Neothetics, Inc. (NASDAQ:NEOT) today provided a business update on
its strategic and operational initiatives and reported financial
results for the second quarter 2016.
“We are pleased with the progress made during the quarter and
remain confident in our efforts to pursue development with a
modified formulation of our lead asset, LIPO-202,” said Martha J.
Demski, Neothetics’ Operating Committee and Board Member. “We look
forward to moving LIPO-202 into the clinic for two anatomical
regions; submental and central abdominal. We believe the market for
localized fat reduction is significant and untapped. The American
Society of Dermatologic Surgeons’ (ASDS) 2016 survey highlighted
60% of U.S. consumers surveyed are considering an aesthetic
procedure and 83% are concerned by excess fat. We believe LIPO-202
has the potential to address a significant unmet need in the U.S.
aesthetic market.”
In the second quarter of 2016, Neothetics engaged Therapeutics
Inc., a leading dermatology development CRO, for the services of
medical aesthetic and dermatology veteran Dan Piacquadio M.D., to
lead the newly formed Development Committee. The Development
Committee also includes members from the Neothetics’ management
team and outside consultants with established track-records in
aesthetic innovation, fat reducing injectable drugs, and
lyophilized drug formulations. The Development Committee is
responsible for general oversight and overall strategy for the
LIPO-202 development plan activities including Chemistry,
Manufacturing and Controls (CMC), clinical and regulatory.
Dr. Piacquadio will report directly to the Operating Committee of
the Board of Directors. The Operating Committee consists of
Board Members: Martha J. Demski, Kim P. Kamdar, Ph.D., and Jeffrey
M. Nugent, who together with management oversee the strategic
direction and day-to-day operations of the company. Ms. Demski, Dr.
Kamdar, and Mr. Nugent bring combined comprehensive leadership and
experience in medical aesthetics, corporate turn-arounds, and
mergers and acquisitions.
Mr. Nugent, Neothetics’ Operating Committee and Board Member,
said, “Dr. Piacquadio is recognized as an accomplished leader in
medical aesthetic and dermatology innovation. The depth and breadth
of his experience will enhance the rigor of our clinical research
and development. We believe that we have the right team in place to
further develop and maximize the value of LIPO-202.”
“A measured, comprehensive process is the cornerstone of drug
development and Neothetics’ commitment to disciplined drug
development as well as the differentiated properties of their lead
asset, LIPO-202, attracted me to this opportunity,” said Dr.
Piacquadio.
Following comprehensive review and evaluation of the LIPO-202
program by the Development Committee, including a review of the
timelines required to develop and manufacture the modified
formulation of LIPO-202, Neothetics is updating its LIPO-202
program timelines.
Neothetics plans to initiate a Phase 2 proof of concept study
with a modified formulation of LIPO-202 in the fourth quarter of
2016 for the reduction of localized fat deposits under the chin
(submental fat), which the company anticipates having top-line data
from 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.
The company also plans to initiate a Phase 2 trial with a
modified formulation of LIPO-202 in the first quarter of 2017
for the reduction of central abdominal bulging which the company
anticipates having top-line data from in the third quarter of 2017.
This Phase 2 study will be a randomized, double–blind,
placebo–controlled trial designed to assess the efficacy, safety
and tolerability of LIPO-202.
Based on its current development plans, the company expects its
cash and investments to fund each of the studies and its operations
into the fourth quarter 2017.
Additional Second Quarter 2016 Highlights
- The United States Patent and Trademark Office (USPTO) recently
issued Neothetics U.S. Pat. No. 9,370,498. This particular
patent is directed to injectable formulations and methods of
treating regional fat deposits using LIPO-202. The company’s
patent portfolio now includes five issued patents, two patent
applications that have been allowed by the USPTO, and several
additional patent applications that are pending, all in the United
States, as well as granted and pending foreign counterparts of such
U.S patents and pending applications directed to LIPO-202.
Second Quarter and Six Months Ended June 30, 2016
Financial Results
Research and development expenses for the
second quarter of 2016 were $1.4 million, compared to $7.5 million
for the same quarter in 2015. Research and development expenses for
the six months ended June 30, 2016 were $4.7 million, compared to
$12.2 million for the same period in 2015. The decrease in
research and development expenses year over year primarily reflects
the completion of Phase 3 LIPO-202 AbCONTOUR1 and AbCONTOUR2
clinical trials and reduction in various research and development
expenses.
General and administrative expenses for the
second quarter of 2016 were $1.1 million, compared to $1.7 million
for the same quarter in 2015. Total general and administrative
expenses for the six months ended June 30, 2016 were $3.6 million,
compared to $3.7 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
costs.
Net loss for the second quarter of 2016 was
$2.7 million, or $0.19 basic and diluted net loss per share,
compared to a net loss of $9.5 million, or $0.69 basic and diluted
net loss per share, for the same period in 2015. For the six months
ended June 30, 2016, net loss was $8.7 million, or $0.63 basic and
diluted net loss per share, compared to a net loss of $16.4
million, or $1.20 basic and diluted net loss per share for the six
months ended June 30, 2015.
