Fortress Biotech Reports First Quarter 2016 Financial Results and Recent Corporate Highlights

On May 10, 2016 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, reported its financial results and recent corporate highlights for the quarter ended March 31, 2016 (Press release, Fortress Biotech, MAY 9, 2016, View Source;FID=1500085377 [SID:1234512312]).

Dr. Lindsay A. Rosenwald, Chairman, President and CEO of Fortress, said, "This year, we have continued to build our portfolio of products under development and Journey Medical Corporation’s roster of marketed products. We have also made significant progress advancing the pipeline of many of our other Fortress Companies, including Mustang Bio, which presented positive initial Phase I data on its CAR‐T therapy MB‐101 for the treatment of glioblastoma at the American Society of Gene and Cell Therapy 19th Annual Meeting. In addition, we are excited to possibly bring National Holdings Corporation under the Fortress umbrella with the goal of building a world‐class biotech and life sciences investment banking operations franchise. In 2016, we plan to continue to seek business development opportunities for Fortress and our Fortress Companies, as we expand our therapeutic focus and advance multiple milestones in our robust pipeline. We look forward to another transformative year in support of our mission of rapidly advancing meaningful treatments to people in need."

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Financial Results:
At March 31, 2016, Fortress’ consolidated cash and cash equivalents totaled $81.4 million compared to $98.2 million at December 31, 2015, a decrease of $16.8 million for the quarter. These totals exclude restricted cash of $14.6 million. The majority of the cash payments were related to Fortress and Fortress Companies previously accrued liabilities and upfront fees.

Revenue totaled $0.7 million for the first quarter of 2016.

Research and development expenses were $7.7 million for the first quarter of 2016, compared to $1.6 million for the first quarter of 2015.  

General and administrative expenses were $7.9 million for the first quarter of 2016, compared to $3.5 million for the first quarter of 2015.   

Net loss was $12.2 million, or $0.31 per share, for the first quarter of 2016, compared to a net loss of $12.1 million, or $0.31 per share, for the first quarter of 2015.   

Noncash stock‐based compensation expense included in net loss for the first quarter of 2016 was $2.9 million, compared to $1.5 million for the first quarter of 2015.

Recent Corporate Highlights:

Avenue Therapeutics, Inc.
During the three months ended March 31, 2016, Avenue completed a pharmacokinetics (PK) study for intravenous (IV) Tramadol.

Checkpoint Therapeutics, Inc.
In February 2016, Checkpoint repaid its National Securities Corporation (NSC) Debt of $2.8 million.

FBIO Acquisition, Inc.
In April 2016, Fortress, FBIO Acquisition, Inc. and National Holdings Corporation ("NHLD") entered into an agreement and plan of merger for the acquisition of NHLD by FBIO Acquisition, Inc.

Helocyte, Inc.
In February 2016, Helocyte entered into an Investigator‐Initiated Clinical Research Support Agreement with the City of Hope National Medical Center, to support a Phase 2 clinical study of its Triplex immunotherapy for CMV control in allogeneic stem cell transplant recipients. The Phase 2 study is additionally supported by grants from the National Cancer Institute.   

In February 2016, Helocyte entered into an option agreement with The University of Texas Health Science Center at Houston, for the exclusive rights to license certain intellectual property and clinical data relating to the use of bone marrow derived mononuclear cells for the treatment of severe Traumatic Brain Injury.   

In March 2016, Helocyte entered into an Investigator‐Initiated Clinical Research Support Agreement with the City of Hope National Medical Center, to support a Phase 2 clinical study of its PepVax immunotherapy for CMV control in allogeneic stem cell transplant recipients. The Phase 2 study is additionally supported by grants from the National Cancer Institute.  

Journey Medical Corporation (JMC)
In January 2016, JMC entered into a licensing agreement with a third party to distribute a prescription wound cream. JMC intends to commercialize this product in the second quarter of 2016.  

In January 2016, JMC entered into a licensing agreement with a third party to distribute an emollient for the treatment of various types of dermatitis. JMC intends to commercialize this product in the second quarter of 2016. Both products will be marketed under the JMC brand.

Mustang Bio, Inc.
In April 2016, Mustang announced that two abstracts pertaining to MB‐101 (IL13Rα2‐specific CAR T cells) for the treatment of glioblastoma were selected for presentation at the American Society of Gene and Cell Therapy 19thAnnual Meeting (ASGCT) (Free ASGCT Whitepaper). Pre‐clinical and preliminary Phase I data were presented at ASGCT (Free ASGCT Whitepaper) on Thursday, May 5.