Regulus Therapeutics Inc.
Regulus Therapeutics Inc. (Form: 8-K, Received: 08/01/2017 16:17:51)

 

 

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): August 1, 2017

 

 

Regulus Therapeutics Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-35670   26-4738379

(State

of incorporation)

 

(Commission

File No.)

 

(IRS Employer

Identification No.)

10614 Science Center Drive

San Diego, CA

  92121
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (858) 202-6300

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))

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 August 1, 2017, we issued a press release announcing our financial results for the second quarter ended June 30, 2017. A copy of the press release is attached hereto as Exhibit 99.1. The information in this Item 2.02 and the attached Exhibit 99.1 are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 2.02 and the attached exhibit shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.


Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

No.

  

Description

99.1    Press release issued by Regulus Therapeutics Inc. on August 1, 2017 relating to financial results


SIGNATURES

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.

 

    Regulus Therapeutics Inc.
Date: August 1, 2017     By:  

/s/ Joseph P. Hagan

      Joseph P. Hagan
      President and Chief Executive Officer


EXHIBIT INDEX

 

Exhibit

No.

  

Description

99.1    Press release issued by Regulus Therapeutics Inc. on August 1, 2017 relating to financial results

Exhibit 99.1

 

LOGO

Regulus Reports Second Quarter 2017 Financial Results and Recent Events

Completed Public Offering Raising $46 Million in Gross Proceeds

Conference Call Today at 5:00 p.m. ET

LA JOLLA, Calif., August  1, 2017 Regulus Therapeutics Inc . (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported financial results for the six months ended June 30, 2017 and recent events.

“The successful completion of our recent public offering significantly strengthens our financial position through key clinical milestones of our lead programs, RG-012 and RGLS4326,” said Jay Hagan, President and Chief Executive Officer of Regulus. “We remain on track to deliver data from the RG-012 renal biopsy study and file an IND for RGLS4326 by year-end.”

Second Quarter Corporate Highlights and Recent Events

 

    Completed public offering of common stock: In July, Regulus issued 50,600,000 shares at $0.91 per share raising approximately $46.0 million in gross proceeds.

 

    Refocused pipeline programs: In June, Regulus announced a pipeline update that included the discontinuation of the RG-101 and RGLS5040 development programs.

 

    Streamlined operations: In May, Regulus announced a corporate restructuring plan to focus on its most promising discovery and development programs. The restructuring plan included a workforce reduction of approximately 30%, which was completed in June.

 

    Strengthened leadership team: During the second quarter, Jay Hagan was promoted to President and Chief Executive, Dan Chevallard was promoted to Chief Financial Officer, and Dr. Mark Deeg was promoted to Chief Medical Officer. In addition, Pascale Witz joined the Regulus board of directors.

Second Quarter Financial Results

Cash Position: As of June 30, 2017, Regulus had cash, cash equivalents and short-term investments of $40.1 million. In July 2017, Regulus completed an underwritten public offering of its common stock, and received net proceeds of approximately $43.0 million after deducting underwriting discounts, commissions and other estimated offering expenses.

Research and Development (R&D) Expenses: R&D expenses were $14.3 million and $30.0 million for the three and six months ended June 30, 2017, respectively, compared to $18.0 million and $34.8 million for the same periods in 2016. The decreases in R&D expenses were primarily driven by reductions in spend on the RG-101 program subsequent to the FDA clinical hold and non-cash stock-based compensation. These decreases were partially offset by non-recurring severance costs associated with our May 2017 corporate restructuring.

 

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General and Administrative (G&A) Expenses: G&A expenses were $7.1 million and $11.0 million for the three and six months ended June 30, 2017, respectively, compared to $3.7 million and $8.8 million for the same periods in 2016. The increases in G&A expenses were attributable to non-recurring severance costs and non-cash stock-based compensation charges associated with our May 2017 corporate restructuring.

Revenue: Revenue was less than $0.1 million for each of the three and six months ended June 30, 2017, compared to $0.5 million and $1.0 million for the same periods in 2016.

Net Loss: Net loss was $21.6 million and $41.6 million for the three and six months ended June 30, 2017, respectively, compared to a net loss of $21.1 million and $42.3 million for the same periods in 2016. Basic and diluted net loss per share was $0.41 and $0.78 for the three and six months ended June 30, 2017, respectively, compared to $0.40 and $0.80 for the same periods in 2016.

Conference Call Details

Regulus will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss second quarter 2017 financial results and corporate highlights. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 57973022. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 57973022. The webcast and telephone replay will be archived on the Company’s website following the call.

About Regulus

Regulus Therapeutics Inc. (Nasdaq: RGLS) is a clinical stage biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a rich intellectual property estate to retain its leadership in the microRNA field. Regulus is advancing several programs in renal, hepatic and central nervous systems diseases. Regulus maintains its corporate headquarters in La Jolla, CA. For more information, please visit http://www.regulusrx.com .

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Regulus to undertake certain activities and accomplish certain goals (including with respect to development and other activities related to RG-012 or RGLS4326), the projected timeline of clinical development activities, and expectations regarding future therapeutic and commercial potential of Regulus’ business plans, technologies and intellectual property related to microRNA therapeutics and biomarkers being discovered and developed by Regulus. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking

 

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statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Regulus’ financial position and programs are described in additional detail in Regulus filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Relations Contact:

Allison Wey

858-202-6321

awey@regulusrx.com

 

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Regulus Therapeutics Inc.

Selected Financial Information

Condensed Statement of Operations

(In thousands, except share and per share data)

 

    

Three months ended

June 30,

   

Six months ended

June 30,

 
     2017     2016     2017     2016  
     (Unaudited)  

Revenues:

        

Revenue under strategic alliances

   $ 18     $ 483     $ 36     $ 972  

Operating expenses:

        

Research and development

     14,278       18,007       30,030       34,772  

General and administrative

     7,057       3,664       11,016       8,767  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     21,335       21,671       41,046       43,539  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (21,317     (21,188     (41,010     (42,567

Other (expense) income, net

     (419     90       (751     258  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (21,736     (21,098     (41,761     (42,309

Income tax benefit

     128       8       132       13  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (21,608   $ (21,090   $ (41,629   $ (42,296
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.41   $ (0.40   $ (0.78   $ (0.80
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares used to compute basic and diluted net loss per share:

     53,182,330       52,782,643       53,086,887       52,746,657  
  

 

 

   

 

 

   

 

 

   

 

 

 

Regulus Therapeutics Inc.

Condensed Balance Sheets

(In thousands)

 

     Pro forma
June 30, 2017
     June 30,
2017
     December 31,
2016
 
     (Unaudited)      (Unaudited)         

Cash, cash equivalents and short-term investments

   $ 83,087      $ 40,087      $ 76,111  

Total assets

     104,860        61,860        100,661  

Term loan, less debt issuance costs

     19,830        19,830        19,802  

Stockholders’ equity

     62,995        19,995        56,075  

 

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