Toripalimab in combination with chemotherapy and lithium carbonate for first-line treatment of extensive-stage small cell lung cancer in stage Ib/II clinical research

Start Date30 Sep 2025

Sponsor / Collaborator-

NCT06776848

/ RecruitingPhase 1/2IIT

A Pilot, Multicentre, Controlled, Open-label Study Evaluating 24 Months of Lithium Carbonate Treatment in Patients With TBR1-related Neurocognitive Disorder

TBR1 is a human gene encoding a brain-specific transcription factor, principally expressed in the excitatory neurons of the neocortex. It regulates development of axonal projection and expression of numerous genes involved in autism spectrum disorders (ASD) and intellectual disability (ID). Recent progress in detection and analysis of rare variants allowed to identify group of genes with strong statistical evidence for association with ASD risk, of which TBR1. Numerous studies on mice showed that TBR1 heterozygous mice display autistic traits as deficiencies in social interaction, in cognitive flexibility, and in associative memory. Functional analyses on human cell lines have demonstrated that de novo truncating variants in TBR1 identified in patients with sporadic ASD disrupt transcriptional repression activity, localization, homodimerization of TBR1 product.
In 2019, only 12 single nucleotide variants (SNVs) and few copy number variations (CNVs) involving TBR1 have been reported in the literature and clinical descriptions were poor. To provide details on the phenotype linked to TBR1 mutations, we and others gathered 25 new individuals with de novo TBR1 SNV and CNV, complemented by a review of individuals previously reported in the literature. On 38 individuals, all presented developmental delay (DD)/ID, ranging from mild to severe, and 76% of them presented autistic traits. Additional behaviour disorders were observed in 85% of individuals, mainly attention deficit and aggressive behaviour. However, the natural history of patients with TBR1 variations is not well known.
Development of RNA-Seq allowed a better understanding of its transcription factor role and revealed that Tbr1 promotes expression of layer 6 markers as Wnt7b. In heterozygous and homozygous TBR1 mutant mice, Fazel Darbandi et al (1), observed that Wnt7b expression is reduced in cortical layer 6 and that neurons have reduced excitatory and inhibitory synaptic density. They showed that lithium chloride and lithium carbonate, WNT-signalling agonists, rescue the dendritic spines, the synaptic and the axonal defects in Tbr1layer5, Tbr1layer6 and Tbr1 constitutive (Tbr1+/-) mutant mice. They also observed an improvement of social interactions in mice after treatment by lithium. These results suggest an important and novel biological mechanism underlying ASD that may have implications for the treatment of patients with TBR1 variants.
Moreover, lithium treatment has already been evaluated in patients with neurocognitive disorders not linked to TBR1 showing an improvement in the adaptative behaviour and cognition function.
As of today, only symptomatic treatments are available. As lithium increase neuronal activity in mice, and may thus improve the symptoms of this disorder, we propose a clinical trial to study the security and efficacy of lithium carbonate targeting the patients with TBR1-related disorders, with specific and adapted endpoints. Lithium carbonate treatment will be administered after an observation period of 6 to 12 months, allowing to ascertain the stability of neurocognitive abnormalities.

Start Date12 Sep 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Dijon

NCT06921590

/ Active, not recruitingPhase 1

A Randomized, Balanced, Phase 1, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects

The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers. The main questions this study aims to answer are:
How safe and effective is AL001 when compared to Lithium Carbonate? How is AL001 broken down in the brain and body compared to Lithium Carbonate?
Participants will be asked to:
* Take both the study drug (AL001) and Lithium Carbonate each for a period of 14 days
* Stay overnight at MGH's research unit for two separate 2-week periods
* Participate in two separate 24 hour periods of multiple MRIs and blood draws

Start Date09 May 2025

Sponsor / Collaborator

Alzamend Neuro, Inc.

