M&A - NLS Pharmaceutics Ltd.

Form Type: 20-F

Filing Date: 2025-05-16

Corporate Action: Merger

Type: New

Accession Number: 000121390025044868

Filing Summary: NLS Pharmaceutics Ltd. is in the process of merging with Kadimastem Ltd., an Israeli publicly traded company. The merger agreement outlines the merger structure where NLS Pharmaceutics (Israel) Ltd., a wholly owned subsidiary of NLS, will merge with Kadimastem, with Kadimastem being the surviving entity. This development is crucial as the completion and timing of the transaction are uncertain and dependent on several factors, including regulatory approvals and market conditions. The risks associated with this merger include the potential failure to close the transaction, negative impacts on NLS's share price and operations, and integration challenges following the merger. Additionally, NLS is facing financial uncertainty, with a disclosure indicating substantial doubt about its ability to continue as a going concern and reminders that they have not generated revenue to date, relying heavily on the success of their product candidates, Quilience and Nolazol. The complexity of drug development and regulatory approval processes loom as significant risks moving forward.

Form Type: 425

Filing Date: 2025-04-15

Corporate Action: Merger

Type: New

Accession Number: 000121390025031780

Filing Summary: On April 15, 2025, NLS Pharmaceutics Ltd. announced positive results from Study KO-943, demonstrating that Mazindol can reduce fentanyl-induced reward in animal models, suggesting its potential as a non-opioid treatment for fentanyl use disorder. The urgency for effective treatment options for the fentanyl crisis is emphasized given the rising opioid-related overdose deaths in the United States. NLS Pharmaceutics discussed their strategic merger with Kadimastem Ltd., which involves a funding initiative where NLS raised up to $3 million. After the merger, NLS will focus on developing Kadimastem's cell therapy assets and will retain several NLS assets, including the DOXA platform and Mazindol ER. The merger aims to enhance NLS’s position in the rapidly growing substance use treatment market, projected to exceed $60 billion by 2029. Additional insights into the efficacy of Mazindol in addressing withdrawal symptoms were highlighted, showcasing its potential to alter the opioid treatment paradigm.

Form Type: 6-K/A

Filing Date: 2025-04-04

Corporate Action: Merger

Type: Update

Accession Number: 000121390025028988

Filing Summary: On April 4, 2025, NLS Pharmaceutics Ltd. filed an amendment to its previous Form 6-K to provide additional information regarding a $3 million private placement financing transaction. The original filing on March 31, 2025, discloses the company's entry into a securities purchase agreement, executed on March 27, 2025, with three accredited investors for the issuance of 1,212,122 preferred shares at a conversion price of $1.65, and common share purchase warrants for 787,879 common shares with an exercise price of $1.80. The initial closing provided gross proceeds of $2 million that will be utilized for working capital and corporate purposes, including expenses associated with the company's merger with Kadimastem Ltd. The amendment includes disclosure on a common share purchase warrant and lists relevant exhibits related to the agreements. Furthermore, the company established a committed equity facility of up to $25 million under a separate agreement, allowing it to sell common shares over time based on market conditions.

Form Type: 425

Filing Date: 2025-03-31

Corporate Action: Merger

Type: Update

Accession Number: 000121390025025889

Filing Summary: On March 31, 2025, NLS Pharmaceutics Ltd. filed a Form 425 report detailing significant corporate actions. A principal point of interest is their merger with Kadimastem Ltd., which is underscored by the company’s private placement financing transaction that raised $3 million. On March 27, 2025, NLS engaged in a securities purchase agreement for the issuance of 1,212,122 preferred shares at a conversion price of $1.65, aimed to garner $2 million in gross proceeds, with an additional $1 million available pending shareholder approval. On the same day, the company announced their committed equity facility of up to $25 million with an institutional investor, allowing NLS to sell common shares over time under set conditions. The funding from both endeavors is designated for working capital, general corporate purposes, and expenses associated with the merger. The merger details and related agreements are elaborated, including customary warranties, conditions, and the issuance of additional securities as incentives for investors involved in these transactions.

