NLS Pharmaceutics Ltd.

ZURICH, SWITZERLAND / ACCESSWIRE / October 21, 2024 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) (“NLS” or the “Company”), a Swiss clinical-stage biopharmaceutical company dedicated to developing therapies for rare and complex central nervous system disorders, is pleased to announce that its Japanese patent application No. 2020-513594 has been granted. The patent covers the use of Mazindol ER (extended-release) for the treatment of heroin dependence, providing a new therapeutic strategy for opioid use disorder. “The development of mazindol as a treatment for substance use disorder could represent a significant breakthrough, offering new hope for patients battling addiction. It is crucial we align our strategy with the evolving landscape of pharmaceutical innovation in this area.” said Alex Zwyer, Chief Executive Officer of NLSP. “This application highlights the continued commitment from NLS to pioneer therapeutic approaches to address significant unmet medical needs.” Key Highlights of this Patent Mazindol ER for Heroin Dependence : Mazindol, a tetracyclic compound with unique pharmacological properties, has shown promising in vivo results in reducing heroin dependence by modulating neurotransmitter systems involved in reward signaling and addiction pathways. The patent protects the use of Mazindol ER as a treatment for opioid addiction, specifically targeting heroin, one of the most potent and addictive opioids. Mechanism of Action : Unlike traditional opioid agonists and antagonists, Mazindol works by indirectly modulating the reward systems of the brain, targeting opioid receptors such as μ-opioid, κ-opioid, and δ-opioid receptors. By influencing these receptors, Mazindol reduces cravings and compulsive drug-seeking behaviors, helping to mitigate the effects of opioid use disorder without inducing the same level of dependence associated with other treatments. Focus on Long-Term Efficacy : The patent includes claims for the sustained-release formulation of Mazindol, which allows for a steady release of the drug over time, improving patient compliance and reducing the risk of relapse. This extended-release formulation is designed to maintain therapeutic levels of the drug in the bloodstream for prolonged periods, providing more consistent symptom management for individuals recovering from heroin addiction. Scientific Basis Opioid Use Disorder (OUD), particularly heroin addiction, poses a significant public health challenge worldwide. Heroin binds strongly to opioid receptors in the brain, leading to intense euphoria followed by physical dependence and withdrawal symptoms. Traditional treatments often rely on opioid substitution therapies, which can carry their own risks of dependence. Mazindol offers an innovative, non-opioid approach that addresses the brain’s addiction circuitry, potentially reducing the risk of relapse and improving recovery outcomes. The unique effect of Mazindol on heroin dependence lies in its ability to regulate the meso-corticolimbic system, which includes the ventral tegmental area (VTA) and nucleus accumbens-key regions in the brain’s reward circuitry. By normalizing these pathways, Mazindol helps reduce the compulsive behaviors associated with opioid use disorder, offering hope for individuals struggling with heroin addiction. Appeal Decision in Japan NLS Pharmaceutics successfully appealed the original rejection of its patent application, receiving a favorable decision from the Japan Patent Office (JPO) on October 2, 2024. The granted patent, which includes eight claims, provides robust protection for Mazindol ER and its specific use in treating opioid dependence, particularly heroin addiction. This decision reflects an innovative contribution to addiction medicine and positions Mazindol ER as a potentially transformative treatment for heroin dependence in Japan and beyond. About NLS Pharmaceutics Ltd. NLS Pharmaceutics Ltd. is a global development-stage biopharmaceutical company working with internationally recognized scientists and world-class partners to develop innovative therapies for patients with rare and complex central nervous system disorders. Headquartered in Switzerland and founded in 2015, NLS is led by an experienced management team with a track record of successfully developing and commercializing product candidates. For more information, visit . Safe Harbor Statement This press release contains forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS discusses potential benefits of its products and the granted patent. Forward-looking statements are based on the current expectations of NLS management and are subject to numerous factors and uncertainties that could cause actual results to differ. These factors include technology changes, delays or obstacles in launching clinical trials, and the non-approval of NLS products by regulatory agencies. NLS undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this release unless required by law. Detailed risk information is included in NLS’s filings with the U.S. Securities and Exchange Commission (SEC), available at . Contact: Investor Relations Contact InvestorRelations@nls-pharma.com SOURCE: NLS Pharmaceutics AG View the original press release on accesswire.com

