SCYNEXIS Reports Second Quarter 2017 Financial Results and Provides Company Update
August 08 2017 - 4:25PM
Dosing Initiated in Phase 2 Study
Evaluating Oral SCY-078 in Vulvovaginal
Candidiasis
SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering
innovative anti-infective therapies for difficult-to-treat and
often life-threatening infections, today reported financial results
for the quarter ended June 30, 2017, and provided an update on
recent operational and clinical developments.
“During the quarter, we commenced enrollment in our Phase 2
trial for vulvovaginal candidiasis, an indication for which oral
SCY-078 may address a large unmet therapeutic need. This milestone
is in line with our strategy to maximize the impact and value of
the SCY-078 platform by advancing the development of our oral
formulation in multiple indications,” said Marco Taglietti, M.D.,
President and Chief Executive Officer of SCYNEXIS. “We continue to
be very encouraged by the breadth of data showing SCY-078’s potent
activity against a wide range of antifungal strains, including
resistant strains.”
SCY-078 Update
- Initiation of Dosing in Phase 2 Vulvovaginal
Candidiasis (VVC) Study (the DOVE Study). In August 2017,
SCYNEXIS initiated dosing in the Phase 2 study evaluating oral
SCY-078 for the treatment of VVC. The randomized, multicenter,
double-blind, active-controlled, dose-finding Phase 2 study is
designed to evaluate the safety and efficacy of oral SCY-078
compared with oral fluconazole, the standard of care, in adult
female patients.
- SCY078 VVC Data to be Presented at the
2017 IDSOG Annual Meeting.
SCYNEXIS will feature data from the Company's lead candidate,
SCY-078, in one oral and two poster presentations at the 2017
Infectious Diseases Society for Obstetrics and Gynecology (IDSOG)
Annual Meeting, occurring August 10-12, 2017 in Park City, UT,
further supporting the potential benefits of SCY-078 as a treatment
for VVC.
|
Title of the
Oral Presentation: A Multicenter, Randomized, Evaluator
Blinded, Active-Controlled Study to Evaluate the Safety and
Efficacy of Oral SCY-078 vs. Oral Fluconazole in 96 Subjects with
Moderate to Severe Vulvovaginal Candidiasis.Date and
Time: Saturday, August 12, 2017, 10:30-10:40 a.m. MT |
|
Title of the
Poster Presentation: The Effect of pH on the In Vitro
Antifungal Activity of SCY-078.Date and Time:
Friday, August 11, 2017, 7:00 a.m.-Saturday, August 12, 2017, 2:00
p.m. MT |
|
Title of the
Poster Presentation: Vaginal Concentrations of SCY-078, a
Novel Glucan Synthase Inhibitor, Following Oral Administration in
Mice. |
|
Date and
Time: Friday, August 11, 2017, 7:00 a.m.-Saturday, August
12, 2017, 2:00 p.m. MT |
- Publication of Data Demonstrates Wide Range of Potent
Activity of SCY-078 Against Multiple Fungal Species.
- In June 2017, SCYNEXIS announced the publication of a study
evaluating the activity of SCY-078 against 351 Candida clinical
isolates from 11 species, including echinocandin-resistant strains,
in the Antimicrobial Agents and Chemotherapy (AAC) medical journal.
These results demonstrate the versatile in vitro anti-Candida
activity of SCY-078.
- In May 2017, results of an expansive study conducted by the
Mycotic Diseases Branch of the Centers for Disease Control and
Prevention (CDC) highlighted the activity of SCY-078 against
Candida auris, an emerging life-threatening and multidrug-resistant
fungus. Study results were published in the AAC medical
journal.
- In May 2017, the AAC medical journal published results of a
study conducted by researchers at Case Western Reserve University
School of Medicine that assessed the activity of SCY-078 and 10
currently available agents against 16 Candida auris strains. In the
study, SCY-078 demonstrated potent activity against all strains
tested.
- Presented SCY-078 Data at ASM Microbe
2017. In June 2017, SCYNEXIS presented
the results of eight studies supporting the strong and consistent
antifungal activity and positive safety and tolerability profile of
SCY-078 at ASM Microbe 2017 in New Orleans.
- Clinical Development Status of Intravenous (IV)
Formulation of SCY-078. On March 2, 2017, SCYNEXIS
announced that the U.S. Food and Drug Administration (FDA) required
the Company to hold the initiation of any new clinical studies with
the IV formulation of SCY-078. The Company met with the FDA in the
second quarter of 2017 and, based on feedback from this meeting,
the Company plans to submit to the FDA a comprehensive analysis of
data from preclinical and clinical studies, including recently
completed and planned preclinical studies for SCY-078.
Upon lifting of the clinical hold, SCYNEXIS plans to test the
intended IV dose regimen first in healthy volunteers and then
expects to initiate the planned Phase 2 study for the treatment of
patients with invasive Candida infections in 2018.
Second Quarter 2017 Financial ResultsCash, cash
equivalents and short-term investments totaled $49.3 million as of
June 30, 2017, with net working capital of $46.2 million.
