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Sir, the US health authorities beat the dog, not me. Trying to assess the dog's health today and going forward. I guess you'd never take your dog to the vet, eh?
Falconer, for the likely upcoming testing of 3-71, what might study/trial times require? If -73 is stuck here, without approvals, although we fortunately have adequate funding to continue, our share price will at best, maintain its price, but potentially could suffer/suffer significantly. Your thoughts?
Falconer, you offer some truly interesting and ambitious hypotheses. But, I'm wondering if you are make the erroneous assumption that AVXL is aware of these opportunities/this science. Are you conveying these thoughts to the company itself....or just assuming that they are 'on the case'? I'd be shocked if anyone from AVXL is looking at investors hub for perspective/ideas for follow-up/testing, or for scientific advice. Hopefully, they are ambitiously making advances in the areas you put forward, but, not so sure.
Worst CEO's of 23': Missling..picked up from stock service:
"From STAT’s worst CEO’s of 2023
Cuong Do of BioVie for believing for a moment that he’d be taken seriously as the CEO of an Alzheimer’s disease company 60% owned by Terren Peizer, the disgraced biotech entrepreneur and financier currently under federal indictment for insider trading. Also, you can’t excuse a failed clinical trial by erasing data from 80% of the enrolled patients.
Chris Missling of Anavex Life Sciences for disappearing the results of a Phase 3 study involving children with Rett syndrome, completed six months ago."
Fair or unfair?
RETT RETT RETT. When is that delivered in its final/acceptable version for the world to see and interpret as a winner? We are a $2-3 stock unless we get the goods with RETT. Very unfortunate data desert here.
Apparently Goldman is having its Alzheimers Disease Day conference today. Invited guests are...BIIB $LLY $ALEC $BIVI $IONS $QTRX $RHHBY $SAVA.
What will it take for AVXL to finally get attention, and respect of the ALZ community? 2023 is almost done. 2024?
Been here 7 years, so I have a bit of patience, but Father Time is kicking in.
Thank you for this post. This comment, from a prominent influencer following the space closely, in another newsletter group, who has balked at full support of AVXL for similar reason: "10 months after the initial PR. I was waiting for a publication of study results. There still isn't any. No data on NfL, though they had measured it."
Hope you are correct about the dam giving way after publication of the peer reviewed articles.
Excellent post. Hope you stay on this board sir. Your comments, such as this one, have significant, albeit non-scientific, value.
Something doesn't add up....they have all those airports, and what is their income? Are they trials at no cost? They have their id systems in the smallest of "cities"....1 stoplight towns. Why can't they get bigger towns/cities? I think they are giving stuff away in order to get presence anywhere. However, they are getting contracts with government and some reputable Fortune 500's, so they must have something of value in their product mix. I think 1/2 is legitimate, and the other 1/2 is just hopeful stuff that they are hoodwinking investors with. They have to watch out, or there could be trouble with how they are communicating on the later.
too big an ego to ever let go, as that would equate to his inability to deliver. plus its the family's store of wealth and his personal piggy bank while he's in charge. he loves the attention and his travels. its always been a coin toss if this company ever makes it, and it still is.....no matter how many shots on goal there are or will ever be.
OMG, Dawson James reduced to $3 target. Was mid $20's within past 12 months. Looks like analysts have formally given up on Mark E.
Each downgrade (to basically a strong sell position) promotes an additional wave of selling. There is no logical reason to swim against this selling tide.
A great speculative buy once again in low $1 range, or this is a wipeout in 2 years time.
Cash is depleting, and $0 sales for years. What would be reason for the stock to go in any direction other than down...unless there are strong, credible, revenue generating deals announced. I don't see them coming anytime soon...but lightning can strike. You're betting on lightning. Most often a poor, risky bet.
