U.S. Markets closed

SCYNEXIS Reports Full Year 2018 Financial Results and Provides Company Update

Phase 3 VANISH program underway, evaluating oral ibrexafungerp for the treatment of acute VVC; anticipate top-line data in the first half of 2020 with NDA submission in the second half of 2020

Oral ibrexafungerp continues to advance across multiple additional indications, including the prevention of recurrent VVC and invasive aspergillosis; recent positive preliminary FURI results showed clinical benefits in refractory invasive fungal infections

Raised $16.0 million in March 2019 via sale of convertible debt to retire maturing term loan, enhancing already strong cash balance and extending cash runway past anticipated NDA submission in the second half of 2020

JERSEY CITY, N.J., March 14, 2019 /PRNewswire/ -- SCYNEXIS, Inc. (SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today reported financial results for the year ended December 31, 2018, and provided an update on recent operational and clinical developments.

"We ended 2018 having accomplished meaningful progress across our ibrexafungerp clinical development programs, including positive results from our Phase 2b DOVE study evaluating the oral formulation of ibrexafungerp in the lead indication of vulvovaginal candidiasis," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We fully intend to carry the momentum of 2018 throughout this year as we conduct our Phase 3 VANISH trials, where we anticipate top-line data in the first half of 2020 with a planned New Drug Application (NDA) submission in the second half of 2020."

Dr. Taglietti continued: "Progress also continues on the development of oral ibrexafungerp across multiple additional indications in severe, difficult-to-treat, hospital-based infections to address a significant unmet need for patients fighting life-threatening and often drug-resistant pathogens. Recently, we disclosed the positive results obtained with oral ibrexafungerp in a group of patients with fungal infections refractory to currently available treatments and we initiated the Phase 2 study in invasive aspergillosis. We remain focused on maximizing the broad clinical utility of ibrexafungerp and realizing the full potential of this first member of a new antifungal class."

Ibrexafungerp (formerly SCY-078), the first representative of a novel antifungal family referred to as triterpenoids, is being developed for oral and intravenous (IV) administration and is in clinical development for the treatment of several serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. If approved, ibrexafungerp would be the only oral alternative to azoles for the treatment of VVC and prevention of recurrent VVC.

Ibrexafungerp Development Update

  • Currently enrolling patients in the VANISH Phase 3 registration program evaluating the safety and efficacy of ibrexafungerp in patients with acute VVC. On track to initiate a planned Phase 3 trial of ibrexafungerp for the prevention of recurrent VVC in the first half of 2019.
  • Progress continues on SCYNEXIS's strategy to expand the use of ibrexafungerp in severe, difficult-to-treat, fungal infections.
  • SCYNEXIS continues to explore development of IV formulation of ibrexafungerp. While oral ibrexafungerp is progressing as a potential valuable option to treat hospital-based invasive fungal infections, as recently shown in the preliminary results from the FURI study, the company continues with the development of the intravenous liposomal formulation of ibrexafungerp and will provide further updates on this program in the future.
  • Presentation of new preclinical data in support of prophylactic use of oral ibrexafungerp. In February 2019, SCYNEXIS announced the presentation of a poster at the upcoming Superbugs and Superdrugs 2019 conference. The poster, titled "Activity of oral ibrexafungerp in murine models of Pneumocystis pneumonia (PCP)," highlights the results from multiple preclinical studies that evaluated oral ibrexafungerp versus trimethoprim/sulfamethoxazole, the current SoC for PCP. Oral ibrexafungerp demonstrated strong activity against PCP in these models, as determined by a reduction in organism burden and improved survival. These results warrant further investigation of ibrexafungerp for both the prevention and treatment of PCP, a potentially life-threatening infection that occurs in vulnerable immunocompromised individuals, including those undergoing solid organ and stem cell transplants.

Corporate Update

  • In March 2019, SCYNEXIS completed the sale of a $16.0 million convertible unsecured senior note in a private placement to Puissance Capital. The sale of the convertible note provides desired funds in a less dilutive manner than typical equity offerings. SCYNEXIS used the proceeds to retire in full the previous term loan, strengthening near-term cash flows and extending the Company's cash runway past an anticipated NDA submission in the second half of 2020.
  • United States Adopted Names (USAN) Council selected "Ibrexafungerp" as non-proprietary name for SCY-078. In February 2019, the USAN Council, in consultation with the World Health Organization's (WHO) International Nonproprietary Names (INN) Expert Committee, selected ibrexafungerp as the non-proprietary name for SCY-078. The USAN Council, by working closely with the INN Programme of the WHO and various national nomenclature groups, aims for global standardization and unification of drug nomenclature to ensure that drug information is communicated accurately and unambiguously. In July 2018, the WHO INN group created the new stem, "-fungerp," indicating that ibrexafungerp is different and unique to any previously-approved antifungal drug, and the first member of a new triterpenoid drug class. Ibrexafungerp has the potential to be the first new antifungal class approved in the last 20 years.
  • In January 2019, SCYNEXIS announced the appointment of Armando Anido to its Board of Directors. Mr. Anido currently serves as Chairman and Chief Executive Officer of Zynerba Pharmaceuticals (ZYNE), a role he has held since October 2014, and has more than 30 years of executive leadership experience in the biopharmaceutical industry. The addition of Mr. Anido to an experienced Board provides invaluable operational and commercial expertise as SCYNEXIS prepares to potentially submit an NDA in the second half of 2020.
  • In January 2019, SCYNEXIS completed the sale of a portion of its Net Operating Losses (NOLs) and received a cash receipt of $6.7 million. This sale was structured through the New Jersey Technology Business Tax Certificate Transfer (NOL) Program, which allows eligible companies to sell their New Jersey NOLs and research and development tax credits up to a maximum lifetime benefit of $15 million per company. This transaction resulted in a pro forma cash balance of $51 million as of January 3, 2019.

