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 now
exists 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.
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 StatementsStatements 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 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.
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 |
|
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:
Fara Berkowitz, R.Ph, Pharm.D
Senior Director, Investor Relations and Corporate Development
646-494-1589
fberkowitz@neothetics.com
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