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SCYNEXIS Announces Presentations Highlighting the Potent Antifungal Activity of its Second-Generation Fungerp, SCY-247 Against Drug-Resistant Fungi, at the Inaugural Interdisciplinary Meeting on Antimicrobial Resistance and Innovation (IMARI)
Globenewswire· 2026-01-28 13:00
This cross-disciplinary meeting highlights the latest discoveries, technologies and translational strategies driving the next generation of antimicrobial solutionsJERSEY CITY, N.J., Jan. 28, 2026 (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 upcoming presentations highlighting data on the Company’s second-generation fungerp drug candidate, SCY-247, at the ina ...
SCYNEXIS Receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designations for SCY-247
Globenewswire· 2026-01-21 13:00
The QIDP designation will ensure at least 10 years of market exclusivity for SCY-247 following approval Recent articles highlight the growing threat from a rapidly spreading, multi-drug resistant, Candida auris fungal infection JERSEY CITY, N.J., Jan. 21, 2026 (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 that the U.S. Food and Drug Administration (“FDA”) ha ...
SCYNEXIS Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Requirement
Globenewswire· 2025-12-22 13:00
Core Viewpoint - SCYNEXIS, Inc. has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement for its common stock, allowing until June 15, 2026, to maintain a closing bid price of at least $1.00 per share for ten consecutive business days [1][2]. Company Overview - SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines to combat difficult-to-treat and drug-resistant infections [4]. - The company is advancing its proprietary antifungal platform "fungerps," with Ibrexafungerp being the first representative licensed to GSK [4]. - The FDA has approved BREXAFEMME® (ibrexafungerp tablets) for treating vulvovaginal candidiasis (VVC) and reducing recurrent VVC incidence [4]. Strategic Objectives - The company plans to leverage its balance sheet to complete a Phase 1 study of an intravenous formulation for SCY-247 and generate proof-of-concept Phase 2 data for its oral formulation targeting invasive candidiasis infections [3]. - SCY-247 is anticipated to provide benefits for both hospitalized and community patients facing challenging infections, and it is highly regarded within the anti-infective scientific community [3]. Compliance Commitment - SCYNEXIS is committed to regaining compliance with all Nasdaq listing requirements and intends to take necessary actions within the 180-day extension period, including a potential reverse stock split if needed [2][3].
SCYNEXIS Completes Transfer of BREXAFEMME® New Drug Application to GSK
Globenewswire· 2025-11-19 12:00
GSK remains committed to the relaunch of BREXAFEMME, and following its relaunch, SCYNEXIS stands to receive up to $145.5 million in annual net sales milestones as well as royalties, net of payments to Merck, in the low to mid single digit range JERSEY CITY, N.J., Nov. 19, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it has completed the transfer of ...
Scynexis Announces Federal Funding of Collaboration Between Hackensack Meridian CDI and Johns Hopkins Researchers to Develop New Therapeutics, Including Novel Fungerps, for Resistant Fungal Infections
Globenewswire· 2025-11-17 15:15
Five-year grant of $7 million annually to the academic researchers is aimed at accelerating the development of new therapeutics to combat resistant fungal infections, including the Company’s next generation of triterpenoid antifungals (fungerps).Next-generation fungerps, in preclinical stages of development, are targeted to have enhanced pharmacological properties to treat fungal infections where current therapies are limited or not effective, while maintaining broad spectrum of activity against resistant f ...
SCYNEXIS Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-05 21:20
SCYNEXIS to receive one-time payments totalling $24.8 million from GSK as part of the resolution of the disagreement related to the restart of the Phase 3 MARIO study in invasive candidiasis. Scynexis agreed to GSK’s request to terminate the study.Following the positive SAD/MAD data results announced in September for SCY-247, its second-generation fungerp, the Company expects to initiate a Phase 1 study with the IV formulation and a Phase 2 study for the treatment of invasive candidiasis. The Company aims t ...
