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

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Companies Advance Collaborative Clinical Development of iTOL-102: A Potential Cure for Diabetes Without the Need for Chronic Life-long Immune Suppression

ZURICH and NESS ZIONA, Israel, Feb. 25, 2025 /PRNewswire/ — NLS Pharmaceutics Ltd. (Nasdaq: NLSP) (“NLS”) and Kadimastem Ltd. (TASE: KDST) (“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).

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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.

Forward Looking Statement
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 It
In 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.

NLS Contacts:
InvestorRelations@nls-pharma.com
www.nlspharma.com

Kadimastem Contacts:
Sarah Bazak, Investors relations
s.bazak@kadimastem.com
www.kadimastem.com 

iTolerance Contacts: 
Investor Contact
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
iTolerance@jtcir.com

Media Contact
Susan Roberts
T: 202.779.0929
sr@roberts-communications.com

Photo: https://mma.prnewswire.com/media/2627327/Kadimastem_s_preIND.jpg

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SOURCE NLS Pharmaceutics Ltd.; Kadimastem Ltd.

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Hexaware Hosts Greater Manchester and West Yorkshire Mayoral Delegation, Deepens Partnership with University of Leeds

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October 23, 2026

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Part of the Great North Mayoral Delegation’s visit to India, discussions focused on Hexaware’s UK expansion and planned R&D centers in Leeds and Manchester

MUMBAI, India, Oct. 23, 2026 /PRNewswire/ — Hexaware Technologies (NSE: HEXT), an AI-first digital and IT services company, hosted a delegation led by Tracy Brabin, Mayor of West Yorkshire, and Bev Craig, Mayor of Greater Manchester, as part of The Great North’s first joint mayoral-led trade mission to India

Hexaware met with Tracy Brabin and delegates from West Yorkshire at its Mumbai office to discuss the company’s UK investment plans, regional employment, and opportunities for technology collaboration across the North of England.

During the visit, Hexaware and the University of Leeds discussed their agreement to strengthen industry–academic collaboration through research, knowledge sharing, and experiential learning opportunities for students.

Earlier in the mission, on October 14 in Bengaluru, Hexaware leaders met Bev Craig, Mayor of Greater Manchester, together with representatives of the British Deputy High Commission and the Invest Manchester team, to discuss Hexaware’s investment in the city region.

Hexaware announced that it will create hundreds of jobs and invest £9 million in a new Design and Innovation Centre at Manchester’s innovation district, SISTER, delivered in collaboration with the University of Manchester. By establishing a base at SISTER, Hexaware will have access to Europe’s largest clinical academic campus on Manchester’s Oxford Road Corridor and a rapidly expanding digital and tech ecosystem within the city.

The visits follow Hexaware’s June 2026 announcement of a £25 million UK expansion, expected to create approximately 1,200 jobs over three to five years across Manchester, Leeds, and Birmingham, including 420 in Manchester and 240 in Leeds. Plans include proposed R&D centers in Manchester and Leeds, with Newcastle also under consideration as a potential future location, given the region’s strong university talent pool and proximity to Scotland.

Parameshwaran Iyer, Executive Vice President & Head – Europe, Hexaware, said, “The North of England is an important part of our UK growth plans. Our investment goes into developing technology capabilities and recruiting graduates from the region’s universities, training them to work with enterprise and public-sector customers. Our new agreement with the University of Leeds will strengthen this pipeline, giving us closer access to graduate talent as we grow our presence in the region. We see considerable potential in the talent and expertise available across these cities.”

Bev Craig, Mayor of Greater Manchester, said, “Greater Manchester has established strengths in healthcare, life sciences, and AI, supported by close cooperation between universities, researchers, and industry. We welcome Hexaware’s plans for Manchester and the opportunities they present for investment, innovation, and employment in these sectors.”

Tracy Brabin, Mayor of West Yorkshire, said, “It was great to visit Hexaware’s headquarters in Mumbai and hear first-hand about the company’s ambitious plans for growth in the UK. Their investment in Leeds and the creation of hundreds of new jobs is fantastic news for West Yorkshire and a strong vote of confidence in our region. Trade missions like this give us the opportunity to meet decision-makers directly, strengthen international relationships and explore how businesses like Hexaware can deepen their links with West Yorkshire to create a stronger, better-off region that works for all.” 

