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
Continued Advancement of IV SCY-078 Program with Liposomal Formulation
Pre-clinical Data Support Continued Development of SCY-078 for Invasive Fungal Infections
Corporate Update
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
[email protected]
Media Relations
George E. MacDougall
MacDougall Biomedical Communications
Tel: 781-235-3093
[email protected]
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 |
SOURCE SCYNEXIS, Inc.
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