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Kadimastem Shareholders Approved the Merger with NLS Pharmaceutics

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NLS Pharmaceutics (NLSP) and Kadimastem have achieved a significant milestone in their merger process as Kadimastem's shareholders approved the merger during a special general meeting. The merger aims to create a combined Nasdaq-traded biotechnology company focusing on advanced therapies for neurodegenerative diseases and diabetes.

NLS, a Swiss clinical-stage biopharmaceutical company specializing in rare and complex central nervous system disorders, plans to convene its own shareholder meeting for final merger approval. Kadimastem, a clinical-stage cell therapy company, develops 'off-the-shelf' allogeneic cell products for neurodegenerative diseases and diabetes treatment.

Both companies view this merger as an opportunity to leverage their combined biotechnology strengths and advance innovative solutions in the biopharmaceutical sector.

NLS Pharmaceutics (NLSP) e Kadimastem hanno raggiunto un traguardo significativo nel loro processo di fusione, poiché gli azionisti di Kadimastem hanno approvato la fusione durante un'assemblea generale speciale. L'obiettivo della fusione è creare una compagnia biotecnologica quotata al Nasdaq, focalizzata su terapie avanzate per malattie neurodegenerative e diabete.

NLS, una compagnia biofarmaceutica svizzera in fase clinica, specializzata in disturbi rari e complessi del sistema nervoso centrale, prevede di convocare una propria assemblea degli azionisti per l'approvazione finale della fusione. Kadimastem, una compagnia di terapia cellulare in fase clinica, sviluppa prodotti cellulari allogenici 'pronti all'uso' per il trattamento delle malattie neurodegenerative e del diabete.

Entrambe le aziende considerano questa fusione come un'opportunità per sfruttare le loro forze biotecnologiche combinate e promuovere soluzioni innovative nel settore biofarmaceutico.

NLS Pharmaceutics (NLSP) y Kadimastem han logrado un hito significativo en su proceso de fusión, ya que los accionistas de Kadimastem aprobaron la fusión durante una reunión general extraordinaria. La fusión tiene como objetivo crear una empresa biotecnológica cotizada en Nasdaq, centrada en terapias avanzadas para enfermedades neurodegenerativas y diabetes.

NLS, una empresa biofarmacéutica suiza en etapa clínica que se especializa en trastornos raros y complejos del sistema nervioso central, planea convocar su propia reunión de accionistas para la aprobación final de la fusión. Kadimastem, una empresa de terapia celular en etapa clínica, desarrolla productos celulares alogénicos 'listas para usar' para el tratamiento de enfermedades neurodegenerativas y diabetes.

Ambas empresas ven esta fusión como una oportunidad para aprovechar sus fortalezas biotecnológicas combinadas y avanzar en soluciones innovadoras en el sector biofarmacéutico.

NLS Pharmaceutics (NLSP)Kadimastem은 Kadimastem의 주주들이 특별 총회에서 합병을 승인함에 따라 합병 과정에서 중요한 이정표를 달성했습니다. 이 합병의 목표는 신경퇴행성 질환과 당뇨병에 대한 최첨단 치료법에 중점을 둔 나스닥 상장 생명공학 회사를 만드는 것입니다.

드물고 복잡한 중추 신경계 질환을 전문으로 하는 스위스 임상 단계 생명공학 회사인 NLS는 최종 합병 승인을 위한 주주 회의를 소집할 계획입니다. 임상 단계 세포 치료 회사인 Kadimastem은 신경퇴행성 질환과 당뇨병 치료를 위한 '기성' 동종세포 제품을 개발합니다.

두 회사 모두 이 합병을 생명공학 강점을 결합하고 생명 의약품 분야의 혁신적인 솔루션을 발전시킬 수 있는 기회로 보고 있습니다.

NLS Pharmaceutics (NLSP) et Kadimastem ont franchi une étape importante dans leur processus de fusion puisque les actionnaires de Kadimastem ont approuvé la fusion lors d'une assemblée générale extraordinaire. L'objectif de cette fusion est de créer une entreprise biopharmaceutique cotée au Nasdaq, axée sur des thérapies avancées pour les maladies neurodégénératives et le diabète.

NLS, une entreprise biopharmaceutique suisse en phase clinique spécialisée dans les troubles rares et complexes du système nerveux central, prévoit de convoquer sa propre assemblée d'actionnaires pour l'approbation finale de la fusion. Kadimastem, une entreprise de thérapie cellulaire en phase clinique, développe des produits cellulaires allogéniques 'prêts à l'emploi' pour le traitement des maladies neurodégénératives et du diabète.

Les deux entreprises considèrent cette fusion comme une opportunité d'exploiter leurs forces biotechnologiques combinées et de promouvoir des solutions innovantes dans le secteur biopharmaceutique.

NLS Pharmaceutics (NLSP) und Kadimastem haben einen bedeutenden Meilenstein in ihrem Fusionsprozess erreicht, da die Aktionäre von Kadimastem die Fusion während einer außerordentlichen Hauptversammlung genehmigt haben. Ziel der Fusion ist die Schaffung eines an der Nasdaq notierten Biotechnologieunternehmens, das sich auf fortschrittliche Therapien für neurodegenerative Krankheiten und Diabetes konzentriert.

NLS, ein Schweizer biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das auf seltene und komplexe Erkrankungen des zentralen Nervensystems spezialisiert ist, plant, eine eigene Hauptversammlung zur endgültigen Genehmigung der Fusion abzuhalten. Kadimastem, ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, entwickelt 'fertige' allogene Zellprodukte zur Behandlung neurodegenerativer Krankheiten und von Diabetes.

