2024-01-03
In this interview, Stian Kildal, CEO of OncoZenge, talks about the company's operations and their work on developing a lozenge for oral pain called "BupiZenge." During the interview, OncoZenge's strategies for getting the product to market, the collaboration with Ensysce Biosciences, the expansion into international markets, financial aspects and the goals for the company in 2024 are discussed.
1. Who is OncoZenge and can you briefly tell us about your business?
OncoZenge has developed a lozenge for oral pain. It is based on the well-known substance bupivacaine, which has been used for decades for pain relief in connection with, for example, surgery and childbirth (epidural). We therefore know that it works well for pain and our focus now is to find a way to market for our drug candidate “BupiZenge”.
2. You have now been CEO for just over 3 months, can you take us through this period and tell us about your reflections on this time?
It has been intense and fantastic fun! I have always enjoyed working on short-term and long-term issues at the same time. In recent weeks, we have managed to solve many practical issues while laying the foundations for our long-term success by, for example, making the necessary decisions regarding analyses that then confirmed that our modified product is pure and thus ready for the next step towards approval. In the meantime, we have also visited several hospitals where oncologists confirmed the great patient need that exists. It was very rewarding and provides motivation to find solutions for the way forward. In order to concretize the need and thus our commercial potential, we have created a model that already provides good support for partner discussions. In the meantime, it has been incredibly fun to meet people who cheer us on and want to see us succeed, and who are also happy to contribute to it. We are now facing a really exciting 2024!
3. What strategies do you have to quickly introduce BupiZenge to the market?
The new board quickly decided on the new strategy that was communicated on September 9, 2023. The key points in the strategy are about the most important steps to create long-term value. An important prerequisite is of course that we have now shown that our product is pure. The shortest path to market approval is within the EU, given the positive 'Scientific Advice' we have received from the EMA. We are now focusing on confirming partners and agreements with pharmaceutical companies that want to carry out this project together with us.
4. Can you describe your collaboration with Ensysce and what role they play?
Ensysce Biosciences has had an interest in BupiZenge for a long time, and sees a portfolio fit as a non-opiate alongside their other drug candidates. They have a very experienced management team that wants to see us succeed, and who have offered to help us with progress in the US. As an example, we have recently submitted an application to the US NIH (National Institutes of Health) to fund some of the toxicology studies the FDA has requested in preparation for a potential US approval. However, we do not have a binding agreement yet, so OncoZenge has everything to gain and nothing to lose from the collaboration. We are keeping an open mind for 2024
5. How do you view the possibility of expanding your market outside the EU and the US, and can such expansions take place in parallel?
There are several markets outside the EU and the US that are commercially very interesting. India, China, Japan, Southeast Asia, etc. are interesting markets where one or more potential partners can drive local and parallel processes towards approval. Our focus now is to secure a significant partner who can help us bear the risk and cost towards approval in the EU, but it could very well be seen in connection with licensing market exclusivity in markets outside Europe and the US. We have a lot to offer a partner.
6. What is your ideal scenario when it comes to licensing partners?
We have previously communicated about a two-stage rocket; our absolute focus is on securing collaboration agreements that will take us to EU approval as soon as possible, and with the right progress in 2024 we can reach the EU market in 2026. We are also convinced that further commercial opportunities will arise for licensing agreements with partners in the US and other markets once we have confirmed a path to EU approval. Our focus on licensing opportunities will therefore broaden in 2024 and as we successfully confirm strategic partners and projects towards EU approval.
7. What is your monthly burn rate, and how long will current capital last without additional funding?
We have not communicated the run rate and will return with more information in the quarterly report on February 15. However, what we communicated in the strategy update on November 24 is that development is now focused on ongoing stability studies, and with a sequentially lower run rate from previous quarters, we have no need for additional operating capital until 2025. This gives us time to work on securing the necessary commercial agreements.
8. If you reach the market in 2026, is the current patent protection sufficient for a licensing partner to generate significant revenue? What potential does an extended patent have to increase value?
The feedback we have received from oncologists reinforces our belief that there is a large global patient need and that licensees with the right organization and distribution have a good opportunity to quickly reach the patient group. The patent period thus enables licensees to establish a brand and a basis for long-term sales and profitability. The relatively limited cost of a Phase 3 program for our product also means that the time to break-even for a strategic partner is short. That said, we are working on the patent issue, and any new patent applications that are then approved would provide an additional 20 years of exclusivity and thus significant value for OncoZenge and its licensees.
9. What are the next steps in the clinical trials and approval process for BupiZenge, considering its pure and stable formulation?
We are now formulating a phase 3 program aimed at a future approval in Europe. We envision this as a multi-center trial that will provide us with the data required for an EU approval and form the basis for a local approval in the home market of a strategic partner. This phase 3 program will begin with the activities previously mentioned by OncoZenge as the “PK study” where we will, among other things, receive data to support decisions on dosage selection for the rest of the project. Early partner discussions have demonstrated the possibilities for more efficient execution, for example in patient recruitment, planning and data compilation, and this in turn gives us a more direct path to an approval in the EU than if we were to run separate projects as previously planned. The data that will be generated in the study will also be a significant piece of the puzzle on the way to the market in the US.
10. Looking ahead to 2024, what are your main goals?
We have already achieved our goal of ensuring through analysis and development that we have a clean drug candidate ready for a Phase 3 program in the EU. In line with our strategic plan, the focus is now on securing a strategic collaboration agreement for the execution of the Phase 3 program and thereby confirming the path towards regulatory approval of BupiZenge. In parallel with this, we are actively working to further strengthen patent protection as it makes the calculation for licensees, and thus OncoZenge, even stronger. We look forward to 2024 with confidence!
We thank Stian Kildal for the interview and look forward to following the company throughout the new year!
Disclaimer:
This is an interview that has been done on behalf of the company. Impala Nordic or people behind Impala Nordic owns no shares in the company at the time of the interview.