Glenn McCauley, Head of Proposition Development at the University of Leeds, said, “We were delighted to join this Great North Mayoral Delegation to India and to discuss with Hexaware leadership and with the Mayor of West Yorkshire how the University of Leeds’ agreement with Hexaware can be a catalyst to drive economic growth in our region.”

India and the North of England are connected above all through people, with more than 81,000 people of Indian heritage living in Yorkshire and the Humber, and 50,000 people of Indian diaspora in Greater Manchester. Thousands of Indian students also choose universities in the two regions every year. Increasingly, Indian companies are also among the region’s investors and employers. The India–UK Comprehensive Economic and Trade Agreement (CETA), in force since July 2026, alongside The Great North’s investment initiatives, gives that relationship fresh momentum.

Hexaware will continue discussions with regional partners on its proposed R&D facilities, graduate recruitment, and technology partnerships across the North of England, drawing on Leeds’ strengths in digital engineering, data science, robotics, fintech, and technology-enabled care, and Manchester’s strengths in healthcare, life sciences, cyber, and AI.

About Hexaware

Hexaware is a global technology and business process services company. Every day, Hexawarians wake up with a singular purpose: to create smiles through great people and technology. With offices across the world, we empower enterprises worldwide to realize digital transformation at scale and speed by partnering with them to build, transform, run, and optimize their technology and business processes. Learn more about Hexaware at https://hexaware.com.

 

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Fosun Wealth Opens Its First Private Wealth Center in Hong Kong at Harbour City, Tsim Sha Tsui

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October 23, 2026

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Appointment-Only Center for High-Net-Worth Clients, Partnering with Fosun Wealth IFA to Expand Wealth Management Capabilities

HONG KONG, Oct. 23, 2026 /PRNewswire/ — Fosun Wealth International Holdings Limited (“Fosun Wealth”) announced the official opening of its first Private Wealth Center on the 23rd floor of Prudential Tower, at The Gateway, Harbour City, Tsim Sha Tsui, Hong Kong. The center provides a dedicated offline space for meetings and wealth planning in Hong Kong, exclusively tailored for high-net-worth clients. Visits are by appointment only, and the center operates in partnership with Fosun Wealth IFA (Independent Financial Advisor), supporting clients from initial discussions and tailored proposals through to signing and implementation.

The opening ceremony, themed “A Starry New Chapter on Victoria Harbour”, brought together business partners from fund, asset management and insurance industries in Hong Kong to celebrate the occasion.

Expanding amid Industry Growth to Address Clients’ Demand for Long-Term Advice

The opening comes as Hong Kong’s wealth management sector continues to expand. According to the Securities and Futures Commission of Hong Kong, as of the end of 2025, total assets under management (AUM) in Hong Kong jumped 20% year-on-year (YoY) to a record high of HK$42.2 trillion. Among the major segments, AUM of private banking and private wealth management business increased by an impressive 24% YoY to HK$12.9 trillion. At the same time, client expectations have shifted. High-net-worth individuals are increasingly looking beyond fragmented, one-off product recommendations and seeking professional institutions that can deliver cross-market and multi-generational support over the long term.

The center’s location in Harbour City offers views across Victoria Harbour and a calm, private setting. It features four dedicated meeting rooms, with each client received by a relationship manager throughout their visit to allow for in-depth discussions in a confidential environment. In addition to client meetings and document signing, the center will also host smaller, focused sessions to help clients better capture opportunities in Hong Kong’s wealth management market.

Strengthening Collaboration with Fosun Wealth IFA to Enrich Service Matrix

The Private Wealth Center will also serve as a working base for Fosun Wealth IFA, supporting professional discussions and the review of more complex cases. Launched by Fosun Wealth in 2025, Fosun Wealth IFA is Hong Kong’s first one-stop platform for independent financial advisors (IFAs) to establish and grow their practices. It has already built a team of nearly 500 advisors. Built on a compliant licensing framework, the platform integrates diversified financial products, AI-powered tools and structured trainings, supporting advisors from licensing through ongoing professional development to independent practice. The goal is to help raise standards and professionalism across Hong Kong IFA industry.

