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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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KarbunWise Introduces Fast, Cost-Effective LCA Platform for the LEED v5 Era at Greenbuild 2026 in New York

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October 23, 2026

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NEW YORK  , Oct. 23, 2026 /PRNewswire/ — As global property developers, architects, and manufacturers face rigorous new green building standards and cross-border carbon scrutiny, KarbunWise, an enterprise climate technology and advisory firm, announced its formal participation in the Greenbuild International Conference + Expo 2026 in New York City.

Exhibiting under this year’s Greenbuild theme, “Invest for Impact,” KarbunWise has launched a modern, cost-effective software to enable real estate developers, AEC (Architecture, Engineering, and Construction) firms, and industrial manufacturers to automate complex Life Cycle Assessments (LCA) and Environmental Product Declarations (EPDs) with verifiable, audit-grade accuracy.

With the rollout of LEED v5, Whole-Building Life Cycle Assessments (WBLCA) and embodied carbon tracking have evolved from optional bonus credits into non-negotiable prerequisites. This is likely to scale the adoption of LCAs, and KarbunWise offers an alternative to legacy incumbent players that are expensive and not customer-centric. KarbunWise’s product translates Building Information Modeling (BIM) data and factory-floor inputs directly into submission-ready WBLCA models (aligned with MRp2 and MRc2 credits).

Representing KarbunWise at the Jacob K. Javits Convention Center were the founders, Arjun Vijayaragavan and Divya Sukumar. “For years, carbon accounting and life cycle assessments were treated as passive, check-the-box exercises. Today, with LEED v5 mandating embodied carbon baselines and global supply chains enforcing strict transparency, carbon data has become commercial infrastructure. Bringing our platform to North America at Greenbuild marks a pivotal step in our mission to make sustainability data as trusted and audit-ready as financial data for 10,000 enterprises worldwide.” said Arjun Vijayaragavan, Founder & CEO of KarbunWise.

To accelerate adoption across US project teams, KarbunWise also announced a major Greenbuild show initiative: free first-year platform access for qualifying architecture firms, consultants, and developers visiting Booth #1044 during expo, backed by continuous 24/7 technical support from certified LCA practitioners.

Already trusted by more than 100 organisations across the UK, Middle East, and India, including listed conglomerates, leading bedding manufacturers, and global infrastructure contractors, KarbunWise’s platform connects over 200,000 verified LCA datapoints across international databases, including USLCI, Ecoinvent, and ÖKOBAUDAT.

About KarbunWise:

Founded in 2023, KarbunWise is an enterprise climate technology and advisory firm building the trust layer for global sustainability. The company combines an integrated, cloud-based software platform with deep consulting expertise to transform complex carbon and ESG data into audit-ready proof for regulators, enterprise buyers, and investors.

Mediacontact-
team@karbunwise.com 

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SOURCE KarbunWise

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Curios Launches Video-on-Demand Tools for Filmmakers as Vimeo On Demand Shuts Down

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October 23, 2026

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The direct-to-fan marketplace gives independent filmmakers a new home to sell films, series, and memberships, with help migrating from Vimeo

AUSTIN, Texas, Oct. 23, 2026 /PRNewswire-PRWeb/ — Curios, the direct-to-fan entertainment marketplace, has launched a full set of video-on-demand tools for independent filmmakers and video creators. The launch gives creators affected by the closure of Vimeo On Demand a new place to sell their work directly to audiences, keep their sales revenue, and hold on to the customer relationships they have spent years building.

Vimeo is phasing out its On Demand service in stages. New uploads were blocked on August 22, 2026, and new purchases and subscriptions stopped on September 21, 2026. Final seller payouts were processed on September 24, and the platform will shut down completely on November 20, 2026. On that date, all Vimeo On Demand storefronts and purchase pages go offline, and viewers lose access to the films and series they previously bought or rented.

