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Exhibit 99.1

 

NEOTHETICS PROVIDES BUSINESS UPDATE AND REPORTS THIRD QUARTER 2016

FINANCIAL RESULTS

 

SAN DIEGO, November 10, 2016 — Neothetics, Inc. (NASDAQ: NEOT) today provided a business update on its strategic initiatives and reported financial results for the third quarter 2016.

 

“We continue to make good progress towards moving LIPO-202 back into the clinic,” said Ms. Martha J. Demski, a member of Neothetics’ Operating Committee and Board of Directors. “We completed manufacturing of the modified formulation of LIPO-202 and are on track to initiate our Phase 2 proof of concept study of LIPO-202 for the reduction of submental fat in December 2016.”

 

Neothetics announced plans to prioritize its efforts and resources on the Phase 2 proof of concept study for the reduction of localized fat deposits under the chin (submental fat). The company plans to initiate this study in December 2016 with top line data expected in the second quarter of 2017. This Phase 2 proof of concept study will be a randomized, double –blind, placebo –controlled dose ranging trial designed to assess the safety, tolerability and efficacy of LIPO-202. Neothetics also plans to continue development for LIPO-202 for central abdominal bulging pending results from the Phase 2 proof of concept study in submental fat reduction.

 

“Our primary focus is on  the development of LIPO-202 for submental fat reduction,” said Mr. Jeffrey Nugent, a member of Neothetics’ Operating Committee and Board of Directors. “There exists now an established regulatory pathway for injectable drugs for submental fat reduction and the submental fat reduction market is expected to be larger than the $2.5B U.S. toxin and filler market.  Moreover, our recent commercial research suggests that LIPO-202 could have exceptional potential in this market.”

 

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 September 30, 2016 Financial Results

 

Research and development expenses for the third quarter of 2016 were approximately $1.0 million, compared to $15.2 million for the same quarter in 2015. Research and development expenses for the nine months ended September 30, 2016 were $5.7 million, compared to $27.4 million for the same period in 2015.  The decrease in research and development expenses year over year is primarily due to the completion of the U.S. Phase 3 LIPO-202 AbCONTOUR1 and AbCONTOUR2 clinical trials and termination of the supplemental clinical trials to support an NDA filing. We anticipate that research and development expenses will increase when we initiate our Phase 2 proof of concept study for the reduction of localized fat deposits under the chin in December.

 

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General and administrative expenses for the third quarter of 2016 were $0.9 million, compared to $1.8 million for the same quarter in 2015. Total general and administrative expenses for the nine months ended September 30, 2016 were $4.4 million, compared to $5.4 million for the same period in 2015.  The decrease in general and administrative expenses year over year is primarily attributable to reduction in headcount and various legal, consulting and travel costs.  

 

Net loss for the third quarter of 2016 was $2.4 million, or $0.17 basic and diluted net loss per share, compared to a net loss of $17.3 million, or $1.26 basic and diluted net loss per share, for the same period in 2015. For the nine months ended September 30, 2016, net loss was $11.0 million, or $0.80 basic and diluted net loss per share, compared to a net loss of $33.6 million, or $2.46 basic and diluted net loss per share for the nine months ended September 30, 2015.

 

Cash and cash equivalents were $14.4 million as of September 30, 2016 compared to $37.7 million as of December 31, 2015. In September, Neothetics repaid in full the remaining outstanding balance of $4M under its Loan and Security Agreement, or Loan Agreement, with Hercules Capital, Inc., in its capacity as administrative agent for itself and the other lenders pursuant to the Loan Agreement.  Neothetics also paid $445,111 as payment in full of outstanding interest, the prepayment fee and final payment fees required under the Loan Agreement.

 

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. 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.  

 

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. 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

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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 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, 2015 and subsequent Quarterly Reports on Form 10-Q.

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Neothetics, Inc.

Condensed Statements of Operations

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

)

Interest income

 

 

13,935

 

 

 

6,035

 

 

 

50,078

 

 

 

20,352

 

Interest expense

 

 

(506,302

)

 

 

(287,916

)

 

 

(1,035,763

)

 

 

(844,839

)

Net loss

 

$

(2,362,480

)

 

$

(17,262,084

)

 

$

(11,046,525

)

 

$

(33,641,894

)

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

 

 

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Neothetics, Inc.

Condensed Balance Sheets

(Unaudited)

 

 

 

September 30,

 

 

December 31,

 

 

 

2016

 

 

2015

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

Restricted cash

 

 

200,000

 

 

 

200,000

 

Property and equipment, net

 

 

132,514

 

 

 

186,372

 

Total assets

 

$

15,205,833

 

 

$

40,111,972

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

797,227

 

 

$

4,017,192

 

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

 

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;

   13,828,496 and 13,750,016 shares issued and outstanding at

   September 30, 2016 and December 31, 2015, respectively

 

 

1,382

 

 

 

1,374

 

Additional paid-in capital

 

 

137,651,010

 

 

 

136,637,678

 

Accumulated deficit

 

 

(123,878,282

)

 

 

(112,831,757

)

Total stockholders’ equity

 

 

13,774,110

 

 

 

23,807,295

 

Total liabilities and stockholders’ equity

 

$

15,205,833

 

 

$

40,111,972

 

 

 

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 Development

646-494-1589

fberkowitz@neothetics.com

 

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