News Hub | News Direct

Direxion Expands Single Stock Leveraged & Inverse ETF Lineup for Exposure to Eli Lilly & Palo Alto Networks

Direxion

Direxion, a pioneer in Single Stock Leveraged and Inverse ETFs, expanded its suite of high-powered trading tools with the launch of four new funds tracking the performance of Eli Lilly and Company (LLY) and Palo Alto Networks, Inc. (PANW). These funds provide traders with amplified, or inverse, exposure to two of the most dynamic sectors – pharmaceuticals and cybersecurity – through the Direxion Daily LLY Bull 2X Shares (Ticker: ELIL) and Direxion Daily LLY Bear 1X Shares (Ticker: ELIS), or the Direxion Daily PANW Bull 2X Shares (Ticker: PALU) and Direxion Daily PANW Bear 1X Shares (Ticker: PALD). “These new ETFs give active traders an edge, whether they want to double down on momentum, or hedge against volatility, in two industry-leading stocks,” said Douglas Yones, CEO of Direxion. “Eli Lilly’s innovation in healthcare, and Palo Alto Networks’ in cybersecurity, make them prime candidates for our growing suite of tactical trading tools. We remain committed to launching new ETF solutions for short-term traders, with more to come in the near future." As ground-breaking products built for active traders, Direxion’s pairs of single stock leveraged and inverse ETFs are meant to be used for short-term trading purposes. Leveraged and inverse single stock ETFs should not be viewed as buy and hold investments, but rather trading tools for traders with a high-risk tolerance. In addition, unlike traditional ETFs, or even other levered and/or inverse ETFs, these ETFs track the price of a single stock rather than an index, eliminating the benefits of diversification. All Direxion leveraged and inverse ETFs are intended only for investors with an in-depth understanding of the risks associated with seeking leveraged investment results, and who plan to actively monitor and manage their positions. There is no guarantee these ETFs will meet their objective. Please visit the Direxion Leveraged and Inverse ETF Education Center, where you will find educational brochures, videos, and a self-paced online course to help you understand if leveraged and inverse ETFs – including single stock ETFs – are right for you. About Direxion: Direxion equips investors who are driven by conviction with ETF solutions built for purpose and fine-tuned for precision. These solutions are available for a broad spectrum of investors, whether executing short-term tactical trades, or investing in thematic strategies. Direxion’s reputation is founded on developing products that precisely express market perspectives and allow investors to manage their risk exposure. Founded in 1997, the company has approximately $47.0 billion in assets under management as of December 31, 2024. For more information, please visit www.direxion.com. There is no guarantee that the Funds will achieve their investment objectives. For more information on all Direxion Shares ETFs, go to www.direxion.com, or call us at 866.301.9214. An investor should carefully consider a Fund’s investment objective, risks, charges, and expenses before investing. A Fund’s prospectus and summary prospectus contain this and other information about the Direxion Shares. To obtain a prospectus and summary prospectus call 866.476.7523 or visit our website at direxion.com. A Fund’s prospectus and summary prospectus should be read carefully before investing. Investing in the funds involves a high degree of risk. Unlike traditional ETFs, or even other leveraged and/or inverse ETFs, these leveraged and/or inverse single-stock ETFs track the price of a single stock rather than an index, eliminating the benefits of diversification. Leveraged and inverse ETFs pursue daily leveraged investment objectives, which means they are riskier than alternatives which do not use leverage. They seek daily goals and should not be expected to track the underlying stock’s performance over periods longer than one day. They are not suitable for all investors and should be utilized only by investors who understand leverage risk and who actively manage their investments. The Funds will lose money if the underlying stock’s performance is flat, and it is possible that the Bull Fund will lose money even if the underlying stock’s performance increases, and the Bear Fund will lose money even if the underlying stock’s performance decreases, over a period longer than a single day. Investing in the Funds is not equivalent to investing directly in LLY or PANW. Direxion Shares Risks – An investment in a Fund involves risk, including the possible loss of principal. Each Fund is non-diversified and includes risks associated with a Fund concentrating its investments in a particular security, industry, sector, or geographic region which can result in increased volatility. A Fund's investments in derivatives such as futures contracts and swaps may pose risks in addition to, and greater than, those associated with directly investing in securities or other investments, including imperfect correlations with underlying investments or the Fund's other portfolio holdings, higher price volatility and lack of availability. As a result, the value of an investment in a Fund may change quickly and without warning. Leverage Risk – The Bull Fund obtains investment exposure in excess of its net assets by utilizing leverage and may lose more money in market conditions that are adverse to its investment objective than a fund that does not utilize leverage. A total loss may occur in a single day. Leverage will also have the effect of magnifying any differences in the Fund’s correlation with LLY or PANW and may increase the volatility of the Bull Fund. Daily Correlation Risk - A number of factors may affect the Bull Fund’s ability to achieve a high degree of correlation with LLY or PANW and therefore achieve its daily leveraged investment objective. The Bull Fund’s exposure to LLY or PANW is impacted by LLY or PANW’s movement. Because of this, it is unlikely that the Bull Fund will be perfectly exposed to LLY or PANW at the end of each day. The possibility of the Bull Fund being materially over- or under-exposed to LLY or PANW increases on days when LLY or PANW is volatile near the close of the trading day. Daily Inverse Correlation Risk - A number of factors may affect the Bear Fund’s ability to achieve a high degree of inverse correlation with LLY or PANW and therefore achieve its daily inverse investment objective. The Bear Fund’s exposure to LLY or PANW is impacted by LLY or PANW’s movement. Because of this, it is unlikely that the Bear Fund will be perfectly exposed to LLY or PANW at the end of each day. The possibility of the Bear Fund being materially over- or under-exposed to LLY or PANW increases on days when LLY or PANW is volatile near the close of the trading day. Eli Lilly and Company Investing Risk – Issuer-specific attributes may cause an investment held by the Fund to be more volatile than the market generally. Eli Lilly and Company faces risks associated with: costly and uncertain research and development of its products; maintaining intellectual property protections; intense competition from multinational pharmaceutical companies, biotechnology companies, and lower-cost generic and biosimilar manufacturers; increasing government price controls and other public and private restrictions on pricing, reimbursement, and access for its drugs; the development of safety or efficacy concerns; among other risks.. Pharmaceutical Industry Risk – The profitability of pharmaceutical companies is highly dependent on the development, procurement and marketing of drugs and the development, protection and exploitation of intellectual property rights and other proprietary information. These companies may be significantly affected by the expiration of patents or the loss of, or the inability to enforce, intellectual property rights. Healthcare Sector Risk — Companies in the healthcare sector may be affected by extensive, costly and uncertain government regulation, rising costs of medical products and services, changes in the demand for medical products and services, an increased emphasis on outpatient services, limited product lines, industry innovation and/or consolidation, changes in technologies and other market developments. Palo Alto Networks, Inc. Investing Risk – Issuer-specific attributes may cause an investment held by the Fund to be more volatile than the market generally. Palo Alto Networks, Inc. faces risks associated with: development of new products and services may be difficult; may be unable to attract new customers; reliance on channel partners; credit and liquidity risk of customers; sales to government entities may be subject to greater scrutiny; intense competition; among other risks. Information Technology Sector Risk — The value of stocks of information technology companies and companies that rely heavily on technology is particularly vulnerable to rapid changes in technology product cycles, rapid product obsolescence, government regulation, and competition, both domestically and internationally, including competition from competitors with lower production cost. Additional risks of each Fund include Effects of Compounding and Market Volatility Risk, Derivatives Risk, Counterparty Risk, Rebalancing Risk, Intra-Day Investment Risk, Industry Concentration Risk, Market Risk, Indirect Investment Risk, and Cash Transaction Risk. Additionally, for the Direxion Daily LLY Bear 1X Shares and Direxion Daily PANW Bear 1X Shares, Shorting or Inverse Risk. Please see the summary and full prospectuses for a more complete description of these and other risks of a Fund. Distributor: ALPS Distributors, Inc. Contact Details Ditto Public Relations Danielle Black, AD direxion@dittopr.co Company Website https://www.direxion.com/

