Immunic, Inc. · NASDAQ:IMUX
Immunic — Investor Presentation (January 2022)
56 slides from Immunic's investor presentation, Jan 10, 2022
Slide 1: Immunic Therapeutics
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 216 of the Securities
Slide 3: Our Mission
Our Mission We are developing a pipeline of next- generation selective oral therapies focused on offering patients with chronic inflammatory and autoimmune diseases new and clinically meaningful treatment options. 3. | ©immunic, inc. | Jan/10/2022 & Immunic
Slide 4: Company is Led by an Experienced Management Team
) Leadership Team 208 Company is Led by an Experienced Management Team Daniel Vitt, Duane Duane Daniel Vitt, 5 PhD iy Nash, MD, > Nash, MD, PhD A JD, MBA JD, MBA Fim y Gare y Gere : vA a} Andreas Hella Tamar PY Muehler, =P kohihof Howson ~~ eo MD, MBA 7 Es CFA bs mo i cso i 1 an i Patrick Joerg Vinc
Slide 5: Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022
Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022 = Completed or ongoing 5 Program _| Target Preclinical Phase 1 Phase 2 Phase 3 Key Milestones RMS interim analysis planned after approx. half of the events occurred PMS interim analysis planned after half of
Slide 6: Vidofludimus Calcium (IMU-838)
Slide 7: Vidofludimus Calcium is Uniquely Positioned in Multiple Large Indications
Vidofludimus Calcium is Uniquely Positioned in Multiple Large Indications There is an opportunity across multiple large indications to address the needs of patients who are seeking best-in-class treatment Large Existing Markets"! Gap in Treatment Options = MS (40%) and UC (25-40%) have significant g
Slide 8: Vidofludimus Calcium Selectively Targets Only Hyperactive Immune Cells
Vidofludimus Calcium Selectively Targets Only Hyperactive Immune Cells Lymphocyte Activated “Stressed” Lymphocyte Insuffi C\ Eee ie recycling | MU-838 Pharmacological Lymphocyte Effects spot fe EF oc ear \\ elongation "47 ———“o —— ——s Disease related / oe activation Metabolically silent, Activation
Slide 9: Vidofludimus Calcium in Multiple Sclerosis (MS)
Slide 10: Despite Limitations of Current Therapies, the Global MS Market Exceeds USD 23 Billion Annually
Despite Limitations of Current Therapies, the Global MS Market Exceeds USD 23 Billion* Annually Oral MS Drugs Have Substantial Vidofludimus Calcium Aims at Significant Share Market Share* of USD 10+ Billion Oral MS Drug Market* S1P Modulators USD 3.07 bn Dimethyl Fumarate USD 5.01 bn + Sales numbers
Slide 11: Treatment Escalation Remains the Typical Approach for Patients With RRMS
Treatment Escalation Remains the Typical Approach for Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) Treatments escalated due to: 1. Long time-course of Escalation (Switch)!22] disease " = Switch most often driven by 2. Lack of efficacy Base Therapy (Initiation) either — Relapse(s) . no
Slide 12: For Patients With Lifelong Illness, Disability is a Critical Concern
For Patients With Lifelong Illness, Disability is a Critical Concern MS is a Lifelong Disease @ Therapeutic Goal: Preventing Disability Worsening = Lifelong disease requiring decades of therapy = Unmet need is prevention of disability = ~2.8 million people affected worldwide (“1M in US)! worsening =
Slide 13: Existing First-Line and Oral MS Therapies Leave Much to be Desired
Existing First-Line and Oral MS Therapies Leave Much to be Desired oa Interferons Teriflunomide os Cladribine S1P Modulators Oral? @ 9 =) e i) @ Relapse Reduction @ Q Q @ @ @ Prevention of Disability Worsening ] @ @ @ @ @ Tolerability e @ @ @ Qo io) Safety @ @ 9 1s) @ e Absence of Infection Risk tJ
