SCYNEXIS Reports First Quarter 2018 Financial Results and Provides Company Update
SCYNEXIS Reports First Quarter 2018 Financial Results and Provides Company Update
Enrollment complete in Phase 2b DOVE study in VVC; on-track for top-line data by July 2018
Phase 3 registration program in VVC planned for the fourth quarter of 2018
IV SCY-078 program continues to advance; Phase 1 study with liposomal formulation expected to initiate in the third quarter of 2018
JERSEY CITY, N.J., May 8, 2018 /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 March 31, 2018, and provided an update on recent operational and clinical developments.
"The first quarter of 2018 was one of significant clinical progress in what has the potential to be a transformative year for SCYNEXIS with multiple anticipated milestones," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We remain on track to report top-line data from the Phase 2b, dose-finding study evaluating oral SCY-078 for the treatment of vulvovaginal candidiasis (VVC) by July 2018, with Phase 3 initiation planned for the fourth quarter. We also anticipate continued progress toward expanding the therapeutic utility of SCY-078 with the planned initiation of clinical trials in invasive candidiasis and invasive aspergillosis in the second half of the year, as well as the advancement of our programs targeting refractory invasive fungal infections. We are well-positioned to realize the promise of SCY-078 as a potent and versatile antifungal agent."
Clinical and Regulatory Update for Lead Program - SCY-078 as a Treatment for VVC
-- In May 2018, SCYNEXIS announced it has completed enrollment in the Phase
2b, dose-finding study of oral SCY-078 for the treatment of VVC (the
DOVE study). SCYNEXIS is on-track to announce top-line data by July
2018. Following successful dose-identification from this trial, SCYNEXIS
plans to initiate a Phase 3 registration program of oral SCY-078 in VVC
in the fourth quarter of 2018, with potential NDA filing for VVC
expected in 2020.
-- In May 2018, SCYNEXIS announced the receipt of Qualified Infectious
Disease Product (QIDP) and Fast Track designations from the U.S. Food
and Drug Administration (FDA) for the treatment of VVC and prevention of
recurrent VVC. The QIDP designation allows SCYNEXIS to have priority
review and an additional five years of market exclusivity in the U.S.
for SCY-078. The FDA's Fast Track Drug Development Program is a process
designed to facilitate the development and expeditious review of drugs
to treat serious conditions and fill unmet medical needs.
Continued Advancement of IV SCY-078 Program with Liposomal Formulation
-- Pre-clinical work on the liposomal IV formulation of SCY-078 continues,
and SCYNEXIS remains on track to initiate a Phase 1 trial evaluating the
safety and tolerability of this formulation in healthy volunteers in the
third quarter of 2018.
-- If successful, following completion of the Phase 1 study and pending FDA
review, SCYNEXIS plans to initiate a Phase 2b, IV-oral step-down study
of SCY-078 in invasive candidiasis patients with the liposomal IV and
oral formulations of SCY-078 in the fourth quarter of 2018.
Pre-clinical Data Support Continued Development of SCY-078 for Invasive Fungal Infections
-- In April 2018, at the 28(th) European Congress of Clinical Microbiology
and Infectious Disease (ECCMID), SCYNEXIS presented pre-clinical data
demonstrating SCY-078's potent antifungal activity against Aspergillus
spp., including azole-resistant isolates, as well as synergistic
activity with approved antifungals against Aspergillus strains.
Additionally, SCYNEXIS presented in vivo data in a mouse model of
Pneumocystis pneumonia that demonstrated the activity of SCY-078 as
determined by improved survival and reduction of fungal burden,
supporting future development for prophylaxis indications.
-- In March 2018, at Superbugs and Superdrugs 2018, SCYNEXIS presented
pre-clinical data demonstrating the inhibitory effect of SCY-078 against
Candida auris biofilms, as well as SCY-078's ability to affect the
ultrastructure of C. auris cells and interrupt cell division.
-- In February 2018, at the 8(th) Advances Against Aspergillosis, SCYNEXIS
presented new pre-clinical data demonstrating synergistic in vivo
activity and improved outcomes of SCY-078 in combination with
isavuconazole for the treatment of invasive pulmonary aspergillosis. The
Company plans to initiate a Phase 2 study in the third quarter of 2018
to test the clinical efficacy of oral SCY-078 in combination with
standard of care for the treatment of invasive aspergillosis.
-- All posters and presentations are available on the Scientific
Publications page of the SCYNEXIS website.
