NEW YORK - Immunic, Inc. (NASDAQ:IMUX), a biotechnology company focusing on chronic inflammatory and autoimmune diseases, announced new data on its lead drug candidate, vidofludimus calcium (IMU-838), at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The data presented included positive interim results from the phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and preclinical findings suggesting neuroprotective and antiviral effects.
The CALLIPER trial's interim analysis revealed a significant reduction in serum neurofilament light chain (NfL) levels among all PMS patients treated with vidofludimus calcium compared to placebo. This reduction was consistent across various subtypes of PMS and patient subgroups based on age and disability levels at baseline. The results suggest that vidofludimus calcium may effectively slow disease progression in PMS by reducing NfL levels, a marker of neuronal damage.
Further, vidofludimus calcium demonstrated antiviral activity, including the potential to prevent Epstein-Barr virus (EBV) reactivation, which is associated with post-COVID fatigue and may contribute to fatigue in MS patients. This antiviral effect, along with the drug's potential to reduce fatigue, is being investigated in ongoing CALLIPER and phase 3 ENSURE trials, as well as in the RAPID_REVIVE trial in post-COVID syndrome (PCS) patients.
Preclinical studies also highlighted vidofludimus calcium's neuroprotective role through the activation of the nuclear receptor related 1 (Nurr1) and its effectiveness in reducing pathogenic peripheral T helper cells, which may be a treatment pathway in MS.
Immunic's CEO, Daniel Vitt, Ph.D., stated that the strength of the data generated supports the therapeutic potential of vidofludimus calcium as a new treatment option for MS. The company expects to release top-line data from the CALLIPER trial in April next year, which could differentiate vidofludimus calcium from other MS medications based on its safety, tolerability, and effectiveness.
Vidofludimus calcium is a small molecule investigational drug that combines neuroprotective and anti-inflammatory effects and has been tested in more than 1,800 individuals. It is not yet licensed or approved in any country.
The information presented is based on a press release statement from Immunic, Inc.
In other recent news, Immunic Inc. reported a Q1 2024 loss of $29.6 million, a significant increase from the previous year's Q1 net loss of $2.3 million. Despite this, the company successfully raised $240 million through a private placement, projected to fund operations through Q3 2025. Piper Sandler, EF Hutton, Leerink Partners, and B.Riley have all maintained positive ratings on Immunic, highlighting the potential of the company's lead drug candidate, Vidofludimus Calcium, in the treatment of Multiple Sclerosis. The success of the upcoming CALLIPER PMS study and ENSURE trials could significantly elevate the drug's status in the treatment of multiple sclerosis. In addition, Immunic has extended the contract of its Executive Chairman, Dr. Duane Nash, to December 31, 2025, and increased his monthly base salary. The company also welcomed Simona Skerjanec to its board of directors and appointed Jason Tardio as the new Chief Operating Officer and President. These are the recent developments at Immunic Inc.
InvestingPro Insights
Immunic, Inc. (NASDAQ:IMUX) has been making strides with its lead drug candidate, vidofludimus calcium, as evidenced by the recent positive data presented at ECTRIMS. While the scientific community assesses the therapeutic potential of vidofludimus calcium, investors are closely monitoring Immunic's financial health and stock performance.
An InvestingPro Tip highlights that Immunic holds more cash than debt on its balance sheet, which is a positive sign for the company's financial stability. This is particularly relevant for biotech companies like Immunic, which often require significant capital to fund research and development before reaching profitability. Additionally, the company's liquid assets exceed its short-term obligations, providing a cushion for ongoing operational expenses.
On the performance front, Immunic's stock price has seen a strong return over the last three months, with a 49.07% price total return, reflecting investor optimism. However, it's important to note that analysts do not anticipate the company will be profitable this year, and the stock price movements have been quite volatile, which may indicate a higher risk profile for potential investors.
Looking at the real-time metrics from InvestingPro, Immunic's market capitalization stands at $145.03 million. The company's price-to-book ratio as of the last twelve months is 2.28, which could be used to assess the company's valuation in relation to its net asset value. Despite the challenges, the strong recent returns could be a sign that investors are confident in the company's prospects.
For those looking to delve deeper into Immunic's financial and stock performance, InvestingPro offers additional tips to help investors make informed decisions. Currently, there are 9 more InvestingPro Tips available for Immunic, Inc., which can be found by visiting the dedicated page at https://www.investing.com/pro/IMUX.
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