PharmaEssentia Announces Subsidiary FORUS Therapeutics Inc.'s Approval of BESREMi (Ropeginterferon alfa-2b) by Health Canada for Adult Polycythemia Vera (PV)

1. Date of Event: 115/07/02

2. Name or Code of the New Drug: BESREMi (Ropeginterferon alfa-2b, also known as P1101)

3. Indication: For the treatment of adult patients with polycythemia vera (PV).

4. All Planned Research and Development Stages: Not applicable.

5. Current Stage of Research and Development (please specify whether this stage involves application submission/approval/rejection; if rejected, describe risks and countermeasures, future business direction, and cumulative R&D expenses incurred):

(1) Application submission/approval/rejection, results of clinical trials (including interim analyses), or other significant events affecting drug development:

The company's new drug BESREMi (Ropeginterferon alfa-2b), prefilled syringe injection solution 500 mcg/mL (BESREMi 500 mcg/mL solution for injection in prefilled syringe), has been approved by Health Canada for use in adult patients with polycythemia vera (PV).

(2) If not approved by the relevant regulatory authority, clinical trial results (including interim analyses) not statistically significant, or other major events affecting drug development—risks faced by the company and corresponding countermeasures: Not applicable.

(3) If approved by the relevant regulatory authority, clinical trial results (including interim analyses) statistically significant, or other major events affecting drug development—future business direction:

FORUS Therapeutics Inc. will officially launch commercial sales and marketing activities for ropeginterferon alfa-2b in Canada as planned.

(4) Cumulative R&D expenses incurred:

Due to future marketing strategies and to protect the interests of the company and investors, this information will not be disclosed at this time.

6. Next Planned R&D Stage (expected completion date and expected obligations):

(1) Expected completion date: Not applicable.

(2) Expected obligations: None.

7. Market Status:

Polycythemia vera (PV) is a type of myeloproliferative neoplasm (MPN). While excessive red blood cell production is most prominent, white blood cells and platelets are also often elevated. PV patients face a high risk of cardiovascular complications such as thrombosis and embolism, and may progress to secondary myelofibrosis (MF) or acute myeloid leukemia (AML), affecting survival and quality of life. Market research estimates approximately 17,000 PV patients in Canada. Current clinical treatments include phlebotomy, hydroxyurea (HU) capsules, interferon, and JAK2 inhibitors.

8. Other Matters to be Disclosed (if the event or resolution involves a publicly listed company or above, this material information also meets the criteria under Article 7, Clause 8 of the Enforcement Rules of the Securities and Exchange Act, significantly affecting shareholder rights or securities prices):

Ropeginterferon alfa-2b is a next-generation, long-acting interferon independently developed and manufactured by the company. It has now been approved in approximately 50 countries worldwide for adult PV patients, including major pharmaceutical markets such as the United States, Japan, China, and the European Union.

9. New drug development involves long timelines, high investment costs, and no guarantee of success, which may expose investors to risks. Investors are advised to carefully assess and make prudent investment decisions.