en.Wedoany.com Reported - SCYNEXIS (NASDAQ: SCYX), a clinical-stage biotechnology company, reported its second-quarter financial results for the period ended June 30, 2026, and disclosed that a Phase 1 study of its candidate drug SCY-770 has been initiated, designed to support the subsequent planned Phase 2 trial in autosomal dominant polycystic kidney disease (ADPKD). David Angulo, M.D., President and Chief Executive Officer, stated that ADPKD affects approximately 140,000 patients in the U.S. alone, and that SCY-770, as a highly selective oral direct AMPK activator, is designed to intervene in cyst growth and disease progression across multiple potential drivers, with preclinical data and safety profile supporting its potential as a differentiated therapeutic option.
The Phase 1 study of SCY-770 was initiated on June 30, 2026, and is evaluating food effect and characterizing the pharmacokinetics of two dosing regimens to support dose selection for the Phase 2 study in ADPKD patients, with topline data expected in the third quarter of 2026. SCYNEXIS remains on track to initiate the Phase 2 proof-of-concept study of SCY-770 in ADPKD patients in the fourth quarter of 2026, with early efficacy readouts expected in the second half of 2027. SCY-770 has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of ADPKD, and has previously been evaluated in multiple Phase 1 trials and a Phase 2a trial in patients with non-alcoholic fatty liver disease (NAFLD), with safety data characterized from more than 270 trial participants.
Patient dosing has been completed in the Phase 1 study of the intravenous formulation of SCY-247, a next-generation antifungal agent, with topline data expected in the third quarter of 2026. The company also stated that it continues to explore non-dilutive financing opportunities to support the development of SCY-247. Regarding BREXAFEMME, which has been licensed to GSK, the company believes GSK is committed to driving the product's relaunch, and following the relaunch, SCYNEXIS expects to be eligible to receive up to approximately $146 million in annual net sales milestone payments and low- to mid-single-digit percentage net royalties.
On the financial front, for the three months ended June 30, 2026, research and development expenses were $3.9 million, a decrease of $3.3 million (46%) from $7.1 million in the same period of 2025, primarily driven by a $1.6 million decrease in chemistry, manufacturing, and controls (CMC) expenses, a $0.8 million decrease in preclinical expenses, a $0.5 million decrease in clinical expenses, and a net $0.4 million decrease in other R&D expenses. Selling, general, and administrative (SG&A) expenses were $4.1 million, an increase of $0.3 million (9%) from $3.8 million in the same period of 2025, primarily attributable to an increase in professional service fees. Total other income was $15.2 million, compared to $2.7 million in the prior-year period, with the difference primarily attributed to fair value adjustments related to warrant liabilities, which recognized a fair value adjustment gain of $14.2 million in the second quarter of 2026, compared to $2.2 million in the same period of 2025.
As of June 30, 2026, the company's total cash, cash equivalents, and investments were $71.1 million, compared to $56.3 million as of December 31, 2025. On March 31, 2026, SCYNEXIS announced the execution of securities purchase agreements with certain new and existing institutional and accredited investors, with net proceeds of $36.9 million after deducting placement agent fees and transaction-related expenses, and total gross proceeds of up to $52.2 million if all related common warrants are exercised in full. The private placement closed on April 1, 2026. The company expects its current cash position to be sufficient to support operations into 2029.
SCY-770 is a novel, highly selective direct activator of adenosine monophosphate (AMP)-activated protein kinase (AMPK), being developed as a disease-modifying therapy for ADPKD. ADPKD is a progressive inherited kidney disease and the leading genetic cause of end-stage renal disease, affecting approximately 140,000 diagnosed patients in the U.S. AMPK activation inhibits the mTOR and cAMP signaling pathways that drive cyst cell proliferation and fluid secretion in ADPKD. The company stated that preclinical pharmacological data support the drug's potential use in ADPKD, with development goals of reducing cyst growth and disease progression and improving patients' quality of life.
SCYNEXIS is a clinical-stage biotechnology company focused on innovative therapies for serious rare diseases, with its proprietary antifungal platform "fungerps" including BREXAFEMME® (ibrexafungerp tablets), licensed to GSK, and SCY-247, which is in clinical development. More information is available at www.scynexis.com. The company also noted that this press release contains statements about expected future events or results that are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and actual results may differ materially from those expressed due to various risks and uncertainties, which are more fully described in the company's filings with the U.S. Securities and Exchange Commission.
