Ibrexafungerp Citrate

Clinical study reports for the FURI, CARES and NATURE trials in refractory or resistant invasive fungal infections were delivered to GSK, triggering a $10 million development milestone payment to SCYNEXIS, received in Q3 2024. SCY-247 preclinical studies were presented at medical conferences and continue to show potent and broad antifungal activity. Phase 1 study initiation is anticipated in Q4 2024. SCYNEXIS ended Q3 2024 with cash, cash equivalents and investments of $84.9 million, including the recently earned $10.0 million development milestone, and projects a cash runway into Q3 2026. SCYNEXIS will attend Guggenheim’s Inaugural Global Healthcare Conference in Boston on November 12thand hold one-on-one meetings with investors. JERSEY CITY, N.J., Nov. 06, 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 third quarter ended September 30, 2024. “We see substantial value in our ibrexafungerp partnered programs and have been making significant progress advancing the manufacturing of clinical trial materials, which would enable the re-start of the Phase 3 MARIO trial in invasive candidiasis, anticipated in early 2025.” said David Angulo, M.D., President and Chief Executive Officer. “Additionally, SCY-247 has demonstrated highly encouraging preclinical results in a broad range of invasive fungal infections, underscoring its potential to be a new therapeutic to fight hard-to-treat fungal pathogens. We continue to share these promising results with the scientific community, most recently at IDWeek 2024. A planned Phase 1 trial of SCY-247 remains on track to initiate in the fourth quarter of 2024. We are also pleased to have completed the FURI, CARES and NATURE studies of ibrexafungerp in refractory invasive fungal infections, which showed positive results consistent with results reported from previous interim analyses. Delivery of final study reports to our partner triggered a $10 million milestone payment received in the third quarter.” SCY-247 Preclinical Development Program Preclinical data from studies of SCY-247, the second generation fungerp from SCYNEXIS’ proprietary antifungal platform, were presented at multiple medical meetings, including the Mycoses Study Group Education & Research Consortium (MSGERC) Biennial Meeting in September 2024 and IDWeek in October 2024. These presentations highlighted encouraging preclinical efficacy and pharmacokinetic data on SCY-247 in multiple models of invasive fungal infections, including: Positive dose-dependent efficacy against Candida albicans mouse model following oral administration;Significant and dose-dependent reductions in kidney and lung fungal burden in Candida glabrata mouse model;Prolonged survival and reductions in lung and brain fungal burden in a pulmonary mucormycosis mouse model; andHigh tissue distribution into organs of concern for invasive fungal infections. Phase I initiation continues to be anticipated in Q4 2024. Ibrexafungerp Clinical Updates Final study reports from the completed FURI, CARES and NATURE studies were delivered to partner, GSK in July 2024. Delivery of these reports triggered a $10 million development milestone payment to SCYNEXIS which was received in the third quarter of 2024. Results from the FURI and CARES studies are planned to be presented by GSK at a future medical meeting. For more information on the trials, please visit ClinicalTrials.gov (CARES: NCT03363841; FURI: NCT03059992). Third-party manufacturing of new batches of ibrexafungerp for use in clinical trials is in progress, and SCYNEXIS anticipates restarting the Phase 3 MARIO study in invasive candidiasis in Q1 2025. Guggenheim Conference Participation Scynexis management will be participating in the Guggenheim Securities Healthcare Conference, taking place in Boston from November 11-13, 2024. Please contact your Guggenheim representative to schedule a meeting with the team. Date: November 12, 2024Format: 1x1 Meetings Third Quarter 2024 Financial Results For the three months ended September 30, 2024 and 2023, revenue primarily consists of $0.7 million and $2.4 million, respectively, in license agreement revenue associated with the GSK license agreement. Research and development expense for the three months ended September 30, 2024 was $8.1 million compared to $6.5 million for the same period in 2023. The increase of $1.6 million, or 25%, for the three months ended September 30, 2024, was primarily driven by an increase of $2.2 million in chemistry, manufacturing, and controls (CMC) expense, an increase of $0.9 million in preclinical expense, and a net increase in other research and development expense of $0.4 million, offset in part by a decrease of $1.6 million in clinical expense and a decrease of $0.3 million in salaries primarily associated with medical affairs. SG&A