As communicated in the company's financial report for the 3rd quarter 2023 on October 31st, significant progress is being made towards the goals set out in the revised strategy communicated on September 9th. Furthermore, as communicated on November 21st, comprehensive analyses show that the adjusted formulation of BupiZenge™ is clean. The company therefore provides this strategy update to offer more transparency regarding ongoing activities and the plan going forward.
 

•       Distinct partner tracks being pursued with focus on USA and Europe/RoW, respectively.
•       Estimated annual market potential of $200M to $1.3B in Europe and USA, with additional upside in Rest of the World and future potential in indications beyond oral mucositis.
•       OncoZenge sees a need for additional operational capital in 2025 should the ongoing partnering efforts be delayed.

 
Taking BupiZenge™ to market
 
As previously communicated, a partnering approach has been adopted for BupiZenge™ to conduct a clinical phase III-trial and potential market approval with minimal upfront expenses. Ongoing partner engagement is closely tied to the regulatory guidance received from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Regarding product development, stability studies are continuing, and study protocols for the next phase of clinical phase III development will be updated as appropriate in close collaboration with potential partners.
 
The additional requirements for marketing approval posed by the FDA, beyond those required by EMA, mean that the shortest path to approval in a market with significant commercial potential is in the EU, and other geographies that use EU approval as a reference for their own approval processes. 
 
Provided successful partnering, EU market approval in 2026 is considered feasible. To de-risk this effort and accelerate preparations for the European phase III program OncoZenge has started preparations to file for PRIority MEdicines (PRIME) status with EMA, which provides enhanced regulatory support to drug candidates that have the potential to address significant unmet clinical needs. 
 
In parallel with efforts to secure a strategic partner for Europe and non-EU/non-US markets, OncoZenge is in dialog with parties that show an interest in advancing BupiZenge™ in the valuable US market. 
 
Market potential
 
Potential partners for OncoZenge will consider several factors. Besides the merits of the product itself as a safe and effective, non-opioid pain reliever for oral pain, the commercial market potential is important. Market potential in turn is dependent on the size of the patient population, assumptions on post-approval take up, treatment duration, and more. OncoZenge's impression from dialogue with potential partners is a clear recognition of the significant market need and commercial potential. There is a clear portfolio logic in working with OncoZenge for pharmaceutical companies active in both the pain and oncology treatment areas.
 
OncoZenge has built a comprehensive valuation model including multiple scenarios for market introduction based on the feedback from key opinion leaders regarding the large unmet medical need, in oral mucositis. Following discussions with external parties on regulatory strategy the probability for a market approval is estimated to be high, pending successful phase III results, considering that bupivacaine is a well-known substance with decades of safety data obtained in other indications.
 
To give an illustrative scenario: In the US alone, BupiZengeTM has a potential of $100M to $800M, annually, assuming a patient population of 2 million cancer diagnoses, a 6-week treatment period, a prevalence of oral mucositis of 30-50%, adoption rates of 20-40% and pricing of $5-12 per lozenge. In Europe, the potential ranges from $110M to $540M annually based on similar assumptions with a patient population of 2.7 million and a pricing of $4-6.
 
Other markets such as India, China, Japan, and South Korea have significant potential considering their 7-plus million combined patient populations. The global potential outside of the US and Europe can thus be estimated to several hundred million dollars, annually.
 
In addition, significant label expansion opportunities exist for OncoZenge and our partners over time, by broadening approval to other indications beyond oral mucositis. Examples include pain relief in endoscopy, tonsillectomy and other surgeries in mouth and throat, dental applications, Burning Mouth Syndrome (BMS), and more.
 
Looking ahead
 
Considering the significant investments made to date in the development of BupiZengeTM, 2024 will be focused on business development and value adding activities such as securing new IP and partnerships. Based on current assumptions, investment plans and the partner-led go-to-market strategy, the previously communicated capital needs amounting to SEK 60 million will not be required. However, OncoZenge does envisage a need for additional operational capital in 2025 should the ongoing partnering efforts be delayed. 
 
"We are looking forward to providing further updates on the company's progress towards the goals set out in our revised strategy. We are determined to make every effort to meet the needs of the millions of patients suffering from oral mucositis and other oral pain conditions by finding the optimal path to the market for BupiZenge™", says Stian Kildal, CEO for OncoZenge.
 
The company will provide more details of the financial outlook in the year-end report for 2023, scheduled to be published on February 22nd, 2024.
 
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
Michael Owens, CFO, mobile: +46 73 324 4988, e-mail: michael.owens@oncozenge.se
Daniel Ehrenstråhle, Chairman of the Board, e-mail: daniel.ehrenstrahle@oncozenge.se
Certified Adviser
OncoZenge's Certified Adviser is Erik Penser Bank AB, Box 7405, 103 91 Stockholm, Sweden
Phone: +46-084638000, e-mail: certifiedadviser@penser.se.

About this information
OncoZenge publishes this information in accordance with the EU Market Abuse Regulation (MAR). The information was submitted for publication on 24 November 2023 at 14:15 CEST through the contact persons above.

OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden

About OncoZenge

OncoZenge develops a novel, effective, safe and well-tolerated treatment for oral pain in conditions where currently available treatment options either do not achieve sufficient pain relief or are associated with significant side effects. BupiZenge™ is a new oral lozenge formulation of bupivacaine, an anaesthetic with decades of clinical experience. OncoZenge's lead indication is oral pain due to an inflammatory condition called oral mucositis that affects millions of patients receiving cancer treatment. Oral mucositis causes profound physical and psychological suffering, and is a large unmet medical need for an effective, opioid-sparing treatment option. BupiZenge™ has shown significantly better pain relief compared to standard of care in this indication in a Phase 2 trial.
OncoZenge has its headquarters in Stockholm, Sweden, and its share is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ.