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    NLS Pharmaceutics
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    The Circle 6 | P.O. Box CH - 8058 Zurich
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    +41 44 512 21 50
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    • Development Update
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    NLS Pharmaceutics to Proceed with Phase 3 Clinical Program (AMAZE) for Mazindol ER for the Treatment of Narcolepsy Following FDA Review and IRB Approval...

    Details:

    NLS-2 (mazindol ER) is a triple monoamine reuptake inhibitor and partial Orexin-2 receptor agonist. It is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders.


    Lead Product(s): Mazindol

    Therapeutic Area: Sleep Product Name: NLS-2

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 03, 2023

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    NLS Pharmaceutics Announces Positive Safety Data From In Vitro CYP450 and Transporter Mediated Drug-Drug Interaction Studies of Mazindol

    Details:

    Quilience (mazindol ER) is a triple monoamine reuptake inhibitor and partial Orexin-2 receptor agonist. It is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders.


    Lead Product(s): Mazindol

    Therapeutic Area: Sleep Product Name: Quilience

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 14, 2023

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    NLS Pharmaceutics Receives Green Light from the U.S. FDA to Proceed with Phase 3 Clinical Program (AMAZE) for Quilience(R) (Mazindol ER) for the Treatme...

    Details:

    Quilience® (mazindol ER) is a triple monoamine reuptake inhibitor and partial Orexin-2 receptor agonist. It is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders.


    Lead Product(s): Mazindol

    Therapeutic Area: Sleep Product Name: Quilience

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 02, 2023

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    NLS Pharmaceutics Announces Open Label Extension Study Six-Month Data for Quilience(R) (Mazindol ER) in the Treatment of Narcolepsy Type 1 and Type 2

    Details:

    Quilience® (mazindol ER) is a triple monoamine reuptake inhibitor and partial Orexin-2 receptor agonist. It is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders.


    Lead Product(s): Mazindol

    Therapeutic Area: Sleep Product Name: Quilience

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 27, 2023

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    NLS Pharmaceutics Announces Completion of Open Label Extension Study with Quilience(R) (Mazindol ER) for the Treatment of Narcolepsy

    Details:

    Quilience®, is a proprietary extended-release formulation of Mazindol (Mazindol ER) which is a triple monoamine reuptake inhibitor and partial Orexin-2 Receptor agonist which is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders.


    Lead Product(s): Mazindol

    Therapeutic Area: Sleep Product Name: Quilience

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 30, 2023

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    NLS Pharmaceutics Announces New In-Vitro Data Reconfirming Quilience's(R) (Mazindol ER) Unique Dual Mechanism of Action Involving Significant Orexin-2 R...

    Details:

    Quilience® (mazindol ER) is a triple monoamine reuptake inhibitor and partial Orexin-2 Receptor agonist. It is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders.


    Lead Product(s): Mazindol

    Therapeutic Area: Sleep Product Name: Quilience

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 23, 2023

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    • Development Update
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    NLS Pharmaceutics Announces Israeli Patent Grant Covering Mazindol for Treatment of Attention Deficit Hyperactivity Disorder and Other Sleep Disorders T...

    Details:

    Quilience (Mazindol ER), the Company's lead product candidate and proprietary extended-release formulation of Mazindol (Mazindol ER), is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders such as idiopathic hypersomnia (IH).


    Lead Product(s): Mazindol

    Therapeutic Area: Psychiatry/Psychology Product Name: Nolazol

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 19, 2022

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    NLS Pharmaceutics Announces Closing of Initial Tranche of US$10.0 Million Purchase Agreement with BVF Partners L.P.

    Details:

    Quilience®, is a proprietary extended-release formulation of Mazindol (mazindol ER) and is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders such as idiopathic hypersomnia (IH).


    Lead Product(s): Mazindol

    Therapeutic Area: Sleep Product Name: Quilience

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: BVF Partners

    Deal Size: $10.0 million Upfront Cash: Undisclosed

    Deal Type: Agreement December 14, 2022

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    NLS Pharmaceutics Announces Purchase Agreement with BVF Partners L.P. to Raise Aggregate Gross Proceeds of up to $30 Million

    Details:

    NLS intends to use the net proceeds from the offering to accelerate the ongoing clinical development of its lead product, Quilience® (mazindol ER) for the treatment of narcolepsy, to advance NLS-4 and other product candidates.


    Lead Product(s): Mazindol

    Therapeutic Area: Sleep Product Name: Quilience

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: BVF Partners L.P.

    Deal Size: $70.6 million Upfront Cash: Undisclosed

    Deal Type: Agreement December 07, 2022

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    • Development Update
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    NLS Pharmaceutics Announces Notice of Allowance for U.S. Patent Covering Mazindol for Opioid Dependence and Substance Use Disorder

    Details:

    Quilience®, is a proprietary extended-release formulation of Mazindol (Mazindol ER) and is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders such as idiopathic hypersomnia (IH).


    Lead Product(s): Mazindol

    Therapeutic Area: Psychiatry/Psychology Product Name: Quilience

    Highest Development Status: PreclinicalProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 01, 2022

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