OncoZenge provides update on regulatory status of incoming investment

OncoZenge provides update on regulatory status of incoming investment

OncoZenge AB (publ) ("OncoZenge" or the "Company") today provides an update on the status of the regulatory process in China regarding the investment agreement that the Company has entered into with Sichuan-Yangtian Biopharmaceuticals Co., Ltd ("Yangtian Pharma" or the "Investor") on January 27, 2025. Following completion, the NDRC has accepted the Investor's application, and a subsequent notification has been submitted to the Ministry of Commerce.

On January 27, the Company announced its intention to collaborate with Yangtian Pharma as a new strategic investor in the Company through an investment agreement that through four directed issues to Yangtian Pharma will finance the phase 3 study for BupiZenge™ with the goal of obtaining market approval in Europe. The investment is subject to customary regulatory approvals, through a shareholder resolution in Sweden granted on March 3, as well as the successful completion of the mandatory foreign direct investment (ODI) process in China.

The Company has been informed that the National Development and Reform Commission (NDRC) has reviewed the application and requested additional information, which Yangtian Pharma has prepared and submitted. Following this, the NDRC has confirmed that the application is complete and an inter-ministerial case number has been assigned, enabling the Investor to make the mandatory notification to the Ministry of Commerce (MOFCOM). A notification to the State Administration of Foreign Exchange (SAFE) will be made in accordance with the ODI process.

In order to take into account the processing time to complete the ODI process, OncoZenge and Yangtian Pharma have today entered into a supplementary agreement to the original investment agreement, where the timeframe for the ODI process is extended to May 31, 2025, without affecting other terms and conditions.

Yangtian Pharma and OncoZenge fully expect the process to end with a positive outcome, which will release the financing for Phase 3 in accordance with the investment agreement.

BupiZenge™ – Potential to be the leading treatment for oral pain.
 

For further information, please contact:
Stian Kildal, CEO, Mobile: +46 76 115 3797, e-post: stian.kildal@oncozenge.se

Certified Adviser
OncoZenges Certified Adviser är Redeye AB.

OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden

About this information
The information was submitted for publication on April 25, 2025 at 08.30 CET, through the agency of the contact persons set out above.

About OncoZenge
OncoZenge is developing a novel, effective, safe and well-tolerated treatment for oral pain in conditions where the currently available treatment options either do not achieve adequate pain relief or are associated with significant side effects. BupiZenge™ is a novel oral lozenge formulation of bupivacaine, a topical anesthetic with decades of clinical experience. OncoZenge's main indication for BupiZenge™ is oral pain due to an inflammatory condition called oral mucositis that affects millions of patients receiving cancer treatment. Oral mucositis causes severe physical and mental suffering with a high unmet medical need for an effective, opioid-sparing treatment option. BupiZenge™ has shown significantly better pain relief compared to standard care in this indication in a phase 2 study.

OncoZenge is headquartered in Stockholm, Sweden, and the company's shares are listed on Nasdaq FirstNorth Growth Market (OMX: ONCOZ).