Print 10 November 2016
“We continue to make good progress towards moving LIPO-202 back into the clinic,” said Ms.
“Our primary focus is on the development of LIPO-202 for submental fat reduction,” said Mr.
Based on its current plans, the company expects its cash and investments to fund operations into the first quarter, 2018.
Third Quarter and Nine Months Ended
Research and development expenses for the third quarter of 2016 were approximately
General and administrative expenses for the third quarter of 2016 were
Net loss for the third quarter of 2016 was
Cash and cash equivalents were
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. 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 ß2-adrenergic receptors on fat cells, triggering the metabolism of triglycerides stored in the fat cells, and thereby shrinking them across the treatment area.
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 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
|Condensed Statements of Operations|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||964,937||$||15,211,268||$||5,653,432||$||27,381,864|
|General and administrative||905,176||1,768,935||4,407,408||5,435,543|
|Total operating expenses||1,870,113||16,980,203||10,060,840||32,817,407|
|Loss from operations||(1,870,113||)||(16,980,203||)||(10,060,840||)||(32,817,407||)|
|Net loss per share, basic and diluted||$||(0.17||)||$||(1.26||)||$||(0.80||)||$||(2.46||)|
|Weighted average shares used to compute basic and diluted net loss per share||13,816,464||13,702,177||13,786,207||13,683,470|
|Condensed Balance Sheets|
|September 30,||December 31,|
|Cash and cash equivalents||$||14,363,899||$||37,748,603|
|Prepaid expenses and other current assets||509,420||1,976,997|
|Total current assets||14,873,319||39,725,600|
|Property and equipment, net||132,514||186,372|
|Liabilities and stockholders’ equity|
|Accrued clinical trial expenses||71,156||1,422,810|
|Other accrued expenses||563,340||903,148|
|Long-term debt, current portion||—||2,756,351|
|Total current liabilities||1,431,723||9,099,501|
|Long-term debt, net of current portion||—||7,205,176|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding||—||—|
|Common stock, $0.0001 par value; 300,000,000 shares authorized; 13,828,496 and 13,750,016
shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively
|Additional paid-in capital||137,651,010||136,637,678|
|Total stockholders’ equity||13,774,110||23,807,295|
|Total liabilities and stockholders’ equity||$||15,205,833||$||40,111,972|
Russian pharmaceutical company NovaMedica, a portfolio company of RUSNANO, announces the start of construction of a plant for the production of sterile injectable drugs as part of its long-term strategy to localize innovative medicines and technologies of their development and production in Russia. The plant will be built in the industrial park “Vorsino” in the Kaluga region.
25 September 2017
25 September 2017