StandArd VEC vs high dose VEC with local THErapy for VIsion and globe Salvage in advanced IntraOcular retiNoblastoma (group D): A comparative RCT (SAVE-THE-VISION) study - NULL

Start Date01 May 2024

Sponsor / Collaborator-

CTRI/2021/09/037013 / RecruitingNot ApplicableIIT

A prospective, observational, open label study to evaluate efficacy and safety of Anidulafungin in comparison to Caspofungin in Invasive Candida infections in India (ADVANCE)

Start Date15 Oct 2021

Sponsor / Collaborator-

NCT05426499 / Active, not recruitingNot ApplicableIIT

Translational PKPD Modeling of Anti-infective Drugs in Children Treated in Pediatric Units on the Example of Selected Antibiotics and Antifungals.

Pharmacokinetic and pharmacodynamic modeling (PKPD) is becoming an essential tool for optimizing pharmacotherapy. Building mechanistic models allows determining the relationship between the dose, concentration, pharmacological effect, and side effects in various populations. The growing resistance to drugs among bacteria is a challenge for medicine, and the progress in pharmacometrics enables us to make rational clinical decisions. A particular group of patients is children with differences in PK and PD of drugs. The lack of clinical studies often forces to extrapolate dosing based on the results obtained in adults. In intensive care units, up to 70-90% of drugs in children are used off-label. Drug agencies point to the importance of the population-based approach to data analysis, especially in infants and children. Under the project, work will focus on the PK and PD of antifungal drugs (fluconazole, isavuconazole, and anidulafungin) and antibiotics (cefotaxime and meropenem) in the pediatric and adult populations. The choice of topic is dictated by the growing need to create PKPD models of the drugs mentioned above in children. The hypothesis is the assumption that using a mathematical model will enable to describe the time course of the drug in the organism, the relationship between the effect and the dose of the medicine and its concentration in the plasma, and the influence of individual factors on the PKPD profile of a drug.

Start Date01 Oct 2021

Sponsor / Collaborator

Poznan University of Medical Science

[+1]

100 Clinical Results associated with Anidulafungin

100 Translational Medicine associated with Anidulafungin

100 Patents (Medical) associated with Anidulafungin

2,558

Literatures (Medical) associated with Anidulafungin

01 Feb 2025·Parasitology International

Pulmonary infection by Lophomonas spp. and Aspergillus spp. in a B-cell acute lymphocytic leukemia patient from Chile

Article

Author: Cabrera, Johanna ; Hidalgo, Alejandro ; Fonseca-Salamanca, Flery ; Iturrieta-González, Isabel ; Chahin, Carolina ; Briones, Javier ; Moenen-Locoz, Enzo ; Concha, Carla ; Vega, Fernando

The flagellated protozoan Lophomonas spp. is a commensal microorganism found in the intestinal tracts of cockroaches, termites, mites, and certain birds. It is the causative agent of a rare infection in humans called lophomoniasis, primarily affecting the lungs and mainly immunocompromised individuals. This parasitosis is transmitted to humans by air or through ingestion of the cystic forms of the parasite. We describe the case of a 50-year-old patient treated at a tertiary hospital in southern Chile with a history of B-cell acute lymphocytic leukemia. Radiological findings, along with increased levels of inflammatory parameters and galactomannan antigen in serum and Bronchoaveolar Lavage (BAL) raised the suspicion of a pulmonary infection. Microscopic study of BAL revealed oval to pyriform cells with mobile flagella at the anterior end, which were identified as Lophomonas spp. trophozoites, which based on EORTC/MSG criteria were associated with diagnosis of a probable pulmonary aspergillosis. Lophomoniasis was treated with metronidazole (500 mg IV every 8 h) for 14 days and pulmonary aspergillosis required a combination of fluconazole, voriconazole, anidulafungin, liposomal amphotericin B and isavuconazole. The patient responded favorably and was discharged after 95 days of hospitalization. This case highlights the importance of recognizing lophomoniasis as a parasitic infection in respiratory samples from immunocompromised patients who present pulmonary symptoms, especially those who do not respond satisfactorily to conventional antimicrobial treatments. Further research is needed to understand the various sources of Lophomonas spp. infection and develop infection prevention strategies particularly for high-risk patients.

