Immunic, Inc. · NASDAQ:IMUX
Immunic — Corporate Update (June 2022)
27 slides from Immunic's corporate update, Jun 2, 2022
Slide 1: Top-Line Data Phase 2 CALDOSE-1 Trial in Ulcerative Colitis and Corporate Update
Immunic Therapeutics Top-Line Data Phase 2 CALDOSE-1 Trial in Ulcerative Colitis and Corporate Update NASDAQ: IMUX | June 2, 2022
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 21E of the Securities
Slide 3: Top-Line Data Phase 2 CALDOSE-1 Trial in Ulcerative Colitis (UC)
Top-Line Data Phase 2 CALDOSE-1 Trial in Ulcerative Colitis (UC)
Slide 4: CALDOSE-1: Readout of Induction Phase Data
CALDOSE-1: Readout of Induction Phase Data Phase 2 Trial Design in Moderate-to-Severe UC, NCT03341962 Induction Phase Maintenance Phase Placebo (n=64) Placebo Optional 10 mg IMU-838 QD open-label (n=67) Patients with symptomatic extension remission 10 mg IMU-838 QD period to at weeks obtain long- 30
Slide 5: CALDOSE-1: Clinical Phase 2 Trial in UC
CALDOSE-1: Clinical Phase 2 Trial in UC NCT03341962 Coordinating investigator: Primary endpoint: Dr. Geert D’Haens Proportion of patients (AMC Amsterdam) with clinical remission Patient population: (symptomatic remission and § Male and female patients, endoscopic remission) Conducted with active IND
Slide 6: CALDOSE-1: Demographics
CALDOSE-1: Demographics Stratification at Randomization for Prior Biologics and Concurrent Corticosteroid Use Treatment Groups 10 mg 30 mg 45 mg Total Placebo IMU-838 IMU-838 IMU-838 N % N % N % N % N % Concurrent Use of Corticosteroids No 28 41.8 26 38.8 26 39.4 26 41.3 106 40.3 Yes Biologic-Naïve
Slide 7: CALDOSE-1: Clinical Remission
CALDOSE-1: Clinical Remission Primary Endpoint Not Achieved* Clinical Remission at Week 10 10 mg 30 mg 45 mg ITT Data Set IMU-838 IMU-838 IMU-838 Placebo (ITT Data Set) Number of 25% 67 66 66 64 Randomized Patients 20% Number of Patients Meeting Primary 10 7 9 8 14.9% 15% 13.6% Endpoint 12.5% 10.6%
Slide 8: Interference Between Vidofludimus Calcium and Concurrent Use of Corticosteroids
Interference Between Vidofludimus Calcium and Concurrent Use of Corticosteroids 𝚫 11.4% The graphs use the concurrent use of corticosteroids, as used as stratification factor for randomization provided by the investigator, not actual use of concurrent corticosteroids. However, actual steroid use…
Slide 9: Safety and Tolerability Profile of Vidofludimus Calcium in Line with Previous Investigations
Safety and Tolerability Profile of Vidofludimus Calcium in Line with Previous Investigations in Other Patient Populations The Safety and Tolerability Profile of Vidofludimus Calcium in the CALDOSE-1 Trial Was in Line with Previous Trials § No increase in infections or infestations as compared to pla
Slide 10: Summary of Clinical Trial Results
Summary of Clinical Trial Results Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in UC § Primary endpoint was not achieved as a result of an unexpected interference between vidofludimus calcium and concurrent use of corticosteroids: § Given the wealth of compelling opportunities - Patient populatio
Slide 11: Corporate Update
Corporate Update
Slide 12: Strategic Conclusions
Strategic Conclusions Multiple Advanced Clinical-Stage Programs with Upcoming Value Inflection Points Immunic will take this opportunity to sharpen its focus R&D personnel and financial resources can be focused on its other promising programs Vidofludimus Calcium Development IMU-935 in Psoriasis IMU
Slide 13: Multiple Clinical Data Readouts Expected Throughout 2022
Multiple Clinical Data Readouts Expected Throughout 2022 Program Target Preclinical Phase 1 Phase 2 Phase 3 Key Milestones Relapsing Multiple Sclerosis (RMS) – ENSURE Trials § RMS interim analysis planned after approx. half of the events occurred Progressive Multiple Sclerosis (PMS) – CALLIPER Trial
Slide 14: EMPhASIS Trial: Strong Reduction of MRI Lesion Activity
EMPhASIS Trial: Strong Reduction of MRI Lesion Activity Pooled Cohorts 1 & 2 Double-Blind, Placebo-Controlled, Randomized, Reduction in Cumulative CUA Lesions up to Week 24 Reduction in Gd+ Lesions up to Week 24 Parallel-Group Phase 2 Trial in RRMS § Blinded main treatment period of 24 weeks § Rando
Slide 15: EMPhASIS Trial: Encouraging Signals of Neuroprotective Effects
