Immunic, Inc. · NASDAQ:IMUX
Immunic — Needham Healthcare Conference 2019
29 slides from Immunic's conference presentation, Apr 10, 2019
Slide 1: Immunic Therapeutics: Developing Selective Oral Drugs in Immunology
Immunic Therapeutics Developing Selective Oral Drugs in Immunology Company Overview Needham Healthcare Conference, April 10th, 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 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securitie
Slide 3: Additional Information and Where You Can Find It
Additional Information and Where You Can Find It Additional Information About the Proposed Transaction between Vital Therapies, Inc. and Immunic AG and Where to Find it • This communication is being made in respect of a proposed transaction involving Immunic AG and Vital Therapies, Inc. Vital Therap
Slide 4: Vital Therapies – Immunic Combination
Vital Therapies – Immunic Combination • Follows Vital Therapies’ extensive review of strategic alternatives • All-stock transaction: Vital Therapies to acquire all outstanding shares of Immunic in exchange for newly issued shares of Vital Therapies common stock; Immunic AG will become a wholly-owned
Slide 5: Vital Therapies – Immunic Leadership
Vital Therapies – Immunic Leadership • Company will be led by an experienced management team Daniel Vitt, PhD Andreas Muehler, MD, MBA Hella Kohlhof, PhD Manfred Groeppel, PhD CEO CMO CSO COO • Board to be comprised of 5 directors, 4 from Immunic and 1 from Vital Therapies Daniel Vitt, PhD Joerg Nee
Slide 6: Immunic Company and Product Overview
Immunic Company and Product Overview
Slide 7: Our Vision
Our Vision We are developing new therapies with best-in-class potential for the treatment of chronic inflammatory and autoimmune diseases. © Immunic AG 10.04.19 7
Slide 8: Key Investment Highlights
Key Investment Highlights • Deep and diversified product pipeline, orally available and potent drugs Three potential best-in- • IMU-838: Potent DHODH inhibitor well-tolerated in prior clinical studies class therapies • IMU-935: High demand target with substantial deal potential • IMU-856: Novel targ
Slide 9: Development Pipeline
Development Pipeline Preclinical Phase 1 Phase 2 Phase 3 IMU-838 Ulcerative Colitis DHODH Crohn’s Disease DHODH Multiple Sclerosis DHODH IST study will be performed PSC DHODH by Mayo Clinic / NIH * IMU-935 Psoriasis ROR!t Orphan AI ROR!t Diseases Intestinal IMU-856 IBD Barrier Function Completed In
Slide 10: IBD: Therapeutic Pyramid
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 Surgery immunosuppressants[1] [2] [3] Severe • Antibodies lose activity over time[4] TNFa-mABs Vedolizumab Selec
Slide 11: IMU-838: Key Strengths That Address Limitation of Existing Therapies
IMU-838: Key Strengths That Address Limitation of Existing Therapies No clinical evidence of increased rate of viral re-activations – in-vitro data of direct anti-viral effect Mode of action provides a new Small molecule with treatment option for low production costs patients failing other therapies
Slide 12: IBD Phase 2a ENTRANCE: Primary Efficacy Results
IBD Phase 2a ENTRANCE: Primary Efficacy Results 30 ENTRANCE study:[1] Non-Responders (11.5%) • Study performed 25 26 3 Number of Patients with active moiety 9 20 Partial of vidofludimus Responders (34.6%) • Patients with 15 88.5% 14 steroid-dependent Total Response 10 IBD disease mITT[2] Complete •
Slide 13: IMU-838: Clinical Phase 2 in UC Ongoing
IMU-838: Clinical Phase 2 in UC Ongoing • Active IND in the US • Currently more than 60 active sites in 8 countries • USA, Western, Central and Eastern Europe • Study design* • Central endoscopy assessment for active disease for study eligibility in order to reduce placebo rate • Composite endpoint:
Slide 14: IBD: Overall Study Program
IBD: Overall Study Program Final 1° Two phase 1 Ulcerative colitis (UC) trial UC efficacy trials analysis Definition of dose strengths for CD trial based on UC dosing analysis* Final 1° Crohn’s disease (CD) trial CD efficacy analysis * An interim dosing analysis is expected to be performed mid-2019
