MAIA 10-Q
MAIA Biotechnology, Inc. (MAIA)
b
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
(Zip Code) |
(
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address and fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of November 12, 2024, the registrant had
Table of Contents
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1 |
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2 |
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Item 1. |
2 |
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Condensed Consolidated Balance Sheets as of September 30, 2024 (Unaudited) and December 31, 2023 |
2 |
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3 |
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4 |
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5 |
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7 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
8 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
23 |
Item 3. |
34 |
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Item 4. |
34 |
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35 |
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Item 1. |
35 |
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Item 1A. |
35 |
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Item 2. |
36 |
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Item 3. |
36 |
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Item 4. |
36 |
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Item 5. |
36 |
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Item 6. |
38 |
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39 |
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i
CAUTIONARY NOTICE ABOUT FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). This Report contains a number of forward-looking statements that reflect management’s current views and expectations with respect to our business, strategies, products, future results and events, and financial performance. All statements other than statements of historical facts contained in this report, including statements regarding our future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, forward-looking statements may be identified by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "would," "expect," "objective," "plan," "potential," "seek," "grow," "target," "if,", variations of such words, the negative of these terms and similar expressions intended to identify forward-looking statements. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors, including those which we discuss under “Risk Factors,” elsewhere in this Quarterly Report on Form 10-Q and in our other filings with the Securities and Exchange Commission (the "SEC").
Readers should not place undue reliance on these forward-looking statements, which are based on management’s current expectations and projections about future events, are not guarantees of future performance, are subject to risks, uncertainties and assumptions and apply only as of the date of this Report. Our actual results, performance or achievements could differ materially from historical results as well as from the results expressed in, anticipated or implied by these forward-looking statements. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Report or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the U.S. Securities and Exchange Commission could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Any public statements or disclosures by us following this Report that modify or impact any of the forward-looking statements contained in this Report will be deemed to modify or supersede such statements in this Report.
For a discussion of some of the factors that may affect our business, results and prospects, see “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024 and in our other reports we file with the SEC, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Readers are also urged to carefully review and consider the various disclosures made by us in this Report and in our other reports we file with the SEC, including our Quarterly Reports on Forms 10-Q and Current Reports on Form 8-K, and those described from time to time in our press releases and other communications, which attempt to advise interested parties of the risks and factors that may affect our business, prospects and results of operations.
Unless the context indicates or otherwise requires, “the Company,” “our Company,” “we,” “us,” and “our” refer to MAIA Biotechnology, Inc., a Delaware corporation, and its consolidated subsidiaries.
1
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
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September 30, |
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December 31, |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash |
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$ |
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$ |
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Prepaid expenses and other current assets |
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Australia research and development incentives receivable |
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Total current assets |
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Other assets |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Total current liabilities |
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Long term liabilities: |
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Warrant liability |
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Total liabilities |
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Stockholders' equity |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
) |
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( |
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Accumulated other comprehensive loss |
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( |
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( |
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Total stockholders' equity |
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Total liabilities and stockholders' equity |
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$ |
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$ |
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See the accompanying notes to the unaudited condensed consolidated financial statements.
2
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
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Three Months Ended |
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Nine Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development expenses |
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$ |
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$ |
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$ |
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$ |
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General and administrative expenses |
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Total operating expenses |
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Loss from operations |
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( |
) |
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( |
) |
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( |
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( |
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Other (expense) income: |
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Interest expense |
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( |
) |
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( |
) |
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( |
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( |
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Interest income |
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Australian research and development |
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Change in fair value of warrant liability |
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( |
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Loss on fair value of warrants over proceeds |
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— |
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— |
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( |
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— |
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Other (expense) income, net |
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( |
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Net loss |
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( |
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( |
) |
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( |
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( |
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Net loss attributable to MAIA |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Net loss per share |
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Basic and diluted |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
Weighted average common shares |
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See the accompanying notes to the unaudited condensed consolidated financial statements.
3
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited)
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Three Months Ended |
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Nine Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
Foreign currency translation adjustment |
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( |
) |
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( |
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Comprehensive loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
See the accompanying notes to the unaudited condensed consolidated financial statements.