Corporate Update
-- In April 2018, SCYNEXIS received confirmation of the renewal of its
Small and Medium Enterprise (SME) designation by the European Medicines
Agency (EMA). With this designation, SCYNEXIS is eligible to receive
financial incentives, regulatory fee reductions and waivers, and
European Union funding. SCYNEXIS remains committed to the European
market and has designed its registration programs such that concurrent
FDA and EMA approvals would be possible. European sites are actively
enrolling in the FURI study, a global, open-label study, designed to
evaluate oral SCY-078 for the treatment of fungal infections that are
refractory to or intolerant of standard therapies.
-- On March 8, 2018, SCYNEXIS raised $30.0 million in gross proceeds by
issuing 17,751,500 shares of the Company's common stock and two series
of warrants to purchase up to an aggregate of 21,301,800 shares of the
Company's common stock. The offering resulted in approximately $27.9
million of net proceeds after deducting the underwriting discount and
estimated offering expenses.
First Quarter 2018 Financial Results
Cash and cash equivalents and short-term investments totaled $63.7 million as of March 31, 2018, with net working capital of $53.5 million.
Research and development expenses increased to $5.3 million in the first quarter of 2018, compared to $4.0 million in the first quarter of 2017. The increase of $1.3 million, or 33%, was primarily driven by an increase of $0.7 million in pre-clinical development expense, a $0.7 million increase in clinical development expense, a $0.4 million increase in chemistry, manufacturing, and controls (CMC), and a net increase of $0.2 million in other research and development costs; offset by a decrease in consulting expense of $0.7 million.
Selling, general and administrative expenses of $2.0 million in the first quarter of 2018 were consistent compared to the selling, general and administrative expenses of $2.1 million in the first quarter of 2017.
Total other income increased to $3.2 million in the first quarter of 2018 due to a $3.6 million non-cash gain recorded on the fair value adjustment of the warrant liabilities.
Net loss for the first quarter of 2018 was $4.0 million, or $0.12 basic net loss per share. This compares to a net loss for the first quarter of 2017 of $4.9 million, or $0.19 basic net loss per share.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) 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 a novel IV/oral antifungal agent in Phase 2 clinical and pre-clinical development for the treatment of several serious and life-threatening invasive fungal infections caused by Candida and Aspergillus species. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding expected future events or results, including but not limited to the Company's plans regarding clinical developments, timing of data review for the DOVE trial, possible initiation of a Phase 3 registration program in VVC and timing of potential NDA filing, are "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's ability to successfully develop and obtain FDA approval for SCY-078; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS's reliance on third parties to conduct SCYNEXIS's clinical studies. These and other risks are described more fully in SCYNEXIS's 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
George E. MacDougall
MacDougall Biomedical Communications
Tel: 781-235-3093
george@macbiocom.com
SCYNEXIS, INC.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Three Months Ended March 31,
2018 2017
---- ----
Revenue $64 $64
Operating expenses:
Research and development,
net 5,326 4,020
Selling, general and
administrative 1,971 2,060
----- -----
Total operating expenses 7,297 6,080
Loss from operations (7,233) (6,016)
Other (income) expense:
Amortization of debt
discount 111 100
Interest income (167) (69)
Interest expense 379 345
Warrant liabilities fair
value adjustment (3,554) (1,523)
------ ------
Total other income (3,231) (1,147)
------ ------
Net loss $(4,002) $(4,869)
======= =======
Warrant liability fair
value adjustment - (1,523)
--- ------
Net loss attributable to
common stockholders -
diluted $(4,002) $(6,392)
------- -------
Net loss per share attributable to
common stockholders - basic
Net loss per share - basic $(0.12) $(0.19)
====== ======
Loss per share attributable to common
stockholders -diluted
Net loss per share -
diluted $(0.12) $(0.25)
====== ======
Weighted average common shares outstanding:
Basic 33,579,025 25,364,429
Diluted 33,579,025 25,562,027
SCYNEXIS, INC.
UNAUDITED CONDENSED BALANCE SHEETS
(in thousands)
March 31, 2018 December 31,
2017
Cash and
cash
equivalents $27,223 $11,469
Short-
term
investments 36,477 32,424
Total
current
assets 64,345 44,960
Total assets 65,488 45,850
Loan
payable,
current
portion 3,599 4,349
Warrant
liability 2,728 -
Total
current
liabilities 10,852 10,144
Warrant
liabilities 6,571 3,872
Loan
payable,
long term 11,164 10,303
Total
liabilities 28,644 24,440
Total
stockholders'
equity 36,844 21,410
Total
liabilities
and
stockholders'
equity $65,488 $45,850
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SOURCE SCYNEXIS, Inc.
