SCYX
SCYNEXISDDocument history
Earnings documents stored for SCYX.
Investor releaseQuarter not tagged2026-08-10SCYNEXIS Reports Second Quarter 2026 Financial Results and Provides Corporate Update
GlobeNewswire
SCYNEXIS Reports Second Quarter 2026 Financial Results and Provides Corporate Update
Initiated a Phase 1 study of SCY-770, a first-in-class, potent and direct AMPK activator for treatment of ADPKD; topline data are expected in Q3 2026 and are anticipated to inform dose selection for the planned Phase 2 study The Phase 2 proof-of-concept study of SCY-770 in patients with ADPKD remains on track for initiation in Q4 2026, with an early efficacy read-out expected in the second half of 2027 Completed dosing in the Phase 1 study of the IV formulation of second-generation antifungal SCY-247, with topline data on track for Q3 2026 Ended Q2 2026 with cash, cash equivalents and investments of $71.1 million, supporting a cash runway into 2029 JERSEY CITY, N.J., Aug. 10, 2026 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX) (“SCYNEXIS” or the “Company”), a clinical-stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update highlighting the initiation of a Phase 1 study of SCY-770 in support of its planned Phase 2 trial in Autosomal Dominant Polycystic Kidney Disease (ADPKD). “The initiation of our Phase 1 study marks an important milestone in the advancement of SCY-770 and our commitment to developing a potentially transformative treatment for patients living with ADPKD, a disease that affects about 140,000 patients in the United States alone,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “SCY-770 is a highly selective orally available direct AMPK activator designed to address multiple underlying drivers of cyst growth and disease progression. Supported by compelling preclinical data and a well-characterized safety profile, we believe that SCY-770 has the potential to offer a differentiated therapeutic approach for this underserved patient population. We are encouraged by the progress of the program and remain on track to initiate our Phase 2 proof-of-concept trial later this year.” “We are also progressing development of our next-generation antifungal, SCY-247. We completed dosing patients in the Phase 1 study of the IV formulation, and we are on track for topline data in Q3 of this year. With a strong balance sheet and cash runway into 2029, we remain confident in our ability to execute across our pipeline and deliver on our near-term milestones,” continued Dr. Angulo. SCY-7…Read full documentShow less
Initiated a Phase 1 study of SCY-770, a first-in-class, potent and direct AMPK activator for treatment of ADPKD; topline data are expected in Q3 2026 and are anticipated to inform dose selection for the planned Phase 2 study The Phase 2 proof-of-concept study of SCY-770 in patients with ADPKD remains on track for initiation in Q4 2026, with an early efficacy read-out expected in the second half of 2027 Completed dosing in the Phase 1 study of the IV formulation of second-generation antifungal SCY-247, with topline data on track for Q3 2026 Ended Q2 2026 with cash, cash equivalents and investments of $71.1 million, supporting a cash runway into 2029 JERSEY CITY, N.J., Aug. 10, 2026 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX) (“SCYNEXIS” or the “Company”), a clinical-stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update highlighting the initiation of a Phase 1 study of SCY-770 in support of its planned Phase 2 trial in Autosomal Dominant Polycystic Kidney Disease (ADPKD). “The initiation of our Phase 1 study marks an important milestone in the advancement of SCY-770 and our commitment to developing a potentially transformative treatment for patients living with ADPKD, a disease that affects about 140,000 patients in the United States alone,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “SCY-770 is a highly selective orally available direct AMPK activator designed to address multiple underlying drivers of cyst growth and disease progression. Supported by compelling preclinical data and a well-characterized safety profile, we believe that SCY-770 has the potential to offer a differentiated therapeutic approach for this underserved patient population. We are encouraged by the progress of the program and remain on track to initiate our Phase 2 proof-of-concept trial later this year.” “We are also progressing development of our next-generation antifungal, SCY-247. We completed dosing patients in the Phase 1 study of the IV formulation, and we are on track for topline data in Q3 of this year. With a strong balance sheet and cash runway into 2029, we remain confident in our ability to execute across our pipeline and deliver on our near-term milestones,” continued Dr. Angulo. SCY-770 Development Program Update On June 30, 2026, SCYNEXIS announced the initiation of a Phase 1 study of SCY-770, a first-in-class, potent and direct AMP-activated protein kinase (AMPK) activator. The study is characterizing the food-effect and defining the pharmacokinetics of two dosing regimens of SCY-770 to support dose selection for the planned Phase 2 study in ADPKD patients. Top line data are expected in the third quarter of 2026. SCYNEXIS remains on track to initiate its Phase 2 proof-of-concept study of SCY-770 in ADPKD patients in Q4 2026, with an anticipated early efficacy readout in the second half of 2027. SCY-770 has been granted Orphan Drug Designation by the FDA for the treatment of ADPKD and has been evaluated in several Phase 1 trials and one Phase 2a trial in patients with nonalcoholic fatty liver disease (NAFLD), with a well-characterized safety profile across more than 270 clinical trial participants. SCY-247 Development Program Update Dosing has been completed in the Phase 1 study of the IV formulation of SCY-247 and topline data are expected in the third quarter of 2026. SCYNEXIS continues to explore non-dilutive funding opportunities to support the further development of SCY-247. Ibrexafungerp / GSK Update The Company believes GSK is committed to the relaunch of BREXAFEMME. Following the relaunch, SCYNEXIS has the potential to receive up to approximately $146 million in annual net sales milestones as well as net royalties in the low to mid-single digit range. Second Quarter 2026 Financial Results Research and development expenses for the three months ended June 30, 2026, were $3.9 million compared to $7.1 million for the same period in 2025. The decrease of $3.3 million, or 46%, was primarily driven by a decrease of $1.6 million in chemistry, manufacturing, and controls (CMC) expense, a $0.8 million decrease in preclinical expense, a $0.5 million decrease in clinical expense and a net decrease of $0.4 million in other research and development expense..SG&A expenses for the three months ended June 30, 2026, increased to $4.1 million compared to $3.8 million for the same period in 2025. The increase of $0.3 million, or 9%, was primarily due to the increase of $0.3 million in professional fees.Total other income was $15.2 million for the three months ended June 30, 2026, versus total other income of $2.7 million for the same period in 2025. The variance is mainly due to the fair value adjustment related to the warrant liabilities. For the three months ended June 30, 2026 and 2025, SCYNEXIS recognized gains of $14.2 million and $2.2 million, respectively, in the fair value adjustment related to the warrant liabilities primarily due to the decrease in our stock price during the respective periods. Cash Balance Cash, cash equivalents and investments totaled $71.1 million on June 30, 2026, compared to $56.3 million on December 31, 2025. On March 31, 2026, SCYNEXIS announced that it entered into a securities purchase agreement with certain new and existing