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NLS Pharmaceutics (NASDAQ: NLSP) has launched a preclinical program to evaluate Mazindol ER as a treatment for fentanyl dependence. The program, designated Study KO-943, comes amid a major global health crisis, with CDC reporting 105,007 drug overdose deaths in 2023, 90% involving synthetic opioids like fentanyl.

Mazindol ER, protected by patents until September 2038, offers a non-opioid alternative through multiple mechanisms: 5-HT1A receptor modulation, mu-opioid receptor interaction, and orexin-2 receptor partial agonist activity. The preclinical study will evaluate safety, efficacy, and pharmacokinetics, with completion expected within 12-18 months.

The company holds key patents, including US Patent No. 11,207,271 for oral formulations and No. 11,596,622 for heroin dependence treatment. The development program aims to address the limitations of traditional treatments like methadone and buprenorphine.

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.

NLS Pharmaceutics (Nasdaq: NLSP) announced a private placement offering of up to 322,580 common shares at $3.10 per share, representing a 15% premium to market price, for total gross proceeds of up to $1.0 million. The offering will be executed in two tranches: an initial closing of $500,000 expected by January 10, 2025, and a potential subsequent closing of another $500,000 within 15 days following specific conditions, including shareholder approval and maintaining share price above $3.10 for ten consecutive trading days. The company plans to use proceeds for general corporate purposes.

NLS Pharmaceutics (NASDAQ:NLSP) announced promising preclinical data for its dual orexin receptor agonist (DOXA) platform. The study focuses on AEX-41 and AEX-2, first-in-class non-sulfonamide DOXAs targeting both orexin-1 and orexin-2 receptors while inhibiting cathepsins. In orexin knockout mice, AEX-41 showed significant increase in wakefulness and reduced REM sleep duration, with efficacy comparable to existing OX2R agonists. The company plans to expand research in 2025 to study neuroinflammation impact, with an IND application planned for 2026-2027. The dual-action mechanism could potentially address both sleep-wake regulation and neurodegenerative processes.

NLS Pharmaceutics has provided insights into its preclinical program evaluating dual orexin receptor agonist (DOXA) platform. The company is developing AEX-41 and AEX-2, two first-in-class non-sulfonamide DOXAs targeting both orexin-1 and orexin-2 receptors while inhibiting cathepsins. The ongoing studies at the Centre for Neuroscience Research of Lyon use an orexin knockout mouse model to evaluate wakefulness promotion, sleep quality enhancement, and cataplexy suppression. The study employs EEG/EMG technology and includes stress condition testing. First results are expected in early December 2024, with potential applications extending to other conditions like ALS.

NLS Pharmaceutics (Nasdaq: NLSP) announced it has regained full compliance with Nasdaq listing requirements. The company received notice from Nasdaq confirming compliance with both the bid price requirement (Rule 5550(a)(2)) and equity requirement (Rule 5550(b)(1)). The compliance was achieved through balance sheet improvements, including capital raising and implementation of a reverse share split.

NLS Pharmaceutics (NASDAQ:NLSP) has announced the closing of a private placement offering, raising $3.2 million through the issuance of 806,452 common shares and warrants at $3.97 per unit. The company also closed a debt purchase agreement, converting $4.0 million of debt into 806,452 convertible preferred shares at $4.96 each.

Additionally, NLS believes it has regained compliance with Nasdaq's minimum bid price requirement and expects to meet the stockholders' equity requirement for continued listing on the Nasdaq Capital Market. The securities were offered under exemptions from registration requirements and have not been registered under the Securities Act.

NLS Pharmaceutics (Nasdaq:NLSP) announced a 1-for-40 reverse share split of its common shares, expected to be implemented on September 27, 2024. The company's shares will continue trading on the Nasdaq Capital Market under the symbol 'NLSP' but with a new CUSIP Number. This decision was approved by shareholders on September 18, 2024.

Post-split, NLS's outstanding common shares will reduce from 46,880,000 to approximately 1,172,000. No fractional shares will be issued, with cash provided in lieu. The split will not significantly impact shareholders' ownership percentages or voting power. All outstanding options and warrants will be adjusted accordingly. VStock Transfer, will serve as the exchange agent for this process.

NLS Pharmaceutics, a Swiss clinical-stage biopharmaceutical company specializing in treatments for rare and complex CNS disorders, announced a registered direct offering of 3,277,750 common shares at $0.24 per share. This offering is expected to close around July 1, 2024, subject to customary conditions. Additionally, NLS will issue unregistered warrants for the same number of shares, exercisable immediately at $0.24 per share and expiring in five years. The gross proceeds of $786,660 will support working capital, R&D, and strategic expansion. H.C. Wainwright & Co. is acting as the exclusive placement agent.