JERSEY CITY, N.J., March 07, 2016 (GLOBE NEWSWIRE) -- Drug development company SCYNEXIS, Inc. (Nasdaq:SCYX) today reported financial results for the year ended December 31, 2015, and provided an update on recent operational and clinical developments.
"2015 was an important transition year for the company as we successfully achieved our stated goals and strengthened all key aspects of our operations,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “Most notably, we made tremendous progress advancing the development of SCY-078, potentially the first glucan synthase inhibitor available in both oral and intravenous (IV) formulations, as a treatment for invasive, life-threatening and drug-resistant fungal infections. We also made great strides exploring the development of SCY-078 in vulvovaginal candidiasis (VVC), an indication with a large patient population and limited number of effective oral treatment options.”
“In addition to these clinical developments, we strengthened our balance sheet and assembled a management team that is highly-experienced in anti-infective development and commercialization. Looking ahead to 2016, I am confident we have the elements in place to achieve our key milestones,” Dr. Taglietti concluded.
Select 2015 Corporate Accomplishments
- Successfully completed a $41 million follow-on public offering, providing us with sufficient capital to reach beyond the achievement of multiple clinical milestones;
- Strengthened our leadership team with the addition of Marco Taglietti, M.D., as President and Chief Executive Officer, David Angulo, M.D., as Chief Medical Officer, and Eric Francois as Chief Financial Officer;
- Significantly realigned the composition of our Board of Directors in support of our focused strategic direction through the addition of five new directors and the retirement of four directors; augmenting the Board’s strategic, clinical development, financial and operational industry expertise;
- Strategically focused our resources on the development of SCY-078 through the sale of our former contract research and development services business to Accuratus Lab Services, Inc. (doing business as “Avista Pharma Solutions”); and
- Relocated to our new corporate headquarters in Jersey City, New Jersey, and expanded the core support team.
- We developed an IV formulation of SCY-078 and are enrolling healthy volunteers in a single ascending dose Phase 1 study. We expect to complete the study and report results in the second quarter of 2016;
- We initiated enrollment of a multicenter Phase 2 study with primary endpoints of safety and efficacy of the oral formulation of SCY-078 in patients with VVC in the fourth quarter of 2015. We expect to complete the study and report top line data in the second quarter of 2016;
- We continue to enroll patients in the Phase 2 study with primary endpoints of safety, tolerability, and pharmacokinetics of the oral formulation of SCY-078 as step-down treatment in patients initially treated with echinocandin therapy for invasive Candida infections. We have opened new investigational sites in the U.S. and in Latin America and we are in the process of opening more sites in these regions and in Europe. Based on the data collected on the enrolled patients, together with the data from our recently completed Phase 1 biocomparison study, we expect to achieve the primary objectives of the study with fewer patients than originally planned. We expect to report top line data by the end of the second quarter of 2016;
- We completed a Phase 1 biocomparison study of a new, well-tolerated citrate salt formulation of SCY-078 that has a comparable pharmacokinetic profile and potential formulation advantages over the previously used phosphate salt formulation. This new formulation will be used in development of both the oral and IV formulations going forward, and has the potential to extend composition of matter patent protection up to 2035; and
- We secured Fast Track and Qualified Infectious Disease Product designations from the U.S. Food and Drug Administration for the IV formulation of SCY-078 in both invasive candidiasis and invasive aspergillosis.
Full Year 2015 Financial Results
Cash and cash equivalents totaled $47.0 million as of December 31, 2015, with net working capital of $41.8 million.
Research and development expenses increased to $16.4 million in 2015, compared to $8.3 million in 2014. The increase of $8.1 million was primarily due to an increase in third-party service provider expenses related to our ongoing clinical development activities, including our Phase 1 and Phase 2 studies of oral SCY-078, the preclinical and clinical development of the IV formulation of SCY-078, and continued chemistry, manufacturing, and controls activities.
Loss from continuing operations in 2015 was $28.3 million, compared to a loss from continuing operations of $5.6 million in 2014. The $22.7 million increase in the loss from continuing operations between the two periods was due to an $8.1 million increase in research and development expenses, a $4.6 million increase in selling, general, and administrative expenses primarily related to certain non-recurring charges including a non-cash stock compensation charge and accrued severance and other compensation costs, a $7.8 million decrease in other income associated with discrete non-cash transactions in 2014, a $1.0 million decrease in revenue from continuing operations, and a $1.2 million decrease in income tax benefit.
Loss from discontinued operations was $4.3 million in 2015, compared to income from discontinued operations of $1.4 million in 2014.
Diluted net loss attributable to common stockholders was $32.6 million, or $2.68 per diluted common share, in 2015. This compares to diluted net loss attributable to common stockholders of $15.9 million, or $2.69 per diluted common share, in 2014.1
About SCYNEXIS, Inc.
SCYNEXIS is a pharmaceutical company committed to the development and commercialization of novel anti-infectives to address significant unmet therapeutic needs. We are developing our lead product candidate, SCY-078, as an oral and IV drug 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 regarding matters that are expected to occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, any statements related to SCYNEXIS' continued growth, that it has sufficient capital, that it will achieve the primary objectives of its Phase 2 study of the step-down treatment of SCY-078 and report top line data by the end of the second quarter of 2016, that it will complete the VVC study and report top line data in the second quarter of 2016, that its new citrate salt formulation of SCY-078 has the potential to extend composition of matter patent protection up to 2035, and that it will complete the Phase 1 study of the IV formulation of SCY-078 and report results in the second quarter of 2016. 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, risks inherent in SCYNEXIS' ability to successfully develop SCY-078, including SCYNEXIS' ability to 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. 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 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 full year 2015 and the comparable period in 2014.
|STATEMENTS OF OPERATIONS|
|(in thousands, except share and per share data)|
|Years Ended December 31,|
|Research and development||16,440||8,287|
|Selling, general and administrative||12,166||7,616|
|Total operating expenses||28,606||15,903|
|Loss from operations||(28,349||)||(14,647||)|
|Total other (income) expense||(11||)||(7,878||)|
|Loss from continuing operations before taxes||(28,338||)||(6,769||)|
|Income tax benefit||—||1,166|
|Loss from continuing operations||(28,338||)||(5,603||)|
|Income (loss) from discontinued operations, net of income tax expense||(4,285||)||1,369|
|Deemed dividends, accretion, and allocation of net income to convertible|
|Net loss attributable to common stockholders - basic||$||(32,623||)||$||(5,867||)|
|Derivative fair value adjustment||—||(10,080||)|
|Net loss attributable to common stockholders - diluted||$||(32,623||)||$||(15,947||)|
|Net income (loss) per share attributable to common stockholders - basic|
|Net loss per share - basic||$||(2.68||)||$||(1.04||)|
|Net income (loss) per share attributable to common stockholders - diluted|
|Net loss per share - diluted||$||(2.68||)||$||(2.69||)|
|Weighted average common shares outstanding:|
|BALANCE SHEET DATA|
|December 31, 2015||December 31, 2014|
|Cash and cash equivalents||$||46,985||$||32,243|
|Total current assets||48,437||39,647|
|Total current liabilities||6,664||5,348|
|Total stockholders’ equity||41,949||33,431|
|Total liabilities and stockholders’ equity||49,273||39,672|
CONTACT: Media Relations Heather Savelle MacDougall Biomedical Communications Tel: 781.235.3060 email@example.com Investor Relations Susan Kim Argot Partners Tel: 212-203-4433 firstname.lastname@example.org