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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): March 16, 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 March 16, 2018, Fortress Biotech, Inc. issued a press release to provide a corporate update and to announce its financial results for the year ended December 31, 2017. 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 March 16, 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: March 16, 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 Fourth Quarter and Full-Year 2017 Financial Results and Recent Corporate Highlights

 

New York, NY – March 16, 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 fourth quarter and full year ended December 31, 2017.

 

Lindsay A. Rosenwald, M.D., Fortress Biotech’s Chairman, President and Chief Executive Officer, said, “In 2017, we continued to build our portfolio of subsidiary companies, with the launch of Aevitas Therapeutics, Caelum Biosciences, Cyprium Therapeutics and Tamid Bio, strengthening our position in gene therapy and rare disease. In addition, our established Fortress Companies achieved several significant milestones, including the expansion of Mustang Bio’s CAR T pipeline and a partnership with Harvard University and Beth Israel Deaconess Medical Center for the development of CRISPR/Cas9-enhanced CAR T therapies. In the third quarter of 2017, Mustang announced an exclusive, worldwide licensing agreement with the Fred Hutchinson Cancer Research Center for CD20-specific CAR T technology, which is currently in a Phase 1/2 clinical trial at Fred Hutch evaluating the safety and efficacy of the CD20 technology in patients with relapsed or refractory B-cell non-Hodgkin lymphomas. Other significant milestones achieved by our Fortress Companies include an FDA RMAT designation for Cellvation’s CEVA101 in severe traumatic brain injury, the dosing of a pivotal Phase 3 trial of Avenue Therapeutics’ IV tramadol in postoperative pain and the Nasdaq listing of three Fortress Companies.”

 

Dr. Rosenwald continued, “The year culminated with the presentation of clinical data on Caelum’s CAEL-101 and Mustang’s MB-102 in oral sessions at the American Society of Hematology Annual Meeting in December. In 2018, we look forward to building on the momentum of 2017, as we continue to advance promising therapies through clinical development and evaluate additional opportunities to fortify our portfolio.”

 

Financial Results:

 

·As of December 31, 2017, Fortress’ consolidated cash, cash equivalents, short-term investments (certificates of deposit), cash deposits with clearing organizations and restricted cash totaled $168.3 million, compared to $172.6 million as of September 30, 2017, and $105.2 million as of December 31, 2016, a decrease of $4.3 million for the fourth quarter and an increase of $63.1 million year-to-date.
·Net revenue totaled $187.6 million as of December 31, 2017, compared to $16.5 million as of December 31, 2016. Total revenue as of December 31, 2017 includes $17.2 million of Fortress revenue and $170.4 million of revenue from National Holdings Corporation (“National”). Total revenue as of December 31, 2016, includes $6.2 million of Fortress revenue and $10.3 million of revenue from National. No revenue is attributable to National prior to Fortress’ acquisition of the company in September 2016.

 

 

 

 

·Research and development expenses were $48.3 million for the year ended December 31, 2017, of which $40.6 million was related to Fortress Companies. This compares to $29.6 million for 2016, of which $27.6 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in research and development were $4.0 million for the year ended December 31, 2017, compared to $4.7 million for 2016.
·Research and development expenses from license acquisitions totaled $4.2 million for the year ended December 31, 2017, compared to $5.5 million for 2016.
·General and administrative expenses were $50.9 million for the year ended December 31, 2017, of which $31.4 million was related to Fortress Companies. This compares to $34.0 million for 2016, of which $16.5 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in general and administrative expenses were $9.4 million for the year ended December 31, 2017 compared to $7.4 million for 2016.
·National’s operating expenses totaled $181.8 million for the year ended December 31, 2017, compared to $12.3 million for 2016, with no expenses attributable to National prior to Fortress’ acquisition of the company in September 2016.
·Net loss attributable to common stockholders was $66.9 million, or $1.61 per share, for the year ended December 31, 2017, compared to a net loss attributable to common stockholders of $55.1 million, or $1.38 per share, for 2016.

 

2017 and Recent Fortress Biotech and Fortress Company Highlights:

 

Fortress Biotech, Inc.

·In November 2017, Fortress closed an underwritten public offering of its 9.375 percent Series A Cumulative Redeemable Perpetual Preferred Stock at a price of $25.00 per share and received net proceeds totaling approximately $22.2 million.
·As of December 31, 2017, Fortress raised a total of $28.4 million in a subordinated note financing. National Securities Corporation, a subsidiary of National, acted as placement agent in connection with such financing.
·In 2017, Fortress launched four Fortress Companies: Caelum Biosciences, Inc., focused on treatments for amyloid light chain (“AL”) amyloidosis; Cyprium Therapeutics, Inc., to develop novel therapies for the treatment of Menkes disease and related copper metabolism disorders; Aevitas Therapeutics, Inc., to develop novel gene therapy approaches for complement-mediated diseases; and Tamid Bio, Inc., to develop adeno-associated virus (“AAV”) gene therapies in orphan diseases with unmet medical needs.

