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SCYNEXIS Reports First Quarter 2024 Financial Results and Provides Corporate Update

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SCYNEXIS, a biotechnology company, reported its first-quarter financial results for 2024, ending with $94.2 million in cash, with a projected cash runway of over two years. They continue to progress with SCY-247's development and anticipate a Phase I trial by 2024. The company is working on new manufacturing agreements due to clinical hold issues with ibrexafungerp and presented promising preclinical data for SCY-247 at a conference. SCYNEXIS expects to deliver study reports to GSK, triggering a $10 million milestone payment. Financially, revenue consisted of $1.4 million from a license agreement with GSK. Research and development expenses increased slightly, while SG&A expenses decreased. Net income for Q1 2024 was $0.4 million compared to a loss in the same period in 2023.

Positive
  • Progress in SCY-247's development and anticipation of Phase I trial in 2024.

  • Promising preclinical data for SCY-247 presented at a conference.

  • Expected delivery of study reports to GSK triggering a $10 million milestone payment.

  • Net income of $0.4 million for Q1 2024 compared to a loss in the same period in 2023.

  • Compared to December 31, 2023, the cash balance decreased slightly, but SCYNEXIS believes it has a cash runway beyond two years.

Negative
  • New manufacturing agreements needed due to clinical hold issues with ibrexafungerp.

  • Research and development expenses slightly increased for the quarter ended March 31, 2024.

  • SCY-247’s IND-enabling activities continue to progress, with initiation of Phase I anticipated in the second half of 2024
  • Clinical study reports for the FURI, CARES and NATURE trials in refractory invasive fungal infections remain on track for delivery to GSK in mid 2024, which would trigger a $10 million development milestone payment to SCYNEXIS
  • SCYNEXIS ended Q1 2024 with cash, cash equivalents and investments of $94.2 million and projects a cash runway of more than two years

JERSEY CITY, N.J., May 08, 2024 (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 first quarter ended March 31, 2024.

“We continue to be impressed by the highly promising preclinical results of our next generation compound SCY-247,” said David Angulo, M.D., President and Chief Executive Officer. “SCY-247 consistently demonstrates potent activity against a broad range of invasive fungal pathogens, including resistant species for whom there are few or no treatment options. We plan to begin a Phase I trial by year-end. In response to the hold on clinical studies of ibrexafungerp due to possible beta-lactam cross contamination, we have entered into certain new manufacturing agreements with third-party contract manufacturers to begin producing new batches of ibrexafungerp. We believe this new material will allow us to lift the clinical hold and restart the Phase 3 MARIO study evaluating ibrexafungerp in patients with invasive candidiasis."

SCY-247 Preclinical Development Program

  • Phase I-enabling development activities for SCY-247, the second generation fungerp from SCYNEXIS’ proprietary antifungal platform, continue to progress. A portion of these activities, including assessing SCY-247 efficacy against Candida auris and Mucorales, are being supported by National Institute of Health (NIH) grants. Phase I initiation is anticipated in the second half of 2024.
  • Presented preclinical efficacy data on SCY-247 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global, formerly ECCMID) in Barcelona, Spain from April 27-30, 2024. An oral presentation presented by Nathan Wiederhold, Ph.D. featured an in vivo study that demonstrated significant fungal burden reduction in the kidneys and lungs of mice with Candida glabrata invasive candidiasis treated with SCY-247. Additional poster presentations highlighted potent in vitro activity of SCY-247 on a broad range of susceptible and multidrug-resistant pathogenic fungi.

Ibrexafungerp Clinical and Regulatory Updates

  • Final study reports from the completed FURI, CARES, NATURE, SCYNERGIA, and VANQUISH studies are anticipated to be delivered to partner GSK in mid 2024, delivery of the first three of which would trigger a $10 million development milestone payment to SCYNEXIS. Data analysis for the FURI study is ongoing, and top line data from the CARES study are positive and consistent with previously disclosed results from interim analyses.

First Quarter 2024 Financial Results

For the three months ended March 31, 2024, revenue consists of the $1.4 million in license agreement revenue associated with the license agreement with GSK. For the three months ended March 31, 2023, revenue consisted of $1.1 million product sales of BREXAFEMME.

Research and development expense for the quarter ended March 31, 2024 was $7.2 million compared to $6.8 million for the same period in 2023. The increase of $0.4 million, or 6%, for the three months ended March 31, 2024, was primarily driven by an increase of $1.6 million in chemistry, manufacturing, and controls (CMC) expense and a $0.3 million increase in preclinical expense, offset in part by a $0.8 million decrease in clinical expense and a decrease of $0.5 million in salaries primarily associated with medical affairs.

SG&A expense for the quarter ended March 31, 2024 decreased to $3.7 million from $4.8 million for the same period in 2023. The decrease of $1.2 million, or 24%, for the three months ended March 31, 2024, was primarily driven by a decrease of $0.8 million in professional fees and a decrease of $0.4 million in commercial expense due to the costs incurred in the prior comparable period associated with BREXAFEMME.

Total other income was $10.5 million for the quarter ended March 31, 2024, versus total other expense of $23.2 million for the same period in 2023. The variance is mainly due to the fair value adjustment related to the warrant liabilities. For the three months ended March 31, 2024 and 2023, we recognized a gain of $9.6 million and a loss of $21.7 million, respectively, on fair value adjustment for warrant liabilities primarily due to the decrease and increase in our stock price during the periods, respectively.

