UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission file number: 001-40582 UNICYCIVE THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of (Prima ...

Exhibit 99.1 Unicycive Announces Full Year 2023 Financial Results and Provides Business Update – Oxylanthanum Carbonate (OLC) Topline Data Expected in Q2 2024 – – UNI-494 Granted Orphan Drug Designation in Delayed Graft Function of Acute Kidney Injury – – UNI-494 Phase 1 Single Ascending Dose Portion of Clinical Trial Complete – LOS ALTOS, Calif., March 28, 2024 – Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the "Company" or "Unicycive"), a clinical- stage biotechnology company developing therapies for pati ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact name of registrant as specified in its charter) FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to _________ Commission file number 001-40582 UNICYCIVE THERAPEUTICS, INC. | Delaware | 81-3638692 | | --- | --- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number: 001-40582 UNICYCIVE THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisd ...

Financial Performance - The company reported a net loss of $15.4 million for the six months ended June 30, 2023, compared to a net loss of $7.2 million for the same period in 2022, resulting in an accumulated deficit of $49.3 million as of June 30, 2023[166]. - Net loss for the six months ended June 30, 2023 was $18.4 million, representing an increase of $11.2 million, or 157%, compared to the net loss of $7.2 million for the same period in 2022[186]. - The company expects to incur substantial additional losses in future periods and had an accumulated deficit of $52.4 million as of June 30, 2023[195]. Operating Expenses - Total operating expenses increased by $686,000, or 19%, from $3.6 million in Q2 2022 to $4.3 million in Q2 2023[182]. - Research and development expenses increased by approximately $407,000, or 22%, from approximately $1.9 million for the three months ended June 30, 2022, to approximately $2.3 million for the same period in 2023[183]. - General and administrative expenses rose by $279,000, or 16%, from approximately $1.8 million for the three months ended June 30, 2022, to approximately $2.1 million for the same period in 2023[184]. - Research and development expenses rose by approximately $1.5 million, or 40%, from $3.8 million in the six months ended June 30, 2022 to $5.3 million in the same period of 2023, primarily due to increased drug development costs[188]. - General and administrative expenses increased by $522,000, or 15%, from approximately $3.4 million for the six months ended June 30, 2022 to approximately $3.9 million for the same period in 2023[189]. - The company expects significant increases in operating expenses as it advances product candidates through clinical development and seeks regulatory approval[166]. Cash Flow and Financing - Net cash used in operating activities was $9.4 million for the six months ended June 30, 2023, primarily due to development costs associated with drug candidates and increased research and development activities[202]. - Net cash provided by financing activities was $27.8 million during the six months ended June 30, 2023, primarily due to a private placement financing agreement[206]. - The company anticipates needing to raise additional capital before the end of the second quarter of 2024 to continue operations and fund future expenditures[196]. - The company entered into a securities purchase agreement on March 3, 2023, which is expected to result in up to $130 million in gross proceeds, with initial funding of $30 million[169]. - The company entered into a securities purchase agreement on March 3, 2023, which will provide up to $130 million in gross proceeds, including initial upfront funding of $30 million[194]. Revenue and Income - Licensing revenues increased by approximately $0.7 million, or 100%, from $0 in the six months ended June 30, 2022 to $0.7 million for the same period in 2023 due to an upfront payment associated with a licensing agreement[187]. - The company reported interest income of $234,000 and a change in fair value of warrant liability of $282,000 for the three months ended June 30, 2023[182]. - Other income (expenses) decreased by $9.9 million, or 100%, from $0 in the six months ended June 30, 2022 to $(9.9) million for the same period in 2023, primarily due to the change in fair value of warrant liability[190]. Market Outlook - The number of patients with end-stage renal disease (ESRD) is projected to reach between 971,000 and 1,259,000 by 2030, indicating a growing market for the company's therapies[162]. - The company plans to pay dividends to all stockholders on a quarterly basis, amounting to at least 75% of annual net cash flow from operations following FDA approval of its product, Oxylanthanum Carbonate[172]. Research and Development - Research and development expenses include costs for third-party research, consulting, laboratory supplies, and personnel-related expenses, with all expenses recognized as incurred[211]. - The company anticipates that its research and development expenses will continue to increase substantially for at least the next few years as it initiates additional clinical trials[178]. Accounting and Compliance - The company has chosen to take advantage of the extended transition periods under the JOBS Act for complying with new accounting standards[214]. - The company intends to rely on exemptions provided by the JOBS Act until it meets certain revenue or debt thresholds, including total annual gross revenues of $1.235 billion or more[215]. - There are no off-balance sheet arrangements currently in place as defined under SEC rules[217]. Stock-Based Compensation - Stock-based compensation is estimated using the Black-Scholes model, with fair value recognized over the requisite service period[212]. - The company established a warrant liability as of March 3, 2023, representing the fair value of warrants that may be issued upon conversion of Series A-1 Preferred Stock[210].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission file number: 001-40582 UNICYCIVE THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of (Addre ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to _________ Commission file number 001-40582 UNICYCIVE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Delaware | 81-3638692 | | --- | --- ...

