Immunic, Inc. (NASDAQ:IMUX) Q4 2023 Earnings Call Transcript

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Immunic, Inc. (NASDAQ:IMUX) Q4 2023 Earnings Call Transcript February 22, 2024

Immunic, Inc. beats earnings expectations. Reported EPS is $-0.48, expectations were $-0.51. IMUX isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Jessica Breu: Good morning to everybody on the line. I would like to welcome you to Immunic's Fourth Quarter and Year End 2023 Earnings Call. My name is Jessica Breu, Vice President, Investor Relations and Communications at Immunic. I will also be the moderator today. Speaking on the call are Dr. Daniel Vitt, our Chief Executive Officer and President; as well as Glenn Whaley, our Chief Financial Officer. Please note that all participants will be in listen-only mode, and this event is being recorded. After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Before we begin, I would like to remind you that this presentation may contain forward-looking statements. Such statements can be identified by words such as may, will, expect, anticipate, estimate or words with a similar meaning, and such statements involve a number of risks and uncertainties that could cause Immunic's actual results to differ materially from those discussed here.

Please note that these forward-looking statements reflect Immunic's opinions only as of the date of this presentation, and it undertakes no obligation to revise or publicly release the result of any revision to these forward-looking statements in light of new information or future events. Please refer to Immunic's SEC filings for a more detailed description of the risk factors that may affect Immunic's results and these forward-looking statements. I would now like to turn the call over to our CEO and President, Dr. Daniel Vitt, to begin the presentation. Daniel?

A scientist in a lab coat, using a microscope to study a sample of cells related to the company's biopharmaceuticals.
A scientist in a lab coat, using a microscope to study a sample of cells related to the company's biopharmaceuticals.

Daniel Vitt: Yes. Thank you, Jessica. I would also like to welcome everybody to today's earnings call. Earlier this morning, we announced our financial results for the fourth quarter and the year ended December 31st, 2023, in our press release and Form 10-K. During the call today, we will walk through our fourth quarter's 2023 achievements and subsequent highlights, year-end financial and operating results as well as anticipated upcoming milestones. As Jessica noted, after the presentation, you will have the opportunity to ask questions. Let's start with a review of our fourth quarter 2023 and subsequent highlights. Punctuating our remarkable progress throughout 2023, we announced a three-tranche private placement of up to $240 million last month.

The round, led by BVF Partners, included participation from a group of top tier new and existing investors, including Avidity Partners, Janus Henderson Investors, Soleus Capital, RTW Investments and Adage Capital Partners. We received a total of $75 million in net proceeds from the first tranche, which closed on January 8th, 2024. The second and third tranches of $80 million each are conditioned on the announcement of Phase IIb top line data for our CALLIPER trial expected in April 2025, volume weighted average share price levels and minimum trading volumes. Any of these conditions in the second or third tranche can be waived by holders of a majority of the outstanding securities, including the lead investor. This financing completed in a challenging capital markets environment and with such a strong group of investors confirms the enormous value inherent in our two advanced clinical programs.

In October, we reported overwhelmingly positive interim data from the Phase II CALLIPER trial of our potentially groundbreaking lead asset, nuclear receptor-related one over one activator, vidofludimus calcium, in progressive multiple sclerosis, or PMS. In total, 203 patients were included in this analysis. The overall population, which includes all subtypes of PMS, saw a 22.4% improvement in serum neurofilament light chain, or NfL, for vidofludimus calcium over placebo at week 24. We believe that this is a substantial and meaningful difference in favor of vidofludimus calcium in this PMS population. Even a statistically significant difference was found for arithmetic mean serum NfL levels at week 24 between vidofludimus calcium and placebo with a p-value of 0.01.

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