Fortress Biotech 8K Developing Unique Products for Autoimmune | FBIO 30 Aug 13

Developing Unique Products for Autoimmune

Diseases and Cancer (NASDAQ: CNDO)

September 2013

Harlan F. Weisman, MD

Chairman and CEO

Exhibit 99.1

Statements

this

presentation

that

are

not

descriptions

historical

facts

are

forward-looking

statements

within

the

meaning

the

“safe

harbor”

provisions

the

Private

Securities

Litigation

Reform

Act

1995.

have

attempted

identify

forward-looking

statements

terminology

including

“anticipates,”

“believes,”

“can,”

“continue,”

“could,”

“estimates,”

“expects,”

“intends,”

“may,”

“plans,”

“potential,”

“predicts,”

“should,”

“will”

the

negative

these

terms

other

comparable

terminology.

Forward-looking

statements

are

based

management’s

current

expectations

and

are

subject

risks

and

uncertainties

that

could

negatively

affect

our

business,

operating

results,

financial

condition

and

stock

price.

Factors

that

could

cause

actual

results

differ

materially

from

those

currently

anticipated

risks

include

those

set

forth

our

SEC

filings

including,

particular,

risks

relating

to:

our

ability

attract,

integrate

and

retain

key

personnel;

the

results

research

and

development

activities;

uncertainties

relating

preclinical

and

clinical

testing,

financing

and

strategic

agreements

and

relationships;

the

early

stage

products

under

development;

our

need

for

substantial

additional

funds;

government

regulation;

patent

and

intellectual

property

matters;

our

ability

successfully

manufacture

TSO

the

US;

dependence

third

party

manufacturers;

and

competition.

expressly

disclaim

any

obligation

undertaking

update

revise

any

statements

contained

herein

reflect

any

change

our

expectations

any

changes

events,

conditions

circumstances

after

the

date

this

presentation.

Forward-Looking Statements

Two biologic product candidates in clinical stage development

Focused on autoimmune diseases and cancer immunotherapy

Strong proprietary position

Novel treatments with broad therapeutic applications

addressing multi-billion dollar markets

Four efficacy clinical trials completed and multiple additional trials

ongoing

TSO:

Trichuris suis

ova

(CNDO-201) in Crohn’s Disease, Ulcerative

Colitis (UC) and Multiple Sclerosis (MS)

CNDO-109:

Tumor Activated NK Cells

in relapsed Acute Myeloid

Leukemia (AML)

Experienced management team and board of directors

Value Proposition

TSO (Trichuris suis ova or CNDO-201)

Indication

Pre-Clinical

Phase 1

Phase 2a*

Phase 2

Phase 3

Crohn’s Disease

Ulcerative Colitis

Multiple Sclerosis

Autism

Psoriasis

Type-1 Diabetes

Psoriatic Arthritis

Rheumatoid Arthritis

CNDO-109 (Tumor-Activated Natural Killer Cells)

Acute Myeloid Leukemia

Multiple Myeloma

Coronado Pipeline Overview

2H2013

* TSO Phase 2a studies being conducted as Investigator-Initiated Studies; CNDO-109 Phase 2a AML study is a Phase 1/2 study

Planned

2H2013

2014

2H2013

Porcine whipworm ova

Represents a novel approach to treating autoimmune diseases –

the

“Hygiene Hypothesis”

Natural immunomodulator -

regulates T-Reg cells and inflammatory

cytokines

Clinical proof of principle established in Inflammatory Bowel

Disease and Multiple Sclerosis

Phase 2 studies ongoing in Crohn’s disease

Planned and ongoing studies in multiple additional autoimmune

indications

Natural properties suggest strong potential for a safe profile

North and South America and Japanese rights for all indications

TSO: Trichuris suis ova (CNDO-201)

(adapted from Bach, NEJM, 2002)

Rapid Emergence of Autoimmune

and Immune Mediated Diseases

There are >100 immune-

mediated diseases affecting

50 million Americans

Second highest cause of

chronic disease in United

States and number one

cause of morbidity in women

In contrast, most of these

diseases are rare in less

developed countries

Walsh SJ, Rau LM. Am J Public Health 2000

Faustman, D. Institute of Medicine Report, “Women’s Health Research: Progress,

Pitfalls, and Promise, 2010

Epidemiological data demonstrate:

