Alzamend Neuro Inc (ALZN)

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Alzamend Neuro Reports Encouraging Pharmacodynamic Data from Phase II Clinical Trial of AL001 "Lithium in Brain" Study in a Trial Conducted at Massachusetts General HospitalApril 7, 2026 8:00 AM
PR Newswire (US)

Potentially Distinct Brain Profile: Across multiple brain regions, AL001 and lithium carbonate appeared to trend in opposite directions in brain chemistry measures, suggesting that AL001 may interact with the brain in a distinct manner and generate a lower neurochemical footprint than lithium carbonateExpected Trends for Myo-Inositol Reduction: Both AL001 and lithium carbonate showed a trend toward reducing myo-inositol, potentially supporting the hypothesis that AL001 retains lithium's core mechanism of actionPotentially Preserved Glutamate Balance: Lithium carbonate showed large effects across all brain regions whereas AL001 showed minimal glutamate effect in most brain regions, which may suggest better long-term tolerabilityATLANTA, April 7, 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 type 1 ("BD"), major depressive disorder ("MDD") and post-traumatic stress disorder ("PTSD"), today announced encouraging pharmacodynamic findings from a brain magnetic resonance spectroscopy ("MRS") analysis conducted in healthy human subjects (N=6) in a trial conducted at Massachusetts General Hospital. The study assessed changes in five key brain metabolites across 18 brain regions when participants received two-weeks of blood bioequivalent and lithium-dose equivalent AL001 or lithium carbonate relative to baseline. Early data suggest AL001 may work like lithium carbonate by selectively impacting brain chemicals where needed, however, AL001 appears to be leaving other, healthy brain chemicals more undisturbed than lithium carbonate, a potentially meaningful tolerability advantage. These interpretations are based solely on qualitative review of all analyses and need to be further statistically confirmed in additional patient populations, the first of which is currently underway.







Pharmacodynamic MRS Preliminary FindingsPotential Distinct Neurochemical Footprint: When participants took AL001, multiple brain chemicals trended downward, while the same chemicals trended upward in those same participants when they took lithium carbonate. This suggests that AL001 may interact with the brain in a distinct manner and have a less disruptive effect on healthy brain tissue than lithium carbonate.Trends Towards Myo-Inositol Reduction: Both AL001 and lithium carbonate reduced levels of a key brain chemical called myo-inositol - which is exactly what lithium-based treatments are supposed to do. Notably, AL001 affected this target in nearly twice as many brain regions (17 out of 18) as lithium carbonate (8 out of 18), suggesting AL001 may deliver lithium's intended benefits more broadly throughout the brain.Potentially Preserved Glutamate Homeostasis: Glutamate, a key chemical messenger in the brain, was largely undisturbed in 10 of the 18 brain regions of patients after two-weeks of AL001, while two-weeks of lithium carbonate seemed to have caused disruptions to glutamate levels across every brain region measured. Keeping glutamate stable is important for long-term brain health, which suggests AL001 may have fewer side effects than lithium carbonate over time, however, this needs confirmation over a longer duration of exposure."Lithium carbonate has been a cornerstone of psychiatric treatment for over 55 years, but its harsh side effect profile has always limited how widely and how long it can be used," said Stephan Jackman, Chief Executive Officer of Alzamend. "These findings suggest AL001 may finally change that equation, delivering what lithium does best, without much of what makes it difficult to tolerate. That is a potential game changer for 43+ Million Americans living with BD, Alzheimer's, MDD and PTSD. We are seeking to confirm these findings in larger, adequately powered studies."Hypotheses Generated for Future Confirmatory StudiesBased on these initial findings, Alzamend has identified the following pharmacodynamic hypotheses to be tested in future confirmatory studies involving subjects with Alzheimer's, BD, MDD and PTSD:AL001 causes less disruption to healthy brain tissue than lithium carbonate, potentially resulting in fewer side effects and better long-term tolerability;AL001 produces the same beneficial brain response that makes lithium an effective treatment, by reducing a key brain chemical, myo-inositol, suggesting it works through the same proven mechanism of action as lithium carbonate, just with a potentially better safety profile;AL001 appears to leave glutamate levels in healthy brain tissue largely undisturbed, a potentially important advantage over lithium carbonate, which appears to disrupt glutamate broadly. Stable glutamate levels in healthy tissue may mean fewer cognitive side effects and better long-term tolerability for patients; andUnlike lithium carbonate, AL001 may help preserve the health of brain cell membranes in healthy tissue, the protective outer layer of brain cells that play a critical role in how they function and communicate. If confirmed, this could mean AL001 is better tolerated by patients over the long-term than lithium carbonate.AL001: A Differentiated Lithium Therapy for a Large Unmet NeedAlthough lithium has remained the gold standard treatment for bipolar disorder for more than 55 years, its clinical utility is constrained by a narrow therapeutic window and the need for regular therapeutic drug monitoring to manage renal, thyroid, and other systemic toxicity risks. AL001 is Alzamend's patented ionic cocrystal formulation of lithium combined for delivery with L-proline and salicylate, which is designed to deliver a full therapeutic amount of lithium to the brain with less systemic exposure than lithium carbonate, potentially enabling a safer, better-tolerated therapy across Alzheimer's, BD, MDD and PTSD.About this StudyBrain metabolite concentrations were assessed using ultra-high field high-resolution magnetic resonance spectroscopic imaging (MRSI) in six healthy volunteers following blood-bioequivalent and lithium-dose equivalent 14-day multiple doses of AL001 and lithium carbonate treatments in a randomized, crossover design across 18 brain regions. The five metabolites analyzed were: total creatine (Cr+PCr), glutamate (Glu), glycerophosphocholine plus phosphocholine (GPC+PCh), myo-inositol (Ins), and N-acetylaspartate plus N-acetylaspartylglutamate (NAA+NAAG). Statistical analyses used the Wilcoxon signed-rank test and Hedges' g effect-size measure, with a pre-specified ≥20% absolute threshold to screen for pharmacodynamically relevant signals. The MRS neuroimaging methodology was developed by the lab of Dr. Ovidiu C. Andronesi, the study's principal investigator, Associate Professor of Radiology at Harvard University, and the Director of Multinuclear MR Imaging, Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School. All findings are exploratory, hypothesis-generating, and require confirmation in adequately powered studies.About Alzamend NeuroAlzamend is a clinical-stage biopharmaceutical company developing novel therapies for 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 delivering lithium with salicylate and L-proline designed to improve brain delivery and safety compared to conventional lithium, and ALZN002, a patented cell-based therapeutic vaccine designed to restore the immune system's ability to clear Alzheimer's beta-amyloid. The latter is a next-generation active-immunity approach offering potential advantages in dosing frequency and cost compared to approved passive-immunity antibody therapies. Both candidates are exclusively licensed from the University of South Florida Research Foundation under royalty-bearing worldwide licenses.Forward-Looking StatementsThis 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 www.Alzamend.com.














