Designation to facilitate expedited development and review of  CEVA101 for TBI
CEVA101 is being developed in partnership with The University of  Texas Health Science Center at Houston (UTHealth)

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New York, NY – November 8, 2017 – Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, today announced that the U.S. Food and Drug Administration (FDA) has granted Cellvation’s CEVA101 (autologous bone marrow-derived stem cells) Regenerative Medicine Advanced Therapy (“RMAT”) designation for the treatment of traumatic brain injury (“TBI”). Under terms of the RMAT designation, the FDA will help facilitate the program’s expedited development and review, and will provide guidance on generating the evidence needed to support approval of CEVA101 for TBI. CEVA101 is currently being assessed in Phase 2 clinical trials for severe TBI in children (ClinicalTrials.gov Identifier: NCT01851083) and adults (ClinicalTrials.gov Identifier: NCT02525432).

“The FDA’s grant of RMAT designation for CEVA101 further validates the compelling safety and efficacy data generated to date, and affirms the program’s potential to address a serious and life-threatening condition,” said Frank Taffy, Co-Founder, CEO, President & Board Member of Cellvation. Mr. Taffy continued, “We will continue to work closely with the FDA and our partners at UTHealth to drive the development of this critically-needed treatment option.”

Charles S. Cox, Jr., M.D., principal investigator, the George and Cynthia Mitchell Distinguished Chair in Neurosciences at UTHealth, professor in the Department of Pediatric Surgery and co‐director of the Memorial Hermann Red Duke Trauma Institute, said, “The RMAT designation represents a positive, rigorous review of our entire portfolio of translational and clinical stage work on CEVA101 for severe traumatic brain injury. Most importantly, it is a recognition that CEVA101 is a potential breakthrough to treat severe TBI.”

The RMAT designation makes a regenerative medicine advanced therapy product eligible for the same actions to expedite the development and review of a marketing application that are available to drugs that receive Breakthrough Therapy Designation, including timely advice and interactive communications with FDA, as well as proactive and collaborative involvement by senior FDA managers and experienced review and regulatory health project management staff. A product designated as an RMAT also may be eligible for other FDA-expedited programs, such as Priority Review. The FDA also may conduct a rolling review of products in its expedited programs, reviewing portions of a marketing application before the complete application is submitted.

The FDA’s RMAT designation is a primary component of the 21st Century Cures Act, signed into law in December 2016. According to this legislation, eligible drugs include regenerative medicine therapy, further defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or a combination product using such therapies or products. Further, eligible drugs are those intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and present preliminary clinical evidence indicating that the drug has the potential to address unmet medical needs for such disease or condition. The FDA has determined that CEVA101 for the treatment of TBI with Glasgow Coma Score between 3 and 8 meets the criteria for RMAT designation.

About The University of Texas Health Science Center at Houston
Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in The UT System and the U.S. Gulf Coast region, UTHealth is home to schools of biomedical informatics, biomedical sciences, dentistry, nursing and public health and the John P. and Kathrine G. McGovern Medical School. UTHealth includes The University of Texas Harris County Psychiatric Center and a growing network of clinics throughout the region. The university’s primary teaching hospitals include Memorial Hermann‐Texas Medical Center, Children’s Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital. For more information, visit www.uth.edu.

UTHealth is a leader in cell therapeutics for neurological injury and has developed novel approaches to the treatment of traumatic brain injury. McGovern Medical School at UTHealth is a collaborator with Memorial Hermann‐Texas Medical Center in the Memorial Hermann Red Duke Trauma Institute and Memorial Hermann Mischer Neuroscience Institute. Memorial Hermann‐TMC is one of the busiest Level 1 American College of Surgeons‐verified Adult and Pediatric Trauma Centers in the country.

About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes its products both within Fortress and through subsidiary companies, also known as Fortress Companies, and also develops other products relating to financial services through its affiliate, National Holdings Corporation (NASDAQ: NHLD). In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals.

