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 30 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 30 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

58% 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

58% 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

58% 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

58% 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

58% 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

58% 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

58% 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

58% 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

58% 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 approximate percentage ownership in Fortress partner company and corresponding direct product sales royalties owed to Fortress as of 9/30/2021

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

CUTX-101

Menkes Disease

72% Cyprium; 4.5% Royalty | 2.5% Equity Dividend

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)

17% Mustang; 4.5% Royalty | 2.5% Equity Dividend

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)

17% Mustang; 4.5% Royalty | 2.5% Equity Dividend

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 3

cSCC, NSCLC

19% Checkpoint; 4.5% Royalty | 2.5% Equity Dividend

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

Olafertinib

Frontline NSCLC with EGFR Mutations

19% Checkpoint; 4.5% Royalty | 2.5% Equity Dividend

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 4

AL Amyloidosis

42% 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 5

Rosacea

58% 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)

82% 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 | 2.5% Equity Dividend

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 | 2.5% Equity Dividend

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

IV Tramadol

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.

18% Avenue

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA Filed Phase in progress
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 approximate percentage ownership in Fortress partner company and corresponding direct product sales royalties owed to Fortress as of 12/31/2021
  3. Potential to support 1 or more BLA filings
  4. 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 $56.9 million of such upfront amount and is eligible to receive ~42% of the proceeds from all future milestone payments
  5. Fortress currently owns 58% of Journey Medical Corporation on an issued and outstanding basis as of 12/31/2021

Early Stage Product Candidates

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

MB-102

AML, BPDCN, and hrMDS

17% Mustang; 4.5% Royalty | 2.5% Equity Dividend

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)

17% Mustang; 4.5% Royalty | 2.5% Equity Dividend

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)

17% Mustang; 4.5% Royalty | 2.5% Equity Dividend

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)

17% Mustang; 4.5% Royalty | 2.5% Equity Dividend

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

17% Mustang; 4.5% Royalty | 2.5% Equity Dividend

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)

17% Mustang; 4.5% Royalty | 2.5% Equity Dividend

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

17% Mustang; 4.5% Royalty | 2.5% Equity Dividend

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

61% Baergic; 4.5% Royalty | 2.5% Equity Dividend

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

66% Urica Therapeutics | 2.5% Equity Dividend

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

MB-110

RAG1-SCID

17% Mustang; 4.5% Royalty | 2.5% Equity Dividend

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

In Vivo CAR T Technology

Hematologic and Solid Tumor Malignancies

17% Mustang; 4.5% Royalty | 2.5% Equity Dividend

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
  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 approximate percentage ownership in Fortress partner company and corresponding direct product sales royalties owed to Fortress as of 12/31/2021

Preclinical

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

AVTS-001

AMD, PNH, and aHUS

54% Aevitas; 4.5% Royalty | 2.5% Equity Dividend

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 | 2.5% Equity Dividend

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

19% Checkpoint; 4.5% Royalty | 2.5% Equity Dividend

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 | 2.5% Equity Dividend

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

19% Checkpoint; 4.5% Royalty | 2.5% Equity Dividend

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

19% Checkpoint; 4.5% Royalty | 2.5% Equity Dividend

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

82% Helocyte; 4.5% Royalty | 2.5% Equity Dividend

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 | 2.5% Equity Dividend

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 | 2.5% Equity Dividend

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 approximate percentage ownership in Fortress partner company and corresponding direct product sales royalties owed to Fortress as of 12/31/2021

World-Class Partners

We have established relationships with some of the world's leading academic research institutions and biopharmaceutical companies.

Alexion Pharmaceuticals, Inc.
Logo for Alexion Pharmaceuticals, Inc.

Alexion Pharmaceuticals, Inc.

In January 2019, Caelum Biosciences, Inc., a Fortress Biotech partner company, signed an agreement with Alexion Pharmaceuticals, Inc. to advance the development of CAEL-101 for light chain (AL) amyloidosis. The collaboration leverages Alexion’s expertise in rare disease antibody development and commercial franchise in hematology.

AstraZeneca
Logo for AstraZeneca

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines used by millions of patients worldwide. In December 2019, we entered into an exclusive worldwide licensing agreement with AstraZeneca for BAER-101 (formerly known as AZD7325), a novel α2/3–subtype-selective GABA A positive allosteric modulator (“PAM”). BAER-101 is currently in development at our partner company, Baergic Bio, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of central nervous system (“CNS”) disorders.

City of Hope
Logo for City of Hope

City of Hope

City of Hope is a world-renowned independent cancer research and treatment center. Our partner company Mustang Bio, Inc. entered into exclusive, worldwide licensing agreements with City of Hope on patents covering five novel CAR T cell therapies in development for multiple forms of cancer: MB-101 (IL-13Rα2 CAR T), MB-102 (CD123 CAR T), MB-103 (HER2 CAR T), MB-104 (CS1 CAR T) and MB-105 (PSCA CAR T). These CAR T cell therapies are currently in clinical development at City of Hope and supported by Mustang Bio, Inc. Another partner company, Helocyte, Inc., entered into exclusive, worldwide licensing agreements with City of Hope for the use of Triplex and ConVax, two novel immunotherapies to prevent and control cytomegalovirus (CMV).

Fred Hutchinson Cancer Research Center
Logo for Fred Hutchinson Cancer Research Center

Fred Hutchinson Cancer Research Center

In September 2017, we entered into an exclusive, worldwide licensing agreement with Fred Hutchinson Cancer Research Center for the use of MB-106, a CAR T therapy related to autologous T cells engineered to express a CD20-specific chimeric antigen receptor (CD20 Technology). MB-106 is currently in development at our partner company, Mustang Bio, Inc.

St. Jude Children’s Research Hospital
Logo for St. Jude Children’s Research Hospital

St. Jude Children’s Research Hospital

In August 2018, we entered into an exclusive worldwide license agreement with St. Jude Children’s Research Hospital for the development of MB-107, a first-in-class ex vivo lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID), also known as bubble boy disease. MB-107 is currently in development at our partner company, Mustang Bio, Inc.

Nationwide Children’s Hospital
Logo for Nationwide Children’s Hospital

Nationwide Children’s Hospital

In February 2019, we entered into an exclusive worldwide license agreement with Nationwide Children’s Hospital to develop MB-108, an oncolytic virus (C134) for the treatment of glioblastoma multiforme. MB-108 is currently in development at our partner company, Mustang Bio, Inc.

The University of Texas Health Science Center at Houston
Logo for The University of Texas Health Science Center at Houston

The University of Texas Health Science Center at Houston

In November 2016, we entered into an exclusive worldwide license agreement with The University of Texas Health Science Center at Houston (UTHealth) to secure rights to three programs for the treatment of traumatic brain injury (TBI), including two Phase 2 cell therapies (CEVA-101 pediatric and adult), CEVA-102 and a next-generation bioreactor called CEVA-D that enhances the anti-inflammatory potency of bone marrow‐derived cells without genetic manipulation. CEVA-101 is currently in development at our partner company, Cellvation, Inc.

Cincinnati Children’s Hospital Medical Center

Cincinnati Children’s Hospital Medical Center

Cincinnati Children’s is one of the oldest and most distinguished pediatric hospitals in the United States. In December 2019, we entered into an agreement with Cincinnati Children’s to advance clinical development of BAER-101, a novel α2/3–subtype-selective GABA A positive allosteric modulator (“PAM”), in select central nervous system (“CNS”) disorders. BAER-101 is currently in development at our partner company, Baergic Bio, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of CNS disorders.

Stock Information