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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 13, 2018

 

Mustang Bio, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware
(State or Other Jurisdiction
of Incorporation)

001-38191
(Commission File Number)

47-3828760
(IRS Employer Identification No.)

 

 

2 Gansevoort Street, 9th Floor

New York, New York 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 x

 

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. x

 

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On November 13, 2018, Mustang Bio, 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 Mustang Bio, Inc., dated November 13, 2018.

 

 

 

 

SIGNATURES

 

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

 

  Mustang Bio, Inc.
  (Registrant) 
Date: November 14, 2018   
  By:  /s/ Manuel Litchman, M.D.  
    Manuel Litchman, M.D.  
    President and Chief Executive Officer  

 

 

 

 

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Section 2: EX-99.1 (EXHIBIT 99.1)

 

Exhibit 99.1

 

  

Mustang Bio Reports Third Quarter 2018 Financial Results and Recent Corporate Highlights

 

New York, NY – November 13, 2018 – Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (“CAR T”) technology and gene therapies for rare diseases, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2018.

 

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “The third quarter of 2018 and recent months have been marked by clinical progress and a key addition to our management team with the appointment of Martina A. Sersch, M.D., Ph.D., as Chief Medical Officer. Notably, we expanded our pipeline into gene therapy by securing an exclusive worldwide license agreement with St. Jude Children’s Research Hospital (“St. Jude”) for the development of a first-in-class, ex vivo, clinical-stage lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (“X-SCID”). Data from a multicenter Phase 1/2 trial led by St. Jude in infants under the age of two years old are extremely encouraging. Eight patients under the age of two with X-SCID have been treated to date, with results presented at the 21st Annual Meeting of the American Society of Gene & Cell Therapy in May 2018. The therapy was well tolerated. In addition, six patients achieved reconstituted immune systems within three to four months following treatment, with the remaining two patients continuing to progress favorably in earlier stages of recovery. Four of these six patients have discontinued monthly infusions of intravenous immunoglobulin, and the remaining patients, at earlier stages of recovery, continue to progress favorably. In three patients who had disseminated infections prior to therapy, all infections resolved completely. In addition, the therapy is being investigated in patients over the age of two in a second Phase 1/2 trial at the National Institutes of Health (“NIH”), with equally encouraging data and an excellent safety profile to date. The two patients with the longest follow-up have seen sustained restoration of antibody production after immunization, and all five patients treated experienced a decrease in viral infections and overall clinical improvement.”

 

Dr. Litchman continued, “We also recently announced updates on two Phase 1 clinical trials at City of Hope using our HER2-specific CAR T cell therapy, including a first-of-its-kind trial using intraventricular delivery of CAR T cells to brains of patients with HER2-positive breast cancer with brain metastases. As we look ahead to the fourth quarter of 2018, we look forward to filing our first Investigational New Drug (IND) application to support a Phase 1/2 trial of MB-102 in acute myeloid leukemia (“AML”), blastic plasmacytoid dendritic cell neoplasm and high-risk myelodysplastic syndrome.”

 

Recent Corporate Highlights:

 

·In July 2018, Mustang completed a pre-IND meeting with the U.S. Food and Drug Administration (“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 AML, 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 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 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.

 

 

 

 

Financial Results:

 

·As of September 30, 2018, Mustang’s consolidated cash, cash equivalents, short-term investments (certificates of deposit) and restricted cash totaled $41.3 million, compared to $47.2 million as of June 30, 2018, and $61.5 million as of December 31, 2017, a decrease of $5.9 million for the quarter and a decrease of $20.2 million year-to-date.
·Research and development expenses were $5.3 million for the third quarter of 2018, compared to $2.2 million for the third quarter of 2017. Non-cash, stock-based compensation expenses included in research and development were $0.7 million for third quarter of 2018, compared to $0.3 million for the third quarter of 2017.
·Research and development expenses from license acquisitions were $1.0 million for the third quarter of 2018, compared to $0.3 million for the third quarter of 2017.
·General and administrative expenses were $1.3 million for the third quarter of 2018, compared to $4.6 million for the third quarter of 2017. Non-cash, stock-based compensation expenses included in general and administrative expenses were $0.2 million for the third quarter of 2018, compared to $0.5 million for the third quarter of 2017.
·Net loss attributable to common stockholders was $7.5 million, or $0.28 per share, for the third quarter of 2018, compared to $6.9 million, or $0.27 per share, for the third quarter of 2017. Net loss attributable to common stockholders was $18.9 million, or $0.70 per share, for the first nine months of 2018, compared to $15.7 million, or $0.63 per share, for the first nine months of 2017.