View original content to download multimedia:https://www.prnewswire.com/news-releases/alzamend-neuro-reports-encouraging-pharmacodynamic-data-from-phase-ii-clinical-trial-of-al001-lithium-in-brain-study-in-a-trial-conducted-at-massachusetts-general-hospital-302735711.htmlSOURCE Alzamend Neuro, Inc.

Original: Alzamend Neuro Reports Encouraging Pharmacodynamic Data from Phase II Clinical Trial of AL001 "Lithium in Brain" Study in a Trial Conducted at Massachusetts General Hospital

Alzamend Neuro Reports Positive Topline Data from Phase II Clinical Trial of AL001 "Lithium in Brain" Study; AL001 Achieves Bioequivalence and Demonstrates Superior Brain Delivery Across All Measured Brain RegionsMarch 26, 2026 8:00 AM
PR Newswire (US)

Bioequivalence Confirmed: AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium levels vs. standard lithium carbonateSuperior Brain Penetration: AL001 showed numerically higher lithium concentrations in all measured brain regions, including whole brainFaster Brain Uptake: AL001 reached peak brain concentration in 6.7 hours vs. 8.4 hours for standard lithium carbonateATLANTA, March 26, 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 type 1 ("BD"), major depressive disorder ("MDD") and post-traumatic stress disorder ("PTSD"), today announced positive topline data from its first Phase II "Lithium in Brain" clinical trial in healthy human subjects, demonstrating that AL001 meets bioequivalence standards while also showing numerically superior lithium delivery to the brain compared to standard lithium carbonate across all 26 measured brain regions including whole brain. These results suggest a promising differentiated pharmacological profile with significant implications for patients with Alzheimer's, BD, MDD and PTSD. The trial was conducted at Massachusetts General Hospital ("MGH") and represents a meaningful clinical and regulatory advance for AL001.







