OncoZenge Provides Market and Strategy Update

OncoZenge AB (publ) (“OncoZenge” or “the Company”) today announced a comprehensive market and strategy update after successfully securing full funding for its BupiZenge™ Phase 3 clinical trial aimed at achieving European Medicines Agency (EMA) approval for the European market. This critical milestone moves OncoZenge closer to establishing BupiZenge™ as the new standard of care for treating the pain caused by oral mucositis.

OncoZenge estimates that at least 35% of cancer patients develop oral mucositis after beginning treatment, and most of these patients will experience more effective and better tolerated pain relief with BupiZenge™ than with current treatments. OncoZenge projects the global revenue potential for commercial licensees to amount to more than 10 billion SEK annually, and OncoZenge’s own revenues could exceed 2 billion SEK annually by 2034.

A potential approval by EMA based on the Phase 3 trial is expected to enable a 2027 commercial launch of BupiZenge™ in Europe, Latin America, parts of Asia, Canada, and Africa. OncoZenge’s annual revenues from royalties in these markets are expected to grow to 800 million SEK by 2034, while the Company’s costs are expected to remain similar to current levels.

Shareholders and interested parties are invited to a Capital Markets Day in September 2025 (date to be announced) for an in-depth discussion on the commercial opportunity, execution plans, and a Q&A session.

Key highlights and strategic progress

• Addressing a critical unmet need: OncoZenge is dedicated to establishing BupiZenge™ as the new global standard of care for treating the pain caused by oral mucositis (OM), a debilitating condition affecting millions of cancer patients.
• Clear regulatory pathway: The Company's primary focus is to secure the fastest, most cost-effective path to a European approval of BupiZenge™. This approval will not only enable European commercialization but also serve as a crucial lever for entry into adjacent markets (Latin America, parts of Asia, Canada, Africa, etc.). Evaluation of pathways to US and Chinese market approvals is also ongoing.
• Successful partner-led strategy: Launched in September 2023, OncoZenge’s partner-led strategy has successfully attracted robust commercial partners, operational expertise, and essential investment to bring BupiZenge™ to patients.
• Expert team in place: The OncoZenge sponsor team, overseeing trial and regulatory responsibilities, has been strategically built in collaboration with PharmaRelations, ensuring flexible access to deep industry expertise.
• Key commercial partnership secured: Molteni Farmaceutici (“Molteni”) has been granted commercial rights for the European market, contributing significant milestone payments and royalties of up to 20% on sales revenues.
• Patent portfolio in support of global licensing: The Intellectual Property (IP) portfolio has been broadened and extended through a close collaboration with Marie Mannerlöf, PhD, Patent Attorney and CEO of Imariel AB. The Company’s most recent PCT-filing has received positive confirmation of patentable claims and will be locally filed in lockstep with the PCT process, and global licensee, requirements.
• Manufacturing plans progressing: Manufacturing rights of BupiZenge™ for the European markets are being assessed together with Molteni, aligning with OncoZenge's strategy to seek an external manufacturer and minimize any own COGS.
• De-risked Phase 3 trial design: The Phase 3 trial design has been refined and de-risked through extensive collaboration with PharmaRelations, Molteni, OncoZenge’s Scientific Advisory Board, and other key stakeholders throughout the first half of 2025. The scope now includes 150 European patients across multiple European sites.
• Fully funded Phase 3 trial: An additional MSEK 46.7 in funding has been secured during 2025, ensuring the Phase 3 trial is now considered fully funded based on current planning assumptions by Management and the Board of Directors.
• Clinical material production underway: Meribel Pharma Solutions (formerly Recipharm in Sweden) has been contracted for the manufacture of clinical study material, with production of BupiZenge™ lozenges scheduled for the second half of 2025.
• Site feasibility study nearing completion: LINK Medical is conducting a feasibility study across European clinical sites focusing on Germany and the Nordics, with completion targeted for August 2025. The Clinical Research Organization (CRO) contract is expected to be awarded in the third quarter 2025.
• Anticipated timelines: Depending on regulatory lead-times, patient enrollment for the trial is expected to start in early to mid-2026, with commercialization of BupiZenge™ in Europe and adjacent markets anticipated during 2027.
  

Daniel Ehrenstråhle, Chairman of OncoZenge, comments:"Our commitment is to create the new global standard of care for treating the pain caused by oral mucositis in cancer patients. We believe that our product, BupiZenge™, has the potential to unlock a global revenue opportunity exceeding BSEK 10 annually for current and future commercialization partners. Over the past year, our focus has been on securing additional funding, partner selection, and meticulously preparing and de-risking our Phase 3 project focused on EMA approval. We have now secured the necessary MSEK 46.7 of additional funding, on what we believe are very favorable terms for our shareholders. We are incredibly excited to embark on this next chapter to secure commercial launch in Europe and adjacent markets where a European approval can be leveraged."

