NLS Pharmaceutics and Kadimastem Enter into a Definitive Merger Agreement
NLS Pharmaceutics (NASDAQ:NLSP) and Kadimastem have announced a definitive merger agreement to combine their companies. The merger will focus on advancing NLS's Dual Orexin Agonist platform and Kadimastem's allogeneic cell therapy program. Post-merger, NLS plans to divest its legacy assets except for DOXA, with proceeds distributed to shareholders. The initial target share split is 85% Kadimastem/15% NLS, but current estimates suggest 80%/20% based on NLS's recent financing. The merger is expected to close in January 2025, subject to shareholder and Nasdaq approval. Kadimastem plans to initiate Phase IIa trials for ALS treatment and progress its diabetes program with a pre-IND submission in Q1 2025.
NLS Pharmaceutics (NASDAQ:NLSP) e Kadimastem hanno annunciato un accordo di fusione definitivo per unire le loro aziende. La fusione si concentrerà sull'avanzamento della piattaforma Dual Orexin Agonist di NLS e del programma di terapia cellulare allogenica di Kadimastem. Dopo la fusione, NLS prevede di cedere i suoi beni legacy ad eccezione di DOXA, con i proventi distribuiti agli azionisti. La suddivisione iniziale delle azioni target è del 85% per Kadimastem e del 15% per NLS, ma le stime attuali suggeriscono una distribuzione dell'80%/20% basata sul recente finanziamento di NLS. Si prevede che la fusione si concluda a gennaio 2025, soggetta all'approvazione degli azionisti e della Nasdaq. Kadimastem prevede di avviare studi di fase IIa per il trattamento della SLA e di progredire con il suo programma di diabete con una presentazione pre-IND nel primo trimestre del 2025.
NLS Pharmaceutics (NASDAQ:NLSP) y Kadimastem han anunciado un acuerdo de fusión definitivo para combinar sus empresas. La fusión se centrará en el avance de la plataforma Dual Orexin Agonist de NLS y en el programa de terapia celular alogénica de Kadimastem. Tras la fusión, NLS planea desinvertir sus activos heredados, excepto DOXA, con los ingresos distribuidos a los accionistas. La distribución inicial de acciones objetivo es del 85% para Kadimastem y del 15% para NLS, pero las estimaciones actuales sugieren un 80%/20% basado en la reciente financiación de NLS. Se espera que la fusión se cierre en enero de 2025, sujeta a la aprobación de los accionistas y de Nasdaq. Kadimastem planea iniciar ensayos de fase IIa para el tratamiento de la ELA y avanzar en su programa de diabetes con una presentación pre-IND en el primer trimestre de 2025.
NLS Pharmaceutics (NASDAQ:NLSP)와 Kadimastem은 두 회사를 합병하기 위한 최종 합의에 도달했다고 발표했습니다. 이번 합병은 NLS의 이중 오렉신 작용제 플랫폼과 Kadimastem의 동종 세포 요법 프로그램을 발전시키는 데 중점을 둘 것입니다. 합병 후 NLS는 DOXA를 제외한 기존 자산을 매각할 계획이며, 자산 매각 수익은 주주에게 분배될 것입니다. 초기 목표 주식 배분은 Kadimastem 85% / NLS 15%이지만, 최근 NLS의 자금 조달에 따라 현재 추정치는 80%/20%를 제안하고 있습니다. 합병은 2025년 1월에 완료될 것으로 예상되며, 주주 및 나스닥 승인을 받을 것입니다. Kadimastem은 ALS 치료를 위한 IIa상 임상시험을 시작하고, 2025년 1분기에 IND 전 제출과 함께 당뇨병 프로그램을 발전시킬 계획입니다.