Fortress and the Fortress Companies may seek licensing, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.com.

Forward‐Looking Statements
This press release may contain “forward‐looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. 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 include: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law.

Contacts:

Cellvation, Inc.
Frank Taffy, Co-Founder, CEO, President, Board Member
(212) 554-4520
frank@cellvation.com

Fortress Biotech, Inc.
Jaclyn Jaffe
(781) 652-4500
ir@fortressbiotech.com

Fortress Biotech Media Relations
Laura Bagby
6 Degrees
(312) 448-8098
lbagby@6degreespr.com

PUBLISHED IN STEM CELLS

Cell therapy safe, effective in mitigating neuroinflammatory response and preserving brain tissue after TBI
Positive Phase 1 data support ongoing Phase 2 trials in pediatric and adult patients

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New York, NY – November 17, 2017 – Cellvation, Inc., a clinical‐stage biopharmaceutical company and majority‐owned subsidiary of Fortress Biotech, Inc. (NASDAQ: FBIO) developing novel cell therapies for the treatment of traumatic brain injury (“TBI”), announced today data demonstrating a patient’s own stem cells may be safe and effective in diminishing neuroinflammatory response and preserving brain tissue in adults following severe TBI. Data from a Phase 1 study of Cellvation’s CEVA101, an autologous bone marrow‐derived mononuclear cell therapy, were published online this month in the journal STEM CELLS.

Researchers at The University of Texas Health Science Center at Houston (UTHealth) conducted the dose‐escalation study in 25 adults with severe TBI and without signs of irreversible brain injury. Bone marrow harvest,  cell  processing  and  re‐infusion  occurred  within  48  hours  after  injury.  The  bone  marrow  mononuclear cells were observed to be safe and well‐tolerated, with no serious adverse events related to the harvest or infusion. Furthermore, investigators in the study found evidence of central nervous system structural preservation, consistent with data from a Phase 1 pediatric trial of Cellvation’s CEVA101, and the mitigation of inflammatory biomarkers following cell infusion.

“The data derived from this trial moves beyond just testing safety of this approach,” said Charles S. Cox, Jr., M.D., principal investigator, the George and Cynthia Mitchell Distinguished Chair in Neurosciences at UTHealth, professor in the Department of Pediatric Surgery and co‐director of the Memorial Hermann Red Duke Trauma Institute. “We now have a hint of a treatment effect that mirrors our pre‐clinical work, and we are  now pursuing  this approach in a Phase 2b  clinical  trial sponsored  by the  Joint Warfighter  Program within the U.S. Army Medical Research Acquisition Activity, as well as our ongoing Phase 2b pediatric severe TBI clinical trial – both using the same autologous cell therapy.”

The Phase 1 study was supported by U.S. Department of Defense grant W81XWH‐11‐1‐0460, National Institutes of Health grant 2T32 GM 0879201‐11, the Glassell Foundation Stem Cell Research Program and The Brown Foundation, Inc. “To our knowledge, the STEM CELLS publication is the first reported clinical assessment of an IV‐infused cell  therapy  for  the  treatment  of  severe  TBI  in  adults.  The  data  set  is  compelling  and  suggests  that  CEVA101 could be a safe and effective approach in the acute trauma setting,” said Frank Taffy, co‐founder, interim CEO, President and a member of Cellvation’s Board of Directors. “We are thrilled to be working with UTHealth to advance this innovative program in a high‐risk setting characterized by significant unmet medical need.”
Charles S. Cox, Jr., M.D., and UTHealth have research‐related financial interests in Fortress, including its subsidiary Cellvation.

