Diazepam

• Aquestive received positive feedback in October 2023 from the U.S. Food and Drug Administration (FDA) on the Company's pivotal Phase 3 Pharmacokinetic (PK) clinical protocol for Anaphylm.
• Aquestive commenced dosing in December 2023 in the Phase 3 pivotal PK clinical study of Anaphylm.
• Non-GAAP adjusted EBITDA loss was $2.8 million in the fourth quarter 2023, compared to a $9.6 million loss in the fourth quarter 2022.
• During the fourth quarter 2023, the Company accessed capital net proceeds of $3.7 million under its "At-the-Market" (ATM) facility.

• But experiencing a seizure does not always mean a person has epilepsy.
• Seizures can be provoked by acute head injuries, alcohol withdrawal and high blood sugar, among other things.

What does a seizure look like?

• For some people, their seizure is a purely internal sensation.
• In fact, most people with epilepsy have only relatively subtle, nonconvulsive seizures at first, then develop convulsive seizures over time.
• This is the type of seizure most of us are familiar with, probably because it’s the kind most frequently depicted, though not always accurately, in movies and on television.
• The most common type of epileptic seizure are those that are focal – that is, they arise from a confined region of the brain.

What causes a seizure to occur?

Seizures are the result of abnormal electrical activity in the brain. The bursts of activity disrupt normal functioning and initiate hyperactivity in the affected brain area, which then can affect the corresponding body part. For instance, if the seizure arises from the part of the brain involved in arm movement, that arm will experience involuntary hyperactivity.

If you’re a bystander, how can you help?

• Many seizure-related injuries occur due to falling or coming in contact with sharp or hard objects.
• If they begin to fall, help them to the floor as gently as possible and put something soft under their head.
• During the convulsive phase of a seizure, breathing may be intermittent.
• So turn the person on their side so they can breathe more easily and lower the risk of aspiration.
• Following the seizure, and as the person gradually recovers and wakes up, help them sit up in a safe space.

Are new treatments available?

• People with epilepsy, particularly those who experience frequent seizures, will often have emergency medications in their possession.
• The most common emergency medications – also called seizure rescue medications – are a type of anticonvulsants called benzodiazepines.
• Patients and their caretakers may have access to rescue medications and know how to use them.

What if it’s not a seizure?

If a bystander does not witness a seizure, but instead finds someone unresponsive or minimally responsive, call 911. They may be suffering from other medical issues, such as a drug overdose. And if you are interested in training and certification for seizure first aid, or if you simply want to know more, the Epilepsy Foundation has more information.

• Jacob Pellinen has received research support from the Department of Neurology at the University of Colorado School of Medicine, the Colorado Clinical and Translational Sciences Institute, NIH/NINDS, and the American Epilepsy Society.
• J. Pellinen serves as chair of the professional advisory board for the Epilepsy Foundation of Colorado and Wyoming (unpaid), serves as the Epilepsy Section Editor for Current Neurology and Neuroscience Reports, and has received compensation for serving on the scientific advisory board for SK Life Science.

• China Medical System actively responds to national policies to promote innovative products to be included in the NRDL.
• In addition, innovative drug Methotrexate Injection (Metoject) indicated for psoriasis approved in March 2023 has been included in category A of the National Reimbursement Drug List.
• It is the first nasal spray formulation of diazepam in China and the first drug approved in China for the treatment of seizure clusters.
• CMS actively responds to national policies to promote innovative products to be included in the National Reimbursement Drug List.

• 11,793,786 (the '786 Patent).
• The '786 Patent is listed in the U.S. Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, as it relates to VALTOCO®, and is solely owned by Neurelis.
• "We will continue to expand our intellectual property, memorializing the scientific innovation that drives Neurelis' commitment to improving patient outcomes.
• The '786 Patent, with an expiry date of March 2029, joins five other Orange Book listed patents that currently provide exclusivity to the VALTOCO franchise through 2029.