NLS Pharmaceutics (NASDAQ:NLSP) et Kadimastem ont annoncé un accord de fusion définitif pour combiner leurs entreprises. La fusion se concentrera sur le développement de la plateforme Dual Orexin Agonist de NLS et du programme de thérapie cellulaire allogénique de Kadimastem. Après la fusion, NLS prévoit de céder ses actifs hérités, à l'exception de DOXA, avec les produits distribués aux actionnaires. La répartition initiale des actions cible est de 85 % pour Kadimastem et de 15 % pour NLS, mais les estimations actuelles suggèrent une répartition de 80 %/20 % basée sur le récent financement de NLS. La fusion devrait se conclure en janvier 2025, sous réserve de l'approbation des actionnaires et de la Nasdaq. Kadimastem prévoit de lancer des essais de phase IIa pour le traitement de la SLA et de faire progresser son programme sur le diabète avec une soumission pré-IND au premier trimestre 2025.
NLS Pharmaceutics (NASDAQ:NLSP) und Kadimastem haben einen endgültigen Fusionsvertrag zur Vereinbarung beider Unternehmen bekannt gegeben. Die Fusion konzentriert sich auf den Fortschritt von NLS's Dual Orexin Agonist-Plattform und Kadimastems allogenem Zelltherapie-Programm. Nach der Fusion plant NLS, seine Altbestandteile mit Ausnahme von DOXA zu veräußern, wobei die Erlöse an die Aktionäre verteilt werden. Die anfängliche Zielaktienaufteilung liegt bei 85% Kadimastem / 15% NLS, jedoch legen aktuelle Schätzungen nahe, dass dies auf 80%/20% auf der Grundlage der kürzlichen Finanzierung von NLS sinken könnte. Die Fusion soll im Januar 2025 abgeschlossen werden, vorbehaltlich der Genehmigung der Aktionäre und der Nasdaq. Kadimastem plant, die Phase-IIa-Studien zur ALS-Behandlung zu beginnen und sein Diabetes-Programm mit einer Vor-IND-Einreichung im ersten Quartal 2025 voranzubringen.
- Merger provides access to U.S. capital markets through Nasdaq listing
- NLS shareholders to receive proceeds from legacy assets divestment through CVR agreement
- Combined company will advance two clinical-stage programs (ALS and diabetes)
- Phase 2a studies planned post-merger closure
- Significant dilution for current NLS shareholders (80-85% ownership going to Kadimastem)
- Divestment of established NLS assets (including Mazindol ER)
Insights
This merger represents a significant strategic shift for both companies. The deal structure, with an 80/20 split favoring Kadimastem shareholders, reflects the relative valuation and strategic importance of Kadimastem's cell therapy pipeline. The transaction includes a clever CVR mechanism for NLS shareholders regarding legacy assets, particularly Mazindol ER, which helps mitigate dilution concerns.
The combined entity will gain enhanced access to U.S. capital markets through the Nasdaq listing, potentially improving funding opportunities for clinical development. Key near-term catalysts include the planned Phase 2a ALS trial and the pre-IND submission for the diabetes program in Q1 2025. The retention of the DOXA platform while divesting other legacy assets suggests a focused therapeutic strategy moving forward.
The merger creates a diversified pipeline combining NLS's DOXA platform with Kadimastem's advanced cell therapy programs. The AstroRx® program for ALS and IsletRx for diabetes represent significant market opportunities in areas of high unmet need. Having Professor Michel Revel, the inventor of Rebif®, as CSO adds considerable credibility to the development strategy.
The "off-the-shelf" allogeneic approach for cell therapies could provide competitive advantages in manufacturing scalability and cost-effectiveness compared to autologous alternatives. The planned multi-site Phase 2a trial for AstroRx® and upcoming pre-IND activities for IsletRx indicate near-term clinical development momentum.
