Slide 1: Positive Data from Maintenance Phase of Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Ulcerative Colitis
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements This presentation contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21€ of the Securities
Slide 3: CALDOSE-1: Final Week 50 Maintenance Phase Data
Slide 4: CALDOSE-1: Phase 2 Trial Design in UC
CALDOSE-1: Phase 2 Trial Design in UC NCT03341962 Placebo (n=60) 10 mg IMU-838 QD Patients with Optional (60) TT ¥mptomatic open-label remission extension penny > 10mg IMU-838 QD period to | Aaa obtain long- 301mg MU-#380D serrate: (n=112) up to 9 years + 30mg IMU-838.QD 45 mg IMU-838 QD (n=60) 10 w
Slide 5: Dose-Linear Increase in Clinical Remission at Week 50
5 Dose-Linear Increase in Clinical Remission at Week 50 For Vidofludimus Calcium as Compared to Placebo Clinical Remission at Week 50 Full Analysis Setyp (Npgo = 27, Nao = 45, Nap = 40) | Clinical Remission at Week 50 100% Data Set: Feene 10mg 30 mg (n-evaluable/n-total of (N=18/21) IMU-833. IMU-838
Slide 6: Exploratory Statistical Analysis of Clinical Remission
Exploratory Statistical Analysis of Clinical Remission Statistically Significant Difference in Favor of 30 mg Vidofludimus Calcium Versus Placebo 30 mg of vidofludimus calcium found to be statistically superior to achieve clinical remission during maintenance Clinical Remission at Week 50 treatment
Slide 7: 10-Week Induction Phase Data: UC Patients Without Concomitant Corticosteroids Responded Well
10-Week Induction Phase Data: UC Patients Without Concomitant Corticosteroids Responded Well (Previously Reported in June 2022) Without Concurrent Steroids (n=125) With Concurrent Steroids (n=138) 35.0% 35.0% 30.0% mel 30.0% 224% 25.0% 24.2% 25.0% 23.1% 1% A114% 20.6% 20.6% 20.0% 20.0% 16.7% 14.7% 1
Slide 8: Comparison to Other Maintenance Data
Comparison to Other Maintenance Data Vidofludimus Calcium Shows Competitive Maintenance Data in UC 70% 433.7% 60% a 50% - A 19.8% A25.9%" A 28.9% 30.0% A 14.4% : 40% 418.5% A 23.2% 30% 20% 10% 0% Vidofludimus Calcium Stelara® Stelara® Entyvio® Entyvio® Rinvog® Xeljanz® 30mg 90 mg 90 mg 300 mg 300 mg
Slide 9: Steroid-Free Clinical Remission at Week 50
Steroid-Free Clinical Remission at Week 50 Vidofludimus Calcium Superior as Compared to Placebo Steroid-Free Clinical Remission Full Analysis Setyp (Npgo = 27, Nao = 45, Nao = 40) Steroid-Free Clinical Remission at Data Set: placebo 10mg 30mg (n-evaluable/n-total of (N=18/21) IMU-838 IMU-838 group)
Slide 10: Steroid-Free Clinical Remission at Week 50: Subgroup Analysis
Steroid-Free Clinical Remission at Week 50 Subgroup Analysis of Patients Who Received Corticosteroids During Induction Phase Clinical Remission Modified Full Analysis Setyp (Npgo = 17, Nap = 22, Ngo = 22) 10 mg 30mg Placebo IMU-838 IMU-838 N % N % N % No 8 72.7 8 61.5 4 33.3 Yes 2 27.3 5 38.5 8 66.7
Slide 11: Endoscopic Healing at Week 50
Endoscopic Healing at Week 50 Vidofludimus Calcium Superior as Compared to Placebo Endoscopic Healing Full Analysis Setyp (Npgo = 27, Nao = 45, Ngo = 40) Endoscopic Healing at Week 50 100% Data Set (n- 10 mg 30 mg Placebo = levaluated/n-total of (N=17/21) IMU-838 | IMU-838 N=19/26 group) (N=28/35) |
Slide 12: Exploratory Statistical Analysis of Endoscopic Healing
Exploratory Statistical Analysis of Endoscopic Healing Statistically Significant Difference in Favor of 30 mg Vidofludimus Calcium Versus Placebo 30 mg of vidofludimus calcium found to be statistically superior to achieve endoscopic healing at week 50 as compared to placebo Endoscopic Healing at Wee
Slide 13: Summary Efficacy Results Maintenance Phase CALDOSE-1 Trial
13 | © immunic, inc. | Apr/05/2023 Summary Efficacy Results Maintenance Phase CALDOSE-1 Trial Maintenance phase results confirm the previous hypothesis (from the analysis of patients without concomitant corticosteroid use during the induction phase) that vidofludimus calcium provides a benefit regar
Slide 14: Incidence of TEAEs Lower in 10 mg and 30 mg Vidofludimus Calcium Groups Than in Placebo
Incidence of TEAEs Lower in Both 10 mg and 30 mg Vidofludimus Calcium Groups Than in Placebo Group Number of patients with TEAEs, serious TEAEs, and TEAEs of special interest Safety Setyyp (Nego = 27, Nig = 45, Ngo = 40) Placebo 10 mg IMU-838 30 mg IMU-838 Total TEAEN(n) | TEAE(%) | TEAEN(n) | TEAE(
