Newron Completes Enrollment of Pivotal Phase 3 ENIGMA-TRS 1 Study

Total of 618 patients randomized

Topline 12-week data expected in Q1 2027 

Milan, Italy, and Morristown, NJ, USA – October 22, 2026, 07:00 am CEST – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that it has completed enrollment in the pivotal Phase 3 ENIGMA-TRS 1 study evaluating evenamide, its proprietary investigational first-in-class glutamate modulator, as a potential first add-on therapy to second-generation antipsychotics in patients meeting established international consensus criteria for treatment-resistant schizophrenia (TRS). A total of 618 patients have been enrolled at more than 80 study centers in 19 countries across Europe, Asia, Latin America and Canada.

Newron expects to disclose topline 12-week data in Q1 2027. The study will continue under double-blind, placebo-controlled conditions through 52 weeks.

“Reaching this important milestone in the ENIGMA-TRS 1 study reflects the tremendous commitment of investigators and clinical teams, alongside the close collaboration of our academic and regulatory partners, as well as the patients and their families. The study is particularly important given the complexity of conducting a first long-term, randomized, double-blind, placebo-controlled add-on study in patients with TRS, an area of considerable unmet medical need.”

“Of the 996 patients who entered screening, 618 were found to be eligible for the study and were randomized to receive evenamide at 15 mg or 30 mg twice daily, or placebo, following strict adherence to the eligibility criteria by the Independent Eligibility Assessment Committee and five CRO psychiatrists. We look forward to continuing working closely with the investigators and their teams towards successful completion of the study”, said Ravi Anand, MD, Chief Medical Officer of Newron.

Evenamide targets the modulation of excessive release of glutamate in patients suffering from treatment-resistant schizophrenia (TRS).
 

About ENIGMA-TRS

ENIGMA-TRS 1 is an ongoing, international, 52-week, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy, tolerability, and safety of the 15mg BID and 30mg BID therapeutic doses of evenamide compared to placebo. Patients on second-generation antipsychotics, including clozapine, were required to meet Treatment Response and Resistance Psychosis international consensus criteria for TRS. The study has completed enrollment, with a total of 618 patients enrolled at study centers in 19 countries in Europe, Asia, Latin America, and Canada.

The primary assessment of efficacy and safety of ENIGMA-TRS 1 will be performed 12 weeks after randomization to treatment. Following this initial period, the study will continue to be double-blind and placebo-controlled until the 26- and 52-week time points. The primary efficacy endpoint of the trial will be the change from baseline in the Positive and Negative Syndrome Scale (PANSS) scores at 12 weeks. Newron expects to announce results from the 12-week primary endpoint assessment in Q1 2027.

ENIGMA-TRS 2 is enrolling patients at study centers in Asia and Latin America, with additional sites planned in Europe. The study uses the same screening procedure as ENIGMA-TRS 1. ENIGMA-TRS 2 will include at least 400 patients in a 12-week, randomized, double-blind, placebo-controlled Phase 3 study, designed to evaluate the efficacy, tolerability, and safety of the 15mg BID dose of evenamide compared to placebo. The efficacy and safety analysis will be performed at the 12-week point following successful completion of the study. The FDA clinical hold remains in place at U.S. study centers, where no patients have received evenamide.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently being developed in the global pivotal ENIGMA-TRS Phase 3 program. Clinical trial results to date demonstrate the benefits of this drug candidate in TRS as well as in poorly responding patient populations, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide, has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: https://www.newron.com and connect with us on LinkedIn.

For more information, please contact:

Newron
Stefan Weber – CEO; pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com  

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
John Fraunces, LifeSci Advisors; +1 917 355 2395, jfraunces@lifesciadvisors.com
 

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

CorTec Brain Interface Electrodes Record Stable Signals for More Than Four Years

Peer-reviewed data from the 10th Graz BCI Conference show four years of electrode durability and signal stability in non-human primates — the longest observation period to date for CorTec’s electrode platform, which also powers the Brain Interchange system now in clinical evaluation at the University of Washington

Freiburg, Germany, October 21, 2026 — CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), today announced peer-reviewed preclinical data showing robust neural recordings from its cortical surface electrodes for more than four years. The data come from two non-human primates (Macaca mulatta) implanted at Weill Cornell Medicine in New York with micro-electrocorticography (µECoG) arrays manufactured by CorTec in Freiburg. In the animal still under study, 63 of 64 electrode contacts continue to deliver meaningful signals more than four years after implantation. The results were presented at and published in the Proceedings of the 10th Graz Brain-Computer Interface Conference in September 2026.