EMPhASIS Trial: Encouraging Signals of Neuroprotective Effects Based on EDSS Assessments, Pooled Cohorts 1 & 2 Change of EDSS from Baseline to Week 24 Proportion of Patients With Unconfirmed EDSS Progression up to Week 24 Percent 2,9 25 21,1% 2,8 20 2,7 15 11,8% 12,1% 11.1% 2,6 10 2,5 5 2,4 0 Baseli
Slide 16: EMPhASIS Trial: Relative Change of Serum NfL Concentrations
EMPhASIS Trial: Relative Change of Serum NfL Concentrations Versus Placebo After 24 Weeks, Pooled Cohorts 1 & 2 50% The relative change of serum neurofilament light chain versus placebo is proportional to vidofludimus calcium dose. § May reflect increasing trough -9% levels and related improved effe
Slide 17: Vidofludimus Calcium Showed Interesting Hints for Clinical Anti-Infection and Anti-SARS-CoV-2 Activity
Vidofludimus Calcium Showed Interesting Hints for Clinical Anti-Infection and Anti-SARS-CoV-2 Activity Treatment Corresponds with Decreased Treatment Does Not Interfere With Antibody Number of Opportunistic COVID-19 Infections Development During SARS-CoV-2 Infection 35% 33.0% 30% 25.0% Day 6 Day 14
Slide 18: Multiple Clinical Data Readouts Expected Throughout 2022
Multiple Clinical Data Readouts Expected Throughout 2022 Program Target Preclinical Phase 1 Phase 2 Phase 3 Key Milestones Relapsing Multiple Sclerosis (RMS) – ENSURE Trials § RMS interim analysis planned after approx. half of the events occurred Progressive Multiple Sclerosis (PMS) – CALLIPER Trial
Slide 19: IMU-935 Phase 1 Clinical Trial: Trial Design and Current Status
IMU-935 Phase 1 Clinical Trial Trial Design and Current Status PART A PART B PART C Evaluation of Evaluation of Evaluation of single ascending doses (SAD) multiple ascending doses (MAD) moderate-to-severe psoriasis patients receiving 28-day Healthy human subjects Healthy human subjects treatment of
Slide 20: IMU-935 Phase 1 Clinical Trial: Part C in Psoriasis Patients
IMU-935 Phase 1 Clinical Trial Part C in Moderate-to-Severe Psoriasis Patients Detecting Therapeutic Activity of IMU-935 in Moderate-to-Severe Psoriasis Patients § Double-blind, placebo-controlled dose escalation study to evaluate safety, tolerability, pharmacodynamics and exploratory efficacy of IM
Slide 21: Multiple Clinical Data Readouts Expected Throughout 2022
Multiple Clinical Data Readouts Expected Throughout 2022 Program Target Preclinical Phase 1 Phase 2 Phase 3 Key Milestones Relapsing Multiple Sclerosis (RMS) – ENSURE Trials § RMS interim analysis planned after approx. half of the events occurred Progressive Multiple Sclerosis (PMS) – CALLIPER Trial
Slide 22: Celiac Disease is a Serious Autoimmune Disease
Celiac Disease is a Serious Autoimmune Disease Celiac disease is a multifactorial, complex autoimmune disease caused by an immune reaction against a degradation product of gluten and is strongly associated with specific HLA gluten protein gut lumen class II gene variants (HLA-DQ2 and -DQ8)[1] gliadi
Slide 23: IMU-856: Three-Part, Double-Blind, Randomized, Placebo-Controlled Phase 1 Clinical Trial
IMU-856: Three-Part, Double-Blind, Randomized, Placebo- Controlled Phase 1 Clinical Trial Performed at Approx. 10 Sites in Flow Chart of Part C in Celiac Disease Australia and New Zealand § Conducted in three parts: Day 1-28: Treatment IMU-856/placebo Day 14-28: - Safety and pharmacokinetics in heal
Slide 24: Multiple Clinical Data Readouts Expected Throughout 2022
Multiple Clinical Data Readouts Expected Throughout 2022 Advanced clinical pipeline: Oral IL-17 inhibitor IMU-935: three differentiated investigational medicines in proof-of-concept data in psoriasis expected in various phases of clinical development H2/2022; further development in CRPC RMS phase 3
Slide 25: Q&A Session
Q&A Session
Slide 26: Immunic currently has three investigational medicines in active clinical trials
Immunic currently has three investigational medicines in active clinical trials from phase 1 to phase 3 with multiple important data readouts ahead in H2/2022 § Discussions planned with clinical experts and potential partners to enhance the understanding of the strategic implications of the CALDOSE-
Slide 27: Thank You!
Thank You! Immunic, Inc. Immunic AG 1200 Avenue of the Americas Lochhamer Schlag 21 New York City, NY 10036 82166 Gräfelfing (Munich) USA Germany Immunic Research GmbH Weinberg Campus Halle (Saale) Jessica Breu Germany Head of IR & Communications Phone: +49-89-2080477-09 Email: [email protected] Immunic A