“We are extremely pleased with the progress made during the quarter,” said
First Quarter 2017 and Recent Corporate Highlights
April 2017, Neotheticsannounced the issuance of U.S. Patent Number 9,597,531 by the United States Patent and Trademark Office (USPTO). This patent is directed to specific methods of using LIPO-202 and other agents for the reduction of fat accumulation. The ’531 patent is expected to expire no earlier than the first quarter of 2031, extending the coverage time of the company’s intellectual property portfolio. This is the eighth issued U.S. patent directed to Neothetics' lead product candidate LIPO-202, which is being evaluated for the reduction of submental fat.
March 2017, Neotheticsannounced completion of subject enrollment for its Phase 2 proof of concept trial, LIPO-202-CL-31, for the reduction of submental subcutaneous fat. LIPO-202-CL-31 is a multi-center, randomized, double-blind, placebo-controlled Phase 2 proof of concept trial to evaluate the safety and efficacy of two doses of LIPO-202 versus placebo for the reduction of submental bulging due to subcutaneous fat.
The trial has enrolled approximately 150 subjects at 12 sites across the United States. Subjects will be randomized 1:1:1 and receive up to either 0.3 mcg or 3.0 mcg dose of LIPO-202, or placebo. Subjects will receive up to 30 subcutaneous injections of LIPO-202 or placebo once a week for eight weeks and follow up visits to assess safety and efficacy will occur one week and four weeks post the last treatment.
The study endpoints include both safety and efficacy measurements. Efficacy measures will assess improvement in the subject’s submental region as evaluated by both the patient and clinician, covering overall subject satisfaction and evaluation of submental fat thickness by calipers.
First Quarter Ended
Research and development expenses for the first quarter of 2017 were approximately
General and administrative expenses for the first quarter of 2017 were
Net loss for the first quarter of 2017 was
Cash and cash equivalents were
LIPO-202 is a proprietary, first-in-class injectable formulation of the well-known long-acting ß2-adrenergic receptor agonist, salmeterol xinafoate, which is an active ingredient of FDA-approved inhaled products such as SEREVENT DISKUS®, ADVAIR HFA® and ADVAIR DISKUS®. Our studies suggest that salmeterol xinafoate activates ß2 -adrenergic receptors on fat cells, triggering the body’s natural process of metabolizing stored triglycerides (fat) resulting in a reduction in size and volume of the fat cells in the treatment area without damage of nearby tissues. LIPO-202 has an extremely favorable safety profile, with little to no adverse post treatment effects. LIPO-202 is being evaluated for the reduction of submental fat commonly referred to as a double-chin.
Neothetics is a San Diego based clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market. Our initial focus is on localized fat reduction and body contouring. Our lead product candidate, LIPO-202, is a first-in-class injectable formulation of the long-acting ß2-adrenergic receptor agonist, salmeterol xinafoate, which is an active ingredient in the U.S. Food and Drug Administration, or FDA, approved inhaled products SEREVENT DISKUS®, ADVAIR HFA® and ADVAIR DISKUS®. 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 the ability to develop a modified formulation of LIPO-202, timing of conducting and obtaining results from Phase 2 trials and proof of concept study with a modified formulation of LIPO-202, whether our modified formulation of LIPO-202 is able to demonstrate positive results, Neothetics’ plans to research, develop and commercialize LIPO-202 and other product candidates, our expectations regarding the potential market size and opportunity of LIPO-202, 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, such as the ability to timely initiate clinical trials and enroll a sufficient number of patients on a timely basis into clinical trials, the extent to which top-line data is available and whether the clinical trials achieve positive results, product development activities, obtaining regulatory approval to commercialize LIPO-202 and other product candidates, Neothetics’ use of cash, our ability to continue as a going concern, and the need to raise additional funding, when needed, in order to conduct our clinical trials and other 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.
|Condensed Statements of Operations|
|Three Months Ended March 31,|
|Research and development||$||1,549,912||$||3,260,298|
|General and administrative||1,476,259||2,520,871|
|Total operating expenses||3,026,171||5,781,169|
|Loss from operations||(3,026,171||)||(5,781,169||)|
|Net loss per share, basic and diluted||$||(0.22||)||$||(0.44||)|
|Weighted average shares used to compute basic and diluted net loss per share||13,807,622||13,757,582|
|Condensed Balance Sheets|
|March 31,||December 31,|
|Cash and cash equivalents||$||9,749,756||$||11,477,852|
|Prepaid expenses and other current assets||853,592||1,029,546|
|Total current assets||10,603,348||12,507,398|
|Property and equipment, net||36,452||109,320|
|Liabilities and stockholders’ equity|
|Other accrued expenses||742,427||398,453|
|Total current liabilities||1,697,737||902,192|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no|
|shares issued and outstanding||—||—|
|Common stock, $0.0001 par value; 300,000,000 shares authorized;|
|13,831,747 and 13,828,496 shares issued and outstanding at|
|March 31, 2017 and December 31, 2016, respectively||1,383||1,382|
|Additional paid-in capital||137,898,053||137,763,499|
|Total stockholders’ equity||9,035,445||11,914,526|
|Total liabilities and stockholders’ equity||$||10,733,182||$||12,816,718|
Susan A. KnudsonChief Financial Officer 858-500-7780 firstname.lastname@example.org Fara Berkowitz, R.Ph, Pharm.D Senior Director, Investor Relations and Corporate Development 646-494-1589 email@example.com