Beskrivning
Land | Sverige |
---|---|
Lista | First North Stockholm |
Sektor | Hälsovård |
Industri | Bioteknik |
OncoZenge AB (publ) ("OncoZenge" or the "Company") today provides an update on the status of the regulatory process in China for the investment agreement entered into by the Company and Sichuan-Yangtian Biopharmaceuticals Co, Ltd ("Yangtian Pharma" or the "Investor") on January 27th, 2025. The filing is currently in review with the provincial Department of Commerce, and the necessary documentation has been provided to the counterparty bank appointed by the State Administration of Foreign Exchange.
On January 27th the Company announced the intention to partner with Yangtian Pharma as a new strategic investor in the Company, by entering into an investment agreement that through four tranches of directed share issues to Yangtian Pharma will provide the financing for the phase 3 trial for BupiZenge™ targeting European market approval. The investment is conditional on customary regulatory approvals, through a shareholder resolution in Sweden granted on March 3rd, and the successful completion of the mandatory Overseas Direct Investment (ODI) process in China. On April 25th an amendment was signed extending the date of the investment agreement to May 31st 2025, to reconfirm both parties definite intent to execute the agreement despite longer ODI process lead times than initially anticipated.
As previously communicated by the Company, the National Development and Reform Commission (NDRC) has already approved the investment. In accordance with the ODI process the Investor has proceeded to submit a filing to the Ministry of Commerce (MOFCOM). The case was subsequently delegated to the provincial Department of Commerce, which requested amendments and clarifications prepared and submitted by Yangtian Pharma. In parallel the Investor has made the mandatory filing to the State Administration of Foreign Exchange (SAFE), the final authority in the ODI process. SAFE has reviewed the filing and delegated it to its designated counterparty bank for processing. Thus the Company and Yangtian Pharma currently await the final approval from the local Department of Commerce in support of the banks processing the foreign exchange transfers in accordance with the investment agreement.
To cater for the lead-time in the ODI process to complete, OncoZenge and Yangtian Pharma has today entered into an amendment to the investment agreement, with the timeframe of the ODI process being extended to June 30th, 2025, all other terms unaffected.
Yangtian Pharma and OncoZenge fully expect the process to conclude with a positive outcome, which will release the phase 3 funding in accordance with the investment agreement.
BupiZenge™ - Potential to be the leading treatment for oral pain.
For additional information, please contact:
Stian Kildal, CEO, mobile: +46 76 115 3797, e-mail: stian.kildal@oncozenge.se
Certified Adviser
OncoZenge's Certified Adviser is Redeye AB.
OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden
About this release
The information in this release was submitted for publication, through the agency of the contact persons set out above, at 08:45 CEST on May 30, 2025.
About OncoZenge
OncoZenge is dedicated to developing an innovative, effective, and well-tolerated treatment for oral pain in conditions where current options fall short, often due to insufficient pain relief or significant side effects. BupiZenge™ is a novel oral lozenge formulation of bupivacaine, a local anesthetic with decades of clinical experience. The lead indication for BupiZenge™ is oral pain caused by oral mucositis, an inflammatory condition affecting millions of cancer patients. Oral mucositis leads to severe physical and psychological distress, representing a significant unmet medical need for an effective, opioid-sparing treatment. In Phase 2 trials, BupiZenge™ demonstrated substantially better pain relief compared to the standard of care.
OncoZenge is headquartered in Stockholm, Sweden, and is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ.