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IMMUNIC (IMUX)

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Earnings summaries and quarterly performance for IMMUNIC.

Recent press releases and 8-K filings for IMUX.

Immunic Presents Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium
IMUX
New Projects/Investments
  • 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.
3 days ago
Immunic Highlights 2025 Accomplishments and Upcoming Milestones
IMUX
New Projects/Investments
  • 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.
Jan 7, 2026, 11:30 AM
Immunic Therapeutics Provides Update on MS Programs and Funding Strategy
IMUX
New Projects/Investments
Guidance Update
Product Launch
  • 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.
Dec 4, 2025, 2:35 PM
Immunic Therapeutics Highlights Vidofludimus Calcium's Clinical Progress and Market Potential in MS
IMUX
New Projects/Investments
Product Launch
Revenue Acceleration/Inflection
  • 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.
Dec 4, 2025, 2:35 PM
Immunic, Inc. Reports Q3 2025 Financial Results and Provides Clinical Updates
IMUX
Earnings
Guidance Update
New Projects/Investments
  • 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.
Nov 13, 2025, 12:26 PM
Immunic, Inc. Reports Q3 2025 Financial Results and Clinical Updates
IMUX
Earnings
Guidance Update
  • 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.
Nov 13, 2025, 11:30 AM
smartbax Announces €4.7 M Pre-Series A Funding Round
IMUX
New Projects/Investments
  • 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.
Oct 22, 2025, 8:00 AM
Immunic Presents Positive Vidofludimus Calcium Data at ECTRIMS
IMUX
New Projects/Investments
Guidance Update
  • 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.
Sep 25, 2025, 11:01 AM
Immunic Presents Positive Clinical Data for Vidofludimus Calcium in Multiple Sclerosis
IMUX
New Projects/Investments
  • 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.
Sep 25, 2025, 10:30 AM