Neurelis Provides Business Update Highlighting Transformational 2025 Results

2025 Net Revenue of $295-300M, EBITDA margin of 30%+

Expansion of VALTOCO (diazepam nasal spray) Patent Portfolio, Extending Market Exclusivity with multiple issuances through 2032

Accelerated Uptake with VALTOCO FDA Label Expansion Approval Including 2 to 5 years of Age

SAN DIEGO, Jan. 12, 2026 /PRNewswire/ -- Neurelis, Inc., the innovator behind VALTOCO® (diazepam nasal spray), today provides a business update highlighting the Company's recent achievements in strengthening its product franchise and improving patient care: 

• Estimated net sales of $295-300 million for 2025, more than doubling 2024 net sales, and EBITDA margin of 30%+
  
  
• Strong balance sheet with no bank debt and cash of $175+ million at 12/31/25
  
  
• Over 12,000 patients, age 2 to 5, prescribed VALTOCO following approval from the U.S. Food and Drug Administration (FDA) for an expanded indication. VALTOCO is now approved for children and adults ages 2 and above; and
  
  
• Three additional issued patents significantly strengthen and expand the Orange Book portfolio for VALTOCO, which now includes a total of six listed patents - the latest extending exclusivity into October of 2032.  

"We are very pleased with the significant strides we made this year improving patient care and treatment options for people with epilepsy, their care partners, and families," said Craig Chambliss, Neurelis Co-Founder and CEO. "We continue to align our efforts in enabling prescribers to empower patients and those caring for them. The label expansion granted by the FDA for VALTOCO reflects the safety and effectiveness of this product by extending the clinical benefits to an even younger patient population. The tremendous growth of VALTOCO in 2025 is significant progress in ensuring patients have an immediate-use seizure treatment when and where they need it. We are also pleased to enhance our VALTOCO intellectual property portfolio with additional patent issuances, which reinforce the highly differentiated clinical profile of VALTOCO and provide extended opportunity for our efforts in positively impacting the epilepsy community."

Mr. Chambliss continued, "Neurelis is in a stronger position than ever, with a sound financial foundation and cash flow generation, to continue advancing CNS-focused treatments that address unmet needs and empower providers and patients." 

Business Update Highlights

• Commercial Packaging Enhancement to Align Prescriber Intent with Patient Need: An independent prescription audit in 2024 revealed a discrepancy between the amount of medication prescribed by a health care provider and the amount dispensed by the pharmacy, which could negatively impact patient care. Following extensive research with physicians, patients, and payers, Neurelis introduced new retail packaging for VALTOCO to  effectively address this discrepancy. The new five-dose packaging gives patients the number of doses intended by their provider while conforming within the FDA-approved product label (treating up to five seizure episodes per month, with a maximum of ten doses per month). 
  
  Price per dose of VALTOCO remains the same and the exceptional managed care coverage VALTOCO patients have come to expect is unchanged. Additionally, the shelf life of VALTOCO was extended to 32-36 months.
  
  
• Label Expansion for Two- to Five-year Olds: The FDA approved expansion of the VALTOCO label for treatment of episodes of frequent seizures in children ages 2 to 5. The non-invasive intranasal formulation of Neurelis' VALTOCO was previously recognized by the FDA as clinically superior to the rectal gel formulation of diazepam in patients ages 6 and above resulting in its orphan drug exclusivity designation.
  
  
• Patent Portfolio Expansion and Extension of Market Exclusivity: The issuance of new United States Patents No. 12,324,852 (the '852 patent) and No. 12,337,061 (the '061 patent), covering methods of treating acute seizure clusters with intranasal administration of diazepam, extends patent protection for VALTOCO through October 2032. The patented method demonstrates significant clinical benefits, including a reduction in seizure severity, frequency, and probability of recurrence, along with rapid treatment onset and duration lasting up to 24 hours. 
  
  Together, Neurelis' patents secure a robust and extended intellectual property estate for VALTOCO, reinforcing its distinct value in the treatment of episodes of frequent seizures in people with epilepsy.

These 2025 developments position the Company to sustain the momentum of VALTOCO, advance its CNS pipeline, and pursue additional products that leverage its CNS-focused commercial engine, supported by a strong financial profile.

About Neurelis

Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' 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 an individual's usual seizure pattern in adult and pediatric patients 2 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs. For more information on VALTOCO, please visit www.valtoco.com. For the latest scientific information on VALTOCO, please visit http://www.neurelismedicalaffairs.com/. Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit www.neurelis.com. 

Important Safety Information about VALTOCO:

Indication

VALTOCO^® (diazepam nasal spray) is indicated 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 patients with epilepsy 2 years of age and older.

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

• Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
• The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.
• The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO. 

Contraindications: VALTOCO is contraindicated in patients with:

• Hypersensitivity to diazepam
• Acute narrow-angle glaucoma

Central Nervous System (CNS) Depression
Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits.

The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner.

Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior.

Glaucoma
Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma.

Neonatal Sedation and Withdrawal Syndrome
Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly.

Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative
VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.

Adverse Reactions
The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort.

Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance.

To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please read full Prescribing Information, including Boxed Warning.

Contacts:
Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100

SOURCE Neurelis, Inc.