The Additional Payment is for the Progress Presented by the Companies in the Development of the Treatment
Ness Ziona, Israel, November 27th, 2024 , Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company, developing and manufacturing "off-the-shelf" allogeneic cell products using its innovative groundbreaking platform technology to develop treatments for different neurodegenerative diseases and a potential cure for diabetes is in an advanced process towards completing the merger with NLS Pharmaceutics Ltd. traded on NASDAQ, it received another important vote of confidence from the BIRD Foundation.
The BIRD Foundation has informed the company that it will transfer an additional payment from the grant of $1 million (approximately NIS 3.7 million) that it has allocated for the co-development of the innovative diabetes treatment by Kadimastem and the Miami based company iTolerance Inc. The transfer of the additional payment in total amount of approximately NIS 612,000 to the two companies together is after the partnership presented progress in the co-development of the diabetes treatment.
Since the beginning of the development project, the BIRDF has approved a cumulative sum of NIS 2.4 million for the two companies. Kadimastem Ltd. and iTolerance Inc. intend to submit a Pre-IND application to the FDA by the end of 2024 or during the first quarter of 2025, once the co-development of the treatment is completed.
Ronen Twito, Chairman and President of Kadimastem: "This is another expression of confidence in the company's developments, as last week the company also received reinforcement from Prof. Michel Revel, who serves as the company's chief scientist and director and is a substantial shareholder, announced his agreement to invest NIS 3.4 million in the company, by way of converting the balance of qualifying loans that he had provided to the company in the past."
Last week, the company was also strengthened by Prof. Michel Revel, who serves as the company's chief scientist, director and is a substantial shareholder in the company, announced his agreement to invest NIS 3.4 million in the company, by way of converting the balance of qualifying loans that he had previously provided to the company.
The conversion of the balance of Revel's loans will be carried out according to the company's share price as expected at the date of completion of Kadimastem's merger transaction with NLS Pharmaceutics or according to the company's share price at the time of fund raising (if any) close to the completion of the aforementioned merger transaction, and subject to the approval of the general shareholder’s meeting. The merger transaction embodies an estimated total value of approximately 72 million USD (NIS 270 million) to the merged company and about USD 57.6 million (NIS 216 million) to Kadimastem[1]. As of the date of signing the merger agreement (4/11/24), in accordance with Kadimastem's derivative value based on the NLS Pharmaceutics price on NASDAQ.
About Kadimastem
Kadimastem is a clinical stage cell therapy company whose shares are listed on the Tel Aviv Stock Exchange “KDST.TA”. Kadimastem is 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®, Kadimastem’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 Kadimastem’s treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon. IsletRx is intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, CSO of Kadimastem, who is 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 drug sold worldwide.
About iTolerance, Inc.
iTolerance is an early-stage privately held regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression. Leveraging its proprietary biotechnology-derived Strepavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. The company’s lead program, iTOL-102, leverages significant advancements in stem cells to derive pancreatic islets which allows an inexhaustible supply of insulin-producing cells. Utilizing iTOL-100 to induce local immune tolerance, iTOL-102 has the potential to be a cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the company is developing iTOL-201 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.
About NLS Pharmaceutics Ltd.
NLS Pharmaceutics Ltd. is a global development-stage biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists. NLS is focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders. Headquartered in Switzerland and founded in 2015, NLS is led by an experienced management team with a track record of developing and commercializing product candidates. For more information, please visit www.nlspharma.com.
Safe Harbor Statement
This press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses the expected execution of a definitive agreement, and the expected timing of the execution of the definitive agreement and closing of the Transaction, the expected structure of the Transaction, the potential benefits of NLS’ and Kadimastem’s products and product candidates, the positive effects observed by Kadimastem’s compounds, the potential development of additional compounds and that the new product candidates are expected to further enhance the understanding and treatment of neurodegenerative processes. These forward-looking statements and their implications are based on the current expectations of the management of NLS and Kadimastem, 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; 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’ 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.
Kadimastem Contact:
Sarah Bazak
Business Operations Manager
iTolerance Contacts:
Investor Contact
Jenene Thomas Chief Executive Officer JTC Team, LLC
T: 833.475.8247
Media Contact Susan Roberts
T: 202.779.0929
NLS Contact:
Investor Relations ContactInvestorRelations@nls-pharma.comwww.nlspharma.com
[1] Calculated in accordance with the value of NLSon the NASDAQ exchange as of November 4, 2024 (based on the share price and the number of shares ofNLSincluding listed preferred shares) divided by 20% which is the approximate percentage ofNLSin the merged entity. The shekel amount is calculated according to the representative exchange rate of USD as of November 4, 2024 which is 3.75.
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