Various immunological and autoimmune diseases are much less common in

the developing world than the industrialized world

Immigrants to the industrialized world from the developing world

increasingly

develop immunological disorders in relation to the length of time since arrival

in the industrialized world

Distribution of Autoimmune Disorders

and Helminths

Autoimmune disorders incidence

Helminths infestation incidence

Elliott & Weinstock, Ann NY AcadSci, 2012

The Biology Supporting the Hygiene

Hypothesis

Does not multiply in human host

Colonization is self-limited in

humans

No systemic phase

No direct transmission

Ova stable

Oral dosing; 1 tbsp solution

taken once every 2 weeks

Clear, odorless, tasteless

Ova are Microscopic

Benefits of Trichuris suis ova (TSO)

Effect of TSO in Crohn’s Disease

75.9

62.1

79.3

72.4

Patients

and

Methods

•

29 CD patients with

CDAI>220 (mean=294)

•

Median duration of the

disease : 4 yrs

•

Baseline meds –

5ASA, low

dose steroids, 6-MP or Aza,

washout of TNF

inhibitors

•

2500 TSO every 3 weeks for

24 weeks

•

Remission defined as a

CDAI of < 150 points

•

Response defined as a

CDAI > 100 point drop from

baseline

Summers, et.al., GUT2004

Effect of TSO in Ulcerative Colitis

p=0.04

16.7%

43.3%

Placebo

T. suis

Summers, et.al., Gastroenterology 2005

Patients

and

Methods

•

n = 54 UC patients with a

UCDAI score > 4 points

•

Average score 8.7-8.8

•

Duration of disease

averaged 8 years

•

2500 TSO every 2 weeks

for 3 months

•

Most patients refractory to

previous therapy

•

Response was defined as

> 4 point drop

12 week, dose ranging study

Double-blind, randomized,

placebo controlled

TSO 250, 2500, 7500 or placebo

N=240 (2

interim)

Crohn’s patients

•

CDAI = 220-350

•

CRP 2X ULN or Calprotectin 1X

ULN

Outcome –

Remission rates

Interim –

4Q 2013

TSO Phase 2 Crohn’s Disease Studies

TRUST -

12 week study

Double-blind, randomized,

placebo controlled

TSO 7500 or placebo

N=250

Crohn’s patients

•

CDAI = 220-450

•

Endoscopic evidence of

inflammation

Outcome –

Response rates

Topline data –

4Q 2013

Impact of Parasitic Infections on the

Course of Multiple Sclerosis

Correale J, Farez MF.

J Neuroimmunol. 2011;233:6

Effect of TSO in Multiple Sclerosis

Fleming, et.al., Multiple Sclerosis Journal 2011

Indication

Pre-Clinical

Phase 1

Phase 2a*

Phase 2

Phase 3

Design

Crohn’s Disease

~500pts, DB, PC

Ulcerative Colitis

120 pt, DB, PC

Ulcerative Colitis (MOA)

18 pt, DB, PC

Multiple Sclerosis (US)

15 pt, SB

Multiple Sclerosis (EU)

50 pt, DB, PC

Autism

10 pt, DB, Cross

Autism

60 pt, DB, PC

Psoriasis

20 pt, OL

Type-1 Diabetes

36 pt, DB, PC

Early Intervention

Type-1 Diabetes

100 pt, DB, PC

Early intervention

Type-1 Diabetes

150 pt, DB, PC

Prevention

Psoriatic Arthritis

24 pt, DB, PC

Rheumatoid Arthritis

50 pt, DB, PC

TSO Pipeline

* TSO Phase 2a studies being conducted

as Investigator-Initiated Studies

Planned

OL = Open-Label DB = Double-Blind

SB= Single-Blind PC = Placebo-Controlled

2H2013

Two phase 2 studies

2H2013

TSO Manufacturing Process

Certified specific pathogen-free minipigs

Observation and pathogen testing

Oral Inoculation with OVA from master bank

Development of infection

Harvest OVA from pigs

Isolation and purification

Processing and pathogen inactivation

API

Quality and pathogen testing

Incubation and sterilization

Formulation process

Fill/finish

DRUG Product

Quality and microbiological testing

Three issued US patents entitled ‘Use of Parasitic Biological Agents for

Prevention and Control of Autoimmune Disease’

