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Section 1: 8-K (FORM 8-K)

 

  

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

 

FORM 8-K

 

 

  

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): November 9, 2018

 

Fortress Biotech, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

001-35366

 

20-5157386

(State or Other Jurisdiction of Incorporation) 

 

(Commission File Number) 

 

(IRS Employer Identification No.) 

 

2 Gansevoort Street, 9th Floor

New York, NY 10014

(Address of Principal Executive Offices)

 

(781) 652-4500

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨Written communications pursuant to Rule 425 under the Securities Act.

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act.

 

¨Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act.

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

 

 

 

 

Item 2.02.Results of Operations and Financial Condition.

 

On November 9, 2018, Fortress Biotech, Inc. issued a press release to provide a corporate update and to announce its financial results for the third quarter ended September 30, 2018. A copy of such press release is being furnished as Exhibit 99.1 to this report.

 

Item 9.01.Financial Statements and Exhibits.

 

(d)Exhibits.

 

The following exhibit is furnished herewith:

 

Exhibit
Number
  Description
99.1    Press release issued by Fortress Biotech, Inc., dated November 9, 2018.

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: November 9, 2018 Fortress Biotech, Inc.
  (Registrant)
     
  By:   /s/ Lindsay A. Rosenwald, M.D.
    Lindsay A. Rosenwald, M.D.
    Chairman, President and Chief Executive Officer

 

 

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Section 2: EX-99.1 (EXHIBIT 99.1)

 

Exhibit 99.1

 

 

 

Fortress Biotech Reports Third Quarter 2018 Financial Results and Recent Corporate Highlights

 

New York, NY – November 9, 2018 – Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2018.

 

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “Fortress and our subsidiaries continued to achieve important corporate and clinical milestones in the third quarter of 2018. Mustang Bio expanded its pipeline into gene therapy by securing an exclusive worldwide license for the development of a potentially first-in-class ex vivo lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (“X-SCID”) from St. Jude Children’s Research Hospital (“St. Jude”). Additionally, Checkpoint Therapeutics announced positive interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor being evaluated in advanced non-small cell lung cancer (“NSCLC”). Finally, Cyprium Therapeutics’ product candidate for patients diagnosed with classic Menkes disease, CUTX-101, was granted Fast Track Designation by the U.S. Food and Drug Administration (“FDA”). We plan to continue to acquire and develop compelling and, in some instances, potentially life-saving product candidates, which could lead to maximizing shareholder value.”

 

Financial Results:

 

·As of September 30, 2018, Fortress’ consolidated cash, cash equivalents, short-term investments (certificates of deposit), cash deposits with clearing organizations and restricted cash totaled $136.1 million, compared to $168.3 million as of December 31, 2017, a decrease of $32.2 million year-to-date.

·Net revenue totaled $63.7 million for the third quarter of 2018, compared to $46.9 million for the third quarter of 2017. Total revenue as of September 30, 2018 includes $5.2 million of Fortress revenue, primarily from the sale of Journey Medical Corporation products, and $58.5 million of revenue from National Holdings Corporation1 (“National Holdings”). Total revenue as of September 30, 2017 included $2.5 million of Fortress revenue and $44.4 million of revenue from National Holdings.

·Research and development expenses were $16.1 million for the third quarter of 2018, of which $15.1 million was related to Fortress Companies. This compares to $15.9 million for the third quarter of 2017, of which $14.2 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in research and development were $1.8 million for the third quarter of 2018, compared to $1.6 million for the third quarter of 2017.

·Research and development expenses from license acquisitions were $3.7 million for the third quarter of 2018, compared to $0.3 million for the third quarter of 2017.

·General and administrative expenses were $12.2 million for the third quarter of 2018, of which $7.4 million was related to Fortress Companies. This compares to $15.1 million for the third quarter of 2017, of which $10.5 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in general and administrative expenses were $2.3 million for the third quarter of 2018, compared to $2.6 million for the third quarter of 2017.

·National Holdings’ operating expenses totaled $55.2 million for the third quarter of 2018, compared to $47.7 million for the third quarter of 2017.

·Net loss attributable to common stockholders was $16.6 million, or $0.37 per share, for the third quarter of 2018, compared to a net loss attributable to common stockholders of $27.1 million, or $0.67 per share, for the third quarter of 2017. For the first nine months of 2018, net loss attributable to common stockholders was $59.3 million or $1.36 per share, compared to $56.5 million or $1.39 per share in the first nine months of 2017.

 

 

 

 

Recent Fortress and Fortress Company Highlights:

 

Aevitas Therapeutics, Inc.

·In August 2018, Aevitas announced that it entered into a sponsored research agreement with the laboratory of Wenchao Song, Ph.D., at the University of Pennsylvania to evaluate Aevitas’ adeno-associated virus (“AAV”) gene therapy technology in the university’s proprietary animal models of complement-mediated diseases.

 

Caelum Biosciences, Inc.