 

Aevitas Therapeutics, Inc.

·In February 2018, Aevitas entered into a sponsored research agreement with the laboratory of Guangping Gao, Ph.D., at the University of Massachusetts Medical School to evaluate construct optimization in the development of gene therapies based on Aevitas’ AAV technology.

 

Avenue Therapeutics, Inc.

·In February 2017, the U.S. Patent and Trademark Office (USPTO) issued Avenue two continuation patents covering methods of administration for IV tramadol for the treatment of acute pain.
·In May 2017, Avenue announced a Notice of Allowance from the USPTO for a new patent application (U.S. Application No. 15/163,111) titled "Intravenous Administration of Tramadol.” The patent application describes and claims a dosing regimen of IV 50 mg tramadol that provides certain pharmacokinetic parameters that are similar to those of 100 mg tramadol HCl administered orally every six hours at a steady state. The patent (U.S. Patent No. 9,693,949) was issued in July 2017.
·In June 2017, Avenue completed an initial public offering of 6,325,000 shares of common stock at a public offering price of $6.00 per share, resulting in net proceeds of $34.2 million. Avenue’s common stock began trading on The NASDAQ Capital Market in June 2017 under the ticker symbol “ATXI.”

 

 

 

 

·In September 2017, Avenue dosed the first patient in its pivotal Phase 3 trial of IV tramadol for the management of moderate to moderately severe postoperative pain in patients following bunionectomy surgery. Topline data are expected in the second quarter of 2018.
·In December 2017, Avenue dosed the first patient in the Phase 3 safety trial of IV tramadol for the management of moderate to moderately severe postoperative pain.

 

Caelum Biosciences, Inc.

·In January 2017, Caelum entered into an agreement with Columbia University (“Columbia”) to secure exclusive, worldwide license rights to CAEL-101, a monoclonal antibody for the treatment of AL Amyloidosis.
·In April 2017, the U.S. Department of Health & Human Services confirmed the transfer of two U.S. Food and Drug Administration (“FDA”) Orphan Drug Designations for CAEL-101 from Columbia to Caelum. The designations cover use of CAEL-101 as a therapeutic agent for patients with AL amyloidosis and as a radio-imaging agent in amyloidosis.
·In May 2017, Columbia dosed the final patient in the Phase 1b trial of CAEL-101 in AL amyloidosis.
·Also, in May 2017, Caelum entered into a biopharmaceutical manufacturing agreement with Patheon Biologics, LLC for process development and current good manufacturing practices (“cGMP”) production to support Phase 2/3 studies of CAEL-101.
·In June 2017, Columbia filed a provisional patent application with the USPTO pertaining to CAEL-101 that will provide composition of matter protection effective upon a grant of a U.S. patent. In August 2017, Columbia filed a second provisional patent application for additional method of treatment claims directed to positive outcomes observed in the Phase 1b trial of CAEL-101.
·In the third quarter of 2017, Caelum raised $9.9 million in a third-party convertible note financing. National Securities Corporation, a subsidiary of National, acted as placement agent in connection with such financing.
·In December 2017, Columbia presented Phase 1a/1b data on CAEL-101 during an oral session at the 59th American Society of Hematology (“ASH”) Annual Meeting. These data support CAEL-101’s tolerability profile and potential to safely promote amyloid resolution.

 

Cellvation, Inc.

·In November 2017, Cellvation announced that the FDA granted CEVA101 (autologous bone marrow-derived stem cells) Regenerative Medicine Advanced Therapy (“RMAT”) designation for the treatment of severe traumatic brain injury (“TBI”). Under terms of the RMAT designation, the FDA will help facilitate the expedited development and review of CEVA101 for severe TBI.

 

Checkpoint Therapeutics, Inc.

·In February 2017, the USPTO issued a composition of matter patent for CK-101, an oral, third-generation epidermal growth factor receptor (“EGFR”) inhibitor in development for the treatment of EGFR mutation-positive non-small cell lung cancer (“NSCLC”).
·In June 2017, Checkpoint’s common stock began trading on The NASDAQ Capital Market under the ticker symbol “CKPT.”
·In September 2017, Checkpoint announced that the FDA granted Orphan Drug Designation to CK-101 for the treatment of EGFR mutation-positive NSCLC.
·In October 2017, Checkpoint announced that the first patient had been dosed in a Phase 1 clinical trial evaluating the safety and tolerability of CK-301, an anti-PD-L1 antibody, in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers.
·In March 2018, Checkpoint completed an underwritten public offering that raised net proceeds of $20.9 million.

 

 

 

 

Cyprium Therapeutics, Inc.

