Full Press Release Details
Therapeutics Announces First Quarter 2026 Financial Results and Provides Business Update
VIEW, Calif., May 12, 2026 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company
developing therapies for patients with kidney disease, today announced its financial results for the first quarter ended March 31, 2026,
and provided a business update.
we approach the June 29th PDUFA target action date, we remain optimistic about the potential approval of OLC and focused on preparations
for the subsequent launch of OLC," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. "Our ongoing dialogue
with the FDA during the review cycle has been constructive and timely. Uncontrolled hyperphosphatemia remains a significant health concern,
affecting nearly 75% of U.S. patients with chronic kidney disease who are undergoing dialysis. OLC has the potential to improve adherence
and phosphorus control with reduced pill burden, compared with currently available phosphate binders."
Highlights & Upcoming Milestones
Results for the Quarter Ended March 31, 2026
of May 11, 2026, unaudited cash, cash equivalents, and marketable securities
totaled $57.1 million. The Company believes that it has sufficient resources to fund planned operations into 2027.
and Development (R&D) expenses were $1.6 million for the quarter ended March 31, 2026, compared to $2.2 million for the three months
ended March 31, 2025. The decrease in research and development expenses was primarily attributed to a decrease in drug development costs
as well as consulting and professional fees.
and Administrative (G&A) expenses were $6.8 million for the quarter ended March 31, 2026, compared to $5.8 million for the three
months ended March 31, 2025. The increase was primarily attributed to an increase in consulting, professional services, and labor costs.
income (expense) was $(4.4) million expense for the quarter ended March 31, 2026, compared to $8.6 million income for the three months
ended March 31, 2025, attributed primarily to an increase in the fair value of the Company's warrant liability.
comprehensive income (loss) attributable to common stockholders, basic for the quarter ended March 31, 2026, was a $(12.8) million loss,
or $(0.54) per share of common stock, compared to $0.5 million income, or $0.04 per share of common stock, for the three months ended
March 31, 2025. Net comprehensive income (loss) attributable to common stockholders, diluted for the quarter ended March 31, 2026, was
a $(12.8) million loss, or $(0.54) per share of common stock, compared to a $(6.2) million loss, or $(0.50) per share of common stock,
for the three months ended March 31, 2025. The increased net loss for the quarter ended March 31, 2026, was attributed primarily to an
increase in the fair value of the Company's warrant liability.
Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead investigational treatment
is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) 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
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.
thousands, except for share and per share amounts)
| As of December 31, 2025 | As of March 31, 2026 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 29,198 | $ | 37,371 | ||||
| Prepaid expenses and other current assets | 7,692 | 8,959 | ||||||
| Marketable securities | 12,071 | 17,215 | ||||||
| Total current assets | 48,961 | 63,545 | ||||||
| Right of use asset, net | 108 | 813 | ||||||
| Property and equipment, net | 66 | 48 | ||||||
| Total Assets | $ | 49,135 | $ | 64,406 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 383 | $ | 1,140 | ||||
| Accrued liabilities | 1,523 | 3,052 | ||||||
| Warrant liability | 16,915 | 21,695 | ||||||
| Operating lease liability - current | 117 | 598 | ||||||
| Total current liabilities | 18,938 | 26,485 | ||||||
| Operating lease liability - long term | - | 217 | ||||||
| Total Liabilities | 18,938 | 26,702 | ||||||
| Commitments and contingencies (Note 7) | ||||||||
| Stockholders' Equity: | ||||||||
| Series A-2 Prime preferred stock, $0.001 par value per share - 21,388.01 Series A-2 Prime shares authorized at December 31, 2025, and March 31, 2026; 2,265 Series A-2 Prime shares issued and outstanding at December 31, 2025, and March 31, 2026 | - | - | ||||||
| Series B-2 preferred stock, $0.001 par value per share - 50,000 Series B-2 shares authorized at December 31, 2025, and March 31, 2026; zero Series B-2 shares issued and outstanding at December 31, 2025, and March 31, 2026 | - | - | ||||||
| Preferred stock, $0.001 par value per share - 10,000,000 shares authorized at December 31, 2025, and March 31, 2026; zero shares issued and outstanding at December 31, 2025, and March 31, 2026 | - | - | ||||||
| Common stock, $0.001 par value per share - 400,000,000 shares authorized at December 31, 2025, and March 31, 2026; 22,114,245 and 25,237,782 shares issued and outstanding at December 31, 2025, and March 31, 2026, respectively | 22 | 25 | ||||||
| Accumulated other comprehensive (loss) income | (1 | ) | 6 | |||||
| Additional paid-in capital | 158,001 | 178,321 | ||||||
| Accumulated deficit | (127,825 | ) | (140,648 | ) | ||||
| Total Stockholders' Equity | 30,197 | 37,704 | ||||||
| Total Liabilities And Stockholders' Equity | $ | 49,135 | $ | 64,406 |
of Operations and Comprehensive Income (Loss)
except for share and per share amounts)
| Three Months Ended March 31, 2025 | Three Months Ended March 31, 2026 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 2,171 | $ | 1,607 | ||||
| General and administrative | 5,818 | 6,830 | ||||||
| Total operating expenses | 7,989 | 8,437 | ||||||
| Loss from operations | (7,989 | ) | (8,437 | ) | ||||
| Other income (expenses): | ||||||||
| Interest income | 226 | 394 | ||||||
| Interest expense | (15 | ) | - | |||||
| Change in fair value of warrant liability | 8,348 | (4,780 | ) | |||||
| Total other income (expenses) | 8,559 | (4,386 | ) | |||||
| Net income (loss) | 570 | (12,823 | ) | |||||
| Other comprehensive loss: | ||||||||
| Unrealized loss on marketable securities, net | - | (1 | ) | |||||
| Net comprehensive income (loss) | $ | 570 | $ | (12,824 | ) | |||
| Net comprehensive income (loss) attributable to common stockholders, basic | $ | 510 | $ | (12,824 | ) | |||
| Net comprehensive (loss) attributable to common stockholders, diluted | $ | (6,214 | ) | $ | (12,824 | ) | ||
| Net comprehensive income (loss) per share | ||||||||
| Basic | $ | 0.04 | $ | (0.54 | ) | |||
| Diluted | $ | (0.50 | ) | $ | (0.54 | ) | ||
| Weighted-average shares outstanding used in computing net comprehensive income (loss) per share: | ||||||||
| Basic | 11,681,881 | 23,908,153 | ||||||
| Diluted | 12,383,477 | 23,908,153 |