orexin

Hemophilia Program: Ongoing registrational PRESent-2 and PRESent-3 studies of SerpinPC for the treatment of hemophilia B; PRESent-2 advancing toward interim analysis planned in 2024 Orexin Agonist Program: Clinical proof-of-concept data for ORX750 in sleep-deprived healthy volunteers planned in 2024 LockBody® Technology Platform: Ongoing Phase 1/2a study of LB101 (PD-L1xCD47)for the treatment of solid tumors BOSTON and LONDON, March 28, 2024 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today reported recent business highlights and financial results for the fourth quarter and full-year ended December 31, 2023. “This is an exciting and pivotal time for Centessa,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “We are laser focused on executing the PRESent registrational studies for SerpinPC, a potential first-in-class subcutaneously administered therapy with a differentiated safety pro individuals with hemophilia B, and advancing our orexin receptor 2 (OX2R) agonist development program into the clinic for the treatment of narcolepsy and other sleep-wake disorders.” Dr. Saha continued, “SerpinPC’s novel mechanism of action is designed to prevent or reduce bleeding in persons with hemophilia without depleting natural anticoagulants that help prevent blood clots. The most recent clinical data from our ongoing Phase 2a study showed that an additional 52-weeks of continuous treatment with SerpinPC reduced the median all-bleed ABR by 96% relative to baseline, and no thrombosis has been observed across the study to date. Within the PRESent registrational studies for SerpinPC, we are looking to replicate this safety pro meaningfully reduce bleeding rates for subjects with hemophilia B, with or without inhibitors. We look forward to confirming a dose and advancing to Part 2 of the PRESent-2 study this year.” “We are very excited with progress within our OX2R agonist development program, and more specifically, ORX750, an orally administered, highly potent and selective OX2R agonist,” said Dr. Saha. “In late 2023, we shared preclinical data that we believe support ORX750’s potential to be a best-in-class oral OX2R agonist for the treatment of narcolepsy and other sleep-wake disorders. We remain on track with our goal to share clinical proof-of-concept data for ORX750 in sleep-deprived healthy volunteers this year.” “In parallel, we continue to evaluate our proprietary LockBody technology platform in a first-in-human clinical study of LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody designed to selectively drive CD47 into the tumor microenvironment while avoiding systemic toxicity, in solid tumors. We look to this study to provide valuable insights regarding the safety and tolerability of LB101, as well as the performance of our LockBody platform in a clinical setting.” Recent Highlights In December 2023 and February 2024, the Company presented data from an additional 52-weeks of continuous treatment from the third year (Part 5) of the ongoing Phase 2a study of SerpinPC, an investigational subcutaneously administered novel inhibitor of activated protein C (APC) for the treatment of hemophilia, during presentations at the American Society of Hematology (ASH) Annual Meeting and the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD). Part 5 data from the Phase 2a study showed a continued favorable safety and tolerability pro SerpinPC, as well as sustained long-term efficacy results, as measured by a 96% reduction in the median all-bleed annualized bleeding rate (ABR) from the prospective baseline measured during the pre-exposure observation period. To date, there have been no thromboembolic events and no treatment-related sustained elevations of D-dimer observed throughout the Phase 2a study. In October 2023, the Company announced the dosing of the first subject in its registrational PRESent-3 clinical study of SerpinPC for the treatment of hemophilia B with inhibitors. The Company initiated dosing in its registrational PRESent-2 clinical study of SerpinPC for the treatment of hemophilia B without inhibitors in July 2023. In October 2023, the Company announced preclinical data from in vivo and in vitro studies of its investigational, novel OX2R agonist, ORX750, that we believe support a potential best-in-class pro the