As filed with the U.S. Securities and Exchange Commission on February 6, 2023. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MAIA Biotechnology, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 83-1495913 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial (I.R.S. Employer Identification No.) Classification Code Number) 444 West Lak ...

Financial 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].

Pipeline and Clinical Trials - THIO-101 is in a Phase 2 trial for Non-Small Cell Lung Cancer (NSCLC), combining THIO with LIBTAYO® (cemiplimab), with plans to evolve into a pivotal trial including US sites and a readout expected in 2024 and potential accelerated approval filing in 2025[2] - THIO-102 is planned to initiate a pivotal Phase 2 trial in 2023 for CRC, HCC, and SCLC, sequenced with Libtayo, Keytruda, or Tecentriq[2] - The company anticipates 30-60% ORR (Overall Response Rate) with THIO → LIBTAYO in NSCLC, compared to 11-23% with current SOC (chemo)[14] - The company anticipates 6-12 months PFS (Progression-Free Survival) with THIO → LIBTAYO in NSCLC, compared to 4-4.5 months with current SOC (chemo)[14] - The company anticipates 14-20 months OS (Overall Survival) with THIO → LIBTAYO in NSCLC, compared to 8.1-10.5 months with current SOC (chemo)[14] THIO Mechanism and Preclinical Data - Telomerase is present in over 85% of human cancer cells across various tumor types[4] - Preclinical studies showed complete response with no recurrence in lung, colorectal, and liver cancers using THIO[3] - THIO induces telomere dysfunction-induced foci (TIFs) in telomerase-positive cancer cells, but not in normal cells[51] - In vivo studies in colorectal cancer (CRC) showed that THIO followed by PD-L1 blockade turned immunologically cold tumors "hot" and was curative[56] Market and Financials - The Immune Checkpoint Inhibitors market had sales of $23 billion in 2021[28] - NSCLC drug sales accounted for $12 billion of the $23 billion total checkpoint inhibitor sales in 2021[28] - As of June 30, 2022, the company had a cash balance of $8,150,012, with gross proceeds of $11.5 million from an IPO completed on August 1, 2022[33]

Company Focus - The company is focused on developing therapies for lung cancer, specifically targeting Non-Small Cell Lung Cancer (NSCLC), which accounts for 85% of all lung cancers[108]. Financial Performance - The net loss attributable to MAIA Biotechnology, Inc. shareholders for the six months ended June 30, 2022, was $7,170,306, a 62.42% increase from $4,414,708 in the prior year[120]. - Total operating costs and expenses for the six months ended June 30, 2022, were $6,885,602, a 169.60% increase from $2,553,969 in the same period of 2021[120]. - Net cash used in operating activities for the six months ended June 30, 2022 was approximately $4,827,000, compared to $1,204,000 for the same period in 2021[128]. - Net cash provided by financing activities was approximately $2,411,000 for the six months ended June 30, 2022, down from $7,322,000 for the same period in 2021[133]. - The Company expects to continue to incur operating losses for the foreseeable future and may never become profitable[124]. Research and Development - Research and development expenses increased by approximately $1,475,000 or 229% from $644,000 in Q2 2021 to $2,119,000 in Q2 2022, primarily due to clinical trial preparations[115]. - Research and development expenses for the six months ended June 30, 2022, totaled approximately $4,197,000, a 362.84% increase from $907,000 in the same period of 2021[121]. - The company initiated its Phase 2 clinical study (THIO-101) in Australia, with the first patient administered THIO in July 2022[113]. - 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[143]. Expenses - General and administrative expenses rose by approximately $463,000 or 54% from $859,000 in Q2 2021 to $1,322,000 in Q2 2022, driven by increased payroll and professional fees[116]. - General and administrative expenses increased by approximately $1,042,000 or 63% from $1,647,000 for the six months ended June 30, 2021 to $2,689,000 for the six months ended June 30, 2022[122]. - Other income (expense), net increased approximately $2,094,000, or 109% from approximately ($1,928,000) for the six months ended June 30, 2021 to approximately $166,000 for the six months ended June 30, 2022[123]. Capital and Financing - The company raised approximately $10 million from an initial public offering by selling 2,000,000 shares at $5.00 per share[113]. - 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[144]. - The Company plans to raise additional capital to fund operations and develop new products, with no assurance that financing will be available on acceptable terms[126]. Market Designation - The FDA granted Orphan Drug Designation to THIO for treating hepatocellular carcinoma and small cell lung cancer, providing potential market exclusivity for up to seven years[113]. Cash Position - As of June 30, 2022, available cash totaled approximately $8,150,000, a decrease of approximately $2,424,000 compared to December 31, 2021[124]. Stock Compensation - Stock-based compensation is recognized based on the grant date fair value of awards, with significant reliance on subjective assumptions such as expected stock price volatility[146]. - The fair value of restricted stock awards is determined by the company's common stock price, while stock options and warrants are estimated using the Black-Scholes-Merton model[146]. - The company estimates expected stock volatility based on the historical volatility of peer companies due to a lack of company-specific data[146]. - Changes in clinical trial results could impact the fair value of the company's common stock, introducing uncertainty in financial statements[147]. - The total expense related to stock options is material to the financial statements, with potential for significant fluctuations in compensation expense due to volatility assumptions[147]. - The company is classified as a smaller reporting company and is not required to provide additional market risk disclosures[149]. Operational Impact - The company is actively monitoring the impact of the COVID-19 pandemic and the war in Ukraine on its operations and financial condition[111][112].