Long-term stability matters to patients. Each replacement surgery adds risk. A BCI earns trust and a place in clinical care only when one implant serves for years or even decades.

What the study shows

Researchers at Weill Cornell Medicine and CorTec recorded activity from prefrontal and premotor cortex while the animals performed a visual-motor reaction task, comparing recordings from three time points up to day 1,361 after implantation. Spatial patterns and spectral characteristics stayed stable and consistent across the full period. The recordings reliably showed differences between an alert, task-engaged state and a drowsy state — the type of difference a decoder, an algorithm used to classify and interpret brain signals, relies on.

In the animal still under study, one of 64 contacts stopped working after about 14 months; the remaining 63 continue to record more than four years after implantation, and additional recordings are obtained regularly. The first animal, implanted with a smaller eight-contact array, kept all contacts functional until the planned end of its study. Across both animals, no further contact has failed.

“We see the same brain signatures on day 176 and more than three and a half years later,” said Dr. C. A. Gkogkidis, Head of Clinical Business Development at CorTec and first author of the study. “A chronic BCI needs two things: long-term stability of materials and signals, and the ability to record meaningful, potentially decodable activity over years. Our data meet both. However, the current study is a snapshot of a larger data set; follow-up analysis will reveal the full picture.”

“The stability and longevity of the cortical recordings have advanced our understanding of central thalamic deep brain stimulation (CT-DBS), an investigational therapy aimed at restoring cognitive function following traumatic brain injury,” said Jonathan L. Baker PhD, Assistant Professor of Neuroscience, Weill Cornell Medicine.

From electrode to system to patient

The arrays rest on the dura, the protective membrane over the brain, and do not penetrate brain tissue. CorTec manufactures them in its Freiburg cleanrooms from medical-grade silicone and platinum-iridium — the same materials and methods used for the electrodes of Brain Interchange, CorTec’s fully implantable, wireless BCI system. The durability evidence now spans three levels:

• Electrode arrays. More than four years of stable recordings in non-human primates (this study).
• Complete wireless system. More than 500 days of stable recordings in non-human primates, published in Nature Scientific Data (2025). The new data more than double this.
• In the clinical setting. The complete Brain Interchange system remained implanted for nine months in the first participant of the NIH-funded stroke rehab study at the University of Washington (UH3NS121565; NCT06506279) and was then safely removed, as planned per the study protocol.

“Durability decides whether a brain implant becomes a therapy,” said Dr. Frank Desiere, CEO of CorTec. “Our electrodes rest on the brain surface and never enter brain tissue. Four years of stable signals show this approach holds up over time. With two FDA Breakthrough Device Designations, entry into the FDA TAP program and three patients implanted in Seattle this year, Brain Interchange has moved from technology to a clinical research platform for stroke, paralysis and epilepsy.”

Brain Interchange is being investigated as a therapeutic BCI to support motor recovery after stroke and as an assistive BCI to restore control of a computer cursor — both on identical hardware.

Brain Interchange at a glance

• Non-penetrating, wireless, battery-free. Electrodes rest on the brain surface; an external head piece powers the implant through the skin by inductive link.
• Bidirectional and closed-loop. Records brain activity and delivers targeted stimulation on the same 32 channels, with continuous streaming of raw brain data.
• Two FDA Breakthrough Device Designations (2026). Stroke motor rehabilitation (April) and communication in people with non-progressive quadriplegia (August). To CorTec’s knowledge, the only BCI designated for stroke motor rehabilitation.
• Clinical footprint. Three patients implanted in the NIH-funded, FDA-authorized IDE stroke study at the University of Washington (UH3NS121565; NCT06506279), including the first reported volitional BCI control by a person with chronic stroke (Graz BCI Conference, September 2026). 13 patients enrolled in the epilepsy study at Mayo Clinic (NCT05439655). More than 50 CorTec cortical electrodes implanted in humans over more than a decade.
• Regulatory record. FDA 510(k) clearance for AirRay subdural cortical electrodes (2019), FDA IDE (2024), FDA Total Product Life Cycle Advisory Program, TAP (2026).