About Bone Marrow‐Derived Stem Cells for the Treatment of Traumatic Brain Injury
Traumatic brain injury (“TBI”) remains one of the greatest unsolved problems in clinical trauma care today. Cell‐based  therapy  is  distinguished  from  small  molecule  strategies  by  the  pleiotropic  mechanisms  of  action that have been determined in preclinical data and an excellent safety profile in early clinical trials. The mechanism of action appears to be related to down‐regulation of neuroinflammatory response of the innate immune system. Proof of concept data have been generated by The University of Texas Health Science Center at Houston (UTHealth) using bone marrow mononuclear cells (BMMNCs) in both stroke and  TBI.  These  data  formed  the  foundation  for  Phase  1  and  2  clinical  trials  of  Cellvation’s  BMMNCs  (CEVA101) in pediatric patients with severe TB and in adults with severe TBI. Cellvation also maintains rights to CEVA‐D, a novel bioreactor that amplifies anti‐inflammatory gene programs in adherent bone marrow‐derived mesenchymal stromal cells without external gene transfection approaches. The utility of this approach has been confirmed using in vivo models of TBI. Development of this pipeline of cellular therapeutics represents an opportunity to fundamentally change the approach to TBI treatment.

About The University of Texas Health Science Center at Houston
Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care education,  innovation,  scientific  discovery  and  excellence  in  patient  care.  The  most  comprehensive  academic health center in The UT System and the U.S. Gulf Coast region, UTHealth is home to schools of biomedical informatics, biomedical sciences, dentistry, nursing and public health and the John P. and Kathrine  G.  McGovern  Medical  School.  UTHealth  includes The University  of  Texas  Harris  County  Psychiatric Center and a growing network of clinics throughout the region. The university’s primary teaching  hospitals  include Memorial  Hermann‐Texas  Medical  Center, Children’s  Memorial  Hermann  Hospital and Harris Health Lyndon B. Johnson Hospital. For more information, visit www.uth.edu.

UTHealth is a leader in cell therapeutics for neurological injury and has developed novel approaches to the  treatment  of  traumatic  brain  injury.  McGovern  Medical  School  at  UTHealth  is  a  collaborator  with  Memorial Hermann‐Texas Medical Center in the Memorial Hermann Red Duke Trauma Institute and Memorial Hermann Mischer Neuroscience Institute. Memorial Hermann‐TMC is one of the busiest Level 1 American College of Surgeons‐verified Adult and Pediatric Trauma Centers in the country.

About Cellvation
Cellvation, Inc., is a clinical‐stage biopharmaceutical company developing novel cellular therapeutics for the  treatment  of  traumatic  brain  injury  (“TBI”).  Cellvation  is  currently  advancing  clinical‐stage  cell  therapies in severe TBI: a Phase 2 study of CEVA101 in pediatric patients (ClinicalTrials.gov Identifier: NCT01851083), and a Phase 2 study of CEVA101 in adults (ClinicalTrials.gov Identifier: NCT02525432). These studies are supported by grants of approximately $10 million from the National Institutes of Health and the Department of Defense. Cellvation is also developing CEVA‐D, a novel bioreactor that enhances the anti‐inflammatory potency of bone marrow‐derived cells without genetic manipulation. Cellvation is a majority‐owned subsidiary of Fortress Biotech (NASDAQ: FBIO) and is based in New York City.

About Fortress Biotech
Fortress Biotech, Inc.(“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and  commercializing  novel  pharmaceutical  and  biotechnology  products.  Fortress  develops  and  commercializes products both within Fortress and through certain of its subsidiary companies, also known as Fortress Companies. Additionally, Fortress recently acquired a controlling interest in National Holdings Corporation (NASDAQ: NHLD), a diversified independent brokerage company (together with its subsidiaries,  “NHLD”).  In  addition  to  its  internal  development  programs,  Fortress  leverages  its  biopharmaceutical business expertise and drug development capabilities and provides funding and management  services  to  help  the  Fortress  Companies  achieve  their  goals.  Fortress  and  the  Fortress  Companies may seek licensings, acquisitions, partnerships, joint ventures and/or public and private financings  to  accelerate  and  provide  additional  funding  to  support  their  research  and  development  programs. For more information, visit www.fortressbiotech.com.

