Alzamend Neuro Initiates Phase II Clinical Trial of AL001 "Lithium in Brain" Study in Patients with Bipolar Disorder in Collaboration with Massachusetts General Hospital

Alzamend Neuro (Nasdaq: ALZN) initiated a Phase II crossover trial of AL001 in bipolar disorder type 1 at Massachusetts General Hospital to compare brain and blood lithium pharmacokinetics versus lithium carbonate.

Rhea-AI Summary

Alzamend Neuro (Nasdaq: ALZN) initiated a Phase II crossover trial of AL001 in bipolar disorder type 1 at Massachusetts General Hospital to compare brain and blood lithium pharmacokinetics versus lithium carbonate. Topline BD data are expected in Q3 2026; healthy-subject imaging topline data expected end-March 2026.

The study uses 14-day TID dosing periods, a 14-day washout, intensive 24-hour PK sampling with MRI/MRS lithium imaging, and an engineered head coil; the selected MTD equals a lithium carbonate equivalent of 240 mg TID.

Positive

• Phase II trial initiated at Massachusetts General Hospital
• Study includes advanced MRI/MRS whole-brain lithium imaging
• Selected MTD of 240 mg TID designed to limit plasma lithium exposure

Negative

• No efficacy or clinical outcome data yet; BD topline expected Q3 2026
• Healthy-subject imaging topline pending by end of March 2026

Argus Mar 16 session

+2.94% close to close Open Argus

Details

News Market Reaction – ALZN

On Mar 16, the day this news came out, ALZN closed 2.94% above the previous close.

Data tracked by StockTitan Argus for the Mar 16 session.

Key Figures

Net loss (quarter): $2.2 million Net loss (nine months): $5.9 million Cash balance: $2.7 million +5 more

Net loss (quarter)

$2.2 million

Quarter ended January 31, 2026

Net loss (nine months)

$5.9 million

Nine months ended January 31, 2026

Cash balance

$2.7 million

As of January 31, 2026

Working capital

$1.8 million

As of January 31, 2026

ATM equity program size

$3.0 million

At-the-market common stock offering

Shares outstanding

3,804,741 shares

As of March 6, 2026 prospectus supplement

AL001 MTD dose

240 mg TID

Lithium carbonate equivalent maximum tolerated dose

Americans potentially affected

Over 43 million

BD, other neuropsychiatric and neurodegenerative conditions

Previous Partnership,clinical trial Reports

4 past events · Latest: Aug 19

Same Type 4 events

1. Aug 19

   PTSD Phase II partnership

   24h Move

   +186.8%

   Announced AL001 Phase II PTSD trial collaboration with Massachusetts General Hospital.

2. Aug 12

   MDD Phase II partnership

   24h Move

   +3.0%

   Detailed AL001 Phase II MDD trial with MGH, targeting safer lithium delivery.

3. Aug 06

   Bipolar Phase II partnership

   24h Move

   -9.8%

   Outlined AL001 Phase II bipolar trial design and lithium dosing strategy with MGH.

4. Aug 05

   Alzheimer’s Phase II partnership

   24h Move

   -22.1%

   Announced AL001 Phase II Alzheimer’s study with MGH assessing brain lithium levels.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pharmacokinetics, magnetic resonance imaging, magnetic resonance spectroscopy, therapeutic drug monitoring, +4 more

8 terms

pharmacokinetics medical

"will compare lithium blood and brain/brain-structure pharmacokinetics in bipolar disorder"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

magnetic resonance imaging medical

"in conjunction with advanced magnetic resonance imaging ("MRI") and magnetic resonance"

Magnetic resonance imaging (MRI) is a medical scan that uses strong magnets and radio waves to make detailed pictures of the inside of the body without X-rays or surgery. For investors, MRI matters because the machines, software, maintenance, and scan services represent steady capital spending and revenue streams for equipment makers, hospitals and imaging centers; advances or wider adoption can change market size, pricing power and competitive dynamics much like a camera upgrade transforms picture quality and demand.

magnetic resonance spectroscopy medical

"magnetic resonance imaging ("MRI") and magnetic resonance spectroscopy ("MRS") neuroimaging"

Magnetic resonance spectroscopy is a noninvasive imaging technique that uses the same physics as MRI to measure the chemical makeup of tissues, producing a “fingerprint” of molecules such as metabolites instead of detailed anatomical pictures. Investors care because this biochemical information can serve as a diagnostic marker, a drug-development endpoint, or a regulatory biomarker—helping assess clinical value, shorten trials, and guide commercial potential for medical products.

