Edgar Filing: VITAL THERAPIES INC

425

Immunic

Therapeutics

Developing Selective Oral Drugs in Immunology

Company Overview

March 2019

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

13.03.2019

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 Securities Litigation Reform Act of 1995, known as the PSLRA. These include

statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue

reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected.

Vital Therapies and Immunic

undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the

extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,”

“estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be

covered by the safe-harbor provisions of the PSLRA.

•

Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those

expressed or implied in the statements due to a number of factors, including, but not limited to, risks relating to the completion of the transaction, including the

need for Vital Therapies stockholder approval and the satisfaction of closing conditions; the anticipated financing to be completed concurrently with the closing

of the transaction; the cash balance of the company following the closing of the transaction and the financing, and the expectations with respect thereto; the

business and prospects of the company following the transaction; and the ability of Vital Therapies to remain listed on the Nasdaq Capital Market. Risks and

uncertainties related to Immunic

that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but

are not limited to: Immunic’s

plans to develop and commercialize its product candidates, including IMU-838, IMU-935 and IMU-856; the timing of initiation of

Immunic’s

planned clinical trials; expectations regarding potential market size; the timing of the availability of data from Immunic’s

clinical trials; the timing of

any planned investigational new drug application or new drug application; Immunic’s

plans to research, develop and commercialize its current and future

product candidates; Immunic’s

ability to successfully collaborate with existing collaborators or enter into new collaborations, and to fulfill its obligations under

any such collaboration agreements; the clinical utility, potential benefits and market acceptance of Immunic’s

product candidates; Immunic’s

commercialization,

marketing and manufacturing capabilities and strategy; Immunic’s

ability to identify additional products or product candidates with significant commercial

potential; developments and projections relating to Immunic’s

competitors and industry; the impact of government laws and regulations; Immunic’s

ability to

protect its intellectual property position; and Immunic’s

estimates regarding future revenue, expenses, capital requirements and need for additional financing

following the proposed transaction.

•

These risks, as well as other risks associated with the transaction, are more fully discussed in the final proxy statement/prospectus that is included in the

registration statement that was filed by Vital Therapies with the SEC in connection with the proposed transaction. Additional

risks and uncertainties are identified

and discussed in the “Risk Factors” section of Vital Therapies’ Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time

to time with the SEC. Forward-looking statements included in this presentation are based on information available to Vital Therapies and Immunic

as of the date

of this presentation. Neither Vital Therapies nor Immunic

undertakes any obligation to update such forward-

looking statements to reflect events or

circumstances after the date of this presentation.

13.03.2019

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 Therapies and Immunic

intend to file

relevant materials with the U.S. Securities and Exchange Commission (the “SEC”) and Vital Therapies has filed a registration statement on Form S-4 and a final

proxy statement/prospectus. The registration statement was declared effective by the SEC on February 14, 2019, and the definitive proxy statement was first

mailed or otherwise made available to Vital Therapies stockholders on February 19, 2019 in connection with the Vital Therapies special meeting of stockholders

to be held to vote on matters relating to the proposed transaction. The proxy statement/prospectus contains information about

Vital Therapies, Immunic, the

proposed transaction, and related matters. STOCKHOLDERS ARE URGED TO READ THE FINAL PROXY STATEMENT/PROSPECTUS (INCLUDING ANY

AMENDMENTS

OR SUPPLEMENTS THERETO) AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE, AS THEY CONTAIN

IMPORTANT INFORMATION THAT STOCKHOLDERS OF VITAL THERAPIES SHOULD CONSIDER BEFORE MAKING A DECISION ABOUT THE PROPOSED TRANSACTION

AND RELATED MATTERS. In addition to receiving the final proxy statement/prospectus and proxy card by mail, Vital Therapies stockholders can also obtain the

final proxy statement/prospectus, as well as other filings containing information about Vital Therapies, without charge, from

the SEC’s website

(http://www.sec.gov) or, without charge, by directing a written request to: Vital Therapies, Inc., 15222-B Avenue of Science, San Diego, CA 92128, Attention:

Investor Relations.

