SCYNEXIS, Inc. Reports Third Quarter 2016 Financial Results and Provides Company Update
November 07 2016 - 4:30PM
-- Positive Results From Multiple Studies Provide
Clear Evidence of Clinical Antifungal Activity and Favorable
Safety Profile of SCY-078 --
Drug development company SCYNEXIS, Inc. (Nasdaq:SCYX), a
pharmaceutical company developing novel anti-infectives to address
unmet therapeutic needs, today reported financial results for the
quarter ended September 30, 2016, and provided an update on recent
operational and clinical developments.
“We made significant progress during the third quarter of 2016,
achieving all our clinical and financial goals, and we continue to
advance the development of our lead product candidate, SCY-078, a
novel oral and intravenous drug for the treatment of several fungal
infections,” said Marco Taglietti, M.D., President and Chief
Executive Officer of SCYNEXIS. “We reported positive results from
our two completed Phase 2 studies providing clear evidence of the
clinical antifungal activity of oral SCY-078 in two different forms
of Candida infection in humans. In addition, we announced the
completion of two Drug-Drug-Interaction studies that further
validate the favorable safety and tolerability profile of this
promising compound. These data, together with data from our earlier
studies, support our ongoing development of SCY-078 as a broad
spectrum antifungal therapy with the potential to address the
growing public health threat of fungal infections, particularly due
to resistant pathogens.”
Corporate Update
- In September 2016, we closed a $15 million term loan with Solar
Capital, fully funded at close. This funding will allow us to
expand pipeline indications for SCY-078, accelerate other
development programs and extend our cash runway.
SCY-078 Update
- In October 2016, we announced final results from a Phase 2 oral
step-down study of SCY-078 in patients with invasive candidiasis.
The study met its primary objectives by confirming that the once
daily oral dose of SCY-078 750mg is well tolerated and achieves the
target exposure at steady state in patients with invasive
candidiasis;
- In October 2016, we announced final results from a Phase 2 oral
dosing study of SCY-078 in patients with vulvovaginal candidiasis
(VVC). This proof-of-concept study met its primary objectives and
provided further evidence of the clinical antifungal activity of
oral SCY-078 in patients with Candida infections. These
positive results also support future development of oral SCY-078
for the VVC indication;
- We completed two additional Drug-Drug Interaction (DDI)
studies, demonstrating the low potential of SCY-078 to cause
DDIs;
- More than 300 subjects and patients have now been exposed to
SCY-078, providing extensive characterization of SCY-078’s
favorable safety profile;
- The Food and Drug Administration (FDA) granted Orphan Drug
Designation (ODD) to SCY-078 for the treatment of invasive
Aspergillus infections. SCY-078 is the first intravenous (IV) and
oral non-azole antifungal agent with ODD for both invasive
Aspergillus and invasive Candida infections;
- We are conducting Phase 1 clinical trials to investigate the
safety and pharmacokinetics of an intravenous formulation
of SCY-078 and we expect to report results in November 2016;
and
- We plan to initiate studies evaluating SCY-078 in patients with
refractory invasive fungal infections in the fourth quarter of
2016, and in patients with invasive candidiasis in the first
quarter of 2017.
Third Quarter 2016 Financial Results
Cash, cash equivalents and investments totaled $58.4 million as
of September 30, 2016, including $15 million from the Solar Capital
term loan.
Research and development, net expenses increased to $4.9 million
in the third quarter of 2016, compared to $3.5 million in the third
quarter of 2015. The increase of $1.4 million was primarily due to
a $1.4 million increase in preclinical development, an increase of
$1.1 million in clinical development, offset by a decrease of $0.3
million in chemistry, manufacturing and controls (CMC), a decrease
of $0.7 million in compensation, severance, and consulting expense,
and a decrease of $0.1 million in other research and development
costs.
Selling, general and administrative expenses decreased to $1.9
million in the third quarter of 2016, compared to $4.1 million in
the third quarter of 2015. The decrease of $2.3 million was
primarily due to $2.3 million in non-recurring severance and stock
based compensation related expense recognized in the third quarter
of 2015.
Loss from operations for the third quarter of 2016 was $6.7
million, compared to a loss from operations of $7.5 million for the
third quarter of 2015. The $0.9 million decrease in the loss from
operations between the two periods was due to a $1.4 million
increase in research and development expense, offset by a decrease
in selling, general and administrative expense of $2.3 million.
Total other expense increased to $4.5 million in the third
quarter of 2016 due to a $4.6 million non-cash loss recorded on the
adjustment in the fair value of warrant liability.