therapeutic drug monitoring medical

"the need for regular therapeutic drug monitoring ("TDM") to mitigate risks"

Therapeutic drug monitoring is the routine measurement of a medicine’s level in a patient’s blood to make sure the dose is high enough to work but low enough to avoid harmful side effects. Investors should care because monitoring can shape how widely a drug is used, influence the need for accompanying tests or devices, affect regulatory approval or labeling, and alter long-term sales and liability risks—like using a thermostat to keep a room at the right temperature for reliable performance.

maximum tolerated dose medical

"the selected maximum tolerated dose ("MTD") for further development was determined"

Maximum tolerated dose is the highest amount of a substance, such as a medication or chemical, that can be used without causing unacceptable side effects or harm. It’s like finding the maximum speed you can drive without risking a ticket or accident. For investors, understanding this concept helps gauge how much risk or exposure is safe or sustainable in a given situation.

Phase II clinical trial medical

"announced the initiation of its Phase II clinical trial evaluating AL001 in patients"

A Phase II clinical trial is a mid-stage study in humans that tests whether an experimental drug or treatment actually works and what dose is effective, typically involving dozens to a few hundred patients and often comparing outcomes to a placebo or standard care. For investors, Phase II results are a major inflection point: clear positive data can substantially increase the odds of later regulatory approval and company value, while negative or uncertain results raise development risk and can sharply reduce expectations—like a detailed test drive after basic safety checks.

crossover design medical

"The study will utilize a crossover design intended for multiple six-subject cohorts."

A crossover design is a clinical trial setup where each participant receives two or more treatments one after the other, with a break between them, so the same person serves as their own comparison. Think of it like trying two recipes in the same kitchen to judge which is better. For investors, this matters because it can make results clearer with fewer participants and faster readouts, but it can also be inappropriate for long‑lasting effects, which affects how reliable the efficacy and safety data will be for regulatory and commercial decisions.

biomarker medical

"metabolism, and biomarker effects."

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• Head-to-head studies of AL001 versus marketed lithium carbonate will compare lithium blood and brain/brain-structure pharmacokinetics in bipolar disorder type 1 patients
• Topline data expected in third quarter of 2026
• Topline data from the clinically completed "lithium in brain" imaging study in healthy subjects expected by the end of March 2026

ATLANTA, March 16, 2026 /PRNewswire/ -- Alzamend Neuro, Inc. (Nasdaq: ALZN) ("Alzamend"), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease ("Alzheimer's"), bipolar disorder ("BD"), major depressive disorder ("MDD") and post-traumatic stress disorder ("PTSD"), today announced the initiation of its Phase II clinical trial evaluating AL001 in patients diagnosed with BD type 1. The trial is being conducted at Massachusetts General Hospital ("MGH") and represents a significant step toward advancement of AL001 as a potentially safer and more effective lithium-based therapy.

This Phase II study builds upon Alzamend's prior "Lithium in Brain" clinical trial in healthy subjects, for which the clinical portion was completed in November 2025. Topline data from that study are expected by the end of March 2026. Following completion in healthy volunteers, Alzamend and MGH are now expanding the program to subjects with BD type I, with plans to also initiate further trials in the near future in MDD, Alzheimer's and PTSD.

The study will utilize a crossover design intended for multiple six-subject cohorts. Following screening, participants are randomized into one of two treatment sequences: AB (AL001 followed by lithium carbonate) or BA (lithium carbonate followed by AL001). Each treatment period consists of 14 days of 3-times daily ("TID") dosing. A washout period of 14 days is planned between treatment periods.

During days 14 and 15 of each treatment period, participants undergo intensive 24-hour lithium pharmacokinetic blood sampling in conjunction with advanced magnetic resonance imaging ("MRI") and magnetic resonance spectroscopy ("MRS") neuroimaging. The MRI and MRS neuroimaging methods were developed by the lab of Dr. Ovidiu Andronesi, the study's principal investigator, Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging, Martinos Center for Biomedical Imaging, Department of Radiology, MGH, Harvard Medical School. The study also incorporates a specialized, engineered head coil developed by Tesla Dynamic Coils BV, designed to enable high-resolution, whole-brain lithium imaging. This approach enables simultaneous quantification of lithium concentrations in blood and brain including individual structures, as well as assessment of brain and individual brain structure chemistry, metabolism, and biomarker effects.

The BD study specifically evaluates AL001's ability to enhance lithium delivery to targeted brain regions while reducing systemic exposure - an approach designed to address the long-standing safety and tolerability limitations associated with traditional lithium salts. Although lithium has remained the gold standard treatment for BD for more than 35 years, its clinical utility is constrained by a narrow therapeutic window and the need for regular therapeutic drug monitoring ("TDM") to mitigate risks of renal, thyroid, and other systemic toxicity.

