- Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by
U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date ofJune 29, 2026 - Commercial readiness activities ongoing in anticipation of potential commercial launch of OLC in 3Q26
- As of
March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled$54.9 million , with expected runway into 2027
“This year is shaping up to be pivotal for Unicycive, underscored by the
Key Highlights & Upcoming Milestones
- In
January 2026 , the Company announced the FDA has accepted the resubmission of its NDA for OLC, an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a PDUFA target action date ofJune 29, 2026 . The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers and a tolerability study in patients with CKD on dialysis), multiple preclinical studies and chemistry, manufacturing and controls (CMC) data. The FDA did not raise any concerns regarding the preclinical, clinical or safety data for OLC included in the original NDA submission. The resubmission inDecember 2025 was based on the progress made by the third-party manufacturing vendor responsible for the drug product (Drug Product). - As part of Unicycive’s continued preparation to support a potential launch of OLC later this year, the Company is continuing to strengthen its commercial infrastructure and advance market readiness initiatives.
Financial Results for the Year Ended
Research and Development (R&D) expenses were
General and Administrative (G&A) expenses were
Other income was
Net loss attributable to common stockholders for the year ended
As of
About Unicycive Therapeutics
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended
Investor Contacts:
kgardner@lifesciadvisors.com
Media Contact:
Real Chemistry
llitsinger@realchemistry.com
SOURCE:
| Balance Sheets | ||||||||
| (in thousands, except for share and per share amounts) | ||||||||
| As of | As of | |||||||
| 2024 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 26,142 | $ | 29,198 | ||||
| Prepaid expenses and other current assets | 4,806 | 7,692 | ||||||
| Marketable securities | - | 12,071 | ||||||
| Total current assets | 30,948 | 48,961 | ||||||
| Right of use asset, net | 645 | 108 | ||||||
| Property and equipment, net | 75 | 66 | ||||||
| Total assets | $ | 31,668 | $ | 49,135 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,058 | $ | 383 | ||||
| Accrued liabilities | 3,562 | 1,523 | ||||||
| Warrant liability | 18,936 | 16,915 | ||||||
| Operating lease liability - current | 564 | 117 | ||||||
| Total current liabilities | 24,120 | 18,938 | ||||||
| Operating lease liability - long term | 117 | - | ||||||
| Total liabilities | 24,237 | 18,938 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Series A-2 Prime preferred stock, | - | - | ||||||
| Series B-2 preferred stock, | - | - | ||||||
| Preferred stock, | - | - | ||||||
| Common stock, | 11 | 22 | ||||||
| Accumulated other comprehensive loss | - | (1 | ) | |||||
| Additional paid-in capital | 108,690 | 158,001 | ||||||
| Accumulated deficit | (101,270 | ) | (127,825 | ) | ||||
| Total stockholders’ equity | 7,431 | 30,197 | ||||||
| Total liabilities and stockholders’ equity | $ | 31,668 | $ | 49,135 | ||||
| Statements of Operations | ||||||||
| (in thousands, except for share and per share amounts) | ||||||||
| Year Ended | Year Ended | |||||||
| 2024 | 2025 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 20,014 | $ | 9,121 | ||||
| General and administrative | 12,103 | 20,396 | ||||||
| Total operating expenses | 32,117 | 29,517 | ||||||
| Loss from operations | (32,117 | ) | (29,517 | ) | ||||
| Other income (expenses): | ||||||||
| Interest income | 1,261 | 1,012 | ||||||
| Interest expense | (71 | ) | (71 | ) | ||||
| Change in fair value of warrant liability | (5,802 | ) | 2,021 | |||||
| Total other income (expenses) | (4,612 | ) | 2,962 | |||||
| Net loss | (36,729 | ) | (26,555 | ) | ||||
| Other comprehensive loss: | ||||||||
| Unrealized loss on marketable securities, net | - | (1 | ) | |||||
| Net comprehensive loss | $ | (36,729 | ) | $ | (26,556 | ) | ||
| Dividend to Series B-1 preferred stockholders | (1,095 | ) | - | |||||
| Net loss attributable to common stockholders | $ | (37,824 | ) | $ | (26,555 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (5.65 | ) | $ | (1.67 | ) | ||
| Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 6,698,513 | 15,886,876 | ||||||
