Earnings summaries and quarterly performance for IMMUNIC.
Executive leadership at IMMUNIC.
Daniel Vitt
Chief Executive Officer
Andreas Muehler
Chief Medical Officer
Glenn Whaley
Chief Financial Officer
Hella Kohlhof
Chief Scientific Officer
Inderpal Singh
General Counsel
Jason Tardio
President and Chief Operating Officer
Patrick Walsh
Chief Business Officer
Werner Gladdines
Chief Development Officer
Board of directors at IMMUNIC.
Research analysts who have asked questions during IMMUNIC earnings calls.
Jun-Goo Kwak
Piper Sandler
5 questions for IMUX
Matthew Kaplan
Ladenburg Thalmann
4 questions for IMUX
William Wood
B. Riley Securities
4 questions for IMUX
Matthew Cowper
Leerink Partners
3 questions for IMUX
Mayank Mamtani
B. Riley Securities
2 questions for IMUX
Thomas Smith
Leerink Partners
2 questions for IMUX
Medicine Azad
B Riley
1 question for IMUX
Nat Charoensook
Leerink Partners
1 question for IMUX
Yasmeen Rahimi
Piper Sandler & Co.
1 question for IMUX
Recent press releases and 8-K filings for IMUX.
- Immunic, Inc. announced the presentation of additional positive data from its phase 2 CALLIPER trial for vidofludimus calcium (IMU-838) in progressive multiple sclerosis (PMS) at the ACTRIMS Forum 2026.
- The data showed reductions in acute and chronic inflammatory disease activity based on MRI markers, with the proportion of patients in the vidofludimus calcium group having gadolinium-enhancing lesions decreasing to 0% at week 120 (compared to 2.9% for placebo).
- Vidofludimus calcium also demonstrated statistically significant reductions in EBV-specific T-cell receptor sequences (p=0.0004), indicating broad-spectrum antiviral effects and lower Epstein-Barr virus reactivations.
- Vidofludimus calcium is currently in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data anticipated by the end of 2026.
- Immunic, Inc. completed enrollment for both Phase 3 ENSURE trials of its lead asset, vidofludimus calcium (IMU-838), in relapsing multiple sclerosis (RMS), with top-line data expected by the end of 2026.
- Positive Phase 2 CALLIPER data for vidofludimus calcium in progressive multiple sclerosis (PMS) demonstrated clinically meaningful reductions in 24-week confirmed disability worsening (24wCDW) and statistically significant 24-week confirmed disability improvement (24wCDI).
- A U.S. patent was allowed for dose strengths of vidofludimus calcium in progressive multiple sclerosis, strengthening intellectual property protection into 2041.
- In 2025, Immunic closed a $5.1 million registered direct offering and an oversubscribed $65 million underwritten public offering.
- Immunic Therapeutics (IMUX) is focused on its lead drug candidate, vidofludimus calcium, with Phase 3 data for relapsing MS (ENSURE trial) expected in Q4 2026.
- The Phase 2 CALLIPER study for vidofludimus calcium in progressive MS demonstrated a 34% reduction in disability worsening in a specific patient population and achieved statistically significant confirmed disability improvement.
- Vidofludimus calcium is differentiated by its neuroprotective effect (Nurr1 activation) in addition to anti-inflammatory benefits, positioning it as a potential "oral of choice" with a favorable benefit-risk profile compared to existing oral MS treatments.
- The company estimates a $500 million to $1 billion opportunity in the US market alone for patients sequencing off anti-CD20 therapy.
- Immunic raised $65 million in June and anticipates up to an additional $65 million from cash warrants by year-end, with ongoing discussions to fund remaining clinical development, a potential Phase 3 progressive MS study, and commercial launch preparations.
- Immunic Therapeutics' lead drug candidate, vidofludimus calcium, is in Phase 3 trials (ENSURE) for relapsing MS, with top-line data anticipated in Q4 2026.
- The Phase 2 CALLIPER study for progressive MS showed a 34% reduction in disability worsening in PPMS patients without active inflammation and achieved statistically significant confirmed disability improvement.
- Vidofludimus calcium is differentiated by its direct neuroprotective effect and is expected to offer a superior safety and tolerability profile compared to current oral MS therapies, positioning it for key market segments, including patients switching from anti-CD20 therapy.