For filmmakers, the impact is immediate. Sales have already stopped, so every week without a new storefront means lost revenue. And with Vimeo only allowing sellers to export buyers who opted in to updates, many creators risk losing touch with a large part of their audience.

“Every time a platform shuts down, creators get a painful reminder that they never really owned their audience,” said Grant Powell, founder of Curios. “Filmmakers on Vimeo On Demand did everything right, and they’re still losing their storefront. We launched Curios so that can’t happen. You sell directly, you keep your revenue, and every buyer’s contact details are yours to keep, whatever happens next.”

A complete home for independent film

Curios gives filmmakers flexible ways to sell, including full support for TVOD and SVOD, with possible plans for AVOD in the future. Creators can sell titles to own permanently (Electronic sell-through / EST), for one-time rental (Download-to-rent / DTR), offer pay-per-view (PPV) access for events and premieres, and run subscription memberships covering an entire catalog, a single series, or selected titles.

Pre-orders, timed releases, and limited quantities help build excitement around a launch. Bundles and deluxe editions, automated upsells and cross-sells, coupons, and an affiliate program help filmmakers grow each sale and reach new audiences. Free claims let creators give away trailers, extras, or short films in exchange for viewers’ email addresses.

Filmmakers decide whether each title is streaming-only or downloadable. Buyers watch in the Curios mobile app, where films and series sit alongside ebooks, audiobooks, and music. To help creators get started, Curios has also published pricing guidance for film, suggesting typical ranges of $9.99 to $29.99 for titles sold to own.

Better economics and full access to buyers

Curios takes no commission on sales, so creators keep their full sale price. They pay for platform access through a Curios subscription, with a free plan available and no credit card required to sign up. As merchant of record, Curios collects and files sales tax and VAT worldwide, removing a major administrative burden for independent creators.

Filmmakers on Curios receive the contact details of every buyer, along with sales, traffic, and viewing analytics, so they can see how audiences engage with their work and market future releases directly.

Moving from Vimeo On Demand in three steps

Curios has published an automatic importer, and a step-by-step migration guide for Vimeo On Demand sellers. Filmmakers simply connect with Vimeo account to Curios, then Curios automatically migrates their original files, trailers, extras, and artwork directly from Vimeo. Finally, they replace their old Vimeo On Demand links with a single Curios link and let their fans know where to find them.

Curios will also import a filmmaker’s existing Vimeo buyers who opted in to updates. Imported customers will find the films they already own waiting in their Curios library, ready to watch, so viewers who were about to lose access can keep enjoying the work they paid for. Customer lists from other platforms can be imported as well.

Curios is continuing to expand its video tools, with caption and subtitle uploads, region restrictions, country-specific pricing, and smart TV apps currently in development.

Filmmakers can create a free account and read the full migration guide at studio.curios.com.

About Curios

Curios is a direct-to-fan entertainment and content marketplace helping creators publish, promote, sell, and distribute their work directly to audiences. Built for authors, musicians, filmmakers, comedians, and creators of all kinds, Curios supports digital and physical formats in one place.

Creators keep 100% of every sale, retain full ownership of their work, and get direct access to customer data. As merchant of record, Curios handles sales tax, along with customer support, content delivery, fraud disputes, and fast payouts, giving creators the infrastructure to sell direct without having to build it themselves.

Media Contact

Grant Powell, Curios, Inc, 1 3102952129, support@curios.com, https://www.curios.com

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SOURCE Curios, Inc

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Violet PR Wins Five PRSA-NJ Awards for Campaigns Driving Economic Growth and Innovation

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October 23, 2026

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Award-winning media relations initiatives generated hundreds of news stories for clients

MONTCLAIR, N.J., Oct. 23, 2026 /PRNewswire/ — Violet PR, a national public relations agency specializing in economic development and place branding, has earned five awards from the Public Relations Society of America’s New Jersey Chapter (PRSA-NJ). Together, the campaigns generated more than 425 earned media placements in national, international, regional and niche outlets.

