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 ...

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 June 30, 2022 OR Classification Code Number) (I.R.S. Employer Identification Number) 4300 El Camino Real, Suite 210 Los Altos, CA 94022 (650) 351-4495 ☐ 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: ...

Financial Performance - For the three months ended March 31, 2022, total operating expenses increased to approximately $3.5 million, a 384% increase from $731,000 in the same period in 2021[123] - The net loss for the three months ended March 31, 2022, was $3.5 million, a 267% increase from a net loss of $964,000 in the same period in 2021[123] - As of March 31, 2022, the accumulated deficit stood at $19.5 million, indicating ongoing financial challenges[129] - For the three months ended March 31, 2022, net cash used in operating activities was $2.957 million, primarily due to development costs and corporate expenditures[143] - The company incurred a net loss of $3.5 million for the three months ended March 31, 2022, after accounting for non-cash adjustments[143] - The company had no cash flows from financing activities for the three months ended March 31, 2022, compared to $820,000 in the same period of 2021[146] Operating Expenses - Research and development expenses rose to approximately $1.9 million, reflecting a 330% increase from $450,000 for the three months ended March 31, 2021, primarily due to increased drug development costs[124] - General and administrative expenses increased by 471% to approximately $1.6 million from $281,000 for the same period in 2021, driven by higher insurance and labor costs[125] Funding and Capital Needs - The company raised approximately $22.3 million in net proceeds from its IPO on July 15, 2021, intended for clinical studies and regulatory filings[128] - The company expects to require additional funding before the end of Q2 2023 to sustain operations and meet future expenditures[131] - The company anticipates needing to raise substantial additional capital, influenced by factors such as drug discovery efforts, clinical trials, and regulatory reviews[133] - The company issued convertible notes in 2021 totaling approximately $1,098,000, with a 12% annual interest rate, maturing between January and May 2022[137] - The company may need to delay or terminate development programs if it fails to raise necessary capital[135] Business Model and Development - The company’s business model focuses on licensing technologies and drugs for development and commercialization in global markets[109] - The company is developing two novel therapies: Renazorb for hyperphosphatemia in chronic kidney disease and UNI 494 for acute kidney injury[106] Impact of COVID-19 - The COVID-19 pandemic has introduced uncertainties that may delay clinical trials and increase costs, impacting the company's financial condition[115] Agreements and Accounting - The company plans to amend its Service Agreement with Globavir to reflect a reduced service fee of $6,000 per month[136] - The company accounted for the 2021 and 2020 Notes as stock-settled debt, accruing the carrying amount to the settlement amount through maturity[138][140] - The company has chosen to take advantage of the extended transition periods under the JOBS Act for complying with new accounting standards[155]

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, 2021 ☐ 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 charter) | Delaware | 81-3638692 | | --- | --- | | ...

| --- | --- | --- | |-------|-------|----------------------| | | | NASDAQ: UNCY | | | | Novel Treatments | | | | for Kidney Diseases | | | | Company Presentation | | | | February 2022 | LALIA LINE 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 forward-looking statements, including st ...

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, 2021 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 in ...

LLALLOULE | --- | --- | --- | --- | |-------|-------|----------------------|-------| | | | | | | | | Novel Treatments | | | | | for Kidney Diseases | | | | | Company Presentation | | | | | September 2021 | | 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 forward-looking statements, i ...