RESEARCH TRIANGLE PARK, N.C., Aug. 19, 2015 (GLOBE NEWSWIRE) -- Drug discovery and development company SCYNEXIS, Inc. (Nasdaq:SCYX) today reported financial results for the second quarter of 2015.
"In reflecting on the first quarter and subsequent period of my tenure as CEO at SCYNEXIS, I've been impressed by the dedication and performance of my team and the progress we have achieved. This has been a transformative period for us as we completed a follow-on public offering that provides a solid financial position, accomplished the divestiture of the services business which allows us to focus on the further development of our lead compound, SCY-078, and initiated the relocation of our newly realigned operations to New Jersey," said Marco Taglietti, M.D., SCYNEXIS' Chief Executive Officer. "Most importantly, we are continuing to advance the development of both the oral and intravenous formulations of SCY-078, our key asset, which is representative of a new class of antifungals for life-threatening invasive fungal infections while we also assess SCY-078's broader clinical utility and look to further expand its development into other areas of unmet need."
- SCYNEXIS raised $41 million through the successful completion of a follow-on public offering. These additional funds have created a solid financial foundation for the company. We ended the quarter with $57 million in cash, and we expect these resources to be sufficient to fund us through the first half of 2017.
- As part of our strategic objective to devote our resources to the development of SCY-078, we completed an asset sale with Accuratus Lab Services, Inc. for the divestiture of SCYNEXIS' contract research and development services business. The services business was no longer strategic to our core business and did not provide any meaningful operating capital.
- In connection with the sale, we are relocating our newly realigned team and corporate headquarters to Jersey City, New Jersey.
- To support SCY-078's development, we have added additional talent to our team. Notably, David Angulo, M.D., joined SCYNEXIS as our Chief Medical Officer, bringing a proven track record in developing antifungals and broad expertise in drug development.
- We have also realigned the composition of our Board of Directors during the second quarter of 2015 and subsequent period in support of our focused strategic direction. As such, Guy Macdonald was appointed Chairman of the Board of Directors and Pamela J. Kirby, Ph.D., Laurent Arthaud and Jean-Yves Nothias, Ph.D., did not stand for reelection and retired from the Board. Additionally, SCYNEXIS' founder and President Yves J. Ribeill, Ph.D., stepped down from his position as President but remains on the Board of Directors.
- We are conducting an ongoing Phase 2 study of the oral formulation of SCY-078 as a step-down treatment in patients initially treated with echinocandin therapy for invasive Candida infections. In order to facilitate patient enrollment, we have implemented protocol amendments; we have opened new investigational sites in the U.S.; we intend to open sites outside of the U.S.; and we are evaluating subsequent amendments to the protocol. We expect to complete our Phase 2 study and report top line results in the first half of 2016.
- We are also currently developing an IV formulation of SCY-078 and we expect to start the first Phase 1 study with the IV formulation in the fourth quarter of 2015.
- In addition to these programs, we are also investigating the potential clinical utility of SCY-078 in other areas of unmet need such as for the treatment of genital infections caused by Candida spp. (vulvovaginal candidiasis, VVC). VVC is a highly prevalent condition with limited therapeutic options for infections caused by azole-resistant Candida spp. We plan to commence a Phase 2 study of the oral formulation of SCY-078 during the fourth quarter of 2015 with top line results expected in the first half of 2016.
Second Quarter 2015 Financial Results
SCYNEXIS reported a loss from operations of $6.5 million for the second quarter of 2015, compared with a loss from operations of $4.0 million for the second quarter of 2014. The increase in the loss from operations of $2.5 million for 2015 compared to 2014 was due to an increase in research and development expenses (as discussed below) and an increase in selling, general and administrative expenses of $1.0 million in the 2015 period primarily associated with continued public reporting company operating expenses, a non-recurring non-cash stock compensation charge, and accrued severance and other compensation costs.
SCYNEXIS reported a loss from continuing operations of $6.5 million for the second quarter of 2015. Comparison of reported loss from continuing operations to the same quarter in 2014 is difficult because the underlying loss from operations of $4.0 million in the second quarter of 2014 was offset by certain non-recurring non-cash adjustments totaling a net gain of $5.9 million, which resulted in income from continuing operations of $1.7 million. The non-recurring non-cash adjustments included a $7.3 million gain from a derivative fair value adjustment and a $1.4 million loss on extinguishment of debt.