No Offer or Solicitation

•

This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or

subscribe for any securities or the solicitation of any vote or approval in any jurisdiction in connection with the proposed transaction or otherwise, nor shall there

be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a

prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Participants in Solicitation

•

Vital Therapies and its executive officers and directors may be deemed to be participants in the solicitation of proxies from

Vital Therapies’ stockholders with

respect to the matters relating to the proposed transaction. Immunic

may also be deemed a participant in such solicitation. Information regarding Vital

Therapies’ executive officers and directors is available in Vital Therapies’ proxy statement on Schedule 14A for its 2018 annual

meeting of stockholders, filed with

the SEC on April 12, 2018. Information regarding any interest that Vital Therapies, Immunic

or any of the executive officers or directors of Vital Therapies or

Immunic

may have in the transaction with Immunic

is set forth in the final proxy statement/prospectus that Vital Therapies has filed with the SEC in connection

with its stockholder vote on matters relating to the proposed transaction. Vital Therapies stockholders are able to obtain this information by reading the proxy

statement/prospectus.

13.03.2019

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 subsidiary of Vital Therapies

•

Vital Therapies stockholders are expected to own approximately 11%

and

Immunic stockholders approximately 89%

of the company upon completion

of the proposed transaction

•

Current shareholders of Immunic committed to invest 26 million EUR at

closing of the transaction

•

Transaction has been approved by the boards of directors of both

companies and by Immunic stockholders

•

Expected to

close in Q2 2019, subject to the approval of the stockholders of

Vital Therapies and other closing conditions

•

Company expected to operate under the name Immunic, Inc. and trade on

the NASDAQ Stock Market under the symbol “IMUX”

13.03.2019

•

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 the US with R&D site based in Munich, Germany

Vital Therapies –

Immunic Leadership

Daniel

Vitt, PhD

CEO

Andreas

Muehler, MD, MBA

CMO

Hella

Kohlhof, PhD

CSO

Manfred

Groeppel, PhD

COO

Daniel

Vitt, PhD

CEO of Immunic

Joerg

Neermann, PhD

Life Science Partners

Jan

van den Bossche

Fund+

Duane Nash, MD, JD, MBA

CEO

of Vital Therapies

Vincent

Ossipow, PhD, CFA

Omega Funds

Immunic

Company and Product

Overview

13.03.2019

Our Vision

We are developing new

therapies with best-in-class

potential for the treatment

of chronic inflammatory

and autoimmune diseases.

13.03.2019

•

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:

Novel

target

–

potentially

disease

modifying

for

IBD

Three potential best-in-

class therapies

Strong IP position

•

IMU-838: Patent application coverage until 2038

•

IMU-935: New compound IP filed in 2017

•

IMU-856: Compound patent filed in 2018

Key Investment Highlights

High value markets

•

Autoimmune & immunology with high unmet medical needs

•

Large markets for IBD, MS and psoriasis with multibillion USD sales potential

•

Well financed with cash runway to near-term value-driving events

Experienced

management team

•

Experienced management team with strong track record and over 70 years

of leadership experience in the pharmaceutical industry

•

Focused on efficient use of capital to maximize investor return

Supported by experienced

life science investors

•

Strong support of sophisticated board members and life science investors

•

Life Sciences Partners as lead investor

•

Omega Funds, Fund+, LifeCare Partners, High-Tech Gründerfonds, Bayern

Kapital and IBG as further investors

13.03.2019

IST study will be performed

by Mayo Clinic / NIH *

Development Pipeline

* IST: Investigator-Sponsored Trial

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

Orphan AI

Diseases

ROR

IMU-856

IBD

Intestinal

Barrier Function

13.03.2019

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 University

•

25+ years experience in the life science industry

•

Medical expertise in the field of IBD with

experience in several IBD product launches

Dr. Manfred Groeppel, COO

•

PhD in Chemistry from University of Erlangen

•

18 years industry experience with US and

German biotech companies

•

Project leader and member of the vidofludimus

development at 4SC

Dr. Hella Kohlhof, CSO

•

PhD in Biology from LMU Munich

•

More than 10 years experience in Biotech R&D

and Immunology

•

Track-record in clinical project management

IMU-838

in Inflammatory Bowel

Disease (IBD)

New Oral Treatment with Promising Safety Profile

13.03.2019

Crohn’s Disease (CD)

•

A patchy, transmural inflammation involving the entire bowel wall

•

May

affect

any

part

the

gastro

intestinal

tract

from

the

mouth

the anus

•

Most commonly, CD affects the lower part of the small intestine

and colon

•

Symptoms include: abdominal pain, diarrhea, and weight loss

•

Structural problem (like e.g. fistulas, abscesses) are common

Ulcerative Colitis (UC)