treatment of narcolepsy and other sleep-wake disorders. Anticipated Upcoming Program Milestones Hemophilia Program - The registrational PRESent-2 (hemophilia B without inhibitors) and PRESent-3 (hemophilia B with inhibitors) studies of SerpinPC are ongoing. For PRESent-2, the Company plans to confirm a dose and advance to Part 2 of the study based on a review of Part 1 (dose justification) data in 2024 (interim analysis). The primary endpoint of the PRESent-2 study is the rate of treated bleeds (expressed as ABR) during the first 24 weeks of treatment with SerpinPC (Part 2) compared to the observation period. The Company plans to share Part 1 data at a medical conference in late 2024 or early 2025. Orexin Agonist Program - Upon Investigational New Drug (“IND”) clearance, the Company plans to rapidly advance ORX750 into clinical development with the goal of sharing clinical proof-of-concept data in sleep-deprived healthy volunteers in 2024. LockBody Technology Platform - The Phase 1/2a first-in-human clinical study of LB101 (PD-L1xCD47 LockBody) is ongoing. Where applicable, the Company plans to provide updates on preclinical programs including follow-up orexin agonists and LB206, a PD-L1xCD3 LockBody, when they advance toward clinical studies. Fourth Quarter and Full-Year 2023 Financial Results Cash, Cash Equivalents and Short-term Investments: $256.5 million as of December 31, 2023, which includes approximately $6.2 million in net proceeds through ATM sales in the fourth quarter ended December 31, 2023. In addition, the Company received approximately $9.7 million in net proceeds through ATM sales in January 2024. The Company expects its cash, cash equivalents and short-term investments will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility. Research & Development Expenses: $29.7 million for the fourth quarter ended December 31, 2023, compared to $27.8 million for the fourth quarter ended December 31, 2022, and $124.4 million for the full-year 2023 compared to $155.1 million for the full-year 2022. General & Administrative Expenses: $12.3 million for the fourth quarter ended December 31, 2023, compared to $13.8 million the fourth quarter ended December 31, 2022, and $53.7 million for the full-year 2023 compared to $55.2 million for the full-year 2022. Net Loss Attributable to Ordinary Shareholders: $36.8 million for the fourth quarter ended December 31, 2023, compared to $43.2 million for the fourth quarter ended December 31, 2022, and $151.1 million for the full-year 2023 compared to $216.2 million for the full-year 2022. About Centessa Pharmaceuticals Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients. Our most advanced programs include a hemophilia program, an orexin agonist program for the treatment of narcolepsy and other sleep-wake disorders and an immuno-oncology program focused on our LockBody® technology platform. We operate with the conviction that each of our programs has the potential to change the current treatment paradigm and establish a new standard of care. For more information, visit , which does not form part of this release. About SerpinPC SerpinPC is an investigational subcutaneously administered novel inhibitor of APC being developed as a potential treatment for hemophilia, regardless of severity or inhibitor status, and which may also be developed to prevent bleeding associated with other bleeding disorders. The registrational program for SerpinPC in hemophilia B includes a set of clinical studies with multiple components. PRESent-5 is an observational feeder study to collect prospective observational data for minimum defined periods before switching to dosing subjects in the interventional studies. The interventional studies include PRESent-2 (moderately severe to severe hemophilia B without inhibitors, and severe hemophilia A with or without inhibitors) and PRESent-3 (hemophilia B with inhibitors). Additional information on the trials can be accessed at (NCT05605678, NCT05789524, NCT05789537). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC for the treatment of hemophilia B, with or without inhibitors. SerpinPC has not been approved by the FDA or any other regulatory authority for any use. About ORX750 ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1). ORX750 has been shown in preclinical studies to potently activate the OX2R with an in vitro EC50 of 0.11 nM and 9,800-fold selectivity over the human orexin receptor (hOX1R). ORX750 is Centessa’s first orexin product candidate being developed for the treatment of narcolepsy with potential expansion into other sleep-wake disorders. ORX750 has not been approved by the FDA or any other regulatory authority. About the LockBody Technology Platform and LB101 Centessa’s proprietary LockBody technology platform aims to redefine immuno-oncology treatment for patients with cancer. LockBody drug candidates are designed to selectively drive potent effector function activity, such as CD47 or CD3, to the tumor micro-environment (TME) while avoiding systemic toxicity. The first LockBody candidate is LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody which has two anti-CD47 domains blocked by two anti-PD-L1 domains, with proprietary human IgG-derived hinges linking the anti-CD47 and anti-PD-L1 domains. The cell-killing mechanism of action, CD47, is designed to be blocked by the PD-L1 tumor targeting domain until the IgG-derived hinges are naturally degraded in the TME, thus unlocking and activating the CD47 effector function activity in the tumor. LB101 is in a Phase 1/2a clinical trial. Additional information on the trial can be accessed at (NCT05821777). LB101 is an investigational agent that has not been approved by the FDA or any other regulatory authority. Forward Looking Statements This press release contains forward-looking statements. These statements may be identified by words such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” “aim,” “seek,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including statements related to the Company’s ability to discover and develop transformational medicines for patients; its expectations for executing on the Company's pipeline; its expectations on its anticipated cash runway; the timing of commencement of new studies or clinical trials or clinical and preclinical data related to SerpinPC, LB101, LB206, other LockBody candidates, the LockBody technology platform, ORX750 and other orexin agonist molecules; its ability to identify, screen, recruit and maintain a sufficient number of or any subjects in its existing and anticipated studies or clinical trials including PRESent-5, the observational feeder study, PRESent-2 and PRESent-3 and studies or trials of LB101, LB206, and any other LockBody candidates, ORX750 and other orexin agonist molecules and its expectations on executing its research and clinical development plans and the timing thereof; the Company’s ability to differentiate SerpinPC, LB101, LB206, other LockBody candidates, ORX750 and other orexin agonist molecules from other treatment options; the development, design and therapeutic potential of SerpinPC, LB101, LB206, other LockBody candidates, the LockBody technology platform, ORX750 and other orexin agonist molecules; and regulatory matters, including the timing and likelihood of success of obtaining regulatory clearance, obtaining authorizations to initiate or continue clinical trials. Any forward-looking statements in this press release are based on our current expectations, estimates, assumptions and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the safety and tolerability pro our product candidates; our ability to identify, screen and recruit a sufficient number of or any subjects in our existing and anticipated new studies or clinical trials including PRESent-2, PRESent-3, PRESent-5, and studies or trials of LB101 or within anticipated timelines; our ability to execute IND-enabling activities in a timely manner or at all, including with respect to ORX750 and LB206; our ability to protect and maintain our intellectual property position; business (including commercial viability), regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company; risks inherent in developing product candidates and technologies; future results from our ongoing and planned clinical trials; our ability to obtain adequate financing, including through our financing facility with Oberland, to fund our planned clinical trials and other expenses; trends in the industry; the legal and regulatory framework for the industry, including the receipt and maintenance of clearances to