institutional and accredited investors for net proceeds of $36.9 million, after deducting placement agent fees and transaction-related expenses, and up to an additional $52.2 million in gross proceeds if associated common warrants are fully exercised. The private placement closed on April 1, 2026. The company expects its current cash position to be sufficient to fund operations into 2029. About SCY-770 SCY-770, a novel and highly selective, direct Adenosine Monophosphate (AMP)-activated protein kinase (AMPK) activator, is being developed as a disease-modifying therapy for ADPKD, a progressive genetic kidney disorder and the leading genetic cause of end-stage renal disease, affecting approximately 140,000 diagnosed patients in the United States. AMPK activation suppresses the mTOR and cAMP signaling pathways that drive cyst cell proliferation and fluid secretion in ADPKD, providing a mechanistically differentiated approach to slowing disease progression. SCY-770 has been evaluated in several Phase 1 trials and one Phase 2a trial in patients with nonalcoholic fatty liver disease (NAFLD). Compelling preclinical pharmacology data supports its potential utility in ADPKD. The Company aims to develop SCY-770 with the goal of reducing cyst growth and disease progression and improving patient quality of life. SCY-770 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of ADPKD. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a clinical-stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases. SCY-770 is being developed for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and has been granted Orphan Drug Designation. SCYNEXIS’s proprietary antifungal platform “fungerps” includes BREXAFEMME® (ibrexafungerp tablets), the first approved representative of this novel class, which has been licensed to GSK, and SCY-247, currently in clinical stages of development. 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: the plans to report topline data from the Phase 1 study of SCY-770 in the third quarter of 2026, the anticipated initiation of the SCY-770 Phase 2 study in Q4 of 2026 and the anticipated early efficacy readout in the second half of 2027, the plans to report topline data from the Phase 1 IV trial of SCY-247 in the third quarter of 2026, the potential for the Company to receive net sales milestones and royalties in connection with a relaunch of BREXAFEMME® by GSK and the statements concerning the Company’s cash runway into 2029, and other statements identified by words such as “will,” “potential,” “could,” "can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. 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. For the Company, this includes the future prospects of the Company’s SCY-770 program, the timing and results of the Company’s anticipated Phase 2 proof-of-concept clinical study evaluating SCY-770, stock price volatility and uncertainties relating to the financial markets, the medical community and the global economy, and the impact of instability in general business and economic conditions, including changes in inflation and interest rates. These and other risks are described more fully in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including without limitation, its most recent Annual Report on Form 10-K filed on March 4, 2026, including under the caption "Risk Factors,” and in other filings the Company makes with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company 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 RelationsJohn FrauncesLifeSci AdvisorsTel: [email protected]
Investor releaseQuarter not tagged2026-08-10Scynexis: Q2 Earnings Snapshot
Associated Press
Scynexis: Q2 Earnings Snapshot
JERSEY CITY, N.J. (AP) — JERSEY CITY, N.J. (AP) — Scynexis Inc. (SCYX) on Monday reported profit of $7.4 million in its second quarter. The Jersey City, New Jersey-based company said it had net income of 63 cents per share. Losses, adjusted for non-recurring gains, came to 32 cents per share. The pharmaceutical company posted revenue of $235,000 in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on SCYX at https://www.zacks.com/ap/SCYX
Investor releaseQuarter not tagged2026-05-12Scynexis: Q1 Earnings Snapshot
Associated Press
Scynexis: Q1 Earnings Snapshot
JERSEY CITY, N.J. (AP) — JERSEY CITY, N.J. (AP) — Scynexis Inc. (SCYX) on Monday reported a loss of $21.3 million in its first quarter. The Jersey City, New Jersey-based company said it had a loss of 42 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on SCYX at https://www.zacks.com/ap/SCYX
Investor releaseQuarter not tagged2026-05-12SCYNEXIS Reports First Quarter 2026 Financial Results and Provides Corporate Update
GlobeNewswire
SCYNEXIS Reports First Quarter 2026 Financial Results and Provides Corporate Update
Completed transformative acquisition of PXL-770, (now SCY-770), an innovative, highly selective, direct AMPK activator for the treatment of autosomal dominant polycystic kidney disease (ADPKD) A Phase 2 proof-of-concept study of SCY-770 in ADPKD patients is anticipated to begin in Q4 2026 with an early efficacy readout anticipated in the second half of 2027 Completed a private placement with net proceeds of approximately $37.2 million, after deducting placement agent fees and other transaction related expenses, with certain new and existing institutional and accredited investors. Approximately $24 million of the proceeds were received on March 31st with the balance received on April 1st SCYNEXIS announced dosing of the first patient using the intravenous (IV) formulation of SCY-247 in a Phase 1 study and plans to report topline data in the third quarter of 2026; SCYNEXIS is accepting requests for granting access to oral SCY-247 via expanded access program GSK is committed to the relaunch of Brexafemme which has the potential to provide up to approximately $146 million in annual net sales milestones. SCYNEXIS ended Q1 2026 with cash, cash equivalents and investments of $72.4 million, this coupled with the approximately $16.0 million in proceeds received on April 1st extends SCYNEXIS’ cash runway to mid-2029 JERSEY CITY, N.J., May 11, 2026 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a clinical-stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases, today reported financial results for the first quarter ended March 31, 2026. “Following our recent acquisition of SCY-770, we plan to initiate a Phase 2 proof-of-concept study in ADPKD patients in Q4 2026 to demonstrate the potential of this highly differentiated molecule, which targets multiple key drivers of disease progression,” said David Angulo, M.D., President and Chief Executive Officer. “We would like to thank our existing and new investors who participated in our recent private placement financing. Combined with our existing cash position, this additional capital significantly extends our cash runway to the middle of 2029 approximately one year beyond the anticipated completion of the Phase 2 study for SCY-770.” “As we move ahead with the SCY-770 clinical program, we also continue to make progress with our second generation fungerp, SCY-247. After completion…Read full documentShow less
