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Neurelis Enters $208 Million Agreement to Monetize Intravail Royalties

San Diego, CA – November 14, 2024 – Neurelis, Inc. (“Company”), today announced a transaction with OrbiMed for the sale of the Company’s rights, royalty interests, and related sales milestone payments on global net sales of neffy® (nasal epinephrine) (the “Neffy Receivables”). Neurelis, through its subsidiary Aegis Therapeutics, LLC (“Aegis”),

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

First in human study will evaluate safety, tolerability, and pharmacokinetic parameters of NRL-1049, a Rho kinase (ROCK) inhibitor SAN DIEGO, CA  — March 24, 2023 — 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

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

Pre-clinical data recently presented at Society for Neuroscience’s annual meeting demonstrates NRL-1049 potential safety, Neurelis to advance further studies SAN DIEGO, CA  — January 9, 2023  — 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

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

Investigational Phase 3 study of VALTOCO® (diazepam nasal spray) CIV shows double the time between seizure clusters when administered over a 12-month period Poster addresses myths associated with rescue therapy for seizure clusters Additional poster highlights investigational non-surgical treatment option for cerebral cavernous malformations SAN DIEGO, CA  — December 2,

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

SAN DIEGO, CA  — November 28, 2022  — 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 that corporate leadership will participate in a fireside chat and one-on-one

NEURELIS RANKED THIRD BEST PLACE TO WORK IN SoCAL 2022

SAN DIEGO, CA  — October 24, 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. This distinction is based on responses from a detailed and

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

Two posters highlight findings from a long term safety study of VALTOCO in a pediatric population The first features investigational data indicating a doubling of time between VALTOCO treated seizure clusters across 12 months The second summarizes a sub-analysis showing no long-term safety differences for VALTOCO in patients with Lennox-Gastaut

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

Analysis of 12-month, Phase 3 study shows 2-fold increase in time between VALTOCO treated seizure clusters, or SEIzure interVAL (SEIVAL) SAN DIEGO, CA  — October 12, 2022  — Neurelis, Inc., a commercial-stage neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic

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

Novel clinical data highlights the potential for future research into additional benefits of rescue medications in treating individual seizure clusters SAN DIEGO, CA  — September 7, 2022  — Neurelis, Inc., announced the recent online publication of a novel data analysis, evaluating the time interval between seizure clusters, or SEIzure interVAL

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

Company culture cultivates passioned innovation and purpose in employees to empower those impacted by epilepsy and other rare disorders SAN DIEGO, CA  — August 18, 2022  — Neurelis, Inc., is pleased to announce it has been named one of the Best Places to Work in SoCal 2022 by Best Companies

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

SAN DIEGO, CA  – June 9, 2022  — Neurelis, Inc., announced the publication of a study recently available online in the peer-reviewed, scientific journal Epilepsia. Epilepsia is the world’s leading journal of original scientific research on multiple aspects of epilepsy. Epilepsia publishes reviews, opinion pieces, and guidelines that foster understanding

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

Fifth patent combined with a growing body of clinical data demonstrate safety and effectiveness of VALTOCO in this patient population, enhancing potential to expand clinical and commercial value. SAN DIEGO, CA — April 26, 2022 — Neurelis, Inc., a neuroscience-based company dedicated to enhancing therapeutic benefits and addressing significant unmet needs

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

SAN DIEGO, CA — January 25, 2022 — 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 which includes Australia, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, New Zealand,

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

SAN DIEGO, CA — December 3, 2021 — 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. Harrison was diagnosed at age 8 with focal onset

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

Financing to fund commercialization of Neurelis’ lead product, VALTOCO® (diazepam nasal spray), and to advance its product pipeline while allowing the company to explore certain additional strategic opportunities SAN DIEGO, CA — August 11, 2021 — Neurelis, Inc., announced today that it has completed a senior term loan facility of

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

Adds to Neurelis’s growing pipeline of innovative neuroscience programs There are no currently FDA-approved treatments for Cerebral Cavernous Malformations (CCMs) Neurelis intends to submit an Investigational New Drug (IND) application with the FDA on BioAxone’s lead compound, BA-1049, in 2022 SAN DIEGO, CA — June 21, 2021 — Neurelis, Inc.,

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

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

— ARS Pharmaceuticals’ lead product, ARS-1 (epinephrine nasal spray) to treat severe allergic reactions, has previously been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) — Neurelis’ lead product, VALTOCO® (diazepam nasal spray), approved by the FDA for seizure cluster rescue, also utilizes Intravail® as a

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