conduct or continue clinical testing; our operating costs and use of cash, including cash runway, cost of development activities and conducting clinical trials, future expenditures risks; the risk that any one or more of our product candidates will not be successfully developed and/or commercialized; the risk that the historical results of preclinical studies or clinical studies will not be predictive of future results in ongoing or future studies; economic risks to the United States and United Kingdom banking systems; and geo-political risks such as the Russia-Ukraine war or the Israeli-Palestinian conflict. These and other risks concerning our programs and operations are described in additional detail in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and our other reports, which are on the U.S. Securities and Exchange Commission (SEC). We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law. Contact: Kristen K. Sheppard, Esq. SVP of Investor Relations investors@centessa.com Centessa Pharmaceuticals plc Consolidated Statements of Operations and Comprehensive Loss (unaudited) (amounts in thousands except share and per share data) Quarter Ended December 31, 2023 Quarter Ended December 31, 2022 Year Ended December 31, 2023 Year Ended December 31, 2022 License and other revenue $ 6,853 $ — $ 6,853 $ — Operating expenses: Research and development 29,716 27,835 124,405 155,083 General and administrative 12,315 13,768 53,731 55,200 Change in fair value of contingent value rights — — — 1,980 Loss from operations (35,178 ) (41,603 ) (171,283 ) (212,263 ) Interest income 2,933 39 10,476 244 Interest expense (2,570 ) (2,203 ) (9,906 ) (7,277 ) Other (expense) income, net (878 ) (70 ) (5,428 ) 2,342 Loss before income taxes (35,693 ) (43,837 ) (176,141 ) (216,954 ) Income tax (benefit) expense 1,144 (664 ) (25,056 ) (747 ) Net loss (36,837 ) (43,173 ) (151,085 ) (216,207 ) Other comprehensive income (loss): Foreign currency translation adjustment 459 198 1,700 (2,185 ) Unrealized gain on available for sale securities, net of tax 255 — 1,290 — Total comprehensive loss $ (36,123 ) $ (42,975 ) $ (148,095 ) $ (218,392 ) Net loss per ordinary share - basic and diluted $ (0.38 ) $ (0.45 ) $ (1.57 ) $ (2.31 ) Weighted average ordinary shares outstanding - basic and diluted 97,923,585 94,603,860 96,177,578 93,400,513 Centessa Pharmaceuticals plc Condensed Consolidated Balance Sheets (unaudited) (amounts in thousands) December 31, 2023 December 31, 2022 Total assets: Cash and cash equivalents $ 128,030 $ 393,644 Short-term investments 128,519 — Other assets 103,697 50,663 Total assets $ 360,246 $ 444,307 Total liabilities Other liabilities $ 48,302 $ 38,338 Long term debt 75,700 69,800 Total liabilities 124,002 108,138 Total shareholders’ equity 236,244 336,169 Total liabilities and shareholders' equity $ 360,246 $ 444,307

引言虽然胆汁酸在抑郁症中起着显著的作用，但胆汁酸TGR5膜型受体在该疾病中的病理意义尚不清楚。2024年3月21日，中国药科大学洪浩、唐苏苏、浙江大学王浩共同通讯在Neuron 在线发表题为“TGR5-mediated lateral hypothalamus-dCA3-dorsolateral septum circuit regulates depressive-like behavior in male mice”的研究论文，该研究表明TGR5介导的下丘脑外侧-dCA3背外侧隔膜回路能够调节雄性小鼠的抑郁样行为。利用慢性社会失败应激和慢性约束应激的雄性小鼠抑郁模型，发现抑郁样小鼠下丘脑外侧区(LHA) GABA能神经元TGR5显著降低，其兴奋性增加。上调LHA中TGR5或抑制GABA能兴奋性可显著缓解抑郁样行为，而下调TGR5或增强GABA能兴奋性可促进应激诱导的抑郁样行为。TGR5还通过细胞外调节蛋白激酶依赖的Kv4.2通道双向调节LHA GABA能神经元的兴奋性。值得注意的是，LHA gabaergy神经元特异性地支配背侧CA3 (dCA3) CaMKIIα神经元，介导抑郁样行为。LHA GABAergic TGR5通过去抑制dCA3 CaMKIIα神经元投射到背外侧隔(DLS)发挥抗抑郁样作用。这些发现促进了人们对TGR5和LHAGABA/dCA3CaMKIIα /DLSGABA回路的理解，有助于开发抑郁症的潜在治疗策略。抑郁症是一种高度异质性的情绪障碍，是世界范围内致残的主要原因在复杂的抑郁症病因中，慢性压力是一个主要的危险因素。应激可导致细胞、分子和神经系统功能障碍，这是抑郁症的潜在治疗靶点。新出现的临床证据发现，抑郁症患者和健康人血液中的胆汁酸(BAs)水平存在显著差异，以及BAs与抑郁症症状之间的相关性。动物研究表明，全身服用牛磺酸去氧胆酸(一种亲水性BA)可产生类似抗抑郁的作用。值得注意的是，人类和动物研究都表明BA信号与抑郁症有关。Takeda G蛋白偶联受体5 (TGR5)，也称为G蛋白偶联BA受体(GPBAR1)，是第一个被发现的针对BAs的G蛋白偶联受体。虽然外周TGR5是一种已知的代谢调节因子，但最近的研究表明中枢TGR5参与能量调节。TGR5激动剂可在脑疾病中发挥有益作用。之前的研究发现慢性应激导致海马和下丘脑的TGR5减少，背侧CA3 (dCA3) CaMKIIα神经元的TGR5对抑郁样行为有调节作用，这些发现提出了关于下丘脑TGR5在抑郁症中的潜在参与的有趣问题。模式图（Credit: Neuron）人类神经影像学研究已经报道了抑郁状态下下丘脑的结构、功能和相关网络异常。神经内分泌研究表明，大多数抑郁症患者的下丘脑-垂体-肾上腺(HPA)轴过度活跃。下丘脑外侧区(LHA)，构成下丘脑的很大一部分，在协调各种生理功能(如应激、摄食和睡眠-觉醒状态)中起着重要的神经解剖学中枢作用。LHA是一种异质核，包含GABA能、谷氨酸能和肽能神经元，如食欲素和黑色素浓缩激素(MCH)。人类研究表明，主要由LHA中表达orexin或MCH的神经元合成的orexin或MCH的失调参与了抑郁症的发病机制。LHA - orexin或MCH-表达神经元外侧缰核(LHb)或伏隔核(Acb)介导应激诱导的抑郁样行为。从LHA到LHb的谷氨酸能轴突也参与应激诱导的抑郁症发病，然而，LHA GABA能神经元是否介导抑郁样行为仍不清楚。该研究检测了下丘脑TGR5在雄性小鼠抑郁样行为中的区域和细胞类型特异性作用以及TGR5介导的回路机制。该研究确定了TGR5、LHA GABA能神经元、TGR5介导的细胞信号传导和LHAGABA/ dCA3CaMKIIα/DLSGABA回路在抑郁相关状态中的作用。这项研究增强了人们对TGR5和LHA GABA能神经元作为开发潜在抗抑郁策略的新靶点的理解。原文链接https://www-cell-com.libproxy1.nus.edu.sg/neuron/abstract/S0896-6273(24)00152-1责编|探索君排版|探索君文章来源|“iNature”End往期精选围观一文读透细胞死亡(Cell Death) | 24年Cell重磅综述（长文收藏版）热文Nature | 破除传统：为何我们需要重新思考肿瘤的命名方式热文Nature | 2024年值得关注的七项技术热文Nature | 自身免疫性疾病能被治愈吗？科学家们终于看到了希望热文CRISPR技术进化史 | 24年Cell综述

