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HERE'S THE LATEST NEURELIS NEWS

Neurelis to Join Epilepsy Community at 12th Annual Sofie's Journey Epilepsy Awareness Day and Education Expo at Disneyland® Resort

One of the largest gatherings of people with epilepsy, care partners, and healthcare practitioners to address unmet needs for increased education

Neurelis Enters $208 Million Agreement to Monetize Intravail Royalties

OrbiMed agrees to purchase Neurelis’ rights and interests in ARS Pharmaceuticals’ neffy® global net sales royalties and milestones

NEURELIS TO SHARE CLINICAL STUDY DESIGN INSIGHTS FOR INVESTIGATION OF VALTOCO® (DIAZEPAM NASAL SPRAY) IN AGES 2 TO 5 AT CHILD NEUROLOGY SOCIETY ANNUAL MEETING

Presentation highlights study-enrollment challenges and strategies to overcome potential barriers

NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS AT THE 76TH ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY

Findings include analysis of seizure cluster treatment patterns with use of VALTOCO® (diazepam nasal spray) CIV and characterization of a diazepam dosing regimen in an animal model

Neurelis Pipeline Update - Advancements to Address Unmet Needs in Neuroscience – Replay

Neurelis hosted an investor call to highlight updates on two of its neuroscience product development candidates, NRL-1004 for acute agitation episodes and NRL-1049 for cerebral cavernous malformations (CCMs).  A replay can be found at the link here.

Neurelis to Host Virtual Pipeline Update to Discuss Advancements Addressing Unmet Needs in Neuroscience on March 7, 2024

Investor call to feature presentations from Leslie Lucien Citrome, MD, MPH, Issam Awad, MD, FACS and Connie Lee, PsyD

NEURELIS ANNOUNCES PRESENTATIONS AT THE AMERICAN EPILEPSY SOCIETY ANNUAL MEETING

New analyses from phase 3, long-term, open-label, repeat-dose study of VALTOCO® (diazepam nasal spray) CIV will be presented Additional presentations explore anticipatory anxiety of seizures, short-term impacts of seizures on daily life and comparison of treated versus untreated seizure clusters

NEURELIS SECURES NEW ORANGE BOOK LISTED U.S. PATENT FOR VALTOCO® (DIAZEPAM NASAL SPRAY) CIV

Sixth patent together with growing clinical evidence of the safety and effectiveness of VALTOCO reinforce clinical and commercial potential

Neurelis, Inc. to Participate in the 6th Annual Evercore ISI HealthCONx Conference

Neurelis, Inc., a company focused on epilepsy and orphan neurologic disorders, today announced that corporate leadership will participate in and host one-on-one investor meetings at the 6th Annual Evercore ISI HealthCONx Conference

NEURELIS TO PARTICIPATE IN 11th ANNUAL SOFIE’S JOURNEY EPILEPSY AWARENESS DAY AND EDUCATION EXPO AT DISNEYLAND® RESORT

• Largest gathering of people with epilepsy, their care partners, and health care providers • Epilepsy and care partner testimonials from Neurelis Ambassadors • Seizure alert and response puppy-in-training from Little Angels Service Dogs

NEURELIS TO PRESENT ANALYSES OF VALTOCO® (diazepam nasal spray) CIV AT THE 52nd CHILD NEUROLOGY SOCIETY ANNUAL MEETING

Neurelis, Inc., today announced additional findings from the post hoc analysis of the long-term phase 3 safety study of VALTOCO® (diazepam nasal spray) in a pediatric population, aged 6-17 years, as well as an analysis of real-world data on impact of administration of rescue medication on seizure timing.

NEURELIS WINS MULTIPLE AWARDS AS A BEST PLACE TO WORK IN SOUTHERN CALIFORNIA

Company recognized for culture that fosters a highly engaged and passionate team dedicated to improving lives through innovation.