Full Year 2018 Financial Results

Cash, cash equivalents and short-term investments totaled $44.2 million as of December 31, 2018.

Research and development expenses increased to $21.6 million for the year ended December 31, 2018, compared to $18.3 million for the year ended December 31, 2017. The increase of $3.2 million, or 17.6%, was primarily driven by an increase of $2.9 million in clinical development, an increase of $1.3 million in chemistry, manufacturing, and controls (CMC), and an increase of $0.8 million in salary and personnel related costs, offset in part by a decrease of $1.5 million in consulting fees and a net decrease of $0.3 million in other research and development expenses.

Selling, general and administrative expenses increased to $8.7 million in 2018, compared with $8.3 million in 2017. The increase of $0.4 million, or 5.2%, in 2018, was primarily driven by the $0.2 million charge for deferred offering costs recognized during the year ended December 31, 2018.

Total other income was $10.8 million in 2018, compared to other income of $1.3 million in 2017 due to a $11.9 million non-cash gain recorded on the adjustment in the fair value of the warrant liabilities.

Income tax benefit increased to $6.7 million in 2018, compared to zero in 2017, due to the $6.7 million sale of a portion of SCYNEXIS's NOLs through the New Jersey Technology Business Tax Certificate Transfer (NOL) Program.

Net loss for 2018 was $12.5 million, or $0.28 per share. This compares with a net loss for 2017 of $25.1 million, or $0.94 per share.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and VVC, and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

About SCYNEXIS
SCYNEXIS, Inc. (SCYX) is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by developing innovative therapies. The SCYNEXIS team has extensive experience in the life sciences industry, having discovered and developed more than 30 innovative medicines over a broad range of therapeutic areas. SCYNEXIS's lead product candidate, ibrexafungerp (formerly known as SCY-078), is a novel IV/oral antifungal agent in Phase 3 clinical and preclinical development for the treatment of multiple 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 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 ibrexafungerp; the expected costs of studies and when they might begin or be concluded; whether the positive results from the FURI trial to date will continue to be achieved as the study continues; uncertainties about the regulatory standards for approval through LPAD; 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
Heather Savelle
Argot Partners
Tel: 212-600-1902
heather@argotpartners.com

Media Relations
George E. MacDougall
MacDougall Biomedical Communications
Tel: 781-235-3093
george@macbiocom.com

 

SCYNEXIS, INC.

STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)










Years Ended December 31, 


2018


2017


Revenue

$

257



$

257


Operating expenses:





Research and development, net

21,560



18,326


Selling, general and administrative

8,680



8,251


Total operating expenses

30,240



26,577


Loss from operations

(29,983)



(26,320)


Other expense (income):





Amortization of debt discount

428



400


Interest income

(967)



(386)


Interest expense 

1,626



1,455


Warrant liabilities fair value adjustment

(11,866)



(2,729)


Total other income:

(10,779)



(1,260)


Loss before taxes


(19,204)




(25,060)


Income tax benefit


6,736





Net loss

$                  (12,468)



$                  (25,060)


Net loss per share – basic and diluted

$                      (0.28)



$                      (0.94)


Weighted average common shares outstanding – basic and diluted

43,883,995


26,746,322


 


SCYNEXIS, INC.



 BALANCE SHEETS



(in thousands)














December 31, 2018


December 31, 2017

Cash and cash equivalents


$

11,439


$

11,469

Short-term investments


32,718


32,424

Total current assets


51,463


44,960

Total assets



53,170



45,850

Loan payable, current portion





4,349

Total current liabilities


5,877


10,144

Loan payable expected to be refinanced


15,082


10,303

Total liabilities


21,945


24,440

Total stockholders' equity


31,225


21,410

Total liabilities and stockholders' equity


$

53,170


$

45,850











 

Cision

View original content:http://www.prnewswire.com/news-releases/scynexis-reports-full-year-2018-financial-results-and-provides-company-update-300812830.html