SCYNEXIS began reporting its services business operating results in discontinued operations for the three and six months ended June 30, 2015, and 2014, respectively. It reported a loss from discontinued operations of $3.0 million for the second quarter of 2015, compared to income from discontinued operations of $0.6 million for the second quarter of 2014. The loss from discontinued operations for the second quarter of 2015 includes a non-cash impairment charge of approximately $1.4 million as a result of the classification of services business assets as held for sale.
Diluted net loss attributable to common stockholders for the second quarter of 2015 was $9.5 million, or $0.78 per diluted common share. This compares to diluted net loss attributable to common stockholders for the second quarter of 2014 of $5.3 million, or $0.98 per diluted common share.1
About SCYNEXIS, Inc.
SCYNEXIS is a pharmaceutical company committed to the discovery, development and commercialization of novel anti-infectives to address significant unmet therapeutic needs. We are developing our lead product candidate, SCY-078, a novel antifungal in Phase 2, as an oral and intravenous (IV) drug for the treatment of serious and life-threatening invasive fungal infections in humans. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding matters that are not historical facts, including any future clinical trials, future performance of product candidates, the potential of SCY-078 to treat invasive fungal infections, the therapeutic and commercial potential of SCY-078, and the anticipated timing of clinical trials and therapeutic and commercial potential of SCY-078 are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results and the timing of these events, including regarding the further development of SCY-078, could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of SCYNEXIS's product development activities, including any current and future clinical trials of SCY-078; any delays or inability to obtain or maintain regulatory approval of product candidates in the United States or worldwide; the company's ability to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide; and the market potential for the company's product candidates. Risks are described more fully in SCYNEXIS'S filings with the Securities and Exchange Commission, including without limitation its most recent Quarterly Report on Form 10-Q 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.
1 The issuance of common stock during our follow-on public offering in April 2015 caused a significant increase in common shares outstanding and has impacted the comparability of our net loss per share calculations between the second quarter of 2015 and the comparable period in 2014.
|UNAUDITED CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except share and per share data)|
|Three months ended June 30,||Six months ended June 30,|
|Total revenue and gross profit||$64||$65||$129||$130|
|Research and development||3,282||1,823||7,069||3,143|
|Selling, general and administrative||3,275||2,255||5,485||3,461|
|Total operating expenses||6,557||4,078||12,554||6,604|
|Loss from operations||(6,493)||(4,013)||(12,425)||(6,474)|
|Total other (income) expense||(1)||(5,684)||(2)||(7,877)|
|(Loss) income from continuing operations||(6,492)||1,671||(12,423)||1,403|
|(Loss) income from discontinued operations, including $1,350 impairment charge on classification as held for sale for the three and six months ended June 30, 2015||(3,005)||562||(3,458)||1,242|
|Net (Loss) income||(9,497)||2,233||(15,881)||2,645|
|Deemed dividends, accretion, and allocation of net income to convertible preferred stockholders||—||(262)||—||(1,936)|
|Net (loss) income attributable to common stockholders - basic||(9,497)||1,971||(15,881)||709|
|Derivative fair value adjustment||—||(7,297)||—||(10,080)|
|Net loss attributable to common stockholders - diluted||$(9,497)||$(5,326)||$(15,881)||$(9,371)|
|(Loss) income per share attributable to common stockholders - basic|
|Net (loss) income per share - basic||$(0.78)||$0.38||$(1.53)||$0.26|
|(Loss) income per share attributable to common stockholders - diluted|
|Net loss per share - diluted||$(0.78)||$(0.98)||$(1.53)||$(3.08)|
|Weighted average common shares outstanding:|
|BALANCE SHEET DATA|
| June 30, 2015 |
| December 31, |
|Cash and cash equivalents||$57,057||$32,243|
|Total current assets, including assets held for sale, net||64,645||39,647|
|Total current liabilities, including liabilities related to assets held for sale||7,051||5,348|
|Total stockholders' equity||56,772||33,431|
|Total liabilities and stockholders' equity||64,678||39,672|
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