Form 8-K Neothetics, Inc. For: Dec 01

December 1, 2015 7:31 AM EST

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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): December 1, 2015

 

 

NEOTHETICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

 

 

Delaware

 

001-36754

 

20-8527075

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

9171 Towne Centre Drive, Suite 270, San Diego, CA 92122

(Address of principal executive offices, with zip code)

(858) 750-1008

(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 8.01Other Events. 

On December 1, 2015, Neothetics, Inc. (NASDAQ: NEOT) (“Neothetics”) announced updated guidance regarding the timing of release of topline data for its two pivotal U.S. Phase 3 trials titled AbCONTOUR1 and AbCONTOUR2 of LIPO-202 to mid-December.

The press release dated December 1, 2015 announcing the updated guidance of the timing of the release of topline data is attached hereto as Exhibit 99.1.  

Item 9.01.

Financial Statements and Exhibits

(d) Exhibits.

 

 

 

Exhibit No.

  

Description

 

 

99.1

  

Press Release, dated December 1, 2015.

 


 


 

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.

 

 

NEOTHETICS, INC.

 

 

 

Date:  December 1, 2015

By: /s/ George W. Mahaffey

George W. Mahaffey

President and Chief Executive Officer


 


 

 

 

 

Exhibit No.

  

Description

 

 

99.1

  

Press Release, dated December 1, 2015.

 

 

Exhibit 99.1

 

NEOTHETICS TIGHTENS GUIDANCE FOR TIMING OF TOPLINE PIVOTAL PHASE 3 DATA

 

SAN DIEGO, December 1, 2015 — Neothetics, Inc. (NASDAQ: NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today tightened its guidance regarding the timing of release of top-line data for its two pivotal U.S. Phase 3 trials titled AbCONTOUR1 and AbCONTOUR2 of LIPO-202 to mid-December. LIPO-202 is the first non-invasive injectable drug candidate for reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects.

 

About LIPO-202

LIPO-202 is an injectable formulation of salmeterol xinafoate, a well-known long-acting ß2-adrenergic receptor agonist used in several FDA-approved drugs, including ADVAIR® for asthma. Neothetics’ studies suggest that salmeterol xinafoate also activates ß2-adrenergic receptors on fat cells, triggering the breakdown of triglycerides stored in the cells, causing them to shrink by means of a natural process called lipolysis. LIPO-202 is initially being developed as a non-surgical, convenient method to reduce non-obese individuals’ central abdominal bulging due to subcutaneous fat – commonly characterized as a pot-belly, stomach rolls, or a pouch.

 

About Neothetics, Inc.

Neothetics is a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market. The lead product candidate, LIPO-202, is for the reduction of subcutaneous fat in the central abdomen in non-obese patients, an indication for which there is no FDA-approved drug. If approved, LIPO-202 may be the first-in-class injectable formulation, non-surgical, non-ablative procedure for localized fat reduction and body contouring. For more information on Neothetics, please visit www.neothetics.com.

 

Neothetics, LIPO-202, LIPO-102 and the Neothetics logo are trademarks or registered trademarks of Neothetics, Inc. Other names and brands may be claimed as the property of others.

 

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. Such statements include, but are not limited to, statements regarding Neothetics’ plans to research, develop and commercialize LIPO-202 and other product candidates, as well as expected timing for reporting results from clinical trials. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Neothetics’ 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 statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with clinical trials and obtaining regulatory approval to commercialize LIPO-202 and other product candidates, product

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development activities, the need to raise additional funding, when needed, in order to conduct our business, the degree of market acceptance of LIPO-202 by physicians, patients and others in the medical community, our reliance on third parties, including third-party suppliers for manufacturing and distribution of products, regulatory developments in the United States and foreign countries, Neothetics’ ability to obtain and maintain intellectual property protection for LIPO-202 and its product candidates, competition in the aesthetics industry and other market conditions. All forward-looking statements contained in this press release speak only as of the date on which they were made. Neothetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at www.sec.gov, including without limitation, Neothetics’ Form 10-K for the year ended December 31, 2014 and subsequent Quarterly Reports on Form 10-Q.

 

 

 

 

 

COMPANY CONTACTS:

Susan A. Knudson

Chief Financial Officer

858-500-7780

sknudson@neothetics.com

 

Fara Berkowitz, R.Ph, Pharm.D

Senior Director, Investor Relations and Corporate Strategy

917-460-9307

fberkowitz@neothetics.com

 

 

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