Completed transformative acquisition of PXL-770, (now SCY-770), an innovative, highly selective, direct AMPK activator for the treatment of autosomal dominant polycystic kidney disease (ADPKD) A Phase 2 proof-of-concept study of SCY-770 in ADPKD patients is anticipated to begin in Q4 2026 with an early efficacy readout anticipated in the second half of 2027 Completed a private placement with net proceeds of approximately $37.2 million, after deducting placement agent fees and other transaction related expenses, with certain new and existing institutional and accredited investors. Approximately $24 million of the proceeds were received on March 31st with the balance received on April 1st SCYNEXIS announced dosing of the first patient using the intravenous (IV) formulation of SCY-247 in a Phase 1 study and plans to report topline data in the third quarter of 2026; SCYNEXIS is accepting requests for granting access to oral SCY-247 via expanded access program GSK is committed to the relaunch of Brexafemme which has the potential to provide up to approximately $146 million in annual net sales milestones. SCYNEXIS ended Q1 2026 with cash, cash equivalents and investments of $72.4 million, this coupled with the approximately $16.0 million in proceeds received on April 1st extends SCYNEXIS’ cash runway to mid-2029 JERSEY CITY, N.J., May 11, 2026 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a clinical-stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases, today reported financial results for the first quarter ended March 31, 2026. “Following our recent acquisition of SCY-770, we plan to initiate a Phase 2 proof-of-concept study in ADPKD patients in Q4 2026 to demonstrate the potential of this highly differentiated molecule, which targets multiple key drivers of disease progression,” said David Angulo, M.D., President and Chief Executive Officer. “We would like to thank our existing and new investors who participated in our recent private placement financing. Combined with our existing cash position, this additional capital significantly extends our cash runway to the middle of 2029 approximately one year beyond the anticipated completion of the Phase 2 study for SCY-770.” “As we move ahead with the SCY-770 clinical program, we also continue to make progress with our second generation fungerp, SCY-247. After completion of the Phase 1 studies with the oral formulation of SCY-247, we are now accepting requests for access to this innovative antifungal for patients with limited or no other treatment options via our expanded access program. We also anticipate announcing topline Phase 1 data of the IV formulation of SCY-247 in the third quarter of 2026.” Corporate Update: On March 31, 2026, SCYNEXIS announced that it entered into a securities purchase agreement with certain new and existing institutional and accredited investors for net proceeds of approximately $37.2 million, after deducting placement agent fees and transaction-related expenses, and up to an additional $52.2 million in gross proceeds if associated common warrants are fully exercised. The private placement closed on April 1, 2026. SCY-770 Development Program Update On March 31, 2026, SCYNEXIS announced that it entered into a definitive agreement with Poxel S.A. to acquire PXL-770 (now SCY-770). SCY-770 is a novel, highly selective, direct AMP-activated protein kinase (AMPK) activator for the treatment of ADPKD, the leading genetic cause of end-stage renal failure. SCY-770 is designed to address many of the underlying drivers of ADPKD by reducing cyst growth and disease progression. SCY-770 is an oral therapy that has been evaluated in eight clinical trials, with a favorable safety profile. SCYNEXIS expects to begin a Phase 2 proof-of-concept study in ADPKD patients in Q4 2026, with an anticipated early efficacy readout in the second half of 2027. SCY-770 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). SCY-247 Development Program Update Presented 9 papers at the European Society of Clinical Microbiology and Infectious Diseases Conference (ESCMID) in Munich in April, highlighting the positive pre-clinical and Phase 1 clinical data for SCY-247. In response to patients’ needs and physicians’ requests, and now with a completed Phase 1 study confirming adequate tolerability and achievement of preliminary target exposures with oral SCY-247, SCYNEXIS is accepting requests under the expanded access program to facilitate access to this innovative antifungal for patients with limited or no other treatment options. On February 26th, SCYNEXIS announced the initiation of dosing in a Phase 1 study with the IV formulation of SCY-247, with topline data expected in the third quarter of 2026. SCYNEXIS continues to explore non-dilutive funding opportunities to support the further development of SCY-247. SCYNEXIS presented data highlighting SCY-247 at the inaugural Interdisciplinary Meeting on Antimicrobial Resistance and Innovation (IMARI), which took place from January 28-30, 2026, in Las Vegas, Nevada. An oral presentation was included in the Plenary session “New Antimicrobial Agents in The Pipeline: Early Clinical Development”. The U.S. Food and Drug Administration (FDA) granted the Company Qualified Infectious Disease Product (QIDP) Fast Track and Orphan Drug Designations for SCY-247. Ibrexafungerp / GSK Update GSK is committed to the relaunch of BREXAFEMME, and following its relaunch, SCYNEXIS has the potential to receive up to approximately $146 million in annual net sales milestones. First Quarter 2026 Financial Results Research and development expenses for the three months ended March 31, 2026, were $12.4 million compared to $5.1 million for the same period in 2025. The increase of $7.2 million, or 140%, was primarily driven by the $8.0 million IPR&D expense recognized for the acquisition of SCY-770 in the three months ended March 31, 2026 and an increase of $0.3 million in clinical expense, offset in part by a decrease of $0.7 million in preclinical expense and a decrease of $0.4 million in salary expense. SG&A expenses for the three months ended March 31, 2026, increased to $4.6 million compared to $3.7 million for the same period in 2025. The increase of $0.9 million, or 23%, was primarily due to the $0.8 million write off of offering costs for the March 2026 private placement warrant issuance in the three months ended March 31, 2026. Total other expenses was $4.4 million for the three months ended March 31, 2026, versus total other income of $3.2 million for the same period in 2025. The variance is mainly due to the fair value adjustment related to the warrant liabilities. For the three months ended March 31, 2026 and 2025, SCYNEXIS recognized a loss of $5.2 million and a gain of $2.9 million, respectively, in the fair value adjustment related to the warrant liabilities primarily due to the increase and decrease in our stock price during the respective periods. Cash Balance Cash, cash equivalents and investments totaled $72.4 million on March 31, 2026, compared to $56.3 million on December 31, 2025. The balance at March 31st includes approximately $24 million of the gross proceeds of $40 million from the private placement that closed on April 1st with certain new and existing institutional and accredited investors. The March 31st balance plus the approximately $16 million in gross proceeds received on April 1st extends the Company’s cash runway to mid-2029. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a clinical stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases. SCY-770 is being developed for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and has been granted Orphan Drug designation. SCYNEXIS’s proprietary antifungal platform “fungerps” includes BREXAFEMME® (ibrexafungerp tablets), the first approved representative of this novel class, which has been licensed to GSK, and SCY-247, currently in clinical stages of development. 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: the anticipated initiation of the SCY-770 Phase 2 study in Q4 of 2026 and the anticipated early efficacy readout in the second half of 2027, the plans to report topline data from the Phase 1 IV trial of SCY-247 in the second half of 2026 and the statements concerning expected extension of the company’s cash runway to the middle of 2029, and other statements identified by words such as “will,” “potential,” “could,” "can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. 