Immunic, Inc. · NASDAQ:IMUX
Immunic — Investor Presentation (January 2020)
51 slides from Immunic's investor presentation, Jan 8, 2020
Slide 1: Immunic Therapeutics: Developing Selective Oral Drugs in Immunology
Immunic THERAPEUTICS Immunic Therapeutics Developing Selective Oral Drugs in Immunology Soa NASDAQ: IMUX January 2020
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 Securitie
Slide 3: Company and Product Overview
Immunic THERAPEUTICS Company and Product Overview
Slide 4: Our Vision
@ Our Vision We are developing new therapies with best-in-class potential for the treatment of chronic inflammatory and autoimmune diseases. © Immunic ©immurie,ine 08.01.2020
Slide 5: 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 6: Immunic Leadership Team
Immunic Leadership Team Company is led by an experienced management team D © Daniel Vitt, PhD ‘Andreas Muebler, MD, MBA Hella Kohlhof, PhD ‘Manfred Groeppel, PhD Sanjay. Patel, CFA CEO & President co cso coo CFO Renowned international board of directors P Duane Nash, MD, JD, MBA Daniel itt, PhD Tama
Slide 7: 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 8: IMU-838 in Multiple Sclerosis
Immunic THERAPEUTICS IMU-838 in Multiple Sclerosis Mode of Action of IMU-838 Enables Broad Therapeutic Use
Slide 9: 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 10: Key Advantages of Targeting DHODH
Key Advantages of Targeting DHODH Aubagio® demonstrated IMU-838 has DHODH target Other DHODH allows selective shown anti- aun targeting of viral activity ee ib a good activity in metabolically which could ne. rash preventing a e due to anti-viral Solna highly activated prevent virus effects/2! disab
Slide 11: Aubagio, the only approved DHODH inhibitor for MS
ts substantial Os ts, Aubagio’ Aubagio” (teriflunomide) is currently the only approved DHODH inhibitor for MS ; 7 1 Korman ee ere @immunk;in. —o801.2020 tt
Slide 12: Challenges of Aubagio
Challenges of Aubagio® * Aubagio® hits off targets, e.g. protein kinases EGFR and Aurora A/2/, leading to off-target toxicities!) * Diarrhea (in 13-14 % of patients) * Hair loss (in 10-13 % of patients)! * Neutropenia (in 4-6 % of patients)! * Aubagio® has a half-life of about 18-19 days in humans!?
Slide 13: IMU-838: A New, Easy-to-Use Treatment Option for RRMS
IMU-838: A New, Easy-to-Use” Treatment Option for RRMS * IMU-838 does not inhibit kinases, such as EGFR and Aurora A, at relevant concentrations * No decrease of bone marrow cellularity observed in animal experiments at high doses!) * Noincreased rate of diarrhea, neutropenia or alopecia observed so
Slide 14: IMU-838: Compelling Safety and Efficacy Data
IMU-838: Compelling Safety and Efficacy Data + Safety + Animal and in-vitro data show selective effect on activated immune cells and no general detrimental effect on bone marrow * Already more than 400 individuals treated with active moiety of IMU-838 * Two phase 1 trials of IMU-838 formulation esta
Slide 15: 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 16: IMU-838: Phase 2 Trial Design in RRMS
IMU-838: Phase 2 Trial Design in RRMS Extended treatment period EoMT 30 mg IMU-838 H 30 or 45 mg IMU-838, 45 mg IMU-838 H 30 or 45 mg IMU-838, H 30 mg IMU-838 L | J | Ser. exam. BL MRI 30 or 45 mg IMU-838, 30 or 45 mg IMU-838 D-28 D-14 DO W24/EoMT At time of final analysis of main part WS516/EoT EoS
Slide 17: Potential Positioning of IMU-838 in RRMS
Potential Positioning of IMU-838 in RRMS Prevents virus reactivations, and potentially PML! Slows disability progression, due to unique properties of DHODH inhibitors!/ Sustained activity even after multiple prior DMTs!2 Superior safety profile! may enable (for the first time) ccombination/maintenan
Slide 18: IMU-838 in Inflammatory Bowel Disease (IBD)
Immunic THERAPEUTICS IMU-838 in Inflammatory Bowel Disease (IBD) New Oral Treatment with Promising Safety Profile