·In March 2017, Cyprium entered into a Cooperative Research and Development Agreement (“CRADA”) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (“NICHD”), for the advancement of Phase 3 candidate CUTX-101, a Copper Histidinate injection, for the treatment of Menkes disease and related copper metabolism disorders.
·Also, in March 2017, Cyprium and the NICHD entered into a worldwide, exclusive license agreement to develop and commercialize the AAV-based gene therapy AAV-ATP7A for use in combination with CUTX-101 in Menkes disease.

 

Mustang Bio, Inc.

·Mustang completed a private placement offering that raised aggregate gross proceeds totaling $95.1 million, $56.0 million of which was raised in 2017.
·In June 2017, Mustang announced exclusive, worldwide licensing agreements with City of Hope (“COH”) for the use of three CAR T therapies in the development of cancer treatments: human epidermal growth factor receptor 2 CAR T technology (“HER2”) for initial application in glioblastoma multiforme; CS1-specific CAR T technology (“CS1”) to be directed against multiple myeloma; and prostate stem cell antigen CAR T technology (“PSCA”) for the treatment of prostate, pancreatic, bladder and gastric cancers.
·In August 2017, Mustang’s common stock commenced trading on The NASDAQ Global Market under the symbol “MBIO.”
·In September 2017, Mustang announced an exclusive, worldwide licensing agreement with the Fred Hutchinson Cancer Research Center (“Fred Hutch”) for CD20-specific CAR T technology (“CD20”). As part of the transaction, Mustang entered into an investigator-initiated clinical trial agreement to provide partial funding for a Phase 1/2 clinical trial at Fred Hutch evaluating the safety and efficacy of the CD20 technology in patients with relapsed or refractory B-cell non-Hodgkin lymphomas. The trial began recruiting participants in the fourth quarter of 2017.
·In October 2017, Mustang announced that COH received a $12.8 million grant from the California Institute for Regenerative Medicine to fund an ongoing Phase 1 study of Mustang’s MB-101 (IL13Rα2-specific CAR T cells) for the treatment of patients with recurrent and refractory malignant glioma, including glioblastoma.
·Also, in October 2017, Mustang entered into a lease agreement with the UMass Medicine Science Park in Worcester, Massachusetts, for a cell processing facility to support the clinical development and commercialization of Mustang’s CAR T product candidates. The facility is expected to be operational in 2018.
·In December 2017, Mustang entered into a license agreement with Harvard University and a sponsored research agreement with Beth Israel Deaconess Medical Center for the development of CRISPR/Cas9-enhanced CAR T therapies for the treatment of cancer.
·In December 2017, COH presented initial data from an ongoing Phase 1 clinical trial of MB-102 (CD123 CAR) in acute myeloid leukemia (“AML”) and blastic plasmacytoid dendritic cell neoplasm (“BPDCN”) during an oral session at the American Society of Hematology Annual Meeting. These data demonstrated that MB-102 achieved the first complete response from a CAR T therapy in a BPDCN patient, with an additional complete response in AML.

 

Tamid Bio, Inc.

·In November 2017, Tamid entered into three exclusive licensing agreements with the University of North Carolina at Chapel Hill for three preclinical AAV gene therapies to be applied in orphan diseases with unmet medical needs. Tamid’s lead program, Tamid-001, targets the ocular manifestations of Mucopolysaccharidosis type I (“MPS I”), a rare and progressively debilitating disorder, caused by mutations in the IDUA gene, leading to the accumulation of glycosaminoglycans (“GAGS”) in multiple organs. Tamid also in-licensed two earlier-stage assets, which will target dysferlinopathies and corneal transplant rejection.

 

 

 

 

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 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:

Laura Bagby

6 Degrees

(312) 448-8098

lbagby@6degreespr.com

 

 

 

 

FORTRESS BIOTECH, INC. AND SUBSIDIARIES

Consolidated Balance Sheets

($ in thousands except for share and per share amounts)

 

   December 31, 
   2017   2016 
ASSETS          
Current assets          
Cash and cash equivalents  $113,915   $88,294 
Accounts receivable   7,758    1,830 
Short-term investments (certificates of deposit)   36,002    - 
Cash deposits with clearing organizations   1,041    1,030 
Receivables from broker-dealers and clearing organizations   7,395    3,357 
Forgivable loans receivable   1,616    1,712 
Securities owned, at fair value   1,985    2,357 
Inventory   171    203 
Other receivables - related party   618    1,790 
Prepaid expenses and other current assets   12,680    9,061 
Total current assets   183,181    109,634 
           