Partner-led strategy in detail

OncoZenge focuses on European approval for BupiZenge™ as the next critical step for the company due to its potential as the fastest route to market with very attractive returns on investment. Towards this goal, the management team and Board have invested heavily in identifying and onboarding the most suitable partners, securing critical competencies, and targeting low-risk, fast, and cost-effective delivery.

Stian Kildal, CEO of OncoZenge, comments: "We are thrilled to have assembled such a formidable team with deep industry expertise for our internal sponsor oversight function and to partner with exceptional organizations for project execution and commercialization. Crucially, we all share the purpose of bringing BupiZenge™ to market as swiftly as possible while ensuring compliance and quality. With bupivacaine, a proven and effective active ingredient, compelling earlier study results, a novel formulation for local oral delivery, and a well-defined global unmet patient need, it is highly encouraging to now be in this final stage of clinical trials toward regulatory approval."

OncoZenge Phase 3 Sponsor team:

    •    Chief Medical Officer: Christoph Nowak (also OncoZenge Board member)
    •    Phase 3 Program Manager: Anna Asplind (PharmaRelations)
    •    Regulatory Affairs Manager: Christina Junvik (PharmaRelations)
    •    CMC: Tuulikki Lindmark (RegSmart)
    •    Quality / QxP: Mihai Florescu (PharmaRelations)
    •    Clinical Research Manager: Åsa Nilsson (PharmaRelations)

This sponsor team is further supported by the Scientific Advisory Board, including Dr. Steven Sonis, Dr. Paolo Bossi, and Dr. Pooja Nandwani.

Development, Manufacturing, and Trial Execution Partners:

    •    CDMO: Meribel Pharma Solutions [https://meribelpharma.com]
    •    European Phase 3 Site Feasibility Study: LINK Medical [https://linkmedical.eu]
    •    CRO: To be awarded post-feasibility study completion.

Commercial Partners:

    •    European Licensee & Development Advisor: Molteni Farmaceutici [https://moltenifarma.it/en]
    •    GCC Distribution Partner: Avernus Pharma [https://avernuspharma.com]

Strategic Investor: Yangtian Bio-Pharmaceutical (“Yangtian Pharma”), a new investor in OncoZenge (MSEK 30.2 investment), will join the OncoZenge Board of Directors once their shareholding reaches at least 20%. Discussions are underway to evaluate pathways to Chinese approval and commercialization.

Scope of the phase 3 trial: 100% European patient pool

The Phase 3 study for BupiZenge™ is a randomized, open-label, active comparator arm study designed to confirm the efficacy and safety of the BupiZenge™ lozenge for the treatment of oral mucositis pain in patients with head and neck cancer (HNC).

Chris Nowak, CMO and Board Member of OncoZenge, comments: "We have carefully designed the study based on input from patient advocates, regulatory and clinical trial specialists, academic leaders in the field of supportive cancer care, and experts representing the payor perspective. We have a stellar team with robust experience of delivering on clinical milestones. This will be an exciting chapter in OncoZenge’s path to addressing an underappreciated unmet medical need.”

• Design: Multi-country, multi-center trial in Europe
• Comparator: BupiZenge™ will be compared to lidocaine gel representing current standard of care, building on learnings from the Phase 2 trial.
• Target sample size: 150 patients.
• Duration: 6-week treatment period and 1-month follow-up.
• Cost-efficiency: The study’s costs care curbed by its focused scope and efficiency gained by leveraging patients’ existing radiotherapy visits.
• Primary objective: Evaluate the effect of BupiZenge™ compared to lidocaine in treating oral cavity pain in HNC patients receiving radiotherapy with or without chemotherapy.
• Secondary objectives: Include safety and tolerability, consumption of systemic opioids, patient-reported quality of life, ability to eat and drink, progression of oral mucositis, and pharmacokinetics (in a subset of patients).

An overview of the Phase 3 study design, presented at the Multinational Association of Supportive Care in Cancer (MASCC) annual meeting in Seattle, USA, in June 2025, is available under 'Downloads' on the Company’s website: https://oncozenge.se/downloads/

Financing of the OncoZenge phase 3 trial

The MSEK 46.7 in additional financing secured during 2025 ensures full funding of the Phase 3 trial based on current assumptions and proposals from CDMO and CRO partners. MSEK 30.4 of this funding is contingent on the submission and approval of the Phase 3 Clinical Trial Application (CTA).