NEURELIS TO PRESENT ANALYSES OF VALTOCO® (diazepam nasal spray) CIV HIGHLIGHTING EFFECTS ON TIMING OF SEIZURES AT THE 35TH INTERNATIONAL EPILEPSY CONGRESS

Neurelis, Inc. will present additional clinical findings from the complete long-term, open-label, repeat-dose safety study of VALTOCO for the treatment of episodes of frequent seizure activity (i.e., seizure clusters) in people with epilepsy for ages 6 to 65 at the 35th International Epilepsy Congress (IEC) in Dublin, Ireland, September 2 to 6. The congress is organized by the International League Against Epilepsy (IBE).

NEURELIS ANNOUNCES NEW ROLES FOR TOP EXECUTIVES TO ADVANCE CLINICAL AND STRATEGIC INITIATIVES AND POSITION FOR FUTURE GROWTH

Neurelis, Inc., announced today the promotion of Adrian L. Rabinowicz, MD, to Chief Medical Officer and the establishment of a new leadership position of Senior Vice President, Strategic Initiatives for Enrique Carrazana, MD. This enhanced and expanded leadership team will serve a critical function to Neurelis, as the company continues to seek and leverage novel scientific approaches to improve the lives of people around the world with CNS disorders.

NEURELIS ANNOUNCES FOUR POSTER PRESENTATIONS AT THE 75TH ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY

Neurelis, Inc. will present four posters from the completed long-term, open-label, repeat-dose safety study of VALTOCO for the treatment of episodes of frequent seizure activity (i.e., seizure clusters) in patients with epilepsy ages 6 to 65 years.

NEURELIS ANNOUNCES FIRST HEALTHY SUBJECTS DOSED IN INVESTIGATIONAL STUDY OF NRL-1049, A RHO KINASE (ROCK) INHIBITOR WITH POTENTIAL TO TREAT CEREBRAL CAVERNOUS MALFORMATIONS

Neurelis, Inc., announced the first two cohorts dosed in the investigational clinical trial of NRL-1049, a Rho kinase (ROCK) inhibitor, a potential treatment for people living with cerebral cavernous malformations (CCM), a disease characterized by abnormally enlarged capillary cavities in the brain and spinal cord. This is a first-in-human study designed to establish safety, tolerability, and pharmacokinetic parameters of NRL-1049.

NEURELIS WINS 2023 PM360 PHARMA CHOICE MULTICHANNEL GOLD AWARD FOR ‘GIVE SEIZURES THE SPRAYER’ MARKETING CAMPAIGN

'Give Seizures the Sprayer’, marketing campaign led by Beth Henriksen, Director of Marketing, Neurelis, Inc., wins the 2023 PM360 Pharma Choice Multichannel Gold Award

NEURELIS ANNOUNCES FILING OF ITS INVESTIGATIONAL NEW DRUG APPLICATION FOR NRL-1049, A RHO KINASE (ROCK) INHIBITOR WITH POTENTIAL TO TREAT CEREBRAL CAVERNOUS MALFORMATIONS

Neurelis, Inc., announced the successful filing of its investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NRL-1049, a Rho kinase (ROCK) inhibitor with a potential treatment for people living with cerebral cavernous malformations (CCM), a disease characterized by abnormally enlarged capillary cavities in the brain and spinal cord.

NEURELIS CONGRATULATES INTRAVAIL® LICENSEE, ARS PHARMACEUTICALS, FOR FDA ACCEPTANCE OF INTRANASAL EPINEPHRINE NDA

ARS Pharmaceuticals, Inc., announced that the U.S. Food & Drug Administration (FDA) has accepted its New Drug Application (NDA) for neffy (previously referred to as ARS-1), for the emergency treatment of severe type I allergic reactions in children and adults who weigh 30 kilograms (66 pounds) or more. In accordance with FDA guidelines, an anticipated target action date of mid-2023 has been set for the PDUFA (Prescription Drug User Fee Act).

NEURELIS TO PRESENT NINE POSTERS AT THE 76th AMERICAN EPILEPSY SOCIETY ANNUAL MEETING

Neurelis, Inc., announced the company will present nine posters at the 76th American Epilepsy Society Annual Meeting (AES), December 2 – 6, 2022, Nashville, TN. Poster presentations will occur on Monday, December 5, 2022, 12:00 – 1:45 PM CT.

