Unicycive Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
UNCY$3.55+2.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001213900-25-076007
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001213900-25-108600
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 89 previous paragraphs and 84 current paragraphs.
65 unchanged; 14 reworded; 5 added; 9 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 16 previous and 16 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
On October 28, 2025,we announced an update from its meeting with the U.S. Food and Drug Administration (FDA) and timing of the resubmission of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) following receipt of a Complete Response Letter (CRL) on June 30, 2025. The Type A FDA meeting was held to discuss the resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor. No other concerns have been identified to us, including pre-clinical, clinical, or safety data submitted as part of the NDA. Following receipt of the official meeting minutes from the Type A meeting and engaging in discussions with its third-party manufacturing vendor, we plan to resubmit the NDA for OLC by year-end
Current report
Research and development expenses decreased by approximately $81,000, or 3%, from approximately $3.1 million for the three months ended September 30, 2024, to approximately $3.0 million for the three months ended September 30, 2025. The decrease in research and development expenses was primarily due to a $235,000 decrease in professional services and drug development costs, partially offset by increases in labor, travel, and other costs of $154,000.
Current report
General and administrative expenses increased by $1.2 million, or 37%, from approximately $3.2 million for the three months ended September 30, 2024, to approximately $4.4 million for the three months ended September 30, 2025. The increase in general and administrative expenses was primarily due to an increase of $0.5 million in consulting and other professional services expenses as well as an increase of $0.6 million in labor and other costs.
Current report
Comparison of the Nine months ended September 30, 2024 and 2025
Current report
General and administrative expenses increased by $7.3 million, or 90%, from approximately $8.1 million for the nine months ended September 30, 2024 to approximately $15.4 million for the nine months ended September 30, 2025 primarily due to an increase of $5.4 million in consulting and professional services expenses as well as an increase of $1.9 million in labor and other costs.
Removed paragraphs (9)
Previous report
On June 11, 2025, we issued 300,000 shares of common stock, upon conversion of 3,000 shares of our Series B-2 Preferred Stock.
Previous report
In June 2025, we issued 277,000 shares of common stock, upon conversion of shares of our Series A-3 Preferred Stock related to exercise of Tranche A warrants.
Previous report
Reverse Stock Split
Previous report
On June 18, 2025, the Company filed the Charter Amendment with the Secretary of State of the State of Delaware to effectuate a reverse stock split. The Company’s common stock began trading on a split-adjusted basis at the opening of trading on the Nasdaq Capital Market on June 20, 2025. When the reverse stock split became effective, every 10 shares of common stock were automatically reclassified and combined into one share of common stock. No fractional shares were issued as a result of the split. Stockholders who would otherwise be entitled to receive a fractional share will instead automatically have their fractional interests rounded up to the next whole share, after aggregating all the fractional interests of a holder resulting from the split. The split affects all stockholders uniformly and will not change any stockholder’s percentage ownership interest or any stockholder’s proportionate voting power, except for immaterial changes that may result from the treatment of fractional shares. The split did not change the number of authorized shares of common stock or the par value per share of the common stock.
Previous report
As a result of the reverse stock split, proportionate adjustments were made to the per share exercise prices of, and the number of shares underlying, the Company’s outstanding stock options, as well as to the number of shares available for future awards granted under the Company’s stock incentive plans. In addition, proportionate adjustments were made to the per share exercise prices of, and the number of shares underlying, outstanding warrants to purchase shares of the Company’s common stock. Further, a proportionate adjustment was made to the per share conversion price of the Company’s series A-2 prime preferred stock, pursuant to its terms. Following the reverse stock split we had 12,768,239 shares of our common stock outstanding, which excludes approximately 49,000 shares of our common stock that were issued for rounding up fractional shares resulting from the reverse stock split. The reverse stock Split is retroactively reflected in the Company’s condensed consolidated balance sheets, condensed consolidated statements of operations, condensed consolidated statements of changes in shareholders’ equity and loss per share data.
Previous report
Research and development expenses decreased by approximately $3.1 million, or 64%, from approximately $4.9 million for the three months ended June 30, 2024, to approximately $1.8 million for the three months ended June 30, 2025.
Previous report
General and administrative expenses increased by $2.7 million , or 106%, from approximately $2.5 million for the three months ended June 30, 2024, to approximately $5.2 million for the three months ended June 30, 2025 primarily due to an increase of $2.2 million in marketing, consulting and other expenses related to our commercial launch, increase of $417,000 in labor costs, increase of $201,000 of insurance, travel and other costs, partially offset by a decrease of $47,000 in stock-based compensation.