expense for the three months ended September 30, 2024 decreased to $2.9 million from $5.0 million for the same period in 2023. The decrease of $2.1 million, or 42%, for the three months ended September 30, 2024, was primarily driven by a decrease of $1.5 million in professional fees and a decrease of $0.5 million in commercial expense due to the costs incurred in the prior period associated with BREXAFEMME. Total other income was $7.1 million for the three months ended September 30, 2024, versus total other income of $8.3 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 September 30, 2024 and 2023, we recognized gains of $6.8 million and $7.5 million, respectively, on the fair value adjustment for warrant liabilities primarily due to the changes in our stock price during the periods. Net loss for the three months ended September 30, 2024, was $2.8 million, or $0.06 basic loss per share, compared to a net loss of $1.8 million, or $0.04 basic loss per share for the same period in 2023. Cash Balance Cash, cash equivalents and investments totaled $84.9 million on September 30, 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 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 into Q3 2026; anticipated initiation of Phase 1 clinical studies of SCY-247 in Q4 of 2024; and the anticipated resumption of the Phase 3 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 September 30, 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 RelationsIrina KofflerLifeSci AdvisorsTel: (646) 970-4681ikoffler@lifesciadvisors.com SCYNEXIS, INC.UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except share and per share data) Three Months Ended September 30, 2024 2023 Revenue: Product (loss) revenue, net $— $(614) License agreement revenue 660 2,375 Total revenue 660 1,761 Operating expenses: Cost of product revenue — 379 Research and development 8,073 6,466 Selling, general and administrative 2,907 5,014 Total operating expenses 10,980 11,859 Loss from operations (10,320) (10,098) Other (income) expense: Amortization of debt issuance costs and discount 441 360 Interest income (1,020) (1,263) Interest expense 213 212 Warrant liabilities fair value adjustment (6,751) (7,468) Derivative liabilities fair value adjustment — (182) Total other income (7,117) (8,341) Loss before taxes (3,203) (1,757) Income tax benefit (395) — Net loss $(2,808) $(1,757) Net loss per share attributable to common stockholders – basic Net loss per share – basic $(0.06) $(0.04) Net loss per share attributable to common stockholders – diluted Net loss per share – diluted $(0.06) $(0.04) Weighted average common shares outstanding – basic and diluted Basic 48,618,693 47,891,996 Diluted 48,618,693 47,891,996 SCYNEXIS, INC.UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share and per share data) September 30, 2024 December 31, 2023 Assets Current assets: Cash and cash equivalents $28,730 $34,050 Short-term investments 40,098 40,312 Prepaid expenses and other current assets 1,538 5,548 License agreement receivable 153 2,463 License agreement contract asset 9,509 19,363 Restricted cash 435 380 Total current assets 80,463 102,116 Investments 16,116 23,594 Deferred offering costs 187 175 Restricted cash 109 163 Operating lease right-of-use asset 2,163 2,364 Total assets $ 99,038 $ 128,412 Liabilities and stockholders’ equity Current liabilities: Accounts payable $4,955 $7,149 Accrued expenses 5,508 7,495 Deferred revenue, current portion 1,642 1,189 Operating lease liability, current portion 389 340 Warrant liabilities — 130 Convertible debt and derivative liability 13,225 — Total current liabilities 25,719 16,303 Deferred revenue 1,294 2,727 Warrant liabilities 11,212 21,680 Convertible debt and derivative liability — 12,159 Operating lease liability 2,284 2,581 Total liabilities 40,509 55,450 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.001 par value, authorized 5,000,000 shares as of September 30, 2024 and December 31, 2023; 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023 — — Common stock, $0.001 par value, 150,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 37,943,241 and 37,207,799 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 41 40 Additional paid-in capital 430,590 428,169 Accumulated deficit (372,102) (355,247) Total stockholders’ equity 58,529 72,962 Total liabilities and stockholders’ equity $ 99,038 $ 128,412

