Fortress Biotech 8K Regulation FD Disclosure | FBIO 4 Sep 12

Exhibit 99.1

September 2012

Bobby W. Sandage, Jr., PhD

President & Chief Executive Officer

Developing Unique Products for Autoimmune

Diseases and Cancer (NASDAQ: CNDO)

Statements in this presentation that are not descriptions of historical facts are forward-looking

statements within the meaning of the “safe harbor”

provisions of the Private Securities Litigation

Reform Act of 1995. We have attempted to identify forward-looking statements by terminology

including “anticipates,”

“believes,”

“can,”

“continue,”

“could,”

“estimates,”

“expects,”

“intends,”

“may,”

“plans,”

“potential,”

“predicts,”

“should,”

or “will”

or the negative of these terms or other

comparable terminology. Forward-looking statements are based on management’s current

expectations and are subject to risks and uncertainties that could negatively affect our business,

operating results, financial condition and stock price. Factors that could cause actual results to

differ

materially

from

those

currently

anticipated

risks

include

those

set

forth

our

SEC

filings

including, in particular, risks relating to: the results of research and development activities;

uncertainties relating to preclinical and clinical testing, financing and strategic agreements and

relationships; the early stage of products under development; our need for substantial additional

funds; government regulation; patent and intellectual property matters; dependence on third

party manufacturers; and competition. We expressly disclaim any obligation or undertaking to

update or revise any statements contained herein to reflect any change in our expectations or

any changes in events, conditions or circumstances after the date of 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)

Crohn’s

Disease,

Ulcerative

Colitis (UC) and Multiple Sclerosis (MS)

CNDO-109

Tumor

Activated

Cells

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

Other indications**

CNDO-109 (Tumor-Activated Natural Killer Cells)

Acute Myeloid Leukemia

Multiple Myeloma, Solid

Tumors

2H2012

4Q2012

* TSO Phase 2a studies being conducted as Investigator-Initiated Studies

** Other indications include Rheumatoid Arthritis and Psoriatic Arthritis

Planned

4Q2012

1Q2013

2013

1Q2013

Coronado Pipeline Overview

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

Ongoing Phase 2 studies ongoing in Crohn’s disease

Planned 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)

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

Rapid

Emergence

Autoimmune

and

Immune

Mediated

Diseases

Autoimmune disorders incidence

Helminths infestation incidence

High

Moderate

Low

High

Moderate

Low

Various immunological and autoimmune diseases are much less common in the

developing world than the industrialized world

Immigrants

the

industrialized

world

from

the

developing

world

increasingly

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

the industrialized world

Epidemiological data demonstrate:

Distribution of Autoimmune Disorders

and Helminths

Weinstock and Elliott, Inflamm Bowel Dis, Jan 2009

POOR SANITATION,

IMPURE FOOD

AND CROWDED

LIVING CONDITIONS

Helminthic

and bacterial

exposures

Inhibits

Excess

Reactivity

Viral, bacterial and

protozoan

infections

Crohn’s Disease,

Ulcerative Colitis,

Multiple Sclerosis

other

autoimmune

diseases

Elliott & Weinstock, Ann NY Acad Sci, 2012

(Prevents)

The Biology Supporting the Hygiene

Hypothesis

Excess

Th1

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

Benefits of Trichuris suis ova (TSO)

75.9

62.1

79.3

72.4

Patients

and

Methods

•

29 CD patients with

CDAI>220 (mean=296)

•

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., GUT

2005

Effect of TSO in Crohn’s Disease

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

Effect of TSO in Ulcerative Colitis

12 week, dose ranging study

Double-blind, randomized,

placebo controlled

TSO 250, 2500, 7500 or placebo

N=250 (2

interim)

Crohn’s patients

•

CDAI = 220-350

•

CRP 2X ULN or Calprotectin 1X

ULN

Outcome –

Remission rates

Interim –

Mid-2013

TRUST -

12 week study

Double-blind, randomized,

placebo controlled

TSO 7500 or placebo

N=220

Crohn’s patients

•

CDAI = 220-450

•

Endoscopic evidence of

inflammation

Outcome –

Response rates

Topline data –

2H 2013

TSO Phase 2 Crohn’s Disease Studies

Correale

Farez

MF.

Neuroimmunol.

