- 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
“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
“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
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
.
SG&A expenses for the three months ended
was primarily due to the increase of
Total other income was
Cash Balance
- Cash, cash equivalents and investments totaled
$71.1 million onJune 30, 2026 , compared to$56.3 million onDecember 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 onApril 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
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.
| UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands, except share and per share data) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,487 | $ | 21,259 | ||||
| Short-term investments | 43,596 | 18,772 | ||||||
| Prepaid expenses and other current assets | 1,540 | 263 | ||||||
| Restricted cash | 80 | 80 | ||||||
| Deferred offering costs | 533 | — | ||||||
| Total current assets | 56,236 | 40,374 | ||||||
| Investments | 17,047 | 16,247 | ||||||
| Deferred offering costs | — | 533 | ||||||
| Restricted cash | 109 | 109 | ||||||
| Operating lease right-of-use asset | 1,578 | 1,764 | ||||||
| Total assets | $ | 74,970 | $ | 59,027 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,265 | $ | 2,225 | ||||
| Accrued expenses | 2,034 | 2,791 | ||||||
| Deferred revenue | — | 235 | ||||||
| Operating lease liability, current portion | 526 | 483 | ||||||
| Total current liabilities | 5,825 | 5,734 | ||||||
| Warrant liability | 796 | 2,225 | ||||||
| Operating lease liability | 1,419 | 1,692 | ||||||
| Total liabilities | 8,040 | 9,651 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 10 | 5 | ||||||
| Additional paid-in capital | 465,966 | 434,515 | ||||||
| Accumulated deficit | (399,046 | ) | (385,144 | ) | ||||
| Total stockholders’ equity | 66,930 | 49,376 | ||||||
| Total liabilities and stockholders’ equity | $ | 74,970 | $ | 59,027 | ||||
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (in thousands, except share and per share data) | ||||||||
| Three Months Ended | ||||||||
| 2026 | 2025 | |||||||
| License agreement revenue | $ | 235 | $ | 1,364 | ||||
| Operating expenses: | ||||||||
| Research and development | 3,891 | 7,141 | ||||||
| Selling, general and administrative | 4,119 | 3,784 | ||||||
| Total operating expenses | 8,010 | 10,925 | ||||||
| Loss from operations | (7,775 | ) | (9,561 | ) | ||||
| Other (income) expense: | ||||||||
| Interest income | (685 | ) | (510 | ) | ||||
| Other income | (335 | ) | — | |||||
| Warrant liabilities fair value adjustment | (14,152 | ) | (2,166 | ) | ||||
| Total other income | (15,172 | ) | (2,676 | ) | ||||
| Net income (loss) | $ | 7,397 | $ | (6,885 | ) | |||
| Net income (loss) per share – basic and diluted | $ | 0.63 | $ | (1.11 | ) | |||
| Weighted average common shares outstanding – basic and diluted | 11,824,078 | 6,218,614 | ||||||
CONTACT:
Investor Relations
Tel: 917-355-2395
jfraunces@lifesciadvisors.com
