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

2,535

Literatures (Medical) associated with Anidulafungin

31 Dec 2024·Emerging Microbes & Infections

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

Article

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

INTRODUCTION:

Drug 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.

FINDINGS:

Six 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).

INTERPRETATION:

Echinocandin-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.

31 Dec 2024·Emerging microbes & infections

Evaluation of outbreak persistence caused by multidrug-resistant and echinocandin-resistant Candida parapsilosis using multidimensional experimental and epidemiological approaches

Article

Author: Mansour, Michael K ; Perry, Austin M ; Jusuf, Sebastian ; Butler, Geraldine ; Floyd, Daniel J ; Ebadati, Arefeh ; Apostolopoulou, Anna ; Ghahfarokhy, Pegah Mosharaf ; Lass-Flörl, Cornelia ; Elizabeth Yvanovich, Emma ; Nobile, Clarissa J ; Arastehfar, Amir ; Birinci, Asuman ; Daneshnia, Farnaz ; Ilkit, Macit ; Ryan, Adam P ; Jeffries, Nathan Elias ; Hilmioğlu-Polat, Süleyha ; Munoz, Julieta

Candida parapsilosis is known to cause severe and persistent outbreaks in clinical settings. Patients infected with multidrug-resistant C. parapsilosis (MDR Cp) isolates were identified in a large Turkish hospital from 2017-2020. We subsequently identified three additional patients infected with MDR Cp isolates in 2022 from the same hospital and two echinocandin-resistant (ECR) isolates from a single patient in another hospital. The increasing number of MDR and ECR isolates contradicts the general principle that the severe fitness cost associated with these phenotypes could prevent their dominance in clinical settings. Here, we employed a multidimensional approach to systematically assess the fitness costs of MDR and ECR C. parapsilosis isolates. Whole-genome sequencing revealed a novel MDR genotype infecting two patients in 2022. Despite severe in vitro defects, the levels and tolerances of the biofilms of our ECR and MDR isolates were generally comparable to those of susceptible wild-type isolates. Surprisingly, the MDR and ECR isolates showed major alterations in their cell wall components, and some of the MDR isolates consistently displayed increased tolerance to the fungicidal activities of primary human neutrophils and were more immunoevasive during exposure to primary human macrophages. Our systemic infection mouse model showed that MDR and ECR C. parapsilosis isolates had comparable fungal burden in most organs relative to susceptible isolates. Overall, we observed a notable increase in the genotypic diversity and frequency of MDR isolates and identified MDR and ECR isolates potentially capable of causing persistent outbreaks in the future.

01 Dec 2024·Techniques in Coloproctology

Efficacy and safety of RD2 Ver.02, a whole blood clot therapy, coupled with a minimally invasive procedure in pilonidal sinus: a phase II study

Article

Author: Carter, D ; Nachmany, I ; Horesh, N ; Ram, E ; Anteby, R ; Haik, J ; Zager, Y

BACKGROUND:

PNS is caused by an infection in the sacrococcygeal area triggered by hair particle accumulation in skin tunnels, resulting in infection. Surgical options range from simple excision to complex flap constructions. Primary wound healing failure and recurrence rates contribute to the burden of PNS. RD2 Ver.02, a novel autologous whole-blood clot product, demonstrated safety and efficacy in treating complex cutaneous wounds and was investigated for the management of PNS.

METHODS:

A Phase II open-label, pilot, single-arm prospective study was conducted from May 2021 to May 2023 (Ethics Committee approval #7952-20). Patients with PNS underwent a minimally invasive trephine procedure under local anesthesia followed by RD2 Ver.02 instillation into the cavity. Primary healing was assessed at 3, 6, and 12 months. Secondary outcomes included the collection of adverse events.

RESULTS:

Overall, 51 patients participated in the study. At 3 months, 42/51 healed (82.4%), 7/51 (13.7%) were granulating but not completely healed, and 2/51 (3.9%) failed to heal. At 6 and 12 months, 46/51 (90.2%) and 42/51 (82.4%) achieved complete healing, respectively. At 6 months, two PNSs recurred after initial healing and an additional four instances of PNS recurrence observed in 12 months, so a total of recurrence in six patients (11.8%). There were five adverse events (AEs) with no severe adverse events.

CONCLUSION:

RD2 Ver.02 is a safe and effective treatment of PNS when coupled with a minimally invasive trephine PNS procedure. Further comparative studies are needed to fully assess the role of this novel therapy for PNS.