[+1]

100 Clinical Results associated with Lithium carbonate

100 Translational Medicine associated with Lithium carbonate

100 Patents (Medical) associated with Lithium carbonate

16,756

Literatures (Medical) associated with Lithium carbonate

01 Dec 2025·Nano-Micro Letters

Photo-Energized MoS2/CNT Cathode for High-Performance Li–CO2 Batteries in a Wide-Temperature Range

Article

Author: Hu, Kang ; Cui, Xueliang ; Lian, Wenyi ; Yao, Tengyu ; Li, Qiuju ; Shen, Laifa ; Hu, Tingsong

Abstract:

Li–CO2 batteries are considered promising energy storage systems in extreme environments such as Mars; however, severe performance degradation will occur at a subzero temperature owning to the sluggish reaction kinetics. Herein, a photo-energized strategy adopting sustainable solar energy in wide working temperature range Li–CO2 battery was achieved with a binder-free MoS2/carbon nanotube (CNT) photo-electrode as cathode. The unique layered structure and excellent photoelectric properties of MoS2 facilitate the abundant generation and rapid transfer of photo-excited carriers, which accelerate the CO2 reduction and Li2CO3 decomposition upon illumination. The illuminated battery at room temperature exhibited high discharge voltage of 2.95 V and mitigated charge voltage of 3.27 V, attaining superior energy efficiency of 90.2% and excellent cycling stability of over 120 cycles. Even at an extremely low temperature of − 30 °C, the battery with same electrolyte can still deliver a small polarization of 0.45 V by the photoelectric and photothermal synergistic mechanism of MoS2/CNT cathode. This work demonstrates the promising potential of the photo-energized wide working temperature range Li–CO2 battery in addressing the obstacle of charge overpotential and energy efficiency.

01 Dec 2025·JOURNAL OF THE EUROPEAN CERAMIC SOCIETY

High temperature stability in Li2CO3-doped PYN-PZT co-fired multilayer piezoelectric actuators

Author: Du, Zongzheng ; Liu, Hong ; Tong, Xingye ; Zhang, Guozheng ; Yang, Yuting

Improving the performance stability of piezoelec. ceramic materials over a wide temperature range, especially at high temperatures, is a challenge and a research hotspot.In this study, the outstanding piezoelec., dielec., and ferroelec. properties of 0.15Pb(Yb_1/3Nb_2/3)O₃-0.37PbZrO₃-0.48PbTiO₃ (PYN-PZT) ceramics are achieved by introducing the sintering additive Li₂CO₃.These ceramics achieved excellent performance (d₃₃ = 459 pC/N, d₃₃* = 573 pm/V, T_C = 401 ° C) at 1100 ° C, which enables co-firing with the internal electrode.Furthermore, they demonstrate excellent temperature stability (Variation = 5.84 %) over a wide temperature range (30-190 ° C).Subsequently, PYN-PZT+ 0.05Li multilayer piezoelec. actuators (MLAs), with dimensions of 7 x 7 x 36 mm, were fabricated using the tape casting method.The PYN-PZT+ 0.05Li-MLAs exhibit superior performance (S = 0.0689 %) and temperature stability (Variation = 9.87 %) across the temperature range (30-190 °C) and retain 88.5 % of their performance at 270°C.The service temperature and temperature stability are significantly higher than those of previously reported materials and com. actuators, suggesting that the PYN-PZT+ 0.05Li-MLAs hold great promise for significantly expanding the high-temperature range of MLAs.

01 Dec 2025·Brain and Behavior

Efficacy of Different Combination Therapies for Mania in Bipolar Disorder: A Systematic Review and Meta‐Analysis

Review

Author: Ni, Pingan ; Yao, Peiling ; Yin, Liqin

ABSTRACT:

Objective:

To systematically evaluate the efficacy and safety of different combination therapies in the treatment of mania in bipolar disorder, and to provide evidence‐based support for individualized clinical treatment.

Methods:

PubMed, Web of Science, Cochrane Library, CNKI, VIP, and Wanfang databases were systematically searched from inception to July 2025. Randomized controlled trials comparing ziprasidone or olanzapine combined with mood stabilizers (lithium carbonate or sodium valproate) for the treatment of manic episodes in bipolar disorder were included. Two reviewers independently performed literature screening, data extraction, and quality assessment. Meta‐analysis was conducted using RevMan 5.4 software.