Previous report
Comparison of the Six Months Ended June 30, 2024 and 2025
Previous report
General and administrative expenses increased by $6.1 million, or 124%, from approximately $4.9 million for the six months ended June 30, 2024 to approximately $11.0 million for the six months ended June 30, 2025 primarily due to an increase of $5.0 million in marketing, consulting and other expenses related to our commercial launch, increase of $884,000 in labor costs, increase of $284,000 of insurance, travel and other costs, partially offset by a decrease of $42,000 in stock-based compensation.
Reworded paragraphs (14)
Previous wording
Since our formation we have devoted substantially all of our resources to developing our product candidates. We have incurred significant operating losses to date. Our net losses were $11.1 million and $5.9 million for the six months ended June 30, 2024 and June 30, 2025, respectively. As of June 30, 2025, we had an accumulated deficit of $107.1 million. We expect that our operating expenses will increase significantly as we advance our product candidates through pre-clinical and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization; acquire, discover, validate and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel.
Current wording
Since our formation we have devoted substantially all of our resources to developing our product candidates. We have incurred significant operating losses to date. Our net losses were $15.2 million and $11.9 million for the nine months ended September 30, 2024 and September 30, 2025, respectively. As of September 30, 2025, we had an accumulated deficit of $113.2 million. We expect that our operating expenses will increase significantly as we advance our product candidates through pre-clinical and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization; acquire, discover, validate and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel.
Previous wording
During the six months ended June 30, 2025, the Company sold 2,009,616 shares of common stock pursuant to a sales agreement, with Guggenheim Securities, LLC, at an average price of $6.07 per share and paid $379,000 in commissions, resulting in net proceeds to the Company of approximately $12.2 million.
Current wording
During the nine months ended September 30, 2025, the Company sold 8,046,736 shares of common stock pursuant to a sales agreement, with Guggenheim Securities, LLC, at an average price of $4.94 per share and paid $1.2 million in commissions, resulting in net proceeds to the Company of approximately $38.6 million.
Previous wording
Other income (expenses) decreased $16.7 million, or 165%, from $17.3 million in the three months ended June 30, 2024 to $0.5 million for the three months ended June 30, 2025 due primarily to the change in fair value of our warrant liability of $16.4 million and a decrease in interest income of $307,000.
Current wording
Other income (expenses) decreased $0.8 million, or 38%, from $2.2 million in the three months ended September 30, 2024 to $1.3 million for the three months ended September 30, 2025. The decrease was primarily due to the change in fair value of our warrant liability of $0.7 million.
Previous wording
Research and development expenses decreased by approximately $7.7 million, or 66%, from approximately $11.7 million for the six months ended June 30, 2024 to approximately $3.9 million for the six months ended June 30, 2025. The decrease in research and development expenses was primarily due to an $8.1 million decrease in drug development costs, partially offset by an increase in labor costs of $239,000, consulting and other costs of $110,000, and stock-based compensation of $13,000.
Current wording
Research and development expenses decreased by approximately $7.9 million, or 53%, from approximately $14.7 million for the nine months ended September 30, 2024 to approximately $6.9 million for the nine months ended September 30, 2025. The decrease in research and development expenses was primarily due to an $8.2 million decrease in drug development costs, partially offset by an increase in labor costs of $0.4 million.
Previous wording
Other income (expenses) increased by $3.6 million (income), or 65%, from $5.5 million expense in the six months ended June 30, 2024 to $9.0 million income for the six months ended June 30, 2025 due primarily to the change in fair value of our warrant liability of $3.7 million, partially offset by a decrease in interest income of $151,000.
Current wording
Other income (expenses) increased by $2.8 million, or 36%, from $7.7 million expense in the nine months ended September 30, 2024 to $10.4 million income for the nine months ended September 30. The increase was primarily due to the change in fair value of our warrant liability.
Previous wording
On November 13, 2024, we entered into a sales agreement, with Guggenheim Securities, LLC pursuant to which, we may offer and sell shares of common stock having an aggregate offering price of up to $50.0 million, subject to certain limitations and in accordance with the terms of the sales agreement, from time to time through or to Guggenheim Securities, LLC acting as sales agent or principal. During the six months ended June 30, 2025, the Company sold 2,009,616 shares of common stock at an average price of $6.07 per share and paid $379,000 in commissions, resulting in net proceeds to the Company of approximately $12.2 million.