March 26, 2025 09:00 AM Eastern Daylight Time

Market Alert: Inspira Technology Gains Industry Exposure as FDA-Cleared Technology Showcased at Major Conference

Global Markets News

Market News Alerts Reports: Inspira Technologies (NASDAQ: IINN)* is gaining attention today as their FDA-cleared INSPIRA™ ART100 life-support system is being showcased at the prestigious AmSECT International Conference in San Diego, potentially exposing their technology to hundreds of perfusion professionals. This high-profile exhibition comes at a strategic moment for Inspira, with recent developments showing momentum: The FDA-cleared INSPIRA ART100 system is being prepared for deployment in leading U.S. hospitals Recent clinical studies demonstrated 96% accuracy for their HYLA blood sensor technology The company is advancing development of their flagship INSPIRA ART500 system With the company visionairy approach targeting approximately 20 million ICU patients with acute respiratory failure annually worldwide, Inspira aims to address significant markets: the $5.7B blood gas analyzer market and the $19B mechanical ventilation sector. The company's approach allows patients to remain awake during treatment without ventilators—addressing a need where current solutions face significant challenges. This conference appearance raises Inspira's profile within the perfusion community, potentially supporting their commercialization strategy as they work to introduce their technology to medical institutions. * Disclaimer: Nothing in this report constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This report is published Market News Alerts Research, a promotional content brand which is part of the Wall Street Wire™ network. The operators of Wall Street Wire are not registered brokers, dealers, or investment advisers. This distribution contains paid promotional content related to Inspira Technologies and was produced as part of their paid subscription to Wall Street Wire. This report has not been reviewed or approved by Inspira prior to publication. Please review the full disclaimers and compensation disclosures here: redditwire.com/terms. Contact Details Markets News Alerts Editorial Desk globalmarkets.media@gmail.com