Results:

A total of 10 RCTs involving 842 patients were included. Meta‐analysis showed no significant difference between the two groups in overall clinical efficacy (OR = 1.18, 95% CI: 0.80–1.75, p = 0.41). Ziprasidone was superior to olanzapine in reducing YMRS scores (MD = −1.47, 95% CI: −1.97–0.96, p < 0.00001). The incidence of adverse reactions was significantly lower in the ziprasidone group compared to the olanzapine group (OR = 0.16, 95% CI: 0.08–0.31, p < 0.00001). Furthermore, ziprasidone was associated with significantly greater increases in BDNF and T 3 levels after treatment.

Conclusion:

Although the efficacy of ziprasidone plus mood stabilizers is comparable to that of olanzapine plus mood stabilizers in the treatment of manic episodes of bipolar disorder, ziprasidone offers advantages in improving manic symptoms (YMRS scores), reducing adverse events, and enhancing neuroendocrine indicators. It may serve as a favorable alternative in clinical practice. Further high‐quality, multicenter, large‐sample studies are needed to confirm its efficacy and safety.

News (Medical) associated with Lithium carbonate

02 Dec 2025

·www.businesswire.com

Fresenius Kabi Expands Operating Room Portfolio with New Simplist ® Prefilled Syringes

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced two new products in its Simplist® portfolio of ready-to-administer prefilled syringes: Simplist® Ephedrine Sulfate Injection, USP and Simplist® Succinylcholine Chloride Injection, USP. Both medications are used in anesthesia and critical care, and their introduction extends the Simplist line’s use into operating rooms, supporting clinicians with safe, efficient and reliable medication delivery. Fresenius Kabi has expanded its Simplist® ready-to-administer portfolio, introducing new presentations that extend its use into operating rooms and support clinicians in anesthesia and critical care. Simplist Succinylcholine Chloride Injection, USP, is a paralytic used in addition to general anesthesia for intubation and during mechanical ventilation in pediatric and adult patients. Simplist Ephedrine Sulfate Injection, USP is indicated for the treatment of clinically important hypotension (low blood pressure) during anesthesia. “As part of our commitment to simplify medication delivery and improve patient safety, the expansion of our Simplist portfolio into the operating room demonstrates how we’re supporting anesthesiologists and nurse anesthetists in their vital work,” said Arun Verma, president of Fresenius Kabi Region U.S. and member of the Executive Leadership Team at Fresenius Kabi AG. “These ready-to-administer medications are designed to help clinicians throughout the hospital by helping to reduce complexity, help minimize waste, and reduce the number of drug-preparation steps where errors can occur.” About the Products: Simplist Succinylcholine Chloride Injection, USP is available in 100 mg per 5 mL (20 mg per mL) and 200 mg per 10 mL (20 mg per mL) strengths. It offers an 18-month shelf life and is stored in a refrigerator at 36°F (2°C) to 46°F (8°C). The single dose prefilled syringes are stable for up to 14 days at room temperature without loss of potency. Simplist Ephedrine Sulfate Injection, USP is available in 25 mg per 5 mL (5 mg per mL) and 50 mg per 10 mL (5 mg per mL) presentations. It can be stored at room temperature and has a 24-month shelf life. Both prefilled syringes are manufactured and prepared by Fresenius Kabi, eliminating the need for assembly or dilution at the point of care to simplify medication administration, enhance workflow efficiency, and support best practices in medication administration safety. To learn more about Fresenius Kabi’s expanding manufacturing and other operations in the U.S., visit www.MoreInAmerica.com. IMPORTANT SAFETY INFORMATION Succinylcholine Chloride Injection, USP WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS CONTRAINDICATIONS In patients with skeletal muscle myopathies In patients with known hypersensitivity to succinylcholine After the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury In patients with a personal or familial history or suspected genetic susceptibility to malignant hyperthermia WARNINGS AND PRECAUTIONS Anaphylaxis: Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. Some cases have been life-threatening and fatal. Take necessary precautions, such as the immediate availability of appropriate emergency treatment. Risk of Death due to Medication Errors: Unintended administration of Succinylcholine Chloride Injection may result in paralysis, respiratory arrest and death. