Immunic, Inc. · NASDAQ:IMUX
Immunic — Vital Therapies — Merger or Acquisition (March 2019)
43 slides from Immunic's merger presentation, Mar 14, 2019
Slide 1: Immunic Therapeutics Company Overview
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 March 14, 2019 ImmunicTherapeutics De
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 AGImmunic and Where to Find it • This communication is being made in respect of a proposed transaction involving ImmunicAG and Vital Therapies, Inc. Vital Therapie
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 DanielVitt, PhD AndreasMuehler, MD, MBA HellaKohlhof, PhD ManfredGroeppel, PhD CEO CMO CSO COO • Board to be comprised of 5 directors, 4 from Immunic and 1 from Vital Therapies DanielVitt, PhD JoergNeermann,
Slide 6: Immunic Company and Product Overview
ImmunicCompany 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 13.03.2019 7
Slide 8: Key Investment Highlights
Key Investment Highlights • Deepand diversifiedproduct pipeline,orally availableand 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:Noveltarget – p
Slide 9: Development Pipeline
Development Pipeline Preclinical Phase 1 Phase 2 Phase 3 IMU-838 Ulcerative Colitis DHODH Crohn’s Disease DHODH Multiple SclerosisDHODH 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 p
Slide 10: Proven Leadership in Drug Development & Licensing
Proven Leadership in Drug Development & Licensing Dr. Andreas Muehler, CMO Dr. Daniel Vitt, CEO • MD degree (CharitéBerlin) + MBA Duke University • PhD in Chemistry from University of Würzburg • 25+ years experience in the life science industry • 19 years track record as biotech entrepreneur • Medic
Slide 11: IMU-838 in Inflammatory Bowel Disease (IBD)
IMU-838 in Inflammatory Bowel Disease (IBD) New Oral Treatment with Promising Safety Profile
Slide 12: IBD: Two Indications with High Unmet Medical Need
IBD: Two Indications with High Unmet Medical Need Crohn’s Disease (CD) • A patchy, transmural inflammation involving the entire bowel wall • Mayaffectanypart of the gastrointestinaltract from the mouth to the anus • Most commonly, CD affects the lower part of the small intestine and colon • Symptoms
Slide 13: Large Market Opportunity
Large Market Opportunity • Global market for IBD in 2023 estimated to be approximately7.6 billionUSD[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 2,600,000 1,300,000 233,000 UC 1,500,000 700,000 104,000 C
Slide 14: 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 Surgery immunosuppressants [1] [2] [3] Severe • Antibodies lose activity over time [4] TNF -mABs Vedolizumab IMU
Slide 15: 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 16: Mode of Action: DHODH Targeting Leads to Metabolic Stress
Mode ofAction: DHODH Targeting Leads to Metabolic Stress in Metabolically Activated Cells Resting Activated Stressed Pharmacological Lymphocyte Lymphocyte Lymphocyte Effects © Immunic AG 13.03.2019 16
Slide 17: 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 350 individuals treated with active moiety of IMU-838 • Two phase 1 trials of IMU-838 formulation esta
Slide 18: 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 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 • Open-label 5 Respon
Slide 19: 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 20: General Phase 2 Trial Design in UC
General 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 (N=15) 10 mg IMU-838 R (N=~48) 30 mg IMU-838 30 mg IMU-838 R (N=15) (N=45) 30 mg IMU-838 (N=~48) 45 mg IMU-838 45 mg IMU-838 (N=15)
Slide 21: 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 22: 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 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 t
Slide 23: General Phase 2 Trial Design in CD
General Phase 2 Trial Design in CD Blinded treatment (BT) period 38 weeks Induction treatment phase Extended treatment phase 14 weeks 24 weeks Week 0 Week 14 Week 38 Placebo EoI Placebo EoBT EoS R 30 mg IMU-838 EoI 30 mg IMU-838 EoBT EoS Scr. V Scr. V S1 S2 45 mg IMU-838 EoI 45 mg IMU-838 EoBT EoS O