4
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited)
For the Three and Nine Months Ended |
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September 30, 2024 |
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Preferred Stock |
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Common Stock |
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Shares |
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Amount |
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Shares |
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Amount |
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Additional Paid-In Capital |
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Accumulated Deficit |
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Accumulated Other Comprehensive (Loss) Income |
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Total Stockholders' Equity (Deficit) |
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Balance at December 31, 2023 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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Issuance of restricted stock |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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Issuance of common shares in connection with At-The-Market financing, net of $ |
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— |
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— |
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— |
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— |
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Issuance of common shares in connection with the Private Placement Offering #1, net of $ |
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— |
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— |
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— |
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— |
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Issuance of common shares in connection with the Private Placement Offering #2, net of $ |
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— |
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— |
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— |
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— |
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Issuance of warrants in connection with the Private Placement Offering #1 |
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— |
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— |
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— |
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— |
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— |
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— |
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Foreign currency translation adjustment |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Balance at March 31, 2024 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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|||
Exercise of stock options |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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Issuance of common shares in connection with At-The-Market financing, net of $ |
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— |
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— |
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— |
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— |
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Issuance of common shares in connection with the Private Placement Offering #3, net of $ |
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— |
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— |
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— |
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— |
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Issuance of warrants in connection with the Private Placement Offering #3 |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of warrants |
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— |
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— |
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— |
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— |
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Reclassification of liability classified warrants to equity |
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— |
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— |
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— |
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— |
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— |
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— |
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Foreign currency translation adjustment |
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— |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Balance at June 30, 2024 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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Issuance of restricted stock |
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||||||||
Exercise of stock options |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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||
Issuance of common shares in connection with At-The-Market financing, net of $ |
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— |
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— |
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— |
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— |
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||||
Foreign currency translation adjustment |
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— |
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— |
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— |
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— |
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— |
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— |
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||
Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
|
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— |
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( |
) |
Balance at September 30, 2024 |
|
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
See the accompanying notes to the unaudited condensed consolidated financial statements.
5
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited)
For the Three and Nine Months Ended |
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September 30, 2023 |
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Preferred Stock |
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Common Stock |
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Shares |
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Amount |
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Shares |
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Amount |
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Additional Paid-In Capital |
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Accumulated Deficit |
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Accumulated Other Comprehensive (Loss) Income |
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Total Stockholders' Equity |
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Balance at December 31, 2022 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
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$ |
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||||
Issuance of restricted stock |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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Foreign currency translation adjustment |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
|
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— |
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( |
) |
Balance at March 31, 2023 |
|
|
— |
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of restricted stock |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Issuance of common shares in connection with follow-on offering, net of $ |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Issuance of warrants to underwriter in connection with follow-on offering |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Issuance of stock options to satisfy accrued bonus |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
- |
|
|
|
|
||
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Balance at June 30, 2023 |
|
|
— |
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of common shares upon exercise of stock options |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Issuance of restricted stock |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Balance at September 30, 2023 |
|
|
— |
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
See the accompanying notes to the unaudited condensed consolidated financial statements.
6
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
Nine Months Ended |
|
||||||
|
2024 |
|
|
2023 |
|
|||
Cash flows from operating activities: |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
|
|
|
|
||
Consulting expense for restricted shares issued |
|
|
|
|
|
|
||
Change in fair value of warrant liability |
|
|
|
|
|
( |
) |
|
Loss on fair value of warrants over proceeds |
|
|
|
|
|
— |
|
|
Change in operating assets and liabilities: |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
( |
) |
|
|
|
|
Australia research and development incentives receivable |
|
|
|
|
|
|
||
Accounts payable |
|
|
( |
) |
|
|
|
|
Accrued expenses |
|
|
( |
) |
|
|
|
|
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
||
Deferred offering costs |
|
|
— |
|
|
|
( |
) |
Proceeds from exercise of stock options |
|
|
|
|
|
|
||
Proceeds from sale of common stock in follow-on offering |
|
|
— |
|
|
|
|
|
Proceeds from private placement round 1 |
|
|
|
|
|
— |
|
|
Proceeds from private placement round 2 |
|
|
|
|
|
— |
|
|
Proceeds from private placement round 3 |
|
|
|
|
|
— |
|
|
Proceeds from ATM Offerings |
|
|
|
|
|
— |
|
|
Payment of offering transactions costs |
|
|
( |
) |
|
|
( |
) |
Net cash provided by financing activities |
|
|
|
|
|
|
||
Net effect of foreign currency exchange on cash |
|
|
|
|
|
( |
) |
|
Net increase (decrease) in cash |
|
|
|
|
|
( |
) |
|
Cash at beginning of period |
|
|
|
|
|
|
||
Cash at end of period |
|
$ |
|
|
$ |
|
||
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
||
Options issued for accrued bonus |
|
$ |
— |
|
|
$ |
|
|
Warrants issued to underwriters in connection with the follow-on offering |
|
$ |
— |
|
|
$ |
|
|
Warrants issued in connection with private placement offering #1 |
|
$ |
|
|
$ |
— |
|
|
Warrants issued in connection with private placement offering #2 |
|
$ |
|
|
$ |
— |
|
|
Warrants issued in connection with private placement offering #3 |
|
$ |
|
|
$ |
— |
|
|
See the accompanying notes to the unaudited condensed consolidated financial statements.