Neurelis, Inc. to Participate in the 5th Annual Evercore ISI HealthCONx Conference

Neurelis, Inc. today announced that corporate leadership will participate in a fireside chat and one-on-one investor meetings at the 5th Annual Evercore ISI HealthCONx Conference, to be held virtually from November 29 – December 1, 2022.

NEURELIS SUPPORTS SOFIE’S JOURNEY EPILEPSY AWARENESS DAY AND EDUCATION EXPO AT DISNEYLAND® RESORT

Neurelis is a proud supporter of the 10th Annual Sofie’s Journey Epilepsy Awareness Day and Education Expo at Disneyland Resort (EADDL), the largest worldwide gathering of people with epilepsy, their families/care partners, and healthcare providers.

NEURELIS RANKED THIRD BEST PLACE TO WORK IN SoCAL 2022

Neurelis, Inc., is pleased to announce it was ranked third among medium-size employers on the Best Places to Work in SoCal 2022 list by Best Companies Group (BCG), a BridgeTower Media Company.

NEURELIS PRESENTS NOVEL, INVESTIGATIONAL ANALYSIS OF VALTOCO® (DIAZEPAM NASAL SPRAY) CIV DEMONSTRATING INCREASED TIME BETWEEN SEIZURE CLUSTERS AT THE 51ST CHILD NEUROLOGY SOCIETY ANNUAL MEETING

Neurelis, Inc., today announced findings from a novel, investigational analysis of the time between seizure clusters in pediatric patients using VALTOCO® (diazepam nasal spray). Findings indicate a significant increase in these intervals, or SEIzure interVAL (SEIVAL) data, over a 12-month period.

NEURELIS ANNOUNCES PRESENTATION OF ANALYSIS OF TIME BETWEEN SEIZURE CLUSTERS WITH VALTOCO® (DIAZEPAM NASAL SPRAY) CIV AT THE 2022 ANNUAL MEETING OF THE ACADEMY OF MANAGED CARE PHARMACY

Neurelis, Inc., a commercial-stage neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need, today announced it will present an analysis of a Phase 3 safety study of VALTOCO® (diazepam nasal spray) CIV at the 2022 Annual Meeting of the Academy of Managed Care Pharmacy (AMCP NEXUS), Oct. 14 to 22, in National Harbor, MD.

NEURELIS STRENGTHENS LEADERSHIP TO FURTHER ENHANCE GROWING MOMENTUM IN SEIZURE-RESCUE MARKET

Building on a transformative year of growth and success, Neurelis, Inc., announced today that it promoted former CFO Brittany Bradrick to COO and CFO.

STUDY PUBLISHED IN EPILEPSIA SHOWS SIGNIFICANT PROLONGATION OF TIME INTERVALS BETWEEN SEIZURE CLUSTERS TREATED WITH NEURELIS’ VALTOCO® (DIAZEPAM NASAL SPRAY) CIV

Neurelis, Inc., announced the recent online publication of a novel data analysis, evaluating the time interval between seizure clusters, or SEIzure interVAL (SEIVAL) in Epilepsia that indicates a significant increase in time between seizure clusters treated with VALTOCO® (diazepam nasal spray) CIV

Neurelis, Inc., Little Angels Service Dogs Present Aug. 25 “Barks ‘n Blues Music & More” Concert to Build Epilepsy Awareness at Local Community Event

Neurelis and Little Angels Service Dogs are proud to present the “Barks ‘n Blues Music & More” concert for epilepsy awareness at the Quartyard, 1301 Market St., San Diego, Thursday, Aug. 25 at 5 p.m. PT

NEURELIS, INC., NAMED TO LIST OF BEST PLACES TO WORK IN SoCAL 2022

Neurelis, Inc., is pleased to announce it has been named one of the Best Places to Work in SoCal 2022 by Best Companies Group (BCG), a BridgeTower Media Company. This distinction is based on responses from a detailed and comprehensive survey of its employees.