01 Jan 2025·Journal of Pharmaceutical and Biomedical Analysis

Multiparametric LC-MS/MS method for simultaneous determination of eleven antifungal drugs and metabolites in human plasma

Article

Author: Bendjilali-Sabiani, Jean-Joseph ; Mathieu, Olivier ; Cazaubon, Yoann ; Constans, Céline

A multiparametric liquid chromatography-tandem mass spectrometry method has been developed for the simultaneous quantification of 11 antifungal drugs and their metabolites in human plasma. This method addresses the critical need for therapeutic drug monitoring in the treatment of invasive fungal infections, which are increasingly prevalent among immunocompromised patients and those in intensive care units. The method quantifies flucytosin, fluconazole, itraconazole, hydroxy-itraconazole, posaconazole, isavuconazole, voriconazole, voriconazole-N-oxide, anidulafungin, caspofungin, and micafungin. Key challenges in method development included optimising mass spectrometer settings, chromatographic conditions, and sample preparation techniques to ensure accurate, sensitive, and specific detection. Validation of this method was conducted in accordance with the guidelines set by the USA Food and drug administration and the European Medicines Agency covering linearity, precision, accuracy, selectivity, matrix effect, and stability. The method exhibited robust performance with intra- and inter-assay precision under 10 % and average accuracy for intra- and inter-assay comparison of -2.35 % and 0.80 %, respectively. Limits of detection (0.002 to 0.110 mg/L) and a quantification range between 0.005 and 200 mg/L make this method suitable for clinical TDM applications. The ability to simultaneously analyse eleven antifungals and their metabolites within a single 5-minute run enhances its utility in clinical settings, particularly for critically ill patients who may experience significant pharmacokinetic variations. The method requires only 100 µL of plasma, demonstrating good analytical performances rendering it a valuable tool for optimising antifungal therapy and improving patient outcomes in ICU management.

31 Dec 2024·Emerging Microbes & Infections

Evolutionary accumulation of FKS 1 mutations from clinical echinocandin-resistant Candida auris

Article

Author: Rong, Chen ; Zhang, Jingping ; Li, Hailong ; Wu, Yusheng ; Wu, Na ; Shang, Hong ; Jiang, Ning ; Tian, Sufei ; Chu, Yunzhuo

INTRODUCTIONDrug resistance to echinocandins, first-line drugs used to treat Candida auris infection, is rapidly emerging. However, the accumulation of mutations in genes other than FKS1 (before an isolate develops to resistance via FKS1 mutations), remains poorly understood. Methods: Four clinical cases and 29 isolates associated with the incremental process of echinocandin resistance were collected and analyzed using antifungal drug susceptibility testing and genome sequencing to assess the evolution of echinocandin resistance.FINDINGSSix echinocandin minimum inhibitory concentration (MIC)-elevated C. auris strains and seven resistant strains were isolated from the urinary system of patients receiving echinocandin treatment. Meanwhile, phylogenetic analyses illustrated that the echinocandin-resistant strains were closely related to other strains in the same patient. Genomic data revealed that the echinocandin-resistant strains had FKS1 mutations. Furthermore, three categories (ECN-S/E/R) of non-synonymous mutant SNP genes (such as RBR3, IFF6, MKC1, MPH1, RAD2, and MYO1) in C. auris appeared to be associated with the three-stage-evolutionary model of echinocandin resistance in C. glabrata: cell wall stress, drug adaptation, and genetic escape (FKS mutation).INTERPRETATIONEchinocandin-resistant C. auris undergoes spatial and temporal phase changes closely related to echinocandin exposure, particularly in the urinary system. These findings suggest that FKS1 mutations mediate an evolutionary accumulation of echinocandin resistance followed by modulation of chromosome remodelling and DNA repair processes that ultimately lead to FKS1 hot spot mutations and the development of drug resistance. This study provides an in-depth exploration of the molecular pathways involved in the evolution of Candida auris echinocandin resistance.

News (Medical) associated with Anidulafungin

06 Nov 2024

·www.globenewswire.com

SCYNEXIS Reports Third Quarter 2024 Financial Results and Provides Corporate Update

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

Phase 1Drug ApprovalLicense out/inFinancial StatementClinical Result

08 Aug 2024

·www.globenewswire.com

SCYNEXIS Reports Second Quarter 2024 Financial Results and Provides Corporate Update