HCWainright analyst Bernardino lowered his target to $6. That is being kind to Mark E. Selling is now happening into that lowering of expectations. The trajectory is down/down significantly on market weakness, UNTIL/UNLESS Mark E. scores a goal. Hasn't yet, since he reset his business model. Looking at a $1.50 to $2.50 range in the meantime....Ouch. Only reason its above $2 is it's cash position. Otherwise we'd be <$1. A bad stretch in the market and this is a penny stock, once again.
I was under the impression ,that aside from AD and PDD, the smaller neuromuscular disease populations were easily able to justify a very viable/profitable business for AVXL. Plus Orphan Drug designations etc.
If that assumption is correct, then the share price should still be at least several. multiples higher than today's prices. But, perhaps that is the commonly accepted view....that the smaller indications don't add up to a viable company, and that AVXL is not worth anyone's time or investment until the big targets are fully and completely conquered. If that's the case, looks like its about 2 years before the market gives credit through a much appreciated share price.
Thanks for report.
50/50 SRNE goes the distance. If it collapses we are left with nothing in the near/mid-term for incoming cash/sales. An upcoming 'collaboration' means little. Sanofi yielded nothing at the end of years of collaboration. Look out below if the SRNE deal is gone. OTOH, if SRNE moves ahead, we could easily double back to $7. A crapshoot. Mark's demeanor suggested that he believes its a crapshoot as well.
Nails are not in the coffin yet... May never know why it fell apart. But, it appears that SRNE CEO may be a bit of a sleazeball. Unfortunate that Mark can't attract better partners. He has a very poor record so far.
Dump dump dump. The communications from Management is scandalously poor. Are the wheels falling off this jalopy? How much worse can this get? Hard to believe...And, it appears no one does believe...Therefore this share price that is perhaps going to penny land?
'Big runner' is down significantly, and not moving/playing dead. What's going to change that?
The most encouraging part of the cc was the addition of the new hire. Otherwise, Mark seemed very tired, and seemed to have lost a step or two. I think the SRNE blow was a very significant loss, and will be challenging to properly address and overcome....assuming the deal is dead.
Out of cash by end of quarter...will need to do a raise...big time...and they are bleeding cash big time. This could turn into a disaster (regardless of the sales) as they need money to keep their doors open. They blew through $100M, their entire cash hoard, and now they are on fumes. A friggin mess, courtesy of Vered. Oh, and she gave herself a $4Million bonus. She may have shipwrecked this company. The next 2 months will determine whether this lives to see another year of solvency. A total F-up.
Would agree. Waiting for cc transcript to read. This will take patience. They'd better have a transcript, as the call was difficult to hear. We may have to wait another quarter for this to pop. Sales have to grow consecutive quarters. Market cap is 3x sales...so, very cheap here.
Nice find...Bangladesh?!?! Could he find a more questionable country? Maybe Somlia is next.. It sounds like this company doesn't have the wherewithall to produce an aspirin never mind a complex product. Concrete takes too long to use in the site's development so they are using steel. What could possibly go wrong in an area with regular 200 MPH typhoons. Lord, we are scraping the bottom of so many barrels. Sounds like DYAI will be on the hook to get the plant built, running, etc, and probably funding a good part of it. DYAI is smart not to put out a PR at this time.
Lot of eggs in this SRNE basket. 20% drop in response to the lack of closure....and possibly a lot more to come. Maybe SRNE realizes they've got Mark over a barrel and pushing for much better terms. Why not. This partnership is Mark's 1 trick pony, and the other guy has the reigns. Always a drama with this company. What happened to animal health?
Only retail is buying here. If they were close to a deal, there would be natural resource funds buying. None are....so far. WMLLF has come up empty handed for a long time. Will be a miracle if that pattern changes now.
Benzinga Conference
scroll over to the 3:13 (3 hours and 13 minutes) timeframe to Dyadic’s presentation
When the panel discussion starts scroll over to the 3:47:30 timeframe..Sorrento CEO relationship w/Dyadic/expectations...listen to what Mark Emalfarb has to say.
BTIG will be doing updates, and raising target price, as each of these disease state dominos fall into place. Others will follow BTIG lead. AVXL will be on a slow, steady path of appreciation...until there is some kind of mass media pick-up. My CNS/ALZ/Cancer bets are on the undiscovered , proving out in human picks: AVXL and INMB.