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. Hyperkalemia: Succinylcholine Chloride Injection may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia. Malignant Hyperthermia: Malignant hyperthermia may occur, especially in individuals with known or suspected susceptibility based on genetic factors or family history. Discontinue triggering agents, administer intravenous dantrolene sodium, and apply supportive therapies. Bradycardia: Intravenous bolus administration may result in profound bradycardia or, rarely asystole. The incidence is higher following a second dose of succinylcholine. Pretreatment with anticholinergic agents (e.g. atropine) may reduce the occurrence of bradyarrhythmias. ADVERSE REACTIONS Adverse reactions reported with succinylcholine are cardiac arrest, malignant hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension, hypotension, hyperkalemia, prolonged respiratory depression or apnea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Drugs that May Enhance the Neuromuscular Blocking Action of Succinylcholine: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, terbutaline, and drugs that reduce plasma cholinesterase activity. INDICATIONS AND USAGE Succinylcholine Chloride Injection is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: As an adjunct to general anesthesia To facilitate tracheal intubation To provide skeletal muscle relaxation during surgery or mechanical ventilation This Important Safety Information does not include all the information needed to use Succinylcholine Chloride Injection, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for Succinylcholine Chloride Injection, USP 100 mg per 5 mL and 200 mg per 10 at www.fresenius-kabi.com/us. Ephedrine Sulfate Injection, USP WARNINGS AND PRECAUTIONS Pressor Effects with Concomitant Use with Oxytocic Drugs: Pressor effect of sympathomimetic pressor amines is potentiated. Tachyphylaxis and Tolerance: Repeated administration of ephedrine may cause tachyphylaxis. ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Interactions that Augment Pressor Effect: clonidine, oxytocin and oxytocic drugs, propofol, monoamine oxidase inhibitors (MAOIs), and atropine. Monitor blood pressure. Interactions that Antagonize the Pressor Effect: Antagonistic effects with α-adrenergic antagonists, β-adrenergic antagonists, reserpine, quinidine, mephentermine. Monitor blood pressure. Guanethidine: Ephedrine may inhibit the neuron blockage produced by guanethidine, resulting in loss of antihypertensive effectiveness. Monitor blood pressure and adjust the dosage of pressor accordingly. Rocuronium: Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. Be aware of this potential interaction. No treatment or other interventions are needed. Epidural anesthesia: Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia. Monitor and treat the patient according to clinical practice. Theophylline: Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia. Monitor patient for worsening symptoms and manage symptoms according to clinical practice. Cardiac glycosides: Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. Carefully monitor patients on cardiac glycosides who are also administered ephedrine. INDICATIONS AND USAGE Ephedrine Sulfate Injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. This Important Safety Information does not include all the information needed to use Ephedrine Sulfate Injection, USP safely and effectively. Please see full prescribing information, for Ephedrine Sulfate Injection, USP at www.fresenius-kabi.com/us.” About Fresenius Kabi As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving essential medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit www.fresenius-kabi.com/us. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook. This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