Unicycive Leadership Board of Directors Brigitte Schiller, MD SVP, Medical Officer, Fresenius Medical Care Scientific Advisory Board $130 Million in Long-Term Financing RENAZORB □ NDA filing in mid 2023 ✓ Animal safety studies completed □ FDA IND filing for Phase 2 POC study Investor Relations Novel Treatments for Kidney Disease Un NASDAQ: UNCY Company Presentation March 2023 Forward Looking Statements Unique product candidates with proven mechanisms of action · RENAZORB™(lanthanum dioxycarbonate) is an inv ...

Financial Performance - The net loss for the three months ended September 30, 2022, was $5.6 million, representing a 7% increase compared to a net loss of $5.2 million for the same period in 2021[138]. - The company incurred significant losses of $12.7 million for the nine months ended September 30, 2022, compared to $7.3 million for the same period in 2021[123]. - The net loss for the nine months ended September 30, 2022, was $12.7 million, a 75% increase from a net loss of $7.3 million in the same period of 2021[151]. - The company had an accumulated deficit of $28.7 million as of September 30, 2022, reflecting significant operating losses incurred to date[123]. - As of September 30, 2022, the company had an accumulated deficit of $28.7 million[151]. Revenue Generation - The company recorded licensing revenues of $1.0 million for the three months ended September 30, 2022, due to a licensing agreement with Lee's Pharmaceutical (HK) Limited, marking a 100% increase compared to the prior period[139]. - Licensing revenues for the nine months ended September 30, 2022, were $1.0 million, a 100% increase from $0 in the prior period due to a licensing agreement with Lee's Pharmaceutical[145]. - The company recognizes revenue from product sales when control of the goods is transferred, following the ASC 606 revenue recognition standard[171]. Expenses - Research and development expenses increased by approximately $1.0 million, or 27%, from approximately $3.8 million for the three months ended September 30, 2021, to approximately $4.8 million for the same period in 2022[140]. - Research and development expenses increased by approximately $3.8 million, or 82%, from $4.7 million in 2021 to $8.6 million in 2022, primarily due to increased drug development costs[146]. - General and administrative expenses rose by $763,000, or 81%, from approximately $939,000 for the three months ended September 30, 2021, to approximately $1.7 million for the same period in 2022[141]. - General and administrative expenses rose by $3.6 million, or 238%, from $1.5 million in 2021 to $5.1 million in 2022, driven by higher insurance, consulting, and labor costs[147]. - The company anticipates that general and administrative expenses will increase due to higher personnel costs and expanded infrastructure associated with being a public company[135]. Cash Flow and Financing - Cash used in operating activities was $9.6 million for the nine months ended September 30, 2022, compared to $4.4 million in the prior year[165]. - Net cash provided by financing activities was $22.4 million for the nine months ended September 30, 2021, primarily from the initial public offering and issuance of convertible notes[169]. - The company expects to require additional capital before the end of the first quarter of 2023 to continue operations and fund future expenditures[152]. - The company raised approximately $22.3 million in net proceeds from its IPO on July 15, 2021, intended for clinical studies and regulatory filings[150]. - No cash flows from financing activities were reported for the nine months ended September 30, 2022[168]. Market Outlook - The number of patients with end-stage renal disease (ESRD) in the US is projected to reach between 971,000 and 1,259,000 by 2030, indicating a growing market for the company's therapies[120]. - The company expects operating expenses to increase significantly as it advances product candidates through pre-clinical and clinical development, seeks regulatory approval, and prepares for commercialization[123]. Accounting and Compliance - Research and development expenses include costs for third-party research, consulting, laboratory supplies, and personnel-related expenses, with no material changes in accounting policies during the nine months ended September 30, 2022[172]. - Stock-based compensation is recognized over the requisite service period, with fair value estimated using the Black-Scholes model[173]. - The fair value of common stock is determined from closing prices on the NASDAQ exchange post-IPO[176]. - The company has chosen to take advantage of the extended transition periods under the JOBS Act for complying with new accounting standards[178]. - There are no off-balance sheet arrangements currently in place[182]. - The company intends to remain an "emerging growth company" until certain revenue or debt thresholds are met[179]. - There were no significant market risks disclosed in the report[183].

LALIA LE | --- | --- | --- | --- | |-------|-------|----------------------|---------------------| | | | | NASDAQ: UNCY | | | | | Novel Treatments | | | | | for Kidney Diseases | | | | Company Presentation | | | | | August 2022 | | Forward Looking Statements This presentation contains certain "forward-looking" statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical or present facts, are forwar ...