OREANDA-NEWS. Neothetics, Inc. (NASDAQ:NEOT) today reported financial results and business progress for the first quarter 2016.

First Quarter 2016 Highlights

  • Neothetics plans to conduct a Phase 2 trial with a modified formulation of LIPO-202 in the third quarter of 2016 for the reduction of central abdominal bulging, which the company anticipates having top-line data from in the first quarter of 2017. This Phase 2 study will be a randomized, double-blind, placebo-controlled trial designed to assess the efficacy, safety and tolerability of a modified formulation of LIPO-202. Neothetics also plans to conduct a Phase 2 proof of concept study of LIPO-202 for the reduction of localized fat deposits under the chin (submental fat) in the third quarter of 2016, which the company anticipates having top-line data from by year end 2016.

First Quarter Ended March 31, 2016 Financial Results

Research and development expenses for the first quarter of 2016 were $3.3 million, compared to $4.7 million for the same quarter in 2015. The decrease in R&D expenses in year over year primarily reflects completion of the Phase 3 LIPO-202 AbCONTOUR1 and AbCONTOUR2 clinical trials and reduction in various R&D expenses. 

General and administrative expenses for the first quarter of 2016 were $2.5 million, compared to $1.9 million for the same quarter in 2015. The increase in general and administrative expenses year over year is primarily attributable to costs incurred in connection with separation agreements with our former Chief Executive Officer and other former employees. 

Net loss for the first quarter of 2016 was $6.0 million, or $0.44 basic and diluted net loss per share, compared to a net loss of $6.9 million, or $0.50 basic and diluted net loss per share, for the same period in 2015.

Cash and cash equivalents were $24.1 million as of March 31, 2016 compared to $37.7 million as of December 31, 2015. Revision of our loan facility, which included a partial repayment of $6 million, drove a portion of the decrease in cash quarter over quarter.  

Administerial Matters In order to enable the Company to satisfy its compliance requirements, Susan Knudson has been appointed as principal executive officer on an interim basis.

About LIPO-202
LIPO-202 is an injectable formulation of salmeterol xinafoate, a well-known long-acting ?2-adrenergic receptor agonist used in several FDA-approved drugs, including ADVAIR® for asthma. LIPO-202 is designed to be a locally-injected drug that causes localized shrinking of fat cells without any effect on nearby tissues. LIPO-202 activates ?2-adrenergic receptors on fat cells, triggering the metabolism of triglycerides stored in the fat cells, and thereby shrinking them across the treatment area.  LIPO-202 clinical research is focused on reducing undesirable localized areas of fat, including central abdominal fat in non-obese patients (stomach rolls) and submental fat (double chin).

About Neothetics, Inc.
Neothetics is a clinical-stage specialty pharmaceutical company focused on development and commercialization of therapeutics for the aesthetic market.  Our current focus is on localized fat reduction and body contouring. Neothetics’ product candidate, LIPO-202, is a potential injectable treatment for undesirable, localized areas of fat that requires no pain management before or after treatment and no downtime without damage to nearby tissues.

 
Neothetics, Inc.
Condensed Statements of Operations
(Unaudited)
       
    Three Months Ended March 31,  
    2016     2015  
Operating expenses:                
Research and development   $ 3,260,298     $ 4,700,668  
General and administrative     2,520,871       1,937,321  
Total operating expenses     5,781,169       6,637,989  
Loss from operations     (5,781,169 )     (6,637,989 )
Interest income     19,737       7,455  
Interest expense     (265,124 )     (271,846 )
Net loss   $ (6,026,556 )   $ (6,902,380 )
Net loss per share, basic and diluted   $ (0.44 )   $ (0.50 )
Weighted average shares used to compute basic and diluted net loss per share     13,757,582       13,671,311  
                 
Neothetics, Inc.
Condensed Balance Sheets
(Unaudited)
             
    March 31,     December 31,  
    2016     2015  
Assets                
Current assets:                
Cash and cash equivalents   $ 24,089,869     $ 37,748,603  
Prepaid expenses and other current assets     1,075,300       1,976,997  
Total current assets     25,165,169       39,725,600  
                 
Restricted cash     200,000     200,000  
Property and equipment, net     168,596       186,372  
Total assets   $ 25,533,765     $ 40,111,972  
Liabilities and stockholders’ equity                
Current liabilities:                
Accounts payable   $ 1,420,315     $ 4,017,192  
Accrued clinical trial expenses     630,419       1,422,810  
Other accrued expenses     1,038,685       903,148  
Long-term debt, current portion     785,123       2,756,351  
Total current liabilities     3,874,542       9,099,501  
Long-term debt, net of current portion     3,154,380       7,205,176  
Stockholders’ equity:                
Preferred stock, $0.0001 par value; 5,000,000  shares authorized; no shares 
   issued and outstanding		   —     —  
Common stock, $0.0001 par value; 300,000,000 shares authorized; 
   13,799,196 and 13,750,016 shares issued and outstanding at  
   March 31, 2016 and December 31, 2015, respectively		     1,379       1,374  
Additional paid-in capital     137,361,777       136,637,678  
Accumulated deficit     (118,858,313 )     (112,831,757 )
Total stockholders’ equity     18,504,843       23,807,295  
Total liabilities and stockholders’ equity   $ 25,533,765     $ 40,111,972