Kamis, 29 Mei 2025

Breaking Now: (ALZN) Makes An Approx. 146% Overnight Move On Phase II News

*Sponsored by Alzamend Neuro, Inc.

Krypton Street Initiates Coverage On Alzamend Neuro, Inc. (Nasdaq: ALZN) Starting This Morning—Thursday, May 29, 2025

Ultra-Low Float Structure Could Set The Stage For Significant Swing Potential If Demand Begins To Shift.

Recent Research Coverage Could Bring Additional Visibility To (ALZN)'s Clinical Focus.

Phase II Trial Enrollment Has Begun For AL001 vs lithium carbonate In A Head-To-Head Comparison Study. .

(ALZN) Is Advancing Trials Across Four Major Neurological Conditions With Broad Impact.

Combined Target Areas Are Projected To Surpass $120B In Global Market Size By 2034.

Take A Look At (ALZN) While It's Still Early…

May 29, 2025

Thursday's Watchlist: (ALZN) is Lighting Up Our Radar This Morning

Dear Reader,

This morning, Alzamend Neuro (Nasdaq: ALZN) reached $8.18 in the early session, marking an approximate 146% overnight move from yesterday's $3.32 close—just as the company confirmed the first patient was dosed in its Phase II clinical trial of AL001 at Massachusetts General Hospital.

The study pits AL001 head-to-head against standard lithium carbonate to test brain vs. blood absorption—aiming to minimize side effects while enhancing central nervous system delivery.

With topline data expected by year-end, and preclinical models showing lower systemic lithium levels with greater brain targeting, AL001 could reshape how lithium-based therapies are deployed for Alzheimer's, Bipolar Disorder ("BD"), Post-traumatic Stress Disorder ("PTSD"), and Major Depressive Disorder ("MDD").

If you missed my note from around 8:00 AM EST this morning, keep reading to see why we're so excited to bring you (ALZN) right now.

Something is happening deep inside one of the most challenging frontiers in medicine—and almost no one is talking about it yet.

A new brain-targeted therapeutic is currently undergoing a pivotal Phase II study, and the results could pave the way to becoming a blockbuster dr-ugs with a massive addressable market!

Early-stage momentum is quietly taking shape, but the anticipated year-end data is already drawing significant attention.

That's why Alzamend Neuro, Inc. (Nasdaq: ALZN) is lighting up our radar as the next potential breakout idea.

In early March of 2025, Edward Woo, CFA of Ascendiant Capital Markets, issued a $20 target on (ALZN) when it was trending around $0.68—a figure that suggested more than 2,800% upside at the time.

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Then on May 8, the company announced a reverse-split that reduced its issued and outstanding shares to under 801,000.

With approximately 770,000 shares now listed as available to the public, (ALZN) has entered what can only be described as an ultra-low float scenario—where even modest shifts in demand could produce outsized moves.

From the outside, it may look like Alzamend Neuro, Inc. (Nasdaq: ALZN) has only recently stepped into the spotlight.

But behind the scenes, this clinical-stage biopharmaceutical company has spent years preparing a quietly radical shift in how the brain may one day be treated—and possibly protected—across multiple major neurodegenerative diseases and psychiatric disorders.

Its lead therapeutic, AL001, is already drawing increased attention after clearing a Phase IIA clinical trial in Alzheimer's patients.

And with fivePhase II trials lined up across healthy human subjects and patients afflicted with Alzheimer's, Bipolar Disorder ("BD"), Post-traumatic Stress Disorder ("PTSD"), and Major Depressive Disorder ("MDD")—all tied to a U.S. patient population exceeding 43M—the setup could now be too large to ignore.

Forecasts show consistent growth across each of these therapeutic areas:

  • The Alzheimer's therapeutics market is projected to grow approximately 111%, expanding from $5.7B in 2025 to $12.07B by 2034.
  • The bipolar disorder treatment market is forecasted to grow about 60%, from $9.74B to $15.67B over the same time frame.
  • PTSD therapies are expected to grow roughly 44%, rising from $2.37B in 2025 to around $3.42B by 2034.
  • And the global Major Depressive Disorder market is forecasted to grow around 96%, from $47.6B in 2025 to approximately $93.65B by 2032.

Against this backdrop of rising need and expanding markets, Alzamend Neuro, Inc. (Nasdaq: ALZN) is now positioning itself to become a serious contender in multiple verticals—all through a single platform.

The Lithium You Know—Reengineered for the Brain

AL001 isn't just another lithium therapy. It's a patented ionic cocrystal combining lithium, proline, and salicylate—engineered to deliver the benefits of lithium carbonate without the harsh safety tradeoffs.

Where traditional lithium treatments come with a narrow therapeutic window, side effects, and a strict need for monitoring, AL001 has now shown in both Phase I and IIA trials to:

  • Demonstrated a bioequivalence of 300 mg lithium carbonate using just 150mg of lithium-equivalent
  • Exhibit brain-penetrating behavior without producing lithium spikes tied to toxic reactions
  • Achieve steady-state lithium levels while potentially eliminating the need for routine blood monitoring

What the Trial Results Just Confirmed

In its most recent Phase IIA study, AL001 was tested in both healthy adults and Alzheimer's patients. The findings—reported October 2024—confirmed the maximum tolerated dose, with no serious adverse events recorded and plasma lithium levels holding within a target range.

More notably, a 240 mg equivalent dose of AL001 was shown to safely reduce the overall lithium exposure while delivering more of it to the brain. This may lead to better outcomes with fewer systemic risks.