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. For the Company, this includes the future prospects of the Company’s SCY-770 program, the timing and results of the Company’s anticipated Phase 2 proof-of-concept clinical study evaluating SCY-770, stock price volatility and uncertainties relating to the financial markets, the medical community and the global economy, and the impact of instability in general business and economic conditions, including changes in inflation and interest rates. These and other risks are described more fully in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including without limitation, its most recent Annual Report on Form 10-K filed on March 4, 2026, including under the caption "Risk Factors,” and in other filings the Company makes with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company 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 John Fraunces LifeSci Advisors Tel: 917-355-2395 [email protected] SCYNEXIS, INC. UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) SCYNEXIS, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) CONTACT: Investor Relations John Fraunces LifeSci Advisors Tel: 917-355-2395 [email protected]
Investor releaseQuarter not tagged2026-03-05SCYNEXIS Reports Full Year 2025 Financial Results and Provides Corporate Update
GlobeNewswire
SCYNEXIS Reports Full Year 2025 Financial Results and Provides Corporate Update
SCYNEXIS received a one-time non-refundable payment in Q4 2025 totalling $24.8 million from GSK SCYNEXIS announced dosing of the first patient using the intravenous (IV) formulation of SCY-247 in a Phase 1 study and plans to report topline data in the second half of 2026 Responding to patients’ need for alternatives to existing anti-fungal therapies, SCYNEXIS plans to initiate an expanded access program for SCY-247 in the first half of 2026 SCYNEXIS ended Q4 2025 with cash, cash equivalents and investments of $56.3 million, resulting in a cash runway of more than two years JERSEY CITY, N.J., March 04, 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 reported financial results for the year ended December 31, 2025. “In the fourth quarter, we continued to advance our second generation fungerp, SCY-247, and also strengthened our balance sheet with the receipt of $24.8 million from GSK, extending our cash runway for more than two years,” said David Angulo, M.D., President and Chief Executive Officer. “Looking ahead, SCYNEXIS remains well positioned to explore a number of opportunities to enhance shareholder value, including releasing Phase 1 data from our SCY-247 intravenous (IV) formulation study later this year.” Ibrexafungerp / GSK Update On November 19, 2025, the SCYNEXIS announced that it completed the transfer of the BREXAFEMME (ibrexafungerp) New Drug Application (NDA) to GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK). 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. On October 15, 2025, SCYNEXIS announced that it would receive a one-time non-refundable payment of $24.8 million from GSK as part of the resolution of the disagreement with GSK related to the restart of the Phase 3 MARIO study in invasive candidiasis (IC) under a binding memorandum of understanding (Binding 2025 MOU). SCYNEXIS also announced that it would promptly commence appropriate wind-down activities associated with the termination of the MARIO study. SCY-247 Development Program Update On September 2025, SCYNEXIS announced positive Phase 1 SA…Read full documentShow less
SCYNEXIS received a one-time non-refundable payment in Q4 2025 totalling $24.8 million from GSK SCYNEXIS announced dosing of the first patient using the intravenous (IV) formulation of SCY-247 in a Phase 1 study and plans to report topline data in the second half of 2026 Responding to patients’ need for alternatives to existing anti-fungal therapies, SCYNEXIS plans to initiate an expanded access program for SCY-247 in the first half of 2026 SCYNEXIS ended Q4 2025 with cash, cash equivalents and investments of $56.3 million, resulting in a cash runway of more than two years JERSEY CITY, N.J., March 04, 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 reported financial results for the year ended December 31, 2025. “In the fourth quarter, we continued to advance our second generation fungerp, SCY-247, and also strengthened our balance sheet with the receipt of $24.8 million from GSK, extending our cash runway for more than two years,” said David Angulo, M.D., President and Chief Executive Officer. “Looking ahead, SCYNEXIS remains well positioned to explore a number of opportunities to enhance shareholder value, including releasing Phase 1 data from our SCY-247 intravenous (IV) formulation study later this year.” Ibrexafungerp / GSK Update On November 19, 2025, the SCYNEXIS announced that it completed the transfer of the BREXAFEMME (ibrexafungerp) New Drug Application (NDA) to GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK). 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. On October 15, 2025, SCYNEXIS announced that it would receive a one-time non-refundable payment of $24.8 million from GSK as part of the resolution of the disagreement with GSK related to the restart of the Phase 3 MARIO study in invasive candidiasis (IC) under a binding memorandum of understanding (Binding 2025 MOU). SCYNEXIS also announced that it would promptly commence appropriate wind-down activities associated with the termination of the MARIO study. SCY-247 Development Program Update On September 2025, SCYNEXIS announced positive Phase 1 SAD/MAD results for the oral formulation of its second-generation fungerp, SCY-247, demonstrating good tolerability, favorable pharmacokinetics, and ability to achieve target exposures against fungi that are often resistant to other antifungal agents. In response to patients’ needs and physicians’ requests, and now with a completed Phase 1 study confirming adequate tolerability and achievement of target exposures with oral SCY-247, SCYNEXIS is working towards enabling an expanded access program to facilitate access to this innovative antifungal to patients with limited or no other treatment options and plans to initiate this program in the first half of 2026. On February 26th, SCYNEXIS announced the initiation of dosing in a Phase 1 study with the IV formulation of SCY-247, with topline data expected in the second half of 2026. A clinical proof-of-concept Phase 2 study is planned in patients with IC later in the year. SCYNEXIS is also continuing to explore non-dilutive funding opportunities to support the further development of SCY-247. SCYNEXIS presented data highlighting SCY-247 at the inaugural Interdisciplinary Meeting on Antimicrobial Resistance and Innovation (IMARI), which took place from January 28-30, 2026, in Las Vegas, Nevada. An oral presentation was included in the Plenary session “New Antimicrobial Agents in The Pipeline: Early Clinical Development”. On January 21, 2026, SCYNEXIS announced that the U.S. Food and Drug Administration (FDA) granted the Company Qualified Infectious Disease Product (QIDP) and Fast Track Designations for SCY-247. Additional Fungerps On November 17, 2025, SCYNEXIS announced that a novel series of antifungal compounds utilizing SCYNEXIS’ proprietary triterpenoid antifungal platform were among the five projects funded by the federal grant awarded to the new accelerator consortium led by researchers from Hackensack Meridian Center for Discovery and Innovation (CDI) and the Johns Hopkins Bloomberg School of Public Health. A five-year federal grant will establish a Center of Excellence in Translational Research (CETR) jointly between researchers from the Bloomberg School and the CDI, and other academic and commercial collaborators. The CETR expects to receive