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 5, 2015

 

 

REGENXBIO INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   001-37553   47-1851754

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

9712 Medical Center Drive, Suite 100

Rockville, Maryland

  20850
(Address of principal executive offices)   (Zip Code)

(240) 552-8181

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

 

 

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 (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On November 5, 2015, REGENXBIO Inc. issued a press release regarding its results of operations and financial condition for the quarter ended September 30, 2015. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The information in Item 2.02 of this Current Report on Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

No.

  

Description

99.1    REGENXBIO Inc. Press Release dated November 5, 2015


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.

 

    REGENXBIO INC.
Date: November 5, 2015     By:   /s/ Kenneth T. Mills
      Kenneth T. Mills
      President and Chief Executive Officer


EXHIBIT INDEX

 

Exhibit

No.

  

Description

99.1    REGENXBIO Inc. Press Release dated November 5, 2015
EX-99.1

Exhibit 99.1

 

LOGO

REGENXBIO Reports Third Quarter 2015 Results

Closed initial public offering raising $145.2 million in net proceeds

ROCKVILLE, MD, November 5, 2015 – REGENXBIO Inc. (Nasdaq: RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy, today reported recent operational highlights and financial results for the quarter ended September 30, 2015.

“So far, 2015 has been a truly transformative year for REGENXBIO and we look forward to building upon this success in the future,” said Kenneth T. Mills, President and CEO of REGENXBIO. “We have raised more than $200 million in capital this year, including the completion of an initial public offering in September, which strengthened our balance sheet and continued to add leading healthcare investors as stockholders. We remain focused on advancing our lead investigational gene therapy candidates toward the clinic, and we plan to initiate a clinical trial for RGX-501 for the treatment of homozygous familial hypercholesterolemia and to file an Investigational New Drug application for RGX-111 for the treatment of mucopolysaccharidosis Type I in the first half of 2016.”

Recent Operational Highlights:

 

    Completed an initial public offering of common stock at $22.00 per share, raising $145.2 million, net of underwriting discounts and commissions and offering expenses.

 

    Received orphan drug designation from the U.S. Food and Drug Administration for our investigational gene therapy product candidate RGX-111 for the treatment of mucopolysaccharidosis Type I (MPS I).

 

    Received endorsement from the U.S. National Institutes of Health Office of Biotechnology Activities’ Recombinant DNA Advisory Committee, commonly referred to as the RAC, for our RGX-111 protocol.

 

    Further strengthened our management team with the addition of Curran Simpson, SVP of Technical Operations. Most recently, Mr. Simpson was the Head, North American Supply Chain and Interim Chief Operating Officer and Integration Lead with GlaxoSmithKline and Human Genome Sciences, a division of GlaxoSmithKline.

 

    Appointed David C. Stump, M.D., to our board of directors. Most recently, Dr. Stump was Executive Vice President, Research and Development at Human Genome Sciences.

Financial Results

Revenues were $1.1 million for the quarter ended September 30, 2015, compared to $0.5 million for the quarter ended September 30, 2014.

Net cash used in operating activities during the nine months ended September 30, 2015 was $18.1 million. Cash, cash equivalents and marketable securities as of September 30, 2015 were $224.4 million.

Total operating expenses were $8.5 million for the quarter ended September 30, 2015, compared to $2.2 million for the quarter ended September 30, 2014.

Net loss was $7.3 million, or $1.52 net loss per basic and diluted share, for the quarter ended September 30, 2015, compared to a net loss of $1.8 million, or $0.73 net loss per basic and diluted share, for the quarter ended September 30, 2014.

About REGENXBIO

REGENXBIO is a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy. REGENXBIO’s NAV Technology Platform, a proprietary AAV gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9


and AAVrh10. REGENXBIO’s mission is to transform the lives of patients suffering from severe diseases with significant unmet medical need by developing and commercializing in vivo gene therapy products based on REGENXBIO’s NAV Technology Platform. REGENXBIO seeks to accomplish this mission through a combination of internal development efforts and third-party NAV Technology Platform licensees. As of September 30, 2015, REGENXBIO’s NAV Technology Platform is being applied in the development of 23 product candidates for a variety of diseases, including five product candidates being developed internally by REGENXBIO and 18 product candidates being developed by REGENXBIO’s licensees.