在后新冠时代，那些曾经在疫情期间销售额攀上神坛的药物逐渐走向没落，而取而代之的是一类以治疗新冠后遗症Long COVID（长新冠）为代表的药物。 以这一概念为卖点的Biotech公司仍然能在2024年这个时间点获取一定的融资和NIH层面上的补贴（NIH在去年启动它自己关于长新冠的一揽子试验，用来测试潜在的长冠状病毒肺炎疗法，会给予参与企业一定补贴），但在最近这一概念似乎在逐步走向破灭。 越来越多的相关公司在这一概念的尝试中受到重挫。 GeNeuro：“黑暗”势力遭横扫出局 GeNeuro公司的卖点是利用人类基因组中未解明的黑暗区域来治疗Long-Covid，去年10月该公司宣布与Alphabet（谷歌母公司）旗下的精准健康技术公司Verily合作，研究与SARS-CoV-2感染中促炎HERV-W包膜蛋白（W-ENV）激活相关的生物标志物。 而通过这一研究的产物就是该公司的长新冠疗法——抗HERV-W-Env抗体temelimab，GeNeuro也因此在瑞士、西班牙和意大利招募了203名长冠状病毒肺炎患者进行II期临床研究。 然而，II期临床并不顺利，上上周五该公司告诉投资者它并没有达到主要终点和大多数次要终点。现在这家公司的母公司GeNeuro SA已经裁减了该公司九份雇佣协议中的七份，所有的高级管理人员都被裁撤。 Axcella：错误的战略决策 Axcella本身是知名风投Flagship Pioneering孵化的产物之一，但这家公司却没有Moderna那样的好运气。 这家公司主要开发的是内源性调节剂，核心管线AXA1125。实际上最开始这一管线在其他领域的表现不算很糟糕，是Axcella错误的战略决策彻底葬送了AXA1125的未来。 AXA1125在NASH领域一度取得积极进展，最开始也一直针对这一领域布局。2022年2月，AXA1125获得FDA授予治疗NASH的快速通道资格。同年9月，Axcella公布了AXA1125治疗NASH的全球IIb期临床研究中期结果，显示多项积极数据。然而，仅3个月后，Axcella突然决定停止AXA1125针对NASH的II期临床研究，掉头开发Long COVID。 然后结果也看到了，AXA1125在Long COVID的IIa期试验中未能达到主要终点。 2023年12月4日，Axcella向美国证券交易委员会（SEC）提交文件，将进行财产清算并解散公司。其股东以压倒性多数批准了解散和清算的决议。 Virios Therapeutics：长新冠失败甩锅毒株 Virios Therapeutics这家公司管线主要是抗病毒药物IMC-1（泛昔洛韦+塞来昔布），这里主要针对的是协同抑制单纯疱疹病毒HSV-1的激活和复制，最终降低HSV-1介导的疾病症状。HSV-1是疱疹病毒科中感染人类的病毒，在人群中普遍存在且通过接触传染。由HSV-1激活的过度免疫应答被认为是如纤维肌痛（FM）、肠易激疾病（IBS）、慢性疲劳综合征（CFS）等慢性疾病的发病原因。 而长新冠的一种理论就认为是新冠诱导了HSV-1激活的过度免疫应答导致患者纤维肌痛。 有趣的是，Virios Therapeutics在IMC-1临床失败时，给出的理由过于离谱。 说是不同的COVID-19毒株与HSV-1激活之间的相互作用造成了不同时期入组患者疗效上的差异？？？ 这一过于离谱的理由毫无证据，市场也完全不信，这导致这家公司股价跌至0.2美元，基本丧失了流动性。 现在这家公司基本在破产边缘徘徊…… Tonix：山穷水尽 Tonix Pharmaceuticals对纤维肌痛样长冠状病毒肺炎的治疗也同样未能作为疼痛治疗而脱颖而出。去年9月，该公司药物TNX-102 SL的在对长冠状病毒肺炎患者的2期试验中，与安慰剂相比，在疼痛症状方面没有显示出统计学上的显著改善。 笼罩着Tonix的是一条快速萎缩的现金跑道，目前该公司的现金流赛道几乎耗竭，根据今年第一季度披露只剩下了704.90万美元，现在只能靠着和美国政府之间的一些合同获得微薄的收入，也不知道这家公司要如何渡过这个2024年…… 总结 许多Biotech看到了去研究长新冠的补贴而选择了开设相应管线，但是却忽视了管线开设是否合理，毕竟长新冠概念本身其实就很抽象，之前也有研究指出长新冠的发生率其实没想象的那么高，开发难度可能也较为困难。例如辉瑞的Paxlovid实际上就在这种从治疗新冠延伸到治疗长新冠的过程中失败了。 类似的Biotech公司还有Tevogen Bio，NLS Pharmaceutics，AIM ImmunoTech，Laurent Pharmaceuticals等等。他们未来是否会出现类似的情况值得一看。

ZURICH, SWITZERLAND / ACCESSWIRE / June 28, 2024 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP)(Nasdaq:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 3,277,750 of its common shares at a purchase price of $0.24 per share in a registered direct offering. NLS has also agreed to issue in a private placement unregistered warrants to purchase up to an aggregate of 3,277,750 common shares at an exercise price of $0.24 per share. The warrants will become immediately exercisable upon issuance and will expire five years from the date of issuance. The closing of the offering is expected to occur on or about July 1, 2024, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds to the Company from the offering are expected to be $786,660, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for working capital and general corporate purposes, which includes research and development, to advance the Company's technology and general corporate purposes and pursuing strategic opportunities including expanding the Company's pipeline. The common shares offered in the registered direct offering (but excluding the unregistered warrants and the common shares underlying such unregistered warrants) described above are being offered and sold by the Company pursuant to a "shelf" registration statement on Form F-3 (Registration No. 333-262489), including a base prospectus, previously filed with the Securities and Exchange Commission ("SEC") on February 3, 2022, and declared effective by the SEC on February 11, 2022. The common shares to be issued in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC's website located at Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the registered direct offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com. The warrants described above will be issued in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the common shares underlying such warrants, will not be registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying common shares, upon issuance, may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About NLS Pharmaceutics Ltd. NLS is a global development-stage biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders who have unmet medical needs. Headquartered in Switzerland and founded in 2015, NLS is led by an experienced management team with a track record of developing and commercializing product candidates. For more information, please visit Safe Harbor Statement This press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws, including statements related to the timing and completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of proceeds therefrom. These forward-looking statements and their implications are based on the current expectations of the management of NLS only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: market and other conditions; NLS' ability to regain and maintain compliance with Nasdaq's continued listing requirements; changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS' products may not be approved by regulatory agencies, NLS' technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; NLS may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with NLS' process; NLS' products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; NLS' patents may not be sufficient; NLS' products may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; and loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading "Risk Factors" in NLS' annual report on Form 20-F for the year ended December 31, 2023 filed with the SEC, which is available on the SEC's website, , and in subsequent filings made by NLS with the SEC. For additional information: Elena Thyen, CFO NLS Pharmaceutics Ltd. +41(0) 44 512 21 50 etp@nls-pharma.com SOURCE: NLS Pharmaceutics Ltd. View the original press release on accesswire.com