The exclusive License Agreement grants NLS Pharmaceutics global rights to next-generation non-sulfonamide orexin-1 / orexin-2 receptor agonists, tailored to target multiple pathways in neuropharmacological therapies. Medications activating dual OX1R/OX2R target a broader range of mechanisms involved in neurologic disorders including narcolepsy and other hypersomnolence disorders Additional targets covered by the exclusive License Agreement include cathepsins, sigma receptors and catecholaminergic inhibition, addressing neuroprotection, neuroinflammation and neurotransmission. First patent application was filed at the end of 2022 for orexin receptors agonists for treating or preventing neurological diseases and psychiatric disorders including narcolepsy. With this groundbreaking License Agreement, NLS continues to strengthen its neuroscience pipeline in sleep medicine with a unique and holistic approach to central disorders of hypersomnolence and neurodegenerative disorders franchise. NLS to start immediately focusing on these disease modifying compounds which have the potential to be first as well as best in class. ZURICH, SWITZERLAND / ACCESSWIRE / March 20, 2024 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) ("NLS"), a leading Swiss biopharmaceutical company dedicated to pioneering therapies for rare and complex central nervous system disorders, announced today a groundbreaking exclusive worldwide license agreement (the "License Agreement") with Aexon Labs, Inc., a U.S.-based biotech firm ("Aexon"). This license grants NLS the opportunity to acquire global development and commercialization rights to Aexon's Dual Orexin Receptor Agonists platform. These novel compounds are potent oral agents targeting both orexin-1 and orexin-2 receptors as agonists, with potential applications in narcolepsy, idiopathic hypersomnia, and α-Synucleinopathies, including Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy, all of which involve cathepsins. "The License Agreement highlights the transformative potential of these revolutionary chemical compounds compared to first generation sulfa derivatives, selective OX2R agonists," said Eric Konofal, MD, PhD, who works under a part-time consulting agreement for NLS as its Chief Scientific Officer, and who is also President of Aexon. He continued, "These compounds have focused solely on the role of orexin-2 receptors (OX2R) in treating the symptomatology of narcolepsy. Emerging scientific insights suggest a broader range of complex mechanisms at play in the pathophysiology of tetrad narcolepsy." This exclusive, worldwide License Agreement marks a significant milestone in the field of oral therapeutics, highlighting the introduction of two potentially potent candidates, innovative dual orexin receptor agonists. Anticipated to address critical healthcare requirements, one compound in particular, has shown encouraging outcomes in preliminary in vitro experiments. Its dual mechanism of action involves acting as agonist for OX1R and OX2R, while concurrently serving as an inhibitor for cathepsin H (CTSH), showcasing its potential to meet significant medical needs effectively. Orexin receptor pathways play vital regulatory roles in many physiological processes and studies have shown that orexin receptor pathways are involved in pathological processes of neurological diseases such as narcolepsy, depression, ischemic stroke, drug addiction and Alzheimer's disease. Dr. Konofal continued, "By simultaneously targeting the potential benefits of a compound acting as both a dual agonist of orexin receptors and an inhibitor of CTSH for the treatment of narcolepsy, we combine the agonist effect on orexin-1 and orexin-2 receptors, which have been shown to improve wakefulness and reduce cataplexy, with the prospective benefits of CTSH inhibition. Such inhibition is theorized