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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).

Social Media: LinkedIn, X, Facebook, Instagram

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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Wistron Celebrates Grand Opening of First U.S. Smart Factory Marking Milestone in Global Smart Manufacturing Strategy

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July 22, 2026

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FORT WORTH, Texas, July 21, 2026 /PRNewswire/ — Wistron Corporation (“Wistron”) celebrated the grand opening of its D1 AI smart facility in Fort Worth, Texas, the site where the first NVIDIA GB300 Grace Blackwell Ultra Superchip was built and mass-produced in the United States. The US$ 700 million facility, spanning approximately 324,000 square foot, was officially unveiled during a ceremony led by Wistron Chairman Simon Lin and NVIDIA Founder and CEO Jensen Huang. Jessica Rogers, Director of the Economic Development Department for the City of Fort Worth, and Alexander Tah-ray Yui, Taiwan’s Representative to the United States, were among the government officials and business leaders who attended, marking a milestone in the expansion of Wistron’s global footprint and advanced manufacturing capabilities.

This is a key hub in Wistron’s global AI infrastructure manufacturing network. The facility runs on NVIDIA accelerated computing and integrates NVIDIA’s Nemotron and Cosmos open frontier models and Omniverse and Metropolis libraries, using digital twin technology to optimize factory design, production workflows, and operational efficiency. It is Wistron’s first U.S.-based manufacturing facility, established to serve customers locally and produce NVIDIA’s most advanced and cutting-edge products. Wistron Chairman Simon Lin said “The operation here is not typical manufacturing. It is new, very comprehensive, and high-tech. Right now we produce the NVIDIA GB300 Grace Blackwell Ultra Superchip, and beyond, we are also going to produce the NVIDIA Vera Rubin Superchip here. In the next couple of years, this location will be one of the most important, as we build AI infrastructure here in the United States. I think this is the reason we say that there will be the next chapter, and we are going to empower AI from Texas.”

Responding to Customer Needs: Texas, the Newest Global Manufacturing Hub
At this pivotal moment for global AI infrastructure, Wistron is drawing on decades of global manufacturing experience to expand its footprint in Texas, a state with a well-established ecosystem for logistics, talent recruitment, and advanced manufacturing. The new D1 facility produces the NVIDIA GB300 Grace Blackwell Ultra Superchip and soon, the NVIDIA Vera Rubin Superchip — critical to powering the next generation of AI computing. The new Fort Worth facility strengthens a critical upstream layer of the AI infrastructure supply chain by expanding domestic capacity to assemble and test NVIDIA AI systems. These servers can be integrated into NVIDIA DSX infrastructure, with DSX providing the common architecture and technologies needed to deploy and operate energy-efficient AI factories at scale.

One-Stop Operational Ecosystem Strengthens U.S. AI Supply Chain Resilience
Behind every breakthrough in AI computing lies the manufacturing capability to scale it. Wistron is expanding its AI server production capabilities from Taiwan to the United States, guided by a vision of precision, efficiency, and sustainability. This reflects a broader industry shift: AI leadership is determined not only by technological breakthroughs, but also by the operational capability to transform innovation into high-volume production with consistent quality, supply chain resilience, and predictable delivery. By establishing AI infrastructure manufacturing capacity in the United States, Wistron is building a one-stop operational ecosystem spanning manufacturing and after-sales service — shortening delivery timelines and customer support cycles, strengthening supply chain resilience, and laying the foundation for long-term competitive advantage as AI infrastructure continues to scale.

Partnering with NVIDIA to Pioneer a New Model for Smart Manufacturing and Energy Optimization
As the era of physical AI begins, Wistron is extending its smart manufacturing capabilities to the United States, creating a new model for AI infrastructure production built on digital manufacturing, energy optimization, and local operations. Jensen Huang said: “The largest infrastructure buildout in history is underway. Demand for AI factories—the engine of this next industrial revolution—is incredible, and they must be produced everywhere. Together, NVIDIA and Wistron are restoring US advanced manufacturing capacity in Texas, creating skilled jobs and strengthening America’s AI supply chain.” As demand for advanced manufacturing grows in Texas, smarter planning of production loads and energy use will give the plant greater control and flexibility over its electricity needs.

Turning Global Experience into Scalable AI Infrastructure
Simon Lin stressed that the speed the AI era demands comes with its own responsibility. “In the AI era, the pressure of speed is also a form of responsibility,” Lin said. “We don’t just need to build fast; we need to build right.”

The Fort Worth plant will serve as the core engine of Wistron’s U.S. manufacturing operations, the company said, connecting its global production network with ecosystem partners as it scales advanced AI manufacturing. Wistron said that the investment reflects efforts to deepen its technical capabilities, strengthen the resilience and efficiency of global supply chains, and support the next phase of AI infrastructure development.

About Wistron:
Wistron Corporation is a leading global technology service provider delivering advanced ICT products, AI infrastructure, and manufacturing solutions to technology brands worldwide. With more than 63,000 employees across North America, Europe, and Asia, Wistron continues to expand its AI, cloud, and advanced manufacturing capabilities to support the next generation of intelligent computing. For more information about Wistron, please visit the official website at www.wistron.com. Additional information about the event is available on the event website.

Media Contact:
Joyce WL Chou
joyce_wl_chou@wistron.com

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SOURCE Wistron Corporation

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NSG Bio Accelerates Breakthrough Biotech Innovation in Singapore

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July 22, 2026

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New initiative under NSG Bio Tomorrow will support promising startups developing next-generation approaches in respiratory and neonatal care

SINGAPORE, July 22, 2026 /PRNewswire/ — The NSG Bio Tomorrow initiative aims at supporting emerging life sciences startups working on complex challenges in respiratory and neonatal care.