·In November 2018, Caelum announced that global longitudinal strain (“GLS”) data from the Phase 1b study of CAEL-101 (a light chain fibril-reactive monoclonal antibody 11-1F4) in patients with amyloid light chain (“AL”) amyloidosis and imaging data from a pre-clinical study have been selected for two oral presentations at the 60th American Society of Hematology (“ASH”) Annual Meeting, to be held December 1-4, 2018, in San Diego.

 

Checkpoint Therapeutics, Inc.

·In September 2018, Checkpoint announced positive interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation EGFR tyrosine kinase inhibitor (“TKI”) being evaluated in advanced NSCLC. The data were presented in an oral presentation at the International Association for the Study of Lung Cancer (“IASLC”) 19th World Conference on Lung Cancer in Toronto. CK-101 was well tolerated across multiple dose groups and safe. Durable anti-tumor activity was observed, particularly in treatment-naïve EGFR mutation-positive NSCLC patients.
·In October 2018, Checkpoint appointed Christian Béchon to its Board of Directors.

 

Cyprium Therapeutics, Inc.

·In July 2018, Cyprium announced that the FDA granted Fast Track Designation to CUTX-101, a product candidate for patients diagnosed with classic Menkes disease who have not demonstrated significant clinical progression.
·In September 2018, Cyprium announced the publication of preclinical data on AAV-based gene therapy combined with subcutaneous CUTX-101 (“Copper Histidinate”) for Menkes disease in Molecular Therapy: Methods & Clinical Development.

 

Mustang Bio, Inc.

·In July 2018, Mustang completed a pre-Investigational New Drug (“pre-IND”) meeting with the FDA for MB-102 (“CD123 CAR T”). Based on the meeting, Mustang expects to file an IND in the fourth quarter of 2018 to support a Phase 1/2 trial of MB-102 in acute myeloid leukemia, blastic plasmacytoid dendritic cell neoplasm and high-risk myelodysplastic syndrome.
·In August 2018, Mustang announced that it entered into an exclusive worldwide license agreement with St. Jude for the development of a potentially first-in-class ex vivo lentiviral gene therapy for the treatment of X-SCID, also known as bubble boy disease. The therapy is currently being evaluated in a Phase 1/2 multicenter trial in infants under the age of two. This study is the world’s first lentiviral gene therapy trial for infants with X-SCID. The therapy is also being investigated in patients over the age of two in a second Phase 1/2 trial at the National Institutes of Health (“NIH”).
·In October 2018, Mustang appointed Martina A. Sersch, M.D., Ph.D., as Chief Medical Officer.
·Also in October 2018, Mustang announced that a first-of-its-kind Phase 1 clinical trial evaluating the safety and effectiveness of intraventricular delivery of CAR T cells to the brains of patients with HER2-positive breast cancer with brain metastases has been initiated at City of Hope. In addition, Mustang announced that City of Hope has dosed the first patient in a Phase 1 clinical trial of HER2-specific CAR T cells in treating recurrent or refractory grade III-IV glioma. The trial will evaluate the side effects and best dose of HER2-specific CAR T cells in treating patients with grade III-IV glioma that has come back or does not respond to treatment.

 

 

 

 

About Fortress Biotech

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 subsidiary companies, also known as Fortress Companies. 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 arrangements, 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, as amended. 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 relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; 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.

 

Company Contact:

Jaclyn Jaffe

Fortress Biotech, Inc.

(781) 652-4500

ir@fortressbiotech.com

 

Investor Relations Contact:

Jeremy Feffer

Managing Director, LifeSci Advisors, LLC

(212) 915-2568

jeremy@lifesciadvisors.com

 

Media Relations Contact:

Tony Plohoros

6 Degrees

(908) 940-0135

tplohoros@6degreespr.com

 

1 Fortress acquired approximately 56 percent of National Holdings in September 2016.

 

 

 

 

FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
($ in thousands except for share and per share amounts)

 

  

September 30,
2018

  

December 31,
2017

 
   (Unaudited)     
ASSETS          
Current assets          
Cash and cash equivalents  $95,867   $113,915 
Accounts receivable   5,431    7,758 
Short-term investments (certificates of deposit)   22,538    36,002 
Cash deposits with clearing organizations   336    1,041 
Receivables from broker-dealers and clearing organizations   11,884    7,395 
Forgivable loans receivable   1,610    1,616 
Securities owned, at fair value   6,675    1,985 
Inventory   674    171 
Other receivables - related party   414    618 
Prepaid expenses and other current assets   14,089    12,680 
Total current assets   159,518    183,181 
           