Slide 15: No Increase in Liver Events Observed as Compared to Placebo
No Increase in Liver Events Observed as Compared to Placebo Placebo 10 mg IMU-838 30 mg IMU-838 Total TEAEN(n) | TEAE(%) | TEAEN(n) | TEAE(%) | TEAEN(n)| TEAE(%) | TEAEN(n) | TEAE (2%) Hepatobiliary Genders Cholecystitis 0 0 4(1) 2.2% 0 0 4(1) 0.9% Aspartate aminotransferase 11) 357% 6 a e 6 11) 5%
Slide 16: Absence of Hy's Law Cases
Absence of Hy’s Law Cases Indicates Low Potential for Drug-Induced Hepatotoxicity Hy’s Law Plot: Alanine Aminotransferase (ALT) Safety Analysis Setyyp (Neao = 27, Nio = 45, Nao= 40) [Perma Wee = jw 3 3 le ae =3 $ $2. éz aun. erat ne late buwn Safety set maintenance phase allpatients whowere randomiz
Slide 17: No Increase in Renal Events Observed as Compared to Placebo
No Increase in Renal Events Observed as Compared to Placebo Placebo 10 mg IMU-838. 30 mg IMU-838 Total TEAE N(n) | TEAE(%) | TEAEN(n) | TEAE(%) | TEAEN(n) | TEAE(%) | TEAEN(n) | TEAE(%) Blood creatinine increased 1(1) 3.7% 0 0 0 0 1(1) 0.9% Investigations | Bigod urine present 0 0 1(1) 2.2% 0 0 11)
Slide 18: Summary Safety Results Maintenance Phase CALDOSE-1 Trial
Summary Safety Results Maintenance Phase CALDOSE-1 Trial \) ) = Administration of vidofludimus calcium during maintenance phase found to be safe and well-tolerated = Incidence of TEAEs for vidofludimus calcium comparable to placebo = Very few serious TEAEs observed = As compared to placebo, the inci
Slide 19: Pipeline Update and Outlook
Slide 20: Pipeline Focus on Vidofludimus Calcium and IMU-856
Pipeline Focus on Vidofludimus Calcium and IMU-856 = Immunic to focus on the rapidly advancing vidofludimus calcium and IMU-856 programs = Positive data from the CALDOSE-1 trial of vidofludimus calcium shown today support strategic focus on gastroenterology and neurology indications = Totality of av
Slide 21: Summary: Several Clinical Data Readouts Expected in 2023
Summary: Several Clinical Data Readouts Expected in 2023 IMU-856 IMU-856 IMU-838 Initial phase 1b celiac disease data expected in the current quarter Mode of action and molecular target to be presented in the context of an upcoming scientific GI congress Interim analysis of phase 2 CALLIPER trial in
Slide 22: Q&A Session
Slide 23: Thank You!
Thank You! Immunic, Inc. 1200 Avenue of the Americas New York City, NY 10036 USA Immunic AG Lochhamer Schlag 21 82166 Grifelfing (Munich) Germany Jessica Breu Head of IR & Communications & Phone: +49-89-2080477-09 & Email: ir@imux.com ® Web: www.imux.com Immunic Australia Pty. Ltd. Melbourne Austral
Slide 24: CALDOSE-1: Further Information
Slide 25: CALDOSE-1: Clinical Phase 2 Trial in Ulcerative Colitis (UC)
CALDOSE-1: Clinical Phase 2 Trial in Ulcerative Colitis (UC) NCT03341962 @ & QX\ Coordinating investigator: Dr. Geert D’Haens (AMC Amsterdam) Conducted with active IND in the United States Total number of patients randomized: 263 More than 100 sites in 19 countries: USA, Western, Central and Eastern
Slide 26: Reminder About Corticosteroids Use in the CALDOSE-1 Trial
Reminder About Corticosteroids Use in the CALDOSE-1 Trial | During Induction Phase B | During Maintenance Phase = Concomitant use of corticosteroids was allowed: — At doses <20 mg prednisolone equivalent — Steroid dose MUST remain stable for entire induction phase = Approximately 50% of patients had
Slide 27: Patients Per Treatment Group
Patients Per Treatment Group CALDOSE-1 Maintenance Phase Randomized patients maintenance phase N=112 When reaching symptomatic remission at week 10 or 22 10 mg IMU-838 assigned/completed N=45/35, 30 mg IMU-838 assigned/completed N=40/29 Placebo assigned/completed N=27/21 Week 50 endoscopy done N=28
Slide 28: Patient Demographics and Prior Treatment History
Patient Demographics and Prior Treatment History CALDOSE-1 Maintenance Phase 10 mg 30 mg Ueto) iu-g838_| IMU-838 = N=45 N=40 Mean age (years) 40.1 (14.1) | 39.7(13.1) | 43.8 (14.1) Male (N in %) 18 (66.7) | 30(66.7) | 15 (37.5) 173.4 169.7 Mean height (cm) (103) |2748(82)) (oa) ; 72.44 74.A3 Mean we
Slide 29: Multivariate Analysis Shows Concomitant Steroid Use is Main Factor for Outcome
Multivariate Analysis Shows Concomitant Steroid Use is Main Factor for Outcome of Clinical Remission in Induction Phase “il Multivariate analysis shows that concomitant steroids have highest impact on clinical remission data (B) & Estimation of odd ratios for vidofludimus calcium achieving clinical