An Innovative Biopharmaceutical Company Building a Diversified Pipeline of Revenue-Generating Pharmaceutical Products and Development-Stage Product Candidates

At Fortress Biotech, Inc., we leverage our extensive biopharmaceutical business and comprehensive drug development expertise to build a pipeline of both commercial-stage products and development-stage product candidates, as well as to advance our products and pipeline as efficiently as possible with our partners.

About Us

A Robust, Late-Stage Product Pipeline

Over 25 Programs in Development

We are dedicated to developing novel therapies and solutions for a wide variety of patients in need. Our pipeline of more than 25 programs developed across our partner companies spans several large-market therapeutic areas and includes multiple late-stage product candidates.

Diverse Therapeutic Areas

  • Oncology / Hematology
  • Gene Therapy
  • Neurology
  • Pain Management
  • Rare Diseases
  • Infectious Diseases
  • Dermatology
  • CNS Disorders
  • Rheumatology

Our Current Programs1

Commercial

Candidate Indication Partnership2 Preclinical Phase 1 Phase 2 Phase 3 NDA Filed Market

93% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA Filed Phase complete
Market Phase in progress

Acne

93% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA Filed Phase complete
Market Phase in progress

Acne

93% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA Filed Phase complete
Market Phase in progress

Fungal Infections

93% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA Filed Phase complete
Market Phase in progress

Eczema

93% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA Filed Phase complete
Market Phase in progress

Wounds

93% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA Filed Phase complete
Market Phase in progress

Recalcitrant Nodular Acne

93% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA Filed Phase complete
Market Phase in progress
  1. Includes product candidates in development at Fortress, its majority-owned and majority-controlled partner companies and entities in which it holds minority ownership positions.
  2. Column reflects percentage ownership in Fortress partner company; Fortress currently owns 93% of Journey Medical Corporation on an outstanding share basis, 62% on a fully-diluted basis.

IMPORTANT SAFETY INFORMATION FOR ACCUTANE® (ISOTRETINOIN)

CONTRAINDICATIONS AND WARNINGS

Accutane® must not be used by patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

Late Stage Product Candidates

Candidate Indication Partnership; Royalty2 Preclinical Phase 1 Phase 2 Phase 3 NDA Filed Market

IV Tramadol 3

Post-Surgical Acute Pain

Many patients who undergo surgical procedures experience severe postoperative pain. IV Tramadol is being developed as a potential treatment for pain management following surgery, including abdominoplasty and bunionectomy.

Abdominoplasty, or more commonly referred to as a “tummy tuck,” is a cosmetic surgical procedure in which excess skin and fat is removed from the abdomen, resulting in a smoother and firmer abdomen. A bunionectomy is a surgical procedure to remove a bunion from a patient’s foot. Depending on the complexity of these surgeries, some patients will experience severe postoperative pain.

29% Avenue; 10-20% CVR Royalty on Gross Profits

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA Filed Phase in progress
Market Phase not started

CUTX-101

Menkes Disease

72% Cyprium; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase in progress
NDA Filed Phase not started
Market Phase not started

MB-107

Newly Diagnosed X-Linked Severe Combined Immunodeficiency (XSCID)

~18% Mustang; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

MB-207

Previously Transplanted X-Linked Severe Combined Immunodeficiency (XSCID)

~18% Mustang; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

Cosibelimab 4

cSCC

~20% Checkpoint; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

Olafertinib

Frontline NSCLC with EGFR Mutations

~20% Checkpoint; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

CAEL-101 5

AL Amyloidosis

43% Caelum

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase in progress
NDA Filed Phase not started
Market Phase not started

DFD-29 6

Rosacea

93% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

Triplex

Cytomegalovirus (CMV)

81% Helocyte; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

CEVA 101 Pediatric

Traumatic Brain Injury (TBI)

78% Cellvation; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

CEVA 101 Adult

Traumatic Brain Injury (TBI)

78% Cellvation; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started
  1. Includes product candidates in development at Fortress, its majority-owned and majority-controlled partner companies and entities in which it holds minority ownership positions.
  2. Column reflects percentage ownership in Fortress partner company and corresponding direct product sales royalties owed to Fortress
  3. FBIO is eligible to receive ~29% of the proceeds upon the second-stage closing of the InvaGen transaction, and currently owns 23% of Avenue’s issued and outstanding capital stock. Fortress to receive approximately 1/3 of CVR distribution on gross profits if certain net sales thresholds are met. As Avenue did not receive FDA approval for IV Tramadol by April 30, 2021, accordingly, under the SPMA, InvaGen retains an option to consummate the second stage closing until October 31, 2021, and also retains the option to terminate the SPMA.
  4. P1 Registration enabling expansion cohorts ongoing; potential to support 1 or more BLA filings
  5. AstraZeneca’s Alexion acquired Caelum Biosciences on 10/5/2021 for up to $500 million, including $150 million upfront and up to $350 million in future contingent milestone payments. FBIO received ~$64 million of such upfront amount and is eligible to receive ~43% of the proceeds from all future milestone payments.
  6. Fortress currently owns 93% of Journey Medical Corporation on an outstanding share basis, 62% on a fully-diluted basis.

Early Stage Product Candidates

Candidate Indication Partnership; Royalty2 Preclinical Phase 1 Phase 2 Phase 3 NDA Filed Market

MB-102

AML, BPDCN, and hrMDS

~18% Mustang; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

MB-101

Glioblastoma (GBM)

~18% Mustang; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

MB-104

Multiple Myeloma (MM)

~18% Mustang; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

MB-106

B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (CLL)

~18% Mustang; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

MB-103

GBM and Metastatic Breast Cancer to Brain

~18% Mustang; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

MB-108

Glioblastoma (GBM)

~18% Mustang; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

MB-105

Prostate, Pancreatic, Gastric and Bladder Cancers

~18% Mustang; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

BAER-101

CNS Disorders

60% Baergic; 4.5% Royalty

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

Dotinurad

Rheumatology

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started
  1. Includes product candidates in development at Fortress, its majority-owned and majority-controlled partner companies and entities in which it holds minority ownership positions.
  2. Column reflects percentage ownership in Fortress partner company and corresponding direct product sales royalties owed to Fortress

Preclinical

Candidate Indication Partnership; Royalty2 Preclinical Phase 1 Phase 2 Phase 3 NDA Filed Market

AVTS-001

AMD, PNH, and aHUS

61% Aevitas; 4.5% Royalty

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

AAV-ATP7A Gene Therapy

Menkes Disease

72% Cyprium; 4.5% Royalty

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

CK-103

Multiple Solid Tumors

~20% Checkpoint; 4.5% Royalty

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

CEVA-102

Traumatic Brain Injury (TBI)

78% Cellvation; 4.5% Royalty

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

CK-302

Multiple Solid Tumors

~20% Checkpoint; 4.5% Royalty

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

CK-303

Multiple Solid Tumors

~20% Checkpoint; 4.5% Royalty

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

ConVax

Cytomegalovirus Prevention and Control

81% Helocyte; 4.5% Royalty

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

CEVA-D

Traumatic Brain Injury (TBI)

78% Cellvation; 4.5% Royalty

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started

ONCOlogues

Genetically Driven Cancers & Coronaviruses

75% Oncogenuity; 4.5% Royalty

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA Filed Phase not started
Market Phase not started
  1. Includes product candidates in development at Fortress, its majority-owned and majority-controlled partner companies and entities in which it holds minority ownership positions.
  2. Column reflects percentage ownership in Fortress partner company and corresponding direct product sales royalties owed to Fortress

Stock Information