News (Medical) associated with Anidulafungin

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

08 May 2024

·www.biospace.com

SCYNEXIS Reports First Quarter 2024 Financial Results and Provides Corporate Update

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 . 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

Drug ApprovalPhase 1Financial StatementLicense out/inClinical Result

100 Deals associated with Anidulafungin

External Link

KEGG	Wiki	ATC	Drug Bank
D03211	Anidulafungin	J02AX06	DB00362

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Candidiasis, Invasive	EU	Pfizer Europe MA EEIG	20 Sep 2007
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	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
Invasive Pulmonary Aspergillosis	Phase 3	-	Pfizer Inc.	01 May 2012
Neuroaspergillosis	Phase 3	-	Pfizer Inc.	01 May 2012
Neutropenia	Phase 3	BA	Pfizer Inc.	01 Aug 2009
Neutropenia	Phase 3	FR	Pfizer Inc.	01 Aug 2009
Neutropenia	Phase 3	IT	Pfizer Inc.	01 Aug 2009
Neutropenia	Phase 3	PL	Pfizer Inc.	01 Aug 2009
Neutropenia	Phase 3	RU	Pfizer Inc.	01 Aug 2009
Neutropenia	Phase 3	SK	Pfizer Inc.	01 Aug 2009
Fungemia	Phase 3	US	Pfizer Inc.	01 Apr 2009
Fungemia	Phase 3	BE	Pfizer Inc.	01 Apr 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO Annual Meeting (ARVO2021)	Not Applicable	Candidiasis \| Candidemia	56	Echinocandins	vtegjmflcm(fjvzbfqyhn) = agvekazaqp fpjlcwrreb (zrdcvooxoi )	Positive	01 Jun 2021
ARVO Annual Meeting (ARVO2021)	Not Applicable	Candidiasis \| Candidemia	56	Other antifungal drugs	vtegjmflcm(fjvzbfqyhn) = raspcocksc fpjlcwrreb (zrdcvooxoi )	Positive	01 Jun 2021
NCT00548262 \| NCT00689338 \| NCT00537329 \| NCT00496197 \| NCT00806351 \| NCT00805740 (Pubmed \| Clin Drug Investig)	Not Applicable	Solid tumor \| Candidiasis, Invasive	-	Anidulafungin	txxsuguyxg(afwwyjkofi) = omcdoywrcl lqhrrldunn (havnqqcpsk ) View more	-	23 Apr 2021
NCT00761267 (Pubmed \| Pediatr Infect Dis J) Manual	Phase 3	Candidiasis, Invasive	19	fluconazole+anidulafungin	joqvmytbol(zwxqcmzddg) = mild/moderate amaofvxnvd (oskbobolro )	Positive	01 Apr 2020
NCT00548262 \| NCT00689338 \| NCT00537329 \| NCT00496197 \| NCT00805740 (Pubmed \| Eur J Clin Microbiol Infect Dis)	Not Applicable	Candidiasis	-	Anidulafungin	fnykurnbmv(eqkprovola) = zzeuiyjeki pghiurwjvu (ajzywifhti ) View more	-	01 Oct 2019
NCT01734525 (CTgov)	Phase 4	Candidemia	85	Anidulafungin	mhfsijscbk(mxnkdqxcpa) = jntwetrjya grpdmibuwk (evpecmhppt, fmubepngzn - rgeannykwq) View more	-	08 Jul 2019
NCT00761267 (Pubmed \| Pediatr Infect Dis J) Manual	Phase 3	Candidiasis, Invasive	49	Anidulafungin	mkgjauzuog(hhvgazogak) = diarrhea 22.4%, vomiting 24.5% and pyrexia 18.4% being most frequent. uytizwvxis (jnrcepnhfu ) View more	Positive	01 Mar 2019
NCT01307930 (CTgov)	Phase 4	Mycoses \| Obesity	20	Anidulafungin	axnaebalfg(idfwsjqekj) = lkiefjdjne mesoszsspt (ypngmutbjv, nzctqszirk - hfqualohwc) View more	-	09 Jan 2019
NCT00548262 \| NCT00689338 \| NCT00537329 \| NCT00496197 \| NCT00806351 \| NCT00805740 (Pubmed \| Mycoses)	Not Applicable	Candidemia	70	Anidulafungin	pcbfqhnevy(dyuhpinhgi) = ryrvqisukc rgfoixxcbo (iidvguafnv ) View more	-	01 Oct 2017
Pubmed \| J Antimicrob Chemother	Not Applicable	Candidiasis, Invasive	539	Anidulafungin	pglczgzkfv(wpwanwrsjk) = Adverse events (AEs) were consistent with the known AE profile for anidulafungin dnvacumsrf (bzadeqmdnj )	-	01 Aug 2017
NCT01176058 (CTgov)	Phase 3	Candidemia	17	Anidulafungin (Anidulafungin)	atmjonoolf(hdnfjcbete) = lnxosutskx oqqqwhgzji (sbdlxmjawl, tpzhtagliz - bynperornl) View more	-	21 Sep 2015
NCT01176058 (CTgov)	Phase 3	Candidemia	17	Fluconazole (Fluconazole)	atmjonoolf(hdnfjcbete) = tsmzqunuhg oqqqwhgzji (sbdlxmjawl, cvgllkwvru - dxzlxqhfbx) View more	-	21 Sep 2015

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