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 8, 2018

 

 

Sienna Biopharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38155   27-3364627

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification Number)

30699 Russell Ranch Road, Suite 140

Westlake Village, CA 91362

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (818) 629-2256

 

 

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 (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 November 8, 2018, Sienna Biopharmaceuticals, Inc. (the “Company”) announced its financial results for the third quarter ended September 30, 2018. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K, including the attached Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the 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 to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

  

Description

99.1    Press Release dated November 8, 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.

 

Date: November 8, 2018     Sienna Biopharmaceuticals, Inc.
      By:   /s/ Timothy K. Andrews
      Name:   Timothy K. Andrews
      Title:   General Counsel and Secretary
EX-99.1

Exhibit 99.1

 

LOGO

Sienna Biopharmaceuticals® Reports Third Quarter 2018 Financial Results

WESTLAKE VILLAGE, Calif., Nov. 8, 2018 – Sienna Biopharmaceuticals, Inc. (NASDAQ:SNNA), a clinical-stage medical dermatology and aesthetics company, today reported the Company’s financial results for the third quarter of 2018.

“We are pleased to report the results of our third quarter,” said Frederick C. Beddingfield III, MD, PhD, President and Chief Executive Officer of Sienna Biopharmaceuticals®. “August 1 marked the completion of Sienna’s first full year as a public company, and we continue to execute on our plans to bring innovative topical therapies to dermatology and aesthetics practitioners and their patients. Our team is excited, optimistic and focused, working toward clinical data this quarter from our Phase 2b trial with SNA-120 (pegcantratinib) in pruritus associated with psoriasis, as well as our Phase 1/2 exploratory trial with SNA-125 in atopic dermatitis and the first of our pivotal trials with SNA-001 for the reduction of unwanted light-pigmented hair.”

Pipeline Overview

Sienna’s pipeline currently includes multiple clinical-stage programs:

(from the Company’s Topical by Design™ platform)

 

   

SNA-120 for the treatment of pruritus associated with psoriasis and the underlying psoriasis; Phase 2b top-line results expected in the fourth quarter of 2018

 

   

SNA-125 for the treatment of atopic dermatitis; Phase 1/2 results expected in the fourth quarter of 2018

 

   

SNA-125 for the treatment of psoriasis; continued progression to Phase 2

(from the Company’s Topical Photoparticle Therapy™ platform)

 

   

SNA-001 for the reduction of light-pigmented hair

 

   

pivotal results with the 1064 nm wavelength laser expected in the fourth quarter of 2018

 

   

pivotal results with the 810 nm and with the 755 nm wavelength lasers expected in the first quarter of 2019


Selected Financial Results

Total operating expenses for the three months ended Sept. 30, 2018, were approximately $16.6 million, which includes research and development (R&D) expenses totaling approximately $12.1 million and general and administrative (G&A) expenses totaling approximately $4.4 million. Total operating expenses for the three months ended Sept. 30, 2017, were approximately $14.3 million, which included R&D expenses totaling approximately $9.4 million and G&A expenses totaling approximately $4.9 million. The year-over-year increase in R&D expenses was due primarily to increased development costs related to the initiation of clinical trials for SNA-120 and for SNA-125 and increased manufacturing costs related to SNA-125, offset by a reduction in costs related to the ongoing pivotal trials for SNA-001 and a reduction in manufacturing costs related to SNA-120. The year-over-year decrease in G&A expenses was due primarily to a $1.8 million non-cash decrease in the fair value of the contingent consideration liability related to the Company’s acquisition of Creabilis plc in December 2016 and a reduction in legal fees, offset by an increase in personnel costs and an increase in costs related to being a public company.