about $7 million annually, contingent upon the availability of funds, with the support coming from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID). Full Year 2025 Financial Results For the years ended December 31, 2025 and 2024, revenue consists of $20.6 million and $3.7 million in revenue primarily associated with the GSK license agreement. For the year ended December 31, 2025, SCYNEXIS recognized a cumulative catchup of $17.2 million in license agreement revenue associated with the Binding 2025 MOU with GSK. For the year ended December 31, 2025, SCYNEXIS also recognized $1.4 million in product revenue, net for a change in estimate related to prior period revenue associated with the product recall of BREXAFEMME. Research and development expenses for the year ended December 31, 2025, decreased to $22.3 million from $26.4 million for the year ended December 31, 2024. The decrease of $4.1 million, or 15.6%, was primarily driven by a decrease of $3.8 million in CMC expense, a decrease of $1.0 million in salary expense, a $0.5 million decrease in stock-based compensation and a net decrease in other research and development expense of $0.5 million, offset in part by an increase of $1.2 million in preclinical expense and a $0.5 million increase in clinical expense. SG&A expenses for the year ended December 31, 2025, decreased to $14.4 million from $14.5 million for the year ended December 31, 2024. The decrease of $0.1 million, or 0.4%, was primarily driven by a decrease of $0.6 million in professional fees, offset in part by an increase of $0.5 million in business development expense. Total other income was $7.5 million for the full year ended December 31, 2025, versus total other income of $16.0 million for the same period in 2024. The variance is mainly due to the fair value adjustment related to the warrant liabilities. For the years ended December 31, 2025 and 2024, SCYNEXIS recognized gains of $5.8 million and $13.8 million, respectively, for the fair value adjustment for warrant liabilities primarily due to the decrease in SCYNEXIS’ stock price during the periods, respectively. Cash Balance Cash, cash equivalents and investments totaled $56.3 million on December 31, 2025, compared to $75.1 million on December 31, 2024. SCYNEXIS received one-time non-refundable payments of $24.8 million from GSK in Q4 of 2025, resulting in a cash runway of more than two years. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is dedicated to advancing innovative solutions for severe rare diseases, with our lead program in the treatment and prevention of difficult-to-treat and drug-resistant fungal infections. 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) has approved BREXAFEMME® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC. The second generation fungerp SCY-247 is currently in clinical stages of development and has received QIDP and Fast Track designation from the FDA. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phases. 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: Plans to initiate an expanded access program for SCY-247 in the first half of 2026; having a cash runway of more than two years; releasing data from our Phase 1 IV formulation study in the second half of 2026; a clinical proof-of-concept Phase 2 study of SCY-247 in invasive candidiasis planned for 2026; and receipt of future payments from GSK on sales of BREXAFEMME. 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 4, 2026, 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: 917-734-7387 [email protected]
Investor releaseQuarter not tagged2026-03-05Scynexis: Q4 Earnings Snapshot
Associated Press Finance
Scynexis: Q4 Earnings Snapshot
JERSEY CITY, N.J. (AP) — JERSEY CITY, N.J. (AP) — Scynexis Inc. (SCYX) on Wednesday reported profit of $12.3 million in its fourth quarter. The Jersey City, New Jersey-based company said it had profit of 25 cents per share. The pharmaceutical company posted revenue of $18.6 million in the period. For the year, the company reported a loss of $8.6 million, or 17 cents per share. Revenue was reported as $20.6 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on SCYX at https://www.zacks.com/ap/SCYX
Investor releaseQuarter not tagged2025-11-06Scynexis: Q3 Earnings Snapshot
Associated Press Finance
Scynexis: Q3 Earnings Snapshot
JERSEY CITY, N.J. (AP) — JERSEY CITY, N.J. (AP) — Scynexis Inc. (SCYX) on Wednesday reported a loss of $8.6 million in its third quarter. The Jersey City, New Jersey-based company said it had a loss of 17 cents per share. The pharmaceutical company posted revenue of $334,000 in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on SCYX at https://www.zacks.com/ap/SCYX
Investor releaseQuarter not tagged2025-11-06SCYNEXIS Reports Third Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
SCYNEXIS Reports Third Quarter 2025 Financial Results and Provides Corporate Update
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 to release clinical proof of concept data in invasive candidiasis in 2026 and is exploring non-dilutive funding opportunities to support the development of SCY-247. GSK remains committed to the relaunch of BREXAFEMME® with activities ongoing to transfer the NDA before the end of the year. Following the relaunch, SCYNEXIS stands to receive up to approximately $146 million in annual net sales milestones as well as royalties net of payments to Merck, in the low to mid single digit range. SCYNEXIS ended Q3 2025 with cash, cash equivalents and investments of $37.9 million; after receiving the one-time payments of $24.8 million from GSK in Q4 of 2025, the company’s cash runway will be greater than two years. JERSEY CITY, N.J., Nov. 05, 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 reported financial results for the third quarter ended September 30, 2025. “Over the last several weeks, SCYNEXIS realized two significant achievements that we believe position our company for significant growth and success,” said David Angulo, M.D., President and Chief Executive Officer. “First, we announced the positive SAD/MAD data for our second-generation fungerp drug candidate, SCY-247, demonstrating that orally administered SCY-247 was well tolerated and achieved the estimated efficacy exposure at doses lower than the first generation fungerp (ibrexafungerp). We are excited about the favorable tolerability and pharmacokinetics of SCY-247 and look forward to commencing a Phase 2 study in invasive candidiasis, aiming to release proof of concept data in 2026. Secondly, we announced a successful resolution of our disagreement with GSK, which led to the one time payments of $24.8 million to SCYNEXIS which we will receive in Q4 of 2025. This…Read full documentShow less