March 19, 2025 11:28 AM Eastern Daylight Time

Market Alert: NeuroSense Therapeutics Advances Toward Early Canadian Commercialization of ALS Drug

Global Markets News

NeuroSense's Groundbreaking ALS Combination Therapy PrimeC Advances Towards commercialization in Canada potential for revenue in canada alone of $100-150 million dollars. PrimeC Has Previously Demonstrated Unprecedentedly Strong Clinical Efficacy; Market News Alerts Reports -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN)* has announced significant progress toward the early commercialization of PrimeC in Canada. According to a Form 6-K filed with the SEC this morning, Health Canada has invited the company to a pre-New Drug Submission (pre-NDS) meeting to discuss a potential Notice of Compliance/conditional (NOC/c) regulatory pathway for PrimeC as a treatment for Amyotrophic Lateral Sclerosis (ALS). NeuroSense is targeting potential approval in Canada by H1 2026. The company estimates peak annual revenue potential of $100-150M USD in the Canadian market. This meeting marks a critical step in NeuroSense's regulatory strategy for PrimeC PrimeC is NeuroSense's lead drug candidate for ALS, a novel extended-release oral formulation combining ciprofloxacin and celecoxib. The drug has demonstrated promising results in clinical trials, including the Phase 2b PARADIGM study, which showed a 36% reduction in disease progression and 43% improvement in survival rates compared to placebo. In December 2024, NeuroSense reported positive FDA feedback on its Phase 3 trial design for PrimeC, with plans to initiate the pivotal study in mid-2025. The company has also announced entering a binding term sheet with a global pharmaceutical company to advance PrimeC's development, which includes substantial upfront payments and funding for the Phase 3 program. This Canadian regulatory development represents a potential pathway to earlier commercialization while the larger Phase 3 program proceeds for global markets. The neurodegenerative disease treatment market has witnessed transformative licensing deals that highlight the immense value of innovative therapies. GlaxoSmithKline's 2021 collaboration with Alector set a remarkable precedent with a $700 million upfront payment and potential milestone payments of $1.5 billion, while the Biogen and Denali Therapeutics partnership in 2020 involved $560 million upfront and potential milestones approaching $1.125 billion. These deals underscore the pharmaceutical industry's willingness to invest heavily in breakthrough neurological innovations, potentially like NeuroSense's PrimeC. Some Wall Street Analysts reportedly maintain a Buy Rating for NeuroSense with AGP giving the company a $7.50 price target representing a significant premium over current Prices; * Disclaimer: Nothing in this report constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This alert is published by Market News Alerts, a promotional content brand which is part of the Wall Street Wire™ network. The operators of Wall Street Wire are not registered brokers, dealers, or investment advisers. This distribution is paid promotional content related to NeuroSense Therapeutics and was produced as part of their paid subscription to Wall Street Wire. This report has not been reviewed or approved by NeuroSense Therapeutics prior to publication. Please review the full disclaimers and compensation disclosures here: redditwire.com/terms. We are not responsible for the price targets mentioned in this article nor do we it endorse them, they are quoted based on publicly available news reports and additional or price targets may exist that may not have been quoted. Readers are advised to refer to the full reports mentioned on various systems and the disclaimers/disclosures they may be subject to. Contact Details Market News Alerts Editorial Desk globalmarkets.media@gmail.com

March 19, 2025 11:01 AM Eastern Daylight Time

Cortland Biomedical Expands Braiding Capabilities with New Flat and Round-Flat-Round Braiders to Drive Medical Device Innovation

