Immunic, Inc. · NASDAQ:IMUX

Immunic — Vital Therapies — Merger or Acquisition (January 2019)

49 slides from Immunic's merger presentation, Jan 7, 2019

  1. Slide 1: Filed by Vital Therapies, Inc. Pursuant to Rule 425

    © Immunic AG 07.01.2019 1 Filed by Vital Therapies, Inc. Pursuant to Rule 425 under the Securities Act of 1933, as amended, and deemed filed pursuant to Rule 14a - 12 under the Securities Exchange Act of 1934, as amended Subject Company: Vital Therapies, Inc. Commission File No.: 001 - 36201 January

  2. Slide 2: Vital Therapies and Immunic Therapeutics Stock-for-Stock Combination

    Vital Therapies and Immunic Therapeutics Stock - for - Stock Combination NASDAQ: VTL ǀ January 2019

  3. Slide 3: Cautionary Note Regarding Forward-Looking Statements

    © Immunic AG 07.01.2019 3 Cautionary Note Regarding Forward - Looking Statements • Certain statements contained in this presentation regarding matters that are not historical facts, are forward - looking statement s within the meaning of Section 21E of the Securities and Exchange Act of 1934, as ame

  4. Slide 4: Additional Information and Where You Can Find It

    © Immunic AG 07.01.2019 4 Additional Information and Where You Can Find It Additional Information About the Proposed Transaction and Where to Find it • This communication is being made in respect of a proposed transaction involving Immunic AG and Vital Therapies, Inc. Vital Th era pies intends to fi

  5. Slide 5: Vital Therapies – Immunic Combination

    © Immunic AG 07.01.2019 5 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

  6. Slide 6: Vital Therapies – Immunic Combination (Cont'd)

    © Immunic AG 07.01.2019 6 Vital Therapies – Immunic Combination ( Cont‘d ) • NASDAQ - listed company focused on the development of oral therapies for chronic inflammatory and autoimmune diseases • Three drug development programs (IMU - 838, IMU - 935, IMU - 856), with IMU - 838, a potentially best -

  7. Slide 7: Vital Therapies – Immunic Leadership

    © Immunic AG 07.01.2019 7 • Company will be led by an experienced management team • Board to be comprised of 5 directors, 4 from Immunic and 1 from Vital Therapies • Corporate HQ will be located in Boston, MA with R&D site based in Munich, Germany Vital Therapies – Immunic Leadership Daniel Vitt, Ph

  8. Slide 8: Immunic Company and Product Overview

    Immunic Company and Product Overview

  9. Slide 9: Our Vision

    © Immunic AG 07.01.2019 9 Our Vision We are developing new therapies with best - in - class potential for the treatment of chronic inflammatory and autoimmune diseases.

  10. Slide 10: Key Investment Highlights

    © Immunic AG 07.01.2019 10 Three potential best - in - class therapies • Deep and diversified product pipeline, orally available and potent drugs • IMU - 838: Potent DHODH inhibitor well - tolerated in prior clinical studies • IMU - 935: High demand target with substantial deal potential • IMU - 856

  11. Slide 11: Development Pipeline

    © Immunic AG 07.01.2019 11 Completed or ongoing In preparation or planned Preclinical Phase 1 Phase 2 Phase 3 IMU - 838 Ulcerative Colitis DHODH Crohn’s Disease DHODH Multiple Sclerosis DHODH PSC DHODH IMU - 935 Psoriasis ROR ઻ t Orphan AI Diseases ROR ઻ t IMU - 856 IBD Intestinal Barrier Function I

  12. Slide 12: Proven Leadership in Drug Development & Licensing

    © Immunic AG 07.01.2019 12 Proven Leadership in Drug Development & Licensing Dr. Daniel Vitt, CEO • PhD in Chemistry from University of Würzburg • 19 years track record as biotech entrepreneur • Developed start - up into successful IPO Dr. Andreas Muehler, CMO • MD degree (Charité Berlin) + MBA Duke

  13. Slide 13: IMU-838 in Inflammatory Bowel Disease (IBD)

    IMU - 838 in Inflammatory Bowel Disease (IBD) New Oral Treatment with Promising Safety Profile

  14. Slide 14: IBD: Two Indications with High Unmet Medical Need

    © Immunic AG 07.01.2019 14 Crohn’s Disease (CD) • A patchy, transmural inflammation involving the entire bowel wall • May affect any part of the g astro intestinal tract from the mouth to the anus • Most commonly, CD affects the lower part of the small intestine and colon • Symptoms include: abdomin