SCYNEXIS(SCYX) - 2025 Q3 - Quarterly Report
2025-11-05 21:01
Drug Development - SCYNEXIS, Inc. is developing a proprietary antifungal platform called "fungerps," targeting drug-resistant infections, with a focus on triterpenoids that inhibit glucan synthase[64]. - Ibrexafungerp, approved as BREXAFEMME, is indicated for vulvovaginal candidiasis (VVC) and recurrent VVC, with approvals received in 2021 and 2022[65]. - The company is progressing the development of SCY-247, a second-generation fungicide, which has shown potent activity against multidrug-resistant strains in preclinical models[66][72]. - SCY-247 has demonstrated favorable pharmacokinetics, with dose-proportional absorption and efficacy against resistant strains, supporting its continued clinical development[78]. - The company plans to initiate a Phase 1 study for the intravenous formulation of SCY-247 in Q1 2026, with a subsequent Phase 2 study for invasive candidiasis[79]. - SCYNEXIS is committed to addressing unmet medical needs in antifungal treatments, particularly for invasive candidiasis, which has a mortality rate exceeding 30%[74][71]. Financial Performance - License agreement revenue for the three months ended September 30, 2025, was $0.3 million, a decrease of 49.4% from $0.7 million in 2024[91]. - Research and development expenses decreased to $5.5 million for the three months ended September 30, 2025, down 32.5% from $8.1 million in 2024[92]. - Total operating expenses for the three months ended September 30, 2025, were $8.7 million, a decrease of 20.4% from $11.0 million in 2024[91]. - Net loss for the three months ended September 30, 2025, was $8.6 million, an increase of 205.9% from a net loss of $2.8 million in 2024[91]. - For the nine months ended September 30, 2025, license agreement revenue was $2.0 million, a decrease of 29.4% from $2.8 million in 2024[99]. - Research and development expenses for the nine months ended September 30, 2025, decreased to $17.7 million, down 19.7% from $22.1 million in 2024[100]. - Selling, general and administrative expenses increased to $10.8 million for the nine months ended September 30, 2025, an increase of 11% from $9.7 million in 2024[102]. - As of September 30, 2025, cash and cash equivalents were $37.9 million, down from $75.1 million as of December 31, 2024[108]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $23.7 million, compared to $14.1 million in 2024[110]. - The accumulated deficit as of September 30, 2025, was $397.4 million[108]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $23.7 million, primarily due to a net loss of $20.9 million adjusted for non-cash charges[112]. - The net unfavorable change in operating assets and liabilities for the same period was $0.7 million, resulting from a $2.0 million favorable change in operating assets offset by a $2.7 million unfavorable change in operating liabilities[112]. - For the nine months ended September 30, 2024, net cash used in operating activities was $14.1 million, with a net loss of $16.9 million adjusted for non-cash charges[113]. - The net favorable change in operating assets and liabilities for the nine months ended September 30, 2024, was $10.8 million, driven by a $16.2 million decrease in operating assets[114]. - Net cash provided by investing activities for the nine months ended September 30, 2025, was $36.1 million from maturities of investments[115]. - Net cash used in financing activities for the nine months ended September 30, 2025, was $14.1 million, primarily due to the repayment of $14.0 million in convertible debt[116]. Funding and Compliance - The company anticipates substantial additional funding will be required for ongoing research, development, and clinical trials of product candidates[117]. - Future capital requirements will depend on various factors, including regulatory approvals and the progress of clinical development of SCY-247[119]. - The company expects to finance cash needs through equity offerings, debt financings, or other non-dilutive funding sources until substantial revenue is generated[120]. - Management's estimates and judgments are based on historical experience and other factors, which may differ from actual results under different conditions[121]. - The company received a Nasdaq notification regarding its stock price falling below $1.00, with a compliance period until December 17, 2025, to regain compliance[80][81]. Legal Matters - The company has faced legal challenges, including a securities class action lawsuit, which was dismissed, indicating ongoing legal scrutiny[82].
SCYNEXIS and GSK Resolve Their Disagreement Related to the Restart of the Phase 3 MARIO Study
Globenewswire· 2025-10-15 12:00
SCYNEXIS to receive a $22 million payment as part of the resolution related to the restart of the Phase 3 MARIO study on invasive candidiasisScynexis will promptly wind-down and terminate the MARIO studyThe payment from GSK, combined with cash in hand and removal of future MARIO expenditures, extends the company’s cash runway to more than two yearsGSK remains committed to the commercialization of BREXAFEMME (ibrexafungerp tablets) JERSEY CITY, N.J., Oct. 15, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: ...
SCYNEXIS Announces Positive Results from a Phase 1, Single Ascending Dose and Multiple Ascending Dose Study of its Second-Generation Fungerp (SCY-247)
Globenewswire· 2025-09-30 12:00
No safety concerns or dose limiting toxicities observed SCY-247 was able to achieve target exposures at doses lower than our first-generation fungerp Safety, tolerability, and pharmacokinetic profile support the continued clinical development of SCY-247 JERSEY CITY, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced positive results from a Pha ...
SCYNEXIS Announces Multiple Presentations Highlighting Data from its Second-Generation Fungerp, SCY-247, at the 12th Congress on Trends in Medical Mycology (TIMM-12)
Globenewswire· 2025-09-04 12:30
Oral presentation will feature data demonstrating SCY-247 in vitro activity against C. auris strains, including isolates with mutations commonly associated with echinocandin-resistanceAdditional poster presentations highlight SCY-247’s broad spectrum of antifungal activity, against Candida species, including multidrug- and pandrug-resistant C. auris and Aspergillus speciesCompany anticipates reporting Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) data for SCY-247 (oral) in Q3 2025 JERSEY C ...