Slide 19: 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 20: 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 21: 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 22: 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 23: IMU-838: Phase 2 Trial Design in UC
IMU-838: Phase 2 Trial Design in UC Induction Phase Maintenance Phase Enrollment Period 1 Enrollment Period 2 -—> Placebo (N=15) Placebo (N=45)_ > ————> Placebo (N=~24) 10 mg IMU-838 qd 10 mg IMU-838 qd —> 2 & ze I= = z (N=15) (N=45) 2 = RS 10 mg IMU-838 qd ge — — (Ne~48) 30 mg IMU-838qd 30mg IMU-83
Slide 24: 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 ‘© Immunic, Inc. 08.01.2020 ey
Slide 25: IMU-838: Clinical Phase 2 Trial in Crohn's Disease
IMU-838: Clinical Phase 2 Trial in Crohn’s Disease ° Study in preparation * Considerable operational and financial synergies expected . Same systems and service providers used Investigators already familiar with study set-up High-enrolling sites of UC study expected to participate in CD trial Supple
Slide 26: 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 27: IP Position of IMU-838: Several Layers of IP
IP Position of IMU-838: Several Layers of IP * IMU-838 is protected by several layers of patents Patent on the specific salt form and pharmaceutical composition of IMU-838, granted in the US, EU and other key markets — expires in 2031 New patent filed in 2018 on the specific polymorph of IMU-838 use
Slide 28: IMU-935: Unique RORyt Inverse Agonist
Immunic THERAPEUTICS IMU-935 Unique RORyt Inverse Agonist
Slide 29: Autoimmune Diseases and IMU-935
Autoimmune Diseases and IMU-935 Challenge: Solution: * Autoimmune diseases * IMU-935 is a potent small are frequent diseases affecting molecule targeting RORyt millions of patients worldwide!) * Th17/IL-17/RORYt axis is important in auto immunity related diseases!#/ anti-inflammatory pro-inflammator
Slide 30: IMU-935: Main Functions of RORyt
IMU-935: Main Functions of RORyt ° The differentiation [ Satceaint tin Sinan: inl + IMU-935 ] towards Th17 cells is inhibited by 2 ae Oa = @ IMU-935. o= 6 . * The production of IL-17A ayo ara ® we tue el and IL-17F — @: a= @#1 is inhibited by IMU-935. ® Trymocye Normal meer Norsk * Result: IMU-935 a
Slide 31: 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 ICs of 3-5 nM in stimulated human lymphocytes Iso (HM) IL-17A 0.00
Slide 32: 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 33: IMU-856: Restoring Intestinal Barrier Function
Immunic THERAPEUTICS IMU-856 Restoring Intestinal Barrier Function
Slide 34: IMU-856: Targeting Gut Barrier Function With New Mode of Action
IMU-856: Targeting Gut Barrier Function With New Mode of Action Healthy i Gl Disorders Antigen/pathogen | ‘ fF i 7 - i S H <Lumen> H 7 H <IECS> } Immune cells i ee H Current SOCs immunosuppressive [iH ae concept ibhibit inflaramation i © Immunic Source: Adopted from Dah Sankyo Venture Science Labs,
Slide 35: IMU-856: Development Plan
IMU-856: Development Plan * Option and licensing agreement with Daiichi Sankyo * Immunic obtained exclusive rights to commercialization of IMU-856 in all countries, including the United States, Europe and Japan * Option exercised in January 2020 Possible Gl indications * IBD, IBS-D, ICI induced coli
Slide 36: Summary
Immunic THERAPEUTICS Summary
Slide 37: Financial Summary
Financial Summary * Nasdaq: IMUX * Headquarters in New York * Shares outstanding: 10.1 million (as of November 1, 2019) * Cash position of around USD 27 million (as of December 2019) * USD 40 million ATM in place * Cash runway expected to be sufficient beyond important value inflection points into Q
Slide 38: 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 Promising data from interim dosing analysis of UC phase 2 Three oral programs in active development — each with unique positioning * Phase 1 o