Publications

• Gkogkidis, C. A., Schuettler, M., Ulloa, M., Ryou, J. W., Purpura, K. P., Baker, J. L. (2026). Epidural micro-ECoG provides a robust interface to the cortex over 4 years in non-human primates. Proceedings of the 10th Graz Brain-Computer Interface Conference 2026, 547. doi:10.3217/978-3-99161-093-9-094
• Sarma, D., Cho, H., … Ojemann, J. G., Herron, J. A. (2026). Volitional neural control with the CorTec Brain Interchange by an individual with chronic stroke. Proceedings of the 10th Graz Brain-Computer Interface Conference 2026, 588. doi:10.3217/978-3-99161-093-9-101
• Yang, H., … Yanagisawa, T. (2025). Nature Scientific Data. nature.com/articles/s41597-025-06359-w

About CorTec

CorTec GmbH is a clinical-stage neurotechnology company founded in 2010 in Freiburg, Germany, with one purpose: to restore independence to people with neurological conditions. CorTec is developing Brain Interchange™, a fully implantable bidirectional brain-computer interface (BCI) platform currently in FDA-authorized clinical evaluation in the United States, making CorTec the first European company to reach this stage. The device holds two FDA Breakthrough Device Designations: one for stroke motor rehabilitation (April 2026) and a second for communication (August 2026), and it has been admitted to the FDA’s Total Product Life Cycle Advisory Program (TAP). CorTec also operates a revenue-generating contract development and manufacturing (CDMO) business, supplying active implantable technology to partners across the global neurotechnology field, extending the reach of these technologies beyond what any single company could achieve alone.

CorTec — fighting neurological conditions with implantable neurotechnology.

Media assets

Participant video, UW Medicine (2 min): https://www.youtube.com/watch?v=xNXBe8P4Tz8

Company introduction: https://youtu.be/b-lHrH0IqQA

Webinar, Prof. Dr. Jeffrey G. Ojemann on three-patient results: https://youtu.be/Lh5KSRP2YjQ

Disclaimer: Brain Interchange is an investigational device and has not received FDA marketing authorization. The four-year and 500-day results come from preclinical studies in non-human primates. The 2019 FDA 510(k) clearance (K183437) covers AirRay subdural cortical electrodes for temporary use (less than 30 days) and does not cover Brain Interchange. AirRay is not currently available for clinical use in the United States. FDA Breakthrough Device Designation does not change the requirements for marketing authorization and does not guarantee approval. Statements regarding CorTec’s plans, future indications and commercialization intentions are forward-looking and subject to risks and uncertainties.

Immunic Presents New Clinical, Biomarker, and Preclinical Data for Vidofludimus Calcium in Four Poster Presentations at MSToronto2026 – the 10th Joint ACTRIMS-ECTRIMS Meeting

– New Phase 2 CALLIPER Open-Label Extension Data Support Durability of Disability Outcomes Observed During the Double-Blind Period With Continued Vidofludimus Calcium Treatment; Safety and Tolerability Profile Appeared Consistent With That Observed in the Double-Blind Period –

– New Preclinical Data Suggest Nurr1-Dependent Neuronal Survival and Neuroprotective Effects Beyond DHODH Inhibition – 

– Exploratory and Post-hoc CALLIPER Analyses Show Significant Reductions in EBV-Specific T-Cell Receptor Signatures; Observed Reductions Associated With Increased Symbol Digit Modalities Test (SDMT) Scores – 

– Post-hoc Analysis of CALLIPER Using a Proposed Novel Disability Measure Suggests Overall Benefit of Vidofludimus Calcium in Progressive Multiple Sclerosis Patients –

NEW YORK, October 21, 2026 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced that new clinical, biomarker, and preclinical data for its lead investigational asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), are being presented across four poster presentations at MSToronto2026 – the 10th Joint ACTRIMS-ECTRIMS Meeting, taking place October 21-23, 2026, in Toronto. All posters are available on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations. Additionally, the team is available throughout the event at booth #516.

“The data presented at MSToronto2026 provide complementary clinical and mechanistic evidence supporting the differentiated profile of vidofludimus calcium across the multiple sclerosis (MS) spectrum,” said Erik Lundgren, Chief Executive Officer of Immunic. “Importantly, the new CALLIPER open-label extension (OLE) analyses provide favorable long-term follow-up of the disability signals observed during the double-blind treatment period, while the Nurr1, Epstein-Barr virus (EBV), and disability endpoint analyses provide additional insight into the biology of disease progression and how treatment effects may be more comprehensively measured. Together, these findings further support the clinical and scientific rationale for our planned Phase 3 program in progressive MS, which we expect to initiate later this year, while we also approach the top-line results from our fully enrolled Phase 3 ENSURE trials in relapsing MS, expected by year-end 2026.”