Forward‐Looking Statements
This press release may contain “forward‐looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and  any  other  statements  that  are  not  historical  facts.  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 include: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate, and retain key personnel;  the early stage of products  under development; our need for substantial  additional funds;  government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law.

Contacts:

Cellvation, Inc.
Frank Taffy, Co‐Founder, Interim CEO, President, Board Member
(212) 554‐4520
frank@helocyte.com

Fortress Biotech Media Relations
Laura Bagby
6 Degrees
(312) 448‐8098
lbagby@6degreespr.com

Cellvation to Advance Three Programs Licensed from UTHealth
Two Phase 2 Studies Supported by Approximately $10M in Secured Grant Funding
Frank Taffy to Serve as Interim Chief Executive Officer

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New York, NY – November 7, 2016 – Fortress Biotech, Inc., (NASDAQ: FBIO) has formed a new subsidiary company, Cellvation, Inc., to develop novel therapies for the treatment of traumatic brain injury (“TBI”). Cellvation has entered into an agreement with The University of Texas Health Science Center at Houston (UTHealth) to secure exclusive worldwide rights to three programs for TBI, including two Phase 2 cell therapies.

For the pediatric population, a randomized, multi‐center, double‐blind, placebo‐controlled, Phase 2 study of autologous bone marrow‐derived stem cells for the treatment of severe TBI is ongoing and will enroll up to 50 patients (ClinicalTrials.gov Identifier: NCT01851083). For adults, a soon‐to‐becommenced, randomized, double‐blind, placebo‐controlled, Phase 2 study of autologous bone marrowderived stem cells for the treatment of severe TBI will enroll up to 55 patients (ClinicalTrials.gov Identifier: NCT02525432). The Phase 2 studies are supported by secured grants of approximately $10 million from the National Institutes of Health and the Department of Defense. Cellvation plans to strategically supplement this grant funding to open additional clinical sites and accelerate study outcomes.

According to the Centers for Disease Control and Prevention, TBI is a leading cause of death and disability in adults and children in the United States, contributing to almost one third of all injury‐related mortalities. TBI results from a trauma or jolt to the head (or a penetrating head injury) that impacts normal brain function. TBIs range in severity from “mild” (a brief change in mental status or consciousness, often referred to as a concussion) to “severe” (an extended period of unconsciousness typically requiring hospitalization). Based on the National Hospital Discharge Survey, there were approximately 2.5 million TBIs in the United States in 2010, which resulted in more than 50,000 deaths and 280,000 hospitalizations. Injuries associated with TBI cost an estimated $76 billion annually in the United States.

Cellvation also licensed rights from UTHealth to a next‐generation bioreactor that enhances the antiinflammatory potency of bone marrow‐derived cells without genetic manipulation. As Cellvation continues clinical development of its lead programs in the United States, it will explore early market entry in Japan under the recently revised Pharmaceutical Affairs Law, which provides for conditional approval of regenerative medicine products upon demonstration of safety and efficacy in early clinical studies.

The Cellvation programs were developed by Dr. Charles Cox, George & Cynthia Mitchell Distinguished Chair in Neurosciences; Director, Children’s Regenerative Medicine, McGovern Medical School at the UTHeath Department of Pediatric Surgery; and Co‐Director of the Memorial Hermann Red Duke Trauma Institute. Dr. Cox will serve as a key scientific advisor to the Company. “Cellular therapies are a highly promising strategy to mitigate the neuroinflammatory response to TBI that amplifies the initial injury,” said Dr. Cox. “Targeting this ‘secondary brain injury’ is designed to preserve injured tissue and ultimately improve outcomes. We are excited to work with the Cellvation team to advance these important programs.”

Dr. Lindsay A. Rosenwald, Chairman and CEO of Fortress Biotech, stated, “We are pleased to enter into this collaboration with UTHealth and Dr. Charles Cox. TBI is associated with significant unmet medical need and a standard of care that hasn’t evolved much over the past two decades. Data generated by Dr. Cox and his team suggest a cell therapy could reduce further injury following a head trauma and improve long‐term outcomes. We look forward to continuing development of these exciting therapies and delivering them to the bedside.”