Cortland Biomedical

Cortland Biomedical, a full-service biomedical textile product development partner that provides access to a full spectrum of custom engineering services, has expanded its braiding capabilities with the addition of flat braiding and round-flat-round braiding equipment. This latest investment provides Cortland Biomedical’s OEM customers with access to a full suite of braiding technologies, further strengthening the company’s position as a trusted partner enabling less invasive medical devices across a range of surgical applications. Braids plays a critical role in the design and performance of implantable medical textiles, particularly for orthopedic and sports medicine applications such as tendon and ligament repair. Flat braiding enables precise control over width and thickness, offering enhanced customization for applications requiring flexible yet strong structures that are able to distribute and bear force effectively. Meanwhile, round-flat-round braiding allows for seamless transitions between different braid geometries, optimizing load distribution and mechanical properties essential for next-generation medical devices. This unique structure enables a needle to be attached to the round section or tip, providing additional functionality. “With the addition of these new braiders, we are expanding the design possibilities for our customers, giving them even greater flexibility in developing high-performance biomedical textiles,” said Wesley Conger, engineering director, Cortland Biomedical. “This investment underscores our commitment to delivering custom textile solutions that meet the evolving needs of the medical device industry.” The expanded capabilities complement Cortland Biomedical’s existing expertise in braiding – which already included low and high density braiding, and branch braiding -- as well as woven, knitted, and other advanced textile engineering solutions. By offering a comprehensive range of biomedical textile technologies, the company continues to support OEMs in accelerating innovation and improving patient outcomes. About Cortland Biomedical Cortland Biomedical – which is now FDA registered -- custom designs and manufactures high-performance biomedical textile structures leveraging years of experience in medical textile engineering methods including knitting, braiding and weaving. Its thoughtful design concepts challenge the status quo. Cortland Biomedical’s unique combination of advanced equipment and technology, a seasoned medical textile engineering team, and first-rate R&D capabilities allows it to tackle customers’ complex challenges with the innovation and agility expected in the medical device industry. Learn more at cortlandbiomedical.com. Contact Details Jordan Bouclin, SVM Public Relations +1 401-490-9700 Jordan.bouclin@svmpr.com Company Website https://www.cortlandbiomedical.com/

March 19, 2025 10:00 AM Eastern Daylight Time

Bacula Systems Announces Direct Integration with ZFS for Enhanced Backup and Recovery Performance

Bacula Systems

Bacula Systems, a global leader in high-security, high-performance backup and recovery solutions, today announced its latest Use Case: native integration and interoperability with the ZFS file system. This latest enhancement empowers organizations with seamless, high-performance backup and recovery capabilities specifically optimized for ZFS-based infrastructures. The integration of ZFS into Bacula Enterprise enables enterprises and high-performance computing (HPC) environments to take full advantage of ZFS’s advanced storage management features while leveraging Bacula’s robust, scalable, and highly secure backup and disaster recovery capabilities. “Bacula continues to set the standard for reliability, security, and exceptionally high performance in backup and recovery, and our new native ZFS integration further expands our customers’ ability to protect and manage their data in the most efficient way possible. By enabling seamless, high-speed backup and reliable restore operations for ZFS environments, Bacula helps organizations reduce complexity, improve storage efficiency, and maintain strict security and compliance requirements. This is one of a series of important announcements we are making in the high performance file systems space” said Frank Barker, CEO of Bacula Systems. Key Benefits of Bacula’s ZFS Integration: Snapshot-Based Backups: Bacula leverages ZFS snapshots to enable efficient, low-latency backups without impacting system performance. Speed: Bacula’s ZFS capabilities include a fast incremental accelerator for massive file systems and big data volume - all done automatically. Workload Efficiency: Bacula integrates with ZFS's diff feature to quickly backup only necessary/modified files, without needing to scan the entire file system. Advanced Data Protection: Bacula complements its ZFS capabilities with configurable compression, checksum verification, advanced encryption technology, comprehensive ransomware protection, air-gapped architectures, highly flexible immutable storage options and many other highly customizable data protection features for compliance-driven industries. Seamless Scalability: Optimized for large-scale environments, Bacula’s ZFS integration provides ultra-fast backup of snapshot differences of massive datasets. Cost-Efficiency: Organizations can significantly lower their storage costs by leveraging Bacula’s advanced deduplication and compression capabilities in conjunction with Bacula’s efficient data management features. Bacula Systems continues to expand its leadership in providing powerful, customizable, and highly secure backup and recovery solutions tailored for enterprises and HPC environments. The addition of built-in ZFS interoperability underscores Bacula’s commitment to delivering high-performance, flexible, and cost-effective data protection for IT teams managing large and complex workloads. Bacula Systems customers include NASA, Navisite, Texas A&M University, Sky PLC, Warner Bros Discovery, Locaweb and many more. For more information about Bacula’s ZFS integration and enterprise backup solutions, visit www.baculasystems.com. About Bacula Systems: Bacula Enterprise is an exceptionally secure, highly scalable backup and recovery software for large organizations, data centers and MSPs. www.baculasystems.com Contact Details Rob Morrison rob.morrison@baculasystems.com +41 21 641 60 80 rob.morrison@baculasystems.com Company Website https://www.baculasystems.com/

