ALZN: Phase 1 Topline Data due in Dec

another biopharm play here. i was trying to get this DD published this weekend but life got in the way. the price has been moving up since it was on my watchlist (low $2) but i still think there’s room to go.

COMPANY

Alzamend Neuro is preclinical stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders.

52 Week Low - 1.87
52 Week High - 33.55

Shares - 86 million
Float - 44/55 million
Market Cap - $185 million

they have 2 drugs in their pipeline. info on their 2 drugs is taken directly from their website:

AL001

AL001 is an ionic cocrystal of lithium and has been shown to exhibit improved nonclinical pharmacokinetics compared to current FDA-approved lithium products; it is also bioactive in many in vitro models of Alzheimer’s Disease. AL001 is expected to provide clinicians with a major improvement over current lithium-based treatments and may also constitute a means of treating Alzheimer’s and psychiatric disorders. Based on nonclinical data, AL001 cocrystal technology has the potential to improve the therapeutic index of lithium providing a greater bioavailability to the site of action (brain) in comparison to more traditional lithium dosage forms.

AL002

AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that reduces beta-amyloid plaque and seeks to restore the ability of the patient’s immunological system to combat Alzheimer’s disease. This therapy is intended to work by stimulating the body’s own immune system to prevent the formation and breakdown of beta amyloids, which build up in the brain to form a “plaque,” and subsequently block the neurological brain signals, ultimately leading to the symptoms and onset of Alzheimer’s.

both of these drugs target Alzheimer’s and related diseases. they are both in the Phase 1 stage (out of 3).

WHY DO WE CARE/CATALYSTS
the company released a press release stating that their Phase 1 Topline Data for their AL001 clinical trials will be announced in mid to late Dec of this year.

“Top Line Data means, with respect to a clinical study, a summary of demographic data, the data for the primary endpoint and a summary of safety data, which are based upon an unblinded, locked database. All such data will be collected in a database validated in accordance with 21 CFR Part 11 and with full audit trail.”

if the results are positive, this should be a catalyst for the price to jump. at the time of starting this DD, the price was hovering around $2.10, near it’s 52 week low.

i wanted to see if positive top line data results actually moved the stock price in other tickers. a simple Google search and i found a couple examples:

Examples of Topline Phase 1 Clinical Trial Data
Larimar Therapeutics (LRMR)
May 11, 2021 at 7:00am EDT

Reports Positive Topline Phase 1 Clinical Trial Data
https://investors.larimartx.com/news-releases/news-release-details/larimar-therapeutics-reports-positive-topline-phase-1-clinical

stock price
Monday, May 11 (close) - 8.36
Monday, May 17 (close) - 13.66
+63%

Aquestive Therapeutics (AQST)
October 25, 2021 at 8:33am ET

Reports Positive Topline Data from Phase 1

stock price
Monday, Oct 25 (close) - 4.67
Monday, Nov 1 (close) - 5.24
+12%

Edgewise Therapeutics Inc (EWTX)
October 28, 2021 at 6:00am ET

Announces Positive Topline Results from Phase 1
https://investors.edgewisetx.com/news/news-details/2021/Edgewise-Therapeutics-Announces-Positive-Topline-Results-from-the-EDG-5506-Phase-1-Multiple-Ascending-Dose-MAD-Study-in-Healthy-Volunteers-HVs-and-Doses-First-Becker-Muscular-Dystrophy-BMD-Patients/default.aspx

stock price
Thursday, Oct 28 (close) - 16.02
Thursday, Nov 4 (close) - 19.58
+22%

these examples aren’t a direct comparison since they’re different drugs, companies, etc. but it does give us an idea that past positive topline data results has a positive impact on the stock price.

INSIDER BUYING
Ault Milton purchased in the open market over 3.7 million shares ranging in share price from $1.52 to $9.22 from June 2021 to as recently as Nov 2021.
in contrast, there was minimal selling by insiders (Ault Milton sould 1600 shares between the above mentioned period).

in case you were wondering, Ault Milton is the founder of the company and the chairman of the board. i find it a bullish sign when the leaders of the company are buying up shares vs shedding them (looking at you PLTR).

https://alzamend.com/profile/milton-todd-ault-chairman/

MY POSITIONS
i have ALZN 5c for Jan 21 at an average cost of $0.24.

TLDR
ALZN is due to release their Phase 1 Topline data for their Alzheimer drug in mid to late December of this year. i believe with positive results, the stock will run up. as of this writing, the stock has been on a bullish trend. i believe this is a run up in anticipation of the results. find a good entry and wait for the good news.

as always, biopharm/tech plays are highly speculative. the bearish case is that their topline data isn’t positive and the stock price tanks because of it. it’s also very possible that even with positive results, the stock price doesn’t move up at all.

good luck all!

1 Like

this is a pretty good article on ALZN. i know the stock is taking a beating today but the catalyst and thesis is still on. the topline data from phase 1 is still expected any time now til the end of Dec.

the positive topline data for phase 1 announcement came this morning in PM (around 9am).

https://www.businesswire.com/news/home/20211217005145/en/Alzamend-Neuro-Announces-Positive-Topline-Data-from-Phase-1-First-in-Human-Clinical-Trial-for-AL001-Treatment-of-Dementia-Related-to-Alzheimer’s

as of 10 minutes into the trading day, it’s up around 18%. if you got Jan calls, you should be green. i’m taking some profit (half my contracts) and letting some ride into next week as i think there’s going to be room for it to go once the news hits mainstream outlets.

the part in their press release where they state they might be able to reduce or eliminate phase 2/3 is really bullish:

good luck and take profit!