ZURICH, SWITZERLAND and NESS ZIONA, ISRAEL / ACCESSWIRE / November 4, 2024 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP) ("NLS"), a biopharmaceutical company, and Kadimastem Ltd. (TASE: KDST.TA") ("Kadimastem"), a clinical-stage cell therapy company developing and manufacturing "off-the-shelf" allogeneic cell products for the treatment of neurodegenerative diseases and potential cure of diabetes, announced today that they have entered into a definitive merger agreement (the "Merger Agreement") to combine the two companies to focus on advancing NLS' promising, first-in class Dual Orexin Agonist platform ("DOXA") and Kadimastem's allogenic cell therapy program with its clinical assets (mainly targeting diabetes and amyotrophic lateral sclerosis (ALS), with Phase 2a studies that are planned to be initiated in the U.S. following the closing of the transaction). Following the closing of the transactions contemplated by the Merger Agreement (the "Closing"), NLS intends to divest its other legacy assets (including the Mazindol ER but excluding the DOXA platform), and the net proceeds of any such disposition, after deducting certain costs, fees, and expenses as set forth in a contingent value agreement (the "CVR Agreement"), will be distributed to NLS's shareholders and warrant holders, subject to the terms of the Merger Agreement and the CVR Agreement. At the Closing, pursuant to the terms of the Merger Agreement, NLS will issue shares of its common stock to Kadimastem's shareholders based on an initial target fully diluted share split, post transaction, of
‟I believe that the merger is an outstanding opportunity to progress our proprietary DOXA platform and help to enhance Kadimastem's portfolio of neurodegenerative and diabetes candidates,″ said Alex Zwyer, Chief Executive Officer of NLS. "This transaction represents NLS' commitment to delivering value to its shareholders by preserving the value of our legacy assets, including Mazindol, through the contingent value rights agreement, while also providing the opportunity for upside in the combined company with a promising cell therapy technological platform."
Ronen Twito, Kadimastem's Executive Chairman & President, commented, "We are pleased to announce our merger with NLS and believe that the exposure of the combined company's assets to the U.S. capital markets through our new Nasdaq listing will enable us to develop our portfolio and increase Kadimastem shareholder value. We remain focused on initiating our Phase IIa multi-site clinical trial of AstroRx®, a product candidate for the potential treatment of ALS, which is planned to be initiated following the closing of the merger, and jointly progressing our diabetes program IsletRx with our U.S. based partner to a pre-investigational new drug (IND) submission with the U.S. Food and Drug Administration in the first quarter of 2025."
Professor Michel Revel, Kadimastem's Chief Scientific Officer ("CSO"), said, "I'm excited about this merger because the combined company presents a significant opportunity to progress our portfolio and product candidates into and through clinical trials. As the inventor of Rebif® (interferon beta-1a) and having had the experience of taking it from the lab to a blockbuster product on the market, I also see a tremendous opportunity for Kadimastem to further develop our product candidates for ALS and diabetes. Together with the assets from NLS, we believe that we will be well-positioned to promote and expand these promising treatments."
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®, 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 blockbuster drug sold worldwide.
Kadimastem's ordinary shares are listed on the Tel Aviv Stock Exchange.
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 and Kadimastem are using forward-looking statements when they discuss the terms of the proposed merger, the expected timing of certain clinical studies, the expected closing of the transaction and the potential benefits of the transaction to NLS and Kadimastem and their respective shareholders. 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 proposed 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' 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.
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.
Additional Information about the Transaction and Where to Find It
In connection with the proposed transaction, NLS intends to file a registration statement on Form F-4, including a joint 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 joint proxy statement/prospectus or any other document that NLS may file with the SEC. The proxy statement (if and when available) will be mailed to shareholders of NLS and Kadimastem. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE JOINT 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 joint 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' 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 joint proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed transaction when such materials become available. Investors should read the joint 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 using the sources indicated above.
Kadimastem Contact:
Sarah Bazak
Investor Relations and Operations
s.bazak@kadimastem.com
NLS Pharmaceutics Contact:
Investor Relations Contact
InvestorRelations@nls-pharma.com
www.nlspharma.com
SOURCE: NLS Pharmaceutics AG
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