[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss of $8.6 million for the six months ended June 30, 2023, an increase from the $6.7 million loss in the same period of 2022, driven by higher research and development and general administrative expenses. As of June 30, 2023, the company had $9.1 million in cash and an accumulated deficit of $52.8 million. The financial statements were prepared on a going concern basis, but substantial doubt exists about the company's ability to continue as a going concern due to recurring losses and negative cash flows - The company has incurred recurring losses and negative cash flows, resulting in an accumulated deficit of **$52.8 million** as of June 30, 2023. This raises substantial doubt about its ability to continue as a going concern[31](index=31&type=chunk)[119](index=119&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets were $10.3 million, a decrease from $12.0 million at year-end 2022, primarily due to a reduction in cash from $11.0 million to $9.1 million. Total liabilities remained stable at approximately $3.4 million, while total stockholders' equity decreased from $8.5 million to $6.9 million, reflecting the net loss for the period Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $9,146,156 | $10,950,927 | | Total current assets | $9,776,314 | $11,808,037 | | Total assets | $10,268,763 | $12,022,040 | | **Liabilities & Equity** | | | | Total current liabilities | $3,272,829 | $3,268,906 | | Total liabilities | $3,394,429 | $3,514,247 | | Accumulated deficit | $(52,847,772) | $(44,207,272) | | Total stockholders' equity | $6,874,334 | $8,507,793 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the six months ended June 30, 2023, the company reported a net loss of $8.6 million, compared to a net loss of $6.7 million for the same period in 2022. The increased loss was driven by a 14% rise in R&D expenses to $4.8 million and a 51% rise in G&A expenses to $4.1 million. Net loss per share for the six-month period was $0.72, an improvement from $0.90 in the prior year period due to a higher number of weighted average shares outstanding Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $2,599,315 | $2,119,465 | $4,795,306 | $4,196,794 | | General and administrative expenses | $2,065,331 | $1,322,579 | $4,053,590 | $2,688,808 | | Loss from operations | $(4,664,646) | $(3,442,044) | $(8,848,896) | $(6,885,602) | | Net loss | $(4,523,624) | $(3,305,883) | $(8,640,500) | $(6,719,728) | | Net loss per share (Basic and diluted) | $(0.35) | $(0.40) | $(0.72) | $(0.90) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, net cash used in operating activities was $5.9 million, an increase from $4.8 million in the prior-year period. Net cash provided by financing activities was $4.1 million, primarily from a follow-on stock offering, compared to $2.4 million in the same period of 2022. This resulted in a net decrease in cash of $1.8 million, leaving a cash balance of $9.1 million at the end of the period Cash Flow Summary (Unaudited) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,921,281) | $(4,827,231) | | Net cash provided by financing activities | $4,119,522 | $2,411,027 | | Net decrease in cash | $(1,804,771) | $(2,424,280) | | Cash at end of period | $9,146,156 | $8,150,012 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies, including the basis for the going concern uncertainty. Key commitments include patent licensing agreements with UTSW for the THIO compound, which involve potential milestone payments up to $112 million and sales royalties. The company also has a clinical trial collaboration with Regeneron. Stockholders' equity changes were driven by a follow-on offering in April 2023, stock-based compensation, and warrant issuances - The company has a Global Patent Licensing Agreement with the University of Texas Southwestern (UTSW) for its THIO compound, which includes potential milestone payments up to a combined total of **$112 million** and sales-based royalties of **2-5%**[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - A clinical trial agreement is in place with Regeneron Pharmaceuticals to supply its drug cemiplimab at no cost for the THIO-101 trial in Non-Small Cell Lung Cancer (NSCLC)[101](index=101&type=chunk) - On April 27, 2023, the company completed a follow-on offering, selling **2,555,500 shares** at **$2.25 per share**, raising net proceeds of approximately **$4.4 million**[76](index=76&type=chunk)[124](index=124&type=chunk) - As of June 30, 2023, the company had a full valuation allowance against its deferred tax assets due to uncertainty of their realization[102](index=102&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MAIA Biotechnology is a clinical-stage company focused on developing cancer therapies, with its lead candidate THIO targeting Non-Small Cell Lung Cancer (NSCLC). The company highlighted positive initial data from its THIO-101 Phase 2 trial. Operating expenses increased significantly in the first half of 2023 due to expanded clinical activities and costs associated with being a public company. The company's cash of $9.1 million as of June 30, 2023, raises substantial doubt about its ability to continue as a going concern, necessitating future capital raises to fund operations - The company is a clinical-stage biotechnology firm focused on developing therapies for cancer, with its primary target being Non-Small Cell Lung Cancer (NSCLC), which constitutes **85% of all lung cancers**[106](index=106&type=chunk) - Positive topline data from the THIO-101 trial's safety lead-in portion (Part A) showed THIO was well tolerated. Preliminary survival data for the first two heavily pretreated patients showed they remained alive and progression-free for approximately **10 and 9 months**, respectively, which is noteworthy compared to the typical **3-4 month survival** in this population[108](index=108&type=chunk)[110](index=110&type=chunk) - The company acknowledges that its current cash reserves are insufficient to fund operations for the next year, leading to substantial doubt about its ability to continue as a going concern. Additional capital will need to be raised through equity or debt financing[120](index=120&type=chunk)[124](index=124&type=chunk) [Financial Operations Overview and Analysis](index=26&type=section&id=Financial%20Operations%20Overview%20and%20Analysis) For the six months ended June 30, 2023, R&D expenses rose 14% to $4.8 million due to increased pre-clinical activities