 

About Mustang Bio

Mustang Bio, Inc. (“Mustang”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of a broad range of proprietary chimeric antigen receptor engineered T cell (CAR T) immunotherapies and gene therapies in areas of unmet need. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR T and CRISPR/Cas9-enhanced CAR T therapies across multiple cancers, as well as a lentiviral gene therapy for X-SCID. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission. For more information, visit www.mustangbio.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, each 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 value. 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; risks relating to the timing of starting and completing clinical trials; 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 required by law.

 

 

 

 

Company Contact:

Jaclyn Jaffe

Mustang Bio, Inc.

(781) 652-4500

ir@mustangbio.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

 

 

 

 

MUSTANG BIO, INC.

Condensed Balance Sheets

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

 

   September 30,   December 31, 
   2018   2017 
   (Unaudited)     
ASSETS          
Current Assets:          
Cash and cash equivalents  $18,296   $34,975 
Short-term investments (certificates of deposit)   22,538    26,002 
Interest receivable on short-term investments (certificates of deposit)   69    106 
Other receivables - related party   50    - 
Prepaid expenses   872    278 
Total current assets   41,825    61,361 
           
Property, plant and equipment, net   6,760    140 
Fixed assets - construction in process   33    1,241 
Restricted cash   500    500 
Other assets   394    251 
Total Assets  $49,512   $63,493 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Current Liabilities:          
Accounts payable and accrued expenses  $3,777   $3,474 
Payables and accrued expenses -  related party   275    137 
Total current Liabilities   4,052    3,611 
           
Deferred Rent Payable   470    50 
Total Liabilities   4,522    3,661 
           
Commitments and Contingencies          
           
Stockholders' Equity          
Preferred stock ($0.0001 par value), 2,000,000 shares authorized, 250,000 shares of Class A preferred stock issued and outstanding as of September 30, 2018 and December 31, 2017   -    - 
Common Stock ($0.0001 par value), 50,000,000 shares authorized          
Class A common shares, 1,000,000 shares issued and outstanding as of September 30, 2018 and December 31, 2017   -    - 
Common shares, 26,263,631 and 25,236,255 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively   3    3 
Common stock issuable, 0 and 834,756 shares as of September 30, 2018 and December 31, 2017, respectively   -    9,558 
Additional paid-in capital   112,287    98,679 
Accumulated deficit   (67,300)   (48,408)
Total Stockholders’ Equity   44,990    59,832 
Total Liabilities and Stockholders’ Equity  $49,512   $63,493 

 

 

 

 

MUSTANG BIO, INC.

Condensed 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 - related party  $-   $-   $50   $- 
                     
Operating expenses:                    
Research and development   5,316    2,188    13,165    5,388 
Research and development – licenses acquired   1,000    300    1,075    2,375 
General and administrative   1,340    4,596    5,133    8,293 
Total operating expenses   7,656    7,084    19,373    16,056 
Loss from operations   (7,656)   (7,084)   (19,323)   (16,056)
                     
Interest income   138    144    431    369 
Net Loss  $(7,518)  $(6,940)  $(18,892)  $(15,687)
                     
Net loss per common share outstanding, basic and diluted  $(0.28)  $(0.27)  $(0.70)  $(0.63)
                     
Weighted average number of common shares outstanding, basic and diluted   27,146,721    26,186,924    26,871,505    24,936,626 

 

 

 

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