March 05, 2025 07:11 AM Eastern Standard Time

Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment

NLS Pharmaceutics

NLS Pharmaceutics Ltd. (Nasdaq: NLSP”) (“NLS”) and Kadimastem Ltd. (“Kadimastem”), a clinical-stage company specializing in "off-the-shelf" allogeneic cell therapy products for neurodegenerative diseases and diabetes, in collaboration with iTolerance Inc. (“iTolerance”), a U.S. based regenerative medicine company, announced today the result from the Type B pre-IND meeting held by Kadimastem and iTolerance with a committee of the U.S Food and Drug Administration (“FDA”) on February 24, 2025, regarding the development of iTOL-102, a potential cure for diabetes that would not require life-long chronic immune system suppression. iTOL-102 is an investigational biologic for the treatment and potential cure of Type 1 Diabetes consisting of Kadimastem’s allogenic human stem cell-derived pancreatic islets (IsletRx cells) combined with iTolerance’s immunomodulator (iTOL-100). Kadimastem and iTolerance believe that the completion of the pre-IND meeting is a significant milestone toward the clinical development of iTOL-102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by grants received from the Israel-U.S. Binational Industrial Research and Development Foundation. iTOL-102 was evaluated at the fast-track center for testing at the Diabetes Research Institute (“DRI”) at the University of Miami School of Medicine, where it was designated as a potential breakthrough transplantation approach for the treatment of Type 1 Diabetes, as the novel combination of tolerance-inducing agent and human stem cell-derived islets. iTOL-102 demonstrated functional insulin release and disease reversal in an animal model, with full compatibility between IsletRx cells and iTOL-100. Prior to the meeting with the FDA, Kadimastem and iTolerance received a preliminary response document from the FDA, providing critical feedback on their current preclinical and clinical development plans. This guidance is instrumental in moving forward with the next stages of development. Based on the feedback provided at the pre-IND meeting, Kadimastem and iTolerance are now updating their plans for a safety toxicology study and the preparation of a First-in-Human clinical trial. Kadimastem believes its collaboration with iTolerance signifies a potentially transformative step in diabetes treatment, paving the way towards the potential development of iTOL-100 and requesting regulatory approvals for commercialization of a potential cure for type 1 diabetes. iTOL-100 is an immunomodulatory microgel technology being developed by iTolerance designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem’s IsletRx human stem cell-derived islets. Kadimastem’s IsletRx is a clinical-grade product candidate comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the necessary amounts of insulin and glucagon. Dr. Anthony Japour, Chief Executive Officer of iTolerance, commented, “I believe that the feedback from the FDA is a critical milestone in the development of iTOL-102, and we are encouraged by their support for our innovative approach to treating Type 1 diabetes. We believe that the successful outcome of this meeting validates our commitment to bring a game-changing therapy to patients, one that could ultimately eliminate the need for chronic life-long immunosuppression. We look forward to continuing our collaboration with Kadimastem and working closely with the FDA.” Alex Zwyer, CEO of NLS, commented, “I believe that the news demonstrates the strength of the proposed merger of NLS and Kadimastem and its technology platform to build a healthy, strong merged company that will benefit shareholders.” Kadimastem Executive Chairman and CEO Ronen Twito said, "The promising results from the fast-track center for testing at the DRI, combined with the comprehensive studies conducted by iTolerance and Kadimastem, enabled us to complete this important milestone. We are working closely with the FDA on the necessary steps needed to implement this potential innovative technology for patients with Type 1 diabetes and demonstrate a novel islet cell transplantation approach with no need for immunosuppression.” About Kadimastem Kadimastem is a clinical stage cell therapy company, developing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications. IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, Chief Scientific Officer of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST). About iTolerance, Inc. iTolerance is a regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic cadaveric and stem cell-derived pancreatic islet to potentially cure Type 1 diabetes. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com. We are a clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system, or CNS, disorders, who have unmet medical needs. This press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS and Kadimastem are using forward-looking statements when they discuss the belief that the results of the pre-IND meeting with the FDA demonstrates the strength of the proposed merger; that the meeting with the FDA is a significant milestone in the development of iTOL-102, and the expected benefits of iTOL-102 in the treatment of diabetes. These forward-looking statements and their implications are based on the current expectations of the management of NLS and Kadimastem 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: risks related to the companies’ ability to complete the merger on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of the closing conditions related to the merger agreement and risks and uncertainties related to the failure to timely, or at all, obtain shareholder approvals for the transaction; unexpected costs, charges or expenses resulting from the transaction and potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger; changes in technology and market requirements; either or both companies may encounter delays or obstacles in launching and/or successfully completing their clinical trials; the companies’ products may not be approved by regulatory agencies; their technologies may not be validated as they progress and their methods may not be accepted by the scientific community; either of both of the companies may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with the products being advanced by the companies; their products may wind up being more expensive than anticipated; 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; the companies’ patents may not be sufficient; their products may harm recipients; changes in legislation may adversely impact either or both of the companies; 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 candidate products to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, neither Kadimastem nor NLS undertakes any 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’s annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”), which is available on the SEC’s website, www.sec.gov, and in subsequent filings made by NLS with the SEC, including under the heading “Risk Factors” in NLS’s registration statement on Form F-4, filed with the SEC on December 27, 2024. This press release may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under Kadimastem’s control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the company's activity, as well as developments in the general environment and external factors affecting the company's activity. The company's results and achievements in the future may differ materially from any presented herein and the company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This press release does not constitute a proposal to purchase the company's securities or an invitation to receive such offers. Investment in securities in general and in the company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future. No Offer or Solicitation: This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Additional Information about the Transaction and Where to Find ItIn connection with the proposed transaction, NLS has filed a Registration Statement on Form F-4, including a proxy statement/prospectus, with the SEC. NLS may also file other relevant documents with the SEC regarding the proposed transaction. This document is not a substitute for the proxy statement/prospectus or any other document that NLS may file with the SEC. The proxy statement (if and when available) will be mailed or delivered to shareholders of NLS and Kadimastem. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the proxy statement/prospectus (if and when available) and other documents containing important information about NLS and Kadimastem and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by the Company will be available free of charge on NLS’s website at www.nlspharma.com. Participants in the Solicitation: NLS, Kadimastem, and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from NLS and Kadimastem shareholders in respect of the proposed transaction. Information about the directors and executive officers of NLS, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in NLS’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, which was filed with the SEC on May 15, 2024. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed merger when such materials become available. Investors should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from NLS Pharmaceutics using the sources indicated above. Contact Details NLS Pharmaceutics Ltd. NLS Pharmaceutics Ltd. +41 44 512 21 50 contact@nls-pharma.com Kadimastem Ltd. Sarah Bazak +972 73-797-1615 s.bazak@kadimastem.com Company Website https://nlspharmaceutics.com/