NEURELIS STUDY PUBLISHED IN EPILEPSIA, A WORLD-CLASS JOURNAL DEDICATED TO EPILEPSY

Neurelis, Inc., announced the publication of a study recently available online in the peer-reviewed, scientific journal Epilepsia.

NEURELIS PRESENTED CLINICAL DATA SUPPORTING SEIZURE CLUSTER INTERVAL ANALYSIS AT THE EPILEPSY FOUNDATION PIPELINE CONFERENCE

Neurelis, Inc., announced findings from a novel, investigational analysis of VALTOCO® (diazepam nasal spray) CIV. The data indicate that patients using the therapy had a statistical and clinically significant increase in the time between their seizure clusters, or SEIzure cluster interVAL (SEIVAL) over a 12-month period.

NEURELIS TO HIGHLIGHT VALTOCO (DIAZEPAM NASAL SPRAY) CIV DEVELOPMENT PROGRAM Updates AT 16TH EILAT CONFERENCE

Neurelis, Inc., today announced it will provide highlights of its clinical development program for VALTOCO® (diazepam nasal spray), an acute therapy for episodes of frequent seizure activity (seizure clusters), at the 16th EILAT Conference on New Antiepileptic Drugs and Devices, Madrid Spain, May 22-25, 2022.

DATA FROM NOVEL, EXPLORATORY ANALYSIS OF INTERMITTENT VALTOCO® (DIAZEPAM NASAL SPRAY) CIV USE INDICATES MORE THAN TWO-FOLD INCREASE IN MEAN INTERVAL BETWEEN SEIZURE CLUSTERS

Neurelis, Inc., today announced findings from a novel, exploratory analysis of VALTOCO® (diazepam nasal spray). The data indicates that patients using the therapy had a significant increase in the time between their seizure clusters, or SEIzure InterVAL data (SEIVAL) over a 12-month period.

NEURELIS EXPANDS INTELLECTUAL PROPERTY ESTATE FOR VALTOCO®, A PATIENT-CENTRIC NASAL SPRAY FOR ACUTE TREATMENT OF EPISODES OF FREQUENT SEIZURE ACTIVITY

Neurelis, Inc., a neuroscience-based company dedicated to enhancing therapeutic benefits and addressing significant unmet needs in managing central nervous system (CNS) disorders, announced that it has secured the issuance of United States Patent No. 11,241,414 (the ‘414 Patent) for VALTOCO (diazepam nasal spray) CIV for acute treatment of episodes of frequent seizure activity in adult and pediatric patients age six and older.

NEURELIS ANNOUNCES THREE POSTER PRESENTATIONS AT THE 2022 ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY

Neurelis, Inc., will present three posters from the completed long-term, open-label, repeat-dose safety study of VALTOCO for the treatment of episodes of frequent seizure activity (i.e., seizure clusters) in patients with epilepsy ages 6 to 65 at the 73rd Annual Meeting of the American Academy of Neurology (AAN), April 2 to 7, in Seattle, Wash.

NEURELIS SIGNS EXCLUSIVE LICENSING AGREEMENT WITH ACULYS PHARMA FOR THE DEVELOPMENT AND COMMERCIALIZATION OF VALTOCO® (DIAZEPAM NASAL SPRAY) IN JAPAN AND THE ASIA-PACIFIC REGION

Neurelis, Inc. announced that it has signed an exclusive licensing agreement with Aculys Pharma, Inc. for the development and commercialization of VALTOCO® (diazepam nasal spray) in Japan and the Asia-Pacific region.

NEURELIS ANNOUNCES PARTNERSHIP WITH RICK HARRISON, HOST OF TV’S “PAWN STARS” AND EPILEPSY ADVOCATE, TO RAISE AWARENESS OF EPILEPSY AND NEED FOR MORE EDUCATION REGARDING SEIZURE EMERGENCIES

Neurelis, Inc., announced today that it is partnering with epilepsy education advocate Rick Harrison, star of TV’s “Pawn Stars,” to raise awareness of epilepsy and the need for more education regarding seizure emergencies.