Form Type: F-4/A

Filing Date: 2025-03-31

Corporate Action: Merger

Type: Update

Accession Number: 000121390025026428

Filing Summary: NLS Pharmaceutics Ltd. has filed an amendment to its Form F-4 Registration Statement with the SEC regarding its proposed merger with Kadimastem Ltd., which will be executed through the merger of its wholly owned subsidiary, NLS Pharmaceutics (Israel) Ltd. The merger is expected to exchange shares of Kadimastem for NLS Common Shares at a determined Exchange Ratio, with estimates suggesting Kadimastem shareholders will hold approximately 85% of the resulting shares. Conditions of the merger include the increase of share capital and approval of the distribution of cash proceeds from the sale of certain assets. Shareholder approval for the merger and various corporate actions will be sought at an extraordinary general meeting. NLS's Board recommends that shareholders approve all proposed resolutions related to the merger, increase in share capital, change of company name to NUCELX Ltd., and other corporate governance matters. The merger has been agreed upon by the boards and shareholders of both companies, with anticipation for listing the merged entity's shares on Nasdaq.

Form Type: 425

Filing Date: 2025-03-10

Corporate Action: Merger

Type: New

Accession Number: 000121390025021979

Filing Summary: On March 10, 2025, NLS Pharmaceutics Ltd. issued a press release announcing a significant merger agreement with Kadimastem Ltd. This merger is aimed at enhancing the development of advanced biopharmaceutical therapies targeting central nervous system disorders and diabetes through combined resources. Both companies' boards have approved the transaction, and a majority of NLS shareholders have expressed support. Closing of the merger is anticipated in the second quarter of 2025, contingent upon regulatory approvals and shareholder votes. The merger will create a Nasdaq-traded entity called 'NucelX Ltd.' with the ticker symbol 'NCEL'. The letter also highlights advancements in diabetes treatment, including collaboration with iTolerance Inc. on a potential cure for Type 1 Diabetes and plans for a Phase IIa clinical trial of Kadimastem's AstroRx® for ALS post-merger. Further, NLS mentioned a robust financial position and plans for additional research initiatives in the treatment of opioid dependence and sleep disorders. Overall, the document illustrates NLS's commitment to innovation and strategic expansions within the biotechnology sector, aiming to create shareholder value and improve patient outcomes.

Form Type: F-4/A

Filing Date: 2025-03-03

Corporate Action: Merger

Type: Update

Accession Number: 000121390025018981

Filing Summary: NLS Pharmaceutics Ltd. is initiating a merger with Kadimastem Ltd., allowing shareholders of Kadimastem to exchange their shares for NLS Common Shares. The agreement, initially made in November 2024 and amended in early 2025, outlines inherent conversions and share ratios, estimated to give Kadimastem shareholders a majority stake of approximately 85% post-merger. The proposal includes an extraordinary shareholders’ meeting to approve the merger agreement and associated plans to increase the company’s capital and amend various aspects of its articles of association. Key provisions also include the handling of outstanding options and RSUs from Kadimastem and a future name change for the company to NUCELX Ltd.

Form Type: 425

Filing Date: 2025-02-25

Corporate Action: Merger

Type: Update

Accession Number: 000121390025016794

Filing Summary: On February 25, 2025, NLS Pharmaceutics Ltd. announced the successful completion of a pre-IND meeting with the FDA regarding iTOL-102, a potential treatment for Type 1 Diabetes in collaboration with Kadimastem Ltd. The meeting was a significant milestone in the clinical development of the biologic, which combines allogenic human stem cell-derived pancreatic islets with an immunomodulator. The collaboration aims to deliver a treatment that eliminates the need for lifelong immune suppression after transplantation. Feedback from the FDA will help advance the development plans, including upcoming safety and toxicity studies, as well as preparations for a First-in-Human clinical trial. NLS CEO Alex Zwyer emphasized the merger's strength and potential benefits for shareholders. The companies are optimistic about the breakthrough nature of this innovative approach to diabetes treatment and the implications for regulatory approval and commercialization.

Form Type: 425

Filing Date: 2025-02-10

Corporate Action: Merger

Type: New

Accession Number: 000121390025011502

Filing Summary: On February 10, 2025, NLS Pharmaceutics Ltd. announced a planned merger with Kadimastem Ltd., aimed at creating a leading biotechnology entity focused on revolutionizing diabetes treatment. The companies plan to unite their core competencies to address the comprehensive management of diabetes through a multi-target therapeutic strategy. NLS is introducing a next-generation therapeutic approach called DOXA, which integrates neuroscience, metabolism, and regenerative medicine to manage diabetes and its systemic complications. This approach is expected to enhance insulin sensitivity and long-term disease modification beyond the advancements offered by GLP-1 receptor agonists. Executives from both companies expressed optimism about the merger, highlighting its potential to provide innovative solutions and improve outcomes for diabetes patients. The merger aims to leverage the complementary strengths of both firms to strengthen their position in the healthcare market and drive advancements in diabetes care. Preclinical studies supporting the DOXA approach will be presented at the 2025 ASCP Annual Meeting, emphasizing its groundbreaking potential in diabetes management.