and higher payroll. G&A expenses increased 51% to $4.1 million, driven by costs of operating as a public company and increased headcount. This resulted in a 29% increase in the operating loss to $8.8 million compared to the same period in 2022 Comparison of Operating Results (Six Months Ended June 30) | Metric | 2023 | 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $4,795,306 | $4,196,794 | $598,512 | 14% | | General and administrative expenses | $4,053,590 | $2,688,808 | $1,364,782 | 51% | | Loss from operations | $(8,848,896) | $(6,885,602) | $(1,963,294) | 29% | | Net loss | $(8,640,500) | $(6,719,728) | $(1,920,772) | 29% | - The increase in R&D expenses for the six months ended June 30, 2023 was primarily due to a **$662,000** increase in pre-clinical activities and a **$658,000** increase in payroll and bonus expenses from higher headcount[116](index=116&type=chunk) - The increase in G&A expenses was mainly attributable to increased costs for infrastructure to support operations as a public company, including a **$1.3 million** increase in other expenses (investor relations, insurance) and a **$412,000** increase in payroll and benefits[117](index=117&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company had cash of $9.1 million and working capital of $6.5 million. Operations are funded through equity financing, including an IPO in August 2022 and a follow-on offering in April 2023 that raised approximately $4.4 million in net proceeds. Despite these efforts, the company's current funds are not sufficient to cover operations for the next twelve months, reinforcing the going concern uncertainty and the need to raise additional capital - As of June 30, 2023, the company's cash totaled **$9,146,156**. Management has concluded there is substantial doubt about the company's ability to continue as a going concern[119](index=119&type=chunk)[120](index=120&type=chunk) - In August 2022, the company raised total net proceeds of **$9.1 million** from its Initial Public Offering (IPO) and over-allotment option[75](index=75&type=chunk) - On April 27, 2023, the company closed a follow-on offering, raising aggregate net proceeds of approximately **$4.4 million**[124](index=124&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, MAIA Biotechnology, Inc. is not required to provide this information - The company is a smaller reporting company and is not required to provide the information otherwise required under this item[132](index=132&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2023. A material weakness previously identified as of December 31, 2022, related to insufficient segregation of duties and accounting for complex transactions, was remediated during the second quarter of 2023 by reassigning roles and engaging a third-party consultant - Management concluded that as of June 30, 2023, the company's disclosure controls and procedures were effective at a reasonable assurance level[133](index=133&type=chunk) - A material weakness identified for the year ended December 31, 2022, concerning insufficient segregation of duties and accounting for complex transactions, was remediated in the second quarter of 2023[134](index=134&type=chunk) - Remediation actions included reassigning roles and responsibilities in the accounting system and engaging a third-party consultant to assist with complex transactions[135](index=135&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not party to any material legal proceedings[137](index=137&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022 - As of the date of this Quarterly Report, there have been no material changes to the risk factors disclosed in the Annual Report on Form 10-K filed on March 24, 2023[138](index=138&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the quarter, the company issued unregistered shares of common stock to several entities for media, professional relations, and investor services. The use of proceeds from the August 2022 IPO and the April 2023 follow-on offering has not materially changed from the plans described in the respective prospectuses - The company issued unregistered shares of common stock for services to The Money Channel NYC Inc., Acorn Management Partners, LLC, Outside the Box Capital Inc., and FON Consulting[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - There has been no material change in the planned use of proceeds from the initial public offering as described in the final prospectus filed on July 29, 2022[144](index=144&type=chunk) [Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None - None[147](index=147&type=chunk) [Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - Not applicable[147](index=147&type=chunk) [Other Information](index=33&type=section&id=Item%205.%20Other%20Information) None - None[148](index=148&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, underwriting agreements, certifications, and XBRL data files

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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: 001-41455 MAIA BIOTECHNOLOGY, INC. (Exact Name of Registrant as Specified in its Charter) ( State or o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 001-41455 MAIA BIOTECHNOLOGY, INC. (Exact name of Registrant as specified in its Charter) Delaware 83-1495913 (State or other jurisdictio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Commission File Number: 001-41455 MAIA BIOTECHNOLOGY, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 83-1495913 ( State or other jurisdiction of incorporation or organization) 444 West Lake Street, Suite 1700 (I.R.S. Employer Identification No.) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITI ...

BIOTECHNOLOGY TELOMERE TARGETING IMMUNOTHERAPIES FOR CANCER NYSE AMERICAN: MAIA October 2022 DISCLOSURE All statements in this presentation, other than those relating to historical facts, are "forward-looking statements." These forward-looking statements may include, but are not limited to, statements relating to our objectives, plans, and strategies; statements that contain projections of results of operations or of financial condition; statements relating to the industry and government policies and regula ...

WASHINGTON, DC 20549 UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ 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 ☐ 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: 001-41455 MAIA BIOTECHNOLOGY, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 83-1 ...