The company has also confirmed that its formulation could be eligible for the FDA's streamlined 505(b)(2) pathway—potentially accelerating the regulatory timeline.

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What's Ahead in 2025

On the company's latest internal update (referenced in the Phase IIA data report), executives outlined a clear roadmap for 2025:

  • FivePhase II clinical trials—targeting Alzheimer's, BD MDD, and PTSD—are expected to initiate this year.
  • All will use the newly confirmed dosage framework from the October 2024 study.
  • Massachusetts General Hospital is the partner and trial site for the 5 Phase II clinical studies

For a company with a 2021 IPO and early licensing ties to the University of South Florida Research Foundation, this marks a decisive evolution from platform development to clinical execution.

Early-Stage Momentum Is Quietly Taking Shape, But The Anticipated Year-End Data Is Already Drawing Significant Attention.

On May 19, 2025, (ALZN) announced the first patient enrollment in its Phase II trial evaluating AL001 in healthy subjects—conducted with Massachusetts General Hospital using a specialized MRI coil developed with Tesla Dynamic Coils.

This head-to-head study compares AL001 to a marketed lithium product, measuring how each distributes in brain regions tied to mood and cognition.

The aim is to confirm that AL001 delivers targeted brain absorption with lower systemic exposure—potentially reducing the need for routine monitoring.

Topline data is expected by year-end, with results informing (ALZN)'s next steps across Alzheimer's, BD, MDD, and PTSD.

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Behind the Scenes: The Coil That Could Redefine Lithium Monitoring…

As Alzamend prepares for Phase II trials, a first-of-its-kind MRI coil—developed with Tesla Dynamic Coils and Massachusetts General Hospital—may redefine how lithium delivery is measured in the brain.

Unlike traditional blood tests, this device noninvasively tracks lithium levels in key brain regions tied to cognition and mood. It will play a central role in ALZN's upcoming crossover study comparing AL001 to a marketed lithium product, helping researchers assess brain absorption in real time.

Designed to bring greater precision to future dosing strategies, this technology could open the door to more personalized, safer lithium-based care.

Where It's Going Next…

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Beyond AL001, Alzamend is also advancing ALZN002—a next-generation Alzheimer's vaccine designed to train the immune system to identify and attack beta-amyloid plaque, without relying on foreign antibodies.

Its Phase I/IIA trial was initiated in March 2023 and is expected to resume in 2025, following a strategic pause.

Unlike traditional approaches, ALZN002 is adjuvant-free and has shown the ability to create long-lasting antibody responses in preclinical models—with no inflammation spikes.

With two clinical candidates in motion and several high-impact developments converging at once, momentum behind (ALZN) is starting to accelerate.

Here's why we'll be watching this one closely when the bell rings tomorrow:

7 Reasons Why (ALZN) Just Hit Our Radar This Morning…

1. Ultra-Low Float: With just 770,000 shares listed as publicly available, (ALZN) is now operating in an ultra-tight float environment where any shift in demand has the potential to showcase significant swings.

2. Analyst Coverage: In early March, Ascendiant Capital Markets released research coverage on (ALZN), bringing added visibility to the company's therapeutic focus and upcoming clinical milestones.

3. Trial Momentum Building: A head-to-head Phase II trial—comparing AL001 with a marketed lithium carbonate product—recently began enrolling participants under the direction of (ALZN), with topline data expected by year-end.

4. Multiple Indications Active: Across Alzheimer's, BD, PTSD, and MDD, (ALZN) is currently advancing clinical work tied to conditions impacting over 43M people in the U.S. alone.

5. Market Growth Potential: In therapeutic areas projected to exceed a combined $120B in market size over the next decade, (ALZN) is positioned at the center of several high-growth treatment categories.

6. Disruptive Delivery Platform: A novel approach to lithium formulation is now being developed by (ALZN) through AL001—engineered for improved brain targeting and potentially reduced need for routine monitoring.

7. Diagnostic Advantage Emerging: Through its collaboration with Tesla Dynamic Coils and Massachusetts General Hospital, (ALZN) is deploying a new MRI-based tool that may allow real-time brain-level tracking of lithium concentration.

With all of that now in motion, the setup heading into tomorrow's session is impossible to ignore.

Momentum is building—and timing could matter.

Pull Up (ALZN) While It's Still Early…

With clinical momentum accelerating, a precision-targeted therapeutic entering Phase II testing, and a float structure that leaves little room for complacency, Alzamend Neuro, Inc. (Nasdaq: ALZN) is now front and center on our watchlist.

We have all eyes on (ALZN) this morning.

Be sure to take a closer look at (ALZN) while it's still early.

(ALZN) reached $8.18 in the early session, marking an approximate 146% overnight move from yesterday's $3.32 close

Also, watch for my next update—it could be on its way to you any moment.

Sincerely,

Alex Ramsay

Co-Founder / Managing Editor

Krypton Street Newsletter

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Pursuant to an agreement between Media 1717 LLC and TD Media LLC, Media 1717 LLC has been hired for a period beginning on 05/29/2025 and ending on 05/29/2025 to publicly disseminate information about (ALZN:US) via digital communications. Under this agreement, Media 1717 LLC has been paid seven thousand five hundred USD ("Funds"). These Funds were part of the funds that TD Media LLC received from Alzamend Neuro Inc., the issuer of (ALZN:US).

Neither Media 1717 LLC, TD Media LLC and their member own shares of (ALZN:US).

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