Cash and cash equivalents were $21.5 million as
of June 30, 2016 compared to $37.7 million as of December 31, 2015.
Based on its current development plans, the company expects its
cash and investments to fund its operations into the fourth quarter
2017.
Dan Piacquadio, M.D. BiographyDan Piacquadio,
M.D. is the President, Chief Executive Officer and Founder of
Therapeutics, Inc. He started Therapeutics, Inc. as a development
business dedicated to the field of dermatology in June 1997. Dr.
Piacquadio has been active in clinical research and medical product
development since 1985, when he was director of R&D for
Oncotherm GmbH, and was responsible for regulatory affairs and
clinical development. He went on to establish the clinical research
program for the Division of Dermatology at the University of
California, San Diego and served as director of this facility from
1989 to 1997. Dr. Piacquadio has been instrumental in the
non-clinical and clinical development phases of a variety of soft
tissue augmentation products including Hylaform (Biomatrix) and
played a key role in defining regulatory strategy and clinical
development of the first laser-based hair removal technology
pioneered by Thermolase. As a consultant to the FDA Generic Drug
Group he co-led the development of the current bioequivalency
standards for topical steroids. Dr. Piacquadio received a Bachelor
of Science degree in biomedical engineering from Rensselaer
Polytechnic Institute and his medical degree from the University of
Pennsylvania. He received his graduate clinical training at Brown
University as an intern in internal medicine and his dermatology
training at University of California, San Diego.
About LIPO-202LIPO-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. LIPO-202 clinical research is
focused on reducing undesirable localized areas of fat, including
central abdominal fat in non-obese patients (stomach rolls) and
submental fat (double chin).
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, 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,
the company’s 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 June 30, |
|
Six Months Ended June 30, |
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
1,428,196 |
|
|
$ |
7,469,928 |
|
|
$ |
4,688,494 |
|
|
$ |
12,170,596 |
|
General
and administrative |
|
|
1,091,642 |
|
|
|
1,729,287 |
|
|
|
3,612,513 |
|
|
|
3,666,608 |
|
Total operating
expenses |
|
|
2,519,838 |
|
|
|
9,199,215 |
|
|
|
8,301,007 |
|
|
|
15,837,204 |
|
Loss from
operations |
|
|
(2,519,838 |
) |
|
|
(9,199,215 |
) |
|
|
(8,301,007 |
) |
|
|
(15,837,204 |
) |
Interest income |
|
|
16,406 |
|
|
|
6,862 |
|
|
|
36,143 |
|
|
|
14,317 |
|
Interest expense |
|
|
(154,057 |
) |
|
|
(285,077 |
) |
|
|
(419,181 |
) |
|
|
(556,923 |
) |
Net loss |
|
$ |
(2,657,489 |
) |
|
$ |
(9,477,430 |
) |
|
$ |
(8,684,045 |
) |
|
$ |
(16,379,810 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.19 |
) |
|
$ |
(0.69 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.20 |
) |
Weighted average shares
used to compute basic and diluted net loss per share |
|
|
13,800,997 |
|
|
|
13,676,582 |
|
|
|
13,779,290 |
|
|
|
13,673,961 |
|
Neothetics,
Inc. |
Condensed
Balance Sheets |
(Unaudited) |
|
|
|
June 30, |
|
December 31, |
|
|
2016 |
|
2015 |
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
21,471,803 |
|
|
$ |
37,748,603 |
|
Prepaid
expenses and other current assets |
|
|
757,677 |
|
|
|
1,976,997 |
|
Total current
assets |
|
|
22,229,480 |
|
|
|
39,725,600 |
|
|
|
|
|
|
|
|
|
|
Restricted cash |
|
|
200,000 |
|
|
|
200,000 |
|
Property and equipment,
net |
|
|
150,948 |
|
|
|
186,372 |
|
Total assets |
|
$ |
22,580,428 |
|
|
$ |
40,111,972 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,090,119 |
|
|
$ |
4,017,192 |
|
Accrued
clinical trial expenses |
|
|
489,940 |
|
|
|
1,422,810 |
|
Other
accrued expenses |
|
|
961,782 |
|
|
|
903,148 |
|
Long-term
debt, current portion |
|
|
1,190,431 |
|
|
|
2,756,351 |
|
Total current
liabilities |
|
|
3,732,272 |
|
|
|
9,099,501 |
|
Long-term debt, net of
current portion |
|
|
2,809,601 |
|
|
|
7,205,176 |
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, $0.0001 par value; 5,000,000 shares authorized; no
sharesissued and outstanding |
|
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value; 300,000,000 shares authorized;13,815,589
and 13,750,016 shares issued and outstanding atJune 30, 2016 and
December 31, 2015, respectively |
|
|
1,381 |
|
|
|
1,374 |
|
Additional paid-in capital |
|
|
137,552,976 |
|
|
|
136,637,678 |
|
Accumulated deficit |
|
|
(121,515,802 |
) |
|
|
(112,831,757 |
) |
Total stockholders’
equity |
|
|
16,038,555 |
|
|
|
23,807,295 |
|
Total liabilities and
stockholders’ equity |
|
$ |
22,580,428 |
|
|
$ |
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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