28 Jul 2025

·ir.alzamend.com

Alzamend Neuro to Present at the 2025 Military Health System Research Symposium

Session Topic is the Innovation and Current Directions in Military Suicide Prevention, Research, and Programs Presentation Title is Quantitate Differences in Lithium Brain-to-Plasma Exposure in PTSD Subjects Between AL001 and Lithium Carbonate ATLANTA, July 28, 2025 (GLOBE NEWSWIRE) -- 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 it will have a poster presentation at the Military Health System Research Symposium (“MHSRS”), being held from August 4-7, 2025, in Orlando, Florida. “Our upcoming poster presentation at MHSRS 2025 represents an exceptional opportunity to spotlight our cutting-edge innovation and its transformative potential for active-duty service members and military veterans,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We are excited to engage with Department of Defense (DoD) funding directors to pursue non-dilutive funding through grants, which would further validate our technology and accelerate our advancement while strategically preserving shareholder value.” Abstract MHSRS-25-14329 – Poster presentation: Title: Quantitate Differences in Lithium Brain-to-Plasma Exposure in PTSD Subjects Between AL001 and Lithium Carbonate Session Title: Innovation and Current Directions in Military Suicide Prevention, Research, and Programs Session Date and Time: Wednesday, August 6, 2025; 10:00AM ET – 12:00PM ET Session Location: Gaylord Palms Resort & Convention Center, Kissimmee, FL Presenter Details: Stephan Jackman, Chief Executive Officer, Alzamend Neuro, Inc. Summary: The current study is designed to quantitate differences in lithium brain-to-plasma exposure in PTSD subjects between AL001 and lithium carbonate for the purpose of contributing to a composite database of analogously studied brain-plasma assessments that include data from healthy subjects and multiple additional neurodegenerative, neurological and neuropsychiatric disorders. Currently, AL001 is targeted for treatment of Alzheimer’s, BD type 1, MDD and PTSD. It’s anticipated that this study design may help target appropriate AL001 lithium systemic dosing for these indications in future studies. Using this study design, comparable target organ (brain) lithium concentrations may be quantitated between AL001 and lithium carbonate and, by equivalence inference, lithium citrate solution and syrup. 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 a maximum tolerated dose (“MTD”), as assessed by an independent safety review committee. This MTD is designed to be unlikely to require therapeutic drug monitoring 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. In collaboration with Massachusetts General Hospital as its clinical trial site, Alzamend initiated the first of five Phase II clinical studies of AL001 in May 2025, with the first study in healthy human subjects. Alzamend aims to explore the unique properties of AL001 and its potential to deliver lithium more effectively in the brain compared to marketed lithium salts. The study in healthy human subjects will serve as a baseline and assist Alzamend in determining the best path forward in Alzheimer’s, BD, MDD and PTSD patients by demonstrating AL001’s targeted effectiveness and reduced systemic side effects. Previous studies in mice have shown that AL001 ensures better brain absorption while maintaining lower levels of lithium in the blood, paving the way for safer and more efficient treatments. Alzamend expects to present topline data from this study by the end of 2025. 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. 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/. Contacts: Email: Info@Alzamend.com or call: 1-844-722-6333 A PDF accompanying this announcement is available at: http://ml.globenewswire.com/Resource/Download/d17e9294-accc-4f0f-857b-1c352c9a614f A photo accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/4ed3a543-69dc-4102-b467-2ce2711658be Released July 28, 2025

Phase 2Vaccine

23 Jul 2025

·ir.alzamend.com

Alzamend Neuro Reports Annual 2025 Financial Results and Provides Update on Clinical Programs