Phase II Topline ResultsAL001 Achieves Bioequivalence with Standard Lithium Carbonate:The U.S. Food and Drug Administration (the "FDA") requires a new formulation to deliver between 80% to 125% of the reference drug to the bloodstream to support equivalent systemic safety. AL001 delivered 101% of total lithium exposure and 97% of peak lithium levels compared to standard lithium carbonate, which are both squarely within the required FDA range. Achieving bioequivalence supports a Section 505(b)2 new drug application submission for safety, potentially mitigating non-clinical requirements.Superior Brain Penetration Across all 26 Measured Regions, Including Whole Brain:Using a one-of-a-kind Tesla head coil that provides advanced magnetic resonance imaging ("MRI") and magnetic resonance spectroscopy ("MRS") neuroimaging, researchers quantified lithium in 25 discrete brain regions as well as the whole brain. AL001 showed numerically higher lithium concentrations in every single region vs. standard lithium carbonate, including the hippocampus (memory), entorhinal cortex (early Alzheimer's target), cingulate gyrus (cognition), amygdala and accumbens regions. Maximum whole-brain lithium exposure increased ~7.8% for AL001 compared to lithium carbonate. A consistent directional increase across all measured brain regions is a compelling signal, and confirmation is already underway; the second of five planned Phase II trials, enrolling a total of 30 patients across the full program, is already underway at MGH.Faster Brain Uptake Results in Earlier Peak Concentration:AL001 achieved peak brain lithium concentrations at 6.7 hours compared to 8.4 hours for standard lithium carbonate, resulting in a potential ~1.7-hour advantage. Faster brain uptake could have meaningful implications for therapeutic onset and dosing optimization, which will be evaluated in subsequent studies.Second Phase II Clinical Trial Already Underway at MGH:In this first study, brain tissue measurements were conducted in six subjects per arm, which is a sample size that produces directionally meaningful, but not yet statistically definitive, results. The ~7.8% whole-brain lithium trend is worthy of further investigation. To that end, Alzamend has initiated its second Phase II "Lithium in Brain" clinical trial at MGH, this time in patients with BD, with topline data expected in the third quarter of 2026. The third, fourth, and fifth studies in the program enrolling patients with MDD, PTSD and Alzheimer's, respectively, are anticipated to begin in the latter half of 2026, subject to raising sufficient capital. Alzamend believes that results across all five studies, totaling 30 patients, will be adequate to establish statistical significance and advance AL001 toward further regulatory milestones."These data mark a pivotal advancement in the development of AL001," said Stephan Jackman, CEO of Alzamend. "We have clinical evidence that AL001 shows equivalent delivery of lithium in the bloodstream compared to standard lithium carbonate capsules, which is a key regulatory safety measure. And the brain data, while preliminary, show a consistent increase providing higher lithium in every brain region we measured. This can permit lower systemic doses to achieve efficacy thereby providing an enhanced safety profile. Combined with the faster brain uptake, we believe AL001 has a meaningfully differentiated profile compared to conventional lithium; one that could benefit the 43+ million Americans afflicted with Alzheimer's, BD, MDD and PTSD."AL001: A Differentiated Lithium Therapy for a Large Unmet NeedAlthough lithium has remained the gold standard treatment for BD for more than 55 years, its clinical utility is constrained by a narrow therapeutic window and the need for regular therapeutic drug monitoring ("TDM") to manage renal, thyroid, and other systemic toxicity risks. AL001 is Alzamend's patented ionic cocrystal formulation of lithium combined for delivery with L-proline and salicylate, which is designed to deliver a full therapeutic amount of lithium to the brain with less systemic exposure than lithium carbonate, potentially enabling a safer, better-tolerated therapy across Alzheimer's, BD, MDD and PTSD.About this StudyThe study employed a randomized crossover design with multiple six-subject cohorts. Participants were assigned to one of two sequences: AB (AL001 then lithium carbonate) or BA (lithium carbonate then AL001). Each treatment period consisted of 14 days of three-times-daily ("TID") dosing, separated by a 14-day washout.On Days 14–15, participants underwent 24-hour pharmacokinetic blood sampling alongside advanced MRI and MRS neuroimaging, a first-of-its-kind methodology. 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 incorporated a specialized, engineered head coil developed by Tesla Dynamic Coils BV, designed to enable high-resolution, whole-brain lithium imaging. This approach enabled 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 study specifically evaluated 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. The results from the study confirmed that AL001 matches blood levels of standard lithium carbonate, the reference drug, addressing FDA regulatory requirements for a new drug formulation, as well as providing a differentiated, potential dose-sparing benefit profile for patients.About Alzamend Neuro Alzamend is a clinical-stage biopharmaceutical company developing novel therapies for 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 delivering lithium with salicylate and L-proline designed to improve brain delivery and safety compared to conventional lithium, and ALZN002, a patented cell-based therapeutic vaccine designed to restore the immune system's ability to clear beta-amyloid. The latter is a next-generation active-immunity approach offering potential advantages in dosing frequency and cost compared to approved passive-immunity antibody therapies. Both candidates are exclusively licensed from the University of South Florida Research Foundation under royalty-bearing worldwide licenses.Forward-Looking StatementsThis 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 www.Alzamend.com. 