Launched through the support of Chiesi Group, The Impulse initiative will provide a selected startup with one year of NSG Bio membership and access to a dedicated laboratory bench at NSG Bio Singapore. The initiative is designed to help early-stage biotech companies move from promising science toward stronger proof-of-concept work in a fully equipped research environment.

The initiative comes at a time when the biotech industry is increasingly looking for faster, more connected ways to move high-potential science from the lab toward real-world patient impact. For startups, access to infrastructure is only one part of the challenge. Equally important are the right networks, industry visibility, technical environment, and opportunities to engage with partners who understand the path from early discovery to clinical relevance.

The programme will focus on startups developing innovative biotechnological solutions with potential relevance to chronic respiratory diseases and neonatal conditions. Areas of interest include cell therapies, gene therapies, gene-editing technologies, regenerative tissue engineering, engineered or programmable living systems, lung-targeted delivery platforms, preventive approaches, and small-molecule-based approaches.

The selected startup will gain access to NSG Bio’s laboratory infrastructure, shared workspaces, meeting facilities, and wider community of biotech entrepreneurs, researchers, scientific leaders, and industry partners. The support is intended to help the company advance key research milestones while becoming part of Singapore’s growing life-science innovation ecosystem.

For NSG Bio, the initiative is part of NSG Bio Tomorrow, its ecosystem-building arm created to expand the company’s role beyond facilities and real estate. While NSG Bio is known for providing high-quality laboratory and office infrastructure for biotech companies, NSG Bio Tomorrow focuses on building the programmes, partnerships, and opportunities that help startups grow.

“Biotech companies need more than lab space. They need access, momentum, and the right ecosystem around them,” said Hasyim Sim, Co-Founder and Chief Operating Officer, NSG Bio. “Through NSG Bio Tomorrow, we are building initiatives that help promising startups connect with partners, unlock opportunities, and move their science forward. This initiative reflects exactly the kind of role we want to play in the biotech ecosystem.”

“Chiesi is committed to supporting innovation that can make a meaningful difference for patients, and we work with entrepreneurs, researchers and partners to advance meaningful ideas,” said Fabrizio Conicella, Vice President, Center of Open Innovation & Competence at Chiesi Group. “By supporting this NSG Bio Tomorrow initiative, we want to create an opportunity for early-stage innovators to access the infrastructure and ecosystem support needed to develop impactful science in respiratory and neonatal care.”

NSG Bio Tomorrow programme also reinforces Singapore’s position as a growing hub for biotech innovation in Asia, where startups, research institutions, investors, and industry partners are increasingly coming together to support the next generation of healthcare companies.

Applications open on 22 July 2026 at 09:00 a.m. SGT. Finalists will be invited to present at a virtual pitch event, after which the selected startup will be announced.

About NSG Bio

NSG Bio is Singapore’s leading provider of BSL-2 certified co-working laboratory and office spaces, supporting life-science companies from early research through growth. Through its facilities, community, and ecosystem initiatives, NSG Bio enables biotech innovators to accelerate research, access networks, and build companies that address critical healthcare challenges.

About NSG Bio Tomorrow

NSG Bio Tomorrow is NSG Bio’s ecosystem-building arm, created to support the next generation of biotech innovation through partnerships, programmes, community initiatives, and opportunities that extend beyond physical laboratory infrastructure. Its mission is to strengthen the biotech industry by connecting startups with the resources, expertise, and networks they need to thrive.

About Chiesi Group 

Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. 

With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,900 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For further information please visit https://www.chiesi.com/en/home 

Media Contact
Giridharan
Laboratory Manager
NSG Bio
giridharan@nsgbio.com
87797175

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SOURCE NSG Bio

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House Judiciary Committee Passes Bill that Would Prevent Future Immigration Crises: Swift Action Needed by Full House, Says FAIR

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July 22, 2026

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WASHINGTON, July 21, 2026 /PRNewswire/ — Today, the House Judiciary Committee passed an updated version of H.R. 2, the landmark border security bill from last congressional session. The bill now awaits consideration by the full House of Representatives. The Federation for American Immigration Reform (FAIR) urges Speaker Mike Johnson to schedule a final floor vote as soon as possible.

The Secure Border Act systematically closes the loopholes that allowed the Biden administration to unleash the largest and most damaging wave of illegal immigration in American history. Enactment of this legislation would prevent future anti-borders administrations from shirking their responsibilities to secure our borders and enforce our immigration laws; asserting unlimited discretion to parole inadmissible aliens to enter the country; or releasing millions of illegal aliens into the country, rather than detaining them or returning them to the country from which they entered.

“We congratulate the Judiciary Committee for its swift action on this critical legislation,” said Dale Wilcox, executive director and general counsel of FAIR. “Ending border chaos and rampant illegal immigration was a key reason that Republicans regained control of the White House and both chambers of Congress in the last election. The clock is ticking on the 119th Congress, and Republicans only have a short time to deliver on the promises they made to voters in 2024, before the midterms.

“Right now, our immigration laws are being enforced in the interests of the American people. As the last administration demonstrated, enforcement of those laws is not guaranteed unless Congress acts to prevent similar abuse in the future. Now is the time for decisive action in the House, where this bill can be passed with a simple majority vote, and an opportunity for Senate Majority Leader John Thune to put every member of that body on record before voters go to the polls in the fall,” Wilcox concluded.

Hayley Hill, hhill@fairus.org 202-328-7004

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SOURCE Federation for American Immigration Reform (FAIR)

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