Unicycive (NASDAQ: UNCY) Q1 2026 loss deepens as warrant liability swings
Rhea-AI Filing Summary
Unicycive Therapeutics reported a significantly wider loss for the first quarter of 2026, driven mainly by non-cash warrant valuation effects. Net comprehensive loss attributable to common stockholders was $12.8 million, or $(0.54) per share, compared with $0.5 million, or $0.04 per share, a year earlier.
Operating expenses were modestly higher at $8.4 million, as lower R&D spending of $1.6 million was offset by higher G&A of $6.8 million. The swing in other income to a $4.4 million expense from $8.6 million income was primarily due to an increase in the fair value of the warrant liability. As of May 11, 2026, cash, cash equivalents, and marketable securities totaled $57.1 million, which the company believes will fund planned operations into 2027.
Management highlighted preparations for the potential launch of oxylanthanum carbonate (OLC), its lead phosphate binder candidate, ahead of the June 29, 2026 PDUFA target action date for FDA review in hyperphosphatemia in dialysis patients.
Positive
- None.
Negative
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Insights
Results show a larger Q1 loss mainly from warrant revaluation, while cash remains solid ahead of the OLC PDUFA date.
Unicycive posted a Q1 2026 net loss of $12.8 million versus $0.6 million income a year earlier. Core operating costs were stable overall: R&D fell to $1.6 million, while G&A rose to $6.8 million, reflecting higher consulting and labor expenses.
The largest swing came from the non-cash change in fair value of the warrant liability, moving from $8.3 million income to a $4.8 million expense, turning other income of $8.6 million into an expense of $4.4 million. This accounting item affects reported earnings but not operating execution.
Liquidity improved, with cash, cash equivalents, and marketable securities at $57.1 million as of May 11, 2026, which the company believes funds operations into 2027. The key upcoming catalyst is the June 29, 2026 PDUFA target action date for OLC, which could reshape the financial profile depending on the FDA decision.
8-K Event Classification
Key Figures
Key Terms
PDUFA target action date regulatory
warrant liability financial
hyperphosphatemia medical
orphan drug designation regulatory
Delayed Graft Function medical
Phase 1 dose-ranging safety study medical
Earnings Snapshot
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CURRENT REPORT
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Item 2.02 Results of Operations and Financial Conditions.
On May 12, 2026, Unicycive Therapeutics, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2026 and provided a business update. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
The information disclosed under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
| 99.1 | Press Release of Unicycive Therapeutics, Inc. dated May 12, 2026. |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: May 12, 2026
| UNICYCIVE THERAPEUTICS, INC. | ||
| By: | /s/ Shalabh Gupta | |
| Shalabh Gupta | ||
| Chief Executive Officer | ||
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Exhibit 99.1
Unicycive Therapeutics Announces First Quarter 2026 Financial Results and Provides Business Update
| - | U.S. Food and Drug Administration (FDA) review of oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track, with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026 |
| - | Commercial readiness activities continue in anticipation of the potential commercial launch of OLC |
MOUNTAIN 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.
“As 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.”
Key Highlights & Upcoming Milestones
| ● | In January 2026, the Company announced the FDA 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 of June 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 December 2025 resubmission was based on progress made by the third-party manufacturing vendor responsible for the drug product. |
| ● | In preparation for a potential launch of OLC later this year, the Company continues to strengthen its commercial infrastructure and advance market readiness initiatives. Unicycive’s goal is to optimize patient access across all reimbursement settings and intends to provide dedicated access and reimbursement support services for all patients through Unicycive’s UniSource™ reimbursement hub. |
Financial Results for the Quarter Ended March 31, 2026
As 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.
Research 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.
General 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.
Other 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.
Net 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.
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 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 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:
Layne Litsinger
Real Chemistry
llitsinger@realchemistry.com
SOURCE: Unicycive Therapeutics, Inc.
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Unicycive Therapeutics, Inc.
BALANCE SHEETS
(In 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 | ||||
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Unicycive Therapeutics, Inc.
Statements of Operations and Comprehensive Income (Loss)
(In thousands, except for share and per share amounts)
(Unaudited)
| 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 | ||||||
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