7
MAIA Biotechnology, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements
Description of Business, Organization, and Principles of Consolidation
MAIA Biotechnology, Inc. and subsidiaries (collectively, “the Company”) is a biopharmaceutical company that develops oncology drug candidates to improve and extend the lives of people with cancer. MAIA Biotechnology, Inc. (“MAIA”) was incorporated in the state of
Going Concern Considerations
The accompanying unaudited consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
To date, the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $
To meet the Company’s future working capital needs, the Company will need to raise additional equity or enter into debt financing. While the Company has historically been able to raise additional capital through issuance of equity and/or debt financing, and while the Company has implemented a plan to control its expenses in order to satisfy its obligations due within one year from the date of issuance of these financial statements, the Company cannot guarantee that it will be able to raise additional equity, raise debt, or contain expenses. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these financial statements are issued.
Basis of Presentation
Basis of Presentation and Consolidation Principles
The accompanying condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The condensed consolidated financial statements may not include all disclosures required by GAAP; however, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the fiscal year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 21, 2024. The condensed consolidated balance sheet as of December 31, 2023 was derived from such audited financial statements.
In the opinion of management, all adjustments, consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, have been made.
8
The results of operations for the interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods.
The unaudited interim condensed consolidated financial statements include the accounts of the Company's wholly owned subsidiaries. All transactions and accounts between and among its subsidiaries have been eliminated. All adjustments and disclosures necessary for a fair presentation of these unaudited interim condensed consolidated financial statements have been included.
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company and the Company’s chief operating decision-maker, the Company’s Chief Executive Officer, view the Company’s operations and manage its business as a single operating segment, which is the business of discovering and developing products for the treatment of immunotherapies for cancer.
Use of Estimates
The preparation of the Company’s unaudited interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to the valuation of the Company’s common stock, par value $
Certain Risks and Uncertainties
The Company’s activities are subject to significant risks and uncertainties including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, the development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.
Foreign Currency Translation
The financial statements of the Company’s foreign subsidiaries, where the local currency is the functional currency, are translated using exchange rates in effect as of the applicable balance sheet dates for assets and liabilities and average exchange rates during the period for results of operations. The resulting foreign currency translation adjustment is included in stockholders’ equity as accumulated other comprehensive loss.
Off-Balance Sheet Risk and Concentrations of Credit Risk
The Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Cash accounts are maintained at financial institutions that potentially subject the Company to concentrations of credit risk. As of September 30, 2024 and December 31, 2023, substantially all of the Company’s cash was deposited in accounts at two financial institutions. The Company maintains its cash deposits, which at times may exceed the federally insured limits, with a reputable financial institution, and accordingly, the Company believes such funds are subject to minimal credit risk.
9
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with maturities of three months or less to be cash equivalents. As of September 30, 2024 and December 31, 2023, cash includes cash in depository bank accounts. The Company had
Fair Value Measurements
The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurements and Disclosures (“ASC 820”) establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.
Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:
Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the nine months ended September 30, 2024, and as of and during the twelve months ended December 31, 2023. The carrying amount of accounts payable approximated fair value, as they are short term in nature. The fair value of warrants issued for services is estimated based on the Black-Scholes-Merton model during the nine months ended September 30, 2024. The estimated fair value of warrants issued to underwriters represented Level 3 measurements.
General and Administrative
General and administrative expenses primarily consist of costs for corporate functions, including payroll and related expenses, rent, outside legal expenses, insurance costs, and other general and administrative costs.
Research and Development
The Company’s research and development expenses consist primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in ongoing research and development efforts. Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received.
As part of the process of preparing the condensed consolidated financial statements, the Company is required to estimate its accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The majority of the Company’s service providers invoice the Company monthly in arrears for services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses as of each balance sheet date in our consolidated financial statements based on facts and circumstances known to the Company at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes
10
adjustments if necessary. The estimates in the Company’s accrued research and development expenses are related to expenses incurred with respect to contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other vendors in connection with research and development and manufacturing activities.
