JERSEY CITY, N.J., March 31, 2023 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the fourth quarter and full year ended on December 31, 2022.
“We are thrilled to partner with GSK, a leading global organization in the fight against infectious diseases, an area of increasing public health urgency,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “For SCYNEXIS and our shareholders, this deal is transformational and creates significant value, both strengthening our balance sheet and enhancing the opportunity to deliver additional innovative therapies to patients with unmet needs. We will continue advancing ibrexafungerp clinical programs and are in a strong financial position to execute our strategic priorities this year and beyond. With our good track record of efficiently bringing to market first-in-class compounds and the additional resources on hand, our organization is well positioned to continue developing groundbreaking therapies, including our next generation fungerp SCY-247.”
BREXAFEMME Commercial Updates
Ibrexafungerp Clinical and Regulatory Updates
Ibrexafungerp Scientific Presentations and Publications
Corporate Developments
Fourth Quarter 2022 Financial Results
BREXAFEMME net product revenues increased to $1.4 million in Q4 2022, from $0.6 million in Q4 2021.
Cost of product revenue was $0.2 million in Q4 2022, compared to $0.2 million in Q4 2021.
Research and development expense for Q4 2022 was $7.8 million, compared to $7.7 million for Q4 2021.
Selling, General & administrative (SG&A) expenses for Q4 2022 increased to $16.0 million from $15.0 million for Q4 2021.
Total other income was $8.1 million for Q4 2022, versus total expense of $6.9 million for Q4 2021. During Q4 2022 and Q4 2021, SCYNEXIS recognized a non-cash gain of $9.1 million and a non-cash loss of $5.0 million, respectively, on the fair value adjustment of the warrant liabilities.
Net loss for Q4 2022 was $14.4 million, or $0.30 basic loss per share, compared to a net loss of $29.2 million, or $1.05 basic loss per share for Q4 2021.
Full Year 2022 Financial Results
BREXAFEMME generated net product revenue of $5.0 million for the full year 2022, compared to $1.1 million for the full year 2021.
Cost of product revenue was $0.6 million for the full year 2022 compared to $0.3 million for the full year 2021.
Research and development expense for the full year 2022 increased to $27.3 million from $23.8 million versus the comparable prior year. The increase of $3.5 million, or 14.7%, was primarily driven by an increase of $3.0 million in clinical development expense, an increase of $1.0 million in preclinical expense, an increase of $0.5 million in both salary and stock compensation expense, offset by a decrease of $1.3 million in chemistry, manufacturing, and controls (CMC) expense, and a $0.2 million decrease in other research and development expense.
SG&A expense for the full year 2022 increased to $63.0 million from $49.9 million versus the comparable prior year. The increase of $13.0 million, or 26.1%, was primarily driven by a $8.6 million increase in commercial related expense, an increase of $1.6 million in salary and payroll related costs, and an increase of $1.5 million in professional fees, all primarily due to the costs recognized to support the commercialization of BREXAFEMME, an increase of $1.0 million in stock compensation expense, and an increase of $1.9 million in severance expense associated with the reduction in work force, offset in part by a decrease of $0.9 million in medical affairs expense and a $0.7 million decrease in business development expense due to the Hansoh license agreement entered into in 2021.
Total other income was $18.2 million for the full year 2022, versus $24.9 million for the comparable prior year. During the full years 2022 and 2021, SCYNEXIS recognized a non-cash gain of $22.3 million and a non-cash gain of $30.4 million, respectively, on the fair value adjustment of the warrant liabilities and non-cash gains of $1.3 million and $1.2 million, respectively, on the fair value adjustment of derivative liabilities.
Net loss for the full year 2022, was $62.8 million, or $1.47 per share, compared to net loss of $32.9 million, or $1.25 per share for the comparable prior year.
Cash Balance
Cash, cash equivalents and short-term investments totaled $73.5 million on December 31, 2022, compared to $104.5 million in cash and cash equivalents on December 31, 2021. Upon closure of the GSK transaction and receipt of the upfront payment of $90 million, based on its current projections, SCYNEXIS will have a cash runway of more than two years.
About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an 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 in late-stage investigation and development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the oral and IV formulations of ibrexafungerp for the indications of invasive candidiasis (IC), including candidemia, and invasive aspergillosis (IA) and has granted Orphan Drug Designation for the IC and IA indications. The European Medicines Agency (EMA) has granted ibrexafungerp Orphan Medicinal Product designation for the indication of IC. Ibrexafungerp is formerly known as SCY-078.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing its lead asset, ibrexafungerp, as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for treatment of vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional assets in the novel “fungerp” antifungal class are currently in preclinical and discovery phase, including the compound SCY-247. For more information, visit www.scynexis.com.
