- 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 onMarch 31st with the balance received onApril 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 onApril 1 st extends SCYNEXIS’ cash runway to mid-2029
“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
“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 onApril 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 theU.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) inMunich 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 26 th,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 fromJanuary 28-30, 2026 , inLas 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
SG&A expenses for the three months ended
Total other expenses was
Cash Balance
Cash, cash equivalents and investments totaled
About
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
CONTACT:
Investor Relations
Tel: 917-355-2395
jfraunces@lifesciadvisors.com
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 36,671 | $ | 21,259 | ||||
| Short-term investments | 22,592 | 18,772 | ||||||
| Prepaid expenses and other current assets | 919 | 263 | ||||||
| Restricted cash | 80 | 80 | ||||||
| Deferred offering costs | 2,429 | — | ||||||
| Total current assets | 62,691 | 40,374 | ||||||
| Investments | 13,153 | 16,247 | ||||||
| Deferred offering costs | — | 533 | ||||||
| Restricted cash | 109 | 109 | ||||||
| Operating lease right-of-use asset | 1,673 | 1,764 | ||||||
| Total assets | $ | 77,626 | $ | 59,027 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,632 | $ | 2,225 | ||||
| Accrued expenses | 1,529 | 2,791 | ||||||
| Asset Purchase Agreement payable | 8,000 | — | ||||||
| Deferred revenue | 235 | 235 | ||||||
| Operating lease liability, current portion | 504 | 483 | ||||||
| Total current liabilities | 15,900 | 5,734 | ||||||
| Warrant liabilities | 18,862 | 2,225 | ||||||
| Operating lease liability | 1,557 | 1,692 | ||||||
| Total liabilities | 36,319 | 9,651 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 64 | 46 | ||||||
| Additional paid-in capital | 447,686 | 434,474 | ||||||
| Accumulated deficit | (406,443 | ) | (385,144 | ) | ||||
| Total stockholders’ equity | 41,307 | 49,376 | ||||||
| Total liabilities and stockholders’ equity | $ | 77,626 | $ | 59,027 | ||||
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
| Three Months Ended | ||||||||
| 2026 | 2025 | |||||||
| License agreement revenue | $ | — | $ | 257 | ||||
| Operating expenses: | ||||||||
| Research and development | 12,351 | 5,141 | ||||||
| Selling, general and administrative | 4,588 | 3,726 | ||||||
| Total operating expenses | 16,939 | 8,867 | ||||||
| Loss from operations | (16,939 | ) | (8,610 | ) | ||||
| Other (income) expense: | ||||||||
| Amortization of debt issuance costs and discount | — | 312 | ||||||
| Interest income | (535 | ) | (776 | ) | ||||
| Interest expense | — | 173 | ||||||
| Other income | (354 | ) | — | |||||
| Warrant liability fair value adjustment | 5,249 | (2,928 | ) | |||||
| Total other expense (income) | 4,360 | (3,219 | ) | |||||
| Net loss | $ | (21,299 | ) | $ | (5,391 | ) | ||
| Net loss per share – basic and diluted | $ | (0.42 | ) | $ | (0.11 | ) | ||
| Weighted average common shares outstanding – basic and diluted | 50,957,191 | 49,435,500 | ||||||
CONTACT:
Investor Relations
Tel: 917-355-2395
jfraunces@lifesciadvisors.com