16 October 2024 Application supported by positive results from pivotal phase III EAGLE-2 and EAGLE-3 trials 26 March 2025 assigned as action date for FDA decision Gepotidacin could be the first in a new class of oral antibiotic treatment for uUTIs in over 20 years GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for the treatment of female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs). The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of 26 March 2025. Over half of all women are affected by uUTIs in their lifetime1, with approximately 30% suffering from recurrent disease which can cause significant patient burden, including discomfort and restriction of daily activities.2 New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing and can result in higher treatment failure rates.3 Gepotidacin is a late-stage antibiotic in GSK’s growing infectious disease portfolio and could be the first in a new class of oral antibiotics for uUTIs in over 20 years. The NDA is supported by positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials. In these studies, gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care for uUTI, in female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin. In EAGLE-3, gepotidacin achieved statistically significant superiority versus nitrofurantoin, demonstrating therapeutic success in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (treatment difference 14.6%, 95% CI (6.4, 22.8)). In EAGLE-2, gepotidacin demonstrated therapeutic success in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (treatment difference 4.3%, 95% CI (-3.6, 12.1)). The safety and tolerability profile of gepotidacin in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials of gepotidacin. The most commonly reported adverse events (AEs) in gepotidacin participants were gastrointestinal (GI). Diarrhoea was the most common (16% of participants), followed by nausea (9%). Of the participants who reported GI AEs in the gepotidacin group, the maximum severity were mild (69% Grade 1) and moderate (28% Grade 2). Participants with Grade 3 GI events accounted for 3% of all patients with GI events and occurred in <1% of all participants. There was one drug-related serious adverse event in each treatment arm (gepotidacin and nitrofurantoin) across the two trials. The development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the Defense Threat Reduction Agency under agreement number HDTRA1-07-9-0002. About the EAGLE (Efficacy of Antibacterial Gepotidacin Evaluated) phase III programme The global phase III clinical programme for gepotidacin in adults and adolescents consists of three trials: EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and safety of gepotidacin (1,500mg administered orally twice daily for five days) to nitrofurantoin (100mg administered orally twice daily for five days) with 1531 and 1605 female adults and adolescents with uncomplicated urinary tract infections, respectively. Across both trials, the duration of follow-up for participants was approximately 28 days, and the primary endpoint was the combined clinical and microbiological response at the Test-of-Cure (ToC) visit (days 10-13) in patients with qualifying uropathogens susceptible to nitrofurantoin. EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in 628 patients with uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae. About gepotidacin Gepotidacin, discovered by GSK scientists, is an investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct binding site, a novel mechanism of action and for most pathogens, provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most target uropathogens (such as E. coli and S. saprophyticus), and N. gonorrhoeae, including isolates resistant to current antibiotics. Efficacy and safety in patients have been demonstrated in uUTI and gonorrhoea phase III clinical trials, including those with drug-resistant pathogens. Due to the well-balanced inhibition, gepotidacin target-specific mutations in both enzymes are needed to significantly affect susceptibility to gepotidacin. Therefore, leading to a lower potential for resistance development. GSK in infectious diseases GSK has pioneered innovation in infectious diseases for over 70 years, and the Company’s pipeline of medicines and vaccines is one of the largest and most diverse in the industry, with a goal of developing preventive and therapeutic treatments for multiple disease areas or diseases with high unmet needs globally. GSK’s expertise and capabilities in innovation, access and stewardship position the Company uniquely to help prevent and mitigate the challenge of antimicrobial resistance. In antimicrobials, in addition to gepotidacin, GSK entered into an exclusive licence agreement with Spero Therapeutics, Inc. in September 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated urinary tract infections (cUTIs), to the pipeline and are currently enrolling for PIVOT-PO, a phase III trial. In March 2023, GSK announced an exclusive licence agreement with Scynexis for Brexafemme (ibrexafungerp tablets), a first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent VVC. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024. References You might also like