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 to release clinical proof of concept data in invasive candidiasis in 2026 and is exploring non-dilutive funding opportunities to support the development of SCY-247. GSK remains committed to the relaunch of BREXAFEMME® with activities ongoing to transfer the NDA before the end of the year. Following the relaunch, SCYNEXIS stands to receive up to approximately $146 million in annual net sales milestones as well as royalties net of payments to Merck, in the low to mid single digit range. SCYNEXIS ended Q3 2025 with cash, cash equivalents and investments of $37.9 million; after receiving the one-time payments of $24.8 million from GSK in Q4 of 2025, the company’s cash runway will be greater than two years. JERSEY CITY, N.J., Nov. 05, 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 reported financial results for the third quarter ended September 30, 2025. “Over the last several weeks, SCYNEXIS realized two significant achievements that we believe position our company for significant growth and success,” said David Angulo, M.D., President and Chief Executive Officer. “First, we announced the positive SAD/MAD data for our second-generation fungerp drug candidate, SCY-247, demonstrating that orally administered SCY-247 was well tolerated and achieved the estimated efficacy exposure at doses lower than the first generation fungerp (ibrexafungerp). We are excited about the favorable tolerability and pharmacokinetics of SCY-247 and look forward to commencing a Phase 2 study in invasive candidiasis, aiming to release proof of concept data in 2026. Secondly, we announced a successful resolution of our disagreement with GSK, which led to the one time payments of $24.8 million to SCYNEXIS which we will receive in Q4 of 2025. This influx of new capital coupled with our cash and investments on hand, results in a cash runway of more than two years, including the anticipated cost of SCY-247 development activities.” Ibrexafungerp / GSK Update On October 15, 2025, the Company announced that it would receive a one-time payment of $24.8 million from GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) as part of a resolution of the disagreement with GSK related to the restart of the Phase 3 MARIO study on invasive candidiasis. SCYNEXIS also announced that it would promptly commence appropriate wind-down activities associated with the termination of the MARIO study. SCY-247 Development Program On September 30, 2025, the Company announced positive results from a Phase 1 SAD/MAD study of SCY-247, its second-generation triterpenoid antifungal under development for the treatment and prevention of invasive fungal infections with the potential to provide the therapeutic advantages of both an oral and IV formulation. SCY-247 was generally well tolerated with no 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 After positive Phase 1 data, the Company intends to progress the development of SCY-247 towards addressing significant unmet needs in the antifungal space that also represent attractive commercial opportunities. SCYNEXIS anticipates initiating a Phase 1 study with the intravenous (IV) formulation of SCY-247 in Q1 2026. The clinical proof-of-concept Phase 2 study is planned to start using the oral formulation of SCY-247 in patients with invasive candidiasis and subsequent stages of development are anticipated to include studies adequate to support an invasive candidiasis treatment indication, as well as evaluating SCY-247 for the prevention of invasive fungal diseases in patients at high risk. Phase 2 proof-of-concept data are expected to be available in 2026. The Company is exploring non-dilutive funding opportunities to support the development of SCY-247. On September 4, 2025, SCYNEXIS announced multiple presentations highlighting data on the Company’s second-generation fungerp drug candidate, SCY-247, at the 12th Congress on Trends in Medical Mycology (TIMM-12), which took place from September 19th to 22nd, 2025, in Bilbao, Spain. An oral presentation featured data demonstrating SCY-247 in vitro activity against C. auris strains, including isolates with mutations commonly associated with echinocandin-resistance Additional poster presentations highlighted SCY-247’s broad spectrum of antifungal activity, against Candida species, including multidrug- and pandrug-resistant C. auris and Aspergillus species. Third Quarter 2025 Financial Results For the three months ended September 30, 2025 and 2024, revenue primarily consisted of $0.3 million and $0.7 million, respectively, in license agreement revenue associated with the GSK License Agreement. Research and development expenses for the three months ended September 30, 2025, was $5.5 million compared to $8.1 million for the same period in 2024. The decrease of $2.6 million, or 33%, for the three months ended September 30, 2025, was primarily driven by a decrease of $1.4 million in chemistry, manufacturing, and controls (CMC) expense, a decrease of $0.2 million in preclinical expense, a decrease of $0.2 million in clinical expense, a $0.2 million decrease in salary expense, a $0.3 million decrease in stock-based compensation expense, and a net decrease of $0.3 million in other research and development expense. Selling, general and administrative expenses for the three months ended September 30, 2025, increased to $3.3 million compared to $2.9 million for the three months ended September 30, 2024. The increase of $0.4 million, or 13%, for the three months ended September 30, 2025, was primarily driven by an increase of $0.3 million in professional fees. Total other expense was $0.2 million for the three months ended September 30, 2025, versus total other income of $7.1 million for the same period in 2024. The variance is mainly due to the fair value adjustment related to the warrant liabilities. For the three months ended September 30, 2025 and 2024, we recognized a loss of $0.6 million and a gain of $6.8 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, 2025 was $8.6 million, or $(0.17) basic loss per share, compared to net loss of $2.8 million, or $(0.06) basic loss per share for the same period in 2024. Cash Balance Cash, cash equivalents and investments totaled $37.9 million on September 30, 2025, compared to $75.1 million on December 31, 2024. The Company will receive one-time payments of $24.8 million from GSK in Q4 of 2025, resulting in a cash runway of more than 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. The next generation fungerp, SCY-247, is currently in Phase 1 stage of clinical development. Additional analogs of the fungerp class of compunds are in pre-clinical stages of development. 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) has approved BREXAFEMME® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC. Additional antifungal assets from this novel class are currently in clinical, pre-clinical and discovery phases, 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: any advantages of SCY-247 over existing antifungals, continued development of SCY-247, receipt of milestones and royalties from GSK, and the Company’s cash runway. 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 12, 2025, 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: 917-734-7387 [email protected]
Investor releaseQuarter not tagged2025-10-24SCYNEXIS Reports Positive Phase 1 Results for Second-Generation Antifungal SCY-247
Insider Monkey
SCYNEXIS Reports Positive Phase 1 Results for Second-Generation Antifungal SCY-247
SCYNEXIS Inc. (NASDAQ:SCYX) is one of the best long term penny stocks with huge upside potential. On September 30, SCYNEXIS announced positive results from a Phase 1 clinical study evaluating SCY-247, its second-generation triterpenoid antifungal compound. The candidate is being developed for the treatment and prevention of invasive fungal infections to provide the therapeutic advantages of both an oral and an intravenous/IV formulation. The favorable results show orally administered SCY-247 can achieve target exposures for efficacy with favorable tolerability, and at doses lower than their first-generation fungerp, which may offer a tolerability advantage. The Phase 1 study was conducted in healthy participants to assess the safety, tolerability, and pharmacokinetics of orally administered SCY-247. SCY-247 was well tolerated across all SAD and MAD cohorts. The positive safety, tolerability, and pharmacokinetic profile support the continued clinical development of SCY-247. Further details from this study are expected to be presented at an upcoming scientific meeting. SCYNEXIS Inc. (NASDAQ:SCYX) is a biotechnology company that develops medicines to overcome and prevent difficult-to-treat and drug-resistant infections in the US. While we acknowledge the potential of SCYX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.
