Unicycive Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update
Rhea-AI Summary
Unicycive Therapeutics (Nasdaq: UNCY) reported second quarter 2026 results and a business update focused on oxylanthanum carbonate (OLC) for hyperphosphatemia in dialysis patients. In June 2026, the company received an FDA Complete Response Letter (CRL) again citing third-party manufacturing deficiencies, with no new clinical efficacy or safety concerns and no additional data requested.
The third-party vendor has received written FDA notification that a facility inspection has been assigned, and Unicycive expects to resubmit the OLC NDA following a successful inspection. As of June 30, 2026, unaudited cash, cash equivalents and marketable securities totaled $61.4 million, which the company expects will fund operations into 2027.
For Q2 2026, R&D expense was $2.8 million and G&A was $7.4 million. Net loss attributable to common stockholders narrowed to $1.7 million, or $(0.06) per share, from $6.5 million, or $(0.52), mainly due to a change in warrant liability fair value.
Positive
- Cash, cash equivalents and marketable securities $61.4 million at June 30, 2026, with expected runway into 2027
- FDA has assigned a facility inspection to the third-party manufacturing vendor for OLC
- FDA CRL in June 2026 raised no new efficacy or safety concerns and requested no additional clinical data
- Net loss reduced to $1.7 million from $6.4 million year over year for Q2
- Other income increased to $8.4 million, driven by change in warrant liability fair value
- Common shares outstanding increased to 27.9 million, strengthening stockholders’ equity to $53.3 million
Negative
- June 2026 FDA Complete Response Letter again cited third-party manufacturing deficiencies for OLC
- R&D expense rose to $2.8 million from $1.8 million year over year in Q2
- G&A expense increased to $7.4 million from $5.2 million, including $0.4 million for launch preparation
- Total operating expenses grew to $10.1 million from $7.0 million in Q2 year over year
- Warrant liability remains significant at $13.7 million as of June 30, 2026
- Accounts payable and accrued liabilities increased to $4.4 million from $1.9 million since December 31, 2025
News Explained
The balance sheet shows 27,855,257 common shares outstanding at
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 12 | Earnings report | Positive | +2.8% | FDA review remained on track with cash runway extending into 2027 |
| Mar 30 | Earnings report | Positive | -4.4% | NDA resubmission accepted with commercial readiness underway |
| Nov 12 | Earnings report | Positive | +7.3% | Pivotal data showed reduced pill volume and pill count versus prior binders |
| Aug 14 | Earnings report | Positive | +5.0% | OLC demonstrated effective phosphate control in over 90% of dialysis patients |
| May 14 | Earnings report | Positive | -7.8% | Net income improved while commercial launch preparation increased G&A expense |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-specific earnings reactions were mixed, with three positive reactions and two divergences despite generally favorable reported updates.
Key Terms
new drug application regulatory
complete response letter regulatory
warrant liability financial
orphan drug designation regulatory
hyperphosphatemia medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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 June 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled
MOUNTAIN VIEW, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the second quarter ended June 30, 2026, and provided a business update.
“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 Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The latest update from our third-party manufacturing vendor is that the U.S. Food and Drug Administration (FDA) has assigned a facility inspection. This marks a positive step forward, and our dialogue with the FDA on OLC labeling and packaging has been productive and continuous throughout this process. We are optimistic about a successful inspection of the third-party manufacturing facility, which would enable us to promptly resubmit the NDA. In the meantime, we are well positioned to launch OLC as quickly as possible following potential approval, and we are utilizing this time to continue to expand market awareness in preparation for the commercial success of OLC.”
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 2026 Renal Healthcare Association Annual Conference (September 23–26, Savannah, Georgia).
Financial Results for the Quarter Ended June 30, 2026
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 June 30, 2026, was
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.
| Unicycive Therapeutics, Inc. | |||||||||
| Balance Sheets | |||||||||
| (in thousands, except for share and per share amounts) | |||||||||
| As of | As of | ||||||||
| December 31, | June 30, | ||||||||
| 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 | |||||
| Unicycive Therapeutics, Inc. | ||||||||
| Statements of Operations and Comprehensive Loss | ||||||||
| (in thousands, except for share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended June 30, | ||||||||
| 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 | ||||||