View original content to download multimedia:https://www.prnewswire.com/news-releases/alzamend-neuro-reports-positive-topline-data-from-phase-ii-clinical-trial-of-al001-lithium-in-brain-study-al001-achieves-bioequivalence-and-demonstrates-superior-brain-delivery-across-all-measured-brain-regions-302725991.htmlSOURCE Alzamend Neuro, Inc.

Original: Alzamend Neuro Reports Positive Topline Data from Phase II Clinical Trial of AL001 "Lithium in Brain" Study; AL001 Achieves Bioequivalence and Demonstrates Superior Brain Delivery Across All Measured Brain Regions

ALZN.............................................p/m

Alzamend Neuro Initiates Phase II Clinical Trial of AL001 "Lithium in Brain" Study in Patients with Bipolar Disorder in Collaboration with Massachusetts General HospitalMarch 16, 2026 8:00 AM
PR Newswire (US)

Head-to-head studies of AL001 versus marketed lithium carbonate will compare lithium blood and brain/brain-structure pharmacokinetics in bipolar disorder type 1 patientsTopline data expected in third quarter of 2026Topline data from the clinically completed "lithium in brain" imaging study in healthy subjects expected by the end of March 2026ATLANTA, 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 AL001AL001 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 StatementsThis 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. 














View original content to download multimedia:https://www.prnewswire.com/news-releases/alzamend-neuro-initiates-phase-ii-clinical-trial-of-al001-lithium-in-brain-study-in-patients-with-bipolar-disorder-in-collaboration-with-massachusetts-general-hospital-302714440.htmlSOURCE Alzamend Neuro, Inc.

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

Another Ault sucker

Worthless from day 1

ALZN.................................https://stockcharts.com/sc3/ui/?s=ALZN&p=w&b=5&g=0&id=p86431144783

Im pretty bullish on Alzamend, and I love the price here. Have a solid position but between 2 and 2.10 I would buy as much as could muster.

ive beefed up my position in Alzamend, especially now that Todd is gone I feel like this will lift off on the next news which should be in the first quarter, I hope it does of course and we leave Todd in the dust. And if the news is good, I would expect a minimum 5 to 8 bucks.

Lithium...

Goof!!

Its not a scam man. Todd doesnt run that company, thank goodness. We should see a really really nice pop before years end in my opinion as these trials progress I expect an announcement.

Scam alarm is ringing loudly!!!

Not giving up on ALZN, these drugs take forever. I would be a buyer anywhere in here if you have the money.

Nobody believes.....anymore.....the lies

ALZN..................................................https://stockcharts.com/h-sc/ui?s=ALZN&p=W&b=5&g=0&id=p86431144783

Toilet

ALZN...............................................p/m

Burn it down!!

ALZN, new 52 week low

ALZN: effective May 9,2025 a one for 9 reverse split:

https://hedgefollow.com/upcoming-stock-splits.php

ALZN, new 52 week low

Another Ault joke!! Stock split? Now that's funny eh?

Dump and run!!!!

.69 look out below

.767!!!

All green but the Ault junk yard

Soon to die

Headed sub .90 asapAult the consummate crook

ALZN..................................https://stockcharts.com/h-sc/ui?s=ALZN&p=W&b=5&g=0&id=p86431144783

Pure 100% bull shit
Ault cost my family $250,000 with his band of merry men

ALZN 1.02 52 week low 2 out of 3 good flips premarket..stopped out at 1.09 on trade 3 .. Major dilution obviously 12m traded. Find a tradeable bottom for round 3 but would wait until
Afternoon. Other plays going well CSAI $12.33 and IBIO longer term

Round 3 in with 1.12 stop loss 1.09 diluting pig for sure just playing the zones a dangerous play for sure 

ALZN $1.22 Round 3 only if can get some under $1.15 if not good luck as 1.50s most probable resistance zone on regular trading hours 

this isn't the automaker, but still a cool device

ALZN $1.31 + 20% probably headed back to 1.50s resistance zone but taking safe profit.
AI and Tesla used in brain definitely good news ..