•

Diffuse mucosal inflammation limited to the colon (involving only

the upper layer of the bowel wall)

•

95% of UC cases affect the rectum

•

UC may extend in a symmetrical, circumferential and uninterrupted

pattern to affect parts or all of the large intestine

•

Symptoms include: bloody diarrhea, colic, abdominal pain,

cramping, urgency and a constant feeling of needing to empty the

bowel

IBD: Two Indications with High Unmet Medical Need

Source: Datamonitor DMHC2624, Pipeline Insight: Inflammatory Bowel Disease, June 2010

13.03.2019

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

2,600,000

1,300,000

233,000

1,500,000

700,000

104,000

1,100,000

600,000

129,000

[1] Global IBD Market Forecast 2018.

[2] GBD 2015 Lancet.

388

(10053): 1545–1602.

[3] Burisch

et al. Journal of Crohn's

and Colitis 2013 7, 322–337

[4] Hanauer

S. 2006;12:S3-9 (Suppl

1), Kappelmann

MD et al, Clin Gastroenterol

Hepatol.

2007; 5:1424-9.

[5] The Burden of IBD in Canada. www.ccfc.ca. Accessed 16 May 2014

13.03.2019

Traditional

Immunomodulators

Corticosteroids

Budesonide

Aminosalicylates, Antibiotics

Surgery

TNF

-mABs

Vedolizumab

Mild

Moderate

Severe

IMU-838

Current solutions have limitations

•

Substantial side effects due to long-term

use includes increased rate of cancer risk

and virus reactivation of currently used

immunosuppressants

[1]

[2]

[3]

•

Antibodies lose activity over time

[4]

[1] Present, Daniel H., et al. Annals of internal medicine

1989; 111.8: 641-649.

[2] Dayharsh, Gerald A., et al. Gastroenterology 2002; 122.1: 72-77.

[3] Winthrop, Kevin L., et al. Arthritis & rheumatology

2014; 66.10: 2675-2684.

[4] Roda, Giulia, et al. Clinical and translational gastroenterology 2017; 7.1: e135.

IBD: Therapeutic Pyramid

13.03.2019

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 direct

anti-viral effect

Mode of action

provides a new

treatment option for

patients failing other

therapies in IBD

Selective effect

towards metabolically

activated

inflammatory cells

IMU-838: Key Strengths That Address Limitation of

Existing Therapies

13.03.2019

Mode of

Action: DHODH Targeting Leads to

Metabolic Stress in Metabolically Activated Cells

Resting

Lymphocyte

Activated

Lymphocyte

Stressed

Lymphocyte

Pharmacological

Effects

13.03.2019

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 established its safety

up to daily doses of 50 mg

•

Safety profile similar to placebo at therapeutically used doses

•

No increased rate of infections and infestations compared with placebo in

clinical trials

•

Efficacy

•

Mechanism of DHODH inhibition already established successfully in

rheumatoid arthritis and multiple sclerosis

•

Investigator trials with other DHODH inhibitors have shown positive effects

on Crohn’s disease patients

•

Proof-of-concept trial using IMU-838 active moiety (ENTRANCE trial)

provided initial efficacy results in steroid-dependent IBD patients

13.03.2019

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 disease

91.7% in ulcerative colitis

88.5%

Total Response

Complete

Responders

(53.9%)

mITT

[2]

Non-Responders

(11.5%)

Evaluable Patients

IBD Phase 2a ENTRANCE: Primary Efficacy Results

[1] Herrlinger

et.al., 2011, Gastroenterology 140:588.

[2] mITT: modified intent to treat

Partial

Responders

(34.6%)

13.03.2019

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: Proportion of patients with both

symptomatic remission and endoscopic healing at week 10

•

Despite competitive study landscape in IBD

•

Study enrollment is on track

•

Targeted to end enrollment in early 2020

13.03.2019

General Phase 2 Trial Design in UC

Induction Phase

Maintenance Phase

Enrollment Period 1

Enrollment Period 2

Placebo (N=15)

10 mg IMU-838

(N=15)

30 mg IMU-838

(N=15)

45 mg IMU-838

(N=15)

10 or 22 weeks

Dosing

analysis

Placebo (N=45)

30 mg IMU-838

(N=45)

45 mg IMU-838

(N=45)

Final analysis

induction phase

after 10 weeks

Until UC relapse or termination

Placebo (N=~24)

Final analysis

maintenance phase

Patient number

required: N=195

R = randomization

10 mg IMU-838

30 mg IMU-838

(N=~48)

13.03.2019

Ulcerative colitis (UC) trial

Crohn’s disease (CD) trial

Final 1°

UC efficacy

analysis

Final 1°

CD efficacy

analysis

Two phase 1

trials

IBD: Overall Study Program

Definition of dose strengths

for CD trial based on UC

dosing analysis*

* An interim dosing analysis is expected to be performed mid-2019 with the aim of potentially eliminating an ineffective

dose or an intolerant dose, and to continue the study in a more efficient manner using fewer active dose groups.