Forward Looking Statements

This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, REGENXBIO’s research, development and regulatory plans for RGX-501, RGX-111 and other gene therapies. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, the ability to obtain and maintain regulatory approval of REGENXBIO’s product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing REGENXBIO’s product candidates; REGENXBIO’s ability to obtain and maintain intellectual property protection for our product candidates; REGENXBIO’s ability to establish and maintain development partnerships; REGENXBIO’s expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of REGENXBIO’s prospectus dated September 16, 2015, filed pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended, with the Securities and Exchange Commission on September 17, 2015 (the Prospectus) and available on the SEC’s website at www.sec.gov. Additional factors may be described in those sections of REGENXBIO’s quarterly report on Form 10-Q for the quarter ended September 30, 2015, to be filed with the SEC in the fourth quarter of 2015. In addition to the risks described above and in the Prospectus and other filings with the SEC, other unknown or unpredictable factors also could affect REGENXBIO’s results. There can be no assurance that the actual results or developments anticipated by REGENXBIO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, REGENXBIO. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. REGENXBIO cautions investors not to rely too heavily on the forward-looking statements REGENXBIO makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). REGENXBIO undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.


REGENXBIO INC.

BALANCE SHEETS

(unaudited)

(in thousands, except per share data)

 

     December 31,     September 30,  
     2014     2015  

Assets

    

Current assets

    

Cash and cash equivalents

   $ 1,121      $ 205,324   

Marketable securities

     —          8,025   

Accounts receivable

    

Trade receivables

     805        609   

Related party receivables

     750        —     

Unbilled receivables

     327        —     

Prepaid expenses

     28        1,400   

Other current assets

     —          127   
  

 

 

   

 

 

 

Total current assets

     3,031        215,485   

Marketable securities

     —          11,013   

Property and equipment, net

     —          385   

Cost method investments

     303        303   

Deferred issuance costs

     157        —     

Other assets

     —          128   
  

 

 

   

 

 

 

Total assets

   $ 3,491      $ 227,314   
  

 

 

   

 

 

 

Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)

    

Current liabilities

    

Accounts payable

   $ 334      $ 3,105   

Accrued expenses

     1,115        1,727   

Due to related party under services agreement

     1,423        —     

Related party promissory notes

     2,403        —     

Other related party payables

     3,761        349   

Advance payments

     153        127   
  

 

 

   

 

 

 

Total current liabilities

     9,189        5,308   

Deferred rent

     —          198   
  

 

 

   

 

 

 

Total liabilities

     9,189        5,506   

Convertible preferred stock

     12,593        —     

Total stockholders’ equity (deficit)

     (18,291     221,808   
  

 

 

   

 

 

 

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

   $ 3,491      $ 227,314   
  

 

 

   

 

 

 


REGENXBIO INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

(in thousands, except per share data)

 

     Three Months Ended     Nine Months Ended  
     September 30,     September 30,  
     2014     2015     2014     2015  

Revenues

        

License revenue

   $ —        $ 65      $ 3,705      $ 635   

License revenue from related party

     150        1,000        150        2,000   

Reagent sales

     23        61        317        200   

Grant revenue

     310        14        800        305   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     483        1,140        4,972        3,140   

Expenses

        

Costs of revenues

        

Licensing costs to related parties

     —          213        741        527   

Costs of reagent sales (including amounts to related parties)

     12        44        115        94   

Research and development (including amounts to related parties)

     1,085        5,664        2,869        12,471   

General and administrative (including amounts to related parties)

     1,070        2,567        2,732        7,671   

Foreign currency transaction losses (gains)

     25        4        12        41   

Other operating income

     (8     (5     (32     (26
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     2,184        8,487        6,437        20,778   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (1,701     (7,347     (1,465     (17,638

Other Income (Expense)

        

Investment income

     —          15        —          23   

Interest expense

     (92     —          (202     (20
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense)

     (92     15        (202     3   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (1,793   $ (7,332   $ (1,667   $ (17,635
  

 

 

   

 

 

   

 

 

   

 

 

 

Other Comprehensive Loss

        

Unrealized loss on available-for-sale securities

     —          (26     —          (26
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other comprehensive loss

     —          (26     —          (26
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (1,793   $ (7,358   $ (1,667   $ (17,661
  

 

 

   

 

 

   

 

 

   

 

 

 

Reconciliation of net loss to net loss applicable to common stockholders

        

Net loss

   $ (1,793   $ (7,332   $ (1,667   $ (17,635

Accretion and dividends on convertible preferred stock

     (126     —          (592     (1,747

Net gain on extinguishment of convertible preferred stock

     —          —          —          759   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss applicable to common stockholders

   $ (1,919   $ (7,332   $ (2,259   $ (18,623
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net loss per common share

   $ (0.73   $ (1.52   $ (0.85   $ (5.48
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average basic and diluted common shares

     2,643        4,809        2,643        3,397   
  

 

 

   

 

 

   

 

 

   

 

 

 

###

Contact:

Investors

Elizabeth Broder, 646-378-2945

ebroder@troutgroup.com

Media

Laura Bagby, 312-448-8098

lbagby@6degreespr.com