Total operating expenses for the nine months ended Sept. 30, 2018, were approximately $56.7 million, which includes R&D expenses totaling approximately $40.8 million and G&A expenses totaling approximately $15.9 million. Total operating expenses for the nine months ended Sept. 30, 2017, were approximately $34.6 million, which included R&D expenses totaling approximately $21.0 million and G&A expenses totaling approximately $13.6 million. The year-over-year increase in R&D expenses was due primarily to increased development costs related to the initiation of clinical trials for SNA-120 and for SNA-125, increased manufacturing costs related to SNA-125 and increased costs related to early stage research activities, offset by a reduction in costs related to the ongoing pivotal trials for SNA-001. The year-over-year increase in G&A expenses was due primarily to an increase in personnel costs, an increase in expenses related to marketing research and an increase in costs related to being a public company, offset by a $1.6 million non-cash decrease in the fair value of the contingent consideration liability related to the Company’s acquisition of Creabilis plc in December 2016 and a reduction in consulting and legal fees.

Cash burn during the three months ended Sept. 30, 2018, was approximately $15.9 million. Cash burn during the nine months ended Sept. 30, 2018, was approximately $46.1 million. Sienna’s cash and cash equivalents as of Sept. 30, 2018, totaled approximately $64.0 million.

 

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About Sienna Biopharmaceuticals®

Sienna Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on bringing innovations in biotechnology to the discovery, development and commercialization of first-in-class, targeted, topical products in medical dermatology and aesthetics. The Company’s objective is to develop a unique, diversified, multi-asset pipeline of topical therapies that enhance the health, appearance and quality of life of dermatology and aesthetics patients. Sienna® is led by a management team with extensive experience in product development and commercialization at several leading dermatology, aesthetics and biotechnology companies.

For more information, visit the Company’s website at www.SiennaBio.com.

Forward-Looking Statements

This press release contains forward-looking statements, including but not limited to statements regarding the anticipated timing of clinical data readouts from Sienna’s development programs. Such forward-looking statements involve substantial risks and uncertainties that could cause Sienna’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the pharmaceutical drug and medical device development processes, including regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing pharmaceutical drug and medical device products, Sienna’s ability to successfully protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations and the availability or commercial potential of Sienna’s drug candidates. Sienna undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Sienna’s most recent Annual Report on Form 10-K and any subsequent current and periodic reports filed with the Securities and Exchange Commission.

 

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Sienna Biopharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(in thousands, except per share data)

(unaudited)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2018     2017     2018     2017  

Operating expenses:

        

Research and development

   $ 12,146     $ 9,398     $ 40,819     $ 21,020  

General and administrative

     4,438       4,924       15,910       13,562  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     16,584       14,322       56,729       34,582  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (16,584     (14,322     (56,729     (34,582

Other income (expense), net

     (210     (2,154     2,593       (4,986
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss before taxes

     (16,794     (16,476     (54,136     (39,568

Income tax benefit

     —         85       —         212  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (16,794   $ (16,391   $ (54,136   $ (39,356
  

 

 

   

 

 

   

 

 

   

 

 

 

Per share information:

        

Net loss, basic and diluted1

   $ (0.82   $ (1.12   $ (2.66   $ (6.31
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted weighted average shares outstanding2

     20,473       14,674       20,331       6,233  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

1 Diluted net loss per share is the same as basic net loss per share, as the effects of potentially dilutive securities are antidilutive during periods of net loss.

2 As of Sept. 30, 2018, there were 21,140,101 shares of common stock outstanding.

 

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Sienna Biopharmaceuticals, Inc.

Selected Consolidated Balance Sheet Data

(in thousands)

(unaudited)

 

     September 30, 2018      December 31, 2017  

Cash and cash equivalents

   $ 63,975      $ 74,467  

Working capital

     53,250        69,105  

Total assets

     124,630        136,847  

Total current liabilities

     13,809        8,241  

Total liabilities

     79,700        45,648  

Accumulated deficit

     140,033        85,897  

Total stockholders’ equity

     44,930        91,199  

Contact:

Investors

Sean Andrews

sandrews@siennabio.com

818-629-2244

Media

Caroline Van Hove

cvanhove@siennabio.com

818-575-6250

Crystal Muilenburg

cmuilenburg@siennabio.com

818-584-1035

###

Sienna Biopharmaceuticals, Inc.

30699 Russell Ranch Road, Suite 140, Westlake Village, CA 91362

Office 818-629-2256 | Fax 818-706-1214

www.SiennaBio.com

 

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