NEURELIS ANNOUNCES 16 POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE AMERICAN EPILEPSY SOCIETY

Neurelis, Inc. will present a collection of 16 posters describing safety, tolerability and effectiveness results observed in trials evaluating VALTOCO® (diazepam nasal spray), and clinical trials designed to evaluate VALTOCO as a potential rescue therapy in patient groups with unmet needs at the annual meeting of the American Epilepsy Society December 3-7 in Chicago.

NEURELIS ANNOUNCES ADDITION OF BRITTANY BRADRICK AS CFO AND EXPANSION OF LEADERSHIP TEAM AND BOARD OF DIRECTORS

Neurelis, Inc., announced today that it has made the following additions to its leadership team.

NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE CHILD NEUROLOGY SOCIETY

Neurelis, Inc. announced today that it is presenting two posters at the 50th Annual Meeting of the Child Neurology Society in Boston from September 29 through October 2.

NEURELIS INITIATES STUDY OF VALTOCO® (diazepam nasal spray) IN CHILDREN WITH SEIZURE CLUSTERS AGED TWO TO FIVE

Neurelis, Inc. announced today that it has initiated a clinical program to investigate the use of VALTOCO (diazepam nasal spray) in children with epilepsy aged two to five as a treatment for seizure clusters.

NEURELIS SECURES SENIOR TERM LOAN FACILITY OF UP TO $150 MILLION FROM ORBIMED

Neurelis, Inc., announced today that it has completed a senior term loan facility of up to $150 million from OrbiMed, one of the leading investors in the healthcare industry, to help fuel the company’s future growth.

NEURELIS ANNOUNCES ACQUISITION OF RIGHTS TO PORTFOLIO OF NEW CHEMICAL ENTITY (NCE) COMPOUNDS TARGETING CEREBRAL CAVERNOUS MALFORMATIONS, A RARE CNS DISORDER

Neurelis, Inc., announced today that it has acquired from BioAxone Biosciences, Inc. a portfolio of novel ROCK-2 Inhibitors that target cerebral cavernous malformations (CCMs), a rare disorder of the central nervous system (CNS) that currently have no pharmacologic treatments available.

NEURELIS ANNOUNCES FIVE POSTER PRESENTATIONS FOR THE ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY

SAN DIEGO, CA — April 19, 2021 — Neurelis, Inc., announced today that it is presenting five posters at the American Academy of Neurology (AAN) Annual Meeting being held virtually from April 17 through April 22.

NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS FOR THE ANNUAL MEETING OF THE ACADEMY OF MANAGED CARE PHARMACY

SAN DIEGO, CA — April 12, 2021 — Neurelis, Inc., announced today that it is presenting two posters at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting being held virtually from April 12 through April 16.

NEURELIS ANNOUNCES CLOSE OF $114 MILLION SERIES D FINANCING ROUND TO ADVANCE NEUROSCIENCE FOCUS

SAN DIEGO, CA – March 10, 2021 – Neurelis, Inc., announced today that it has closed a $114 million round of Series D preferred stock financing to support the commercialization of the company’s lead orphan drug product, VALTOCO® (diazepam nasal spray), and to continue the development and expansion of the company’s neuroscience pipeline.

Neurelis Announces 12 Poster Presentations for the Annual Meeting of the American Epilepsy Society

SAN DIEGO, CA – December 4, 2020 – Neurelis, Inc., announced today the company has 12 posters being presented at the American Epilepsy Society Annual Meeting being held virtually from December 4 through December 8.

Neurelis Completes Pre-IND Meeting With FDA to Establish Clinical Development Program for NRL-4 in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar 1 Mania in Adults

SAN DIEGO, CA – November 23, 2020 – Neurelis, Inc., announced today that it has concluded a pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) regarding NRL-4. The FDA provided direction for the clinical development pathway for the investigational treatment. NRL-4 is being investigated as a noninvasive, easy-to-administer rescue therapy to address the escalation of acute agitation symptoms outside the medical setting. Acute agitation is associated with several psychiatric disorders, including schizophrenia and bipolar mania 1 in adults.