  15. Slide 15: Large Market Opportunity

    © Immunic AG 07.01.2019 15 Large Market Opportunity • Global market for IBD in 2023 estimated to be approximately 7.6 billion USD [1] • 11.2 million patients affected by UC or CD worldwide in 2015 [2] • Patient numbers continue to grow Europe [3] USA [4] Canada [5] IBD Total 2,6 00,000 1,300,000 233

  16. Slide 16: IBD: Therapeutic Pyramid

    © Immunic AG 07.01.2019 16 Traditional Immunomodulators Corticosteroids Budesonide Aminosalicylates, Antibiotics Surgery TNF a - mABs Vedolizumab M ild M oderate S evere IMU - 838 Selective Immunomodulators IBD: Therapeutic Pyramid Current solutions have limitations • Substantial side effects due to

  17. Slide 17: IMU-838: Key Strengths That Address Limitations of Existing Therapies

    © Immunic AG 07.01.2019 17 Oral effective treatment option that can be prescribed for a large number of IBD patients Once daily oral drug intake – beneficial for patients Small molecule with low production costs No clinical evidence of increased rate of viral re - activations – in - vitro data of di

  18. Slide 18: Mode of Action: DHODH Targeting Leads to Metabolic Stress

    © Immunic AG 07.01.2019 18 Mode of Action: DHODH Targeting Leads to Metabolic Stress in Metabolically Activated Cells Resting Lymphocyte Activated Lymphocyte Stressed Lymphocyte Pharmacological Effects

  19. Slide 19: IMU-838: Compelling Safety and Efficacy Data

    © Immunic AG 07.01.2019 19 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 350 individuals treated with active moiety of IMU - 838 • Two phase 1 t

  20. Slide 20: Phase 2a ENTRANCE: Primary Efficacy Results

    © Immunic AG 07.01.2019 20 ENTRANCE study: [1] • Study performed with active moiety of vidofludimus • Patients with steroid - dependent IBD disease • Open - label • Primary efficacy endpoint: steroid - free/steroid - reduced remission (Week 12) IMU - 838 had response rates of: 85.7% in Crohn’s disea

  21. Slide 21: IMU-838: Clinical Phase 2 in UC Ongoing

    © Immunic AG 07.01.2019 21 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 placeb

  22. Slide 22: IBD: Overall Study Program

    © Immunic AG 07.01.2019 22 Ulcerative colitis (UC) trial Crohn’s disease (CD) trial Final 1 ° UC efficacy analysis Final 1 ° CD efficacy analysis Two phase 1 trials 䘠 IBD: Overall Study Program Definition of dose strengths for CD trial based on UC dosing analysis* * An interim dosing analysis is exp

  23. Slide 23: IMU-838: Phase 2 Trial in Crohn's Disease Expected to Start in mid-2019

    © Immunic AG 07.01.2019 23 IMU - 838: Clinical Phase 2 Trial in Crohn‘s Disease Expected to Start in mid - 2019 ‡ ŽŶƐŝĚĞƌĂďůĞŽƉĞƌĂƚŝŽŶĂůĂŶĚĨŝŶĂŶĐŝĂůƐLJŶĞƌŐŝĞƐĞdžƉĞĐƚĞĚ ‡ ^ĂŵĞƐLJƐƚĞŵƐĂŶĚƐĞƌǀŝĐĞƉƌŽǀŝĚĞƌƐƵƐĞĚ ‡ /ŶǀĞƐƚŝŐĂƚŽƌƐĂůƌĞĂĚLJĨĂŵŝůŝĂƌǁŝƚŚƐƚƵĚLJƐĞƚ Ͳ ƵƉ ‡ ,ŝŐŚ Ͳ ĞŶƌŽůůŝŶŐƐŝƚĞƐŽĨhƐƚ

  24. Slide 24: IMU-838: Phase 2 Study in PSC

    © Immunic AG 07.01.2019 24 IMU - 838: Phase 2 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 sc

  25. Slide 25: IMU-838: Clinical Development Plan in IBD and PSC

    © Immunic AG 07.01.2019 25 IMU - 838: Clinical Development Plan in IBD and PSC 2016 ϮϬϭϳ 2018 2019 2020 2021 Interim Analysis m id - 19 Results UC Induction of Remission Expected Y Ϯ ͬ ϮϬ 02/17 - 11 /17 Phase 1 (SAD * and MAD * ) Q1/18 - Q2/20 Phase 2 Ulcerative Colitis Phase 2 Primary Sclerosing Ch