- The company estimates the relapsing MS market opportunity at over $1 billion peak and each progressive MS indication at over $2 billion upside, with a specific $500 million to $1 billion opportunity in the US for patients sequencing off anti-CD20 therapy.
- Immunic raised $65 million in June and expects another $65 million from cash warrants by year-end, while actively exploring partnerships and preparing for a potential self-launch.
- For the third quarter of 2025, Immunic, Inc. reported a net loss of approximately $25.6 million, or $0.13 per basic and diluted share, compared to a net loss of approximately $24.4 million, or $0.24 per basic and diluted share, for the same period in 2024.
- As of September 30, 2025, cash and cash equivalents totaled $35.1 million, and the company indicated it lacks adequate liquidity to fund operations for at least 12 months without securing additional capital.
- Research and Development expenses for Q3 2025 were $20.0 million, a decrease from $21.4 million in Q3 2024, mainly due to reduced external development costs for IMU-856 and the completion of the phase 2 CALLIPER trial.
- Top-line data from the twin phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis is expected by year-end 2026.
- The company received a Notice of Allowance for a key patent covering dose strengths of vidofludimus calcium for progressive multiple sclerosis, which is expected to provide protection into 2041.
- Immunic, Inc. reported a net loss of $25.6 million (or $0.13 per basic and diluted share) for the third quarter ended September 30, 2025, and a net loss of $77.9 million (or $0.55 per basic and diluted share) for the nine months ended September 30, 2025.
- As of September 30, 2025, cash and cash equivalents were $35.1 million, and the company stated it does not have adequate liquidity to fund operations for at least 12 months from that date without raising additional capital.
- Top-line data from the twin Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis is anticipated by year-end 2026.
- New data from the positive Phase 2 CALLIPER trial in progressive multiple sclerosis demonstrated statistically significant 24-week confirmed disability improvement in the overall patient population.
- smartbax announced the successful first closing of its €4.7 M Pre-Series A financing round on October 22, 2025, led by Anobis Asset and Bayern Kapital, with a second closing remaining open to investors.
- The funds will be used to advance its proprietary pipeline of small-molecule antibiotics, including a lead candidate inhibitor against Gram-negative bacteria that has demonstrated in vivo proof of concept and is progressing through preclinical development.
- The company is also developing a platform of small-molecule activators that induce bacterial self-digestion, effective against both Gram-positive and Gram-negative bacteria, which will be further developed towards lead selection and in vivo proof of concept.
- Immunic, Inc. presented positive Phase 2 CALLIPER trial data for its lead asset, vidofludimus calcium (IMU-838), in Progressive Multiple Sclerosis (PMS) at the 41st Congress of ECTRIMS on September 25, 2025.
- The data demonstrated statistically significant 24-week confirmed disability improvement (24wCDI) with an over two-fold probability over placebo in the overall PMS study population.
- In the overall PMS population, vidofludimus calcium reduced the risk of 24-week confirmed disability worsening (24wCDW) by 23.8% versus placebo.
- Long-term data from the Phase 2 EMPhASIS trial in Relapsing-Remitting Multiple Sclerosis (RRMS) showed favorable safety and tolerability, with 92.7% of patients remaining free of 24wCDW at week 144.
- Top-line data for the fully enrolled twin Phase 3 ENSURE trials in relapsing multiple sclerosis (RMS) is expected by the end of 2026.
- Immunic presented positive Phase 2 CALLIPER trial data for vidofludimus calcium in Progressive Multiple Sclerosis (PMS) at the 41st Congress of ECTRIMS, demonstrating statistically significant 24-week Confirmed Disability Improvement (24wCDI) and a 23.8% reduction in the risk of 24-week Confirmed Disability Worsening (24wCDW) versus placebo in the overall PMS population.
- The CALLIPER findings support vidofludimus calcium's neuroprotective potential and its promise to slow disease progression, with evidence of clinical activity meriting further investigation in a potential Phase 3 program.
- Long-term data from the Phase 2 EMPhASIS trial in Relapsing-Remitting Multiple Sclerosis (RRMS) demonstrated robust efficacy signals and a favorable long-term safety and tolerability profile, with 92.7% of patients remaining free of 24-week Confirmed Disability Worsening at week 144.
- Top-line data for Immunic's fully enrolled twin Phase 3 ENSURE trials in Relapsing Multiple Sclerosis (RMS) is expected by the end of 2026.
Quarterly earnings call transcripts for IMMUNIC.
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