In prior non-clinical studies, AL001 demonstrated higher lithium concentrations in brain tissue at lower doses compared to lithium carbonate. Alzamend's Phase IIA multiple-ascending dose study further evaluated safety and tolerability under steady-state conditions in patients with mild to moderate Alzheimer's and in healthy adult and elderly subjects with adequate renal function. AL001 was well tolerated across all dose levels, and the selected maximum tolerated dose ("MTD") for further development was determined based on maintaining plasma lithium levels below those associated in the medical literature with potential toxicity.

The MTD as assessed by an independent safety review committee, provided AL001's lithium at a lithium carbonate equivalent dose of 240 mg TID. This dose was selected to maintain plasma lithium concentrations below levels commonly associated with toxicity and is designed to be unlikely to require routine lithium TDM. Importantly, the selected MTD is risk-mitigated for use in fragile populations, including Alzheimer's patients.

Alzamend's goal is to find a way to get lithium into the right parts of the brain while keeping the amount in the rest of the body lower, which could reduce the risk of side effects. This approach is being studied for BD, MDDD, Alzheimer's and PTSD.

"The initiation of this Phase II trial in patients with BD marks a pivotal milestone for Alzamend," said Stephan Jackman, Chief Executive Officer of Alzamend. "Our goal with AL001 is to optimize brain lithium delivery while reducing systemic exposure and potentially eliminating the need for burdensome TDM. If successful, AL001 could meaningfully improve treatment outcomes for over 43 million Americans living with BD, other neuropsychiatric conditions, and neurodegenerative diseases."

About AL001

AL001 is a novel lithium-delivery system that has the potential to provide the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend's completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer's patients and healthy subjects identified an MTD, as assessed by an independent safety review committee. This MTD is designed to be unlikely to require TDM while providing lithium at a relatively modest but effective dose. AL001 is designed to favorably distribute lithium in the brain resulting in lower exposure of other body organs and an improved safety profile compared to currently marketed lithium salts. This can serve to mitigate or obviate the disadvantageously low ceiling for toxicity of marketed lithium salts that has limited their usefulness to patients and prescribers.

About Alzamend Neuro

Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate and L-proline, and ALZN002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient's immunological system to combat Alzheimer's by removing beta-amyloid from the brain. The latter is a second-generation active-immunity approach designed to mitigate the disadvantages of approved passive immunity marketed antibody products, particularly by reducing the required frequency and costs of dosing associated with antibody products. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes," "plans," "anticipates," "projects," "estimates," "expects," "intends," "strategy," "future," "opportunity," "may," "will," "should," "could," "potential," or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend's business and financial results are included in Alzamend's filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend's website at https://www.Alzamend.com.

 

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SOURCE Alzamend Neuro, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is the design of Alzamend's AL001 Phase II bipolar disorder trial (ALZN)?

The trial uses a crossover AB/BA design with multiple six-subject cohorts and 14-day TID dosing periods. According to Alzamend, each treatment period includes 24-hour PK sampling plus MRI/MRS imaging with a 14-day washout between periods.

When does Alzamend (ALZN) expect topline data from the bipolar disorder Phase II study?

Topline data for the bipolar disorder Phase II study are expected in the third quarter of 2026. According to Alzamend, the Q3 2026 timing applies to the BD patient cohort evaluation.

What imaging methods will Alzamend use to compare AL001 with lithium carbonate (ALZN)?

AL001 will be compared using advanced MRI and MRS lithium neuroimaging together with a specialized head coil. According to Alzamend, this enables simultaneous quantification of lithium in blood and individual brain structures.

What is the selected maximum tolerated dose (MTD) for AL001 reported by Alzamend (ALZN)?

The selected MTD provides AL001 at a lithium carbonate equivalent of 240 mg TID. According to Alzamend, the MTD was chosen to keep plasma lithium below levels commonly associated with toxicity.

Has Alzamend completed prior AL001 clinical studies before the Phase II BD trial (ALZN)?

Yes. The clinical portion of the healthy-subject "lithium in brain" imaging study was completed in November 2025. According to Alzamend, topline imaging results from that study are expected by end-March 2026.

How could AL001 potentially change lithium treatment for bipolar disorder (ALZN)?

AL001 aims to enhance lithium delivery to targeted brain regions while reducing systemic exposure and routine TDM need. According to Alzamend, this approach targets improved tolerability versus traditional lithium salts.