Beide Unternehmen betrachten diese Fusion als eine Gelegenheit, ihre kombinierten biotechnologischen Stärken zu nutzen und innovative Lösungen im biopharmazeutischen Sektor voranzubringen.

Positive
  • Merger approval from Kadimastem shareholders indicates strong stakeholder support
  • Combined entity will be listed on Nasdaq, potentially improving market visibility and access to capital
  • Merger creates a diversified portfolio spanning neurodegenerative diseases and diabetes treatments
Negative
  • Final merger approval from NLS shareholders still pending
  • Integration challenges and costs may affect short-term performance

Insights

The shareholder approval of Kadimastem's merger with NLS Pharmaceutics represents a strategic consolidation in the specialized biotech space, particularly noteworthy given the current market dynamics. The merger combines two distinct yet complementary technological platforms: NLS's CNS disorder pipeline and Kadimastem's cell therapy expertise.

The strategic rationale appears robust as it addresses several critical aspects: First, it provides NLS immediate access to Kadimastem's 'off-the-shelf' allogeneic cell therapy platform, a highly valuable asset in the rapidly growing cell therapy market. Second, the merger creates a diversified pipeline spanning both neurodegenerative diseases and diabetes, reducing single-program risk. Third, the Nasdaq listing of the combined entity could potentially improve access to capital markets and institutional investors.

From a market perspective, this merger positions the combined entity to address multiple high-value markets:

  • The neurodegenerative disease market, projected to reach $62.7 billion by 2030
  • The diabetes cell therapy market, estimated to grow to $3.6 billion by 2027

However, key execution risks remain, including potential integration challenges and the need for substantial capital to advance multiple clinical programs simultaneously. The pending NLS shareholder approval represents the final major hurdle before merger completion.

ZURICH and NESS ZIONA, Israel, Jan. 31, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. ("NLS") (Nasdaq: NLSP), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for rare and complex central nervous system disorders, and Kadimastem Ltd. ("Kadimastem") (TASE: KDST), a clinical-stage cell therapy company developing and manufacturing "off-the-shelf" allogeneic cell products for the treatment of neurodegenerative diseases and potential cure for diabetes, are pleased to announce that in a special general meeting of shareholders held yesterday, Kadimastem's shareholders approved the merger with NLS (the "Merger"). This key milestone brings NLS and Kadimastem one step closer to creating a combined Nasdaq-traded biotechnology company with a robust portfolio of advanced therapies for neurodegenerative diseases and diabetes.

 

Ronen Twito, Kadimastem's Executive Chairman and CEO, and Alexander C. Zwyer, NLS's CEO & Executive Board Member, stated: “Receiving approval from Kadimastem's shareholders is a significant step forward in the merger process".

 

NLS is also planning to convene a shareholder meeting for final approval of the Merger. The collaborative effort between NLS and Kadimastem underscores the companies' commitment to advance innovative solutions that address unmet medical needs in the biopharmaceutical sector.

Ronen Twito, Executive Chairman and Chief Executive Officer of Kadimastem, stated, "We are happy that our shareholders have approved this significant Merger with NLS. We believe that this approval shows the shareholders' appreciation of the anticipated value creation from the Merger to leverage NLS's and Kadimastem's combined strengths in biotechnology. We look forward to completing the Merger and unlocking new opportunities for growth and innovation."

Alex Zwyer, Chief Executive Officer of NLS, commented, "Receiving approval from Kadimastem's shareholders is a significant step forward in the Merger process. We look forward to the potential benefits of bringing our two companies together and are committed to working collaboratively to advance innovative solutions in biotechnology. We aim to convene our shareholders meeting in the coming weeks to support a smooth transition toward this partnership."

As the Merger process progresses, both companies remain focused on aligning their efforts to become a leading force in developing therapies that address critical health challenges.

About NLS Pharmaceutics Ltd.

NLS is a global development-stage biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders who have unmet medical needs. 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.

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 Kadimastem 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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Safe Harbor 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 expected closing of the transaction and the potential benefits of the transaction to NLS and Kadimastem and their respective shareholders, including value creation for shareholders, as well as the expected strategic position of the combined company following the Merger, if completed. 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.

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.

Photo: https://mma.prnewswire.com/media/2610278/NLS_Pharmaceutics_and_Kadimastem.jpg

NLS contact:
investorrelations@nls-pharma.com
www.nlspharma.com

Kadimastem contact: 
Sarah Bazak
Investors Relations
s.bazak@kadimastem.com
www.kadimastem.com

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SOURCE NLS Pharmaceutics Ltd.; Kadimastem Ltd.

FAQ

What is the strategic rationale behind the NLS Pharmaceutics (NLSP) and Kadimastem merger?

The merger aims to create a combined Nasdaq-traded biotechnology company with a diverse portfolio focusing on advanced therapies for neurodegenerative diseases and diabetes, leveraging both companies' strengths in biotechnology.

What are the key therapeutic areas for the merged NLSP-Kadimastem entity?

The merged company will focus on rare and complex central nervous system disorders, neurodegenerative diseases, and potential diabetes treatments through cell therapy solutions.

What is the current status of the NLSP-Kadimastem merger approval process?

Kadimastem shareholders have approved the merger, while NLS Pharmaceutics plans to convene a shareholder meeting in the coming weeks for final merger approval.

How will the NLSP-Kadimastem merger affect the company's stock market listing?

The merged entity will be traded on Nasdaq, potentially providing better market visibility and access to capital markets.

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