Slide 15: IMU-838: Clinical Phase 2 Trial in Crohn's Disease Expected to Start in mid-2019
IMU-838: Clinical Phase 2 Trial in Crohn’s Disease Expected to Start in mid-2019 • Considerable opera;onal and financial synergies expected • Same systems and service providers used • Inves;gators already familiar with study set-up • High-enrolling sites of UC study expected to par;cipate in CD trial
Slide 16: IMU-838: Phase 2 Proof-of-Concept Study in PSC
IMU-838: Phase 2 Proof-of-Concept Study in PSC • Immunic is collaborating with a prominent hepatologist in the US and two Mayo Clinic locations • PI received a grant approval letter from the NIH for performance of an investigator sponsored trial with IMU-838 in patients with primary sclerosing chola
Slide 17: MS Opportunity
MS Opportunity IMU-838 has the potential to be a best-in-class DHODH Despite it‘s inhibitor and MS drug due substanHal side to improved safety and effects, Aubagio® pharmacokinetics profile Aubagio® reached sales of (teriflunomide) is around 1.8 billion currently the only USD in 2018[1] approved DHOD
Slide 18: IMU-838: Potential Advantages in MS
IMU-838: Poten.al Advantages in MS • Potential advantages of IMU-838 therapy compared with Aubagio® (teriflunomide): • Selectivity and sensitivity[1] [2] [3] [4] • Pharmacokinetic parameters[5] [6] • Safety profile[7] [8] [9] [10] • Drug-drug interaction potential[6] • Phase 2 trial in patients with
Slide 19: IMU-935: Unique RORgt-Inverse Agonist
IMU-935 Unique RORgt-Inverse Agonist
Slide 20: 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 targePng RORgt millions of patients worldwide[1] • Th17/IL-17/RORgt axis is important in auto immunity related diseases[2] • Antibodies targeting this axis
Slide 21: IMU-935: Cytokine Inhibition in Low Nanomolar Range
IMU-935: Cytokine Inhibition in Low Nanomolar Range Report June 6, 2014 • Effect of the development compound IM105935 (IMU-935) in stimulated human PBMCs Structure Determination of • Read-out: effect on cytokine production after 48 Human h RORgamma in Complex with SC98724 at 2.6 Å Resolution IC50 [µ
Slide 22: IMU-856: Restoring Intestinal Barrier Function
IMU-856 Restoring Intestinal Barrier Function
Slide 23: Hypothesis: Bacterial Penetration Through Weakened Cellular Adhesion Causes Immune Overstimulation
Hypothesis: Bacterial Penetration Through Weakened Cellular Adhesion Causes Immune Overstimulation Healthy IBD Antigen/pathogen <Lumen> Mucus layer <Lumen> IMU-856 modulator concept: Ameliorates barrier function ü Accelerates mucosal healing with standard of care due to its new mode of action <IECs>
Slide 24: IMU-856: Development Concept
IMU-856: Development Concept • Main indication: Crohn’s disease (CD) • Clinical development concept • Phase 1 single and multiple ascending dose studies are expected to start in H1 2020 • IMU-856 has substantial further potential for orphan diseases outside IBD • Product is covered by a global PCT p
Slide 25: Summary
Immunic THERAPEUTICS Summary
Slide 26: Financial Status and Cash Runway
Financial Status and Cash Runway • Immunic Series A financing round of 37.5 million USD completed in 2016 and 2017 • Supported by renowned life science investors • Current Immunic investors to invest 26 million EUR additional equity at closing of the transaction with Vital Therapies • Cash runway ex
Slide 27: Key Investment Highlights
Key Investment Highlights • Deep and diversified product pipeline, orally available and potent drugs Three potential best-in- • IMU-838: Potent DHODH inhibitor well-tolerated in prior clinical studies class therapies • IMU-935: High demand target with substantial deal potential • IMU-856: Novel targ
Slide 28: © Immunic AG
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Slide 29: Thank You!
Thank You! Immunic AG Jessica Breu Am Klopfersitz 19 Manager IR & Communications 82125 Planegg-Martinsried Phone: +49 89 250 0794 69 Germany Email: [email protected]