$1.24 flip back out 80% .. “We want to thank Tesla for working with us to create this one-of-a-kind lithium head coil,” stated Stephan Jackman, Chief Executive Officer of Alzamend. “The development of the coil was a long time coming, but we believe the time and effort was necessary to allow us unprecedented knowledge as to how lithium interacts within our brains. We believe that our upcoming studies, utilizing the head coil, has the potential to broaden the application of lithium treatment across numerous neurodegenerative diseases and psychiatric disorders. Its completion allows us to solidify our timeline for the forthcoming clinical trials in collaboration with Massachusetts General Hospital. We look forward to sharing additional details regarding these trials soon.”...

Back in 1.18 for round 2 stop loss 1.15 they almost diluted 9m shares now. See
What happens round 1 was the money maker 

alzn.............................................https://stockcharts.com/h-sc/ui?s=alzn&p=W&b=5&g=0&id=p86431144783

$1.90s nice Tesla news on top of bottom play..
...(“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced the completion of a groundbreaking head coil by Tesla Dynamic Coils BV (“Tesla”). The development of the head coil was necessary to facilitate the five upcoming Phase II clinical trials to be conducted by Alzamend....This

$1.83 + 70% out of remaining 20% 

$1.46 +'35% now we talking quick flipper out of 80%

$1.05 new bottom
Been holding..Alzheimer's low floater but does have a backer 

This year, Alzamend entered into a securities purchase agreement with an institutional investor to purchase up to $25 million of preferred stock and warrants over a two-year period. In addition, Alzamend entered into an at-the-market sales agreement, with the right of Alzamend to strategically sell up to $6.5 million of common stock at its option. Please see Alzamend’s Commission filings for additional information regarding these agreements and the terms of such financing transactions.
 
“These financing transactions have allowed us to greatly improve our financial situation” said Stephan Jackman, Chief Executive Officer of Alzamend. “In the first six months of this fiscal year, we have gone from a stockholder deficit to several million in stockholder equity, significantly reduced our outstanding liabilities and increased our cash on hand. These financial improvements allowed us to regain compliance with all applicable requirements for our stock to continue to be listed on Nasdaq and provides us with the capital in preparation of the upcoming clinical trials to be initiated in 2025.”

ALZN The accompanying condensed financial statements have been prepared on the basis that the Company will continue as a going concern. As of October 31, 2024, the Company had cash of $4.1 million, working capital of $3.5 million, an accumulated deficit of $56.4 million and stockholders’ equity of $3.8 million. For the three and six months ended October 31, 2024, the Company had net losses of $1.4 million and $2.4 million, respectively. For the six months ended October 31, 2024, cash used in operating activities was $4.5 million. Historically, the Company has financed its operations principally through issuances of equity and debt instruments.
 

 
We intend to develop and commercialize therapeutics and vaccines that are better than existing treatments and have the potential to significantly improve the lives of individuals afflicted by Alzheimer’s, BD, MDD and PTSD. To achieve these goals, we are pursuing the following key business strategies:
 
· Advance clinical development of AL001 for Alzheimer’s, BD, MDD and PTSD treatment;
 
· Advance clinical development of ALZN002 for Alzheimer’s treatment;
 
· Expand our pipeline of pharmaceuticals to include additional indications for AL001 and delivery methods;
 
· Focus on translational and functional endpoints to efficiently develop product candidates; and
 
· Optimize the value of AL001 and ALZN002 in major markets.
 
Our pipeline consists of two novel therapeutic drug candidates:
 
· AL001 - A patented ionic cocrystal technology delivering a therapeutic combination of lithium, salicylate and proline through three royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc., as licensor (the “Licensor”); 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 throu

Our most advanced product candidate (lead product) licensed and in clinical development in humans is AL001, an ionic cocrystal of lithium for the treatment of Alzheimer’s, BD, MDD and PTSD. Based on our preclinical data involving mice models, AL001 treatment prevented cognitive deficits, depression and irritability and is superior in improving associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer’s, BD, MDD and PTSD in humans. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized, potentially mitigating the regulatory burden for safety data.
 

At-the-Market Offering
 
On October 3, 2024, we entered into an At-the-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC (the “ATM Offering”), as sales agent to sell shares of our common stock, having an aggregate offering price of up to approximately $6.5 million from time to time, through the ATM Offering. On October 3, 2024, we filed a prospectus supplement with the SEC relating to the offer and sale of up to approximately $6.5 million in shares of common stock in the ATM Offering.
 
