SAN DIEGO, Aug. 13, 2015 (GLOBE NEWSWIRE) — Neothetics, Inc. (NASDAQ:NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today reported financial results and business progress for the second quarter 2015.
“We remain on track for reporting topline results from our pivotal U.S. Phase 3 trials later this year,” said George Mahaffey, president and chief executive officer of Neothetics. “There is clearly high demand for new, safe and effective FDA-approved drug options in the rapidly growing non-invasive body contouring market. If approved, LIPO-202 will be the first drug approved for reduction of central abdominal bulging.”
Second Quarter 2015 Highlights
- Neothetics initiated its pivotal U.S. Phase 3 trials titled AbCONTOUR1 and AbCONTOUR2 of LIPO-202, the first non-invasive injectable drug candidate for abdominal contouring. AbCONTOUR1 and AbCONTOUR2 are randomized, double-blind, placebo-controlled Phase 3 trials designed to assess the efficacy, safety and tolerability of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. The trials will enroll a total of 1,600 subjects to be randomized 1:1 to LIPO-202 or placebo. The trials are being conducted at approximately 80 sites across the U.S.
- Neothetics initiated LIPO-202-CL-23, a double-blind extension study to evaluate the post-treatment safety and duration of clinical effect of LIPO-202 in subjects who have completed either AbCONTOUR1 (LIPO-202-CL-18) or AbCONTOUR2 (LIPO-202-CL-19). The study is by protocol a safety study to evaluate the safety profile of LIPO-202 for up to one year post-treatment. Secondarily, Neothetics will be evaluating post-treatment duration of clinical effect of LIPO-202. This is a supplemental study that Neothetics expects to submit to the U.S. Food and Drug Administration (FDA) as part of the company’s New Drug Application (NDA) package for LIPO-202.
Second Quarter and Six Months Ended June 30, 2015 Financial Results
Research and development expenses for the second quarter of 2015 were $7.5 million, compared to $0.9 million for the same quarter in 2014. R&D expenses for the first six months of 2015 were $12.2 million, compared to $2.3 million in the six month period ended June 30, 2014. The increase in R&D expenses in the first six months of 2015 compared to the same period in the prior year primarily reflects expenses related to conducting the Phase 3 LIPO-202 AbCONTOUR1 and AbCONTOUR2 clinical trials, as well as the planning and initiation of two supplemental clinical studies.
General and administrative expenses for the second quarter of 2015 were $1.7 million, compared to $1.1 million for the same quarter in 2014. Total general and administrative expenses for the first six months of 2015 were $3.7 million, compared to $2.2 million in the six months ended June 30, 2014. The increase in general and administrative expenses in the first six months of 2015 compared to the same period of the prior year is primarily attributable to general legal fees, insurance, and investor and public relations activities increasing as a result of becoming a public company, as well as the hiring of additional personnel.
Net loss for the second quarter of 2015 was $9.5 million, or $0.69 basic and diluted net loss per share, compared to a net loss of $2.3 million, or $4.13 basic and diluted net loss per share, for the same period in 2014. For the six months ended June 30, 2015, net loss was $16.4 million, or $1.20 basic and diluted net loss per share, compared to a net loss of $3.9 million, or $7.15 basic and diluted net loss per share for the six months ended June 30, 2014.
Cash and cash equivalents were $63.0 million as of June 30, 2015 compared to $75.9 million for the year ended December 31, 2014. Based on current operating assumptions, Neothetics believes its existing cash and cash equivalents will allow it to fund completion of its LIPO-202 Phase 3 pivotal trials and related studies in support of the company’s NDA filing.
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 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 a best-in-class, non-surgical, non-ablative procedure and first-in-class injectable formulation 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 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 10Q dated August 13, 2015 and Form 10-K, dated March 26, 2015.
|Condensed Statements of Operations|
| Three Months Ended |
| Six Months Ended June |
|Operating expenses:|| || |
|Research and development||$ 7,469,928||$ 932,106||$12,170,596||$ 2,315,544|
|General and administrative||1,729,287||1,050,683||3,666,608||2,152,213|
|Total operating expenses||9,199,215||1,982,789||15,837,204||4,467,757|
|Loss from operations||(9,199,215)||(1,982,789)||(15,837,204)||(4,467,757)|
|(Gain) loss on change in fair value of preferred stock warrants||—||(271,347)||—||614,661|
|Net loss||$ (9,477,430)||$ (2,279,463)||$ (16,379,810)||$ (3,881,701)|
|Net loss per share, basic and diluted||$ (0.69)||$ (4.13)||$ (1.20)||$ (7.15)|
|Weighted average shares used to compute basic and diluted net loss per share||13,676,582||552,440||13,673,961||543,044|
|Condensed Balance Sheets|
| June 30, |
|December 31, 2014|
|Cash and cash equivalents||$ 62,954,955||$ 75,947,516|
|Prepaid expenses and other current assets||815,520||925,773|
|Total current assets||63,770,475||76,873,289|
|Property and equipment, net||221,923||24,809|
|Total assets||$ 64,192,398||$ 76,898,098|
|Liabilities and stockholders’ equity (deficit)|
|Accounts payable||$ 2,991,697||$ 997,269|
|Long-term debt, current portion||1,228,599||—|
|Total current liabilities||5,990,990||1,909,589|
|Long-term debt, net of current portion||8,616,905||9,741,080|
|Stockholders’ equity (deficit):|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding||—||—|
|Common stock, $0.0001 par value; 300,000,000 shares authorized; 13,690,902 and 13,671,311 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively;||1,369||1,366|
|Additional paid-in capital||135,637,656||134,920,775|
|Total stockholders’ equity||49,584,503||65,247,429|
|Total liabilities and stockholders’ equity||$ 64,192,398||$ 76,898,098|
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