Current wording
On November 13, 2024, we entered into a sales agreement, with Guggenheim Securities, LLC pursuant to which, we may offer and sell shares of common stock having an aggregate offering price of up to $50.0 million, subject to certain limitations and in accordance with the terms of the sales agreement, from time to time through or to Guggenheim Securities, LLC acting as sales agent or principal. During the nine months ended September 30, 2025, the Company sold 8,046,736 shares of common stock pursuant to a sales agreement, with Guggenheim Securities, LLC, at an average price of $4.94 per share and paid $1.2 million in commissions, resulting in net proceeds to the Company of approximately $38.6 million.
Previous wording
We have incurred net losses since our inception. For the six months ended June 30, 2025, we had a net loss of $5.9 million, and we expect to incur substantial additional losses in future periods. As of June 30, 2025, we had an accumulated deficit of $107.1 million.
Current wording
We have incurred net losses since our inception. For the nine months ended September 30, 2025, we had a net loss of $11.9 million, and we expect to incur substantial additional losses in future periods. As of September 30, 2025, we had an accumulated deficit of $113.2 million.
Previous wording
Net cash used in operating activities was $17.3 million for the six months ended June 30, 2025. Cash used in operating activities was primarily due to the use of funds for development costs associated with our drug candidates, labor costs, consulting services, and other corporate expenditures for investor relations, compliance, and legal services.
Current wording
Net cash used in operating activities was $23.3 million for the nine months ended September 30, 2025. Cash used in operating activities was primarily due to the use of funds for development costs associated with our drug candidates, labor costs, consulting services, and other corporate expenditures for investor relations, compliance, and legal services.
Previous wording
Net cash used in operating activities was $12.8 million for the six months ended June 30, 2024. Cash used in operating activities was primarily due to the use of funds for development costs associated with our drug candidates, labor costs, consulting services, and other corporate expenditures for investor relations, compliance, and legal services.
Current wording
Net cash used in operating activities was $22.0 million for the nine months ended September 30, 2024. Cash used in operating activities was primarily due to the use of funds for development costs associated with our drug candidates, labor costs, consulting services, and other corporate expenditures for investor relations, compliance, and legal services.
Previous wording
Net cash used in investing activities was $22,000 for the six months ended June 30, 2025 and was due to the purchase of lab equipment.
Current wording
Net cash used in investing activities was $24,000 for the nine months ended September 30, 2025 and was due to the purchase of lab equipment.
Previous wording
Net cash used in investing activities was $26,000 for the six months ended June 30, 2024 and was due to the purchase of furniture and fixtures for our corporate office.
Current wording
Net cash used in investing activities was $50,000 for the nine months ended September 30, 2024 and was due to the purchase of furniture and fixtures for our corporate office.
Previous wording
Net cash provided by financing activities was $13.5 million during the six months ended June 30, 2025 due primarily to the at the market public offering agreement we signed on November 13, 2024 .
Current wording
Net cash provided by financing activities was $39.9 million during the nine months ended September 30, 2025, due primarily to the at the market public offering agreement we signed on November 13, 2024.
Previous wording
Net cash provided by financing activities was $44.9 million during the six months ended June 30, 2024 due primarily to the private placement financing agreement we signed on March 13, 2024.
Current wording
Net cash provided by financing activities was $44.7 million during the nine months ended September 30, 2024 due primarily to the private placement financing agreement we signed on March 13, 2024.
Previous wording
Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We consider our critical accounting policies and estimates to be related to revenue, research and development, stock-based compensation, debt and equity classification and warrant liabilities. There have been no other material changes to our critical accounting policies and estimates during the six months ended June 30, 2025 from those used for the year ended December 31, 2024. The below policies represent our critical accounting policies.
Current wording
Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We consider our critical accounting policies and estimates to be related to revenue, research and development, stock-based compensation, debt and equity classification and warrant liabilities. There have been no other material changes to our critical accounting policies and estimates during the nine months ended September 30, 2025 from those used for the year ended December 31, 2024. The below policies represent our critical accounting policies.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
The decrease in research and development expenses was primarily due to a $3.1 million decrease in drug development costs, consulting and other costs of $93,000, and stock-based compensation of $23,000, partially offset by an increase in labor costs of $86,000