February 25, 2025 07:00 AM Eastern Standard Time

Image

NAVEX One: The Trusted Partner for NIS2 Risk Alignment

NAVEX Global

NAVEX, the global leader in integrated risk and compliance management software, is pleased to offer the first GRC solution to holistically address NIS2 across training, policies and assessment – all on one platform, NAVEX One. NAVEX continues to provide risk and compliance professionals with the tools they need to align with the latest cybersecurity regulations. As organizations face increasing regulatory demands, NAVEX One integrates policy management, training and risk assessment resources to ensure seamless compliance with the European Union’s Network and Information Security Directive (NIS2). The NIS2 Directive raises the bar for cybersecurity and reporting standards across industries, including banking, healthcare, manufacturing and energy. Organizations must not only comply with these heightened regulations but also ensure their cybersecurity frameworks are strong enough to withstand evolving threats. “NIS2 is a critical milestone in cybersecurity regulation, and organizations need a partner that helps them do more than just check the compliance box,” said A.G. Lambert, chief product officer at NAVEX. “NAVEX One empowers compliance and risk professionals to build a sustainable and proactive approach to cybersecurity, ensuring their programs are compliant and resilient against emerging threats.” NAVEX One serves as an essential tool in the journey toward risk and compliance maturity, helping organizations: Conduct proactive risk assessments to identify and mitigate vulnerabilities Centralize and streamline policy management to meet regulatory expectations Strengthen cybersecurity posture with comprehensive security awareness training Stay ahead of evolving cybersecurity requirements through continuous program improvement and board-ready reporting Extend training, policies and cyber risk practices to align third parties with its cyber risk standards “Organizations today require more than just static risk and compliance checklists—they need dynamic, integrated solutions that evolve with regulatory changes and emerging risks,” said Kyle Martin, vice president of risk solutions at NAVEX. “NAVEX One’s content and capabilities give businesses the confidence to proactively address NIS2 requirements while reinforcing their broader risk management strategies.” By integrating these capabilities within a single platform, NAVEX One simplifies compliance, reduces risk exposure, and supports organizations in building future-proof compliance programs. Click here, for more information on NAVEX One and the NIS2 Directive. NAVEX is trusted by thousands of customers worldwide to help them achieve the business outcomes that matter most. As the global leader in integrated risk and compliance management software and services, we deliver solutions through the NAVEX One platform, the industry’s most comprehensive governance, risk and compliance (GRC) information system. For more information, visit NAVEX.com and our blog. Follow us on Twitter and LinkedIn. Contact Details Navex Global scott.levesque@navex.com Company Website https://navex.com

