MAIA Biotechnology(US:MAIA)2022-11-09 21:46Financial Performance - The net loss for Q3 2022 was approximately $3.93 million, a 24% improvement compared to a net loss of $5.20 million in Q3 2021[111]. - Total operating costs and expenses for Q3 2022 were approximately $3.99 million, a 79% increase from $2.23 million in Q3 2021[111]. - For the nine months ended September 30, 2022, total operating costs and expenses reached approximately $10.88 million, a 127% increase from $4.79 million in the same period in 2021[116]. - The Company expects to continue to incur operating losses for the foreseeable future and may never become profitable[120]. - The Company generated no revenues and is dependent on its ability to raise equity and/or debt financing to continue operations[120]. Expenses - The company reported a 117% increase in research and development expenses, rising from approximately $1.08 million in Q3 2021 to approximately $2.34 million in Q3 2022[112]. - General and administrative expenses increased by 44%, from approximately $1.15 million in Q3 2021 to approximately $1.65 million in Q3 2022[113]. - Research and development expenses increased by approximately $4,551,000 or 229%, from approximately $1,988,000 for the nine months ended September 30, 2021 to approximately $6,540,000 for the nine months ended September 30, 2022[117]. - General and administrative expenses increased by approximately $1,543,000 or 55%, from approximately $2,799,000 for the nine months ended September 30, 2021 to approximately $4,342,000 for the nine months ended September 30, 2022[118]. - Total expense related to stock options is material to the financial statements, with potential fluctuations in volatility assumptions impacting compensation expenses[145]. Cash Flow and Financing - As of September 30, 2022, cash totaled approximately $14,064,000, an increase of approximately $3,489,000 compared to December 31, 2021[120]. - Net cash used in operating activities for the nine months ended September 30, 2022 was approximately $9,146,000, compared to approximately $2,516,000 for the same period in 2021[126]. - Net cash provided by financing activities was approximately $12,670,000 for the nine months ended September 30, 2022, compared to $12,805,000 for the same period in 2021[129]. - The company plans to raise additional capital to fund operations and develop THIO, with no assurances that financing will be available on acceptable terms[123][124]. - The company completed sales of 263,729 shares of common stock at $9.00 per share, resulting in proceeds of approximately $2.4 million from January 27, 2022, to February 28, 2022[141]. Clinical Development - The company received Orphan Drug Designation from the FDA for THIO for the treatment of hepatocellular carcinoma and small-cell lung cancer, providing potential market exclusivity for up to seven years[106]. - The company initiated its Phase 2 clinical study (THIO-101) in Australia, with the first patient administered THIO in July 2022[110]. - The THIO-101 Phase 2 clinical study was approved by the Bellberry Human Research Ethics Committee in Australia, with clinical sites selected in Australia and Europe[140]. - Research and collaboration agreements were established with Nationwide Children's Hospital to evaluate THIO in combination with standard therapies for brain cancer[110]. Market and Operational Risks - The company is actively monitoring the impact of the COVID-19 pandemic and the war in Ukraine on its operations, with potential adverse effects on financial condition and liquidity[108][109]. - The company is classified as a smaller reporting company and is not required to provide additional market risk disclosures[148]. Stock and Compensation - The fair value of the company's common stock was determined to be $5.00 per share for June 2022, based on the initial public offering price[141]. - Stock-based compensation expenses are recognized based on the grant date fair value, with significant reliance on the Black-Scholes-Merton valuation model[144]. - The company estimates prepaid and accrued research and development expenses based on contracts and services performed, confirming accuracy with service providers[146]. - Clinical study expenses are based on estimates of services received from multiple CROs, with financial terms varying by contract[146]. - There have been no material differences between the company's estimates of expenses and actual amounts incurred to date[146].