Lithium carbonate

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

印度仿制药产业在全球医药市场中占据着举足轻重的地位，而太阳制药（Sun Pharma）作为印度最大的制药企业和全球第四大仿制药巨头，其发展历程堪称印度制药工业的缩影。本文将从太阳制药的早期发展、国际化扩张、面临的行业瓶颈以及成功转型四个方面，全面剖析这家印度制药巨头的战略演变路径，为中国制药企业的国际化发展提供有益借鉴。一、草根起家：太阳制药的早期发展（1983-1994）1983年，年仅27岁的Dilip Shanghvi在印度古吉拉特邦Vapi的一个小棚屋里创立了太阳制药，开启了印度制药史上最富传奇色彩的创业故事。这位加尔各答大学商学学士、药品批发商之子，凭借借来的生产设备和父亲资助的1万卢比（约合800美元），开始了他的制药梦想。差异化市场定位成为太阳制药早期成功的关键。Shanghvi敏锐地发现治疗躁狂症的碳酸锂在印度东部市场尚属空白，且生产工艺相对简单。与当时印度上千家仿制药企业扎堆生产普通药品不同，太阳制药选择以精神类药品作为切入点，这类药品不仅利润较高，还避开了印度政府严格的药品价格管制。到1983年底，公司已推出5个精神类药品，首年销售额达75万卢比（约6万美元）。随着业务的扩展，太阳制药在1984年投资5万美元建设正规生产设施，销售网络从加尔各答逐步覆盖全印度。到1987年，公司已完成全国性销售布局。这种"农村包围城市"的市场拓展策略，为太阳制药在印度高度分散的医药市场中赢得了宝贵的一席之地。1990年代初，印度政府为加入WTO开始调整药品专利政策。具有前瞻眼光的太阳制药立即将研发投入强度提升至8%，并在Vadodara建立现代化研发设施，随后成立了太阳制药高级研究中心(SPARC)。1994年，公司成功上市，融资建设了Panoli原料药工厂和Silvassa制剂厂，为后续发展奠定了坚实基础。数据显示，在整个1990年代，太阳制药的销售额增长近30倍，净利润增长约50倍，创造了印度制药行业的增长奇迹。这一时期奠定的"研发+原料药+制剂"垂直一体化模式，成为太阳制药日后参与国际竞争的核心竞争力。二、扬帆出海：国际化扩张战略（1995-2014）随着1995年印度加入WTO，太阳制药开启了国际化征程。与Ranbaxy和Dr.Reddy's等早期出海者不同，太阳制药采取了"原料药先行"的国际化策略。公司先后收购Knoll Pharma、Lyka Organics等原料药企业，到2000年已拥有5个原料药生产基地，原料药销售额达20.6亿卢比（约4400万美元），占总营收的三分之一，其中出口占原料药销售的73%。在制剂国际化方面，太阳制药展现了"不良资产改造"的独特能力。1997年，公司以仅750万美元的价格控股了陷入困境的美国底特律Caraco药厂。经过改造和FDA认证后，Caraco成为太阳制药进军美国市场的桥头堡，到2000年已持有5个ANDA批文。这种"低价收购+改造升级"的模式后来成为太阳制药国际扩张的标配。进入21世纪后，太阳制药加快了国际化步伐。2007年，公司以4.54亿美元收购以色列Taro Pharma，大幅提升了在北美市场的份额。2014年，太阳制药以40亿美元的天价收购陷入"掺假"风波的Ranbaxy，一跃成为全球第四大仿制药巨头。通过这一系列并购，太阳制药在2010年的总营收达到608亿卢比（约13亿美元），拥有225个ANDA批文，规模与Dr.Reddy's、Lupin等印度老牌药企比肩。太阳制药的国际化战略呈现出三个显著特点：一是梯度推进，从周边国家到前苏联地区，再到欧美成熟市场；二是多元化布局，原料药与制剂并重，仿制药与品牌药兼顾；三是本土化运营，通过收购当地企业快速获得注册、生产和销售能力。这种立体化的国际化策略使太阳制药成功实现了从印度本土企业到跨国药企的蜕变。三、瓶颈显现：印度仿制药行业的集体困境（2015-2020）2015年后，全球仿制药市场环境发生剧变，太阳制药与其他印度药企一样，面临着增长瓶颈的严峻挑战。数据显示，2015-2020年间，太阳制药的销售额年均增长率仅为0.8%，远低于Aurobindo的9.5%和Cipla的4.1%。