Neurelis Announces National Wholesale and Retailer Chains and Independent Pharmacies Are Now Stocking VALTOCO® (diazepam nasal spray)

SAN DIEGO, CA – November 9, 2020 – Neurelis, Inc., announced today that the company's lead product, VALTOCO® (diazepam nasal spray), is now available through pharmacies nationwide. VALTOCO was approved by the FDA earlier this year for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in adult and pediatric patients 6 years of age and older. At the time of approval, the FDA also granted VALTOCO 7 years of Orphan Drug Exclusivity. The FDA recognized VALTOCO's intranasal route of administration as clinically superior to the previously approved standard-of-care treatment (a rectal gel formulation of diazepam) as the basis for granting Orphan Drug Exclusivity.

Neurelis Announces FDA Approval of Extended Expiration Dating for VALTOCO® (diazepam nasal spray)

SAN DIEGO, CA – October 19, 2020 – Neurelis, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted extended expiration dating for the company's lead product, VALTOCO® (diazepam nasal spray). VALTOCO was approved by the FDA on January 10, 2020, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in adult and pediatric patients 6 years of age and older. At the time of approval, the FDA also granted VALTOCO 7 years of Orphan Drug Exclusivity. The FDA recognized VALTOCO's intranasal route of administration as clinically superior to the previously approved standard-of-care treatment (a rectal gel formulation of diazepam) as part of the Orphan Drug Exclusivity designation.

Neurelis Announces Four Poster Presentations for the Joint Meeting of the International Child Neurology Association and Child Neurology Society

SAN DIEGO, CA – October 16, 2020 – Neurelis, Inc., announced today the company has four posters being presented at the 16th annual International Child Neurology Association Congress/49th annual Child Neurology Society Meeting. Due to the COVID-19 pandemic, posters are available online during the organizations' virtual meetings.

Neurelis Announces Program to Investigate the Safety and Pharmacokinetics of VALTOCO® (diazepam nasal spray) in Children Aged 2 to 5

SAN DIEGO, CA – September 23, 2020 – Neurelis, Inc., announced today that it will be investigating the safety and pharmacokinetics of the company's lead product, VALTOCO® (diazepam nasal spray), in children with epilepsy aged two to five. VALTOCO is currently available for adults and pediatric patients 6 years of age and older. This is an investigational program for a patient population not included in the current U.S. Food and Drug Administration-approved (FDA) VALTOCO label. VALTOCO was approved by the FDA on January 10, 2020, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern.

NEURELIS ANNOUNCES RAPID AND BROAD PAYER COVERAGE OF THE COMPANY'S FLAGSHIP PRODUCT, VALTOCO® (DIAZEPAM NASAL SPRAY)

SAN DIEGO, CA – June 8, 2020 – Neurelis, Inc., announced today that insurers and managed care plans now provide coverage for more than 176 million lives for the company's lead product, VALTOCO® (diazepam nasal spray). VALTOCO was approved by the U.S. Food and Drug Administration (FDA) on January 10, 2020, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in adult and pediatric patients 6 years of age and older.

NEURELIS ANNOUNCES TOTAL OF NINE POSTER PRESENTATIONS FOR THE AANN, AMCP, AND AAN ANNUAL MEETINGS

SAN DIEGO, CA – May 20, 2020 – Neurelis, Inc., announced today the company has nine total posters accepted for the annual meetings of the American Association of Neuroscience Nurses (AANN), the Academy of Managed Care Pharmacy (AMCP) and the American Academy of Neurology (AAN). The posters are all available for review online due to the cancellation of the organizations' annual meetings because of the COVID-19 pandemic.

