Immunic, Inc. · NASDAQ:IMUX
Immunic — Stifel 2019 Healthcare Conference
32 slides from Immunic's conference presentation, Nov 19, 2019
Slide 1: Immunic Therapeutics: Developing Selective Oral Drugs in Immunology
s Immunic THERAPEUTICS Immunic Therapeutics Developing Selective Oral Drugs in Immunology - 7 . hd NASDAQ: IMUX Stifel 2019 Healthcare Conference, November 19* 2019
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements ‘+ Certain statements contained in this presentation regarding matters that are not historical facts are forward-looking statements within the ‘meaning of Section 21£ of the Securities and Exchange Act of 1934, as amended, and the Private Securiti
Slide 3: Our Vision
@ Our Vision We are developing new therapies with best-in-class potential for the treatment of chronic inflammatory and autoimmune diseases. © Immunic Simmurie ne t8.1449
Slide 4: Key Investment Highlights
Key Investment Highlights IMU-838: Potent DHODH inhibitor currently tested in three phase 2 studies IMU-935: Oral IL-17 inhibitor with substantial potential IMU-856: Novel target — potentially disease modifying for Gl disorders Three potential best-in- class oral therapies + Autoimmune & immunology
Slide 5: Development Pipeline
Development Pipeline Preclinical Phase 1 Phase 2 Phase 3 IMU-838 = Multiple Sclerosis DHODH Crohn’s Disease DHODH as | Ulcerative Colitis. DHODH ee Es Investigator Sponsored Trial performed at Mayo Clinic / Ni PSC DHODH Orphan Al Diseases RORY _——————————————— IMU-935 Psoriasis RORyt Le ren ,.] —==l
Slide 6: IMU-838 in Multiple Sclerosis
Immunic THERAPEUTICS IMU-838 in Multiple Sclerosis Mode of Action of IMU-838 Enables Broad Therapeutic Use
Slide 7: Mode of Action: DHODH Targeting Leads to Metabolic Stress in Metabolically Activated Cells
Mode of Action: DHODH Targeting Leads to Metabolic Stress in Metabolically Activated Cells Resting Lymphocyte Activated Lymphocyte Stressed Lymphocyte Pharmacological Effects ) -Metabolically silent + DHODH is functionally not important Disease related activation 4 Insufficient pyrimidine recycling
Slide 8: Aubagio is currently the only approved DHODH inhibitor for MS
Despite its A substantial side Aubagio” (teriflunomide) is currently the only approved DHODH inhibitor for MS © Immunic sthepnon if 51 822289 0753 OF Aecsed Ae, 2019 @immunie inc. 18.41.19 8
Slide 9: IMU-838: Potential Advantages in MS
IMU-838: Potential Advantages in MS * Potential advantages of IMU-838 therapy compared with Aubagio® (teriflunomide): * Selectivity and sensitivity (2/2) 4) * Pharmacokinetic parameters!! [6 * Safety profile!7 4/9) 201 * Drug-drug interaction potential! [1] FO CDER Pharmacological Review Tenfunomide
Slide 10: IMU-838: Phase 2 Clinical Trial in RRMS
IMU-838: Phase 2 Clinical Trial in RRMS * Phase 2 trial in patients with relapsing-remitting multiple sclerosis (RRMS)* * Study Design * Primary endpoint: cumulative number of combined unique active (CUA) MRI lesions, up to week 24 * Central reading of MRI * Study enrolled 210 patients in 36 centers
Slide 11: Potential Positioning of IMU-838 in RRMS
Potential Positioning of IMU-838 in RRMS Protection against virus reactivations and potentially PML Unique property of DHODH inhibitors on slowing disability progression Suggestion of sustained activity even after multiple prior DMT Unique safety profile may allow (for the first time) combination/ma
Slide 12: IMU-838 in Inflammatory Bowel Disease (IBD)
Immunic THERAPEUTICS IMU-838 in Inflammatory Bowel Disease (IBD) New Oral Treatment with Promising Safety Profile
Slide 13: IBD: Therapeutic Pyramid Current solutions have limitations
IBD: Therapeutic Pyramid Current solutions have limitations * Substantial side effects due to long-term use includes increased rate of cancer risk and virus reactivation of currently used E Surgery immunosuppressants! 2/13) Severe * Antibodi ivi imel4l TNFo.-mABs Antibodies lose activity over time!
