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Earnings Call: Q3 2024

Nov 6, 2024

Carlos de Sousa
CEO, Ultimovacs ASA

Good afternoon, and welcome to Ultimovacs' third quarter 2024 business update and financial results. My name is Carlos de Sousa, and I'm the CEO, and as usual, I have with me Jens Bjørheim, our Chief Medical Officer, and Hans Vassgård Eid, our Chief Financial Officer. If we can move to the next slide just to show you briefly our disclaimer, and we continue to the next slide, so I will make a brief introduction. We will talk then about the clinical update for UV1, brief words about our novel drug conjugation platform, the financial update, and then the news flow, so if we can move to the next slide. This quarter was again, we had the disappointing news about the results from our FOCUS trial in head and neck cancer. We knew that it was a difficult target.

Head and neck cancer is a very difficult cancer to treat, and even the standard of care has very low efficacy, but anyway, we were still disappointed, but as a company, we are still committed to bringing UV1 across the next important data point. That is the DOVACC readout that we expect in the first half of 2025. The good news is that DOVACC is enrolling patients quite nicely, 28 patients in the last quarter, and this good inclusion of patients is a good sign and again helps us for the time being to keep the expected results in the first half of the next year. We also, in September, had to communicate that we stopped the recruitment of patients for the LUNVACC trial in lung cancer, and this discontinuation was due to the very slow rate of patient enrollment in the study.

Anyway, the patients will be analyzed, and results are expected in the first half of 2025. We are continuing the evaluation of a novel drug conjugation technology platform, and we'll provide an update to the market by the end of 2024. We have been continuously working on trying to really be very disciplined in terms of our expenses, and I'm happy to communicate that we were able to further extend our runway through the first quarter of 2026. With this, I give the word to Jens. Next slide.

Jens Bjørheim
CMO, Ultimovacs ASA

Thank you, Carlos. So good afternoon. A short clinical update on the UV1 program. So on the next slide, you can see the clinical trials that we have conducted and is finalized and those that are still running. Our main indication is, as you know, malignant melanoma, and we have been part of four other trials in different indications. This is for background information, so you can look at this. It is in the slide series. Moving on to the next slide, an update on the clinical trials. So the FOCUS results from the trial that unfortunately was negative back in August was published online in the end of October, and it will also soon be in paper format. For the DOVAC trial, as Carlos mentioned, this trial is actively recruiting patients.

The trial is in women with a BRCA negative ovarian cancer, high grade, and it's treated in combination with durvalumab and olaparib. As of now, 148 patients are included in this trial, and the total number should be 184. We expect readout of this trial in the first half of 2025. In the LUNVAC trial, we stopped the recruitment in that trial in September. It's a trial in non-small cell lung cancer where the UV1 vaccine was used in combination with the PD-1 checkpoint inhibitor. And 31 patients were included as of September 24 with a very slow rate. The readout of the 31 patients will come first half of next year. So for all those patients that were included in the trial prior to stop of inclusion, they will be followed up as per protocol, and the results will be reported first half of next year.

Moving on to the next, the drug conjugation platform, some bullets on that one as well if you go to the next slide. So we are, as Carlos mentioned, continuing to evaluate our conjugation technology. This is a technology that was originally developed to expand our vaccine pipeline. This is something that the CMC and research group in Ultimovacs has worked on for several years. This conjugation technology has the possibility to combine different molecules in different indications and therapeutic areas. As of now, we are conducting preclinical proof of concept studies, and we aim to collaborate with industry partners to develop drug partners with the platform. A market update regarding the drug conjugation platform will be provided by the end of this year. With this, I give the word further to Hans for the financial update.

Hans Vassgård Eid
CFO, Ultimovacs ASA

Thank you, Jens, and good afternoon to everyone. Moving on to the next slides. By the end of the third quarter, we had a total cash holding of 131 million NOK, corresponding to roughly $12 million. During the second quarter, as previously communicated, we implemented cash preservation initiatives, including downsizing of the organization. During this last quarter, we have identified additional cash preservation opportunities, which extends the anticipated cash runway through the first quarter of 2026, as Carlos mentioned in the introduction. Looking at the key financial numbers for the quarter, the operating profit or EBIT amounted to -29 million NOK for the third quarter and -103 million NOK for year to date. Profit before tax amounted to -26 million NOK for the quarter and -93 million NOK year to date.

The R&D and IPR expenses were lower this last quarter than the previous quarters as many clinical trials have been finalized. And going forward, we see that the operating expense level, which includes R&D, should be expected to be further reduced as the clinical trials are finalized. And these operational adjustments, the cash preservation initiatives, will start having effect from the second half of 2024. Moving on to the next slide. Looking at the profit and loss statement, we would like to remind the audience that the payroll expenses are significantly influenced by these share option costs, which fluctuates widely with the share price development from quarter to quarter. So if you specifically look at the payroll expenses exclusive of these share option costs, you see that the third quarter costs were approximately at the same level as the same quarter last year.

We expect this to come down going forward as the effect of the cash preservation initiatives and the workforce reductions will start taking a more significant effect. The R&D costs are coming down due to lower costs related to clinical trials and manufacturing. Looking at the operating cash flow on the next slide, the operating cash flow in the third quarter of 2024 was approximately -NOK 42 million, which is differing from the EBIT of -NOK 26 million. So this difference is primarily due to changes in working capital. We expect going forward that there will still be quarterly variations, but overall, we expect the cash flow on average to the negative cash flow to decrease significantly as the implementation of the cash preservation initiatives start taking effect. And also, we will see completion of activities over the next quarters.

On the next slide, we have a quarterly breakdown of the profit and loss statement for information purposes, so I will not spend time on that in this presentation. With that, I will give the word back to Carlos.

Carlos de Sousa
CEO, Ultimovacs ASA

Thank you, Jens. Thank you, Hans. So if we move to the next slide, you know what we can observe is that we have been hitting all the planned milestones. Unfortunately, of course, we cannot control biology of cancer in patients, but the team has been working really hard at delivering these results on time. So until the end of the year, we will present a little bit more detail on this novel drug conjugation technology. We are still going through preclinical activities, and we will keep you updated. As we continue progressing quite nicely with the inclusion of patients in DOVAC, we expect to give you more accurate expectation for top lines during the first half of 2025 as these patients are being enrolled and we conclude enrollment.

We expect also that the investigator will analyze the data from the 31 patients enrolled in the LUNVAC trial that will also be out during the first half of 2025. This will be the update. Hopefully we'll be in touch with you soon. With this, I want to thank you all for taking the time, and we are open for any questions you may have.

Jens Bjørheim
CMO, Ultimovacs ASA

Yes, I see that we have not received any questions today.

Carlos de Sousa
CEO, Ultimovacs ASA

Okay, so I guess that will be it. Again, thank you to the team and thank you all the people on the call for taking the time to listen to our webcast. Have a great day.

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