Net income for the quarter ended March 31, 2024, was $0.4 million, or $0.01 basic income per share, compared to a net loss of $33.9 million, or $0.71 basic loss per share for the same period in 2023.

Cash Balance

Cash, cash equivalents and investments totaled $94.2 million on March 31, 2024, compared to $98.0 million on December 31, 2023. Based upon the company’s current operating plan, SCYNEXIS believes that its existing cash, cash equivalents and investments provide a cash runway beyond two years.

About Triterpenoid Antifungals

Triterpenoid antifungals (also known as “fungerps”) are a novel class of structurally distinct glucan synthase inhibitors that combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. They have demonstrated broad-spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. Ibrexafungerp is the first representative of this novel class of antifungal agents. Ibrexafungerp, formerly known as SCY-078, is currently approved in the U.S. for the treatment of vulvovaginal candidiasis and is in late-stage of development for invasive candidiasis and other indications. SCY-247 is a next generation fungerp in pre-clinical development for the treatment of life-threatening and often multi-drug resistant fungal diseases including Candida auris infections.

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 the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in 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 antifungal assets from this novel class are currently in pre-clinical 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; delivery of clinical study reports to GSK in the first half of 2024, anticipated initiation of Phase I clinical studies of SCY-247 in the second half of 2024; and the resumption of the MARIO study. 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 28, 2024, and form 10-Q for the quarter ending March 31, 2024, 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

 
SCYNEXIS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
 
  Three Months Ended March 31,
   2024   2023 
Revenue:    
Product revenue, net $  $1,130 
License agreement revenue  1,373    
Total revenue  1,373   1,130 
Operating expenses:    
Cost of product revenue     137 
Research and development  7,212   6,835 
Selling, general and administrative  3,669   4,840 
Total operating expenses  10,881   11,812 
Loss from operations  (9,508)  (10,682)
Other (income) expense:    
Amortization of debt issuance costs and discount  401   255 
Interest income  (1,280)  (587)
Interest expense  205   1,447 
Warrant liabilities fair value adjustment  (9,608)  21,673 
Derivative liabilities fair value adjustment  (168)  406 
Total other (income) expense  (10,450)  23,194 
Income (loss) before taxes  942   (33,876)
Income tax expense  (531)   
Net income (loss) $411  $(33,876)
Net income (loss) per share attributable to common stockholders – basic    
Net income (loss) per share – basic $0.01  $(0.71)
Net income (loss) per share attributable to common stockholders – diluted    
Net income (loss) per share – diluted $0.01  $(0.71)
Weighted average common shares outstanding – basic and diluted    
Basic  48,245,559   47,757,246 
Diluted  48,565,051   47,757,246 


SCYNEXIS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
 
  March 31, 2024 December 31, 2023
Assets    
Current assets:    
Cash and cash equivalents $35,482  $34,050 
Short-term investments  44,762   40,312 
Prepaid expenses and other current assets  1,583   5,548 
License agreement receivable     2,463 
License agreement contract asset  19,466   19,363 
Restricted cash  380   380 
Total current assets  101,673   102,116 
Investments  13,943   23,594 
Deferred offering costs  175   175 
Restricted cash  163   163 
Operating lease right-of-use asset  2,300   2,364 
Total assets $118,254  $128,412 
Liabilities and stockholders’ equity    
Current liabilities:    
Accounts payable $8,918  $7,149 
Accrued expenses  4,601   7,495 
Deferred revenue, current portion  1,083   1,189 
Operating lease liability, current portion  356   340 
Warrant liabilities     130 
Convertible debt and derivative liability  12,391    
Total current liabilities  27,349   16,303 
Deferred revenue  2,111   2,727 
Warrant liabilities  12,202   21,680 
Convertible debt and derivative liability     12,159 
Operating lease liability  2,487   2,581 
Total liabilities  44,149   55,450 
Commitments and contingencies    
Stockholders’ equity:    
Preferred stock, $0.001 par value, authorized 5,000,000 shares as of March 31, 2024 and December 31, 2023; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023      
Common stock, $0.001 par value, 150,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 37,779,796 and 37,207,799 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively  41   40 
Additional paid-in capital  428,900   428,169 
Accumulated deficit  (354,836)  (355,247)
Total stockholders’ equity  74,105   72,962 
Total liabilities and stockholders’ equity $118,254  $128,412 

FAQ

What was SCYNEXIS' cash balance at the end of Q1 2024?

SCYNEXIS reported cash, cash equivalents, and investments totaling $94.2 million on March 31, 2024.

What is SCYNEXIS working on due to clinical hold issues with ibrexafungerp?

SCYNEXIS entered into new manufacturing agreements to produce new batches of ibrexafungerp to lift the clinical hold.

What milestone payment is triggered by the delivery of study reports to partner GSK?

The delivery of certain study reports to GSK is expected to trigger a $10 million development milestone payment to SCYNEXIS.

How did SCYNEXIS' net income for Q1 2024 compare to the same period in 2023?

SCYNEXIS reported a net income of $0.4 million for the quarter ended March 31, 2024, compared to a net loss of $33.9 million in the same period of 2023.

What was the revenue source for SCYNEXIS in Q1 2024?

Revenue for the three months ended March 31, 2024, consisted of $1.4 million in license agreement revenue associated with GSK.

SCYNEXIS, Inc.

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JERSEY CITY