Good day, and welcome to the Isofol Medical second quarter 2022 earnings call. All participants will be in listen-only mode. Should you need assistance, please contact the conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Dr. Jungnelius. Please go ahead.
Thank you so much. Let's change slide to slide number four. We are presenting the second quarter results. Keep in mind that we had a press release a couple of weeks ago declaring our study results, the top line results, showing that we did not achieve our endpoint. If we take a look at the company at a glance, it was founded in Gothenburg 14 years ago. We have a strong financial position. We're listed on Nasdaq Stockholm. We have been developing Isofol's drug, arfolitixorin, for the treatment of colorectal cancer. We have a small experienced team in Gothenburg, and we've been very pragmatically working with work orders being data-driven.
Our vision was to contribute to extending lives and improving quality of life for the poor people suffering from metastatic colorectal cancer, a disease with a remaining still high unmet medical need. If we go to the next slide on page five, this is a little bit of depiction of the phase three study, the AGENT study. We have the control arm being modified FOLFOX6 with Avastin, and the experimental arm only replacing leucovorin with arfolitixorin. The study ended up enrolling 490 patients, and we presented top line results, as I said, on August 4th.
We expect the final results, two different type of final results coming in, but we'll have a batch of data coming in on the clinical final data and then another batch coming in that will look on the biomarker and gene expression data. The primary objective of the study was to demonstrate the tumor shrinkage, and then we wanted to reach at least a difference of 10% between the two arms. Then the key secondary endpoint was of course, how long is the tumor stayed still, which is progression-free survival and duration of response. The study was a true international study with sites in North America, Europe, Japan, and Australia. Let's go to the next slide, number six. As we announced earlier, we did not meet the primary or key secondary endpoints. Let me say it this way.
We basically achieved what we wanted to do, but unfortunately, so did the control arm. If we go to slide number seven, the next steps and the priorities for us is first of all, to understand the data in the AGENT study. We got, like, take it between the thumb and the finger, roughly, 200 pages, and we're waiting for another 2,000 pages with the safety data, more detailed data from the clinical subgroups, the gene expression data. Once we understand the extent if there are any good components for us, we will, of course, come out and discuss that. We've been in contact with our advisory boards. We are gonna go in contact with the regulatory agencies as well.
Our ambition is during the coming month to try analyzing the data, trying to be as transparent as possible, sharing data when we can, and we don't want to jeopardize the scientific and commercial value of the results. We will be holding back some stuff, but once we see that there's no reason to hold back, we will also go out and announce results as they come. If we go to slide number eight. Again, coming opportunities for communication, we are looking at two different points in the Q4, as I said. First of all, the clinical study results and then the other packages, including the biomarkers and gene expression. Consulting with regulatory agencies that's relevant will be done in the first half of 2023.
If you want to talk with an agency, you submit a briefing package, and then they have up to 60 days to decide if they want to talk to you. That's the timing it takes just to get in contact with them. We have still the Fast Track designation, so we may actually be able to shorten some of these steps. Once we understand where we stand with the data and also the way forward, we will do as much parallel work as possible, and hopefully that will end up with the clinical results in some type of a congress or publication during next year. Next slide, number nine, over to you, Gustaf.
Thank you. Ulf, financial review for Q2 2022. Revenue still comes in related to the AGENT study in Japan, and that will continue as long as we have patients enrolled in Japan. It will continue further into 2022. Operating costs, generally the cost for AGENT study is decreasing over time since the number of patients in the study is decreasing. Pre-commercialization has continued into Q2 on an increased level, although in line with the plan, our plans. Costs for compiling the study and study results and focusing on the top-line results have increased for the quarter. Staff costs have continued to increase slightly compared to last year, one more FTE, and otherwise costs follow our plans. Turn to page 10, please. Cash flow from operating results, following all material aspects, our operating activities.