Property and equipment, net   9,513    7,376 
Restricted cash   17,387    15,860 
Long-term investments, at fair value   1,390    1,414 
Intangible assets   15,223    17,408 
Goodwill   18,645    18,645 
Other assets   611    394 
Total assets  $245,950   $170,731 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities          
Accounts payable and accrued expenses  $36,127   $24,295 
Accounts payable and accrued expenses – related party   222    - 
Accrued commissions and payroll payable   10,065    11,940 
Deferred clearing and marketing credits   786    995 
Securities sold, not yet purchased, at fair value   151    298 
Warrants issued in 2017 and issuable in 2016 - National   5,597    14,359 
Interest payable   315    88 
Interest payable - related party   669    77 
Notes payable, short-term (net of debt discount of $973 and $0 at December 31, 2017 and December 31, 2016, respectively)   8,528    1,000 
Subsidiary convertible note, short-term, at fair value   4,700    1,031 
Contingently issuable liabilities   -    1,682 
Derivative warrant liability   87    481 
Other current liabilities   181    319 
Total current liabilities   67,428    56,565 
           
Notes payable, long-term (net of debt discount of $62 and $2,009 at December 31, 2017 and December 31, 2016, respectively)   43,222    22,528 
Subsidiary convertible note, long-term, at fair value   10,059    3,656 
Other long-term liabilities   4,739    5,014 
Total liabilities   125,448    87,763 
           
Commitments and contingencies          
           
Stockholders’ equity          
Preferred stock, $.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares 1,000,000 and 0 shares issued and outstanding as of December 31, 2017 and December 31, 2016, respectively   1    - 
           
Common Stock, $.001 par value, 100,000,000 shares authorized, 50,991,285 and 48,932,023 shares issued and outstanding as of December 31, 2017 and December 31, 2016, respectively   51    49 
Common stock issuable, 158,015 and 0 shares as of December 31, 2017 and December 31, 2016, respectively   500    - 
Additional paid-in-capital   364,148    283,697 
Accumulated deficit   (312,127)   (245,251)
Total stockholders’ equity attributed to the Company   52,573    38,495 
           
Non-controlling interests   67,929    44,473 
Total stockholders’ equity   120,502    82,968 
Total liabilities and stockholders’ equity  $245,950   $170,731 

 

 

 

 

FORTRESS BIOTECH, INC. AND SUBSIDIARIES

Consolidated Statement of Operations

($ in thousands except for share and per share amounts)

 

   For the Years Ended December 31, 
   2017   2016   2015 
Revenue               
Fortress               
Product revenue, net  $15,520   $3,587   $273 
Revenue - from a related party   1,725    2,570    590 
Net Fortress revenue   17,245    6,157    863 
                
National               
Commissions   96,807    5,388    - 
Net dealer inventory gains   15,108    253    - 
Investment banking   25,064    2,829    - 
Investment advisory   14,528    904    - 
Interest and dividends   2,764    155    - 
Transfer fees and clearing services   7,393    386    - 
Tax preparation and accounting   7,439    338    - 
Other   1,236    70    - 
Total National revenue   170,339    10,323    - 
Net revenue   187,584    16,480    863 
                
Operating expenses               
Fortress               
Cost of goods sold – product revenue   3,658    790    - 
Research and development   48,322    29,602    18,402 
Research and development – licenses acquired   4,164    5,532    11,408 
General and administrative   50,897    34,003    21,584 
Total Fortress operating expenses   107,041    69,927    51,394 
                
National               
Commissions, compensation and fees   155,187    10,414    - 
Clearing fees   2,343    144    - 
Communications   2,767    177    - 
Occupancy   4,286    193    - 
Licenses and registration   1,726    147    - 
Professional fees   4,531    327    - 
Interest   14    1    - 
Depreciation and amortization   2,089    545    - 
Other administrative expenses   8,808    315    - 
Total National operating expenses   181,751    12,263    - 
Total operating expenses   288,792    82,190    51,394 
Loss from operations   (101,208)   (65,710)   (50,531)
                
Other income (expenses)               
Interest income   819    298    245 
Interest expense and financing fee   (5,860)   (3,690)   (1,484)
Change in fair value of derivative liabilities   8,391    (1,039)   (438)
Change in fair value of subsidiary convertible note   (457)   (78)   - 
Change in fair value of investments   226    (1,071)   (1,675)
Other loss   (234)   -    - 
Total other income (expenses)   2,885    (5,580)   (3,352)
Loss before income taxes   (98,323)   (71,290)   (53,883)
                
Income tax expense   1,513    -    - 
Net Loss   (99,836)   (71,290)   (53,883)
Less: net loss attributable to non-controlling interests   32,960    16,195    5,455 
Net loss attributable to common stockholders  $(66,876)  $(55,095)  $(48,428)
                
Basic and diluted net loss per common share  $(1.61)  $(1.38)  $(1.24)
                
Weighted average common shares outstanding—basic and diluted   41,658,733    39,962,657    39,146,589 

 

 

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