Investor releaseQuarter not tagged2025-09-30SCYNEXIS Announces Positive Results from a Phase 1, Single Ascending Dose and Multiple Ascending Dose Study of its Second-Generation Fungerp (SCY-247)
GlobeNewswire
SCYNEXIS Announces Positive Results from a Phase 1, Single Ascending Dose and Multiple Ascending Dose Study of its Second-Generation Fungerp (SCY-247)
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 Phase 1 study of SCY-247, its second-generation triterpenoid antifungal under development for the treatment and prevention of invasive fungal infections with the potential to provide the therapeutic advantages of both an oral and IV formulation. “We are pleased by the favorable results from this Phase 1 study demonstrating that orally administered SCY-247 can achieve target exposures for efficacy with favorable tolerability,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “We also observed that orally administered SCY-247 was able to achieve target exposures for invasive fungal disease at doses lower than our first generation fungerp, which may translate to a tolerability advantage. There remains a substantial unmet need for safe and effective, oral and intravenous antifungal agents to treat invasive fungal infections, particularly those caused by resistant fungi. The clinical data from our Phase 1 study, along with pre-clinical efficacy data generated to date, favorably position SCY-247 as a strong product candidate to meet these significant needs. We are looking forward to continuing the development of our second generation fungerp.” Phase 1 Study Description: The study evaluated the safety, tolerability and pharmacokinetics of orally administered SCY-247 in healthy participants receiving single ascending doses (SAD) ranging from 50mg to 900mg and multiple ascending doses (MAD) ranging from 50mg to 300mg, once a day for 7 days. Each dose level was evaluated in 8 participants, with 6 participants receiving SCY-247 and 2 receiving a matching placebo. A total of 66 participants received SCY-247 and 22 received placebo in the SAD and MAD cohorts. Phase 1 Study Results: SCY-247 was well tolerated across all evaluated SAD and MAD cohorts. No serious or severe treatment emergent adverse events (TEAEs) were reported. The incidence of TE…Read full documentShow less
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 Phase 1 study of SCY-247, its second-generation triterpenoid antifungal under development for the treatment and prevention of invasive fungal infections with the potential to provide the therapeutic advantages of both an oral and IV formulation. “We are pleased by the favorable results from this Phase 1 study demonstrating that orally administered SCY-247 can achieve target exposures for efficacy with favorable tolerability,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “We also observed that orally administered SCY-247 was able to achieve target exposures for invasive fungal disease at doses lower than our first generation fungerp, which may translate to a tolerability advantage. There remains a substantial unmet need for safe and effective, oral and intravenous antifungal agents to treat invasive fungal infections, particularly those caused by resistant fungi. The clinical data from our Phase 1 study, along with pre-clinical efficacy data generated to date, favorably position SCY-247 as a strong product candidate to meet these significant needs. We are looking forward to continuing the development of our second generation fungerp.” Phase 1 Study Description: The study evaluated the safety, tolerability and pharmacokinetics of orally administered SCY-247 in healthy participants receiving single ascending doses (SAD) ranging from 50mg to 900mg and multiple ascending doses (MAD) ranging from 50mg to 300mg, once a day for 7 days. Each dose level was evaluated in 8 participants, with 6 participants receiving SCY-247 and 2 receiving a matching placebo. A total of 66 participants received SCY-247 and 22 received placebo in the SAD and MAD cohorts. Phase 1 Study Results: SCY-247 was well tolerated across all evaluated SAD and MAD cohorts. No serious or severe treatment emergent adverse events (TEAEs) were reported. The incidence of TEAEs was low and not dose-dependent, with all events being mild or moderate in severity. One participant discontinued the study due to an adverse event that was deemed not to be related to the study drug. The most common adverse events were mild to moderate headache reported in 16.7% of participants receiving SCY-247 and 4.5% of participants receiving placebo, and diarrhea reported in 9% and 9% of participants receiving SCY-247 and placebo respectively. SCY-247 showed generally dose-proportional pharmacokinetics following single and multiple oral doses. The drug was rapidly absorbed (Tmax ranging from 3 to 7 hours), and systemic exposure (Cmax and AUC) increased with dose. The MAD cohorts of 200mg and 300mg once-daily achieved or exceeded the preliminary target for efficacious exposure, based on pre-clinical models of invasive candidiasis available to date, including models with strains such as Candida auris and echinocandin-resistant Candida glabrata that are resistant to current antifungal treatment options. Overall, the safety, tolerability, and pharmacokinetic profile observed in this study support the continued clinical development of SCY-247. Further details of the results from this study will be presented at an upcoming scientific meeting. 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 clinical, pre-clinical and discovery phases, 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: any advantages of SCY-247 over existing antifungals and continued development of SCY-247. 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 12, 2025, 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: 917-734-7387 [email protected]
Investor releaseQuarter not tagged2025-08-15SCYNEXIS Second Quarter 2025 Earnings: Beats Expectations
Simply Wall St.