directed to compositions,

methods of producing compositions, and methods of autoimmune disease with

helminths –

exp. 12/2018

Five additional pending patents

‘Use

Parasitic

Biological

Agents

for

Disease

Prevention

and

Control’

directed

the

treatment

animals/man

with

Th1

Th2

mediated

autoimmune

disease

–

exp.

11/2023

‘Production

Viable,

Storable

Worm

Egg

Suspension’

directed

process

for

preparation

TSO

using

acid

wash

exp.

3/2028

‘Method

for

Characterizing

the

Biological

Activity

Helminth

Eggs,

particular

Trichuris

Eggs’

–

exp.

5/2029

‘Treatment

with

Helminths’

directed

methods

treating

obesity

and

IBS

exp.

10/2029

‘Compositions

and

Methods

for

Treating

IBD’

directed

method

treating

IBD

contacting

isolated

dendritic/macrophage

cell

with

helminth

–

exp.

~9/2032

* Expiration dates do not include any patent term extension

TSO Intellectual Property

Potential TSO Target

Indications

U.S./Japan

Prevalence

U.S./Japan Annual

Market Sales

(USD Mil)

Ulcerative Colitis

669,000

$1,300

Crohn’s Disease

534,000

$2,600

Multiple Sclerosis

485,000

$6,400

Sources:

Decision Resources 2012

The

mechanism

action

TSO

should,

approved,

allow

positioned

variety

autoimmune

disorders,

including

inflammatory

bowel

diseases

and

multiple

sclerosis

well

other

potential

disorders

such

rheumatoid

arthritis

and

psoriasis.

TSO Market Opportunity

NK cells represent the key component of the body’s innate immune

surveillance system

Proof of principle established in patients with high-risk refractory or

relapsed acute myeloid leukemia (AML)

Activation with CNDO-109 does not require toxic cytokines or long-

term culture/expansion, and does not change NK cell phenotypes

Preclinical activity demonstrated in multiple myeloma, breast

cancer, prostate cancer and ovarian cancer

CNDO-109: Activated Natural Killer Cells

Activated ex vivo by tumor cell

lysate (CNDO-109)

Effective from autologous or

allogeneic NK cell source

Uniquely positioned in patients

with “minimal residual disease”

Remains active after

freeze/thaw

CNDO-109 Mechanism of Action

Trigger

receptor

Trigger

receptor

Priming

receptor

Priming

receptor

Trigger

receptor

Priming

receptor

Resting

Donor NK

Primed

Donor NK

Priming

signal

CNDO-109

Trigger

ligand

Patient’s

tumor

Priming –

Signal 1

Triggering –

Signal 2

Primed

Donor NK

“Serial Killer”

Tumor lysis

Phase 1 investigator sponsored open-label trial

To determine the safety of infusion of allogeneic Tumor-activated

NK (TaNK) cells after low dose radiotherapy plus chemotherapy

in high-risk relapse or refractory AML patients

Enrolled 8 AML patients

5 in Complete Remission 2 or 3 (CR2 or CR3)

1 patient in partial relapse (PR)

3/5 experienced a longer CR than their previous CR, in addition

PR patient achieved CR

Kottaridis, et al., ASH 2011

CNDO-109 Phase 1 Study in AML

Initiated Phase 1/2 allogeneic clinical trial for the treatment of

relapsed AML

Once the dose is selected, plan to initiate a randomized Phase 2

trial

Potential for regulatory approval with single randomized, controlled

clinical trial if data are clinically meaningful and statistically persuasive

Future autologous studies planned in other tumor types (including

multiple myeloma, breast, ovarian and prostate)

CNDO-109 Clinical Development

Core patent -

“Method for activating natural killer cells by tumor

cell preparation in vitro”