The Company bases its expense related to CROs and CMOs on its estimates of the services received and efforts expended pursuant to quotations and contracts with such vendors that conduct research and development and manufacturing activities on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the applicable research and development or manufacturing expense. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, the Company adjusts the accrual or prepaid expense accordingly. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period. There have been no material changes in estimates for the periods presented.
Research and Development Incentive
The Company recognizes other income from Australian research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The research and development incentive is one of the key elements of the Australian government’s support for Australia’s innovation system and is supported by legislative law primarily in the form of the Australian Income Tax Assessment Act 1997, as long as eligibility criteria are met. Under the program, a percentage of eligible research and development expenses incurred by the Company through its subsidiary in Australia are reimbursed.
Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the research and development incentive regime described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time, and it is included in Australian research and development incentives in the condensed consolidated statements of operations.
Derivative Financial Instruments
The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates all of its financial instruments to determine if such instruments contain features that qualify as embedded derivatives.
Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract. Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the statement of operations each period.
Stock-Based Compensation
The Company records share-based compensation for awards granted to employees, non-employees, and to members of the board of directors based on the grant date fair value of awards issued, and the expense is recorded on a straight-line basis over the requisite service period. Forfeitures are recognized when they occur.
The Company uses the Black-Scholes-Merton option pricing model to determine the fair value of stock options and warrants. The use of the Black-Scholes-Merton option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. The Company has concluded that its historical share option exercise experience does not provide a reasonable basis upon which to estimate expected term. Therefore, the expected term was determined according to the simplified method,
11
which is the average of the vesting tranche dates and the contractual term. Due to the lack of company specific historical and implied volatility data, the estimate of expected volatility is primarily based on the historical volatility of a group of similar companies that are publicly traded. For these analyses, companies with comparable characteristics, including enterprise value and position within the industry, and with historical share price information sufficient to meet the expected life of the share-based awards, are selected. The Company computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of its share-based awards. The risk-free interest rate is determined by reference to U.S. Treasury zero-coupon issues with remaining maturities similar to the expected term of the options. The Company has not paid, and does not anticipate paying, cash dividends on shares of its Common Stock.
Prior to the Company’s initial public offering (“IPO”) in order to estimate the fair value of shares of the Common Stock, the Company's board of directors considered, among other things, sales of Common Stock to third party investors and valuations of Common Stock, business, financial condition and results of operations, including related industry trends affecting operations; the likelihood of achieving a liquidity event, such as an initial public offering, or sale, given prevailing market conditions; the lack of marketability of our Common Stock; the market performance of comparable publicly traded companies; and U.S. and global economic and capital market conditions.
During the nine months ended September 30, 2024,
All stock-based compensation costs are recorded in general and administrative or research and development costs in the condensed consolidated statements of operations based upon the underlying individual’s role at the Company.
Common Stock Warrants
The Company accounts for Common Stock warrants as either equity instruments or as liabilities in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), depending on the specific terms of the warrant agreement.
When warrants are issued for services provided by non-employees, under ASC 718, Compensation – Stock Compensation (“ASC 718”), the warrants shall be classified as a liability if: (i) the underlying shares are classified as liabilities; or (ii) the entity can be required under any circumstances to settle the warrant by transferring cash or other assets. The measurement of equity-classified non-employee share-based payments is generally fixed on the grant date and are considered compensatory, as defined by ASC 718.
Income Taxes
Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized, assuming examination by the taxing authority. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes any interest and penalties accrued related to unrecognized tax benefits as income tax expense.
Net Loss Per Share
Basic loss per share of Common Stock is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of Common Stock outstanding for the period. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of Common Stock equivalents outstanding for the period, determined using the treasury-stock method. Diluted loss per share excludes,
12
when applicable, the potential impact of stock options, unvested shares of restricted stock awards, and common stock warrants because their effect would be anti-dilutive due to our net loss. Gains on warrant liabilities are only considered dilutive when the average market price of the Common Stock during the period exceeds the exercise price of the warrants. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same.
