Glenn Whaley: Thank you, Daniel. I will now review the financial and operating results for the year ended December 31st, 2023. Let me start with a review of our cash position. We ended the year with $46.7 million in cash, cash equivalents. With these funds and the approximately $75 million in net proceeds raised in the first tranche of our January 2024 private placement, we expect to be able to fund operations into the third quarter of 2025. Regarding the operating results. R&D expenses were $83.2 million for the 12 months ended December 31st, 2023, as compared to $71.2 million for the 12 months ended December 31st, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials, vidofludimus calcium and IMU-856 as well as personnel expenses.
This was partially offset by a decrease in external development costs related to the deprioritization of the IMU-935 program and a reduction in costs related to the vidofludimus calcium program in ulcerative colitis. General and administrative expenses were $16 million for the 12 months ended December 31st, 2023, as compared to $15.3 million for the same period ended December 31st, 2022. The slight increase was spread across numerous categories and was partially offset by a decrease in personnel expense. Other income was $5.6 million for the 12 months ended December 31st, 2023, as compared to negative $0.9 million for the same period ended December 31st, 2022. The increase was primarily attributable to a decrease in foreign exchange losses, our research allowance attributable to the 2021 and 2022 tax years from the German Ministry of Finance and an increase in interest income as a result of higher interest rates.
This was partially offset by a decrease in R&D tax incentives as a result of less spend for clinical trials in Australia. The net loss for the 12 months ended December 31st, 2023, was approximately $93.6 million, or $2.11 per basic and diluted share, based on approximately 44.3 million weighted average common shares outstanding, compared to a net loss of approximately $120.4 million, or $3.78 per basic and diluted share, based on approximately 31.8 million weighted average common shares outstanding for the same period ended December 31st, 2022. With that, I will turn the call back over to Daniel for a review of our upcoming clinical milestones. Daniel?
Daniel Vitt: Thank you, Glenn. I would now like to provide an update on the anticipated upcoming milestones for our clinical development programs. We eagerly anticipate reporting top line data from our Phase II CALLIPER trial of vidofludimus calcium in progressive MS in April 2025. Additionally, we expect to report an interim futility analysis of our Phase III ENSURE program late this year, and to read out the first of our identical twin Phase III ENSURE trials in relapsing MS in the second quarter of 2026. As stated before, based on the strong clinical activity observed thus far, vidofludimus calcium solidly established safety and tolerability profile to date, we believe that the design of our Phase III ESNURE program will provide a straightforward path to potential regulatory approval in relapsing MS.
If the top line CALLIPER data continues to show a neuroprotective effect for PMS patients, we may be able to position vidofludimus calcium as the first oral treatment for advanced secondary progressive MS as well. We also expect that the drug’s potential first-in-class ability to activate Nurr1 will meaningfully benefit the ongoing clinical trials in multiple sclerosis. We are particularly excited about our MS program in light of the recent developments in the MS market. As we have noted before, if approved, we believe that vidofludimus calcium has the potential to be a unique treatment option targeted to the complex pathophysiology of multiple sclerosis based on its combined neuroprotective, anti-inflammatory and antiviral effects. With regard to our IMU-856 program, as previously reported, we have begun preparing for a Phase II clinical trial in ongoing active celiac disease patients.
At the same time, based on the drug’s broad therapeutic potential by targeting physiological epithelial regeneration, we are also considering additional clinical applications in other GI disorders. We are very excited about this program and believe IMU-856 could present an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of old architecture without the serious consequences associated with immunosuppressive therapies. This brings us to the end of our formal presentation. Jessica, please open the call for the Q&A session.
A – Jessica Breu: Thank you, Daniel, and also Glenn for walking us through the fourth quarter 2023 and subsequent highlights as well as our upcoming value inflection points. We will now begin the question-and-answer session. [Operator Instructions] Our first guest today is Caroline Pocher from Wedbush. Caroline, please unmute yourself and go ahead.
Caroline Pocher: Hi. Good morning. This is Caroline on for Andreas. Just two questions from us. So if the data from CALLIPER are positive, can you discuss what the regulatory path forward looks like in advanced SPMS? And then since the last quarterly update, it looks like the times were slightly shifted for the readout from the first ENSURE trial from the end of 2025 to Q2 2026. Just any clarity as to why the slight change and just enrollment progression in both of those trials?
Daniel Vitt: Yes. Thank you, Caroline, for the question. Let me start with CALLIPER. So I think it’s a difficult question to answer. I think the normal process in such an indication — let us pick non-active secondary progressive as the most likely indication where there is nothing approved, basically, or nothing available for patients. That of course may offer an accelerated pathway forward towards approval. But that requires a discussion with the regulators in the different countries. What we know is that likely a Phase III study would only require one study. So we think it will be a pretty lean package we expect after a positive readout of that study. On ENSURE, I think we didn’t change the timelines from our last projection.