BTIG.........
Anavex Life Sciences
(AVXL, Buy, $35 PT)
Anavex Is Targeting a Master Regulator in the Brain; Initiating at Buy
with a $35 PT
WHAT YOU SHOULD KNOW: Anavex is taking a differentiated approach in developing
novel therapeutics for neurodegenerative and neurodevelopmental disorders. The
company's pipeline is focused on the Sigma-1 receptor (Sig-1R), a master regulator that
modulates multiple cellular pathways known to be involved in disease pathogenesis,
to maintain the homeostasis in the central nervous system (CNS). The lead product
candidate ANAVEX 2-73 has demonstrated a strong safety profile and compelling
efficacy in multiple indications including Alzheimer's disease (AD), Parkinson's disease
dementia (PDD), and Rett syndrome. We believe the positive clinical data provide
strong proof-of-concept that ANAVEX 2-73 should have 1) strong versatility in different
CNS disorders, and 2) a higher probability of success in each indication than drug
candidates that modulate single pathways. Anavex is further expanding the pipeline
with new indications for ANAVEX 2-73 and next generation compounds. Even after the
strong one-year and YTD performance (320% and 226% vs. 33% and 19% for S&P 500),
we see strong upside potential in AVXL shares ahead of top-line data readouts from
two Phase 2/3 studies in the coming 12 months.
¦Sig-1R should be an ideal drug target. Sig-1R modulates intracellular calcium flux,
mitochondrial function, unfolded protein response, excitotoxicity, and oxidative
stress, all of which are involved in neurological disorders. There is strong evidence
to suggest that the activation of Sig-1R elicits neuroprotective effects. Therefore,
Sig-1R agonists should be good drug candidates for the development of novel
treatments across different diseases that affect the CNS.
¦Anavex has reported compelling efficacy data. A Phase 2a study in 32 AD
patients, although without placebo control, demonstrated a statistically significant
separation in functional and cognitive measures between patients with higher
plasma concentrations of ANAVEX 2-73 and those with lower concentrations. In
a Phase 2 study in 25 Rett syndrome patients and a Phase 2 study in 132 PDD
patients, ANAVEX 2-73 treatment led to statistically significant improvement in
efficacy endpoints as compared to placebo. We believe the efficacy across different
indications supports ANAVEX 2-73's universal neuroprotective activity.
¦Precision medicine approach should further improve treatment outcomes. A
statistically significant correlation between SIGMAR1 mRNA expression changes
and efficacy readouts in patients with AD, PDD and Rett syndrome should be strong
evidence supporting ANAVEX 2-73's mechanism of action. Moreover, Anavex has
conducted a genomic analysis and identified key drivers that can be applied in
patient selection to further improve outcomes.
¦ANAVEX 2-73 should have blockbuster potential. Single digit market penetration
in only mild AD patients in the U.S. could translate into sales of over $1.5B,
which we believe should still be conservative when compared to historical sales of
FDA approved treatments for AD. Rett syndrome is an Orphan indication with no
treatment options available. Top-line data from two Phase 2/3 studies by YE21 and
in early 2022, if positive, could allow Anavex to initiate filing discussion with the
FDA in 2022. We project a U.S. launch in 2024 and peak sales of over $660M in the
U.S. and EU in 2031.
¦Valuation: Valuation: Our price target of $35 is the average of fair values that we
reach with a discounted earnings model, a DCF model, and a clinical NPV model.