Net loss attributable to common stockholders for the third
quarter of 2016 was $11.2 million, or $0.48 per share. This
compares to net loss attributable to common stockholders for the
third quarter of 2015 of $8.4 million, or $0.60 per share.
About SCYNEXIS, Inc.
SCYNEXIS is a pharmaceutical company committed to the
development and commercialization of novel anti-infectives to
address significant unmet therapeutic needs. We are developing our
lead product candidate, SCY-078, as an oral and IV drug for the
treatment of several fungal infections, including serious and
life-threatening invasive fungal infections. For more information,
visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding matters
that are expected to occur in the future are "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to: the Solar
Capital funding will allow the company to expand pipeline
indications for SCY-078, accelerate other development programs and
extend its cash runway; the company’s expectation to report results
from its Phase 1 clinical trials in November 2016; that it plans to
initiate studies evaluating SCY-078 in patients with refractory
invasive fungal infections in the fourth quarter of 2016, and in
patients with invasive candidiasis in the first quarter of 2017;
and the expected benefits of SCY-078. 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 risks and uncertainties include, but are not
limited, risks inherent in SCYNEXIS' ability to successfully
develop SCY-078, including SCYNEXIS' ability to obtain FDA approval
for SCY-078, the expected costs of studies and when they might
begin or be concluded, and SCYNEXIS' reliance on third parties to
conduct SCYNEXIS' clinical studies. Risks are described more fully
in SCYNEXIS' filings with the Securities and Exchange Commission,
including without limitation, its most recent Annual Report
on Form 10-K under the caption “Risk Factors” and other documents
subsequently filed with or furnished to the Securities and Exchange
Commission. All forward-looking statements contained in this press
release speak only as of the date on which they were made. SCYNEXIS
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
SCYNEXIS, INC.UNAUDITED
CONDENSED STATEMENTS OF OPERATIONS(in thousands,
except share and per share data) |
|
|
Three Months Ended September 30, |
|
|
2016 |
|
2015 |
|
Revenue |
$ |
64 |
|
|
$ |
64 |
|
|
Operating expenses: |
|
|
|
|
Research and development, net |
4,890 |
|
|
3,458 |
|
|
Selling, general and
administrative |
1,880 |
|
|
4,143 |
|
|
Total operating expenses |
6,770 |
|
|
7,601 |
|
|
Loss from operations |
(6,706 |
) |
|
(7,537 |
) |
|
Other (income)
expense: |
|
|
|
|
Warrant liability fair value
adjustment |
4,570 |
|
|
— |
|
|
Interest income |
(48 |
) |
|
(8 |
) |
|
Total other expense
(income) |
4,522 |
|
|
(8 |
) |
|
Loss from continuing
operations |
(11,228 |
) |
|
(7,529 |
) |
|
Discontinued
operations: |
|
|
|
|
Loss from discontinued
operations |
— |
|
|
(826 |
) |
|
Net
loss |
$ |
(11,228 |
) |
|
$ |
(8,355 |
) |
|
Loss per share
attributable to common stockholders - basic and diluted |
|
|
|
|
Continuing operations |
$ |
(0.48 |
) |
|
$ |
(0.54 |
) |
|
Discontinued operations |
— |
|
|
(0.06 |
) |
|
Net loss per share - basic and
diluted |
$ |
(0.48 |
) |
|
$ |
(0.60 |
) |
|
Weighted average common
shares outstanding: |
|
|
|
|
Basic and diluted |
23,425,007 |
|
|
13,904,331 |
|
|
SCYNEXIS, INC.UNAUDITED
CONDENSED BALANCE SHEETS(in thousands, except
share and per share data) |
|
|
September 30, 2016 |
|
December 31, 2015 |
Cash and cash
equivalents |
$ |
29,809 |
|
|
$ |
46,985 |
|
Investments |
28,574 |
|
|
— |
|
Total assets |
|
61,012 |
|
|
|
49,273 |
|
Total current
liabilities |
4,038 |
|
|
6,664 |
|
Total liabilities |
27,836 |
|
|
7,324 |
|
Total stockholders’
equity |
33,176 |
|
|
41,949 |
|
Total liabilities and
stockholders’ equity |
|
61,012 |
|
|
|
49,273 |
|
CONTACT:
Media Relations
Blair McCarthy Atkinson
MacDougall Biomedical Communications
Tel: 781.235.3060
batkinson@macbiocom.com
Investor Relations
Susan Kim
Argot Partners
Tel: 212.203.4433
susan@argotpartners.com
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