Unicycive Therapeutics Inc

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 $14.6 million and $20.9 million for the three months ended March 31, 2023 and March 31, 2024, respectively. As of March 31, 2024, we had an accumulated deficit of $85.5 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 $18.4 million and $11.1 million for the six months ended June 30, 2023 and June 30, 2024, respectively. As of June 30, 2024, we had an accumulated deficit of $75.6 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.

Previous wording

On March 13, 2024, the Company signed a securities purchase agreement with certain healthcare-focused institutional investors that provided $50 million in gross proceeds to us through a private placement. Pursuant to the securities purchase agreement, the Company issued to institutional purchasers $50.0 million in shares of the Company’s Series B Convertible Preferred Stock. 50,000 Shares of Series B Convertible Preferred Stock were issued at a price of $1,000.00 per share and are convertible into common stock at $1.00 per share.

Current wording

On March 13, 2024, we signed a securities purchase agreement with certain healthcare-focused institutional investors that provided $50 million in gross proceeds to us through a private placement. Pursuant to the securities purchase agreement, we issued to institutional investors $50.0 million in shares of our Series B Convertible Preferred Stock. 50,000 Shares of Series B Convertible Preferred Stock were issued at a price of $1,000.00 per share and are convertible into common stock at $1.00 per share.

Previous wording

Licensing revenues of approximately $0.7 million were recorded in the three months ended March 31, 2023. There was no comparable revenue earned in the current period. We may earn additional licensing revenue in the future if we negotiate business development arrangements with third parties.

Current wording

There was no Licensing revenue recorded in the three months ended June 30, 2023 or in the three months ended June 30, 2024. We may earn additional licensing revenue in the future if we negotiate business development arrangements with third parties.

Previous wording

Research and development expenses increased by approximately $3.8 million, or 125%, from approximately $3.0 million for the three months ended March 31, 2023, to approximately $6.8 million for the three months ended March 31, 2024. The increase in research and development expenses was primarily due to a $3.6 million increase in drug development costs. Labor costs increased $50,000 from the prior period. Consulting and other costs increased $59,000. Non-cash stock compensation costs increased $146,000.

Current wording

Research and development expenses increased by approximately $2.6 million, or 115%, from approximately $2.3 million for the three months ended June 30, 2023, to approximately $4.9 million for the three months ended June 30, 2024. The increase in research and development expenses was primarily due to a $2.2 million increase in drug development costs. Labor costs increased $88,000 from the prior period. Consulting and other costs increased $147,000. Non-cash stock compensation costs increased $200,000.

Previous wording

General and administrative expenses increased by $544,000, or 29%, from approximately $1.8 million for the three months ended March 31, 2023, to approximately $2.4 million for the three months ended March 31, 2024 primarily due to an increase of $232,000 in non-cash stock compensation costs. Insurance expense for directors and officers decreased $97,000. Labor costs increased $188,000 from the prior period. Travel, rent, and other costs increased $219,000.

Current wording

General and administrative expenses increased by $478,000, or 23%, from approximately $2.1 million for the three months ended June 30, 2023, to approximately $2.5 million for the three months ended June 30, 2024 primarily due to an increase of $297,000 in non-cash stock compensation costs. Insurance expense decreased $68,000. Labor costs increased $92,000 from the prior period. Travel, rent, and other costs increased $157,000.

Previous wording

Other income (expenses) increased $1.4 million, or 13%, from $10.4 in the three months ended March 31, 2023 to $11.8 million for the three months ended March 31, 2024 due primarily to a change in fair value of our warrant liability.

Current wording

Other income (expenses) increased $ 16.8 million, or 3465%, from $0.5 in the three months ended June 30, 2023 to $17.3 million for the three months ended June 30, 2024 due primarily to a change in fair value of our warrant liability.

Previous wording

On March 13, 2024, the Company entered into a securities purchase agreement with certain accredited investors pursuant to which we agreed to issue and sell, in a private placement, 50,000 shares of our Series B Convertible Preferred Stock, par value $0.001 per share at a purchase price of $1,000 per share with an initial conversion price of $1.00 per share, for an aggregate purchase price of $50.0 million.