SCYNEXIS Second Quarter 2025 Earnings: Beats Expectations
Net loss: US$6.89m (loss narrowed by 52% from 2Q 2024). US$0.14 loss per share (improved from US$0.30 loss in 2Q 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates significantly. Earnings per share (EPS) also surpassed analyst estimates by 26%. Looking ahead, revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Pharmaceuticals industry in the US. Performance of the American Pharmaceuticals industry. The company's shares are down 8.4% from a week ago. It's still necessary to consider the ever-present spectre of investment risk. We've identified 3 warning signs with SCYNEXIS, and understanding these should be part of your investment process. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-08-14SCYNEXIS Reports Second Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
SCYNEXIS Reports Second Quarter 2025 Financial Results and Provides Corporate Update
First new patient dosed in Phase 3 MARIO study following the lifting of the FDA clinical hold, triggering a $10M milestone payment from GSK. An additional $20M milestone will be triggered upon the six month anniversary of the new patient dosing; as previously disclosed GSK disputes these milestone payments. SCYNEXIS vigorously disagrees with GSK’s position and is working towards resolving this disagreement; SCYNEXIS is actively working with GSK to transfer the BREXAFEMME New Drug Application (NDA) to GSK by the end of this year, ahead of anticipated GSK Regulatory interactions in 2026 to discuss the relaunch of the product. The Company anticipates reporting Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) data for SCY-247 (oral) in Q3 2025 Regarding the November 2023 securities class action, that was filed by Brian Feldman against the Company and certain of the Company's executives in the United States District Court, District of New Jersey, the court granted the Company's motion to dismiss with leave to amend on July 30, 2025 SCYNEXIS ended Q2 2025 with cash, cash equivalents and investments of $46.5 million and projects a cash runway into Q4 2026. JERSEY CITY, N.J., Aug. 13, 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 reported financial results for the second quarter ended June 30, 2025. “We are excited about the continued progress of our second-generation fungerp candidate, SCY-247, and we anticipate announcing SAD/MAD data from our ongoing Phase 1 study of oral SCY-247 this quarter,” said David Angulo, M.D., President and Chief Executive Officer. “We also continue to work towards resolving our dispute with GSK as it relates to the payment of the milestones associated with the restart and continuation of the MARIO study. As these discussions continue, GSK has emphasised that it remains committed to the commercialization of Brexafemme in vulvovaginal candidiasis. Per GSK’s request, we have initiated transfer of the New Drug Application for Brexafemme to them which will enable GSK to initiate regulatory interactions to discuss the relaunch of the product.” Ibrexafungerp / GSK Developments SCYNEXIS is working to transfer the BREXAFEMME NDA to GSK by the end of 2025. Once this transfer has been comp…Read full documentShow less
First new patient dosed in Phase 3 MARIO study following the lifting of the FDA clinical hold, triggering a $10M milestone payment from GSK. An additional $20M milestone will be triggered upon the six month anniversary of the new patient dosing; as previously disclosed GSK disputes these milestone payments. SCYNEXIS vigorously disagrees with GSK’s position and is working towards resolving this disagreement; SCYNEXIS is actively working with GSK to transfer the BREXAFEMME New Drug Application (NDA) to GSK by the end of this year, ahead of anticipated GSK Regulatory interactions in 2026 to discuss the relaunch of the product. The Company anticipates reporting Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) data for SCY-247 (oral) in Q3 2025 Regarding the November 2023 securities class action, that was filed by Brian Feldman against the Company and certain of the Company's executives in the United States District Court, District of New Jersey, the court granted the Company's motion to dismiss with leave to amend on July 30, 2025 SCYNEXIS ended Q2 2025 with cash, cash equivalents and investments of $46.5 million and projects a cash runway into Q4 2026. JERSEY CITY, N.J., Aug. 13, 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 reported financial results for the second quarter ended June 30, 2025. “We are excited about the continued progress of our second-generation fungerp candidate, SCY-247, and we anticipate announcing SAD/MAD data from our ongoing Phase 1 study of oral SCY-247 this quarter,” said David Angulo, M.D., President and Chief Executive Officer. “We also continue to work towards resolving our dispute with GSK as it relates to the payment of the milestones associated with the restart and continuation of the MARIO study. As these discussions continue, GSK has emphasised that it remains committed to the commercialization of Brexafemme in vulvovaginal candidiasis. Per GSK’s request, we have initiated transfer of the New Drug Application for Brexafemme to them which will enable GSK to initiate regulatory interactions to discuss the relaunch of the product.” Ibrexafungerp / GSK Developments SCYNEXIS is working to transfer the BREXAFEMME NDA to GSK by the end of 2025. Once this transfer has been completed, GSK will be able to initiate regulatory interactions with the U.S. Food and Drug Administration (FDA) in 2026 to discuss the relaunch of BREXAFEMME for vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) in the U.S. market. On May 28, 2025, the Company announced that the first new patient was dosed in the Phase 3 MARIO study following the lifting of the FDA clinical hold. Resumption of dosing in this study triggers a $10 million milestone payment from GSK. An additional $20 million milestone will be triggered upon the six month anniversary of the resumption of dosing; as previously disclosed GSK disputes these milestone payments, and the Company continues to work towards reaching an agreement with GSK to resolve this matter. In late April, the FDA notified SCYNEXIS that the clinical hold on ibrexafungerp had been lifted and concluded that the Phase 3 MARIO study could resume. The MARIO study is a Phase 3 trial evaluating ibrexafungerp for the treatment of invasive candidiasis. SCY-247 Development Program Presented positive preclinical efficacy data on its second-generation fungerp candidate SCY-247 at the ESCMID meeting, which took place in Vienna, Austria from April 11-15, 2025. Data from the four presentations continues to build upon SCY-247’s positive profile illustrating its unique attributes in the fight against difficult-to-treat fungal infections, including its potent antifungal activity against multi drug-resistant fungi. The Company remains on track to report Phase 1 SAD/MAD data for the oral formulation of SCY-247 in Q3 2025; Corporate Updates On July 30, 2025 the United States District Court, District of New Jersey granted the Company’s motion to dismiss a securities class action lawsuit that was filed by Brian Feldman in November 2023 against the Company and certain of the Company’s executives. Should the plaintiff decide to appeal or file an amended complaint, he has 30 days to do so. Second Quarter 2025 Financial Results For the three months ended June 30, 2025 and 2024, revenue primarily consisted of $1.4 million and $0.7 million, respectively, in license agreement revenue associated with the GSK License Agreement. Research and development expenses for the three months ended June 30, 2025, was $7.1 million compared to $6.8 million for the same period in 2024. The increase of $0.3 million, or 5%, for the three months ended June 30, 2025, was primarily driven by an increase of $0.3 million in chemistry, manufacturing, and controls (CMC) expense, an increase of $0.4 million in preclinical expense, and an increase of $0.2 million in clinical expense, offset in part by a decrease of $0.2 million in salary expense and a net decrease of $0.4 million in other research and development expense. Selling, general and administrative expenses for the three months ended June 30, 2025, increased to $3.8 million compared to $3.2 million for the three months ended June 30, 2024. The increase of $0.6 million, or 20%, for the three months ended June 30, 2025, was primarily driven by an increase of $0.4 million in professional fees. Total other income was $2.7 million for the three months ended June 30, 2025, versus total other expense of $5.2 million for the same period in 2024. The variance is mainly due to the fair value adjustment related to the warrant liabilities. For the three months ended June 30, 2025 and 2024, we recognized a gain of $2.2 million and a loss of $5.8 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 June 30, 2025 was $6.9 million, or $(0.14) basic loss per share, compared to net loss of $14.5 million, or $(0.30) basic loss per share for the same period in 2024. Cash Balance Cash, cash equivalents and investments totaled $46.5 million on June 30, 2025, compared to $75.1 million on December 31, 2024. Based upon the company’s current operating plan, SCYNEXIS believes that its existing cash, cash equivalents and investments provide a cash runway into Q4 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 development for invasive candidiasis. The next generation fungerp, SCY-247, is currently in the late stages of a Phase 1 clinical study. 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 clinical, pre- clinical and discovery phases, 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 Q4 2026; the expectation to release single ascending and multiple ascending dose data from the SCY-247 Phase 1 study in Q3 2025; the plans and expectations regarding the MARIO study and outcome of discussions with GSK; and the clinical and commercial potential for SCY-247. 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 12, 2025, 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: 917-734-7387 [email protected]

