Unicycive Therapeutics Inc

Previous wording

This Quarterly Report on Form 10-Q for the three-month period ended June 30, 2024 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 nine-month period ended September 30, 2024 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

We are a biotechnology company dedicated to developing treatments for kidney disease that have the potential to offer medical benefit. Our development programs are focused on the development of two novel therapies: oxylanthanum carbonate , for treatment of hyperphosphatemia in patients with chronic kidney disease, and UNI 494, for treatment of acute kidney injury (AKI).

Current wording

We are a biotechnology company dedicated to developing treatments for kidney disease that have the potential to offer clinical benefit. Our development programs are focused on the development of two novel therapies: oxylanthanum carbonate , for treatment of hyperphosphatemia in patients with chronic kidney disease, and UNI 494, for treatment of acute kidney injury (AKI).

Previous wording

Chronic kidney disease (CKD) is the gradual loss of kidney function that can get worse over time leading to lasting damage. Our initial focus is developing drugs and getting them approved in the U.S., and then to partner with the other global biopharmaceutical companies in the rest of the world. According to United States Renal Data System (USRDS) 2022 Annual Data Report, 30 million (14%) of adults in the United States are estimated to have CKD and, of these, approximately 13 million patients have advanced CKD (stage 3-5). Approximately 550,000 patients (ESRD) are on dialysis and of those, approximately 450,000 patients (~80%) take phosphate binders to control hyperphosphatemia hyperphosphatemia (too much phosphorus in their blood). The number of patients with ESRD in the U.S. is increasing steadily and is projected to reach between 971,000 and 1,259,000 patients in 2030.

Current wording

Chronic kidney disease (CKD) is the gradual loss of kidney function that can get worse over time leading to lasting damage. Our initial focus is developing drugs and getting them approved in the U.S., and then to partner with the other global biopharmaceutical companies in the rest of the world. According to United States Renal Data System (USRDS) 2022 Annual Data Report, 30 million (14%) of adults in the United States are estimated to have CKD and, of these, approximately 13 million patients have advanced CKD (stage 3-5). Approximately 550,000 patients (ESRD) are on dialysis and of those, approximately 450,000 patients (~80%) take phosphate binders to control hyperphosphatemia (too much phosphorus in their blood). The number of patients with ESRD in the U.S. is increasing steadily and is projected to reach between 971,000 and 1,259,000 patients in 2030.

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 $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.

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 $22.7 million and $15.2 million for the nine months ended September 30, 2023, and September 30, 2024, respectively. As of September 30, 2024, we had an accumulated deficit of $79.7 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, 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.

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-1 Convertible Preferred Stock. 50,000 Shares of Series B-1 Convertible Preferred Stock were issued at a price of $1,000.00 per share and each share is convertible into shares of common stock at a rate equal to the initial $1,000 purchase price divided by the initial conversion price of $1.00 per share.

Previous 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.

Current wording

Research and development expenses decreased by approximately $0.4 million, or 10%, from approximately $3.4 million for the three months ended September 30, 2023, to approximately $3.0 million for the three months ended September 30, 2024. The decrease in research and development expenses was primarily due to a $0.4 million decrease in drug development costs. Labor costs increased $151,000 from the prior period. Consulting and other costs increased $89,000. Non-cash stock compensation costs decreased $176,000.

Previous 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.

Current wording

General and administrative expenses increased by 640,000, or 25%, from approximately $2.6 million for the three months ended September 30, 2023, to approximately $3.2 million for the three months ended September 30, 2024 primarily due to an decrease of $149,000 in non-cash stock compensation costs. Insurance expense decreased $2,000. Labor costs increased $76,000 from the prior period. Travel, rent, and other costs increased $715,000.

Previous 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.

Current wording

Other income (expenses) increased $ 0.5 million, or 34%, from $1.6 million in the three months ended September 30, 2023 to $2.2 million for the three months ended September 30, 2024 due primarily to a change in fair value of our warrant liability.

Previous wording

Licensing revenues decreased approximately $0.7 million, or 100%, from the six months ended June 30, 2023 due to an upfront payment of approximately $0.7 million associated with a licensing agreement entered into with Lotus International Pte Ltd. in February 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

Licensing revenues decreased approximately $0.7 million, or 100%, from the nine months ended September 30, 2023 due to an upfront payment of approximately $0.7 million associated with a licensing agreement entered into with Lotus International Pte Ltd. in February 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.

Previous wording

Research and development expenses increased by approximately $6.4 million, or 121%, from approximately $5.3 million for the six months ended June 30, 2023 to approximately $11.7 million for the six months ended June 30, 2024. The increase in research and development expenses was primarily due to a $5.8 million increase in drug development costs. Labor costs increased $137,000 from the prior period. Consulting and other costs increased $93,000. Non-cash stock compensation increased $345,000.

Current wording

Research and development expenses increased by approximately $6.0 million, or 70%, from approximately $8.7 million for the nine months ended September 30, 2023 to approximately $14.7 million for the nine months ended September 30, 2024. The increase in research and development expenses was primarily due to a $5.4 million increase in drug development costs. Labor costs increased $272,000 from the prior period. Consulting and other costs increased $206,000. Non-cash stock compensation increased $170,000.

Previous wording

General and administrative expenses increased by $1.0 million, or 26%, from approximately $3.9 million for the six months ended June 30, 2023 to approximately $4.9 million for the six months ended June 30, 2024 primarily due to an increase of $530,000 in noncash stock compensation expense. Labor costs increased $281,000. Insurance, travel and other costs increased $212,000 from the prior period.

Current wording

General and administrative expenses increased by $1.7 million, or 26%, from approximately 6.5 million for the nine months ended September 30, 2023 to approximately $8.1 million for the nine months ended September 30, 2024 due to an increase of $380,000 in noncash stock compensation expense. Labor costs increased $355,000. Insurance, travel and other costs increased $928,000 from the prior period.

Previous wording

Other income (expenses) increased by $15.4 million (income), or 156%, from $9.9 million expense in the six months ended June 30, 2023 to $5.5 million income for the six months ended June 30, 2024 due primarily to the change in fair value of our warrant liability.

Current wording

Other income (expenses) increased by $15.5 million (income), or 178%, from $8.7 million expense in the nine months ended September 30, 2023 to $6.8 million income for the nine months ended September 30, 2024 due primarily to the change in fair value of our warrant liability.

Previous 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.

Current wording

We have incurred net losses since our inception. For the nine months ended September 30, 2024, we had a net loss of $15.2 million, and we expect to incur substantial additional losses in future periods. As of September 30, 2024, we had an accumulated deficit of $79.7 million.

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 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.

Current wording

Net cash used in operating activities was $13.8 million for the nine months ended September 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 $26,000 for the six months ended June 30, 2024 and was due to the purchase of lab equipment.

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 lab equipment.

Previous 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.

Current wording

Net cash used in investing activities was $12,000 for the nine months ended September 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 $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.

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 , partially offset by dividends paid to preferred stockholders.

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 $27.7 million during the nine months ended September 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 six months ended June 30, 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 nine months ended September 30, 2024 from those used for the year ended December 31, 2023. The below policies represent our critical accounting policies.