February 18, 2025 12:50 PM Eastern Standard Time

SBC Medical (NASDAQ: SBC) Announces New Translation App After Zacks & Sidoti Initiate Coverage, Emphasize Strong Growth

Benzinga

By Gerelyn Terzo, Benzinga With a potential Goldilocks setup in the economy being encouraged in part by a resilient consumer, the broader stock market was hovering near record territory toward the end of last year. Not to be outdone, healthcare-related companies have also been rallying, as evidenced by a gain of almost 20% in the S&P 500 Health Care Sector Index over the past 12 months. One of the stocks that has captured the attention of Wall Street of late is Tokyo-based SBC Medical Group (NASDAQ: SBC), a fast-growing service provider in the burgeoning medical aesthetics market that trades on Nasdaq. Most recently, Zacks Small-Cap Research (SCR) and Sidoti & Company have initiated coverage on the stock. In the October report, Zacks emphasized SBC Medical Group’s expansion efforts comprising both mergers and acquisitions, and organic growth, owing to a growing franchisee network and revenue base buttressed by a strong balance sheet. SBC Medical has been an early mover in Japan’s aesthetic medicine market, which according to the analyst firm, serves as a tailwind for future growth. Zacks SCR believes SBC Medical has “significant value.” Investors who are looking to back a leader in the medical innovation space can learn more about the opportunity in SBC Medical stock here. SBC Medical’s Growing Revenue Chief among the catalysts for the outlook in the report is SBC Medical’s strong reported revenue growth. The company’s revenue has been growing year-over-year, increasing from $174 million in 2022 to $194 million in 2023. Total revenues for the nine months ending Sep. 30, 2024 were $160 million, representing an increase of 23% from $131 million in the same period of 2023, SBC said. As a franchisor, SBC Medical has been growing its footprint amid a rising number of clinics in its vast network that contribute royalty revenue. In addition to Japan, the company also operates clinics in Los Angeles and Ho Chi Minh City, Vietnam, and has set its sights on a global expansion. SBC Medical is also operating in the black, reporting that with net income for the nine months ending Sep. 30, 2024 of $40.1 million, compared to $24.3 million in the same period of 2023. The company’s performance is being fueled by rising royalty income and other revenue streams with high gross margins, it says. Capitalizing On Medical Tourism For New Revenue Opportunities In 2025 The company has announced numerous initiatives to enhance its revenue streams in order to continue to grow its business both domestically and internationally. In January, SBC announced the launch of its proprietary translation app tailored for medical aesthetics staff and the full-scale implementation of its Inbound-Focused Clinics initiative. SBC says this move is designed to address the growing demand for medical tourism and to ensure that international patients can seamlessly experience Japan's advanced medical aesthetic treatments. Within Asia, rising awareness of aesthetic care and the increasing appeal of medical tourism are positioning countries like Japan, South Korea, and Thailand as top destinations for international patients, SBC notes. In Japan, the influx of foreign patients seeking high-quality medical aesthetics continues to rise. SBC alone says it welcomes over 10,000 inbound patients annually, with inquiries surpassing 20,000 each year. China remains a key market driver, though demand from English-speaking regions is also on the rise, the company says. Recognizing this trend, SBC says it is scaling up its operational capacity and implementing innovative solutions to support sustainable growth in this dynamic sector. Striving To Shift Communication With A Specialized Translation App To address language barriers, SBC has developed a translation app tailored specifically for medical aesthetics. It says the app ensures the accurate translation of specialized terminology, facilitating seamless communication between clinic staff and international patients. Currently supporting English and Chinese, the app plays a pivotal role in enabling smooth consultations and pre-treatment explanations. By creating a welcoming environment where language is no obstacle, SBC says it is empowering patients to feel secure and confident in their treatment choices. Future plans include expanding the app's language capabilities and rolling it out across all clinics nationwide, ensuring comprehensive accessibility for a global clientele, SBC noted. SBC Medical’s Valuation: Opportunities And Risks Zacks SCR pointed out that the medical aesthetic market is one that lacks direct competitors despite some companies offering similar services to SBC Medical. As a result, it is difficult to make apples-to-apples comparisons on the stock valuation as analysts typically do. In response, the Zacks analyst has taken a subset of the medical aesthetics space specializing in the healthcare sector to determine a fair valuation. The estimate is contingent upon the company executing on its growth plans as well as a broadening of its initiatives. Zacks SCR is encouraged by SBC Medical’s engagement with the industry, as evidenced by its participation in the Aesthetic Surgery and Laser Society (ASLS) aesthetic medicine conference in Korea held earlier this year. The firm also mentioned SBC Medical’s recently inked partnership with Tokyo-based technology provider B4A, which provides high-tech business solutions. SBC Medical’s mettle was tested amid a business combination with Pono Capital Two, a deal that was completed in Septemb er 2024, paving the way for the stock’s debut on Nasdaq. When it comes to investing, there are no sure things. Zacks SCR and Sidoti have also outlined potential risks that investors might consider. Among them is the uncertain nature of the wider aesthetic medical industry, which is heavily dependent on emerging technology for its growth. SBC’s international presence presents a foreign exchange risk since Its businesses are transacted in Japanese yen but translated into U.S. dollars for reporting purposes, a dynamic that has affected the company’s year-to-date financial performance in 2024. Investors who believe that the benefits outweigh the risks in SBC Medical’s stock can dive deeper into some of the company’s latest developments and offerings here. Featured photo by nattanan23 on Pixabay Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