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 which we expect to receive in Q3 2024. SCY-247’s IND-enabling activities continue to progress. Pre-clinical in vitro and in vivo studies, presented at several medical conferences, have shown potent and broad antifungal activity. Phase 1 study initiation is planned for Q4 2024. SCYNEXIS ended Q2 2024 with cash, cash equivalents and investments of $83.7 million, not including the recently earned $10 million development milestone, and projects a cash runway of more than two years. JERSEY CITY, N.J., Aug. 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 second quarter ended June 30, 2024. “Successful completion of the FURI, CARES, and NATURE studies is an important achievement for the future development of ibrexafungerp for refractory or resistant invasive fungal infections,” said David Angulo, M.D., President and Chief Executive Officer. “Positive top-line results from the studies are consistent with previously disclosed results from interim analyses, and delivery of the final study reports to GSK triggered a $10 million milestone payment to SCYNEXIS. Work continues to reestablish the clinical supply chain of ibrexafungerp, and we look forward to restarting the Phase 3 MARIO study in invasive candidiasis. We are also continuing to make progress with SCY-247, our next generation fungerp. SCY-247 continues to yield robust preclinical results, highlighting its promising therapeutic potential against a broad range of invasive fungal pathogens. We plan to present these data at upcoming medical meetings, and a planned Phase 1 study is on track to begin in Q4 of 2024.” SCY-247 Preclinical Development Program Preclinical data from studies of SCY-247, the second generation fungerp from SCYNEXIS’ proprietary antifungal platform, are planned to be presented at multiple upcoming medical meetings, including the Mycoses Study Group Education & Research Consortium (MSGERC) Biennial Meeting in September 2024 and ID Week in October 2024. 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 our partner, GSK. Delivery of these reports triggered a $10 million development milestone payment to SCYNEXIS which we expect to receive in Q3 2024. Results from the FURI and CARES studies are planned to be presented 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 looks forward to restarting the Phase 3 MARIO study in invasive candidiasis. Second Quarter 2024 Financial Results For the three months ended June 30, 2024, revenue consists of the $0.7 million in license agreement revenue associated with the license agreement with GSK. For the three months ended June 30, 2023, revenue primarily consisted of the $130.1 million recognized upon the transfer of the license associated with the License Agreement with GSK in May 2023. Research and development expense for the three months ended June 30, 2024 was $6.8 million compared to $7.0 million for the same period in 2023. The decrease of $0.2 million, or 3%, for the three months ended June 30, 2024, was primarily driven by a decrease of $1.1 million in clinical expense and a decrease of $0.3 million in salaries primarily associated with medical affairs, offset in part by a $0.7 million increase in chemistry, manufacturing, and controls (CMC) expense and an increase of $0.5 million in preclinical expense. SG&A expense for the three months ended June 30, 2024 decreased to $3.2 million from $7.5 million for the same period in 2023. The decrease of $4.3 million, or 58%, for the three months ended June 30, 2024, was primarily driven by a decrease of $3.5 million in professional fees and a decrease of $0.3 million in commercial expense due to the costs incurred in the prior comparable period associated with BREXAFEMME. Total other expense was $5.2 million for the three months ended June 30, 2024, versus total other income of $5.7 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 June 30, 2024 and 2023, we recognized a loss of $5.8 million and a gain of $8.2 million, respectively, on 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 June 30, 2024, was $14.5 million, or $0.30 basic loss per share, compared to a net income of $122.3 million, or $2.56 basic income per share. Cash Balance Cash, cash equivalents and investments totaled $83.7 million on June 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 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; anticipated initiation of Phase I clinical studies of SCY-247 in Q4 of 2024; and the 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 June 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 June 30, 2024 2023 Revenue: Product revenue, net $— $468 License agreement revenue 736 130,986 Total revenue 736 131,454 Operating expenses: Cost of product revenue — 426 Research and development 6,807 7,040 Selling, general and administrative 3,166 7,474 Total operating expenses 9,973 14,940 (Loss) income from operations (9,237) 116,514 Other (income) expense: Amortization of debt issuance costs and discount 421 1,998 Interest income (1,130) (737) Interest expense 197 1,249 Warrant liabilities fair value adjustment 5,761 (8,214) Derivative liabilities fair value adjustment (28) (42) Total other expense (income) 5,221 (5,746) (Loss) income before taxes (14,458) 122,260 Income tax expense — — Net (loss) income $(14,458) $122,260 Net (loss) income per share attributable to common stockholders – basic Net (loss) income per share – basic $(0.30) $2.56 Net (loss) income per share attributable to common stockholders – diluted Net (loss) income per share – diluted $(0.30) $2.46 Weighted average common shares outstanding – basic and diluted Basic 48,511,656 47,837,393 Diluted 48,511,656 49,923,361 SCYNEXIS, INC.UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share and per share data) June 30, 2024 December 31, 2023 Assets Current assets: Cash and cash equivalents $25,994 $34,050 Short-term investments 47,044 40,312 Prepaid expenses and other current assets 1,418 5,548 License agreement receivable 233 2,463 License agreement contract asset 19,509 19,363 Restricted cash 380 380 Total current assets 94,578 102,116 Investments 10,657 23,594 Deferred offering costs 175 175 Restricted cash 163 163 Operating lease right-of-use asset (See Note 7) 2,233 2,364 Total assets $107,806 $128,412 Liabilities and stockholders’ equity Current liabilities: Accounts payable $5,350 $7,149 Accrued expenses 5,498 7,495 Deferred revenue, current portion 1,229 1,189 Operating lease liability, current portion (See Note 7) 372 340 Warrant liabilities — 130 Convertible debt and derivative liability (See Note 6) 12,784 — Total current liabilities 25,233 16,303 Deferred revenue 1,817 2,727 Warrant liabilities 17,962 21,680 Convertible debt and derivative liability (See Note 6) — 12,159 Operating lease liability (See Note 7) 2,388 2,581 Total liabilities 47,400 55,450 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.001 par value, authorized 5,000,000 shares as of June 30, 2024 and December 31, 2023; 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023 — — Common stock, $0.001 par value, 150,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 37,856,463 and 37,207,799 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 41 40 Additional paid-in capital 429,659 428,169 Accumulated deficit (369,294) (355,247)Total stockholders’ equity 60,406 72,962 Total liabilities and stockholders’ equity $107,806 $128,412