Slide 14: Vidofludimus Calcium Could Address the Limiting Factors of Other Therapies Across the MS Patient Journey
Vidofludimus Calcium Could Address the Limiting Factors of Other Therapies Across Multiple Segments of the MS Patient Journey Illustrative Patient Flow Advanced MS 65k treated in 2020 Diagnosis PMS treatments Treatment D Sad PEsaTEATES / EVP — — hme Ea Goo l 30% looking to switch each year ] 40% (~1
Slide 15: Vidofludimus Calcium is Targeted to Address Unmet Needs From Both the Patient and Provider Perspective
Vidofludimus Calcium is Targeted to Address Unmet Needs From Both the Patient and Provider Perspective & Intended Value for Patient: Q Intended Value for Neurologist: Mi) Precision Solution @)) Seamless Fit for Patient = Noticeable efficacy = Specific to disease causing cells — Improvements in relap
Slide 16: Phase 2 Data in RRMS: Primary and Key Secondary Endpoints Met
Phase 2 Data in RRMS: Primary and Key Secondary Endpoints Met, Showing Strong Activity on MRI Lesions Suppression of CUA MRI Lesions: Vidofludimus Calcium Versus Placebo Double-Blind, Placebo-Controlled, Randomized, Over 24 Weeks Parallel-Group Phase 2 Trial Percent * Blinded main treatment period o
Slide 17: Phase 2 Data in RRMS: Demonstrated Highly Significant MRI Lesion Suppression
Phase 2 Data in RRMS: Demonstrated Highly Significant MRI Lesion Suppression of Vidofludimus Calcium Compares Favorably to Other First-Line and Oral Base Medications Commercially Available in RRMS* MRI Endpoint Seal Glatiramer | Teriflunomidel® Dimerivl Fingolimod!) | — Qzanimod’! Calcium Acetatel]
Slide 18: Phase 2 Data in RRMS: Positive Signals on Relapse and Unconfirmed Disability
Phase 2 Data in RRMS: Positive Signals on Relapse and Unconfirmed Disability Proportion of Patients With Relapse up to Week 24 Proportion of Patients With Unconfirmed Disability Progression up to Week 24 percent Percent 7 50 45 25 2am 40 % 19.4% 35 18.3% os 23.2% a5 20 a5 11.8% 32.336 2 10 5 ° ° 30
Slide 19: Phase 2 Data in RRMS: Showed Evidence of Potential Neuroprotective Activity
Phase 2 Data in RRMS: Showed Evidence of Potential Neuroprotective Activity Robust Decrease in Serum Neurofilament Light Chain (NfL)!#] NfL has been shown consistently to correlate with disease activity in neurological disorders. Percent 20 10 NfL has become one of the most importantserum biomarkers
Slide 20: Phase 2 Data in RRMS: Indicated Patients Feel Well-Treated
Phase 2 Data in RRMS: Indicated Patients Feel Well-Treated With Vidofludimus Calcium Reflected in Low Discontinuation Rates for Vidofludimus Calcium-Treated RRMS Patients, Considerably Lower Than Placebo* Vitdeliteetins Geiitenees | strani Biastiny) etapa Craaitinanle Calcium Acetatel4] Fumarate!) A
Slide 21: Attractive Pharmacokinetic, Safety and Tolerability Profile Observed in Multiple Clinical Trials
Attractive Pharmacokinetic, Safety and Tolerability Profile Observed in Multiple Clinical Trials = Safety profile similar to placebo: no general safety signals observed in clinical trials so far = No increased rates of diarrhea, neutropenia, or alopecia = No increased rates of infections and infesta
Slide 22: Vidofludimus Calcium's Safety Profile to Date is Unique
Vidofludimus Calcium’s Safety Profile to Date is Unique vidofludimus Dimeti 3) | Teriflunomide' a ea Bl) | Cladribine | Fingolimod! | siponimod® | Ponesimod” | Ozanimod'! PML Risk @ Fumarate! Increased Number of Infections Vaccination Limitations Gastrointestinal Toxicities, Incl. Diarrhea Cardiovas
Slide 23: Phase 3 and Approval Strategy in MS