New Phase 2 CALLIPER Open-Label Extension Data Support Durability of Disability Outcomes

Poster Title: Evaluation of Disability Outcomes from the Open-Label Extension of CALLIPER: A Phase 2 Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis

• Lead Author: Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio and Coordinating Investigator of the CALLIPER trial
• Presentation: Paper Poster, Poster Number P0387
• Date and Time: Poster Session 1, Wednesday, October 21, 2026, 4:30 – 6:30 pm ET

New analyses of the Phase 2 CALLIPER trial showed that the favorable trends on disability outcomes observed during the double-blind main treatment period were maintained during the OLE phase among participants who continued vidofludimus calcium treatment. Only 6.5% of patients discontinued through the January 27, 2026 data cutoff, with a safety and tolerability profile that appeared consistent with that observed in the double-blind period.

Preclinical Models Suggest Nurr1-Dependent Neuronal Survival and Neuroprotective Effects

Poster Title: Vidofludimus Calcium Requires Nurr1 to Promote Neuronal Survival In Vitro and Is Associated with Neuroprotective Effects in Murine Models of Multiple Sclerosis

• Lead Author: Mehrnoosh Jafari, Senior Manager Translational Pharmacology at Immunic
• Presentation: Paper Poster, Poster Number P1273
• Date and Time: Poster Session 2, Thursday, October 22, 2026, 4:30-6:30 pm ET

New preclinical findings across multiple models suggest that vidofludimus calcium promotes neuronal survival under apoptotic stress conditions, an effect requiring Nurr1, and in addition reduces microglia-driven neuronal loss, supporting direct and indirect neuroprotective mechanisms. Under in vitro apoptotic conditions, vidofludimus calcium promoted neuronal survival, an effect not observed with teriflunomide, suggesting that the observed pro-survival effect involves mechanisms beyond DHODH inhibition.

Vidofludimus calcium also reduced disease severity and plasma neurofilament light (NfL) chain levels in murine experimental autoimmune encephalomyelitis (EAE) models, and increased brain-derived neurotrophic factor (BDNF) levels and expression of Nurr1-regulated target genes, providing additional evidence consistent with activation of Nurr1-pathways.

Taken together, these findings provide further preclinical evidence of the profile of vidofludimus calcium on pathways associated with neuroprotective effects.

Exploratory and Post-hoc CALLIPER Analyses Link Reduced EBV-Specific T-Cell Signatures with Improved Cognitive Performance as Measured by the Symbol Digit Modalities Test

Poster Title: Anti-EBV T-cell Receptor Repertoire Reduction Is Linked to Enhanced Cognitive Performance in Progressive Multiple Sclerosis: Evidence from the Phase 2 CALLIPER Trial with Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor

• Lead Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development at Immunic
• Presentation: ePoster, Number EP2473
• Date and Time: ePoster screens within the congress center and on the congress platform for the duration of the congress

An exploratory CALLIPER analysis found that vidofludimus calcium significantly reduced EBV-specific TCRβ chain (TRB) sequence matches versus placebo-treated patients (-0.65 matches; p=0.0004), while influenza A-specific matches were unchanged (+0.08; p=0.5983), suggesting an EBV-selective rather than generalized effect on the T-cell repertoire, consistent with a lowered rate of EBV reactivations. Across all patients, reductions in EBV-specific TRB matches were associated with improved Symbol Digit Modalities Test (SDMT, broadly used to assess processing speed) scores, as assessed in a post-hoc analysis. Safety and tolerability data from the CALLIPER trial are summarized below.

These exploratory findings support further investigation of the relationship between EBV-related immune activity and cognitive function in progressive MS.

Novel CALLIPER Analyses Evaluate Disability Improvement and Worsening Together

Poster Title: Bidirectional Disability Changes in Progressive Multiple Sclerosis Patients: a Proposed Endpoint to Capture Full Treatment Effects

• Lead Author: James Myles, Global Head of Biostatistics at Immunic
• Presentation: ePoster, Number EP2205
• Date and Time: ePoster screens within the congress center and on the congress platform for the duration of the congress

Traditional progressive MS analyses have focused primarily on delaying confirmed disability worsening, with improvement often not captured fully or assessed separately. This analysis evaluates two novel statistical models, Confirmed Disability Change (CDC) and Generalized Pairwise Comparisons (GPC), as proposed methods to integrate confirmed disability worsening and improvement into a single statistical analysis measure.