这种增长乏力主要源于三方面因素：美国市场饱和是最直接的挑战。作为太阳制药最重要的海外市场，美国仿制药市场的替代率已达90%以上。随着竞争的加剧，仿制药价格持续下滑，而印度企业在美国ANDA申请中的占比高达35.3%，内卷严重。虽然印度仿制药在美国的市场份额从2014年的12.8%上升到2021年的22.5%，但增量难以抵消价格下跌的影响。新兴市场开拓受阻加剧了增长困境。太阳制药曾试图通过收购Ranbaxy拓展欧洲和日本市场，但效果不彰。欧洲市场高度碎片化，各国定价和报销政策差异大；日本市场则受政府严格的价格管制，利润微薄。截至2021年，印度仿制药在欧洲市场的份额不足10%，真正取得成功的只有Intas和Aurobindo等少数企业。原料药优势丧失动摇了竞争根基。随着中国原料药产业的崛起，印度在全球原料药市场的领导地位已被取代。太阳制药虽然拥有垂直一体化的生产体系，但在成本上已无法与中国企业抗衡。面对这些挑战，太阳制药的财务表现明显下滑。数据显示，2015-2020年间，公司净利润率从15.8%降至8.5%，反映出仿制药业务的利润空间正在被快速压缩。然而,这种困境是印度仿制药企业"低成本、大批量"传统模式遭遇天花板的必然结果。四、华丽转身：专科药驱动的战略转型（2014-2024）为突破增长瓶颈，太阳制药在2014年收购Ranbaxy后启动了全面转型，战略重心从"规模驱动"转向"价值驱动"。公司制定了清晰的转型路径：通过发展专科药、高壁垒仿制药和品牌药，提升产品组合的附加值。皮肤科成为转型的第一个突破口。2014年，太阳制药通过授权引进默沙东的Ilumya（tildrakizumab），与原有的Sotret、Lulicon等产品组成了皮肤科产品线。随后，公司又收购了Dusa Pharma、日本Pola Pharma和Galderma的皮肤业务，形成了完整的"仿-创结合"产品矩阵。到2023年，皮肤科产品销售额已达5.8亿美元，占专科药业务的56%。在眼科领域，太阳制药通过收购InSite Vision、Ocular Tech等公司，并自主开发BromSite、Cequa等产品，构建了颇具竞争力的眼科管线。这种"自主研发+并购补充"的模式，使太阳制药快速积累了专科药领域的专业知识和市场资源。更值得关注的是太阳制药在肿瘤科的布局。通过授权引进Daromun、Fibromun等产品，公司逐步建立了肿瘤专科产品线。2023年，太阳制药以5.76亿美元收购Concert Pharma，获得氘代芦可替尼（deuruxolitinib），进一步强化了肿瘤管线。太阳制药的转型战略呈现出三大创新点：一是"混搭模式"，将仿制药、品牌药和创新药组合在同一治疗领域；二是"区域差异化"，在不同市场推广不同的产品组合；三是"授权合作"，通过与跨国药企合作降低研发风险。转型成效已经开始显现。数据显示，太阳制药的专科药业务占比从2018年的7%上升至2023年的18%，推动公司销售额在2023年突破60亿美元。更可喜的是，公司净利润率从2020年的8.5%回升至2023年的19.2%，价值转型成效显著。五、启示与展望太阳制药的转型之路为中国药企提供了宝贵经验：首先，战略前瞻性至关重要。太阳制药早在2014年就预见到仿制药市场的饱和趋势，提前布局专科药，这种远见卓识值得学习。其次，并购整合能力是转型成功的关键。太阳制药展示了出色的不良资产改造能力，将收购的Caraco、Taro等企业转化为战略资产。第三，治疗领域聚焦比产品多元化更有效。太阳制药选择皮肤科、眼科和肿瘤科作为重点领域，集中资源建立专业优势。展望未来，随着氘代芦可替尼等新产品的上市，太阳制药的专科药业务有望在未来五年实现翻倍增长。公司已从昔日的印度仿制药企业蜕变为全球专科药领域的重要参与者，其转型经验将为发展中国家的制药企业提供重要借鉴。作者介绍：魏利军，副主任药师，北京药眼信息咨询有限公司，北京慧药实验室科技有限公司，著有《跨国药企成功启示录》、《仿制药企兴衰启示录》、《制药企业的战略与产品管线建设》和《探寻跨国药企的成功基因》（出版中,预期9月发行），以上内容来自作者新书《探寻跨国药企的成功基因》,但为了方便阅读,笔者使用AI工具进行了内容压缩和简化.药事纵横投稿须知：稿费已上调，欢迎投稿