NEURELIS ANNOUNCES THAT INTRAVAIL® LICENSEE, ARS PHARMACEUTICALS’ INTRANASAL EPINEPHRINE PRODUCT, DEMONSTRATES BIOEQUIVALENT EXPOSURE TO EPINEPHRINE INJECTORS

SAN DIEGO, CA – May 4, 2020 – Neurelis, Inc., announced today that the American Academy of Allergy, Asthma & Immunology (AAAAI) presented promising results for ARS Pharmaceuticals' lead asset, ARS-1, a 1-mg intranasal epinephrine product utilizing the Intravail® technology.

NEURELIS ANNOUNCES COMMERCIAL AVAILABILITY OF VALTOCO® (DIAZEPAM NASAL SPRAY) FOR SEIZURE CLUSTER RESCUE

SAN DIEGO, CA – March 2, 2020 – Neurelis, Inc., announced today the commercial availability of VALTOCO® (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older.

NEURELIS TO PRESENT AT SVB LEERINK 9th ANNUAL GLOBAL HEALTHCARE CONFERENCE

SAN DIEGO, CA – February 24, 2020 – Neurelis, Inc., today announced that the company will be participating in the SVB Leerink 9th Annual Global Healthcare Conference at Lotte New York Palace, New York City. Neurelis President and CEO Craig Chambliss will present at 2:15 pm EST on Tuesday, February 25.

NEURELIS ANNOUNCES FDA APPROVAL FOR SEIZURE RESCUE TREATMENT VALTOCO® (DIAZEPAM NASAL SPRAY) THAT INCORPORATES THE SCIENCE OF INTRAVAIL® FOR CONSISTENT AND RELIABLE ABSORPTION

SAN DIEGO, CA – January 13, 2020 – Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in people with epilepsy 6 years of age and older. The unique formulation of VALTOCO incorporates Intravail® for consistent and reliable absorption.

NEURELIS ANNOUNCES NINE POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE AMERICAN EPILEPSY SOCIETY

SAN DIEGO, CA – December 5, 2019 – Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing and commercializing product candidates for epilepsy and the broader central nervous system market,  announced today that the company will have nine poster presentations at the annual meeting of the American Epilepsy Society being held December 6-10 in Baltimore, Maryland.

NEURELIS ANNOUNCES THREE POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE CHILD NEUROLOGY SOCIETY

SAN DIEGO, CA – October 22, 2019 – Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing and commercializing product candidates for epilepsy and the broader central nervous system (CNS) market,  announced today that the company will have three poster presentations at the 48th annual meeting of the Child Neurology Society being held October 23-26 in Charlotte, North Carolina.

UPSHER-SMITH LABORATORIES ANNOUNCES THE LAUNCH OF TOSYMRA™ USING NEURELIS’ INTRAVAIL® TECHNOLOGY

MAPLE GROVE, MN – October 2, 2019 – Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of Tosymra™ (sumatriptan) Nasal Spray, 10 mg for the acute treatment of migraine with or without aura in adults. Tosymra is a fast-acting, easy-to-use acute migraine treatment option that delivers the efficacy of an injectable in a convenient nasal spray.

Neurelis Announces Two Poster Presentations At The Annual Meeting Of The American Academy Of Neurology

SAN DIEGO, CA – April 29, 2019 – Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing, and commercializing product candidates for epilepsy and the broader central nervous system (CNS) market, announced today that the company will have two poster presentations at the 71st annual meeting of the American Academy of Neurology being held May 4-10, 2019 in Philadelphia.

NEURELIS ANNOUNCES COMPLETION OF SENIOR MANAGEMENT TEAM BUILDOUT TO SUPPORT THE ANTICIPATED COMMERCIAL LAUNCH OF VALTOCO™

SAN DIEGO, CA – April 22, 2019 – Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing, and commercializing product candidates for epilepsy and the broader central nervous system (CNS) market,  announced today that the company has completed the buildout of its senior management team to support the anticipated launch of its lead product, VALTOCO™ (diazepam nasal spray).

