Isofol Medical AB (publ) (ISOFOL.ST) Earnings Call Transcript & Summary

Hello, and welcome to today's presentation with Isofol Medical. With us presenting, we have the CEO, Petter Segelman Lindqvist; and CFO, Margareta Hagman. [Operator Instructions].

Thank you, and again, welcome to the presentation of Isofol's second quarter. With me today, I have Margareta Hagman, Chief Financial Officer. We'll spend about 10 minutes today presenting the key financial results of the quarter, including some key events that has taken place. And before I hand over to Margareta to go through the finances, I would just like to mention that we have had a very eventful quarter at Isofol, really making a confirmation of the shift from planning to execution. We have both concluded a financing round and a rights issue with great success and the clinical trial that is ongoing is progressing well according to plan. So in essence, we are exiting this quarter with a strengthened financial position and with good progress in the clinical development plan. I'll come back soon to give some more -- shed some more light on all these aspects. But before that, I'll hand the word over to Margareta for some financial details.

Yes. Thank you. Before I talk about the figures during the quarter, I just want to highlight the -- at the stage we are in, we obviously have no revenue, and the research and development expenses are increasing due to the clinical study that we started in April. That's, of course, has a negative impact on the result, but it is in full alignment with our strategy and also with our internal financial projections. And then we come to the Q2 report. The result for the period amounted to minus SEK 14.7 million compared to minus SEK 11 million last -- the second quarter last year. And the decrease of expenses are due to -- increased expenses are due to the clinical study, of course, but also the regulatory work and planning for the FDA meeting that was completed in July. If we look at the cash flow, the cash flow during the quarter amounted to minus SEK 17 million compared to minus SEK 9 million the year before, mainly related to the result, of course, but also due to change in working capital. January to June, the result for that period was minus SEK 28.3 million compared to minus SEK 19.5 million. And the reason for the increase is the same as for the quarter, clinical -- expenses for clinical study and also regulatory and planning. And that brings us to the cash situation. At the end of June, the cash balance amounted to SEK 65.7 million. And that was before the rights issue that was completed in the beginning of July. As Petter mentioned, the rights issue was oversubscribed to 120%, and we chose to utilize a part of the overallotment. So in total, the issue brought us SEK 91 million before transaction expenses and approximately SEK 84 million after transaction expenses. And now we are well equipped for the future.

Thank you for that. I would then like to shed some more light on other key events of the quarter, but of course, starting with the rights issue in the financial end. We announced this rights issue in the second quarter. It was fully guaranteed. And then we had the great pleasure in early July to announce that the rights issue was oversubscribed. We have noted a strong and continued commitment, sometimes increased commitment from several of our existing shareholders, but we also have the opportunity to welcome new shareholders into the company. Most notably, I would like to mention Solasia Pharma K.K., our Japanese development and commercialization partner, who has taken the step of becoming owners in Isofol. And this really solidifies our strategic alliance between the two companies and sets us up for future success in Japan and also globally. So on the financing side, we exit the quarter with a strengthened position, clearly, as Margareta pointed out. On the clinical development side, we have also made strong progress. The trial that was initiated in the first quarter is progressing well according to plan. We announced the completion of the trial's first dose cohort. For those of you who don't remember the exact trial design, we are testing escalating doses of arfolitixorin in 5 -- up to 5 different dose cohorts. So the first dose cohort was completed. Second dose cohort initiated. And we are currently in the middle of studying the second dose cohort. All in all, the clinical trial is progressing well and according to plan, and we look forward to come back with further updates as we make progress from cohort to cohort throughout the year. We have also participated in both scientific congresses and business conventions. I would like to mention the American Society of Clinical Oncology Annual Meeting in Chicago. This was not only an opportunity to take part in interesting scientific sessions, but also an opportunity for Isofol to inaugurate our new Advisory Board. And I am particularly proud of this Advisory Board and the members in it. We have managed to gather some of the key international experts in the world in this Advisory Board, and I'm very proud to have them in this prominent group, and they are really contributing a lot to the development of arfolitixorin. On the business side, we attended BIO International in Boston in order to strengthen and solidify our partnering discussions and strengthen our partner network, something that for sure will be very useful for the future. And lastly, on the scientific side, just after the quarter ended, we participated in the European Society of Medical Oncology Gastrointestinal meeting in Barcelona with a highly interesting abstract on arfolitixorin. In essence, and to make a long story short, we tested the cytotoxic activity of arfolitixorin in patient-derived tumoroids versus the cytotoxic activity of leucovorin, today's standard treatment, and actually noted significantly higher activity of arfolitixorin versus leucovorin across the board, both in different dosages, but also in different drug combinations. So we can confirm that in that model, arfolitixorin demonstrates a strong activity in -- across the board in combination with various drugs that are used commonly to treat colorectal cancer. And also quite importantly, we have had interactions with the FDA in the U.S. in the first part of the year. This culminated with a so-called pre-IND interaction in early July. And in essence, the FDA gave us very positive feedback on our development plan. It was a good meeting where they validated the plans that we have for the future development of this drug. And this is important, not only because we now have the endorsement of the world's biggest pharmaceutical authority, the FDA, but this comes on top of the endorsement we already had from the European authorities and from the German medical authority to be more precise. Basically, this now sets us up for potential future clinical trials in the United States should we decide to progress and proceed to a formal IND application, which we now can do at the company's discretion without having to adjust development plan, namely. So to summarize the quarter, we are making strong progress across the board and according to plan. We are exiting the second quarter with an enhanced scientific platform. All the additional evidence that we have gathered is pointing in favor of the development of arfolitixorin. And also, we exited the quarter with a stronger financial position than before, and we have, as mentioned, had a very successful completion of the rights issue. By that, I think it's time to terminate the presentation and hand over to the question-and-answer session.

[Operator Instructions] [Foreign Language]

Yes. So I can -- before I answer the question in Swedish, I'd just like to mention for those of you who don't understand Swedish that the operator decided to read Swedish questions in Swedish, the majority of the questions coming in are asked in Swedish. So we will not translate them instantly, but we'll provide an English translation of those questions afterwards. [Foreign Language]

Can investors expect any interim data or updates from the ongoing Phase Ib/II study?

So this is really the same question as we just answered in Swedish. It was quite a lengthy answer. So I propose that we translate that answer as soon as we possibly can following this meeting. But to be very brief and short, we will not provide updates on the data in terms of patient outcomes while the study is in progress. We will, however, bring updates to the market when we are progressing in the study and how we are moving, for example, from dose cohort to dose cohort. And this is normal and general for any medical trials that we -- we usually don't expose and open up the database while the study is ongoing. But progress will for sure be reported as we have promised and as we also have delivered on so far.

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