Applying both methods to CALLIPER post-hoc, progressive MS patients treated with vidofludimus calcium appeared more likely to have positive outcomes as compared to placebo, suggesting these methods may capture the true bidirectional disability trajectory of patients. The CDC method fits an ordinal logistic regression model to three ordered categories of confirmed disability change. Using data from the CALLIPER trial, patients treated with vidofludimus calcium were 2.47 times more likely to experience 24-week confirmed disability improvement (CDI) (nominal p=0.037), and a positive CDC (nominal p=0.042). The GPC method compares all pairs of patients to determine which patient had a better outcome as measured by improvement, stability, or slowed worsening on the Expanded Disability Status Scale (EDSS) score. By this method, patients on vidofludimus calcium were 1.5 times more likely to have a better outcome than those who received placebo, a statistically significant and clinically meaningful result (p=0.042).

These outcomes support further evaluation of a bidirectional endpoint designed to capture treatment effects across both disability worsening and improvement.

About Vidofludimus Calcium (IMU-838) and the CALLIPER Trial

Vidofludimus calcium (IMU-838) is an investigational oral small molecule activating nuclear receptor-related 1 (Nurr1) and selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). It is currently being evaluated in the Phase 3 ENSURE trials in relapsing multiple sclerosis (MS). More than 3,500 individuals have been exposed to vidofludimus calcium, to date.

The Phase 2 CALLIPER trial randomized 467 patients with primary or secondary progressive MS 1:1 to 45 mg once-daily vidofludimus calcium or placebo. While the primary endpoint of percent brain volume change (PBVC) was not met, exploratory imaging and clinical outcomes showed directionally favorable signals. Rates of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were similar to placebo (69.4% vs. 68.5% and 8.1% vs. 6.5%, respectively), with no new safety signals and no Hy’s law range cases observed. Among the 387 participants who entered the OLE phase, 44.4% experienced at least one TEAE, including 5.7% who experienced a serious TEAE. Liver-related TEAEs occurred in 3.1% of participants, and TEAEs leading to discontinuation in 1.8%.

Vidofludimus calcium (IMU-838) is an investigational medicinal product that has not been approved or authorized by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any other regulatory authority for any indication in any jurisdiction. Its safety and efficacy have not been established. Any clinical, biomarker, or preclinical findings described reflect investigational data and are not intended to suggest that vidofludimus calcium is safe or effective for any use.

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently being evaluated in Phase 3 clinical trials for the treatment of relapsing multiple sclerosis, with top-line data expected to be available by the end of 2026. Initiation of an additional Phase 3 clinical trial in progressive MS is expected later in 2026. Vidofludimus calcium has already shown therapeutic potential and a favorable safety and tolerability profile in Phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company’s development pipeline also includes earlier-stage programs, including IMU-381 and IMU-856, aimed at building a broader therapeutics platform addressing neurodegenerative and autoimmune diseases. For further information, please visit: www.imux.com. 

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory Phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company’s products or product candidates, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company’s subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information

Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact
LifeSci Advisors
Joyce Allaire
immunic@lifesciadvisors.com

US Media Contact
Real Chemistry
media@imux.com

Press Release // October 21, 2026

Formycon and Biocelys Combine Complementary Development and Manufacturing Expertise in New Biosimilar Project FYB286
 

• FYB286 expands Formycon’s biosimilar pipeline with a promising development project in an attractive niche indication
• Combining Formycon’s development excellence with the manufacturing expertise of South American specialty pharma company Biocelys enables a highly competitive cost structure
• Upfront financing by Santo Biosimilar GmbH, a company of the ATHOS Group, reflects its continued commitment to biosimilars and strong confidence in the capabilities of both collaboration partners

Planegg-Martinsried, Germany / Montevideo, Uruguay – Formycon AG (FSE: FYB, Prime Standard, “Formycon“) and Biocelys S.A. (“Biocelys”), a company of the ATHOS Group, today announced the launch of a collaboration to develop the biosimilar candidate FYB286. The partnership combines Formycon’s proven expertise in biosimilar development with Biocelys’ state-of-the-art manufacturing infrastructure. The project is being financed upfront by Santo Biosimilar GmbH (“Santo”), an affiliated company of ATHOS KG (“ATHOS”). ATHOS is Formycon’s largest anchor shareholder and indirectly controls both Santo Biosimilar GmbH and Biocelys S.A.