Fosun Wealth subsidiaries hold securities and insurance brokerage licenses. Under strict compliance, they provide access to insurance, securities, asset management, and corporate financing services. Fosun Wealth has also established partnerships with numerous leading fund houses, asset managers, and insurers, supporting both the Private Wealth Center and the IFA platform.

Cheng Kang, CEO of Fosun Wealth, said: “Hong Kong continues to strengthen its position as an international hub for asset and wealth management, supported by its resilience and openness. This creates a valuable opportunity for us to deepen our presence in the local market. The opening of the Private Wealth Center is more than the launch of a new location—it marks a new chapter in Fosun Wealth’s commitment to serving high-net-worth clients in Hong Kong with a more personal, long-term approach, bringing our ‘warm private wealth stewardship’ to a broader client base. Whether we are serving high-net-worth clients or building a stronger ecosystem for financial advisers, we aim to set a high standard in Hong Kong’s wealth management industry. We will focus on turning our capabilities into lasting value for clients, and work with clients and partners to support the continued growth of the sector.”

About Fosun Wealth International Holdings Limited

Fosun Wealth International Holdings Limited (hereinafter referred to as “Fosun Wealth”) is an AI-driven global one-stop Web5(Web2+Web3) wealth management platform wholly owned by Fosun International Limited (stock code: 656.HK) in Hong Kong. With its solid financial position, Fosun Wealth has obtained various licenses via its subsidiaries, including Type 1, 2, 4, 6, and 9 licenses granted by the Securities and Futures Commission(SFC) of Hong Kong, and an insurance broker license granted by the Insurance Authority(IA) of Hong Kong. Fosun International Securities Limited, a subsidiary of Fosun Wealth, is one of the first batch of brokerages to provide virtual asset dealing service. Fosun Wealth has launched several industry-leading brands, including the Fosun Wealth App, Finloop, FinChain, and Fosun Wealth IFA. For more information, please visit: www.fosunwealth.com.

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SOURCE Fosun Wealth International Holdings Limited

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WOLFX Student Super App Reaches 104 Universities One Month After US Launch

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24 minutes ago

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October 23, 2026

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All-in-one college platform reports 300 percent subscription growth following Arizona campaign 

MELBOURNE, Australia, Oct. 23, 2026 /PRNewswire/ — WOLFX, an all-in-one app designed to help college students thrive academically, socially and financially, has been downloaded by students at 104 universities in 130 cities across the US just one month after its launch in Indiana.

The platform recorded a 300 percent increase in subscriptions following its Rush WOLFX campaign in Arizona. Rush WOLFX is a game of skill that involves college fraternities and sororities putting their business skills to the test to win a $10K prize. 

WOLFX plans to hold six additional Rush competitions at Universities across the country next month.

WOLFX brings together AI-powered study tools, wellness support, a student marketplace and opportunities for student entrepreneurs in a single app, giving students who juggle academic, social and financial pressures one place to manage college life.

“I developed WOLFX to make the lives of college kids better. To see the app being so well received across America gives everyone involved a huge boost,” said Simon Bishop, founder of WOLFX. “As a father, I know college can be a daunting time for students and parents. WOLFX is aimed at easing those fears of loneliness and isolation. I’m so happy WOLFX is making a difference.”

Students say the app is already part of their daily routine.

“This is honestly the only college app you’ll ever need,” said Katie Wolf, a cheerleader at Indiana University. “Whether it’s managing my schedule, working on a business idea or even selling some items on the student marketplace, WOLFX has me covered. This app is a game changer for college students.”

WOLFX Platinum is available for $28.99 per month. WOLFX can be downloaded on iOS and Android.

About WOLFX

WOLFX is a student-focused super app designed to help college students navigate campus life through AI-powered study tools, wellness support, a student marketplace and entrepreneurial opportunities. The platform aims to make college life more connected, manageable and rewarding. WOLFX is available on iOS and Android. Learn more at https://wolfxapp.com/.

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SOURCE WOLFX

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