The winning programs ranged from launching a major fitness facility and promoting the growing film industry in New Jersey to showcasing Pittsburgh International Airport’s new terminal, navigating international trade uncertainty in Topeka, Kan., and positioning the Brooklyn Navy Yard as an innovation hub.

“These awards reflect the range of challenges our team helps clients navigate – including building support for emerging industries and elevating major infrastructure investments,” said April Mason, CEO and founder of Violet PR. “Whether we’re promoting a new airport terminal or helping a community navigate international trade uncertainty, our job is to uncover the stories that matter, connect them with influential audiences and deliver results that support our clients’ broader goals.”

For the New Jersey Economic Development Authority (NJEDA), Violet PR’s “Hollywood East: New Jersey Takes Center Stage” campaign earned PRSA-NJ recognition in the “Community Relations” category. Working with the New Jersey Motion Picture & Television Commission and NJEDA, the agency helped build support for the state’s expanding film and television industry by highlighting its economic impact, career opportunities and benefits for local businesses and communities. Over 10 months, the campaign generated 38 earned media placements and more than 336 million impressions.

Violet PR also earned an “Events” award for “Building More Than Muscle: Launching a New Jersey Success Story,” developed for Iron Culture’s new flagship gym in West Orange, N.J. The campaign promoted the grand opening of the $10 million fitness facility, bringing together elected officials, business leaders and community members while generating 45 earned media placements.

The Montclair, N.J.-headquartered agency also won a “Media Relations” award for its campaign, “Brooklyn Navy Yard: From Shipyard to Innovation Engine,” which spotlighted the historic waterfront campus’s transformation into a hub for advanced manufacturing, entrepreneurship and innovation. The campaign generated 85 earned media placements, reaching an audience of 662 million.

The agency’s national work was recognized as well. The “Ready for Takeoff: Commemorating Pittsburgh’s New Airport Opening (2025)” campaign for Pittsburgh International Airport (PIT) earned an award in the “Public Affairs” category. Violet PR executed a strategic communications campaign surrounding the opening of PIT’s new terminal, securing more than 200 earned media placements across national news, business, travel and aviation outlets, with a combined audience reach exceeding 525 million.

In Topeka, Kan., Violet PR’s “The U.S. City Bridging Borders: How Topeka Tackled Tariffs” campaign was recognized in the “PR on a Shoestring Budget” category. As rising U.S.-Canada tariffs threatened up to 20% of local jobs, the agency transformed a complex international trade issue into a compelling story about the economic ties between Kansas and Canada. With a budget of just $10,000 over two months, the campaign secured 57 media placements, with an estimated reach of 224 million.

“What makes these awards especially meaningful is that they recognize five very different campaigns, each requiring a tailored strategy, creative thinking and close collaboration with our clients,” said Christina Forrest, vice president, Violet PR. “We take pride in developing strategic campaigns that deliver meaningful results for our clients, and we’re grateful to PRSA-NJ for the honor.”

The PRSA-NJ Pyramid Awards recognize excellence in public relations and communications, honoring the strategy, creativity and impact of agencies and in-house teams across New Jersey and beyond.

Violet PR continues to earn national recognition for its growth and economic development industry expertise. The agency ranked No. 96 on O’Dwyer’s 2026 list of independent public relations firms following 22.6% year-over-year growth in 2025 and has appeared on the Inc. 5000 list for three consecutive years. Violet PR opened its second office in New York City this year.

About Violet PR

Violet PR is an award-winning public relations firm, recognized nationally as a top agency specializing in economic development, commercial real estate and place branding. The agency partners with cities, states, regions, developers, destinations and mission-driven organizations to build visibility through earned media, thought leadership, social media and strategic storytelling.

Founded in 2010, Violet PR helps clients attract investment, business growth, visitors and talent through earned media campaigns. For more information, visit www.violetpr.com.

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SOURCE Violet Public Relations

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