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Unicycive Therapeutics, Inc.

For the period ended Jun 30, 2026. Filed Aug 12, 2026.

View on SEC.gov

About 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.

Jun 30, 2026 · Filed Aug 12, 2026

UNCY$3.55+2.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-12.

0001213900-26-054708

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-12.

0001213900-26-088013

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The 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 84 previous paragraphs and 82 current paragraphs.

58 unchanged; 18 reworded; 5 added; 8 removed; 0 previous and 1 current paragraphs rearranged.

Tables are not compared: 15 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 June 30, 2026, we announced that we received a CRL from the FDA regarding the resubmitted NDA for OLC. The FDA has not raised any concerns regarding clinical efficacy or safety data, and no additional data was requested from Unicycive. The CRL is based on the same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025.

Current report

General and administrative expenses increased by $2.1 million, or 41%, from approximately $5.2 million for the three months ended June 30, 2025, to approximately $7.4 million for the three months ended June 30, 2026. This increase was primarily driven by a $1.4 million increase in non-cash stock-based compensation as well as increases of $0.3 million in other labor costs. There was also an increase of $0.4 million related to commercial launch preparation.

Current report

Other income (expenses) increased by $7.9 million, or 1,531%, from an income of $0.5 million for the three months ended June 30, 2025, to income of $8.4 million for the three months ended June 30, 2026. This was primarily driven by a decrease of $7.6 million in the fair value of our warrant liability as well as an increase of $0.3 million in interest income.

Current report

Research and development expenses increased by approximately $0.5 million, or 12%, from approximately $3.9 million for the six months ended June 30, 2025, to approximately $4.4 million for the six months ended June 30, 2026. This increase was primarily driven by a $0.9 million increase in non-cash stock-based compensation, partially offset by a decrease in drug development costs of $0.4 million.

Current report

General and administrative expenses increased by $3.2 million, or 29%, from approximately $11.0 million for the six months ended June 30, 2025, to approximately $14.2 million for the six months ended June 30, 2026. This increase was primarily driven by a $1.6 million increase in non-cash stock-based compensation as well as increases of $0.6 million in other labor costs, $0.9 million increase in consulting and professional service costs, and $0.1 million related to commercial launch preparation.
Removed paragraphs (8)

Previous report

On April 6, 2026, Gaurav Aggarwal, M.D., one of our directors, resigned from our Board of Directors. Dr. Aggarwal’s resignation was not a result of any disagreement with us or our management or Board of Directors on any matter related to our operations, policies, or practices.

Previous report

Research and development expenses decreased by approximately $0.6 million, or 26%, from approximately $2.2 million for the three months ended March 31, 2025 to approximately $1.6 million for the three months ended March 31, 2026. This decrease was primarily driven by a reduction in drug development costs of $0.5 million and consulting and professional fees and other expenses of $0.2 million, partially offset by an increase in labor of $0.1 million and stock-based compensation of $0.1 million.
Reworded paragraphs (18)

Previous wording

This Quarterly Report on Form 10-Q for the three-month period ended March 31, 2026 contains “forward-looking statements” within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), and the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements contain information about our expectations, beliefs or intentions regarding our product development and commercialization efforts, business, financial condition, results of operations, strategies or prospects, and other similar matters. These forward-looking statements are based on management’s current expectations and assumptions about future events, which are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict. These statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning.

Current wording

This Quarterly Report on Form 10-Q for the six-month period ended June 30, 2026 contains “forward-looking statements” within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), and the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements contain information about our expectations, beliefs or intentions regarding our product development and commercialization efforts, business, financial condition, results of operations, strategies or prospects, and other similar matters. These forward-looking statements are based on management’s current expectations and assumptions about future events, which are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict. These statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning.

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 income was $0.6 million and our net loss was $12.8 million for the three months ended March 31, 2025 and 2026, respectively. As of March 31, 2026, we had an accumulated deficit of $140.6 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 loss was $5.9 million and $14.6 million for the six months ended June 30, 2025 and 2026, respectively. As of June 30, 2026, we had an accumulated deficit of $142.4 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

We have funded our operations primarily from the sale and issuance of common stock, convertible promissory notes and from a loan, including cash and deferred salary from our Chief Executive Officer and principal stockholder.