The offer and sale of the shares will be made pursuant to our effective “shelf” registration statement on Form S-3 and an accompanying base prospectus contained therein (Registration Statement No. 333-273610) filed with the SEC on August 2, 2023 and declared effective by the SEC on August 10, 2023.
 
During the six months ended October 31, 2024, we sold an aggregate of 755,888 shares of common stock pursuant to the ATM Offering for gross and net proceeds of $1.2 million. From November 1, 2024 to December 10, 2024, we sold an aggregate of 201,543 shares of common stock pursuant to the ATM Offering for gross and net proceeds of $280,000.



This year, Alzamend entered into a securities purchase agreement with an institutional investor to purchase up to $25 million of preferred stock and warrants over a two-year period. In addition, Alzamend entered into an at-the-market sales agreement, with the right of Alzamend to strategically sell up to $6.5 million of common stock at its option. Please see Alzamend’s Commission filings for additional information regarding these agreements and the terms of such financing transactions. “These financing transactions have allowed us to greatly improve our financial situation” said Stephan Jackman, Chief Executive Officer of Alzamend. “In the first six months of this fiscal year, we have gone from a stockholder deficit to several million in stockholder equity, significantly reduced our outstanding liabilities and increased our cash on hand. These financial improvements allowed us to regain compliance with all applicable requirements for our stock to continue to be listed on Nasdaq and provides us with the capital in preparation of the upcoming clinical trials to be initiated in 2025.”
ALZN The accompanying condensed financial statements have been prepared on the basis that the Company will continue as a going concern. As of October 31, 2024, the Company had cash of $4.1 million, working capital of $3.5 million, an accumulated deficit of $56.4 million and stockholders’ equity of $3.8 million. For the three and six months ended October 31, 2024, the Company had net losses of $1.4 million and $2.4 million, respectively. For the six months ended October 31, 2024, cash used in operating activities was $4.5 million. Historically, the Company has financed its operations principally through issuances of equity and debt instruments. 
 We intend to develop and commercialize therapeutics and vaccines that are better than existing treatments and have the potential to significantly improve the lives of individuals afflicted by Alzheimer’s, BD, MDD and PTSD. To achieve these goals, we are pursuing the following key business strategies: · Advance clinical development of AL001 for Alzheimer’s, BD, MDD and PTSD treatment; · Advance clinical development of ALZN002 for Alzheimer’s treatment; · Expand our pipeline of pharmaceuticals to include additional indications for AL001 and delivery methods; · Focus on translational and functional endpoints to efficiently develop product candidates; and · Optimize the value of AL001 and ALZN002 in major markets. Our pipeline consists of two novel therapeutic drug candidates: · AL001 - A patented ionic cocrystal technology delivering a therapeutic combination of lithium, salicylate and proline through three royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc., as licensor (the “Licensor”); 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 throu
Our most advanced product candidate (lead product) licensed and in clinical development in humans is AL001, an ionic cocrystal of lithium for the treatment of Alzheimer’s, BD, MDD and PTSD. Based on our preclinical data involving mice models, AL001 treatment prevented cognitive deficits, depression and irritability and is superior in improving associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer’s, BD, MDD and PTSD in humans. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized, potentially mitigating the regulatory burden for safety data. 
At-the-Market Offering On October 3, 2024, we entered into an At-the-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC (the “ATM Offering”), as sales agent to sell shares of our common stock, having an aggregate offering price of up to approximately $6.5 million from time to time, through the ATM Offering. On October 3, 2024, we filed a prospectus supplement with the SEC relating to the offer and sale of up to approximately $6.5 million in shares of common stock in the ATM Offering. The offer and sale of the shares will be made pursuant to our effective “shelf” registration statement on Form S-3 and an accompanying base prospectus contained therein (Registration Statement No. 333-273610) filed with the SEC on August 2, 2023 and declared effective by the SEC on August 10, 2023. During the six months ended October 31, 2024, we sold an aggregate of 755,888 shares of common stock pursuant to the ATM Offering for gross and net proceeds of $1.2 million. From November 1, 2024 to December 10, 2024, we sold an aggregate of 201,543 shares of common stock pursuant to the ATM Offering for gross and net proceeds of $280,000.

Headed sub $1

Sucker
Ault the thief

Add 1.10s on this micro float 

Added some $1.20s chart wise makes
Sense lower descending W on chart making form . Tiny floater 

Baloney via the Ault baloney mill
Cost us 1/4 of a mill