During the year ended April 30, 2025, net cash provided by financing activities was $10.4 million Stockholder equity of $4.0 million at April 30, 2025, including $3.9 million of cash In May 2025, Alzamend dosed the first patient for the healthy human patients for the AL001 “Lithium in Brain” Studies at Massachusetts General Hospital In June 2025, Alzamend completed the final closing of its $5 million private placement months ahead of schedule ATLANTA, July 23, 2025 (GLOBE NEWSWIRE) -- 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”), reported its financial results for the year ended April 30, 2025, which were disclosed on an annual report on Form 10-K filed on July 22, 2025, with the Securities and Exchange Commission. Alzamend has strengthened its financial position, reflecting a strategic focus on fiscal prudence and effective capital management. Key financial highlights include: Net cash provided by financing activities of $10.4 million for the year ended April 30, 2025; Stockholder equity of $3.9 million at April 30, 2025, compared to a stockholder deficit of $2.6 million at April 30, 2024; Cash of $3.9 million at April 30, 2025, compared to $0.4 million at April 30, 2024; and Total liabilities of $0.6 million at April 30, 2025, compared to $3.2 million at April 30, 2024. Earlier this year, Alzamend entered into a Securities Purchase & Exchange Agreement (the “Agreement”) with a sophisticated investor (the “Investor”), pursuant to which Alzamend agreed to sell to the Investor up to 500 shares of Series C Convertible Preferred Stock (the “Preferred Stock”) and 111,111 warrants (the “Warrants”) to purchase shares of Alzamend’s common stock for a total purchase price of up to $5 million, less a five percent (5%) discount (the “Financing”) in seven monthly tranche closings (a “Tranche Closing”), starting in April 2025, with the Investor having the ability, in its sole discretion, to purchase Preferred Stock prior to the dates set for each Tranche Closing. Subsequent to our year ended April 30, 2025, the Investor accelerated the purchase of an additional $4.0M of Preferred Stock, completing the Financing on June 13, 2025, months ahead of the originally scheduled final Tranche Closing of October 2025. With these additional net proceeds from this Financing received, Alzamend’s financial position has further improved, and Alzamend would receive additional proceeds should the Investor exercise the Warrants. “The successful completion of this Financing, months ahead of schedule, reflects confidence in our mission and strong belief in our vision,” said Stephan Jackman, Chief Executive Officer of Alzamend. “The capital raised will be used to support the five Phase II clinical trials of AL001 “Lithium in Brain” Studies in partnership with Massachusetts General Hospital and Harvard Medical School.” Strategic Clinical Advancements Alzamend is advancing treatments for Alzheimer’s, BD, MDD and PTSD, led by its novel drug candidate AL001, a lithium-salicylate/L-proline cocrystal designed for safer, more effective lithium therapy. Preclinical and nonclinical studies show AL001 achieves higher brain lithium concentrations with less toxicity, even at lower doses, compared to standard lithium carbonate treatments. In August 2024, Alzamend teamed with Massachusetts General Hospital and Harvard Medical School for five Phase II imaging trials, comparing lithium distribution of AL001 to standard lithium in both healthy subjects and patients with Alzheimer’s, BD, MDD and PTSD. To support these trials, Alzamend commissioned Tesla Dynamic Coils to develop a specialized head coil for high-resolution lithium brain imaging, which was finalized in February 2025. The first of five clinical trials began in May 2025 with healthy volunteers, which will assess AL001’s brain/plasma pharmacokinetics, safety, and distribution compared to lithium carbonate. Topline results are expected by year-end 2025, with follow-up trials in BD, MDD, PTSD and Alzheimer’s launching through early 2026. Our secondary therapeutic drug candidate, ALZN002, is a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system. ALZN002 uses autologous dendritic cells engineered to target amyloid-beta proteins, aiming for safe, long-lasting reduction of beta-amyloid plaques—unlike antibody-based approaches that rely on foreign products. In April 2023, we initiated a Phase I/IIA clinical trial for ALZN002 to evaluate its safety, tolerability, and efficacy in 20-30 patients with mild to moderate Alzheimer’s, comparing multiple ascending doses to a placebo. The trial’s primary aim is to determine the optimal ALZN002 dose for a future Phase IIB safety and efficacy trial. In February 2024, our contract research organization (“CRO”) terminated our agreement. We are actively working to engage a new CRO, but the process has been slower than expected due to the trial’s scientific and operational complexities, a limited pool of CROs with the necessary expertise and capacity, and industry-wide challenges, including a shortage of experienced providers and high demand for specialized trial management. “We are deeply grateful for the unwavering support of our stockholders and are steadfast in our commitment to maintaining transparency as we drive forward in our mission to deliver breakthrough therapies for the over 43 million Americans affected by Alzheimer’s, BD, MDD and PTSD,” said Mr. Jackman. “While recent market fluctuations have challenged our stock performance, I am confident that our upcoming studies will significantly advance our product candidates and enhance stockholder value.” 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. 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/. Contacts: Email: Info@Alzamend.com or call: 1-844-722-6333 Released July 23, 2025

Phase 2VaccineFinancial Statement

100 Deals associated with Lithium carbonate

External Link

KEGG	Wiki	ATC	Drug Bank
D00801	Lithium carbonate	N05AN01	DB14509

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Bipolar I disorder	United States	Hikma Pharmaceuticals USA, Inc.	29 Jan 1982
Bipolar Disorder	United States	Solvay Pharmaceuticals, Inc.	06 Apr 1970
Bipolar Disorder	United States	Pfizer Inc.	06 Apr 1970
Schizoaffective disorder	United States	Solvay Pharmaceuticals, Inc.	06 Apr 1970
Schizoaffective disorder	United States	Pfizer Inc.	06 Apr 1970

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Kleine-Levin Syndrome	Preclinical	European Union	Laboratoires Delbert SAS	16 Aug 2023

