Ibrexafungerp Citrate

A GSK pill that offers a lower potential for drug resistance is now FDA approved as a new treatment for a common type of urinary tract infection, the first new oral antibiotic for this indication in decades. The regulatory decision announced Tuesday covers the treatment of female adults and pediatric patients age 12 and older who have uncomplicated urinary tract infections, or uUTIs. The drug, known in development as gepotidacin, will be marketed under the brand name Blujepa. GSK said it plans to launch the new product in the second half of this year. Uncomplicated UTIs are infections of the bladder or urethra that develop in people who are otherwise healthy and don’t have underlying conditions. By contrast, complicated UTI is a broad term that could include those who are pregnant, immunocompromised, or have a medical condition that could lead to patients requiring more extensive treatment for the infection. presented by Sponsored Post How to Improve Employee Benefits While Reducing Insurance Costs Balancing healthcare benefits and insurance costs requires research. From becoming a Difference Card member to offering wellness resources, there are many ways to improve healthcare at low cost. By The Difference Card An estimated 16 million women in the U.S. develop uUTIs annually. While antibiotics are available to treat this common infection, resistance that pathogens can develop to these drugs can result in higher treatment failure rates. Blujepa, which was discovered in the labs of GSK, offers a way to address drug resistance. The drug is a small molecule designed to block two enzymes key to bacterial DNA replication. GSK said this mechanism of action is intended to provide activity against most pathogens associated with urinary tract infections, and it should also lower the potential for drug resistance. Dosing of Blujepa is two pills taken twice daily for five days. FDA approval of Blujepa is based on the results of two Phase 3 studies that showed the therapeutic benefit from the GSK drug was not inferior to treatment with nitrofurantoin, an old antibiotic that is a standard drug therapy for uUTIs. The most common adverse events reported in the studies were gastrointestinal and included diarrhea and nausea. “The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women,” GSK Chief Scientific Officer Tony Wood said in a prepared statement. “We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.” FDA approval of Blujepa covers five bacterial pathogens associated with UTIs. The drug also has potential in other indications. Last year, GSK reported this pill met the goals of a Phase 3 test in uncomplicated gonorrhea. Blujepa’s development was partially supported by funds from the U.S. Department of Health and Human Services among other U.S. federal funding sources. presented by Health Tech The 5 Best Software to Buy for Managing a Spa Franchise Choosing the right software translates directly into better client management, operational efficiency and growth for your spa franchise. Discover which tool is best for your business. By Meevo The GSK antimicrobials pipeline includes tebipenem, a drug licensed from Spero Therapeutics now in late-stage clinical development for complicated UTIs. In 2023, GSK licensed rights to the Syncexis antifungal drug Brexafemme, which is approved for treating vaginal yeast infections. This deal also gave GSK the right to develop Brexafemme for other indications. Photo by GSK

The Phase 1 trial of the second-generation triterpenoid antifungal SCY-247, initiated in December of 2024, continues and results are expected in Q3 of 2025.Four presentations for SCY-247 were accepted by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) congress, April 11-15, 2025 in Vienna, Austria.SCYNEXIS continues to make progress towards the restart of the Phase 3 MARIO study in invasive candidiasis. The Company anticipates the restart, pending the FDA’s lifting of the clinical hold, in the second quarter of 2025.SCYNEXIS ended 2024 with cash, cash equivalents and investments of $75.1 million, and projects a cash runway into Q3 2026. JERSEY CITY, N.J., March 12, 2025 (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 year ended December 31, 2024. “In 2024, we achieved a key milestone with the initiation of a Phase 1 trial of our second-generation fungerp, SCY-247,” said David Angulo, M.D., President and Chief Executive Officer. “In preclinical studies, SCY-247 has consistently demonstrated highly encouraging results in a broad range of invasive fungal infections, highlighting its potential for clinical success. We believe SCY-247 has significant potential to become the next therapeutic to fight resistant fungal pathogens and look forward to completion of the trial later this year. We are also making progress towards restarting the MARIO trial, pending the lift of the clinical hold issued by the Food and Drug Administration (FDA), anticipated in the second quarter of this year.” SCY-247 Development Program Dosing was initiated in a Phase 1 single and multiple ascending dose study of SCY-247, the Company’s second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal infections. The company expects to release single ascending and multiple ascending dose data in Q3 of 2025.Preclinical data from studies of SCY-247 were presented at multiple medical meetings throughout 2024, including at IDWeek, the Mycoses Study Group Education & Research Consortium (MSGERC) Biennial Meeting, the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and the 11th Advances Against Aspergillosis and Mucormycosis (AAAM) Conference. Presentations highlighted encouraging preclinical efficacy and pharmacokinetic data of SCY-247 in multiple models of invasive fungal infections.Four presentations are planned for this year’s European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) congress, April 11-15 2025 in Vienna, Austria. Ibrexafungerp Clinical Updates The final activities to restart the Phase 3 MARIO study in invasive candidiasis are underway. SCYNEXIS anticipates the FDA’s clinical hold to be lifted in the second quarter of 2025.SCYNEXIS received a $10 million milestone payment from partner GSK in 2024, triggered by the delivery of final study