February 07, 2025 08:35 AM Eastern Standard Time

Image

Cognition Therapeutics Presents Phase 2 Results For Drug To Fight DLB At International Conference

Benzinga

By Meg Flippin, Benzinga Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders including dementia with Lewy bodies (DLB), had the opportunity to raise awareness about its experimental drug zervimesine (CT1812) when the company presented trial results in a podium presentation at the International Lewy Body Dementia Conference (ILBDC). The eighth International Lewy Body Dementia Conference, held in Amsterdam last week, drew an international audience of advocates, scientists and physicians looking for ways to fight this debilitating disease. Zervimesine is an experimental, orally delivered small molecule oligomer antagonist designed to treat this progressive form of dementia. Cognition Therapeutics recently reported positive topline results of its exploratory phase 2 SHIMMER study for the drug, announcing zervimesine produced strong therapeutic responses across behavioral, functional, cognitive and movement measures in patients with DLB. “Older adults with DLB are often placed in care facilities not because of memory issues, but due to the severity of neuropsychiatric or motor symptoms that overwhelm their caregivers,” said James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine, who was the study director for SHIMMER. “Patients on zervimesine had fewer cognitive fluctuations and showed better motor control than placebo-treated patients. The results from this exploratory phase 2 trial demonstrated zervimesine could have a meaningful, positive impact on DLB patients across multiple measures of cognitive, behavioral, movement and functional performance, potentially enabling people with DLB to live at home with the assistance of their care partners.” DLB Drug Holds Promise DLB is a progressive form of dementia characterized by symptoms that fluctuate in severity and can be difficult to diagnose early. It can cause people to have hallucinations, delusions and anxiety as well as cognitive declines that impair their thinking and reasoning. It can cause uncontrollable changes in alertness, sleep disruptions, tremors and slow movement. DLB impacts about 1.4 million people in the U.S. and is the costliest form of dementia. The double-blind, placebo-controlled phase 2 SHIMMER study had 130 adults enrolled who were evenly divided into groups that received either a placebo or a daily dose of zervimesine for six months. Cognition Therapeutics reported the study met its primary endpoint of safety and tolerability. As presented at ILBDC, zervimesine-treated DLB patients scored an average of 86% better than placebo-treated patients on the neuropsychiatric inventory (NPI) A-L at the end of the study. This tool describes the frequency and severity of 12 separate behavioral symptoms. The impact on the NPI scale in the SHIMMER trial means that patients receiving zervimesine had fewer or less severe hallucinations and delusions and less anxiety and agitation than placebo-treated patients, the company noted. These symptoms are a hallmark of DLB and can be debilitating for patients. The improvement in these behavioral symptoms was measured not only for patients but also their care partners, who reported improvements in their levels of distress caused by these symptoms. Patients, Caregivers Benefit From Zervimesine Patients who received zervimesine also preserved 52% more of their ability to care for themselves, measured by the activities of daily living (ADCS-ADL) scale, compared to those taking the placebo. Cognition said this was likely due to the improvements in behavioral symptoms as well as a 91% reduction in cognitive fluctuations in zervimesine-treated patients. Cognitive fluctuations are another hallmark of DLB and are described as a non-responsive state that can occur suddenly and last for hours. The person experiencing the fluctuation may or may not be aware that it is happening. On top of all that, the company said that based on trial results, zervimesine treatment allowed patients to maintain 62% better motor function – including gait, balance and tremors – than those on the placebo. “Dr. Galvin’s presentation is an important opportunity to educate an international audience of advocates, scientists and physicians about the impressive efficacy signals that were observed in participants treated with zervimesine (CT1812),” said Anthony O. Caggiano, MD, PhD, Cognition’s CMO and head of R&D. “The improvement we observed across behavioral, cognitive, functional and motor symptoms in zervimesine-treated participants suggest a broad and meaningful impact on their daily lives. These results reinforce zervimesine’s potential to address the complex and debilitating symptoms of this disease.” Featured photo by Pawel Czerwinski on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

February 06, 2025 09:00 AM Eastern Standard Time

Image