SCYNEXIS Reports Third Quarter 2017 Financial Results and Provides Company Update
JERSEY CITY, N.J., Nov. 7, 2017 /PRNewswire/ -- 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 September 30, 2017, and provided an update on recent operational and clinical developments.
"During the quarter, we continued to advance the clinical development of the SCY-078 platform in multiple indications and expanded the body of evidence supporting the versatility of SCY-078 and its activity against a wide variety of fungal diseases," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We've made significant progress in our lead studies, the DOVE study and the FURI study, and we look forward to continuing this momentum with the initiation of a new clinical study (the CARES study) in the fourth quarter to evaluate oral SCY-078 as a treatment for Candida auris infections, an increasingly urgent global health threat. We remain committed to advancing our vision of providing a novel treatment option to patients suffering from difficult-to-treat and often life-threatening infections."
SCY-078 Clinical and Regulatory Advancement
-- Dosing in Two Ongoing Clinical Studies Evaluating Oral SCY-078 Continues
as Planned
-- Phase 2 dose-finding study (DOVE study) for the treatment of
Vulvovaginal Candidiasis (VVC). Patient enrollment in this
U.S.-based study is proceeding as planned with top-line results
expected in mid-2018. This randomized, multicenter, double-blind,
active-controlled, dose-finding Phase 2 study is designed to
evaluate the safety and efficacy of five dosing regimens of oral
SCY-078 compared to oral fluconazole, the standard of care.
-- Global, open-label study for the treatment of patients with invasive
fungal infections that are refractory to or intolerant of standard
antifungal agents (FURI study). Patient enrollment has started in
this global study. It provides access to oral SCY-078 for patients
battling invasive fungal infections, including multi-drug resistant,
azole-resistant- or echinocandin-resistant Candida infections, who
have failed other therapies and for whom treatment options are
limited.
-- Global, Open-Label Candida auris Study (CARES Study) Opening for Patient
Enrollment in the Fourth Quarter. Candida auris is a pathogen that is
often multidrug-resistant, and systemic infections caused by Candida
auris are associated with high mortality. The CARES study is designed to
provide rapid access to oral SCY-078 for patients suffering from this
life-threatening infection.
-- Clinical Development Status of Intravenous (IV) Formulation of SCY-078.
Based on previous discussions with the U.S. Food and Drug Administration
(FDA), SCYNEXIS is in the process of gathering the required data that
will enable the submission of a complete response supporting the
Company's request to lift the clinical hold on the IV formulation of
SCY-078. Upon lifting of the clinical hold, SCYNEXIS plans to test the
intended IV dose regimen first in healthy volunteers before initiating a
Phase 2 study for treatment of patients with invasive Candida
infections. Commencement of this Phase 2 study is expected to occur in
2018.
Preclinical Data Support Clinical Activity of SCY-078
All recent scientific publications can be found at: http://www.scynexis.com/science/scientific-publications.php. Based on promising in vitro and in vivo data of SCY-078 against Aspergillus infections, both as a single agent and in combination with standard of care, described in the first two data reports below, SCYNEXIS is evaluating potential clinical development steps for this indication.
-- Reported Data Further Showing SCY-078's Activity in Numerous Potential
Indications
-- IDWeek 2017 - SCY-078 as a potential treatment for Aspergillus and
Candida infections. In October 2017, SCYNEXIS presented results from
three studies supporting the potent and broad antifungal activity of
SCY-078 against Candida and Aspergillus species. These results
showed SCY-078's potent activity against wild-type (WT) and
azole-resistant strains of A. fumigatus, as well as against WT,
azole-resistant and echinocandin-resistant strains of C.
parapsilosis. In addition, SCY-078 showed significant and
clinically-meaningful penetration into tissues relevant for the
targeted indications, including lung, vaginal mucosa and kidney,
following oral and IV administration in rats and mice.