Current wording

We have funded our operations primarily from the sale and issuance of common stock, convertible promissory notes and from a loan, including cash and deferred salary from our Chief Executive Officer.

Previous wording

Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of our current product candidates and future product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through private or public equity or debt financings, collaborative or other arrangements with corporate sources, or through other sources of financing. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into agreements to raise capital as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our current product candidates and future product candidates.

Current wording

Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of our current product candidates and future product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through private or public equity or debt financing, collaborative or other arrangements with corporate sources, or through other sources of financing. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into agreements to raise capital as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our current product candidates and future product candidates.

Previous wording

General and administrative expenses increased by $1.0 million, or 17%, from approximately $5.8 million for the three months ended March 31, 2025 to approximately $6.8 million for the three months ended March 31, 2026. This increase was primarily driven by a $0.9 million increase in consulting and professional service costs, and $0.3 million in labor and related expenses. Additionally, rent, travel, supplies, and other costs decreased by $0.2 million, while stock-based compensation grew by $0.1 million.

Current wording

Research and development expenses increased by approximately $1.0 million, or 59%, from approximately $1.8 million for the three months ended June 30, 2025, to approximately $2.8 million for the three months ended June 30, 2026. This increase was primarily driven by a $0.9 million increase in non-cash stock-based compensation, and an increase in consulting and professional fees of $0.1 million.

Previous wording

Other income (expenses) decreased by $13.0 million, or 151%, from an income of $8.6 million for the three months ended March 31, 2025, to expense of $4.4 million for the three months ended March 31, 2026. This was primarily driven by a change in the fair value of our warrant liability, partially offset by a decrease of earned interest income during the year as a result of lower average cash balances available for interest-bearing accounts.

Current wording

Other income (expenses) decreased by $5.1 million, or 56%, from an income of $9.1 million for the six months ended June 30, 2025, to income of $4.0 million for the six months ended June 30, 2026. This was primarily driven by a change in the fair value of our warrant liability of $5.5 million, partially offset by an increase of $0.4 million in interest income.

Previous wording

Since our formation through December 31, 2020, we have funded our operations with the sale of common and preferred stock, convertible notes and from a loan from our Chief Executive Officer and principal stockholder.

Current wording

Since our formation through December 31, 2020, we have funded our operations with the sale of common and preferred stock, convertible notes and from a loan from our Chief Executive Officer.

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. On November 14, 2025, the Company entered into an Amendment No. 1 to sales agreement with Guggenheim Securities LLC to increase the number of shares that may be sold under the sales agreement to $100,000,000 (collectively with the November 13, 2024 sales agreement, the “Sales Agreement”).

Current wording

On November 13, 2024, the Company entered into a sales agreement, with Guggenheim Securities, LLC as amended by Amendment No. 1 thereto dated November 14, 2025 and further amended by Amendment No. 2 thereto dated June 5, 2026 (as amended, the “Sales Agreement”) pursuant to which, we may offer and sell shares of common stock having an aggregate offering price of up to $150.0 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.

Previous wording

During the three months ended March 31, 2026, the Company sold 3,123,537 shares of common stock pursuant to the Sales Agreement, at an average price of $6.46 per share and paid $0.6 million in commissions, resulting in net proceeds to the Company of approximately $19.6 million.

Current wording

During the six months ended June 30, 2026, the Company sold 5,278,767 shares of common stock pursuant to a sales agreement, with Guggenheim Securities, LLC, at an average price of $6.64 per share and paid $1.1 million in commissions, resulting in net proceeds to the Company of approximately $34.0 million.

Previous wording

We have incurred net losses since our inception. For the three months ended March 31, 2026, we had a net loss of $12.8 million, and we expect to incur substantial additional losses in future periods. As of March 31, 2026, we had an accumulated deficit of $140.6 million.

