NLS Pharmaceutics CEO Issues Letter to Shareholders
NLS Pharmaceutics (NLSP) CEO Alex Zwyer issued a shareholder letter highlighting recent developments and future strategies. The company has made progress with its Dual Orexin Receptor Agonist (DOXA) platform, developing AEX-41 and AEX-2 compounds for narcolepsy treatment. Preliminary results from AEX-41 studies showed promising outcomes in managing sleep-wake disturbances.
The company regained Nasdaq compliance and strengthened its financial position through two private placements: a $3.2 million placement in October and an announced $1 million placement at $3.10 per share in December. These funds extend the runway to approximately 18 months.
NLSP announced a merger with Kadimastem, expected to close by January 2025. Post-merger, Kadimastem will own DOXA program, while NLSP shareholders will retain rights to benefit from potential sale of legacy assets, including Mazindol, through a CVR agreement.
Il CEO di NLS Pharmaceutics (NLSP), Alex Zwyer, ha pubblicato una lettera agli azionisti evidenziando i recenti sviluppi e le strategie future. L'azienda ha fatto progressi con la sua piattaforma degli Agonisti Duali del Recettore dell'Orexina (DOXA), sviluppando i composti AEX-41 e AEX-2 per il trattamento della narcolessia. I risultati preliminari degli studi su AEX-41 hanno mostrato esiti promettenti nella gestione delle anomalie del sonno e della veglia.
L'azienda ha riacquistato la conformità al Nasdaq e ha rafforzato la sua posizione finanziaria attraverso due collocamenti privati: un collocamento di 3,2 milioni di dollari in ottobre e un collocamento annunciato di 1 milione di dollari a 3,10 dollari per azione in dicembre. Questi fondi estendono la durata finanziaria a circa 18 mesi.
NLSP ha annunciato una fusione con Kadimastem, prevista per chiudere entro gennaio 2025. Dopo la fusione, Kadimastem possiederà il programma DOXA, mentre gli azionisti di NLSP conserveranno i diritti per beneficiare di una potenziale vendita di beni legacy, inclusa la Mazindolo, attraverso un accordo CVR.
El CEO de NLS Pharmaceutics (NLSP), Alex Zwyer, emitió una carta a los accionistas destacando los recientes desarrollos y las estrategias futuras. La compañía ha avanzado con su plataforma de Agonistas Duales del Receptor de Orexina (DOXA), desarrollando los compuestos AEX-41 y AEX-2 para el tratamiento de la narcolepsia. Los resultados preliminares de los estudios de AEX-41 mostraron resultados prometedores en la gestión de las alteraciones del sueño y la vigilia.
La empresa recuperó la conformidad con Nasdaq y fortaleció su posición financiera a través de dos colocaciones privadas: una colocación de 3,2 millones de dólares en octubre y una colocación anunciada de 1 millón de dólares a 3,10 dólares por acción en diciembre. Estos fondos extienden el tiempo de financiamiento a aproximadamente 18 meses.
NLSP anunció una fusión con Kadimastem, que se espera se cierre para enero de 2025. Tras la fusión, Kadimastem poseerá el programa DOXA, mientras que los accionistas de NLSP mantendrán los derechos para beneficiarse de la potencial venta de activos heredados, incluida la Mazindol, a través de un acuerdo CVR.
NLS 제약사 (NLSP)의 CEO인 알렉스 즈비어는 최근 발전상 및 향후 전략을 강조한 주주 서신을 발송했습니다. 이 회사는 이중 오렉신 수용체 작용제(DOXA) 플랫폼을 통해 narcolepsy 치료를 위한 AEX-41 및 AEX-2 화합물을 개발하는 데 진전을 보였습니다. AEX-41 연구의 초기 결과는 수면-각성 장애 관리에서 유망한 결과를 보여주었습니다.
이 회사는 나스닥 규정 준수를 회복하고, 10월에 320만 달러의 사모 펀드를 통한 재정적 위치를 강화했습니다. 12월에는 주당 3.10달러에 100만 달러의 사모 펀드가 발표되었습니다. 이러한 자금은 약 18개월을 지원할 수 있게 해줍니다.
NLSP는 카디마스템과의 합병을 발표했으며, 이는 2025년 1월까지 완료될 것으로 예상됩니다. 합병 후, 카디마스템은 DOXA 프로그램을 소유하게 되며, NLSP 주주들은 CVR 계약을 통해 기존 자산(매진돌 포함)의 잠재적 판매로부터 이익을 받을 권리를 유지합니다.