We have, as mentioned in the CEO comments in the quarterly report, initiated some activities to maintain a strong financial position going forward. In summary, we can conclude that we currently have a good financial position and a strong financial position. Over to you, Ulf, again. Page eleven, please.
Thank you. Page 11. What is our way forward? Again, as I said, we're focusing on analyzing the clinical data, the biomarker data to see if there is anything of value in that. If there is a subgroup that has exceptional results that may be a way forward. We are, as you know, in a partnership with Solasia in Japan and Paladin Labs in Canada, and of course we are in discussions with them. It's very keen, for example, for the Japanese to see if the Japanese behave differently than the Caucasians in the study. That's an interesting subgroup to look at. We will also strategically evaluate possible registration avenues outside. Keep in mind this was a superiority study.
We did not hit our primary objective, so there are other routes to the market than a superiority study. The key thing here is that even if there is a good route to the registration, it has to be commercially attractive as well. That's what we're looking into now. We need to safeguard the company's financial position. Of course, we are looking very critically at the different programs that are running, and we have stopped a number of the programs as soon as we got the results. We're still looking at what more can be sort of saved for that. Basically, that's where we are. The Q2 looked as we expected it, not knowing the results of the top-line results.
Once we got to know that, we took action to basically stop spending that was not necessary. I'll stop there, and I think there is no other slide. No. Questions and answer. Thank you. Over to you, facilitator.
Thank you. We'll now begin the question and answer session. To ask a question over the phone, you may press star then one on your touch tone phone. If you're using a speaker phone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we'll pause momentarily to assemble our roster. Again, if you have a question, please press star then one. Our first question comes from Christian Binder from Redeye. Please go ahead.
Hi, and thank you so much for taking my question. Just for clarification, let's say for example, you would find some interesting subgroups in the gene expression data regarding the way forward, would you say that there's a possibility of getting approval based on that? For example, conditional running a confirmatory study, or would you say that if you find something interesting, you probably will need to run a confirmatory study first before any potential subgroup approval?
Thanks, Christian. A good question. I would say that whatever we find, we need to discuss with the regulatory agencies on the way forward. Of course, this is where we need to be very careful. If the study results for that particular group is extraordinary, of course, you might have a discussion with the FDA, you know, if they feel that it's unethical to do a randomized study with the results. Most probably the agency would say, you know, "Okay, this looks fine, but very few patients. We need more patients." It's then up to us to understand what more patients needs to be.
Right. Understood. Just one more regarding you know that it was a superiority study. In theory, I guess there is a possibility of getting an approval based on non-inferiority. You also said that it would have to be commercially viable.
I guess you're still analyzing your potential avenues there. In terms of pricing, I guess based on what we know now, our arfolitixorin current pricing based on the materiality would probably be in line with leucovorin. How should we think about the commercial viability?
Again, I would rather not speculate at this point as we don't have. I mean, we don't even have safety data. We need to understand what the results look like before taking the next step. Right now the only thing we have is what we have gone out with is the primary objective and one of the secondary objectives. A lot of the information is still unknown to us and we're waiting for that package of more than 2,000 pages to end up on our Chief Medical Officer's table, right? As I said, we perhaps would have 200 patient pages right now. There's a lot of information and this is where we understand what drug do we actually have. Good question.
I'd rather come back later, to have that discussion.
All right. Understood. That was all from my side. Thank you so much.
Yeah, thanks.
Again, if you have a question, please press star then one. We are showing no questions on the audio side. Do we have any web questions at this time?
No questions from the web so far.
Okay. Then I think we should round this up. Again, our quarterly results are in line with what we expected. As I said, we are now in a cost restrictive environment, so we are cutting down a number of things. We're gonna complete the AGENT study. We have more than 30 patients on treatment still. That study needs to be completed according to regulatory requirements. We think we might be able to do that by the end of the year, and then whatever we find we need to discuss with regulators. That's our way forward. Of course, we're looking into other things as well, but we'll come back to that later. Thanks so much for listening in and have a good day. Over to you, facilitator.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.