Neurelis Announces That Intravail® Licensee ARS Pharmaceuticals Intranasal Epinephrine Program Given Fast Track Designation

SAN DIEGO, CA – February 20, 2019 – Neurelis, Inc. announced today that its Intravail® licensing partner, ARS Pharmaceuticals, Inc., received Fast Track designation from the FDA for ARS-1, its novel intranasal epinephrine spray.

Neurelis Announces First Product Approved Using The Company’s Intravail® Platform

SAN DIEGO, CA – January 29, 2019 -- Neurelis announced today that its Intravail® licensing partner, Dr. Reddy’s Laboratories and its U.S. subsidiary, Promius Pharma, LLC, received U.S. Food and Drug Administration (FDA) approval of TOSYMRA™ (sumatriptan nasal spray 10 mg). TOSYMRA™ is indicated for the acute treatment of migraine with or without aura in adults.

INTRAVAIL® LICENSEE, ARS PHARMACEUTICALS, SECURES $20M FINANCING FROM DEERFIELD MANAGEMENT

SAN DIEGO, CA – December 19, 2018 -- ARS Pharmaceuticals, Inc., a pharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions potentially leading to anaphylaxis, has raised $20 million in Series C financing led by Deerfield Management. The Company will use the funds to advance the clinical development of its novel intranasal epinephrine spray, ARS-1, which uses Intravail®, a novel nasal absorption platform licensed from Neurelis.

Neurelis Announces Acquisition Of Aegis Therapeutics, A Leading Drug Delivery Technology Company

SAN DIEGO, CA – December 3, 2018 -- Neurelis, Inc. today announced the acquisition of Aegis Therapeutics, a San Diego-based drug delivery technology company. Aegis Therapeutics’ proprietary portfolio includes Intravail®, ProTek® and Hydrogel™, three non-invasive drug delivery and stabilization technologies applicable to a wide-range of molecules including therapeutic proteins, peptides, non-peptide macromolecules and small molecules.

Neurelis Files New Drug Application With The FDA For VALTOCO™ (Diazepam Nasal Spray), An Investigational Treatment For Pediatric, Adolescent And Adult Epilepsy Patients

SAN DIEGO, CA – Sept. 25, 2018 -- Neurelis, Inc. today announced that the company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for VALTOCOTM (diazepam nasal spray) as a treatment for epilepsy patients six years and older who experience increased bouts of seizure activity, also known as cluster or acute repetitive seizures.

Neurelis Expands Worldwide Patent Portfolio with Latest Issuance in Japan

November 07, 2017 | Company developing NRL-1, a proprietary intranasal formulation of diazepam, for epilepsy patients who experience acute repetitive or cluster seizures

Neurelis Completes Series B Financing

January 05, 2017 | Funds to be utilized to complete development work and begin commercialization preparations for NRL-1. Program has received Orphan Drug and Fast Track Designation from FDA.

Neurelis Recieves FDA Fast Track Designation for NRL-1

January 04, 2017 | Neurelis Intranasal Diazepam Treatment For Epilepsy Granted Fast Track Designation By FDA

Neurelis Finalizes Series A Financing to Advance Lead Program to NDA Filing

February 22, 2016 | The investment, led by LYZZ Capital, is intended to advance the company's lead program, NRL-1 (intranasal diazepam), through the remaining clinical work in preparation for FDA submission of a New Drug Application (NDA) in the US.

Neurelis Initiates Pivotal Clinical Program for NRL-1 in the Treatment of Acute Repetitive Seizures

January 19, 2016 | Following the receipt of Orphan Drug Designation for their lead product, NRL-1 (intranasal diazepam), Neurelis, Inc. ("Neurelis") today announced the receipt of guidance from the FDA for the final clinical trial requirements necessary for approval of NRL-1.

Neurelis Receives FDA Orphan Drug Designation for NRL-1 in the Treatment of Acute Repetitive Seizures

December 21, 2015 | The FDA's Orphan Drug Designation program provides orphan status to drugs intended for the safe and effective treatment of rare disorders that affect fewer than 200,000 people in the United States.