Mr. Craig Mull reports

CIPHER PHARMACEUTICALS ANNOUNCES HEALTH CANADA'S ACCEPTANCE FOR REVIEW OF NEW DRUG SUBMISSION FOR NATROBA (SPINOSAD)

Health Canada has accepted for review Cipher Pharmaceuticals Inc.'s new drug submission (NDS) for Natroba (Spinosad), for the treatment of head lice and scabies.

Natroba (Spinosad) is widely recognized as one of the most effective treatments for the two parasitic indications of head lice and scabies in the United States. It is superior to the widely used permethrin 1 per cent for treating head lice and is the only treatment in the U.S. that meets the Food and Drug Administration's criteria for a complete cure (elimination of all signs and symptoms) in eradicating scabies infestations with a single application. Cipher acquired Natroba (Spinosad) in July, 2024, and since acquisition has marketed and distributed the product in the United States market, through its commercial infrastructure.

If and when approved by Health Canada, Cipher intends to commercialize Natroba (Spinosad) directly through its existing Canadian sales and distribution infrastructure. Existing head lice products in Canada, like the U.S. and globally, have become ineffective from resistance developed by lice due to a gene mutation, coupled with resistance by scabies mites to the most often prescribed products. Natroba fulfills an unmet need in Canada for the treatment of head lice and scabies, with a proven single treatment option.

Craig Mull, interim chief executive officer, commented, "Health Canada's acceptance of our NDS and commitment to review puts us one step closer to providing Canadians with an effective single treatment option for head lice and scabies, which is an objective we had established upon acquiring the product."

About Cipher Pharmaceuticals Inc.

Cipher Pharmaceuticals is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products in Canada, the United States, and South America.

We seek Safe Harbor.