License out/inDrug ApprovalPhase 1Financial StatementPhase 3

23 May 2024

·www.biospace.com

Melinta Therapeutics Announces Publication of the Outcomes by Candida Species from the ReSTORE Phase 3 trial and Recently Approved Rezafungin CLSI Breakpoints for Candida glabrata and Candida auris

Publication reaffirms the efficacy of rezafungin for treatment of candidemia and invasive candidiasis (IC) in adult patients across Candida species PARSIPPANY, N.J.--(BUSINESS WIRE)-- Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults. The data analyses in the article, “Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis,” published in the American Society for Microbiology Antimicrobial Agents and Chemotherapy, demonstrates the efficacy of rezafungin in adult patients across a variety of Candida species. Rates of global cure and mycological eradication at day 14 and all-cause mortality at day 30 were generally comparable between the two treatment groups. The article additionally highlights the approval of the Clinical and Laboratory Standards Institute (CLSI) susceptibility breakpoints for rezafungin against several Candida species including Candida glabrata, a species increasingly associated with reduced susceptibility to treatment with echinocandins, and Candida auris, a highly resistant pathogen that is associated with life-threating infections. Rezafungin is the only antifungal, based on in vitro data, that has a defined susceptibility breakpoint for C. auris approved by CLSI; the efficacy of rezafungin in treating candidemia or invasive candidiasis caused by this pathogen has not been established in adequate and well-controlled clinical trials. Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, said, "We are delighted with the release of this analysis of data from the ReSTORE Phase 3 trial, which supports the effectiveness and safety of REZZAYO in comparison to caspofungin and are also pleased to see that CLSI approved the REZZAYO susceptibility breakpoints for Candida pathogens, including C. auris, which has been identified as a potential global threat by the CDC and WHO.” She added, "Melinta has been leveraging our expertise in hospital and acute care environments to commercialize REZZAYO, making it available to healthcare providers and their patients affected by candidemia and invasive candidiasis. This effort supports our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses." Melinta holds the exclusive rights to commercialize rezafungin in the U.S. from Mundipharma. About REZZAYO® (rezafungin for injection) REZZAYO (rezafungin for injection) is a novel once weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION Contraindications REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Warnings and Precautions Infusion-related Reactions: REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. Photosensitivity: REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Adverse Reactions Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at . About Melinta Therapeutics, LLC Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO® (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit .

Phase 3Drug ApprovalLicense out/inClinical Result

100 Deals associated with Anidulafungin

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KEGG	Wiki	ATC	Drug Bank
D03211	Anidulafungin	J02AX06	DB00362

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Candidiasis, Invasive	IS	Pfizer Europe MA EEIG	20 Sep 2007
Candidiasis, Invasive	LI	Pfizer Europe MA EEIG	20 Sep 2007
Candidiasis, Invasive	NO	Pfizer Europe MA EEIG	20 Sep 2007
Candidiasis, Invasive	EU	Pfizer Europe MA EEIG	20 Sep 2007
Candidiasis	US	Vicuron Pharmaceuticals LLC	17 Feb 2006
Candidiasis	US	Pfizer Inc.	17 Feb 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Candidemia	Phase 2	US	Pfizer Inc.	01 Mar 2003
Invasive aspergillosis	Phase 2	US	Vicuron Pharmaceuticals LLC	01 May 2002
Fungemia	Phase 1	US	Pfizer Inc.	01 Apr 2009
Fungemia	Phase 1	CA	Pfizer Inc.	01 Apr 2009
Fungemia	Phase 1	PT	Pfizer Inc.	01 Apr 2009
Fungemia	Phase 1	BG	Pfizer Inc.	01 Apr 2009
Fungemia	Phase 1	CH	Pfizer Inc.	01 Apr 2009
Fungemia	Phase 1	BE	Pfizer Inc.	01 Apr 2009
Candidemia	Phase 1	US	Pfizer Inc.	01 Mar 2003
Invasive aspergillosis	Phase 1	US	Vicuron Pharmaceuticals LLC	01 May 2002

