Financial Performance - For the fiscal year ended December 31, 2022, the company recorded net revenue from product sales of $15.2 million and a net loss of $60.5 million[224]. - The company reported a comprehensive loss of $60,628,000 for 2022, compared to $110,090,000 in 2021[291]. - The net loss for the year ended December 31, 2022, was $60,513,000, compared to a net loss of $110,090,000 in 2021, reflecting an improvement[288]. - The company incurred net losses of $60.5 million and $110.1 million for the years ended December 31, 2022 and 2021, respectively, with an accumulated deficit of $203.2 million as of December 31, 2022[258]. - The accumulated deficit as of December 31, 2022, was $203.2 million, reflecting ongoing losses since inception[235]. - Total revenue for the year ended December 31, 2022, was $15,216,000, a significant increase from $1,120,000 in 2021[288]. - The company recorded royalties of $1.1 million under the BMS License Agreement for the year ended December 31, 2022[227]. - The company recognized an impairment of $74.2 million for the contract intangible asset acquired in connection with the Merger, reducing its value to $3.9 million[346]. Product Development and Launch - The company launched FYARRO in the United States for the treatment of advanced malignant PEComa on February 22, 2022[224]. - The company initiated a registration-directed tumor-agnostic Phase 2 study ("PRECISION 1") of FYARRO in patients with TSC1 & TSC2 alterations, with preliminary data expected in Q2 2023[224]. - FYARRO generated net product sales of $15.2 million for the year ended December 31, 2022, following its launch on February 22, 2022[234]. - The company launched sales of FYARRO in February 2022, following FDA approval in November 2021, marking a significant product introduction[332]. Expenses and Cost Management - Selling, general and administrative expenses increased to $40.2 million in 2022 from $18.5 million in 2021, reflecting the costs associated with being a public company[247]. - Research and development expenses rose to $32.7 million in 2022, up from $19.7 million in 2021, driven by costs related to the PRECISION 1 trial[247]. - The total operating expenses for 2022 were $77.9 million, a decrease from $112.3 million in 2021, primarily due to a significant impairment charge in 2021[247]. - Cash used in operating activities for the year ended December 31, 2022, was $49.6 million, compared to $22.4 million for the year ended December 31, 2021[262]. - The impairment charge of $3.7 million in 2022 was related to the termination of the Gossamer License Agreement[243]. - Research and development expenses for the year ended December 31, 2022, amounted to $3.310 million, up from $657,000 in 2021, indicating an increase of about 404%[273]. Financing and Capital Structure - The company completed a private placement (2022 PIPE Financing) on September 26, 2022, raising approximately $72.2 million after deducting offering expenses[226]. - Cash provided by financing activities for the year ended December 31, 2022, was $72.6 million, a decrease from $141.8 million for the year ended December 31, 2021[264]. - The Company raised $155.0 million through the 2021 PIPE Financing by selling 11,852,862 shares of common stock, resulting in net proceeds of $145.4 million after expenses[305]. - The estimated fair value of total consideration given in the merger was $110.4 million, based on 3,208,718 shares of common stock at $33.00 per share[301]. Assets and Liabilities - As of December 31, 2022, the company had $172.6 million in cash, cash equivalents, and short-term investments, expected to fund operations into 2025[235]. - Total current assets increased to $180,029,000 in 2022 from $151,272,000 in 2021, showing growth in asset base[286]. - Total liabilities rose to $25,859,000 in 2022 from $21,504,000 in 2021, indicating an increase in financial obligations[286]. - The company’s accumulated deficit increased to $203,198,000 in 2022 from $142,685,000 in 2021, highlighting ongoing financial challenges[286]. Shareholder Equity and Stock Options - The weighted average number of common shares outstanding used in computing net loss per share was 22,511,237 for 2022, compared to 8,923,369 for 2021, reflecting dilution[288]. - As of December 31, 2022, the company had 300,000,000 shares of authorized common stock, with 24,435,007 shares outstanding, an increase from 20,894,695 shares in 2021[372]. - The company recognized total share-based compensation costs of $9.6 million in 2022, significantly up from $2.1 million in 2021[383]. - The company had 29,167 warrants outstanding as of December 31, 2022, down from 36,666 in 2021, with 7,500 warrants exercised during 2022[386]. Management and Governance - The company underwent a leadership transition with the appointment of Scott Giacobello as Interim Chief Executive Officer effective March 15, 2023[224]. - Management concluded that internal control over financial reporting was effective as of December 31, 2022[402]. - The company has adopted a code of business conduct and ethics applicable to all employees, officers, and directors[405].
Aerpio Pharmaceuticals(AADI) - 2022 Q4 - Annual Report