September 23, 2021
Yun Zhong, Ph.D.(212) 588-6523 yzhong@btig.com
Xu Zou, Ph.D., CFA(332) 400-5082 xzou@btig.com
Company Data
Closing Price $17.40
Price Target $35.00
Market Cap (M) $1,317.31
Enterprise Value (M) $235.54
Shares Out (M) 75.71
Avg Daily Vol-3 Months (M) 2.1
Dividend / Yield $0.00 / 0.0%
Revisions
Previous Current
Rating - Buy
Price Target - $35.00
FY21E EPS - (0.54)
FY22E EPS - (0.68)
FY21E REV - 0.00
FY22E REV - 0.00
EPS (GAAP)
FY Sep 2020A 2021E 2022E
Q1 (0.12) (0.12)A (0.16)
Q2 (0.12) (0.12)A (0.17)
Q3 (0.11) (0.14)A (0.17)
Q4 (0.10) (0.16) (0.18)
FY EPS (0.45) (0.54) (0.68)
FY P/E - - -
Revenue (M)
FY Sep 2020A 2021E 2022E
Q1 0.00 0.00A 0.00
Q2 0.00 0.00A 0.00
Q3 0.00 0.00A 0.00
Q4 0.00 0.00 0.00
FY REV 0.00 0.00 0.00
Source: FactSet, BTIG Estimates and Company
Documents reported as $ currency.
FY = Fiscal Year CY = Calendar Year
PLEASE READ: IMPORTANT DISCLOSURES AND ANALYST’S CERTIFICATION APPEAR IN APPENDIX WWW.BTIG.COM
BIOTECHNOLOGY EQUITY RESEARCH
Investment Thesis
Sigma-1 receptor (Sig-1R) mediates multiple cellular pathways that are involved in disease pathogenesis, including protein
misfolding, oxidative stress, mitochondria dysfunction, inflammation, and cellular stress. Sig-1R activation promotes neuronal
survival and restores neuronal function in neurological disorders, likely through the modulation of calcium homeostasis, regulation
of endoplasmic reticulum (ER) and mitochondrial functions, and reduction of neuroinflammation. Anavex's lead product candidate
ANAVEX 2-73 has not only high affinity to Sig-1R, but also moderate affinity to muscarinic acetylcholine receptors (mAChRs), and
therefore could have enhanced neuroprotective activity.
CNS disorders represent a significant market with AD and PD affecting approximately 5.8M and 1M patients in the U.S. respectively.
The high failure rates in the CNS space, particularly in AD, highlight the significant challenges that companies face when developing
novel therapies. We believe an important reason is the complex pathophysiology underlying neurodegenerative diseases, which
is not fully understood and certainly has not been sufficiently addressed by clinical programs that have failed to date. We believe
Anavex is taking a differentiated approach by simultaneously targeting multiple pathways that are known to be involved in disease
pathogenesis. We believe Anavex's approach should be superior to those that targeted single pathways, and therefore could have
a higher probability of success.
Upcoming Catalysts
ANAVEX2-73 for Rett Syndrome
¦Top-line data from Phase 2/3 AVATAR study in adult patients: YE21
¦Top-line data from the Phase 2/3 EXCELLENCE study in pediatric patients: early
2022
ANAVEX2-73 for Parkinson’s disease dementia (PDD)
¦Regulatory pathway discussion: 2H21
ANAVEX2-73 for Alzheimer’s disease (AD)
¦Top-line data from the Phase 2b/3 study: 2H22
Other Programs
¦Initiation of a study of ANAVEX 2-73 in Fragile X syndrome: 2H21
¦Data from the Phase 1 study of ANAVEX3-71: 2H21
Base Case Assumptions: $35 Price Target
The following valuation parameters apply to all cases:
¦Discounted earnings model: 25 x FY2029E EPS, 25% discount rate
¦Discounted cash flow model: 12% discount rate; 2% perpetual growth rate
¦Clinical net present value model: peak sales of ANAVEX 2-73 for Rett syndrome,
AD, and PDD in both US and EU in 2031, 25% discount rate.
