SCYNEXIS

SCYNEXIS, Inc. is a biotechnology company engaged in the development of novel oral and intravenous triterpenoid antifungal for the treatment of several serious fungal infections, including vulvovaginal candidiasis, invasive aspergillosis, invasive candidiasis, and refractory invasive fungal infections. The company was founded by Scot Kevin Huber, Terry Eugene Marquardt, Pierre Bernard Jacques Monnet, Russell J. Outcalt, and Yves Joseph Ribeill on November 4, 1999 and is headquartered in Jersey City, NJ.

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SCYNEXIS, Inc. is a biotechnology company, which engages in the development of novel oral and intravenous triterpenoid antifungal for the treatment of several serious fungal infections, including vulvovaginal candidiasis, invasive aspergillosis, invasive candidiasis, and refractory invasive fungal infections. The company was founded by Scot Kevin Huber, Terry Eugene Marquardt, Pierre Bernard Jacques Monnet, Russell J. Outcalt, and Yves Joseph Ribeill on November 4, 1999 and is headquartered in Jersey City, NJ.

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SCYNEXIS, Inc. (SCYX) CEO Marco Taglietti on Q3 2021 Results - Earnings Call Transcript

Scynexis (SCYX) delivered earnings and revenue surprises of 92.41% and 3.20%, respectively, for the quarter ended September 2021. Do the numbers hold clues to what lies ahead for the stock?

Scynexis (SCYX) Reports Q3 Loss, Tops Revenue Estimates

JERSEY CITY, N.J., Nov. 10, 2021 (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 on September 30, 2021 and provided an update on recent clinical and corporate developments.

SCYNEXIS Reports Third Quarter 2021 Financial Results and Provides Corporate Update

Safety and tolerability of new liposomal IV formulation confirmed to reach target exposure in single ascending dose (SAD) and multiple ascending dose (MAD) study Safety and tolerability of new liposomal IV formulation confirmed to reach target exposure in single ascending dose (SAD) and multiple ascending dose (MAD) study

SCYNEXIS Announces Successful Completion of Phase 1 Trial Evaluating Intravenous (IV) Formulation of Ibrexafungerp

JERSEY CITY, N.J., Nov. 03, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced it will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, November 10, 2021, to provide a corporate update and discuss the Company's financial results for the third quarter ended September 30, 2021.

SCYNEXIS to Provide a Corporate Update and Report Third Quarter 2021 Financial Results on November 10

JERSEY CITY, N.J., Oct. 21, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced the peer-reviewed publication of results from its Phase 3 VANISH-303 and Phase 2 DOVE studies in the Infectious Diseases Society of America's Clinical Infectious Diseases.

SCYNEXIS Pivotal Phase 3 VANISH-303 Trial Results Published in Clinical Infectious Diseases Demonstrate Significant Superiority of Ibrexafungerp Over Placebo for Treatment of Vaginal Yeast Infection

JERSEY CITY, N.J., Oct. 13, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced presentations of a pooled data analysis from its successful VANISH clinical development program during two October medical meetings: the Nurse Practitioners in Women's Health (NPWH) 24th Annual Premier Women's Healthcare Conference and the 4th Congress of the International Society for Infectious Diseases in Obstetrics and Gynecology (ISIDOG).

SCYNEXIS to Present Pooled Data Analysis Results Demonstrating Consistent Efficacy and Safety Outcomes Across Two Phase 3 VANISH Clinical Trials of Oral Ibrexafungerp Therapy for Vaginal Yeast Infection at October Medical Conferences

JERSEY CITY, N.J., Oct. 11, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of preclinical data supporting the potential of its broad-spectrum antifungal, ibrexafungerp, to treat mucormycosis. The data, based on an in vivo mouse model of mucormycosis, were presented at the 10th Trends in Medical Mycology (TIMM) meeting being held in-person in Aberdeen, Scotland, and virtually from October 8-11, 2021.

SCYNEXIS Announces Preclinical Data at the 10th Trends in Medical Mycology Meeting Supporting Potential of Ibrexafungerp to Treat Mucormycosis

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WASHINGTON, Sept. 30, 2021 /PRNewswire/ -- The Antimicrobials Working Group (AWG), a coalition of companies with the mission to combat drug resistant infections and spur life-saving innovations, today announced that 10 of its member companies will present data from their clinical and research programs at IDWeek 2021 taking place virtually from September 29-October 3, 2021.

Antimicrobials Working Group Highlights Member Company Participation at IDWeek 2021

Subpopulation analysis of 74 patients from ongoing Phase 3 FURI study demonstrated similar efficacy against multiple serious fungal infections Subpopulation analysis of 74 patients from ongoing Phase 3 FURI study demonstrated similar efficacy against multiple serious fungal infections

SCYNEXIS Presents Interim Analysis from FURI at Virtual IDWeek 2021 Showing Favorable Therapeutic Response in Severe Hospital-Based Fungal Infections Treated with Oral Ibrexafungerp

Analysis of subpopulations from a total of 74 patients evaluated to date from FURI includes outcomes by disease, bone and joint infections, and mouth and throat candidiasis Analysis of subpopulations from a total of 74 patients evaluated to date from FURI includes outcomes by disease, bone and joint infections, and mouth and throat candidiasis

SCYNEXIS to Present Data on Oral Ibrexafungerp at IDWeek 2021 from Interim Analyses of Phase 3 FURI Clinical Trial Showing Therapeutic Response Rates in Patients with Mucocutaneous and Invasive Fungal Infections

JERSEY CITY, N.J., Sept. 22, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced the U.S. availability of BREXAFEMME® (ibrexafungerp tablets), the first and only oral non-azole prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat vulvovaginal candidiasis (VVC), commonly referred to as vaginal yeast infection.