2011;233:6

Antihelminth

Treatment

(n=4)

Antihelminth

Treatment

(n=4)

12 patients/group

Impact of Parasitic Infections on the

Course of Multiple Sclerosis

Fleming, et.al., Multiple Sclerosis Journal 2011

Effect of TSO in Multiple Sclerosis

TSO (Trichuris suis ova or CNDO-201)

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, OL

Multiple Sclerosis (US)

16 pt, SB

Multiple Sclerosis (EU)

50 pt, DB, PC

Autism

10 pt, DB, Cross

Psoriasis

20 pt, OL

Type-1 Diabetes (early

intervention

60 pt, DB, PC

Type-1 Diabetes

(prevention)

150 pt, DB, PC

Psoriatic Arth/RA

20-30 pt, DB, PC

* TSO Phase 2a studies being conducted

as Investigator-Initiated Studies

Planned

1Q2013

4Q2012

Two phase 2 studies

4Q2012

1Q2013

2013

1Q2013

OL = Open-Label DB = Double-Blind, SB= Single-Blind PC = Placebo-Controlled

TSO Pipeline

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

TSO Manufacturing Process

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 of Helminth Eggs, in 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 of action of TSO should, if approved, allow it to be

positioned in a variety of autoimmune disorders, including inflammatory

bowel

diseases

and

multiple

sclerosis

well

other

potential

disorders

such as 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

Resting

Donor NK

Primed

Donor NK

CNDO-109

Patient’s

tumor

Dead

Tumor

cell

Priming –

Signal 1

Triggering –

Signal 2

Primed

Donor NK

Tumor lysis

Priming

receptor

Trigger

receptor

Priming

receptor

Trigger

receptor

Trigger

receptor

Priming

signal

Priming

receptor

Trigger

ligand

“Serial Killer”

CNDO-109 Mechanism of Action

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

1Q 2012

Filed IND

2H 2012

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

relapsed AML

Once the dose is selected, 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

Australia

–

exp.

3/2026

Pending in Europe, Canada, Japan and India

Patent pending -

“Preserved Compositions of Activated NK Cells

and

Methods

Using

the

Same”

–

exp.

7/2030

Provisional

application

pending

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

large

due

the

fact

that

many

types

tumors

are

sensitive

killing

activated

cells.

CNDO-109 Market Opportunity

Key Management and Board Members

Bobby W. Sandage, Jr., PhD

President & Chief Executive Officer

Served as EVP & CSO of Indevus Pharmaceuticals, Inc.

Over 30 years of pharmaceutical/biotechnology experience

Noah D. Beerman

EVP & Chief Operating Officer

Served as President & CEO of RXi Pharmaceuticals

Over 25 years of pharmaceutical/biotechnology experience

Karin Hehenberger, MD, PhD

EVP & Chief Medical Officer

Served in senior management positions at Juvenile Diabetes

Over 12 years of pharmaceutical/biotechnology experience

Lucy Lu, MD

EVP & Chief Financial Officer

Served Senior Analyst Citi, Lazard and First Albany

Over 10 years of equity research experience

Glenn L. Cooper, MD

Executive Chairman

Served as Chairman & CEO of Indevus Pharmaceuticals, Inc.

Over 25 years of pharmaceutical/biotechnology experience

Eric K. Rowinsky, MD

Vice Chairman

World renown oncologist, former CMO at ImClone, board of

Over 25 years of healthcare experience

Lindsay Rosenwald, MD

Director and Founder

A prolific and successful investor in the life sciences industry

for

Research Foundation and at JNJ Diabetes

Biogen/Idec

over 20 years

Listed on NASDAQ: CNDO

12/19/2011

Market

Cap

8/29/2012

$140M

Shares Outstanding

24.4M

Additional 3.4M options and warrants

Cash

Position

6/30/2012

$38.2M

Additional $15M loan secured in August

Financials

Principal

$15M

Interest

9.25%*

Payment Terms

42 Months

-First 12 months, interest only

-Next 30 months, principal and interest

Warrants

73,009

-Exercise price $5.65

*The loan bears interest at a rate per annum equal to the greater of (i) 9.25% or (ii) 9.25% plus the sum of the

prevailing prime rate minus 3.25%

$15M Hercules Loan

TSO

Initiate Phase 2 Crohn’s study

Completed

Initiate Multiple Investigator Initiated Studies

2H 2012

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

Mid-2013

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

2H 2013

CNDO-109

Initiate US Phase 1/2 study

2H 2012

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)

Crohn’s

Disease,

Ulcerative

Colitis (UC) and Multiple Sclerosis (MS)

CNDO-109:

Tumor

Activated

Cells

relapsed

Acute

Myeloid

Leukemia (AML)

Experienced management team and board of directors

Investment Highlights

Fortress Biotech (FBIO) 8-KRegulation FD Disclosure