reports from the completed FURI, CARES and NATURE studies. The data from FURI and CARES will be presented at the ESCMID Global congress, April 11-15 2025 in Vienna, Austria. For more information on the trials, please visit ClinicalTrials.gov (CARES: NCT03363841; FURI: NCT03059992). Full Year 2024 Financial Results For the full year ended December 31, 2024, revenue primarily consisted of $3.7 million in license agreement revenue associated with the GSK license agreement. For the year ended December 31, 2023, revenue primarily consisted of the $130.1 million recognized upon the transfer of the license associated with the GSK License Agreement in May 2023. Research and development expense for the full year ended December 31, 2024 decreased to $26.4 million compared to $30.9 million for the same period in 2023. The decrease of $4.5 million, or 14.6%, was primarily driven by a decrease of $7.4 million in clinical expense, a decrease of $1.3 million in salary expense primarily associated with medical affairs, and a net decrease in other research and development expense of $0.4 million, offset in part by an increase of $3.9 million in chemistry, manufacturing, and controls (CMC) expense, and an increase of $0.7 million in preclinical expense. SG&A expense for the full year ended December 31, 2024 decreased to $14.5 million from $20.9 million for the same period in 2023. The decrease of $6.5 million, or 30.9%, was primarily driven by a decrease of $5.8 million in professional fees and a decrease of $0.9 million in commercial expense due to the costs incurred in the prior period associated with BREXAFEMME, offset by a net increase of $0.2 million in other selling, general, and administrative expense. Total other income was $16.0 million for the full year ended December 31, 2024, versus total other expense of $5.5 million for the same period in 2023. The variance is mainly due to the fair value adjustment related to the warrant liabilities. For the years ended December 31, 2024 and 2023, we recognized a gain of $13.8 million and a loss of $3.2 million, respectively, for the fair value adjustment for warrant liabilities primarily due to the decrease and increase in our stock price during the periods, respectively. Net loss for the full year ended December 31, 2024, was $21.3 million, or $0.44 basic loss per share, compared to a net income of $67.0 million, or $1.40 basic earnings per share and $1.39 diluted earnings per share for the same period in 2023. Cash Balance Cash, cash equivalents and investments totaled $75.1 million on December 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 into Q3 2026. 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 clinical, pre- clinical and discovery phases, 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 into Q3 2026; the expectation to release single ascending and multiple ascending dose data from the SCY-247 Phase 1 study in Q3 of 2025; the clinical and commercial potential for SCY-247; and the anticipated lifting of the clinical hold of the Phase 3 MARIO study in Q2 of 2025. 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 12, 2025, 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 RelationsIrina KofflerLifeSci AdvisorsTel: (646) 970-4681ikoffler@lifesciadvisors.com SCYNEXIS, INC.CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except share and per share data) Years Ended December 31, 2024 2023 Revenue: Product revenue, net $— $1,044 License agreement revenue 3,746 139,097 Total revenue 3,746 140,141 Operating expenses: Cost of product revenue — 15,624 Research and development 26,405 30,928 Selling, general and administrative 14,458 20,920 Total operating expenses 40,863 67,472 (Loss) income from operations (37,117) 72,669 Other expense (income): Amortization of debt issuance costs and discount 1,726 2,994 Interest income (4,291) (3,954)Interest expense 828 3,130 Other income (235) — Warrant liabilities fair value adjustment (13,812) 3,166 Derivative liability fair value adjustment (196) 154 Total other (income) expense (15,980) 5,490 (Loss) income before taxes (21,137) 67,179 Income tax (expense) (151) (138)Net (loss) income $(21,288) $67,041 Net (loss) income per share attributable to common stockholders – basic Net (loss) income per share – basic $(0.44) $1.40 Net (loss) income per share attributable to common stockholders – diluted Net (loss) income per share – diluted $(0.44) $1.39 Weighted average common shares outstanding – basic and diluted Basic 48,513,073 47,852,833 Diluted 48,513,073 48,390,582 SCYNEXIS, INC.CONSOLIDATED BALANCE SHEETS(in thousands, except share and per share data) December 31, 2024 December 31, 2023 Assets Current assets: Cash and cash equivalents $16,051 $34,050 Short-term investments 43,249 40,312 Prepaid expenses and other current assets 2,184 5,548 License agreement receivable 753 2,463 License agreement contract asset 9,509 19,363 Restricted cash 435 380 Total current assets 72,181 102,116 Investments 15,846 23,594 Deferred offering costs 417 175 Restricted cash 109 163 Operating lease right-of-use asset 2,090 2,364 Total assets $90,643 $128,412 Liabilities and stockholders’ equity Current liabilities: Accounts payable $4,569 $7,149 Accrued expenses 3,793 7,495 Deferred revenue, current portion 1,642 1,189 Operating lease liability, current portion 407 340 Warrant liabilities — 130 Convertible debt and derivative liability 13,688 — Total current liabilities 24,099 16,303 Deferred revenue 1,294 2,727 Warrant liabilities 7,998 21,680 Convertible debt and derivative liability — 12,159 Operating lease liability 2,175 2,581 Total liabilities 35,566 55,450 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.001 par value, authorized 5,000,000 shares as of December 31, 2024 and December 31, 2023; 0 shares issued and outstanding as of December 31, 2024 and December 31, 2023 — — Common stock, $0.001 par value, 150,000,000 shares authorized as of December 31, 2024 and 2023; 37,973,991 and 37,207,799 shares issued and outstanding as of December 31, 2024, and December 31, 2023, respectively 41 40 Additional paid-in capital 431,571 428,169 Accumulated deficit (376,535) (355,247)Total stockholders’ equity 55,077 72,962 Total liabilities and stockholders’ equity $90,643 $128,412