  26. Slide 26: Mode of Action of IMU-838 Enables Broad Therapeutic Use

    Mode of Action of IMU - 838 Enables Broad Therapeutic Use

  27. Slide 27: MS Opportunity

     Ξ/ŵŵƵŶŝĐ' 07.01.2019 27 Aubagio ® (teriflunomide) is currently the only approved DHODH inhibitor for MS Despite it‘s substantial side effects, Aubagio ® reached sales of around 1.8 billion USD in 2017 [1] IMU - 838 has the potential to be a best - in - class DHODH inhibitor and MS drug due to i

  28. Slide 28: IMU-838: Potential Advantages in MS

    © Immunic AG 07.01.2019 Ϯϴ • 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] IMU - 838: Potential Advantages

  29. Slide 29: IP Position of IMU-838: Several Layers of IP

     Ξ/ŵŵƵŶŝĐ' 07.01.2019 29 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 t

  30. Slide 30: IMU-935: Unique RORγt Inverse Agonist

    IMU - 935 Unique ROR g t - Inverse Agonist

  31. Slide 31: Autoimmune Diseases: Broad Disease Spectrum

     Ξ/ŵŵƵŶŝĐ' 07.01.2019 31 Autoimmune Diseases: Broad Disease Spectrum • Autoimmune diseases are frequent diseases affecting millions of patients worldwide [1] • Disruption of the human immune system is a root cause of autoimmune diseases [2] • ROR g t is an important regulator of auto immunity re

  32. Slide 32: IMU-935: Project Status

    © Immunic AG Ϭϳ͘Ϭϭ͘ϮϬϭϵ 32 IMU - 935: Project Status • Preclinical IND enabling studies currently ongoing • Start of clinical phase 1 test of IMU - 935 in healthy volunteers planned for mid - 2019 • Further options for clinical development • Test of IMU - 935 in phase 1b/2a trial in patients with mi

  33. Slide 33: IMU-856: Restoring Intestinal Barrier Function

    IMU - 856 5HVWRULQJ,QWHVWLQDO%DUULHU)XQFWLRQ

  34. Slide 34: IMU-856 inhibitor concept: Ameliorates barrier function

    © Immunic AG 07.01.2019 34 x Accelerates mucosal healing with standard of care due to its new m ode of action x Enhances maintenance of remission , that is the highest unmet medical need in IBD IMU - 856 inhibitor concept : Ameliorates barrier function Mucus layer Antigen/pathogen ф>ƵŵĞŶх <IECs> Imm

  35. Slide 35: IMU-856: Targeting Gut Barrier Function

    © Immunic AG 07.01.2019 35 IMU - 856: Targeting Gut Barrier Function ‡ /Dh Ͳ ϴϱϲ ŝƐĂƉŽƚĞŶƚŝŶŚŝďŝƚŽƌŽĨĂ ŶŽǀĞůƚĂƌŐĞƚ ǁŚŝĐŚǁĂƐ ǀĂůŝĚĂƚĞĚŝŶĂŬŶŽĐŬ Ͳ ŽƵƚĂŶŝŵĂůŵŽĚĞů ‡ ^ŵĂůů ŽƌĂůůLJĂǀĂŝůĂďůĞ ŵŽůĞĐƵůĞƐƵŝƚĂďůĞĨŽƌŽŶĐĞĚĂŝůLJĚŽƐŝŶŐ ‡ ĂƌĞĨƵůůLJƉĞƌĨŽƌŵĞĚůĞĂĚĐŽŵƉŽƵŶĚƐĞůĞĐƚŝŽŶďĂƐĞĚŽŶ Ğ

  36. Slide 36: IMU-856: Development Concept

    © Immunic AG 07.01.2019 36 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 • Produ