-- TIMM 2017 - SCY-078 as a potential agent for combination therapy
against Aspergillus spp. In October 2017, SCYNEXIS presented
preliminary in vivo results of a study conducted by Thomas J. Walsh,
M.D., Professor of Medicine in Microbiology and Immunology at Weill
Cornell Medical College, and his team. SCY-078 was evaluated alone
and in combination with isavuconazole in a neutropenic rabbit model
of pulmonary aspergillosis. Preliminary results showed that SCY-078,
when administered with isavuconazole, led to better outcomes than
single agents.
-- IDSOG Annual Meeting - SCY-078 as a potential treatment of VVC. In
August 2017, SCYNEXIS presented results highlighting SCY-078's high
penetration into vaginal tissue after oral administration and its
potent anti-Candida activity in acidic pH conditions, characteristic
of the vaginal setting, supporting the use of SCY-078 as a novel
treatment of VVC.
Third Quarter 2017 Financial Results
Cash, cash equivalents and short-term investments totaled $47.7 million as of September 30, 2017, with net working capital of $42.0 million. We believe that our existing cash and cash equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2019.
Research and development, net expenses, decreased to $4.5 million in the third quarter of 2017, compared with $4.9 million in the third quarter of 2016. The decrease of $0.4 million, or 8.8%, for the three months ended September 30, 2017, was primarily driven by a decrease of $0.3 million in both clinical and preclinical development and a net increase of $0.2 million in other research and development expenses.
Selling, general and administrative expenses increased to $2.0 million in the third quarter of 2017, compared with $1.9 million in the third quarter of 2016. The increase of $0.1 million, or 6.6%, was primarily driven by an increase of $0.1 million in stock-based compensation, a $0.1 million decrease in professional services and a $0.1 million net increase in other selling, general and administrative expenses.
Total other expense decreased to $2.0 million in the third quarter of 2017, compared with $4.5 million in the third quarter of 2016. The decrease of $2.5 million, or 55.7%, was primarily driven by a decrease of $2.9 million in the non-cash loss 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 third quarter of 2017 was $8.4 million, or $0.31 per share. This compares with a net loss for the third quarter of 2016 of $11.2 million, or $0.48 per share.
About SCY-078
SCY-078 is an antifungal agent in clinical and preclinical development for the treatment of fungal infections caused by Candida and Aspergillus species. SCY-078, a semi-synthetic derivative of the natural product enfumafungin, is the first representative of a family of triterpenoids--a structurally distinct and novel class of glucan synthase inhibitors. 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 FDA 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 SCYNEXIS
SCYNEXIS, 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 IV 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.
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
SCYNEXIS, INC.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Three Months Ended September
30,
2017 2016
---- ----
Revenue $64 $64
Operating expenses:
Research and
development, net 4,459 4,890
Selling, general
and administrative 2,004 1,880
----- -----
Total operating
expenses 6,463 6,770
Loss from
operations (6,399) (6,706)
Other expense (income):
Amortization of
debt discount 100 -
Interest income (109) (48)
Interest expense 373 -
Warrant liability
fair value
adjustment 1,638 4,570
----- -----
Total other expense 2,002 4,522
----- -----
Net loss $(8,401) $(11,228)
======= ========
Net loss per share
- basic and
diluted $(0.31) $(0.48)
====== ======
Weighted average
common shares
outstanding -
basic and diluted 27,091,061 23,425,007
========== ==========
SCYNEXIS, INC.
UNAUDITED CONDENSED BALANCE SHEETS
(in thousands)
September 30, December 31,
2017 2016
Cash and cash
equivalents $8,749 $35,656
Short-term
investments 38,960 22,930
Total current
assets 48,723 59,327
Total assets 49,619 59,792
Loan payable, current
portion 2,849 -
Total current
liabilities 6,675 3,717
Loan payable,
long term 11,703 14,252
Total
liabilities 22,355 24,973
Total
stockholders'
equity 27,264 34,819
Total
liabilities and
stockholders'
equity $49,619 $59,792
View original content:http://www.prnewswire.com/news-releases/scynexis-reports-third-quarter-2017-financial-results-and-provides-company-update-300551312.html
SOURCE SCYNEXIS, Inc.