Current wording

On March 13, 2024, we entered into a securities purchase agreement with certain accredited investors pursuant to which we agreed to issue and sell, in a private placement, 50,000 shares of our Series B Convertible Preferred Stock, par value $0.001 per share at a purchase price of $1,000 per share with an initial conversion price of $1.00 per share, for an aggregate purchase price of $50.0 million.

Previous wording

We have incurred net losses since our inception. For the three months ended March 31, 2024, we had a net loss of $20.9 million, and we expect to incur substantial additional losses in future periods. As of March 31, 2024, we had an accumulated deficit of $85.5 million.

Current wording

We have incurred net losses since our inception. For the six months ended June 30, 2024, we had a net loss of $11.1 million, and we expect to incur substantial additional losses in future periods. As of June 30, 2024, we had an accumulated deficit of $75.6 million.

Previous wording

Net cash used in operating activities was $6.5 million for the three months ended March 31, 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 $ 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.

Previous wording

Net cash used in operating activities was $3.9 million for the three months ended March 31, 2023. 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 $9.4 million for the six months ended June 30, 2023. 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 $6,000 for the three months ended March 31, 2024 and was due to the purchase of furniture and fixtures for our corporate office.

Current wording

Net cash used in investing activities was $12,000 for the six months ended June 30, 2023 and was due to the purchase of furniture and fixtures for our corporate office.

Previous wording

Net cash provided by financing activities was $45.7 million during the three months ended March 31, 2024 due primarily to the private placement financing agreement we signed on March 13, 2024.

Current wording

Net cash provided by financing activities was $44.9 million during the six months ended June 30, 2024 due primarily to the private placement financing agreement we signed on March 13, 2024.

Previous wording

Net cash provided by financing activities was $27.8 million during the three months ended March 31, 2023 due primarily to the private placement financing agreement we signed on March 3, 2023.

Current wording

Net cash provided by financing activities was $27.8 million during the six months ended June 30, 2023 due primarily to the private placement financing agreement we signed on March 3, 2023.

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 three months ended March 31, 2024 from those used for the year ended December 31, 2023. 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 six months ended June 30, 2024 from those used for the year ended December 31, 2023. The below policies represent our critical accounting policies.

Previous wording

In conjunction with the issuance of Series A-1 Preferred Stock (see Note 10), we established a warrant liability as of March 3, 2023, representing the fair value of warrants that may be issued, subject to shareholder approval, upon conversion of the Series A-1 Preferred Stock. We account for these warrants as liabilities (in accordance with ASC 480) on the balance sheets as a result of certain redemption clauses that are not within the control of the Company. The warrant liabilities are initially measured at fair value, resulting in an implied discount on the related preferred stock financing arrangement (recognized as a partial offset to the carrying value of the Series A-1 Preferred Stock), and are remeasured at fair value each reporting period. Changes in the fair value of the warrant liabilities are recognized in earnings during each period. The warrant liabilities are measured using Level 3 fair value inputs. See Note 12 for a description of warrant liabilities and the related valuations.

Current wording

In conjunction with the issuance of Series A-1 Preferred Stock (see Note 10), we established a warrant liability as of March 3, 2023, representing the fair value of warrants that may be issued, subject to shareholder approval, upon conversion of the Series A-1 Preferred Stock. We account for these warrants as liabilities (in accordance with ASC 480,Distinguishing Liabilities from Equity) on the balance sheets as a result of certain redemption clauses that are not within the control of the Company. The warrant liabilities are initially measured at fair value, resulting in an implied discount on the related preferred stock financing arrangement (recognized as a partial offset to the carrying value of the Series A-1 Preferred Stock), and are remeasured at fair value each reporting period. Changes in the fair value of the warrant liabilities are recognized in earnings during each period. The warrant liabilities are measured using Level 3 fair value inputs. See Note 12 for a description of warrant liabilities and the related valuations.