Forward-Looking Statements
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, including but not limited to statements regarding: SCYNEXIS’s expectation that it will have a cash runway of more than two years. 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 regulatory and other costs in developing products. These and other 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 filed on March 31, 2023, including under the caption “Risk Factors.” 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
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com
Media Relations
Debbie Etchison
SCYNEXIS
debbie.etchison@scynexis.com
SCYNEXIS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Years Ended December 31, | |||||||
2022 | 2021 | ||||||
Revenue: | |||||||
Product revenue, net | $ | 4,988 | $ | 1,113 | |||
License agreement revenue | 103 | 12,050 | |||||
Total revenue | 5,091 | 13,163 | |||||
Operating expenses: | |||||||
Cost of product revenue | 628 | 312 | |||||
Research and development | 27,259 | 23,773 | |||||
Selling, general and administrative | 62,961 | 49,916 | |||||
Total operating expenses | 90,848 | 74,001 | |||||
Loss from operations | (85,757 | ) | (60,838 | ) | |||
Other (income) expense: | |||||||
Loss on extinguishment of debt | — | 2,725 | |||||
Amortization of debt issuance costs and discount | 1,589 | 1,303 | |||||
Interest income | (1,415 | ) | (24 | ) | |||
Interest expense | 5,198 | 2,660 | |||||
Other income | (3 | ) | (13 | ) | |||
Warrant liabilities fair value adjustment | (22,301 | ) | (30,365 | ) | |||
Derivative liability fair value adjustment | (1,316 | ) | (1,170 | ) | |||
Total other income | (18,248 | ) | (24,884 | ) | |||
Loss before taxes | (67,509 | ) | (35,954 | ) | |||
Income tax benefit | 4,700 | 3,088 | |||||
Net loss | $ | (62,809 | ) | $ | (32,866 | ) | |
Net loss per share – basic and diluted | $ | (1.47 | ) | $ | (1.25 | ) | |
Weighted average common shares outstanding – basic and diluted | 42,613,510 | 26,384,713 |
The accompanying notes are an integral part of the financial statements.
SCYNEXIS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
December 31, 2022 | December 31, 2021 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 45,814 | $ | 104,484 | |||
Short-term investments | 27,689 | — | |||||
Prepaid expenses and other current assets | 2,503 | 3,569 | |||||
Accounts receivable, net | 2,101 | 861 | |||||
Inventory, net | 899 | 463 | |||||
Restricted cash | 55 | — | |||||
Total current assets | 79,061 | 109,377 | |||||
Other assets | 5,511 | 6,235 | |||||
Deferred offering costs | 73 | 150 | |||||
Restricted cash | 163 | 218 | |||||
Intangible assets, net | 408 | 1,056 | |||||
Operating lease right-of-use asset (Note 10) | 2,594 | 2,801 | |||||
Total assets | $ | 87,810 | $ | 119,837 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 5,937 | $ | 7,848 | |||
Accrued expenses | 5,628 | 5,698 | |||||
Other liabilities, current portion (See Note 9) | 5,771 | — | |||||
Operating lease liability, current portion (Note 10) | 282 | 70 | |||||
Total current liabilities | 17,618 | 13,616 | |||||
Other liabilities | — | 3,345 | |||||
Warrant liabilities | 18,644 | 18,062 | |||||
Convertible debt and derivative liability (Note 9) | 11,001 | 11,607 | |||||
Loan payable (Note 9) | 34,393 | 28,745 | |||||
Operating lease liability (Note 10) | 2,921 | 3,204 | |||||
Total liabilities | 84,577 | 78,579 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock, $0.001 par value, authorized 5,000,000 shares as of December 31, 2022 and December 31, 2021; 0 shares issued and outstanding as of December 31, 2022 and December 31, 2021 |
— | — | |||||
Common stock, $0.001 par value, 150,000,000 shares authorized as of December 31, 2022 and 100,000,000 shares as of December 31, 2021; 32,682,342 and 28,705,334 shares issued and outstanding as of December 31, 2022, and December 31, 2021, respectively |
36 | 32 | |||||
Additional paid-in capital | 425,485 | 400,705 | |||||
Accumulated deficit | (422,288 | ) | (359,479 | ) | |||
Total stockholders’ equity | 3,233 | 41,258 | |||||
Total liabilities and stockholders’ equity | $ | 87,810 | $ | 119,837 |
The accompanying notes are an integral part of the financial statements
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