  37. Slide 37: Immunic Therapeutics

    Immunic THERAPEUTICS

  38. Slide 38: Financial Status and Cash Runway

    © Immunic AG 07.01.2019 38 Financial Status and Cash Runway ‡ /ŵŵƵŶŝĐ^ĞƌŝĞƐĨŝŶĂŶĐŝŶŐƌŽƵŶĚŽĨ ϯϳ͘ϱ ŵŝůůŝŽŶh^ ĐŽŵƉůĞƚĞĚŝŶ ϮϬϭϲ ĂŶĚ ϮϬϭϳ ‡ ^ƵƉƉŽƌƚĞĚďLJƌĞŶŽǁŶĞĚůŝĨĞƐĐŝĞŶĐĞŝŶǀĞƐƚŽƌƐ ‡ ƵƌƌĞŶƚ/ŵŵƵŶŝĐŝŶǀĞƐƚŽƌƐƚŽŝŶǀĞƐƚ Ϯϲ ŵŝůůŝŽŶhZ ĂĚĚŝƚŝŽŶĂůĞƋƵŝƚLJĂƚĐůŽƐŝŶŐŽĨƚŚĞƚƌĂŶƐĂĐƚŝŽŶ

  39. Slide 39: Key Investment Highlights

    © Immunic AG 07.01.2019 39 Three potential best - in - class therapies • Deep and diversified product pipeline, orally available and potent drugs • IMU - 838: Potent DHODH inhibitor well - tolerated in prior clinical studies • IMU - 935: High demand target with substantial deal potential • IMU - 856

  40. Slide 40: Any Questions?

    © Immunic AG Ϭϳ͘Ϭϭ͘ϮϬϭϵ 40 Any Questions?

  41. Slide 41: Thank You!

    Thank You ! Immunic AG Am Klopfersitz 19 82125 Planegg - Martinsried Germany Phone: +49 89 250 0794 69 Email: jessica.breu@immunic.de Vital Therapies, Inc. Investor Relations 15222 - B Avenue of Science San Diego, CA 92128, USA Phone: +1 - 858 - 673 - 6840 Email: InvestorRelations@vitaltherapies.com

  42. Slide 42: Appendix

    Immunic THERAPEUTICS Appendix

  43. Slide 43: Further Information IMU-838

    Further Information IMU - 838

  44. Slide 44: General Phase 2 Trial Design in UC

     Ξ/ŵŵƵŶŝĐ' 07.01.2019 44 General Phase 2 Trial Design in UC Induction Phase Maintenance Phase Enrollment Period 1 Enrollment Period 2 WůĂĐĞďŽ;Eс ϭϱ Ϳ 10 mg IMU - 838 (N=15) 30 mg IMU - 838 (N=15) 45 mg IMU - 838 (N=15) 10 or 22 weeks 10 or 22 weeks Dosing analysis Placebo (N=45) ϯϬ ŵŐ/Dh Ͳ ϴϯ

  45. Slide 45: General Phase 2 Trial Design in CD

    © Immunic AG 07.01.2019 45 General Phase 2 Trial Design in CD WĂƚŝĞŶƚŶƵŵďĞƌ ƌĞƋƵŝƌĞĚ͗EΕ ϮϲϬ Primary endpoint: clinical remission, at W14 Secondary endpoint: endoscopic response Blinded treatment (BT) period 38 weeks Induction treatment phase 14 weeks Extended treatment phase 24 weeks Week 0 Wee

  46. Slide 46: Further Information IMU-935

    Further Information IMU - 935

  47. Slide 47: IMU-935: Unique RORγt Inverse Agonist

    © Immunic AG 07.01.2019 ϰϳ IMU - 935: Unique ROR ઻ t - Inverse Agonist IMU - 935 (IM105935) is a small molecule immune modulator • Inverse agonist of ROR ઻ t • Potent inhibitor of • IL17A, IL17F and IFN ઻ production • TH17 differentiation Target indication • Psoriasis or psoriatic arthritis (first)

  48. Slide 48: Structure Determination of Human RORgamma in Complex with SC98724

    © Immunic AG 07.01.2019 48 Report June 6, 2014 1/6 Structure Determination of Human RORgamma in Complex with SC98724 at 2.6 Å Resolution Client: LEO Author: Dr. Ulrike Hars, Crelux GmbH Abstract: The objective of this project was the crystal structure determination of human RORgamma in complex with

  49. Slide 49: IMU-935: Strong Efficacy Signal in Imiquimod-induced IL-17F Model

    © Immunic AG 07.01.2019 49 IMU - 935: Strong Efficacy Signal in Imiquimod - induced IL - 17F Model • Activity of IMU - 935 on IL - 17F expression in skin was tested in an imiquimod (IMQ) induced mouse model • Topical induction of inflammation with imiquimod • Oral application of IM105935 • Results •

Vital Therapies — Merger or Acquisition (January 2019) on 6ix