Every 8-K that Unicycive Therapeutics, Inc. (UNCY) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow UNCY and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full UNCY filings page.
Unicycive Therapeutics, Inc. reported second quarter 2026 results and provided a regulatory update on its lead kidney disease candidate, oxylanthanum carbonate (OLC). The company expects to resubmit its New Drug Application for OLC assuming completion of a successful FDA inspection of its third-party manufacturing vendor, and states that the FDA has now assigned this facility inspection. Management describes ongoing, productive dialogue with the FDA on OLC labeling and packaging and preparation for a potential commercial launch.
As of June 30, 2026, unaudited cash, cash equivalents and marketable securities totaled $61.4 million, which the company states is expected to provide runway into 2027. For the quarter ended June 30, 2026, research and development expense was $2.8 million and general and administrative expense was $7.4 million, both higher than the prior-year period primarily due to increased non-cash stock-based compensation and commercial launch preparation. Other income was $8.4 million, largely from a change in fair value of warrant liabilities, resulting in a net loss of $1.7 million, or $0.06 per share, compared with a $6.5 million net loss, or $0.52 per share, a year earlier.
Unicycive Therapeutics, Inc. reported an ending cash balance of approximately $61.4 million as of June 30, 2026. This figure is part of the company’s preliminary second-quarter results, which were prepared by management and have not been audited, reviewed, or compiled by its independent registered public accounting firm.
Unicycive Therapeutics, Inc. held its Annual Meeting of Stockholders on June 19, 2025, with 14,964,159 common shares represented, constituting a quorum. Stockholders elected three directors — Dr. Shalabh Gupta, Dr. Sandeep Laumas, and D. Sarawati Kenkare‑Mitra — to serve until the 2027 annual meeting or until successors are elected and qualified.
Support for the nominees ranged from 7,510,434 to 8,131,958 votes "for," with broker non‑votes exceeding 6.6 million for each. Stockholders also ratified the appointment of Grassi & Co. CPAs, P.C. as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 14,667,242 votes in favor, 286,958 against, and 9,928 abstentions.
Unicycive Therapeutics, Inc. entered into a second amendment to its sales agreement with Guggenheim Securities to expand its at-the-market common stock offering capacity to $150,000,000. The at-the-market program allows the company to sell shares of common stock from time to time.
On the same date, Unicycive filed a Shelf Registration Statement on Form S-3, including a sales agreement prospectus, to register up to $50,000,000 of common stock for sale under this at-the-market offering. The amendment itself is incorporated by reference as an exhibit.
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.
Unicycive Therapeutics, Inc. reported that director Gaurav Aggarwal resigned from its Board of Directors effective April 6, 2026.
The company stated that his resignation was not due to any disagreement with management or the Board regarding operations, policies, or practices and expressed gratitude for his service.
Unicycive Therapeutics reported narrower losses for the year ended December 31, 2025 and highlighted regulatory progress for its lead kidney-disease drug candidate. Research and development spending fell to $9.1 million from $20.0 million as major clinical work wound down, while general and administrative costs rose to $20.4 million from $12.1 million due to consulting, professional services, and commercial launch preparation.
Net loss attributable to common stockholders improved to $26.6 million, or $1.67 per share, from $37.8 million, or $5.65 per share, helped by lower R&D and a favorable warrant liability revaluation that turned other income to $3.0 million from a $4.6 million expense. As of March 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled $54.9 million, and the company states it can fund planned operations into 2027. Management noted that the FDA has accepted its New Drug Application resubmission for oxylanthanum carbonate (OLC) for hyperphosphatemia in dialysis patients, with the potential for approval and launch later in 2026.
Unicycive Therapeutics, Inc. has amended its existing at-the-market equity program with Guggenheim Securities to expand potential common stock sales. The company previously could sell shares of common stock with an aggregate offering price of up to $50,000,000 under its Form S-3 shelf registration. As of November 14, 2025, Amendment No. 1 to the Sales Agreement increases the maximum aggregate offering price that may be sold in the ATM offering to $100,000,000. The ATM offering allows the company to issue and sell shares from time to time under its effective shelf registration statement and related sales agreement prospectus, as supplemented.
Unicycive Therapeutics (UNCY) filed a Form 8-K stating it issued a press release announcing financial results for the three months ended September 30, 2025 and provided a business update. The press release is furnished as Exhibit 99.1. The company notes the information under Item 2.02, including Exhibit 99.1, is being furnished and not filed under Section 18 of the Exchange Act.
Unicycive Therapeutics (UNCY) furnished an 8-K with preliminary cash data and a regulatory update. The company expects to report approximately $42 million in cash and cash equivalents as of September 30, 2025, based on preliminary, unaudited figures. The company’s independent registered public accounting firm has not reviewed these figures, and complete quarterly results will appear in the upcoming Form 10-Q for the quarter ended September 30, 2025.
Unicycive also furnished a press release announcing an update from its meeting with the U.S. Food and Drug Administration and the timing of the resubmission of its New Drug Application for Oxylanthanum Carbonate, following a Complete Response Letter dated June 30, 2025.
Unicycive Therapeutics, Inc. disclosed that, after June 30, 2025, it sold 3,549,846 shares of common stock under a sales agreement with Guggenheim Securities, LLC. The shares were sold at an average price of $4.56 per share, generating net proceeds of approximately $16.3 million for the company.
This at-the-market style equity financing increases Unicycive’s cash resources but also adds new shares to its common stock base. The filing does not detail specific uses for the funds, only that the proceeds were received by the company.
Unicycive Therapeutics reported that it has issued a press release announcing its financial results for the three months ended June 30, 2025 and provided a business update. The company furnished that press release as Exhibit 99.1 to its Form 8-K and clarified the disclosure is being furnished, not filed for purposes of the Exchange Act and will not be incorporated by reference into registration statements, except as expressly stated. The Form 8-K also identifies the company as an emerging growth company.
Unicycive Therapeutics (NASDAQ: UNCY) has announced a 1-for-10 reverse stock split effective June 18, 2025, at 4:01 PM ET. The company's common stock began trading on a split-adjusted basis on the Nasdaq Capital Market on June 20, 2025, maintaining its "UNCY" symbol but with a new CUSIP number.
Key details of the reverse split:
- Reduced outstanding shares from 126,409,281 to approximately 12,768,239
- No fractional shares issued - fractional interests rounded up to the next whole share
- Proportionate adjustments made to stock options, warrants, and Series A-2 prime preferred stock conversion prices
- No change to authorized shares or par value
- No material change to stockholders' percentage ownership or voting power
The reverse split follows stockholder approval on June 9, 2025, which authorized the board to implement a split ratio between 1-for-2 and 1-for-20 before June 9, 2026. This corporate action affects multiple registration statements on Forms S-3 and S-8 currently on file with the SEC.