RESEARCH TRIANGLE PARK, N.C., March 30, 2015 (GLOBE NEWSWIRE) -- Drug discovery and development company SCYNEXIS, Inc. (Nasdaq:SCYX) today reported financial results for the year ended December 31, 2014.
"This year was an important year for us in the evolution of the Company, as we successfully accessed the public markets and secured the resources necessary to further advance the clinical development of SCY-078 for the treatment of invasive fungal infections," said Yves J. Ribeill, Ph.D., President and Chief Executive Officer at SCYNEXIS. "I look forward now to smoothly transitioning Marco Taglietti into the role of CEO, and providing continued support as we work to bring SCY-078 to patients with life-threatening fungal infections caused by drug resistant pathogens."
2014-Present Corporate Highlights
- Successfully completed an initial public offering, selling 6.2 million shares of common stock at a price of $10.00 per share, providing net proceeds of $40 million after payment of offering commissions and expenses and repayment of a $15 million credit facility;
- Added relevant new expertise to the Board of Directors through the appointment of directors Steven C. Gilman, Ph.D., Guy Macdonald and Marco Taglietti, M.D.;
- Announced Marco Taglietti as SCYNEXIS' new Chief Executive Officer, to be effective April 1, 2015, with Yves Ribeill, Ph.D., remaining as Company President and a member of the Board of Directors;
- Entered into a license agreement granting Waterstone Pharmaceutical Limited exclusive worldwide rights to develop and commercialize SCY-635 for the treatment of viral diseases in humans;
- Received both fast track and qualified infectious disease product designation from the Food and Drug Administration for the oral formulation of SCY-078 for the treatment of patients with invasive fungal disorders allowing the Company to have priority review and an additional five years of market exclusivity in the U.S. for SCY-078.
Recent SCY-078 Update
- First patient was enrolled in March 2015 in the Phase 2 study of SCY-078 for the treatment of invasive fungal infections;
- Protocol amendments are being prepared to both enhance and expedite recruitment, and following implementation of these amendments, SCYNEXIS expects to have top-line study results in the first half of 2016 as planned;
- SCYNEXIS is also developing an IV formulation of SCY-078, with IND-enabling studies ongoing to support a Phase 1 study of the IV formulation planned to begin in the second half of 2015.
Full Year 2014 Financial Results
SCYNEXIS reported a net loss of $4.2 million, or $2.69 per diluted common share, for the full year 2014, compared to a net loss of $30.5 million, or $139.47 per diluted common share, for the full year 2013.1
Research and development expenses increased to $8.3 million in 2014, compared to $4.4 million in 2013. The increase of $3.9 million was primarily due to increased costs associated with the SCY-078 Phase 2 clinical trial and the preclinical development of intravenous SCY-078.
Cash and cash equivalents totaled $32.2 million as of December 31, 2014.
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, 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 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. Risks are described more fully in SCYNEXIS' 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 IPO in May 2014 caused a significant increase in common shares outstanding and has impacted the comparability of our net loss per share calculations between 2013 and 2014 periods.
| SCYNEXIS, INC. | ||
| STATEMENTS OF OPERATIONS | ||
| (in thousands, except share and per share data) | ||
| Year Ended December 31, | ||
| 2014 | 2013 | |
| Revenue — related party | $7,288 | $7,288 |
| Revenue | 11,736 | 9,569 |
| Total revenue | 19,024 | 16,857 |
| Cost of revenue | 15,446 | 16,305 |
| Gross profit | 3,578 | 552 |
| Operating expenses: | ||
| Research and development | 8,287 | 4,363 |
| Selling, general and administrative | 7,568 | 4,381 |
| Gain on insurance recovery | (165) | — |
| Gain on sale of asset | — | (988) |
| Total operating expenses | 15,690 | 7,756 |
| Loss from operations | (12,112) | (7,204) |
| Other (income) expense: | ||
| Amortization of deferred financing costs and debt discount | 755 | 3,485 |
| Loss on extinguishment of debt | 1,389 | — |
| Interest expense on beneficial conversion feature | — | 10,802 |
| Interest expense — related party | — | 892 |
| Interest expense | 48 | 192 |
| Derivative fair value adjustment | (10,080) | 7,886 |
| Other expense | 10 | — |
| Total other (income) expense: | (7,878) | 23,257 |
| Net loss | $(4,234) | $(30,461) |
| Deemed dividend for beneficial conversion feature on Series D-2 preferred stock | (909) | (4,232) |
| Deemed dividend for antidilution adjustments to convertible preferred stock | (214) | (6,402) |
| Accretion of convertible preferred stock | (510) | (5,714) |
| Net loss attributable to common stockholders - basic | $(5,867) | $(46,809) |
| Derivative fair value adjustment | (10,080) | — |
| Net loss attributable to common stockholders - diluted | (15,947) | (46,809) |
| Per share information: | ||
| Net loss per common share, basic | $(1.04) | $(139.47) |
| Net loss per common share, diluted | $(2.69) | $(139.47) |
| Weighted average shares outstanding: | ||
| Basic | 5,663,311 | 335,612 |
| Diluted | 5,937,087 | 335,612 |
| SCYNEXIS, INC. | ||
| BALANCE SHEET DATA | ||
| (in thousands) | ||
| December 31, 2014 | December 31, 2013 | |
| Cash and cash equivalents | $32,243 | $1,402 |
| Total current assets | 34,736 | 2,953 |
| Total assets | 39,672 | 12,387 |
| Total current liabilities | 3,801 | 18,477 |
| Total liabilities | 6,241 | 33,339 |
| Total stockholders' equity (deficit) | 33,431 | (108,109) |
| Total liabilities, convertible preferred stock, and stockholders' equity (deficit) | 39,672 | 12,387 |