo quoted. By reverting to her normal a week after the blinded trail Penny's mother indicated that she returned to her (worse) old symptoms. The mother is optimistic that Penny will get back to the improved state as Blarcamesine is reintroduced. I am too, particularly on the basis of what we saw happened to the Parkinson's patients once the OLE was resumed.
Perhaps Missling can counter with a "u" in the Blarcamesine brand name and then top it off with a trendy umlaut.
RedShoulder, you neglected to mention the more significant side effects of Blarcamesine: Better sleep and lower blood pressure. (I actually think there are some other nice benefits we don't know of yet, as Mayo's work hints at.) As they used to say mid-century in the streets of New York, "f*ckin' A!"