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].
Unicycive(UNCY) - 2022 Q3 - Quarterly Report