Slide 14: IMU-838: Key Strengths That Address Limitation of Existing Therapies in IBD
IMU-838: Key Strengths That Address Limitation of Existing Therapies in IBD No clinical evidence of increased rate of viral re-activations — in-vitro data of direct Small molecule with anti-viral effect low production costs Mode of action provides a new treatment option for patients failing other th
Slide 15: IBD Phase 2a ENTRANCE: Primary Efficacy Results
IBD Phase 2a ENTRANCE: Primary Efficacy Results ENTRANCE study:/) * Study performed with active moiety vidofludimus. ° All patients failed two attempts to taper down steroids Number of Patients * Open-label * Primary efficacy endpoint: steroid- free/steroid- reduced remission (week 12) 30 25 20 1s 1
Slide 16: IMU-838: Clinical Phase 2 in UC Ongoing
IMU-838: Clinical Phase 2 in UC Ongoing * Active IND in the US; study started in April 2018 * Study design* * Central endoscopy assessment for active disease for study eligibility in order to reduce placebo rate * Endpoint measuring proportion of patients with symptomatic remission and endoscopic he
Slide 17: IBD: Overall Study Program
IBD: Overall Study Program Final 1° Two phase 1 Ulcerative colitis (UC) trial UC efficacy analysis Preparation of phase 2 trial in CD based on interim dosing analysis in UC trials Final 1° CD efficacy analysis Crohn’s disease (CD) trial Immunic ©immuni inc. 18.11.19 Wy
Slide 18: IMU-838: Phase 2 Proof-of-Concept Study in PSC
IMU-838: Phase 2 Proof-of-Concept Study in PSC * Ongoing investigator-sponsored trial (IST): Single-arm, open-label, exploratory study planning to enroll 30 patients, aged 18 to 75 years* * Conducted at two Mayo Clinic sites in Arizona and Minnesota by Prof. Keith Lindor, MD, and Elisabeth Carey, MD
Slide 19: IMU-935: Unique RORyt Inverse Agonist
Immunic THERAPEUTICS IMU-935 Unique RORyt Inverse Agonist
Slide 20: Autoimmune Diseases and IMU-935
Autoimmune Diseases and IMU-935 Challenge: ¢ Autoimmune diseases are frequent diseases affecting millions of patients worldwide!) * Th17/IL-17/RORYt axis is important in auto immunity related diseases!#/ ¢ Antibodies targeting this axis successfully demonstrated this concept but bear the disadvantag
Slide 21: IMU-935: Main Functions of RORyt
IMU-935: Main Functions of RORyt * The differentiation [ E vuimalalder stroll ll + IMU-935 ] towards Th17 cells is inhibi fo) Ditereiaion Becket. panies by (ae st @ Oe ‘Sorerianor @! * The production of IL-17A ® = 0 ive eal and IL-17F — @: pa eo= Saomaat 6. Er | is inhibited by IMU-935. ® Trymoote C
Slide 22: IMU-935: Cytokine Inhibition in Low Nanomolar Range
IMU-935: Cytokine Inhibition in Low Nanomolar Range * Effect of the development compound IM105935 (IMU-935) in stimulated human PBMCs * Inhibition of RORy (20 nM) and DHODH (240 nM) leads to synergistical inhibition of cytokines with ICso of 3-5 nM in stimulated human lymphocytes Iso (HM) IL-17A 0.0
Slide 23: IMU-935: Project Status
IMU-935: Project Status * Clinical phase 1 program started in September 2019 * Ongoing double-blind, placebo-controlled, single and multiple ascending dose trials of IMU-935 in healthy volunteers * Extension of these studies to assess safety and mechanism-related biomarkers in patients with mild to
Slide 24: IMU-856: Restoring Intestinal Barrier Function
Immunic THERAPEUTICS IMU-856 Restoring Intestinal Barrier Function
Slide 25: IMU-856: Targeting Gut Barrier Function With New Mode of Action
IMU-856: Targeting Gut Barrier Function With New Mode of Action Healthy GI Disorders Antigen/pathogen fF 7 — = <Lumen> o <IECs> Immune cells immunosuppressive concept ioe 2 ‘Source: Adopeedrom Dali Sankyo Venture SeenceLabs November 2018 & Immunic Current SOGs Inhibitinflammation IMU-856 is a potent
Slide 26: IMU-856: Development Plan
IMU-856: Development Plan * Possible GI indications * IBD, IBS-D, ICI * Clinical development plan * Phase 1 single and multiple ascending dose studies are expected to start in H1 2020 ¢ IMU-856 has substantial potential for the treatment of further diseases outside GI * Product is covered by a globa
Slide 27: Summary
Immunic THERAPEUTICS Summary
Slide 28: Financial Summary
Financial Summary * Nasdaq: IMUX ¢ Headquarters in New York * Shares outstanding: 10.1 million (as of November 1, 2019) * Cash position of USD 30.5 million (as of September 30, 2019) * Cash runway expected to be sufficient beyond important value inflection points into Q4 2020 * Immunic’s reverse tak
Slide 29: Key Investment Highlights — Three Oral Drugs in Development
Key Investment Highlights — Three Oral Drugs in Development IMU-838 currently tested in three phase 2 trials RRMS phase 2 data of IMU-838 expected in Q3 2020 Very promising data from interim dosing analysis of UC phase 2 Three oral programs in active development — each with unique positioning * Phas
Slide 30: Significant News Flow Potential From Three Development Programs
Significant News Flow Potential From Three Development Programs 12019 #22019 12020 +H2.2020 12021 22021 IMU-838 MS IMU-838 UC IMU-838 IMU-838 IMU-935 IMU-935, IMU-856 ©immunic, Inc 18.11.19 30
Slide 31: sina OS Ti O\D2
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Slide 32: Thank You!
Immunic THERAPEUTICS Thank You! Immunic, Inc. Jessica, Breu 1200 Ave of the Americas, Suite 21 Manager IR & Communications New York, NY 10036 Phone: +49 89 250 0794 69 USA ir@immunic.de