to be able to influence immune responses via HLA-DQB1 and the processing of proteins related to the pathogenesis of narcolepsy. This double dual-action strategy could offer a comprehensive treatment modality for narcolepsy, addressing both symptom management and the underlying causes of the disease." Subject to obtain sufficient funds, Aexon plans to conduct Proof-of-Concept studies in animals and phase 1 First-in-Human clinical development starting in early 2025. Preliminary findings will be unveiled at the 2024 ASCP Annual Meeting (Miami, Florida, May 28 - 31). Mr. Zwyer said, "I believe acquiring rights to this innovative platform, which includes more than 300 compounds, represents a bridge from current to future treatments for sleep and neurodegenerative disorders. The addition of these new compounds to our existing pipeline-Mazindol ER for narcolepsy, NLS-4 for idiopathic hypersomnia, long-COVID, and chronic fatigue syndrome, and NLS-11 for Kleine-Levin Syndrome and neurodegenerative diseases-will significantly enhance and bolster our central disorders of hypersomnolence franchise. NLS continues ongoing discussions around further development of Mazindol and remains committed to a wide range of options with a focus on maximizing shareholder value, including strategic partnerships and other future strategic actions. Several partnership opportunities are currently under way, though have been delayed due to various market factors, but are in advanced stages of negotiations. As always, we continue to approach the sleep medicine market from a holistic perspective." About Narcolepsy Narcolepsy is a life-long sleep disorder caused by the autoimmune-mediated loss of 70,000-90,000 orexin-producing neurons in the hypothalamus, characterized by excessive daytime sleepiness, cataplexy and rapid eye movement sleep abnormalities, and is tightly associated with human leukocyte antigen HLA-DQB1*06:02. Other predisposing factors for narcolepsy are associations with a polymorphism in the T-cell receptor alpha and beta genes, whose products recognize antigens presented by human leukocyte antigens (HLA) molecules, and CTSH. 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 . About Aexon Labs, Inc. Aexon is conducting leading edge research on new compounds to address unmet needs in neurodegenerative disorders, defined by the breakdown of neurons over time. Alzheimer's, Parkinson's, Huntington's, Narcolepsy and Amyotrophic Lateral Sclerosis are just a few examples of brain disorders that have no cure. Current treatments do not address the root cause of each disorder and often lack therapeutical effectiveness and safety for these neurological disorders. For more information, please visit . Eric Konofal, MD, PhD, who works under a part-time consulting agreement for NLS as its Chief Scientific Officer, is the president and founder of Aexon Labs, and owns 59% of Aexon Labs. Alexander Zwyer, Chief Executive Officer of NLS, owns 35% of Aexon Labs. Mr. Zwyer holds no board or executive position at Aexon Labs. Safe Harbor Statement This press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses the potential benefits of NLS' and Aexon's products, including Aexon's Dual Orexin Receptor Agonists platform, that Aexon's platform's double dual-action strategy could offer a comprehensive treatment modality for narcolepsy, addressing both symptom management and the underlying causes of the disease, that Aexon plans to conduct Proof-of-Concept studies in animals and phase 1 First-in-Human clinical development starting in early 2025 and the expected unveiling of those results, NLS' and Aexon's development plans and timing of studies, the timing and expected outcomes of the License Agreement, and NLS' plans to maximize value, including potential strategic partnerships and other strategic actions. 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: 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, 2022 filed with the Securities and Exchange Commission ("SEC"), which is available on the SEC's website, , and in subsequent filings made by NLS with the SEC. For additional information: Marianne Lambertson (investors & media) NLS Pharmaceutics Ltd. +1 239.682.8500 ml@nls-pharma.com ### SOURCE: NLS Pharmaceutics AG View the original press release on accesswire.com