Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment Companies Advance Collaborative Clinical Development of iTOL-102: A Potential Cure for Diabetes Without the N

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

Companies Advance Collaborative Clinical Development

of iTOL-102: A Potential

Cure for Diabetes Without the Need for Chronic Life-long Immune Suppression

ZURICH, SWITZERLAND and NESS ZIONA, ISRAEL, February

25, 2025. 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

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."

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

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).

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