Phase 3 and Approval Strategy in MS Phase 3 ENSURE Program in RMS = Two identical pivotal trials in RMS patients = Goal: Regulatory approval of vidofludimus calcium = Dosage: 30 mg vidofludimus calcium QD = ClinicalTrials.gov: NCTO5134441 Phase 2 CALLIPER Trial in PMS = Phase 2 trial in PMS patients
Slide 24: ENSURE: Ongoing Pivotal Phase 3 Program in RMS
ENSURE: Ongoing Pivotal Phase 3 Program in RMS NCT05134441 Two Multicenter, Randomized, Double-Blind Phase 3 Trials = More than 100 sites in the United States, Latin America, Central i‘ Coordinating Investigator and Eastern Europe, and India in each trial = Randomization to 30 mg vidofludimus calciu
Slide 25: CALLIPER: Ongoing Phase 2 Trial Intended to Run Concurrently With the Phase 3 Program in RMS
CALLIPER: Ongoing Phase 2 Trial Intended to Run Concurrently With and to Complement the Phase 3 Program in RMS eh Multicenter, Randomized, Double-Blind, = Placebo-Controlled Phase 2 Trial* = Approximately 450 patients in more than 70 sites in North i‘ Coordinating Investigator America, Western, Cent
Slide 26: MS Program is Intended to Provide a Straightforward Path Towards Potential Regulatory Approval in RMS
MS Program is Intended to Provide a Straightforward Path Towards Potential Regulatory Approval in RMS Immunic believes that the phase 3 ENSURE program provides a straightforward path towards potential regulatory approval of vidofludimus calcium in RMS. CALLIPER is designed to corroborate vidofludimu
Slide 27: Vidofludimus Calcium in Inflammatory Bowel Disease (IBD)
Slide 28: Vidofludimus Calcium is Targeted to Become the New Standard of Care for IBD Patients
Vidofludimus Calcium is Targeted to Become the New Standard of Care for IBD Patients Goal: New Standard of Care = Highly selective = First-in-class oral, providing increased flexibility and clear switch opportunity for physician and patient Immunomodulators Moderate Traditional Immunomodulators Cort
Slide 29: Vidofludimus Calcium is Targeted to Address Limitations of Existing IBD Therapies
Vidofludimus Calcium is Targeted to Address Limitations of Existing IBD Therapies Selectivity for only metabolically oat. Antiviral effect provides complement hyperactivated inflammatory cells Aus to vaccinations XN Target Profile: First-in-class mode of action would provide alternative for non-resp
Slide 30: Strong Indications for Vidofludimus Calcium's Activity in IBD
Strong Indications for Vidofludimus Calcium’s Activity in IBD ENTRANCE Study: IBD Activity of Vidofludimus “) Crohn’s Investigations 89) Confirm DHODH Activity Phase 2 Data of IMU-838 in RRMS Phase 2a study of vidofludimus in corticosteroid-dependent patients after two unsuccessful withdrawal attemp
Slide 31: ENTRANCE Study: Primary Efficacy Results
ENTRANCE Study: Primary Efficacy Results Number of Patients n=9 Non- ENTRANCE Study: 2 Bere Responders Responders (11.5%) = Study performed with active 6 38.5% (34.6%) moiety vidofludimus Total Response 20 BERG All patients flled two attempts to taper down steroids BEY Oven-label, dosing of 35 mg vi
Slide 32: CALDOSE-1: Phase 2 Trial Design in UC
CALDOSE-1: Phase 2 Trial Design in UC MainteD a tees Placebo (n=60) > Placebo (n=60) Optional 10 mg IMU-838 QD a ner (n=60) > Patients with egal symptomatic eaamion Peaeeine ;—> 10mg IMU-838 QD period to 30 mg IMU-838. QD at weeks Gael eas — (ine) HOG term safety: upto 9 years L_+ 30mgIMU-838 QD 45
Slide 33: CALDOSE-1: Clinical Phase 2 Trial in UC
CALDOSE-1: Clinical Phase 2 Trial in UC NCT03341962 Coordinating Investigator: = : . DeGeerdraens Me Primary Endpoint: (AMC Amsterdam) Proportion of patients Interim Analysis Established wan alee One et, 5 5 and endoscopic healing a INCIVe|IND niche aie aide Effective Dose creeheie United States Be:
