Oncopeptides AB (publ) (ONCO) Earnings Call Transcript & Summary

Hello, and welcome to the Oncopeptides U.S. regulatory update. [Operator Instructions] Today, I am pleased to present CEO, Jakob Lindberg; and CMO, Klaas Bakker. Please begin your meeting.

Thank you very much. This is Jakob Lindberg, CEO of Oncopeptides. And thank you for joining us this morning as we provide an update on our U.S. regulatory process. Let's go immediately to Slide #2. And as you all know, these are the legal ramifications of this call regarding forward-looking statements, et cetera. And please read that it's nothing new here. And then we go to Slide #3. On this call, I will be present, and as you heard, also Klaas Bakker, our Chief Medical Officer. Before we start with the content of this call, I would like to make a preamble consisting of 2 points. The first point is that we fully acknowledge that the action that was communicated Friday night might seem confusing to some. Only 3 months ago, we sent in a letter of voluntary withdrawal of our NDA in the U.S. And now 3 months later, we rescind that letter, i.e., we make that letter null and void. In the meantime, we have gathered a lot of new information as part of our European application process. So this decision was not made lightly. It's not an attempt to game the system. We are simply following the science because the new information that we have is truly material for the interpretation of the OCEAN study. And by following the science, we are also doing what's right for patients. Unfortunately, this also leads to a strange situation today, which leads me to my second point. As a public company and as a pharmaceutical company, we are part of 2 regulatory frameworks in parallel. As a public entity, we are part of the Market Abuse Regulations, which means that material information needs to be provided to the market with -- immediately with very few ways to push this out in time, especially when other parties make such information publicly available. This means that we need to communicate that we had rescinded our voluntary withdrawal letter to the FDA. On the other hand, we're also part of the regulatory framework dictating the rules for companies that create therapeutic or therapeutic drugs or procedures for patients. This leads to the fact that we cannot, in detail, disclose the scientific information that led to this decision today. As soon as we can, we will communicate that. But that also means that this will be tough for the markets today, I think, to assess our probability of success or exactly why we have done it and assess what this will mean for the company since we cannot provide you with the full scientific rationale. I hope you understand that we are just following the 2 regulatory frameworks that we operate under, and this is not done in spite or for any bad reasons. We are just following the rules here. And with that, I would like to leave the word to Klaas Bakker that will go through the actual factual events. And after that, we will, of course, have a Q&A. So please turn to Slide #4. And Klaas, the word is yours.

Thank you very much, Jakob, and good morning, everybody. I would like to reinforce also what Jakob stated that the decision we took is deemed in the best interest of patients and is based on solid scientific grounds. As Jakob mentioned, the voluntary withdrawal took place on the 22nd of October last year. And that was primarily because of the FDA's interpretation of the Overall Survival data in the Phase III OCEAN study. Back then, that decision was taken based on in-depth discussions with the FDA. We were, at that time, also about to have an oral hearing, so-called ODAC, but the discussions with FDA led us to no other conclusion that we, based on the then available analysis, should withdraw our drug from the market. Now we have looked at our own data in more depth and other analysis because we also have an EMA publication ongoing. And of course, every regulatory body comes with their own questions and then sometimes you encounter things that you were not even looking for, but that is material for the interpretation of the trial. Now this was the case and led us to also analyze other clinical trials. And it was only very recently that we arrived at the conclusion that the scientific interpretation of study OP-103 is different with this new analysis at hand. As such, we rescinded our withdrawal in the U.S. Now at this stage, marketing of PEPAXTO in the U.S. is still discontinued. There is no intention to market in the U.S. at this time. And that is also because we are in a dialogue with the regulatory bodies, so that means FDA and Oncopeptides will and are discussing these new data and we don't want any shortcut. We just want to arrive at a common interpretation of study OP-103. So that's the goal of the coming months: to arrive at a joint conclusion with regulatory bodies. As you have heard in between the lines, this was part of the EMA application process. So EMA is also very much aware of our new analysis. But I would like to reemphasize there that we don't expect any impact on the previously communicated EMA time line. So we still expect a decision by the end of quarter 2 this year by EMA. With respect to the FDA, unfortunately, that it would be very speculative to draw any time lines there as to when we would have new news to communicate. With that, acknowledging the limited information we could provide, I would like to hand it back to the operator for question and answer.

[Operator Instructions] At this time, there are no questions. I hand back over to our speakers.

Thank you. So I think the lack of questions also speaks to the fact that the most interesting questions pertain to the actual scientific foundation for our decision, and we fully understand and I hope you understand that we couldn't go through that today. And as soon as we can, we will do that. Do not hesitate to contact our Investor Relations department, myself or Klaas, and we will try to answer questions outside of this webcast. Otherwise, I hope that you have a fantastic week. And we think that we have made the right decision, and we will come back with further updates when we can. Thank you very much, everyone.