Under the agreement with Santo, Formycon will receive arm’s-length compensation for its development services and will participate in future revenues of Santo with a low double-digit percentage share. The technologically demanding development program targets a niche indication with attractive growth potential, making FYB286 a strategically compelling addition to Formycon’s value-focused biosimilar portfolio.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “Biosimilars for niche-busters¹ combine two key elements: they meet the strong demand for high-quality biologic therapies for relatively rare conditions while creating an attractive market opportunity. For FYB286, we expect demand to increase substantially, particularly in emerging markets. Together with Biocelys, we can achieve both objectives: help patients with rare diseases and tap into a new market. Biocelys and Formycon complement each other perfectly by combining state-of-the-art manufacturing capabilities with our extensive expertise and operational excellence in biosimilar development. With Biocelys as part of our network of strategic manufacturing partners, we are strengthening our supply capabilities well beyond the FYB286 project and setting another important cornerstone in our FYB4Growth strategy.”

With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars focused on sustainable value creation: An intelligent portfolio strategy, geographic diversification of target markets, outstanding scientific excellence, and consistent cost efficiency form the foundation of Formycon’s robust and growth-oriented business model.

“In line with our vision to produce high-quality pharmaceuticals from Latin America for patients around the world, our collaboration with Formycon on the FYB286 project marks an important milestone. Our Montevideo site not only features state-of-the-art manufacturing facilities but also the expertise required to manufacture complex biologic molecules. Together with Formycon as our project partner, we will improve access to a much-needed therapy, particularly in regions where patient needs remain largely unmet,” said Adive Carrasco, Managing Director of Biocelys S.A.

“As long-term investors, we support FYB286 as a collaboration model that brings together the complementary strengths of our portfolio companies. The combination of scientific development excellence and modern biopharmaceutical manufacturing provides a solid foundation for executing projects of this kind efficiently and with clear focus on value creation. By providing the upfront financing, we are creating the framework that enables Formycon and Biocelys to implement the project independently and in partnership,” added ATHOS KG.
 

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¹ We define a “niche-buster” as a drug for a niche indication with global annual sales in the low- to mid-single-digit billion-dollar range

About Formycon:
Formycon AG is a listed, independent developer of biosimilars based in Planegg-Martinsried, one of the leading life science locations in Europe, just outside Munich, Germany. Its 200 employees from 27 countries cover the entire development chain, from laboratory analysis through manufacturing and clinical testing to the documents for approval. Three Formycon biosimilars are approved in ophthalmology and immunology and are marketed worldwide through commercialization partners. Four further candidates are in development, among them biosimilars to two of the best-selling biologic medicines in the world. With its products, Formycon makes highly effective therapies affordable for more people.

Formycon AG is listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/en/

About #FYB4Growth:
With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating sustainable value. First, geographic diversification: in addition to Europe and the U.S., Formycon is strategically expanding into high growth regions such as MENA, APAC and Latin America through strong regional partners. Second, a smart portfolio strategy: Formycon relies on an intelligent portfolio strategy that specifically combines blockbuster molecules with selected niche products and creates the foundation for sustainable value generation through efficient regulatory development pathways. Third, excellence and innovation: Formycon positions itself as a technological and regulatory development powerhouse, creating clear competitive differentiation through innovative product solutions and new regulatory approaches. Fourth, consistent cost efficiency: streamlined processes, optimized development structures and the increased use of digital technologies are designed to enhance the scalability of the business model and strengthen Formycon’s competitiveness over the long term. Find out more at: https://www.fyb4growth.com

About Biocelys:
Biocelys S.A. (“Biocelys”), based at Parque de las Ciencias in Canelones, Uruguay, is a biopharmaceutical company for the development and manufacture of biotechnological drug substances. Its focus is on monoclonal antibodies and related recombinant proteins from mammalian cell culture, covering the process from cell bank through cell culture and purification to the released drug substance. The facility is newly built to current technical standards and designed for manufacturing in line with international GMP standards.