Slide 34: Clinical Activity of Vidofludimus Calcium in Further Indications
Slide 35: Vidofludimus Calcium: Opportunities Beyond MS and IBD
Vidofludimus Calcium: Opportunities Beyond MS and IBD Vidofludimus calcium showed a statistically significant reduction of serum ALP Pri WS . levels in PSC patients treated in a small, instigator-sponsored phase 2 trial which LALA STSISCE AALS was conducted at Mayo Clinic C ae C Cholangitis (PSC) =
Slide 36: Vidofludimus Calcium: IP Position
Vidofludimus Calcium: IP Position Vidofludimus Calcium is Protected by Several Layers of Patents: 36 | ©lmmunic, inc. | Jan/10/2022 Patent on the specific salt form and pharmaceutical composition of vidofludimus calcium, granted in the United States, Europe and other key markets — expires in 2031 Ne
Slide 37: IMU-935: Uniquely Acting and Highly Selective RORγt Inverse Agonist
Slide 38: IL-17 is Significant in Many Autoimmune Diseases
IL-17 is Significant in Many Autoimmune Diseases Clear Need for Potent and Specific Inhibition of IL-17 in Multiple Autoimmune Diseases Goal: Develop a Potent, Specific, and Orally Available IL-17 Inhibitor = Imbalance between regulatory T cells (Tyegs) and Th17 cells contributes to autoimmune disea
Slide 39: IMU-935 Inhibits Cytokines Associated With Autoimmune Diseases
IMU-935 Inhibits Cytokines Associated With Autoimmune Diseases With an IC., of 3-5 nM in Stimulated Human Lymphocytes IC59(UM) IL-7A 0.005 IL-7F 0.004 IFNy 0.003 IL-la and b no inhibition 1L-4,5,6,8 no inhibition RORy (MST) 0.024 RORY (cellular, reporter assay) 0.020 Th17 differentiation (murine)!*!
Slide 40: IMU-935 Selectively Inhibits Th17 Differentiation and IL-17 Secretion
IMU-935 Selectively Inhibits Th17 Differentiation and IL-17 Secretion sams, The differentiation towards Th17 cells is inhibited by IMU-935 A) Cytokine 9 IL-A7A The production of IL-17A and Production f in | IL-L7F is inhibited by IMU-935 t out ey Normal remarry Unchanged The physiological maturation
Slide 41: IMU-935 Does Not Induce Thymocyte Apoptosis
IMU-935 Does Not Induce Thymocyte Apoptosis iN In Contrast to IMU-935, Comparator Compounds Have a Negative Impact on Thymocyte Viability and Therefore Bear the Risk of Lymphoma. RORgt* © Ms 1 imtoso3s 0 MRLAT 1 Cintrorgon (agonist) © Cat wee... tL. ey Impact on Th17 differentiation at 500 nM ‘Sun,
Slide 42: IMU-935 Blocks Th17 Differentiation But Allows Normal Thymocyte Maturation: Gene Expression Profiles
IMU-935 Blocks Th17 Differentiation But Allows Normal Thymocyte Maturation: Gene Expression Profiles Thymocytes Th17 cell ROAR orye® Rony? ROREY ROR ‘Smad era acess Mapakte Beran p00 nore Ronyevs ROR 22 naa IMU-935 o Nye 3 conor cso A ao BY] cw g | wz. oe 6 Eno S| nn ‘Th17 cell differentiation Thymo
Slide 43: IMU-935 Allows Normal Thymocyte Maturation in vivo
IMU-935 Allows Normal Thymocyte Maturation in vivo Acute Model, 3 Days of Treatment = IMU-935 (100 mg/kg BID), MRL-871 (100 mg/kg BID) and Cintirorgon (30 mg/kg BID) were tested for 3 days in C57BL/6j mice S16 Vehicle IMU-935 MRL-871 Cintirorgon "o wee HS & Vehicle — 9: x -@ IMU-935 Y} oY S. 2 ibs ~
Slide 44: IMU-935 Allows Normal Thymocyte Maturation in vivo
IMU-935 Allows Normal Thymocyte Maturation in vivo Chronic Model, 28 Days of Treatment = C57BL/6j mice (male, 9wks, n=8-9 per group) were administrated with IMU-935 (100 mg/kg), Cpd1 (40 mg/kg), or Cintirorgon (30 mg/kg) for 4 weeks (BID) In contrast to Cpd1, IMU-935 Vehicle IMU-935 Cpd-1 Cintirorgo
Slide 45: Phase 1 Clinical Trial: Trial Design and Current Status