13.03.2019

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 trial

•

Supplemented by additional sites and additional countries

•

Primary endpoint: clinical remission, at W14;

Secondary endpoint: endoscopic response

•

Study already in start-up preparation mode

•

Accelerate study start after interim analysis of UC trial

13.03.2019

General Phase 2 Trial Design in CD

Patient number required: N ~ 260

Blinded treatment (BT) period 38 weeks

Induction treatment phase

14 weeks

Extended treatment phase

24 weeks

Week 0

Week 14

Week 38

Placebo

30 mg IMU-838

45 mg IMU-838

EoI

EoBT

EoS

Scr. V

Placebo

30 mg IMU-838

45 mg IMU-838

Open-label extension treatment period with 30 mg IMU-838

(optional trial period) for up to 9 years

EoOLE

EoS

BT = blinded treatment; EoBT

= end of blinded treatment; EoI

= end of induction;

EoOLE

= end of open label extension; EoS

= end of study; R = randomization; Scr. = screening

13.03.2019

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 cholangitis (PSC)

•

Single-arm, exploratory study

•

Primary endpoint: change in serum alkaline phosphatase (ALP) at

6 months vs. baseline

•

Dosing: 30 mg IMU-838, (Clinicaltrials.gov: NCT03722576)

•

Investigator IND for IMU-838 and IRB approval already established

•

Immunic

to provide clinical trial material for the patients to clinical sites

•

Assumed start of enrollment in Q1 2019

•

Positive data should enable immediate start of a pivotal trial in this

orphan indication by Immunic

13.03.2019

IMU-838: Clinical Development Plan in IBD and

PSC

2016

2017

2018

2019

2020

2021

Interim

Analysis

mid-19

Results UC

Induction of

Remission

Expected

Q2/20

02/17 -

11/17

Phase 1 (SAD

and MAD

)

Q1/18 -

Q2/20

Phase 2 Ulcerative Colitis

Phase 2 Primary Sclerosing Cholangitis

02/17

FPI

Phase 1

Start of phase 2 study in PSC anticipated

Phase 2 Crohn’s Disease

Start of phase 2 study in CD expected

04/18

FPI Phase 2 UC

SAD: Single Ascending Dose

MAD: Multiple Ascending Dose

FPI: First Patient In

Mode of Action of IMU-838 Enables

Broad Therapeutic Use

13.03.2019

Aubagio

(teriflunomide) is

currently the only

approved DHODH

inhibitor for MS

IMU-838 has the potential

to be a best-in-class DHODH

inhibitor and

MS drug due

to improved safety and

pharmacokinetics profile

MS Opportunity

[1] https://mediaroom.sanofi.com/en/press-releases/2018/sanofi-delivers-2017 Accessed January 2, 2019

13.03.2019

•

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 in MS

•

Phase 2 trial in patients with relapsing-remitting multiple

sclerosis (RRMS) started in February 2019

[1]

FDA CDER Pharmacological Review Teriflunomide

2012

[2]

Merrill JE, et al. J Neurol 256: 89-103, 2009

[3]

Büttner R, et al. Blood 130 (suppl 1): 4426 abstract, 2017

[4]

Cada DJ, et al. Hosp Pharm 48: 231-240, 2013 )

[5]

FDA CDER Clinical Pharmacology and Biopharmaceutics

Review Teriflunomide

2012

[6]

Summary of Product Characteristics Aubagio

[7]

SmPC

Aubagio®

[8]

FDA CDER Medical Review Teriflunomide, 2012

[9]

O’Connor et al, NEJM 365: 1293-1303, 2011

[10]

O’Connor et al, NEJM 365: supplementary appendix, 2011

13.03.2019

General Phase 2 Trial Design in RRMS

BL = baseline; exam. = examination; D = day; EoMT

= end of main treatment; EoS

= end of trial;

EoT

= end of treatment; MRI magnetic resonance imaging; R = randomization; Scr. = screening; W = week

Screening up to

28 days

Blinded

Unblinded

Placebo

30 mg IMU-838

45 mg IMU-838

EoMT

EoS

Scr. exam.