Slide 24: IMU-838: Phase 2 Proof-of-Concept Study in PSC
IMU-838: Phase 2 Proof-of-Concept Study in PSC • Immunicis 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 cholan
Slide 25: IMU-838: Clinical Development Plan in IBD and PSC
IMU-838: Clinical Development Plan in IBDPSC and Phase 1 (SAD * and MAD *) 02/17 -11/17 Phase 2 Ulcerative Colitis Q1/18 -Q2/20 Results UC Induction of Interim Remission FPI* Phase 1 FPI Phase 2 UC Analysis Expected 02/17 04/18 mid-19 Q2/20 2016 2017 2018 2019 2020 2021 Phase 2 Primary Sclerosing Ch
Slide 26: Mode of Action of IMU-838 Enables Broad Therapeutic Use
Mode of Action of IMU-838 Enables Broad Therapeutic Use
Slide 27: MS Opportunity
MS Opportunity IMU-838 has the potential to be a best-in-class DHODH inhibitor andMS drug due to improved safety and pharmacokinetics profile Aubagio® (teriflunomide) is currently the only approved DHODH inhibitor for MS [1] https://mediaroom.sanofi.com/en/press-releases/2018/sanofi-delivers-2017 Ac
Slide 28: IMU-838: Potential Advantages in MS
IMU-838: Potential Advantages in MS • Potential advantages of IMU-838 therapy compared with Aubagio® (teriflunomide): [1] [2] [3] [4] • Selectivity and sensitivity [5] [6] • Pharmacokinetic parameters • Safety profile[7] [8] [9] [10] • Drug-drug interaction potential [6] • Phase 2 trial in patients
Slide 29: General Phase 2 Trial Design in RRMS
General Phase 2 Trial Design in RRMS Screening up to Main treatment period Extended treatment period 28 days 24 weeks up to ~9.5 years Blinded Unblinded 30 mg IMU-838 EoMT 30 mg IMU-838 30 or 45 mg IMU-838 EoT R 45 mg IMU-838 EoMT 45 mg IMU-838 30 or 45 mg IMU-838 EoT EoS Scr. exam.BL MRI 30 mg IMU-
Slide 30: 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,EUandother keymarkets– expiresin 2031 New patent filed in 2018 on the specific polymorphof IMU-838 used in cu
Slide 31: IMU-935: Unique RORγt-Inverse Agonist
IMU-935 Unique ROR t-Inverse Agonist
Slide 32: Autoimmune Diseases: Broad Disease Spectrum
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] • RORt is an important regulator of auto immunity related diseases[2] Source: Faschin
Slide 33: 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 • Read-out: effect on cytokine production after 48 h IC50 [µM] IL-17A 0.005 IL-17F 0.004 IFN 0.003 IL-1a and b no inhibition IL-4,5,6,8 no inhibition ROR 24 nM (MST)
Slide 34: IMU-935: Project Status
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 mild to moderate psoriasis –would pot
Slide 35: IMU-856: Restoring Intestinal Barrier Function
IMU-856 Restoring Intestinal Barrier Function
Slide 36: Hypothesis: Bacterial Penetration Through Weakened Cellular Adhesion
Hypothesis: Bacterial Penetration Through Weakened Cellular Adhesion Causes Immune Overstimulation Healthy IBD Antigen/pathogen <Lumen> Mucus layer <Lumen> IMU-856 inhibitor concept: Ameliorates barrier function Accelerates mucosal healing with standard of care due to its new mode of action <IECs> <
Slide 37: IMU-856: Targeting Gut Barrier Function
IMU-856: Targeting Gut Barrier Function • IMU-856 is a potent inhibitor of a novel target which was validated in a knock-out animal model • Small orally available molecule suitable for once daily dosing • Carefully performed lead compound selection based on exploratory full safety panel, including n
Slide 38: 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 39: Summary
Immunic THERAPEUTICS Summary
Slide 40: 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 41: Key Investment Highlights
Key Investment Highlights • Deepand diversifiedproduct pipeline,orally availableand 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:Noveltarget – p
Slide 42: Any Questions?
Any Questions? © Immunic AG 13.03.2019 42
Slide 43: Thank You!
ThankYou! ImmunicAG Jessica Breu Am Klopfersitz 19 Manager IR & Communications 82125 Planegg-Martinsried Phone: +49 89 250 0794 69 Germany Email: jessica.breu@immunic.de