Biocelys is a company of the ATHOS Group. The company pursues the vision of making high-quality biopharmaceuticals available from Latin America to patients worldwide. Alongside its own process development, Biocelys performs technology transfers for partners and supports projects from process transfer through validation to commercial supply. Adive Carrasco is Managing Director of Biocelys S.A.

About Biosimilars:
Biosimilars are successor products to biologic medicines. They are not copies; each one is developed from the ground up and must demonstrate to the health authorities that it has no clinically meaningful differences from the reference product in terms of safety and efficacy. According to the IQVIA Institute, 118 biologic medicines with sales of USD 232 billion will lose their exclusivity in the US alone by 2034, and for only twelve of them is a biosimilar in development. In Europe, biosimilars have saved EUR 75 billion and made more than seven billion days of treatment possible.

 Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

Cellbox Solutions Completes Series A Financing with Total Proceeds of EUR 5 Million

• Final closing of the Series A marks the next phase of Cellbox Solutions’ commercial development
• New investors add international reach, sector expertise and strategic support
• Funding will support the expansion of warm-chain logistics services and international growth

Cologne, Germany, October 20, 2026 – Cellbox Solutions, a warm-chain logistics technology company, has completed the final closing of its Series A financing, bringing the total proceeds to EUR 5 million. With this additional capital, the company is further developing its business model and expanding its offering to include integrated logistics solutions for cells, tissues, organoids, and other sensitive biological materials.

The financing marks the next phase in the company’s commercial growth, and will help leverage the established technological, product-related, and regulatory advances Cellbox Solutions has achieved in recent years. A key focus is building on the company’s specialized transport capabilities to link controlled transport under physiological conditions even more closely with additional logistics and service offerings.

Following the first closing of approximately EUR 3.5 million in March 2026, Cellbox Solutions has attracted additional investors. The new investors include members of the Baltic Business Angels Invest GmbH, a Canadian family office, and an undisclosed investor with extensive experience in pharmaceutical logistics. Existing investors NRW.BANK and Fraunhofer Venture also participated in the financing. Companisto led the first closing.

Cellbox™ Go and Cellbox™ Shipper make up the core of the company’s technology platform. Both incubators provide controlled temperature and CO₂ conditions during ground and air transport and are already used internationally in research and cell therapy applications.

With over 400 Cellbox systems currently on the market, a growing number of customer relationships and a regulatory foundation that includes Drug Master Files for the Cellbox^TM product family, the company is well positioned to expand its commercial offering. This includes combining Cellbox^TM systems with rental and transport options, as well as recurring services such as monitoring, fleet management, and shipment coordination. The aim is to provide customers with even greater flexibility and comprehensive support for their logistics processes in the future.

“Over the past years, we have built a strong foundation for the controlled transport of living biological materials,” said Prof. Dr. Kathrin Adlkofer, Founder and CEO of Cellbox Solutions. “With the successful completion of our Series A round, we are now expanding our established warm-chain technology platform into a broader offering for physiological logistics. This will allow us to support customers more comprehensively across their logistics workflows and expand our presence in key international markets.”

To this end, the company is continuing to expand its activities in Europe, Asia, and North America and is increasingly focusing on strategic partnerships with logistics providers.

“Completion of the Series A gives us additional resources to scale the commercial model behind our technology. By expanding rental and recurring service offerings and combining them with transportation, monitoring, and complementary logistics services, we can build longer-term customer relationships and a more scalable service model across markets. Our focus is now on translating the strength of the Cellbox platform into sustainable commercial growth,” concluded Dr. Bernd Muehlenweg, CBO and CFO of Cellbox Solutions.

About Cellbox Solutions GmbH

Founded in 2017, Cellbox Solutions GmbH is a Germany-based warm-chain logistics technology company providing innovative solutions for the global healthcare and life sciences industries to transport sensitive biological materials and therapeutics that cannot be frozen and require controlled physiological conditions. The company’s portable CO₂ incubator platform, Cellbox™, creates a regulated environment for the transport of living cells, organoids, tissues, and other advanced biological materials. Temperature and CO₂ levels are individually adjustable to ensure reproducible incubation conditions throughout shipment. Cellbox™ systems are deployed globally and support research, clinical, and advanced therapy applications. Building on its established technology platform, Cellbox Solutions is expanding its offering toward integrated physiological logistics solutions that combine controlled transport with rental, monitoring and related recurring services. For more information, please visit www.cellbox-solutions.com or follow Cellbox Solutions on LinkedIn.