Current wording

We have incurred net losses since our inception. For the six months ended June 30, 2026, we had a net loss of $14.6 million, and we expect to incur substantial additional losses in future periods. As of June 30, 2026, we had an accumulated deficit of $142.4 million.

Previous wording

We expect to continue incurring losses in the future and will be required to raise additional capital in the future to complete our clinical trials, pursue product development initiatives and penetrate markets for the sale of our products. We believe that we will continue to have access to capital resources through possible equity offerings, debt financings, corporate collaborations or other means. There can be no assurance that we will be able to obtain additional financing on terms acceptable to us, on a timely basis or at all. If we are unable to secure additional capital, we may be required to curtail any clinical trials and development of new or existing products and take additional measures to reduce expenses in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. Based on our current level of expenditures, we believe that we have sufficient resources such that there is not substantial doubt about our ability to continue operations for at least one year after the date that these financial statements are available to be issued.

Current wording

We expect to continue incurring losses in the future and will be required to raise additional capital in the future to complete our clinical trials, pursue product development initiatives and penetrate markets for the sale of our products. We believe that we will continue to have access to capital resources through possible equity offerings, debt financing, corporate collaborations or other means. There can be no assurance that we will be able to obtain additional financing on terms acceptable to us, on a timely basis or at all. If we are unable to secure additional capital, we may be required to curtail any clinical trials and development of new or existing products and take additional measures to reduce expenses in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. Based on our current level of expenditures, we believe that we have sufficient resources such that there is not substantial doubt about our ability to continue operations for at least one year after the date that these financial statements are available to be issued.

Previous wording

Net cash used in operating activities was $6.2 million for the three months ended March 31, 2026. 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. We incurred a net loss of $12.8 million after including the effect of non-cash adjustments for stock compensation and change in fair value of our warrant liability.

Current wording

Net cash used in operating activities was $13.8 million for the six months ended June 30, 2026. 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. We incurred a net loss of $14.6 million after including the effect of non-cash adjustments for stock compensation and change in fair value of our warrant liability.

Previous wording

Net cash used in operating activities was $8.9 million for the three months ended March 31, 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. We reported net income of $0.6 million after including the effect of non-cash adjustments for stock compensation and change in fair value of our warrant liability.

Current 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.

Previous wording

Net cash used in investing activities was $5.2 million for the three months ended March 31, 2026 and was due primarily to the purchase of marketable securities.

Current wording

Net cash used in investing activities was $5.2 million for the six months ended June 30, 2026, and was due primarily to the purchase of marketable securities.

Previous wording

Net cash used in investing activities was $16,000 for the three months ended March 31, 2025 and was due to the purchase of furniture and fixtures for our corporate office.

Current 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.

Previous wording

Net cash provided by financing activities was $19.6 million during the three months ended March 31, 2026, due primarily to sales made under the sales agreement with Guggenheim Securities LLC dated November 13, 2024 as amended by Amendment No. 1 thereto dated November 14, 2025.

Current wording

Net cash provided by financing activities was $34.0 million during the six months ended June 30, 2026, due primarily to sales made under the sales agreement with Guggenheim Securities LLC dated November 13, 2024, as amended by Amendment No. 1 thereto dated November 14, 2025 and further amended by Amendment No. 2 dated June 5, 2026.

Previous wording

Net cash provided by financing activities was $2.5 million during the three months ended March 31, 2025 due primarily to the private placement financing agreement we signed on March 13, 2025 and sales made under the sales agreement with Guggenheim Securities LLC dated November 13, 2024.

Current 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.

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 debt and equity classification, warrant liabilities, research and development, and stock-based compensation. There have been no other material changes to our critical accounting policies and estimates during the three months ended March 31, 2026 from those used for the year ended December 31, 2025. 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 debt and equity classification, warrant liabilities, research and development, and stock-based compensation. There have been no other material changes to our critical accounting policies and estimates during the six months ended June 30, 2026 from those used for the year ended December 31, 2025. The below policies represent our critical accounting policies.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Comparison of the Six Months Ended June 30, 2025, and 2026 (in thousands)