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00548262 \| NCT00689338 \| NCT00537329 \| NCT00496197 \| NCT00806351 \| NCT00805740 (Pubmed \| Clin Drug Investig)	Not Applicable	Solid tumor \| Candidiasis, Invasive	-	Anidulafungin	(cqrqtkjhvs) = uasdsxqpbp fivuqukdti (xdykgzfsce ) View more	-	23 Apr 2021
NCT00761267 (Pubmed \| Pediatr Infect Dis J) Manual	Phase 3	Candidiasis, Invasive	19	fluconazole+anidulafungin	(ohheqssiwp) = mild/moderate lauklugaew (gugeofjqfs )	Positive	01 Apr 2020
NCT00548262 \| NCT00689338 \| NCT00537329 \| NCT00496197 \| NCT00805740 (Pubmed \| Eur J Clin Microbiol Infect Dis)	Not Applicable	Candidiasis	-	Anidulafungin	qnjelplavt(yjstqkvbso) = ouqdctmotp kyqzybdxok (lbmsqzouwg ) View more	-	01 Oct 2019
NCT01734525 (CTgov)	Phase 4	Candidemia	85	Anidulafungin	jqrwezbhif(mynoqsbync) = jxbenedjfx dsbgzeuyea (slhyxybcjp, iiizbdjtmu - nadzhjuvnz) View more	-	08 Jul 2019
NCT00761267 (Pubmed \| Pediatr Infect Dis J) Manual	Phase 3	Candidiasis, Invasive	49	Anidulafungin	(gbcqvijymm) = diarrhea 22.4%, vomiting 24.5% and pyrexia 18.4% being most frequent. bnsbxohjks (fbfvayvbpf ) View more	Positive	01 Mar 2019
NCT01307930 (CTgov)	Phase 4	Mycoses \| Obesity	20	Anidulafungin	kkeyhzkogm(tpfykaoufa) = pkgdnahsnh koctdcwzuz (efdgsuiuxu, dmuoajfhlp - uoqatfzsrt) View more	-	09 Jan 2019
P578 (EBMT2018)	Not Applicable	Pneumonia, Pneumocystis	-	Rezafungin (CD101)	mvmjlnyiqu(ygbmrgopyv) = uvribrktmg gatrwbkysw (ogjrvnfotu ) View more	-	19 Nov 2018
P578 (EBMT2018)	Not Applicable	Pneumonia, Pneumocystis	-	Anidulafungin	mvmjlnyiqu(ygbmrgopyv) = mxfvvfwclh gatrwbkysw (ogjrvnfotu ) View more	-	19 Nov 2018
NCT00548262 \| NCT00689338 \| NCT00537329 \| NCT00496197 \| NCT00806351 \| NCT00805740 (Pubmed \| Mycoses)	Not Applicable	Candidemia	70	Anidulafungin	(crhwkpocjy) = daujjomqdm ebignbrpzw (cqkkfhzxbu ) View more	-	01 Oct 2017
Pubmed \| J Antimicrob Chemother	Not Applicable	Candidiasis, Invasive	539	Anidulafungin	bidizoghya(pftkattyts) = Adverse events (AEs) were consistent with the known AE profile for anidulafungin lxdnibbogt (zturduhyyn )	-	01 Aug 2017
NCT01176058 (CTgov)	Phase 3	Candidemia	17	Anidulafungin (Anidulafungin)	zifjgmaeoy(tsojhoutvr) = ebjtosxpwq epxargyfer (jzgxwklaar, rvbwmquohy - dkghfwwaei) View more	-	21 Sep 2015
NCT01176058 (CTgov)	Phase 3	Candidemia	17	Fluconazole (Fluconazole)	zifjgmaeoy(tsojhoutvr) = zoakjyjron epxargyfer (jzgxwklaar, zhwpsijild - zuuesdvwmi) View more	-	21 Sep 2015

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