The following table summarizes the Company’s potentially dilutive securities, in common share equivalents, which have been excluded from the calculation of dilutive loss per share as their effect would be anti-dilutive:
|
|
Nine Months Ended |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Shares issuable upon exercise of stock options |
|
|
|
|
|
|
||
Shares issuable upon exercise of warrants |
|
|
|
|
|
|
||
Recent Accounting Standards
In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2023-07, Segment Reporting – Improvements to Reportable Segment Disclosures (“ASU No. 2023-07”), which provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant segment expenses and increased interim disclosure requirements, among others. ASU No. 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024. Early adoption is permitted, and the amendments should be applied retrospectively. We do not expect the amendments in ASU No. 2023-07 to have a material impact on our consolidated financial statements.
In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures (“ASU No. 2023-09”), which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. We do not expect the amendments in ASU No. 2023-09 to have a material impact on our consolidated financial statements.
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
2. RELATED PARTY TRANSACTIONS
10b5-1 Plan
Certain of our directors and executive officers previously adopted written plans, known as Rule 10b5-1 plans, in which they contracted with a broker to buy shares of our Common Stock on a periodic basis. Each of these plans have expired as of the date of this Quarterly Report. Our directors and executive officers may, in the future, adopt Rule 10b5-1 plans in which they contract with a broker to buy or sell shares of our Common Stock on a periodic basis. Under a Rule 10b5-1 plan, a broker executes trades pursuant to parameters established by the director or officer at the time was entered into, without further direction from the director or officer. The director or officer may amend or terminate the plan in limited circumstances. Our directors and executive officers may also buy or sell additional shares of our Common Stock outside of a Rule 10b5-1 plan when they are not in possession of material nonpublic information.
13
Private Placement
The following Company directors participated in the March 2024 private placement as follows: (i) Stan Smith purchased
The following Company directors participated in the April 2024 private placement as follows: (i) Stan Smith purchased
3. ACCRUED EXPENSES
As of September 30, 2024 and December 31, 2023 accrued expenses consisted of the following:
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Bonus |
|
$ |
|
|
$ |
|
||
Professional fees |
|
|
|
|
|
|
||
Research and development costs |
|
|
|
|
|
|
||
Accrued severance |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total accrued expenses |
|
$ |
|
|
$ |
|
||
Derivative Liability
Financial liabilities consisting of warrant liabilities measured at fair value on a recurring basis are summarized below. The fair value of the warrant liabilities recorded are as follows:
|
|
Fair value at September 30, 2024 |
|
|||||||||||||
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Total liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
|
|
Fair value at December 31, 2023 |
|
|||||||||||||
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Total liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
14
The table below provides a summary of the changes in fair value of the warrant liabilities measured on a recurring basis using significant unobservable inputs (Level 3):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
Warrant liabilities: |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Balance, beginning of period |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Issuance of warrants |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
Exercises of warrants |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
Amendments of warrants |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
Loss (Gain) on fair value of warrant liability |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
Balance, end of period |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Upon the closing of the Company’s IPO, the Company’s shareholders agreement terminated pursuant to its terms. In connection with the closing of the IPO, the Company amended and restated its Amended and Restated Certificate of Incorporation (the “Amended and Restated Certificate of Incorporation”) and amended and restated its Bylaws (the “Amended and Restated Bylaws”). The Amended and Restated Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on August 1, 2022 and became effective on that date, and among other things, increased the authorized number of Common Stock to
At-the-Market Equity Offering
On February 14, 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), to sell shares of its Common Stock, par value $
Share Repurchase Program
On September 28, 2023, the Company announced that its board of directors approved a share repurchase program pursuant to which the Company may repurchase up to $
Private Placement
On March 14, 2024, the Company issued and sold
15
Company received gross proceeds of approximately $
On March 28, 2024, the Company issued and sold
On April 25, 2024, the Company issued and sold
MAIA Biotechnology, Inc. Restricted Stock Awards
During the nine months ended September 30, 2024, the Company expensed $
During the nine months ended September 30, 2023, the Company expensed $
MAIA Stock Warrants
Concurrently with the closing of the IPO, the Company issued warrants to purchase an aggregate of up to
On November 9, 2023, the Company issued warrants to purchase an aggregate of up to
16
was issued