Upside Scenario
¦ANAVEX 2-73 enters the U.S. market for AD and/or PDD before 2025, the year of
our projection
¦ANAVEX3-71 for Frontotemporal dementia generates positive data and contributes
to valuation
Downside Scenario
¦ANAVEX 2-73 fails in any of the ongoing programs (Rett syndrome, AD and PDD)
¦The FDA requests additional clinical study for Rett syndrome, thereby delaying
potential market entry of ANAVEX 2-73
¦ANAVEX 2-73 fails to achieve market penetration rates that we have projected for
each indication
Tailwinds Research is the public site, but then you pay membership for the chat room and zoom sessions. They had DYAI in their portfolio but dropped them. TFFP is a key piece of their portfolio.
Pretty clear what they'd be working on with TFFP (inhalable vaccine delivery). Possibly SRNE is a part of that puzzle, or maybe not..Emelfarb might as well go for a brass ring for break-through production AND delivery systems for Africa, etc.
Otherwise, I'm a fly on the wall, as the chat guys are ex-Wall Street, clubby, and in a different pay grade where I would not intrude...so I'm not asking questions there, just picking up bits of insights.
A private pay for chatroom. TFFP indicated that they have a relationship with Mark. True, that this has not been disclosed officially, but DYAI has lots of MTAs that are not disclosed by Mark. No idea what the comment by the poster truly means.
No link per se, but here's the quote from the chatroom. This is a very smart guy talking...I believe he owns, or owned, both companies: DYAI and TFFP. They now are working together. No greater context than what is below.
'Dyadic’s fungal IP apparently had meaningful issues that I think Emilfarb failed to discuss. This doesn’t seem to be the case with TFFP'
Someone in another chatroom mentioned that Mark E. may have some IP issues with DYAI technology. Anyone know anything about this? Also, wasn't vaccine testing supposed to have begun by now?
Right on schedule..end of Q3 liquidation. IDIOTS couldn't see the writing on the wall? Pride must have gotten in the way of logic. So obvious...
today:
Avenue Therapeutics, Inc. (“Avenue”), received an Appeal Denied Letter from the Office of Neuroscience of the FDA in Response to its Formal Dispute Resolution Request
Looks like we are tied at the hip to SRNE news flow around their vaccine testing/plans. If they are really good at their technology and science development, then we have a winner in DYAI. All chips are on SRNE....unless something happens on the animal/vet side.
DYAI is working with TFFP for inhaled delivery of the upcoming vaccine. particularly well-suited for Africa, or anywhere that temperature control is an issue. Its starting to all come together, but it'll be another year before the rubber really starts to hit the road. There might be additional opportunities to get this back in the low 3's, but one more announcement of significance, and this starts to run.
If I understand correctly, as specified twice in the announcement, this is an EXCLUSIVE deal for all the key world markets (excluding India, Africa, etc.). So, it appears that the Coronavirus business partners are now pretty much locked down, with Sorrento getting exclusive dibs with the biggest potential.
So, the non-Corona BP, and Animal Health will be the next partnerships to be garnered/signed?
Seems like Mark E. has a lot of his chips riding on Sorrento..Hope they come through, as we are now in their hands.
Q2 Catalyst in: $11M qtr. Good sales rate. Very high burn, and CEO just took down a $3.6MILLION BONUS. Unconscionable! Stock will come down from $5+ level as the likelihood of a capital raise is now looming by year end. Cash management here becomes a very large issue. Bad, Bad Optics!!
As expected, a niche, out-of-the-blue type of partner to break with BP traditions. This is a good one, but will take time to go through tests, etc. This is a material transfer agreement for all intents and purposes until they get the vaccine working and approved....similar to the vaccine testing that begins in USA later in Q3. At least now they have an interested party committed to pushing this forward. Hopefully the folks in SA are properly structured to make this happen expeditiously, and are properly funded to make it happen in a businesslike manner. I hope the impetus is saving lives WHILE making significant profits, ie. not a non-profit approach.
Too much effort required (money, logistics, production changes, etc.) for not enough incremental return on that anticipated effort. I think the eventual deal(s) will begin with micro to smaller Pharma that can use this to break through in their niche area. Start of vaccine trial may give DYAI a little recognition...that would be a start, and a surprise deal could still be in store during 2021. In the meantime, it will be tough sledding between now and then.