BL MRI

30 mg IMU-838

45 mg IMU-838

Extended treatment period

Main treatment period

24 weeks

45 mg IMU-838

30 or 45 mg IMU-838

D-28

-9

D-14

-3

W24/EoMT

End of

main

part

1°analysis

At time of

final analysis

main

part

Visits every

12 weeks

W516/EoT

EoS

(EoT+30d)

EoT

up to ~9.5 years

13.03.2019

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

the

US,

and

other

key

markets

–

expires

2031

New patent filed in 2018 on the specific

polymorph

of IMU-838 used in current studies

New dosing regimen, which was developed during

phase 1 testing –

protecting the applied dosing

scheme of all ongoing and planned phase 2

studies –

new patent application filed in 2017

IMU-935

Unique ROR

t-Inverse Agonist

13.03.2019

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

is an important regulator

of auto immunity related

diseases

[2]

Psoriasis

IL-23 axis in psoriasis

Th1/Th17 –

key role in

Uveitis

Key role for Th17 in

Uveitis

Lupus

IFNg

driven

autoimmune disease

Source: Fasching, Patrizia, et al.

Molecules

2017; 22.1: 134.

[1]

Rose, Noel R. American journal of epidemiology

2016; 183.5: 403-406.

[2]

Fasching, Patrizia, et al.

Molecules

2017 22.1: 134.

13.03.2019

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

[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)

ROR

cellular, rep.)

20 nM

Th17 differentiation

100 nM

Resolution 2.6 A of a closely related derivative

compound binds to hydroxycholesterol binding site

13.03.2019

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 potentially offer early read-out of

activity based on four-week treatment

•

Identification of suitable orphan indications with high unmet

medical need for accelerated development

IMU-856

Restoring Intestinal Barrier Function

13.03.2019

Accelerates mucosal healing with

standard of care due to its new mode

of action

Enhances maintenance of remission,

that is the highest unmet medical

need in IBD

IMU-856 inhibitor concept:

Ameliorates barrier function

Mucus layer

Antigen/pathogen

<Lumen>

<IECs>

Immune cells

<Lumen>

<IECs>

Current SOCs

Inhibit inflammation

Current SOCs

Inhibit inflammation

IBD

Healthy

Hypothesis: Bacterial Penetration Through Weakened

Cellular Adhesion Causes Immune Overstimulation

Tight junctions

Source: Adopted from Daiichi Sankyo Venture Science Labs, November 2018

13.03.2019

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 non-GLP 14-day tox

studies

in rats and monkeys

•

Large therapeutic window expected

•

No critical issues identified in genotoxicity and safety pharmacology

studies

•

Pharmacological effect is improving intestinal barrier function:

shown in-vitro and in-vivo to reverse pathophysiology of IBD

•

Optioned from Daiichi Sankyo Venture Science Labs

•

Execution

worldwide

option

after

availability

GLP

tox

data

13.03.2019

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 patent application

Summary

13.03.2019

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 expected to be sufficient beyond important value

inflection points into Q3 2020

13.03.2019

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:

Novel

target

–

potentially

disease

modifying

for

IBD

Strong IP position

•

IMU-838: Patent application coverage until 2038

•

IMU-935: New compound IP filed in 2017

•

IMU-856: Compound patent filed in 2018

Key Investment Highlights

High value markets

•

Autoimmune & immunology with high unmet medical needs

•

Large markets for IBD, MS and psoriasis with multibillion USD sales potential

•

Well financed with cash runway to near-term value-driving events

Experienced

management team

•

Experienced management team with strong track record and over 70 years

of leadership experience in the pharmaceutical industry

•

Focused on efficient use of capital to maximize investor return

Supported by experienced

life science investors

•

Strong support of sophisticated board members and life science investors

•

Life Sciences Partners as lead investor

•

Omega Funds, Fund+, LifeCare

Partners, High-Tech Gründerfonds, Bayern

Kapital

and IBG as further investors

13.03.2019

Any Questions?

Thank

You!

Jessica Breu

Manager IR & Communications

Phone: +49 89 250 0794 69

Email: jessica.breu@immunic.de

Immunic

Am Klopfersitz 19

82125 Planegg-Martinsried

Germany