Property and equipment, net   14,642    9,513 
Restricted cash   17,358    17,387 
Long-term investments, at fair value       1,390 
Intangible assets   13,935    15,223 
Goodwill   18,645    18,645 
Other assets   821    611 
Total assets  $224,919   $245,950 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities          
Accounts payable and accrued expenses  $37,345   $36,127 
Accounts payable and accrued expenses - related party   153    222 
Accrued commissions and payroll payable   11,974    10,065 
Deferred clearing and marketing credits   629    786 
Securities sold, not yet purchased, at fair value   24    151 
Warrants issued - National       5,597 
Interest payable   613    887 
Interest payable - related party   94    97 
Notes payable, short-term (net of debt discount of $447 and $973 at September 30, 2018 and December 31, 2017, respectively)   9,054    8,528 
Subsidiary convertible note, short-term, at fair value   10,657    4,700 
Deferred revenue   155     
Derivative warrant liability       87 
Other current liabilities   77    181 
Total current liabilities   70,775    67,428 
           
Notes payable, long-term (net of debt discount of $445 and $62 at September 30, 2018 and December 31, 2017, respectively)   64,546    43,222 
Subsidiary convertible note, long-term, at fair value       10,059 
Other long-term liabilities   4,961    4,739 
Total liabilities   140,282    125,448 
           
Stockholders’ equity          
Preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 1,000,000 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively; liquidation value of $25.00 per share   1    1 
Common stock, $0.001 par value, 100,000,000 shares authorized, 56,183,480 and 50,991,285 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively   56    51 
Common stock issuable, 347,684 and 158,015 shares as of September 30, 2018 and December 31, 2017, respectively   495    500 
Additional paid-in-capital   408,615    364,148 
Accumulated deficit   (371,394)   (312,127)
Total stockholders’ equity attributed to the Company   37,773    52,573 
           
Non-controlling interests   46,864    67,929 
Total stockholders’ equity   84,637    120,502 
Total liabilities and stockholders’ equity  $224,919   $245,950 

 

 

 

 

FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
($ in thousands except for share and per share amounts)
(Unaudited)

 

  

For the Three Months Ended

September 30,

  

For the Nine Months Ended

September 30,

 
   2018   2017   2018   2017 
Revenue                    
Fortress                    
Product revenue, net  $5,168   $2,170   $17,366   $8,309 
Revenue - from a related party   5    350    525    1,393 
Net Fortress revenue   5,173    2,520    17,891    9,702 
                     
National                    
Commissions   28,397    24,881    85,422    73,380 
Net dealer inventory gains   482    1,789    5,601    6,666 
Investment banking   19,271    8,942    43,012    26,595 
Investment advisory   5,281    3,605    15,811    10,480 
Interest and dividends   771    674    2,003    2,065 
Transfer fees and clearing services   1,606    1,649    5,680    5,834 
Tax preparation and accounting   2,444    2,527    6,835    6,527 
Other   268    299    697    1,016 
Total National revenue   58,520    44,366    165,061    132,563 
Net revenue   63,693    46,886    182,952    142,265 
                     
Operating expenses                    
Fortress                    
Cost of goods sold - product revenue   1,406    505    4,546    1,852 
Research and development   16,082    15,890    58,528    34,683 
Research and development - licenses acquired   3,706    300    3,804    3,394 
General and administrative   12,184    15,104    38,788    36,490 
Total Fortress operating expenses   33,378    31,799    105,666    76,419 
                     
National                    
Commissions, compensation and fees   48,556    39,963    141,462    118,983 
Clearing fees   451    470    1,772    1,826 
Communications   856    690    2,429    2,094 
Occupancy   738    972    2,834    2,916 
Licenses and registration   861    391    2,028    1,223 
Professional fees   1,076    1,082    3,047    3,336 
Interest   26    5    30    13 
Underwriting costs   43        230     
Depreciation and amortization   871    507    2,587    1,513 
Other administrative expenses   1,726    3,610    5,839    7,315 
Total National operating expenses   55,204    47,690    162,258    139,219 
Total operating expenses   88,582    79,489    267,924    215,638 
Loss from operations   (24,889)   (32,603)   (84,972)   (73,373)
                     
Other income (expenses)                    
Interest income   269    204    841    530 
Interest expense and financing fee   (2,228)   (3,220)   (6,455)   (5,298)
Change in fair value of derivative liabilities   -    (639)   (7,931)   5,155 
Change in fair value of subsidiary convertible note   (84)   (74)   26    (359)
Change in fair value of investments   (565)   270    (1,390)   (241)
Other expenses   (146)   (245)   (258)   (232)
Total other expenses   (2,754)   (3,704)   (15,167)   (445)
Loss before income taxes   (27,643)   (36,307)   (100,139)   (73,818)
Income tax expense   944        2,382     
Net loss   (28,587)   (36,307)   (102,521)   (73,818)
Less: net loss attributable to non-controlling interests   (11,949)   (9,191)   (43,254)   (17,355)
Net loss attributable to common stockholders  $(16,638)  $(27,116)  $(59,267)  $(56,463)
                     
Basic and diluted net loss per common share  $(0.37)  $(0.67)  $(1.36)  $(1.39)
                     
Weighted average common shares outstanding-basic and diluted   44,818,186    40,724,115    43,578,763    40,547,364 

 

 

 

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