Slide 39: Back-up IMU-838
Immunic THERAPEUTICS Back-up IMU-838
Slide 40: IMU-838: Development History
IMU-838: Development History Initial clinical trials were done by 4SC with a fr formulation of the active moiety vidofludimus as an ‘amorphous material. In total, 4SC’s clinical tral data ‘encompasses more than 250 individuals treated with the active moiety, thus ‘creating a safety database for furt
Slide 41: IBD: Large Market Opportunity
IBD: Large Market Opportunity * Global market for IBD in 2023 estimated to be approximately USD 7.6 billion! * 11.2 million patients affected by UC or CD worldwide in 2015) * Patient numbers continue to grow ime Europe!) usa“) Canadall IBD Total 2,600,000 1,300,000 233,000 uc 1,500,000 700,000 104,0
Slide 42: ENTRANCE: Steroid Tapering Scheme
ENTRANCE: Steroid Tapering Scheme Tapering down 20 rig steroid Bingsteroid of prednisolone dose 3 Out of 26 patients evaluable for efficacy analysis the steroid dose entering the study was * 6patients on 40 mg/day (23%) Ee] * 6 patients on 30 mg/day (23%) * 14 patients on 20 mg/day (54%) weeks 9-12
Slide 43: ENTRANCE: Steroid-Sparing
ENTRANCE: Steroid-Sparing Development of prednisolone intake over 12 weeks (mITT): 50 3 0 4 é on ety ase tay a 3 ; 20 265° a |e a 5 Geo eon ean) 2s | ws «= fj g 5 x = 3 fem neat Wat g _— = = 3 0 = a we TORE : mLriit 6-1 25 ings #5 0-15) @-10) (o-10) a-10) =a Nem 3 TR GR Te Ke a | 2 ad ce | ky 4a 10
Slide 44: IMU-838: Safety & Tolerability Data
IMU-838: Safety & Tolerability Data Summary of COMPONENT trial of vidofludimus in RA population * Vidofludimus was safe and well tolerated * No relevant differences in the adverse event profile between the vidofludimus and placebo group * No relevant increases of infections, diarrhea, neutropenia, a
Slide 45: IMU-838 Reduces IL-17F/IFNy High-Producers
IMU-838 Reduces IL-17F/IFNy High-Producers * Inhibition of cytokines by IMU-838 (vidofludimus) in PBMCs after 20 hours * The effect is uncoupled from T-cell proliferation and targets the fraction of more pathogenic T-cells . PHA, 0h =__vidofludimus 30uM, 20h = Tose eT 0Be MFI: Mean flourescent MEL 1
Slide 46: Back-up IMU-935
Immunic THERAPEUTICS Back-up IMU-935
Slide 47: IMU-935 Retains Basal Activity of RORyt and Allows Normal Thymocyte Maturation
IMU-935 Retains Basal Activity of RORyt and Allows Normal Thymocyte Maturation * Method: Sorted murine DN thymocytes were cultured on OP9-DL4 fibroblasts with mouse IL-7 for 72 hours and treated in i 1 tomo parallel with oS 40 a aorm IMU-935 £30 * Result: IMU-935 allows normal 8 20 thymocyte maturat
Slide 48: Inhibition of Human RORyt by IMU-935 and Reference Compound
Inhibition of Human RORyt by IMU-935 and Reference Compound * Method: Cellular reporter assay for RORyt activity with LBD of RORy fused to GAL4 reporter from Indigo was used * Result: Approximately 20% remaining basal activity of RORyt by IMU-935 at highest dose, whereas comparator molecule showed f
Slide 49: IMU-935 Potently Inhibited Cytokine Release in Ex-Vivo Stimulated Human Skin Punches
IMU-935 Potently Inhibited Cytokine Release in Ex-Vivo Stimulated Human Skin Punches Cytokine Inhibition in Inflamed Skin Model q B80 S60 Zz i i 20 : i Bo a a 2 322232223 2223 2 FE g 88 8358 8 ee 8 8 egg BG rf ee ae ee: & eg 8 2 8 8 ee 8 28 8 3 a3 2 223 go 8 B28 ae a 2 a 2 a 2 a 2 omese Lara war [es
Slide 50: sina OS Ti O\D2
y sina OS Ti O\D2 RORyts 2S NASDAQS65 = German( 4-8 ie Halle/Saale MayoClinic SIMU mma t opment diseases agonist im IMUX devel £O geo-healthc nology é=__sclerosi DHODHIMU-9355 = pies intestinal] | U-838 barrier functionspecialist ndidate iolm| insrie re U' rt va h 1U = 3 e clinical Nf J < oO gs no o
Slide 51: 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