Phase 1 Clinical Trial: Trial Design and Current Status PART A Evaluation of single ascending doses (SAD) Healthy human subjects randomized to receive single dose of IMU-935 or placebo part B Evaluation of multiple ascending doses (MAD) Healthy human subjects randomized to receive 14-day treatment o
Slide 46: Phase 1 Clinical Trial: Pharmacokinetic Results
Phase 1 Clinical Trial: Pharmacokinetic Results Part B: Summary of QD and BID Dosing Regimen for IMU-935 IMU-935 concentration time profiles (log-linear scale) Favorable PK Properties for IMU-935 at Steady-State Observed Time [days] ie) ed 14 — - Pharmacokinetic parameters ENTLOR asMccm £ in steady-
Slide 47: Phase 1 Clinical Trial: Summary of Safety and Tolerability Findings
Phase 1 Clinical Trial: Summary of Safety and Tolerability Findings Part B 47 | ©immunic, inc. | Jan/10/2022 Daily Dosing of IMU-935 in Healthy Human Subjects Over 14 Days Was Found to Have a Favorable Safety and Tolerability Profile No serious adverse events No dose-dependency in adverse events No
Slide 48: IMU-935 As Treatment Option in Castration-Resistant Prostate Cancer Targeting Key Resistance Mechanism
IMU-935 As Treatment Option in Castration-Resistant Prostate Cancer Targeting Key Resistance Mechanism Inhibition of IL-17 by RORy in Myeloid-Derived RORyt Regulation Suppressor Cells Inhibition of RORy = The androgen-receptor mutant = |L-17 contributes to the formation, = Myeloid-specific expressio
Slide 49: Phase 1/2 Clinical Trial of IMU-935 in CRPC
Phase 1 Clinical Trial of IMU-935 in CRPC NCT05124795 Study Design = Open-label dose escalation trial to evaluate safety, tolerability, anti-tumor activity, and pharmacokinetics of IMU-935 in patients with progressive, metastatic castration-resistant prostate cancer = Main treatment will be single a
Slide 50: IMU-935: A Potentially Best-in-Class Oral IL-17 Inhibitor
IMU-935: A Potentially Best-in-Class Oral IL-17 Inhibitor = |MU-935 showed a very favorable safety, tolerability and PK profile in this phase 1 clinical trial with no serious adverse events seen in the SAD and MAD parts. = In particular, IMU-935 was safe and well-toleratedin 14-day repeated oral dos
Slide 51: IMU-856: Restoring Intestinal Barrier Function
Slide 52: IMU-856: Hypothesis of Therapeutic Approach
IMU-856: Hypothesis of Therapeutic Approach Strengthening the Bowel Barrier Function Leads to Compartmentalization of Microbiome and (2) Intestinal Immune System and Prevents Immune Stimulation That Drives Disease Processes Microbiota Immune System Or xX Focus on Immunosuppression Influencing the Mi
Slide 53: IMU-856: Phase 1 Study Performed in Australia
IMU-856: Phase 1 Study Performed in Australia Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Performed in Three Parts Exclusive global rights to commercialization of IMU-856 in all countries obtained through option and licensing agreement with Daiichi Sankyo Phase 1 study includes patien
Slide 54: Immunic Therapeutics: Summary
Slide 55: Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022
Multiple Clinical Data Readouts for All Three Development Programs Expected Throughout 2022 Advanced clinical pipeline: | Three differentiated products in various phases of clinical development ty @) RMS phase 3 program of vidofludimus as calcium ongoing, to be supported by neuroprotective data from
Slide 56: Thank You!
Thank You! Head of IR & Communications Phone: +49-89-2080477-09 Email: ir@imux.com w.imux.com 56 | ©lmmunic, inc. | Jan/10/2022 Immunic, Inc. 1200 Avenue of the Americas Immunic AG New York City, NY 10036 Gréfelfing (Munich) USA Germany Immunic Research GmbH Weinberg Campus Halle (Saale) Germany Imm