Le PDG de NLS Pharmaceutics (NLSP), Alex Zwyer, a adressé une lettre aux actionnaires mettant en lumière les développements récents et les stratégies futures. L'entreprise a progressé avec sa plateforme d'Agoniste Dual du Récepteur d'Orexine (DOXA), développant les composés AEX-41 et AEX-2 pour le traitement de la narcolepsie. Les résultats préliminaires des études sur AEX-41 ont montré des résultats prometteurs dans la gestion des troubles du sommeil et de l'éveil.
L'entreprise a retrouvé sa conformité avec le Nasdaq et a renforcé sa position financière grâce à deux placements privés : un placement de 3,2 millions de dollars en octobre et un placement annoncé de 1 million de dollars à 3,10 dollars par action en décembre. Ces fonds prolongent la durée financière à environ 18 mois.
NLSP a annoncé une fusion avec Kadimastem, qui devrait être finalisée d'ici janvier 2025. Après la fusion, Kadimastem possédera le programme DOXA, tandis que les actionnaires de NLSP conserveront le droit de bénéficier d'une vente potentielle d'actifs hérités, y compris le Mazindol, via un accord CVR.
Der CEO von NLS Pharmaceutics (NLSP), Alex Zwyer, hat einen Aktionärsbrief veröffentlicht, in dem er die jüngsten Entwicklungen und zukünftigen Strategien hervorhebt. Das Unternehmen hat Fortschritte mit seiner Dual Orexin Rezeptor Agonist (DOXA)-Plattform gemacht und die Verbindungen AEX-41 und AEX-2 zur Behandlung von Narkolepsie entwickelt. Vorläufige Ergebnisse aus den AEX-41-Studien haben vielversprechende Ergebnisse im Umgang mit Schlaf-Wach-Störungen gezeigt.
Das Unternehmen hat die Nasdaq-Konformität wiedererlangt und seine finanzielle Position durch zwei private Platzierungen gestärkt: eine Platzierung in Höhe von 3,2 Millionen Dollar im Oktober und eine angekündigte Platzierung von 1 Million Dollar zu 3,10 Dollar pro Aktie im Dezember. Diese Mittel verlängern die finanzielle Laufzeit auf etwa 18 Monate.
NLSP hat eine Fusion mit Kadimastem angekündigt, die bis Januar 2025 abgeschlossen sein soll. Nach der Fusion wird Kadimastem das DOXA-Programm besitzen, während die NLSP-Aktionäre das Recht behalten, von einem möglichen Verkauf von Altvermögen, einschließlich Mazindol, über einen CVR-Vertrag zu profitieren.
- Successful completion of $3.2M private placement and announcement of additional $1M placement at 15% premium
- Regained full Nasdaq compliance
- Extended cash runway to approximately 18 months
- Promising preliminary results from AEX-41 narcolepsy studies
- Elimination of all debt and strengthened balance sheet
- Transfer of DOXA program ownership to Kadimastem post-merger
- Previous period of Nasdaq listing compliance risk
Insights
The CEO's letter outlines significant financial and strategic developments for NLSP. The company has successfully addressed its Nasdaq compliance issues and strengthened its balance sheet through two private placements totaling up to
The DOXA platform development shows promise, with preliminary results from AEX-41 studies indicating potential therapeutic benefits. However, the
The preclinical development of dual orexin receptor agonists (DOXA) AEX-41 and AEX-2 represents an innovative approach in narcolepsy treatment. The compounds' unique mechanism targeting both OX1R and OX2R receptors while inhibiting cathepsins could potentially offer superior efficacy compared to existing selective OX2R agonists. Early results from the ORX-KO mouse model studies show promising improvements in wakefulness stability, slow-wave sleep continuity and reduction in pathological REM episodes.
The research being conducted at the Centre for Neurological Research of Lyon adds credibility to the program. The potential expansion into ALS treatment suggests broader therapeutic applications. However, these are still early-stage developments that will require extensive clinical validation under Kadimastem's leadership post-merger.
ZURICH, SWITZERLAND / ACCESSWIRE / December 11, 2024 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP)(Nasdaq:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced that its Chief Executive Officer, Alex Zwyer, has issued the following letter to shareholders:
Dear Valued Shareholders,
As we move forward with exciting developments at NLS, I want to update you on the significant progress we've made, key challenges we've overcome, and the strategic opportunities that lie ahead-especially as we approach the expected closing of our transformative merger with Kadimastem Ltd. ("Kadimastem"), an advanced clinical-stage company.