SCYNEXIS Announces U.S. Availability of BREXAFEMME® (ibrexafungerp tablets), the First New Antifungal Class of Therapy Approved by the U.S. FDA for Vaginal Yeast Infections in More Than 20 Years

Submission is part of the Hansoh Pharma licensing agreement and strategic partnership to research, develop and commercialize ibrexafungerp in the Greater China region Submission is part of the Hansoh Pharma licensing agreement and strategic partnership to research, develop and commercialize ibrexafungerp in the Greater China region

SCYNEXIS Announces Hansoh Pharma's Application to National Medical Products Administration (NMPA) in China for Phase 3 Trial of Ibrexafungerp for Treatment of Vulvovaginal Candidiasis (VVC)

JERSEY CITY, N.J., Aug. 16, 2021 (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 on June 30, 2021 and provided an update on recent clinical and corporate developments.

SCYNEXIS Reports Second Quarter 2021 Financial Results and Provides Corporate Update

SCYNEXIS lead drug candidate BREXAFEMME recently got FDA approval for the treatment of Vulvovaginal Candidiasis, commonly known as vaginal yeast infections. BREXAFEMME is the first approved drug in the non-azole class for VVC and also the first approved drug in a novel antifungal class in the past 20+ years.

Scynexis: Leading The Yeast Infection Treatment Industry

JERSEY CITY, N.J., June 23, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that it will present a commercial launch update for its recently FDA-approved drug, BREXAFEMME® (ibrexafungerp tablets). BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC), or vaginal yeast infections. It is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp.

SCYNEXIS to Present Commercial Launch Update for BREXAFEMME® (ibrexafungerp tablets)

JERSEY CITY, N.J., June 11, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS, will present at the BIO Digital International Convention to be held virtually from June 10 – 11 and 14 – 18, 2021. The Company presentation will highlight BREXAFEMME® (ibrexafungerp tablets), in addition to other late-stage clinical trials evaluating ibrexafungerp in the community setting for recurrent vaginal yeast infections, and as a treatment for life threatening fungal infections, including Candida auris, in the hospital setting. The presentation is now available to registered attendees.

SCYNEXIS to Present at the BIO Digital International Convention 2021

JERSEY CITY, N.J., June 09, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) granted BREXAFEMME (ibrexafungerp tablets), five years of exclusivity extension under the Generating Antibiotic Incentives Now (GAIN) Act. This exclusivity will be added to any other applicable exclusivity periods, such as the five years of new chemical entity (NCE) exclusivity, for a combined ten-year period of regulatory exclusivity. BREXAFEMME is also protected by multiple patents, including a composition-of-matter patent covering the ibrexafungerp molecule. With patent term extension, this patent is expected to expire in 2035, providing 14 years of protection from generic competitors in the U.S.

SCYNEXIS Confirms that BREXAFEMME® (ibrexafungerp tablets) Qualifies for 10 Years of Regulatory Exclusivity for Vaginal Yeast Infections

The FDA has approved Scynexis Inc's (NASDAQ: SCYX) Brexafemme (ibrexafungerp tablets) for oral use in patients with vulvovaginal candidiasis (VVC), also known as a vaginal yeast infection. Brexafemme represents the first approved drug in a novel antifungal class in more than 20 years and is the first and only treatment for vaginal yeast infections, both oral and non-azole.

Scynexis Scores FDA Nod For Brexafemme, Oral Treatment For Vaginal Yeast Infection

JERSEY CITY, N.J., June 02, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) has approved BREXAFEMME® (ibrexafungerp tablets), for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. BREXAFEMME, which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from two Phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. SCYNEXIS has partnered with Amplity Health, a leading global contract commercialization organization, to support U.S. commercialization of BREXAFEMME, with commercial launch scheduled in the second half of this year.

SCYNEXIS Announces FDA Approval of BREXAFEMME® (ibrexafungerp tablets) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections

JERSEY CITY, N.J., May 17, 2021 (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 on March 31, 2021 and provided an update on recent clinical and corporate developments.

SCYNEXIS Reports First Quarter 2021 Financial Results and Provides Corporate Update

Scynexis Inc (NASDAQ: SCYX) is taking out a loan to ensure it can hit the ground running for a potential commercial launch of ibrexafungerp for vaginal yeast infections as the PDUFA date of June 1 is just around the corner.  The company closed terms on a $60 million loan with Hercules Capital and Silicon Valley Bank.

Scynexis Raises $60M Via Term Loan Ahead Of Expected Approval Of Vaginal Yeast Infection Treatment

JERSEY CITY, N.J., May 14, 2021 (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 that it has secured a $60 million term loan facility with Hercules Capital, Inc. (NYSE: HTGC) and Silicon Valley Bank (SVB). The capital strengthens SCYNEXIS' balance sheet ahead of the anticipated commercial launch of Brexafemme, the expected trade name for ibrexafungerp, an oral antifungal product candidate for the treatment of vaginal yeast infections, which is under regulatory review by the U.S. Food and Drug Administration (FDA) with a PDUFA target action date of June 1, 2021. This non-dilutive financing further extends SCYNEXIS' projected cash runway into 2023, based on current operating plans.

SCYNEXIS Secures Term Loan Facility for up to $60 Million with Hercules Capital and Silicon Valley Bank

JERSEY CITY, N.J., May 11, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the appointment of Christine Coyne as Chief Commercial Officer, effective May 10, 2021. Ms. Coyne will play a significant role in the anticipated U.S. launch and commercialization of Brexafemme, the expected trade name for ibrexafungerp, an oral antifungal product candidate for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. The New Drug Application (NDA) for Brexafemme is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021.

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