Research and development, net expenses decreased to $4.4 million
in the second quarter of 2017, compared to $6.7 million in the
second quarter of 2016. The decrease of $2.2 million, or 33.2%, for
the three months ended June 30, 2017, was primarily driven by a
decrease of $1.6 million in clinical development and a decrease of
$0.6 million in chemistry, manufacturing and controls (CMC).
Selling, general and administrative expenses increased to $2.4
million in the second quarter of 2017, compared with $1.7 million
in the second quarter of 2016. The increase of $0.7 million,
or 41.1%, for the three months ended June 30, 2017, was primarily
driven by an increase of $0.3 million in business development
related activities, a $0.2 million increase in employee and
stock-based compensation, a $0.1 million increase in professional
legal fees, and a $0.1 million net increase in other selling,
general, and administrative expenses.
Total other income increased to $2.5 million in the second
quarter of 2017 due to a $2.9 million non-cash gain recorded on the
adjustment in the fair value of the warrant liability, offset in
part by a $0.4 million increase in interest expense.
Net loss for the second quarter of 2017 was $4.2 million, or
$0.16 per share. This compares with a net loss for the second
quarter of 2016 of $8.1 million, or $0.56 per share.
About SCY-078 SCY-078 is an antifungal agent in
clinical development for the treatment of fungal infections caused
by Candida and Aspergillus species. SCY-078 is
a triterpenoid, semi-synthetic derivative of the natural product
enfumafungin—a structurally distinct and novel class of glucan
synthase inhibitor. SCY-078 combines the well-established activity
of glucan synthase inhibitors with the potential flexibility of
having IV and oral formulations. By belonging to a chemical class
distinct from other antifungals, SCY-078 has shown in
vitro and in vivo activity against multi-drug
resistant pathogens, including azole- and echinocandin-resistant
strains. The U.S. Food and Drug Administration granted Fast Track,
Qualified Infectious Disease Product and Orphan Drug Designations
for the formulations of SCY-078 for the indications of invasive
candidiasis (including candidemia) and invasive aspergillosis.
About SCYNEXISSCYNEXIS, Inc. is a biotechnology
company committed to positively impacting the lives of
patients suffering from difficult-to-treat and often
life-threatening infections by delivering innovative anti-infective
therapies. The SCYNEXIS team has extensive experience in the life
sciences industry, discovering and developing more than 30
innovative medicines over a broad range of therapeutic areas. The
Company's lead product candidate, SCY-078, is the first
representative of a novel oral and intravenous triterpenoid
antifungal family and is in Phase 2 clinical development 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 maybe, "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. 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, to: risks
inherent in SCYNEXIS' ability to successfully develop SCY-078,
including SCYNEXIS' ability to resolve the FDA's concerns to lift
the clinical hold on the IV formulation of SCY-078 on a timely
basis, if at all, and 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. These and other 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 June 30, |
|
|
2017 |
|
|
|
2016 |
|
Revenue |
$ |
64 |
|
|
$ |
64 |
|
Operating
expenses: |
|
|
|
|
Research
and development, net |
|
4,448 |
|
|
|
6,659 |
|
Selling,
general and administrative |
|
2,361 |
|
|
|
1,673 |
|
Total
operating expenses |
|
6,809 |
|
|
|
8,332 |
|
Loss from
operations |
|
(6,745 |
) |
|
|
(8,268 |
) |
Other (income)
expense: |
|
|
|
|
Amortization of debt discount |
|
100 |
|
|
|
— |
|
Interest
income |
|
(82 |
) |
|
|
(39 |
) |
Interest
expense |
|
360 |
|
|
|
— |
|
Warrant
liability fair value adjustment |
|
(2,924 |
) |
|
|
(101 |
) |
Total other income |
|
(2,546 |
) |
|
|
(140 |
) |
Net
loss |
$ |
(4,199 |
) |
|
$ |
(8,128 |
) |
|
|
|
|
|
Net loss per share –
basic and diluted |
$ |
(0.16 |
) |
|
$ |
(0.56 |
) |
Weighted average common
shares outstanding – basic and diluted |
|
25,813,675 |
|
|
|
14,590,733 |
|
SCYNEXIS, INC.UNAUDITED
CONDENSED BALANCE SHEETS(in
thousands) |
|
|
|
|
|
June 30, 2017 |
|
December 31, 2016 |
Cash
and cash equivalents |
$ |
7,450 |
|
|
$ |
35,656 |
|
Short-term investments |
41,890 |
|
|
22,930 |
|
Total current assets |
50,854 |
|
|
59,327 |
|
Total
assets |
|
51,835 |
|
|
|
59,792 |
|
Loan
payable, current portion |
|
1,349 |
|
|
|
— |
|
Total current liabilities |
4,673 |
|
|
3,717 |
|
Loan
payable, long term |
13,103 |
|
|
14,252 |
|
Total liabilities |
20,179 |
|
|
24,973 |
|
Total stockholders’ equity |
31,656 |
|
|
34,819 |
|
Total
liabilities and stockholders’ equity |
$ |
51,835 |
|
|
$ |
59,792 |
|
CONTACT:
Investor Relations
Susan Kim
Argot Partners
Tel: 212-203-4433
susan@argotpartners.com
Media Relations
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-591-3443
cduong@macbiocom.com
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