SCYNEXIS Reports Third Quarter 2022 Financial Results
and Provides Corporate Update
JERSEY CITY, N.J., November 9, 2022 – 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 third quarter ended on September 30, 2022.
“Recently we have taken important steps to strategically refocus the Company on the successful development of ibrexafungerp in hospital-based indications where there is an urgent unmet need in patients with life-threatening infections,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “We believe there is great potential in this area. Separately, we are seeking a commercialization partner to maximize the value of BREXAFEMME in the U.S. We also look forward to the November 30, 2022, PDUFA date for BREXAFEMME, which, if approved, would make it the only antifungal for both the treatment of vulvovaginal candidiasis (VVC) and prevention of recurrent VVC.”
BREXAFEMME Commercial Update
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Ibrexafungerp Clinical Updates
Ibrexafungerp Scientific Presentations and Publications
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Corporate Developments
Third Quarter 2022 Financial Results
BREXAFEMME increased its net product revenues from $1.3 million in Q2 2022 to $1.6 million in Q3 2022.
Research and development expense for Q3 2022 was $6.4 million, compared to $4.4 million for Q3 2021. The increase is primarily attributed to increased costs associated with the MARIO clinical trial.
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Selling, general & administrative (SG&A) expense for Q3 2022 increased to $16.7 million from $15.4 million for Q3 2021. The increase was primarily driven by increased commercial costs and professional fees recognized to support the commercialization of BREXAFEMME.
Total other expense was $7.8 million for Q3 2022, versus total other income of $18.8 million for Q3 2021. During Q3 2022 and Q3 2021, SCYNEXIS recognized a non-cash loss of $6.5 million and a non-cash gain of $18.8 million, respectively, on the fair value adjustment of the warrant liabilities.
Net loss for Q3 2022 was $29.6 million, or $0.62 basic loss per share, compared to a net loss of $600,000, or $0.02 basic loss per share for Q3 2021.
Cash Balance
Cash, cash equivalents and short-term investments totaled $96.1 million on September 30, 2022, compared to $104.5 million in cash and cash equivalents on December 31, 2021. Based upon its current operating plan, SCYNEXIS believes that its existing cash, cash equivalents and short-term investments will enable the Company to fund its operating requirements into Q2 2024.
Conference call and webcast details
A conference call to discuss the results will be held today at 8:30 a.m. EST
Investors (domestic): 1-844-826-3033
Investors (international): 1-412-317-5185
Conference ID: 10172836
Webcast: HERE
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 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 vitroand in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration (FDA) granted ibrexafungerp Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral 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. 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 scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS has initiated the launch of its first commercial product in the U.S., BREXAFEMME® (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. SCYNEXIS filed a supplemental New Drug Application (sNDA) to expand BREXAFEMME’s
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labelling to include the prevention of recurrent vulvovaginal candidiasis, and the FDA assigned a target PDUFA action date of November 30, 2022, for this additional indication. In addition, late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. 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: the expected benefits of the new corporate strategic direction; potential first approval of ibrexafungerp in hospital indications is expected in 2024; and a Phase 2 study of the IV formulation is planned for 2023; enrollment for the CARES Phase 3 trial is expected to be completed by the end of 2022; enrollment closure for the SCYNERGIA Phase 2 study is anticipated by the end of 2022; the expectation that the restructuring will result in decreased expenses and extend the company’s cash runway into Q2 2024; and our potential to receive approval for the supplemental New Drug Application (sNDA) for a second indication in recurrent vulvovaginal candidiasis (RVVC) by November 30, 2022. 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: BREXAFEMME may not be accepted by physicians and patients at the rate SCYNEXIS expects; risks inherent in SCYNEXIS' ability to successfully develop and obtain FDA approval for ibrexafungerp; unexpected delays may occur in the timing of acceptance by the FDA of an NDA submission; SCYNEXIS’ need for additional capital resources; and SCYNEXIS' reliance on third parties to commercialize its 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 and Quarterly Report on Form 10-Q, including in each case under the caption "Risk Factors," and in 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
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com
Media Relations
Debbie Etchison
SCYNEXIS
debbie.etchison@scynexis.com
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SCYNEXIS, INC. |
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UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(in thousands, except share and per share data) |
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Three Months Ended September 30, |
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2022 |
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2021 |
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Revenue: |
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Product revenue, net |
$ |
1,557 |
|
|
$ |
516 |
|
License agreement revenue |
− |
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|
− |
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Total revenue |
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1,557 |
|
|
|
516 |
|
Operating expenses: |
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|
|
|
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Cost of product revenue |
|
189 |
|
|
|
145 |
|
Research and development |
|
6,430 |
|
|
|
4,401 |
|
Selling, general and administrative |
|
16,739 |
|
|
|
15,411 |
|
Total operating expenses |
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23,358 |
|
|
|
19,957 |
|
Loss from operations: |
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(21,801 |
) |
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(19,441 |
) |
Other expense (income): |
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|
|
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Amortization of debt issuance costs and discount |
|
396 |
|
|
|
413 |
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Interest income |
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(531 |
) |
|
|
(8 |
) |
Interest expense |
|
1,379 |
|
|
|
1,019 |
|
Warrant liabilities fair value adjustment |
|
6,497 |
|
|
|
(18,810 |
) |
Derivative liabilities fair value adjustment |
|
42 |
|
|
|
(1,400 |
) |
Total other expense (income) |
|
7,783 |
|
|
|
(18,786 |
) |
Loss before taxes |
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(29,584 |
) |
|
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(655 |
) |
Income tax benefit |
− |
|
|
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(50 |
) |
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Net loss |
$ |
(29,584 |
) |
|
$ |
(605 |
) |
Net loss per share attributable to common stockholders - basic |
|
|
|
|
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||
Net loss per share - basic |
$ |
(0.62 |
) |
|
$ |
(0.02 |
) |
Net loss per share attributable to common stockholders - diluted |
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Net loss per share - diluted |
$ |
(0.62 |
) |
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$ |
(0.06 |
) |
Weighted average common shares outstanding - basic and diluted |
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|
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Basic |
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47,503,821 |
|
|
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26,616,628 |
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Diluted |
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47,503,821 |
|
|
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27,754,828 |
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SCYNEXIS, INC. |
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UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS |
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(in thousands) |
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September 30, 2022 |
|
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December 31, 2021 |
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Cash and cash equivalents |
$ |
68,620 |
|
|
$ |
104,484 |
|
Short-term investments |
|
27,470 |
|
|
- |
|
|
Total current assets |
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103,565 |
|
|
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109,377 |
|
Operating lease right-of-use asset |
|
2,646 |
|
|
|
2,801 |
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Total assets |
|
112,293 |
|
|
|
119,837 |
|
Total current liabilities |
|
14,264 |
|
|
|
13,616 |
|
Warrant liabilities, long term |
|
27,730 |
|
|
|
18,062 |
|
Convertible debt and derivative liability |
|
11,032 |
|
|
|
11,607 |
|
Loan payable |
|
34,162 |
|
|
|
28,745 |
|
Operating lease liability, long term |
|
2,998 |
|
|
|
3,204 |
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Total liabilities |
|
95,084 |
|
|
|
78,579 |
|
Total stockholders’ equity |
|
17,209 |
|
|
|
41,258 |
|
Total liabilities and stockholders’ equity |
$ |
112,293 |
|
|
$ |
119,837 |
|
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