Completed financing (2025 Year-to-Date):

    •    MSEK 2.8: Molteni commercial partnership signing milestone
    •    MSEK 6.0: Yangtian Pharma Tranche 1 and 2
    •    MSEK 7.5: Linc AB convertible note bridge financing

Additional financing pending regulatory milestones with EMA (until mid-2026):

    •    MSEK 9.1: Yangtian Pharma Tranche 3 (upon submission of EMA trial application)
    •    MSEK 15.1: Yangtian Pharma Tranche 4 (upon approval of EMA trial application)
    •    MSEK 6.2: Molteni accelerated milestone payment (upon approval of EMA trial application, no earlier than March 1, 2026)

Significant market potential

Oral mucositis is a common and painful condition affecting cancer patients receiving radiation therapy in the head and neck area and patients receiving chemotherapy. The current standard of care relies on lidocaine-based “magic mouthwashes” which provide intense but very short pain relief. Most patients require escalation to opioids which are ineffective at relieving pain from oral mucositis and have significant side effects including risk for long-term dependency. There is a significant unmet need for an effective, durable, non-opioid-based, locally acting treatment.

OncoZenge estimates over 35% of cancer patients develop oral mucositis after initiating cancer treatment, and that most of these patients would derive greater benefit from BupiZenge™ for pain management than from current treatments. 

Read the Company’s report “The case for BupiZenge™” to learn more about today’s fragmented Standard of Care and unmet patient needs in cancer care:
[https://oncozenge.se/wp-content/uploads/2024/04/Report-The-Case-for-BupiZenge.pdf]

There are two main BupiZenge™ use cases to manage pain from oral mucositis:

1. Head and neck cancer (HNC) patients receiving radiotherapy: Radiotherapy is typically administered over 6 weeks. More than 90% of patients develop oral mucositis, typically starting 2 weeks into the treatment and lasting several weeks after treatment ends. OncoZenge estimates that the typical use case for BupiZenge™ will be treatment over 6 consecutive weeks with 4 BupiZenge™ lozenges on average administered per day, totaling 168 BupiZenge™ lozenges per treated patient during a radiotherapy cycle.
   
2. Chemotherapy patients: Chemotherapy is the cornerstone of treatment in most cancer patients. Treatment typically lasts 3-6 months with cycles and pauses of 2-4 weeks. 40-80% of these patients develop oral mucositis; typically milder forms during early cycles and more severe forms in later cycles. OncoZenge estimates that the typical use cases for BupiZenge™ will range from 70-120 days total of treatment with 1-4 BupiZenge™ lozenges per day as needed. The average treatment volume will therefore be similar to the treatment received by HNC patients, totaling 168 BupiZenge™ lozenges per patient.
   

Current incremental treatment costs per patient for oral mucositis are significant and are estimated at SEK 15,000-250,000 for radiotherapy patients and SEK 20,000-50,000 per cycle for chemotherapy patients. BupiZenge™ is expected to create significant quality of life improvements for these patients compared to current treatment options and lead to cost reductions by limiting hospital stays, emergency visits, nutritional visits, reducing the need for feeding and gastrostomy tubing and costs of other pain medications.

HNC is increasingly being diagnosed at a younger age as the leading cause is shifting from smoking to Human Papillomavirus (HPV) infection in the Europe and the US. Avoiding risks of opioid dependency and improving quality of life with faster recovery and return to normal social life, education and work is critical to both patients and society.

Furthermore, emerging evidence for novel Antibody-Drug Conjugates (ADC) in cancer treatment confirm oral mucositis as a treatment-adverse event, indicating continued patient needs for years to come even as ADCs supplement or partially replace chemotherapy.

As for any novel drug, there is uncertainty around the future pricing of BupiZenge™ across markets. Proprietary OncoZenge research indicates a potential price range of SEK 10 to SEK 80 per BupiZenge™ lozenge, across markets, with the higher price ranges applicable to the US and European markets.

OncoZenge projects a global revenue potential for commercial licensees exceeding BSEK 10 annually, with OncoZenge global revenue potential reaching BSEK 2.2 annually by 2034, based on the following assumptions.

European market potential:
Pending a successful Phase 3 trial and EMA approval

• Est. no. of patients developing OM annually: 1,300,000 (growing 2-3% p.a.) 
• Assumed peak uptake of BupiZenge™: 30% of patients with OM 
• Price per BupiZenge™ lozenge: SEK 30-35 
• Average revenue per patient treated with BupiZenge™: SEK 5,500 
• Potential annual peak sales of BupiZenge™ 2034: BSEK 2.5 
• Potential OncoZenge annual revenues from royalties 2034: Up to MSEK 500

Adjacent market potential where EMA approval can be leveraged:
LatAm, parts of Asia, Canada, Africa, etc., contingent on local approval across markets

• Est. no. of patients developing OM annually: 2,500,000 (growing 2-3% p.a.) 
• Assumed peak uptake of BupiZenge™: 15% of patients with OM 
• Price per BupiZenge™ lozenge: SEK 15-17 
• Average revenue per patient treated with BupiZenge™: SEK 2,500 
• Potential annual peak sales of BupiZenge™ 2034: BSEK 1.5 
• Potential OncoZenge annual revenues from royalties 2034: Up to MSEK 300 



