- Company expects to resubmit New Drug Application (NDA) for oxylanthanum carbonate (OLC) assuming completion of successful inspection of third-party manufacturing vendor
- FDA has assigned a facility inspection to third-party manufacturing vendor of OLC
- As of
“We are focused on securing approval of oxylanthanum carbonate (OLC) and remain confident in the efficacy and safety of OLC and in its potential to improve care for patients with hyperphosphatemia on dialysis,” said
Key Highlights & Upcoming Milestones
- In June, the Company received a Complete Response Letter (CRL) from the FDA regarding the resubmitted NDA for OLC for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The CRL cites the same third-party manufacturing deficiencies identified in a previous CRL issued in
June 2025 . The FDA has not raised any concerns regarding clinical efficacy or safety data, and no additional data was requested from the Company. - The Company’s third-party vendor has received written notification from the FDA that the facility inspection has been assigned, and the Company plans to provide an update following completion of the FDA inspection.
- In preparation for the potential launch of OLC, the Company continues to advance its commercial readiness initiatives. Unicycive is focused on optimizing patient access across all reimbursement settings and plans to support patients with dedicated access and reimbursement services through its UniSource™ reimbursement hub.
- The Company will also engage with the patient and clinical community at several medical meetings during the third quarter, including the 51st Annual
American Association of Kidney Patients National Patient Meeting (September 11–13,Little Rock, Arkansas ) and the 2026Renal Healthcare Association Annual Conference (September 23–26,Savannah, Georgia ).
Financial Results for the Quarter Ended
Research and Development (R&D) expense was
General and Administrative (G&A) expense was
Other income (expense) was
Net loss attributable to common stockholders, basic and diluted, for the quarter ended
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.
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 December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contacts:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Media Contact:
Unicycive Therapeutics
media@unicycive.com
SOURCE: Unicycive Therapeutics, Inc.
| Balance Sheets | |||||||||
| (in thousands, except for share and per share amounts) | |||||||||
| As of | As of | ||||||||
| 2025 | 2026 | ||||||||
| Assets | (Unaudited) | ||||||||
| Current assets: | |||||||||
| Cash | $ | 29,198 | $ | 44,185 | |||||
| Prepaid expenses and other current assets | 7,692 | 9,895 | |||||||
| Marketable securities | 12,071 | 17,240 | |||||||
| Total current assets | 48,961 | 71,320 | |||||||
| Right of use asset, net | 108 | 668 | |||||||
| Property and equipment, net | 66 | 41 | |||||||
| Total assets | $ | 49,135 | $ | 72,029 | |||||
| Liabilities and stockholders’ equity | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 383 | $ | 2,234 | |||||
| Accrued liabilities | 1,523 | 2,136 | |||||||
| Warrant liability | 16,915 | 13,718 | |||||||
| Operating lease liability - current | 117 | 616 | |||||||
| Total current liabilities | 18,938 | 18,704 | |||||||
| Operating lease liability - long term | - | 55 | |||||||
| Total liabilities | 18,938 | 18,759 | |||||||
| Commitments and contingencies | |||||||||
| Stockholders’ equity: | |||||||||
| Series A-2 Prime preferred stock, | - | - | |||||||
| Series B-2 preferred stock, | - | - | |||||||
| Preferred stock, | - | - | |||||||
| Common stock, | 22 | 28 | |||||||
| Accumulated other comprehensive loss | (1 | ) | (23 | ) | |||||
| Additional paid-in capital | 158,001 | 195,635 | |||||||
| Accumulated deficit | (127,825 | ) | (142,370 | ) | |||||
| Total stockholders’ equity | 30,197 | 53,270 | |||||||
| Total liabilities and stockholders’ equity | $ | 49,135 | $ | 72,029 | |||||
| Statements of Operations and Comprehensive Loss | ||||||||
| (in thousands, except for share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended | ||||||||
| 2025 | 2026 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 1,750 | $ | 2,788 | ||||
| General and administrative | 5,213 | 7,352 | ||||||
| Total operating expenses | 6,963 | 10,140 | ||||||
| Loss from operations | (6,963 | ) | (10,140 | ) | ||||
| Other income (expenses): | ||||||||
| Interest income | 155 | 441 | ||||||
| Interest expense | (13 | ) | - | |||||
| Change in fair value of warrant liability | 374 | 7,977 | ||||||
| Total other income (expenses) | 516 | 8,418 | ||||||
| Net loss | (6,447 | ) | (1,722 | ) | ||||
| Other comprehensive loss: | ||||||||
| Unrealized loss on marketable securities, net | - | (29 | ) | |||||
| Net comprehensive loss | $ | (6,447 | ) | $ | (1,751 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.52 | ) | $ | (0.06 | ) | ||
| Weighted-average shares outstanding used in computing net loss per share | 12,302,059 | 26,917,266 | ||||||