Form Type: F-3

Filing Date: 2025-02-10

Corporate Action: Merger

Type: New

Accession Number: 000121390025011823

Filing Summary: NLS Pharmaceutics Ltd. has filed a registration statement on Form F-3 with the SEC on February 10, 2025, to offer and sell up to $75,000,000 worth of its common shares, warrants, and units. This registration is part of a shelf registration process allowing for offerings to occur from time to time. The company is an emerging growth entity focused on developing therapies for CNS disorders. Additionally, the document outlines an Agreement and Plan of Merger between NLS and Kadimastem Ltd., where Kadimastem's shareholders will receive newly issued common shares of NLS based on an Exchange Ratio that estimates Kadimastem shareholders to hold approximately 85% of the combined company's shares post-merger, subject to adjustments. The merger has already been approved by both companies' boards of directors and Kadimastem's shareholders, and is anticipated to be voted on by NLS's shareholders. The filing summarizes risk factors related to the merger and investment in the company's shares, including potential issues with compliance, shareholder rights, and possible loss of foreign private issuer status for NLS post-merger.

Form Type: F-3

Filing Date: 2025-02-05

Corporate Action: Merger

Type: New

Accession Number: 000121390025010223

Filing Summary: NLS Pharmaceutics Ltd., a clinical-stage biopharmaceutical company focused on CNS disorders, has entered into a merger agreement with Kadimastem Ltd. The merger will involve NLS Pharmaceutics (Israel) Ltd., a wholly owned subsidiary of NLS, merging into Kadimastem, with Kadimastem being the surviving entity. The agreement stipulates that each Kadimastem Ordinary Share will be converted into a certain number of Common Shares of NLS based on an Exchange Ratio, estimated to result in Kadimastem shareholders holding approximately 85% of the combined company post-merger. All necessary approvals, including from the boards and shareholders of both companies, have been obtained. NLS plans to dispose of Legacy Assets, and proceeds will be distributed to shareholders. Key conditions for closing the merger include maintaining certain cash balances for both companies and compliance with various agreements, including a Contingent Value Rights Agreement. The merger addresses the unmet needs in CNS treatment markets and aims to leverage combined capabilities for development of innovative therapies.

Form Type: 425

Filing Date: 2025-01-31

Corporate Action: Merger

Type: New

Accession Number: 000121390025008564

Filing Summary: On January 31, 2025, NLS Pharmaceutics Ltd. issued a press release announcing that Kadimastem Ltd.'s shareholders approved the merger with NLS Pharmaceutics. This decision represents a significant milestone in the merger process, bringing both companies closer to forming a combined Nasdaq-traded biotechnology entity focused on advanced therapies for neurodegenerative diseases and diabetes. NLS is planning a shareholder meeting for final approval of the merger, emphasizing collaboration to meet unmet medical needs in the biopharmaceutical sector. Executives from both companies expressed optimism about the merger and the potential benefits it could bring. The press release highlights the shared commitment to innovation and addressing critical health challenges, detailing Kadimastem's expertise in clinical-stage cell therapies and NLS's focus on rare central nervous system disorders.

Form Type: 425

Filing Date: 2025-01-28

Corporate Action: Merger

Type: New

Accession Number: 000121390025007315

Filing Summary: On January 28, 2025, NLS Pharmaceutics Ltd. announced the launch of a preclinical program evaluating Mazindol ER as a treatment for fentanyl dependence. This decision arises amidst a significant public health crisis, as reported by the CDC, highlighting high rates of drug overdose deaths, predominantly involving synthetic opioids like fentanyl. Mazindol ER proposes to address the neurochemical imbalances associated with fentanyl addiction through a unique pharmacological profile, incorporating 5-HT1A receptor modulation, mu-opioid receptor interaction, and orexin-2 receptor partial agonism. NLS emphasizes the urgent need for non-opioid solutions to tackle opioid dependence and plans to conduct preclinical studies focusing on safety, efficacy, and pharmacodynamics. This launch coincides with NLS's recent filing of a Registration Statement on Form F-4 for a proposed merger with Kadimastem Ltd., which specializes in cell therapy development. The merger aims to enhance the capabilities of both companies in advancing their treatment pipelines, particularly for conditions related to central nervous system disorders. Post-merger, NLS plans to divest remaining assets contingent on value rights agreements for existing shareholders. NLS has secured several patents related to Mazindol, which strengthen its intellectual property position as it moves forward with its development plans.

Form Type: 425

Filing Date: 2025-01-16

Corporate Action: Merger

Type: New

Accession Number: 000121390025004028

Filing Summary: On January 16, 2025, NLS Pharmaceutics Ltd. issued a press release announcing that Kadimastem Ltd. has called for a special general meeting of its shareholders to approve the merger with NLS. This meeting, which has been approved by the Central District Court in Israel, is set to occur within 14 days of the notice, emphasizing the urgency in securing shareholder approval for the merger. The press release highlights NLS’s recent fundraising success, with an initial closing of $500,000 from a $1 million funding round, and the strategic advancement of a previously disclosed $3.2 million investment from October 2024 that supports this merger initiative. Additional context is provided regarding NLS’s filing of an F-4 Registration Statement with the SEC, outlining merger details. Alex Zwyer, CEO of NLS, expressed enthusiasm about completing the merger, emphasizing its potential to enhance shareholder value and innovate in the biotechnology sector. Ronen Twito, CEO of Kadimastem, echoed this sentiment, indicating that the merger would create a powerful biotechnology entity.

Form Type: 425

Filing Date: 2025-01-08

Corporate Action: Merger

Type: Update

Accession Number: 000121390025001822

Filing Summary: On January 8, 2025, NLS Pharmaceutics Ltd. announced the initial closing of a $500,000 fundraising out of a previously announced total of $1 million, following an extraordinary general meeting. The fundraising was executed at a share price of $3.10, which represents a 48% premium over the market share price on January 6, 2025. This financing is crucial for facilitating a proposed merger with Kadimastem Ltd. A Registration Statement on Form F-4 has been filed with the SEC, outlining the merger details. The merger aims to create a combined Nasdaq-listed biotechnology company with advanced clinical development candidates. Both companies express optimism about enhancing their strategic positions and bringing innovative therapies to the market.

Form Type: 425

Filing Date: 2024-12-30

Corporate Action: Merger

Type: New

Accession Number: 000121390024113272

Filing Summary: On December 30, 2024, NLS Pharmaceutics Ltd. announced the filing of a Registration Statement on Form F-4 with the SEC regarding a proposed merger with Kadimastem Ltd. This merger aims to create a Nasdaq-traded biotechnology company specialized in advanced clinical therapies, focusing on allogeneic cell therapy. The merger, which follows a binding agreement signed on November 5, 2024, is expected to complete subject to approvals from shareholders of both companies and to the effectiveness of the Registration Statement. Kadimastem intends to become publicly traded on Nasdaq through this merger. NLS will issue common shares to Kadimastem shareholders, leading them to hold 85% of the combined company's issued shares post-merger, while NLS's existing shareholders retain 15%. Both companies received support commitments from shareholders representing over 40% of their outstanding shares, and the boards of directors have approved the merger. The transaction structure involves a reverse triangular merger, with Kadimastem becoming a wholly owned subsidiary of NLS. The remaining assets of NLS are expected to be divested under a contingent value rights agreement, ensuring current shareholders of NLS receive proceeds from this divestment. Both CEOs expressed enthusiasm about the merger, highlighting potential growth and shareholder value generation.

Form Type: F-4

Filing Date: 2024-12-30

Corporate Action: Merger

Type: New

Accession Number: 000121390024113211

Filing Summary: NLS Pharmaceutics Ltd. has filed a registration statement in connection with the proposed merger with Kadimastem Ltd., where NLS Pharmaceutics (Israel) Ltd., a wholly owned subsidiary, will merge with Kadimastem, and the shareholders of Kadimastem will receive shares in NLS Pharmaceutics as per the established exchange ratio. The terms of the merger were detailed in the Proxy Statement, which outlines the voting agenda for an extraordinary general meeting of shareholders to approve the merger and various capital increases necessary for executing the merger. The new structure includes increased share capital and an eventual change of the company's name to NUCELX AG. The Document is an invitation for shareholder participation along with related proposals for governance changes and financial arrangements following the merger.

Form Type: CORRESP

Filing Date: 2024-11-18

Corporate Action: Merger

Type: Update

Accession Number: 000121390024099734

Filing Summary: NLS Pharmaceutics Ltd. is responding to comments from the U.S. Securities and Exchange Commission regarding their registration statement on Form F-3, originally filed on October 23, 2024. This correspondence includes an update on a merger with Kadimastem Ltd, initiated through a binding term sheet signed on July 29, 2024. The merger is contingent upon entering a definitive agreement and obtaining approvals from both companies' stockholders. A definitive agreement was expected to be finalized by September 2024, with the aim for the transaction to close by December 31, 2024. The company has included pro forma financial statements and additional disclosures about Kadimastem's business in Amendment No. 1, aligning with regulatory requirements.