USA market potential:
Contingent on securing future funding and/or an industry partner for incremental Phase 3 project towards FDA approval

• Est. no. of patients developing OM annually: 750,000 (growing 2-3% p.a.) 
• Assumed peak uptake of BupiZenge™: 40% of patients with OM
• Price per BupiZenge™ lozenge: SEK 60-80 
• Average revenue per patient treated with BupiZenge™: SEK 12,500 
• Potential annual peak sales of BupiZenge™ 2034: BSEK 5 
• Potential OncoZenge annual revenues from royalties 2034: Up to MSEK 1,000 



China market potential:
Contingent on securing funding or a collaboration agreement covering a local Phase 3 or bridging study towards local regulatory approval

• No. of patients developing OM annually: 1,500,000 (growing 2-3% p.a.) 
• Assumed peak uptake of BupiZenge™: 30% of patients with OM 
• Price per BupiZenge™ lozenge: SEK 15-20 
• Average revenue per patient treated with BupiZenge™: SEK 3,000 
• Potential annual peak sales of BupiZenge™ 2034: BSEK 2 
• Potential OncoZenge annual revenues from royalties 2034: Up to MSEK 400
  

OncoZenge anticipates additional revenues from upfront milestones and one-time development and commercial milestones from current and future commercial partners.

The structure of future commercial contracts in the US and China markets could deviate from the European commercial setup given the need for additional local clinical development efforts in these markets.

The Company projects its running costs (outside of direct study costs or additional indications) to remain largely consistent with 2025 levels, with no in-house manufacturing costs, leading to significantly positive profitability from royalty-based sales post-market introduction.

Looking ahead

After a period of strategic transition, OncoZenge’s organization, product, partnerships, and intellectual property are now in place to advance BupiZenge™ through its final registrational trial for a European launch. 

Mats Lindskog, OncoZenge Board member, comments: "Joining OncoZenge at this pivotal stage is a rare opportunity — few Swedish or European pharma companies advance to Phase 3. With a clear unmet medical need in managing pain among cancer patients, this program has the potential to deliver meaningful clinical and commercial impact, while also improving overall treatment outcomes and quality of life."

OncoZenge's key priorities over the next 12 months include:

1. Ensuring robust execution of the European phase 3 trial: Ensure successful completion targeting a European commercial launch during 2027.
2. Securing additional commercial partnerships: Evaluate additional commercial partners in markets where EMA approval can be leveraged, i.e., Latin America, parts of Asia, Canada, Africa, etc.
3. Refining China market entry strategy: Finalize a collaboration agreement with Yangtian Pharma for an efficient route to China market approval and launch.
4. Assessing options for USA market entry: Determine the optimal path to US FDA approval with an industrial pharma or financial partner, optimizing the project scope by leveraging European data and considering evolving FDA priorities. OncoZenge will seek direct interactions with the FDA to discuss the Company's IND and registrational requirements.
5. Exploring additional indications: Continue to assess new indications, with a particular focus on significant opportunities within dental applications.
   

OncoZenge looks forward to welcoming current investors and other interested parties to its first Capital Markets Day in Stockholm, Sweden during September to discuss the significant opportunities ahead, the Company's execution and commercial plans, and to address questions. Details regarding the date, time, place, and registration will be communicated in August.

Additional information and references are available on OncoZenge’s website.

We invite you to join us on our journey to redefine the standard of care for millions of cancer patients suffering from oral pain.

BupiZenge™: The Potential to be the Leading Treatment for Oral Pain.

For additional information, please contact:

Daniel Ehrenstråhle Chairman of the Board E-mail: daniel.ehrenstrahle@oncozenge.se
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

Certified Adviser
OncoZenge’s Certified Adviser is Redeye AB.

About this information
OncoZenge publishes this information in accordance with the EU Market Abuse Regulation (MAR). The information was submitted for publication on 30 July 2025 at 08:50 CEST through the contact persons above.

OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden

About OncoZenge
OncoZenge is a pharmaceutical company dedicated to developing a novel, effective, safe, and well-tolerated treatment for oral pain, addressing conditions where current options are insufficient or carry significant side effects. BupiZenge™ is a new oral lozenge formulation of bupivacaine, an anesthetic with decades of clinical experience. OncoZenge's lead indication is oral pain caused by oral mucositis, an inflammatory condition affecting millions of cancer patients. Oral mucositis leads to profound physical and psychological suffering and represents a large unmet medical need for an effective, opioid-sparing treatment. BupiZenge™ demonstrated significantly superior pain relief compared to standard of care in this indication during a Phase 2 trial.

OncoZenge is headquartered in Stockholm, Sweden, and its shares are publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ.

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