The DOXA Program
Over the past several months, we've made substantial progress with our Dual Orexin Receptor Agonist (DOXA) platform, which we believe holds considerable promise in addressing key challenges in the treatment of sleep and neurodegenerative diseases. Recently, we announced details around our preclinical program to evaluate two candidates, AEX-41 and AEX-2, two first-in-class non-sulfonamide DOXAs designed to target both orexin-1 (OX1R) and orexin-2 (OX2R) receptors while concurrently inhibiting cathepsins. This unique approach aims to address the unmet therapeutic needs in narcolepsy and related neurological disorders.
The preclinical study is being conducted at the Centre for Neurological Research of Lyon (France), a world-class institution specializing in sleep and neurological research, and aims to evaluate the potential superiority of AEX compounds over existing therapies in the space by using an internationally validated orexin knockout (ORX-KO) mouse model of narcolepsy.While existing selective OX2R agonists have demonstrated efficacy in managing narcolepsy symptoms, DOXA are expected to surpass these benchmarks. By engaging both OX1R and OX2R receptors and addressing broader neurological pathways, AEX-41 and AEX-2 offer the potential for enhanced therapeutic outcomes, including greater wakefulness stability and improved sleep quality under real-world conditions.
Earlier in December, we shared preliminary results from this ongoing study of AEX-41 in narcolepsy models which suggested that the compound shows promise as a therapeutic agent for managing narcolepsy-related sleep-wake disturbances.
Key findings from the study included:
Wakefulness: Increased stability with fewer interruptions.
Slow-Wave Sleep (SWS): Reduced fragmentation and improved continuity.
REM Sleep: Significant reduction in pathological episodes.
Final top line results from the ongoing study are expected to be shared by the end of this year. In addition, the Company's broader development plans include exploring the application of its DOXA platform also in other neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis (ALS).
Overcoming Obstacles
Despite significant challenges over the past few months, we have successfully positioned NLS for the next phase of growth:
- Financial growth and Nasdaq Compliance: After a period of risk regarding our Nasdaq listing, we are pleased to have regained full compliance with all Nasdaq continued listing requirements. This achievement was a result of our successful efforts to improve our balance sheet, including settlement agreements with vendors and successfully fundraising from private as well as institutional investors. Full compliance allows us, and eventually the combined company, continued access and exposure to the U.S. capital markets.
- Financial Restructuring: In addition, we have made important strides in eliminating all debt and strengthening our balance sheet. In October 2024, we closed a
Merger with Kadimastem Ltd.
In addition to solving our listing and financial challenges, we also announced a potential merger with Kadimastem, a company we believe offers compelling strategic benefits, not only for the combined company but also for our shareholders. Kadimastem's expertise in the development of innovative cell-based therapies will allow the DOXA program to thrive, and once the merger is finalized, these programs will become part of the merged company's broader pipeline of neurodegenerative and diabetes candidates.
While Kadimastem will assume ownership of the active pipeline assets, including the DOXA program, NLS shareholders will retain an exclusive opportunity to benefit financially from the potential sale of our legacy assets, including Mazindol, through the contingent value rights (CVR) agreement associated with the merger.
Mazindol, which has long been part of our portfolio, is a key asset that received significant attention from private companies and therefore we believe holds significant potential for future value generation post-merger. We remain committed to maximizing this opportunity.
Looking Ahead: A Focused Strategy on Value Creation
The recent months have been a time of great challenge and achievement for NLS. As the merger is expected to close by the end of January 2025 and the integration process begins, we remain grateful for your continued support. We are committed to maximizing shareholder value through the potential sale of our legacy assets in the CVR and the combined company's strengthened neurodegenerative and diabetes focused advanced clinical pipeline. With this strategy in place, we look forward to a future that is focused on value creation and the success of the DOXA program under Kadimastem's leadership.
Thank you for your ongoing support as we move forward with this exciting next chapter.
Sincerely,
Alex Zwyer, CEO
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 DOXA platform, the potential safety and efficacy of AEX-41 and AEX-2, plans to expand its research and timing thereof, NLS' pipeline, the expected timing of the closing, and benefits of, the merger agreement, the expected closing of the transaction and the potential benefits of the transaction to NLS and Kadimastem and their respective shareholders, the expected timing of the release of topline results from NLS' study, the potential closing of the private placement and NLS' expected cash runway. 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.
Contact:
Investor Relations Contact
InvestorRelations@nls-pharma.com
www.nlspharma.com
SOURCE: NLS Pharmaceutics AG
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