Issued in U.S. -

exp. 1/2029

Issued in Australia –

exp. 3/2026

Pending in Europe, Canada, Japan and India

Patent pending -

“Preserved Compositions of Activated NK Cells

and Methods of Using the Same”

–

exp. 7/2030

Provisional application pending in the U.S. -

“Compositions and

Methods for Treating Viral Infections”

* Expiration dates do not include any patent term extension

CNDO-109 Intellectual Property

Potential CNDO-109

Target Indications

G7 Drug

Treatable

Population

G7 Market

Sales

(USD Mil)

Mortality

AML

43,500

$165

5 year mortality rate is 85-90% but varies by age

Multiple Myeloma

44,000

$2,870

Stage III: median survival of 29 months

Breast Cancer

494,000

$10,100

Stage IV: 5 year mortality rate is 76%

Ovarian

57,110

$424

Overall 5 year survival rate of 45%

Prostate

500,000

$4,000

Overall 5-year survival rate of +99%, but 2

leading cause of cancer deaths in men

G7 = U.S., U.K., Germany, France, Italy, Spain, Japan

Sources:

Decision Resources 2011/2012

If Coronado establishes the efficacy of CNDO-109 activated NK cells in the treatment of

AML, Coronado believes the market opportunity for CNDO-109 activated NK cell therapy

is large due to the fact that many types of tumors are sensitive

to killing by activated NK

cells.

CNDO-109 Market Opportunity

Harlan F. Weisman, MD

Chairman and Chief Executive Officer

Company Group Chairman, Research & Development for

Pharmaceuticals at JNJ

President of Research & Development at Centocor

Over 20 years of pharmaceutical/biotechnology experience

Noah D. Beerman

EVP & Chief Operating Officer

President & CEO of RXi Pharmaceuticals

Over 25 years of pharmaceutical/biotechnology experience

Karin Hehenberger, MD, PhD

EVP of Scientific Affairs

Senior positions at private and public investment firms and as an

executive at Eyetech, JNJ and JDRF

MD and PhD from Karolinska, postdoc at Harvard medical school

Key Management and Board Members

Lucy Lu, MD

EVP & Chief Financial Officer

Senior Analyst at Citi Investment Research

Over 10 years of biotech equity research experience

George C. Avgerinos, PhD

Sr. VP, Biologics Operations

Divisional VP, Global Process and Manufacturing Sciences, Abbvie

Over 30 years experience in biopharmaceutical process development

including Humira™

process and manufacturing

Eric K. Rowinsky, MD

Vice Chairman

World renown oncologist, former CMO at ImClone, board of

Biogen/Idec

Over 25 years of healthcare experience

Lindsay Rosenwald, MD

Director and Founder

prolific

and

successful

investor

the

life

sciences

industry

for

over

years

Financials

Listed on NASDAQ: CNDO

Market Cap as of 8/28/2013

~$275M

Shares Outstanding

33.9M

Additional 5.2M options and warrants

Cash Position as of 6/30/2013

$67.9M

Additional $35.9M from ATM through 8/28/13

TSO

Initiate Multiple Investigator Initiated Studies

2H 2013

TRUST-II (Falk) Crohn’s study 2nd Interim Results

4Q 2013

TRUST-I (CNDO) Crohn’s study Topline Results

4Q 2013

CNDO-109

Initiate Multiple Myeloma Study

2014

Anticipated Upcoming Milestones

Two biologic product candidates in clinical stage development

Focused on autoimmune diseases and cancer immunotherapy

Strong proprietary position

Novel treatments with broad therapeutic applications

addressing multi-billion dollar markets

Four efficacy clinical trials completed and multiple additional trials

ongoing

TSO:

Trichuris suis

ova (CNDO-201) in Crohn’s Disease, Ulcerative

Colitis (UC) and Multiple Sclerosis (MS)

CNDO-109:

Tumor Activated NK Cells in relapsed Acute Myeloid

Leukemia (AML)

Experienced management team and board of directors

Investment Highlights

Fortress Biotech (FBIO) 8-KDeveloping Unique Products for Autoimmune