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03185208 (LATTICE, CTgov)	Phase 4	Alzheimer Disease \| Mild cognitive disorder	83	Lithium Carbonate (Lithium Carbonate)	cejrecqwod(antdfwyakn) = rnkffsaoti gdkkmkuqsu (wlcbkzckiq, 4.0) View more	-	11 Sep 2025
NCT03185208 (LATTICE, CTgov)	Phase 4	Alzheimer Disease \| Mild cognitive disorder	83	Placebo oral capsule (Placebo)	cejrecqwod(antdfwyakn) = nknenejbda gdkkmkuqsu (wlcbkzckiq, 4.6) View more	-	11 Sep 2025
NCT02862210 (Lithium, CTgov)	Phase 2	Frontotemporal Dementia	17	Lithium Carbonate (Lithium Carbonate)	pavgvuepfl(arojplsxuu) = unalmunzuh xszeuduncp (zliidyegrp, 1.1) View more	-	03 Feb 2025
NCT02862210 (Lithium, CTgov)	Phase 2	Frontotemporal Dementia	17	Placebo (Placebo)	pavgvuepfl(arojplsxuu) = szzcztblxd xszeuduncp (zliidyegrp, 1.28) View more	-	03 Feb 2025
NCT00961961 (CTgov)	Phase 4	Bipolar Disorder \| Bipolar I disorder	177	Lithium Carbonate+Fluoxetine (Lithium Plus Fluoxetine Phase I)	piyyqghpfr = vkoxypoejn fgbjjyckvw (jbkqwuunyy, abesnanqyf - uropystrxr) View more	-	19 Oct 2020
NCT00961961 (CTgov)	Phase 4	Bipolar Disorder \| Bipolar I disorder	177	Lithium / Placebo (Lithium Plus Placebo Phase I)	piyyqghpfr = crmtdmwzgk fgbjjyckvw (jbkqwuunyy, mtewsvhkcd - lujkhlrqvm) View more	-	19 Oct 2020
NCT02918097 (CTgov)	Phase 4	Bipolar Disorder	78	Lithium Carbonate+risperidone+Nortriptyline+sertraline	lvnqqdqzew = pdvijcnhoe flihncgfps (qweipwitii, tnjgqmrdqt - vaynlawulf) View more	-	14 Oct 2020
NCT01820624 (Pubmed) Manual	Phase 1	Acute Myeloid Leukemia	9	lithium carbonate+tretinoin	qmmazhahiy(kwzwnoksei) = dhcioikbvp kqpqkkkfep (zjwdruxcwu )	Negative	10 Mar 2020
NCT01553916 (CTgov)	Phase 1/2	Small Cell Lung Cancer	19	Prophylactic cranial irradiation+Lithium Carbonate	njxnwpelot = fiqbzabjqw xlzlmeokwz (wxjroaftko, wkktzngfvs - ykmvbgeyum) View more	-	08 Nov 2017
NCT00501540 (CTgov)	Phase 2	Neuroendocrine Tumors	15	Lithium Carbonate	qdbecdfjqk = nfishdnjgm bsioyxjepj (tgpwfrmzxx, hllbofyhnj - wvyzvkcjce) View more	-	03 May 2017
NCT00408681 (GVHD, CTgov)	Not Applicable	Marginal zone lymphoma recurrent \| Gestational Trophoblastic Disease \| Adult Acute Myeloblastic Leukemia ... View more	20	laboratory biomarker analysis+lithium carbonate	mupozhtwnl = bypsnwnkqd ypznjbmntp (vxlrizzaan, vgietrmcez - chqutodkgy)	-	20 Jan 2017
NCT00582712 (CTgov)	Phase 2	Thyroid Cancer, Medullary	5	Lithium carbonate	bgeoqyehfo(nanhgzvcfv) = lwbmvqgnjg ykbhvamdcm (wxjgdcyckj, jvabfwcdjl - fsegdkuixj) View more	-	12 Dec 2016
NCT00240110 (CTgov)	Phase 1/2	Cocaine-Related Disorders \| Bipolar Disorder	152	Lithium Carbonate+Placebo (Lithium Carbonate Add on Placebo)	whpsciaehp(fshgvglaai) = hbijltnobu vulebqvubc (gphcehfzcy, 29.7) View more	-	17 Oct 2016
NCT00240110 (CTgov)	Phase 1/2	Cocaine-Related Disorders \| Bipolar Disorder	152	Lithium Carbonate+Valproate (Lithium Carbonate Add on Valproate)	whpsciaehp(fshgvglaai) = yftvzyojfa vulebqvubc (gphcehfzcy, 20.3) View more	-	17 Oct 2016

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