Fortress also announced the appointment of Frank Taffy as interim Chief Executive Officer, President and member of Cellvation’s Board of Directors. Mr. Taffy identified the Cellvation programs and cofounded the company. He has more than 15 years of experience in life sciences corporate development and operations. Mr. Taffy currently serves as President, Chief Executive Officer and member of the Board of Directors for Helocyte, Inc., a company he also co‐founded that is focused on the development of novel immunotherapies for cancer and infectious disease. He previously held the positons of Head (Senior Director) of Business Affairs at Forest Laboratories (now Allergan) and Director of Corporate Development at Life Technologies (now Thermo Fisher Scientific), where he also held Board positions on behalf of the company. Mr. Taffy began his career as Counsel for Intellectual Property at Procter & Gamble. He holds a J.D. from Syracuse University College of Law and a B.A. in biochemistry from the University of North Texas.

About Bone Marrow‐Derived Stem Cells for the Treatment of Traumatic Brain Injury
Traumatic brain injury (“TBI”) remains one of the greatest unsolved problems in clinical trauma care today. Cell‐based therapy is distinguished from small molecule strategies by the pleiotropic mechanisms of action that have been determined in preclinical data and an excellent safety profile in early clinical trials. Proof of concept data have been developed using bone marrow mononuclear cells in both stroke and TBI, and these data formed the foundation for translation into Phase 1 and 2 clinical trials at UTHealth. The mechanism of action appears to be related to down‐regulation of neuroinflammatory response of the innate immune system. Cellvation further licensed rights from UTHealth to a novel bioreactor that amplifies anti‐inflammatory gene programs in adherent bone marrow derived mesenchymal stromal cells without external gene transfection approaches. The utility of this approach has been confirmed using in vivo models of TBI. Development of this pipeline of cellular therapeutics represents an opportunity to fundamentally change the approach to TBI treatment.

About The University of Texas Health Science Center at Houston
Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in The UT System and the U.S. Gulf Coast region, UTHealth is home to schools of biomedical informatics, biomedical sciences, dentistry, nursing and public health and the John P. and Kathrine G. McGovern Medical School. UTHealth includes The University of Texas Harris County Psychiatric Center and a growing network of clinics throughout the region. The university’s primary teaching hospitals include Memorial Hermann‐Texas Medical Center, Children’s Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital. For more information, visit www.uth.edu.

UTHealth is a leader in cell therapeutics for neurological injury and has developed novel approaches to the treatment of traumatic brain injury. McGovern Medical School at UTHealth is a collaborator with Memorial Hermann‐Texas Medical Center in the Memorial Hermann Red Duke Trauma Institute and Memorial Hermann Mischer Neuroscience Institute. Memorial Hermann‐TMC is one of the busiest Level 1 American College of Surgeons‐verified Adult and Pediatric Trauma Centers in the country.

About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes its products both within Fortress and through subsidiary companies, also known as Fortress Companies, and also develops other products relating to financial services through its affiliate, National Holdings Corporation (NASDAQ: NHLD). In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals.

Fortress and the Fortress Companies may seek licensing, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.com.

Forward‐Looking Statements
This press release may contain “forward‐looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. 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 include: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law.

Contacts:

Cellvation, Inc.
Frank Taffy, Co‐Founder, Interim CEO, President, Board Member
(212) 554‐4520
frank@helocyte.com

Fortress Biotech, Inc.
Lucy Lu, MD, Executive Vice President & Chief Financial Officer
(781) 652‐4500
ir@fortressbiotech.com

Fortress Biotech Media Relations
Laura Bagby
6 Degrees
(312) 448‐8098
lbagby@6degreespr.com

UTHealth Media Relations
Charles Cox, M.D.
Via Deborah Mann Lake
(713) 500‐3030
Deborah.m.lake@uth.tmc.edu