On November 17, 2023, the Company issued warrants concurrently with the Company’s registered direct offering to purchase an aggregate of up to
On November 17, 2023, concurrently with the closing of the Company’s registered direct offering, the Company issued warrants to purchase an aggregate of
Concurrently with the closing of the Company’s private placement on March 14, 2024, the Company issued warrants to purchase an aggregate of up to
Concurrently with the closing of the Company’s private placement offering on March 28, 2024, the Company issued warrants to purchase an aggregate of up to
17
and expire on
Concurrently with the closing of the Company’s private placement offering on April 25, 2024, the Company issued warrants to purchase an aggregate of up to
|
|
Warrants |
|
|
Weighted |
|
|
Weighted |
|
|||
Balance at January 1, 2024 |
|
|
|
|
$ |
|
|
|
|
|||
Issued |
|
|
|
|
|
|
|
|
— |
|
||
Exercised |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
Expired |
|
|
|
|
|
|
|
|
— |
|
||
Balance at September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|||
MAIA Biotechnology, Inc. Stock Option and Equity Incentive Plans
In 2018, the Company adopted the MAIA Biotechnology, Inc. 2018 Stock Option Plan (the “MAIA 2018 Plan”). MAIAs board of directors administers the MAIA 2018 Plan for the purposes of attracting, retaining, and motivating key employees, directors, and consultants of MAIA. The terms of the MAIA 2018 Plan continue to govern the
In 2020, the Company adopted the MAIA Biotechnology, Inc. Amended and Restated 2020 Equity Incentive Plan (the “MAIA 2020 Plan’’), also administered by the board of directors. The MAIA 2020 Plan permitted awards to take the form of stock options, restricted stock and restricted stock units. The terms of the MAIA 2020 Plan continue
18
to govern the
On August 1, 2022 the Company approved MAIA 2021 Plan with
Stock options are to be granted with an exercise price which is at least equal to the stock’s estimated fair value at the date of grant, and with a contractual term of no more than
As of September 30, 2024, only stock options have been awarded pursuant to the MAIA stock option and equity incentive plans.
The following table summarizes the activity and information regarding MAIA’s outstanding and exercisable options for the nine months ended September 30, 2024:
|
|
Options Outstanding |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Balance at January 1, 2024 |
|
|
|
|
$ |
|
|
|
|
|
|
— |
|
|||
Granted |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Exercised |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
Cancelled/forfeited |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
Balance at September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Options exercisable at September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
The value of option grants is calculated using the Black-Scholes-Merton option pricing model with the following assumptions for options granted during the nine months ended September 30, 2024 and 2023:
|
|
2024 |
|
2023 |
Risk-free interest rate |
|
|
||
Expected term (in years) |
|
|
||
Expected volatility |
|
|
||
Expected dividend yield |
|
—% |
|
—% |
19
The weighted-average grant date fair value of stock options issued during the nine months ended September 30, 2024 and 2023 was $
Stock based compensation related to the Company’s stock plans are as follows:
|
|
Three Months Ended |
Nine Months Ended |
|
||||||||||||
|
|
September 30, |
September 30, |
|
||||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
General and administrative |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Legal
From time to time, the Company is involved in legal actions and claims arising in the normal course of business. Management believes there are no matters which will have a material adverse effect on the Company's financial position, operations or cash flows.
Patent Licensing, Sponsored Research, and Patent & Technology Agreements
THIO
In November 2018 and as amended in December 2020, the Company entered into a Global Patent Licensing Agreement (“PLA”) titled “Patent and Technology License Agreement AGT. NO. L2264 – MAIA Biotechnology” with the University of Texas Southwestern (“UTSW”) to license patent families for a specific compound (“THIO”) from UTSW to MAIA (the “UTSW Agreement”). The UTSW Agreement, as amended, has a term of
Also in December 2020, the Company entered into a second license agreement with UTSW titled “Patent and Technology License Agreement AGT. NO. L3648 — MAIA Biotechnology” pursuant to which UTSW is licensing an additional compound to MAIA (the “UTSW2 Agreement”). The UTSW2 Agreement has a term of
The Company will also pay UTSW running royalties on a yearly basis as a percentage of Net Sales (as defined in the UTSW2 Agreement) of the Company or its sublicensee.
20
last Valid Claim in each country or
Regeneron
In February 2021, the Company entered into a Drug Supply Agreement (the “Drug Supply Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”) to perform one clinical trial for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) involving a Regeneron drug candidate that utilizes one of the Company’s compounds/agents. The Company is responsible for all costs of the study with Regeneron supplying their drug cemiplimab representing a cost savings for the Company, the first phase of which is expected to take approximately two years. The overall term of the agreement is for
The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The issuance of shares in connection with the Company’s IPO, as well as prior share issuances, may result in limitations on the utilization of the Company’s net operating loss carryforwards under IRS section 382. As of September 30, 2024, and December 31, 2023, the Company had a full valuation allowance against its deferred tax assets.
For the nine months ended September 30, 2024 and 2023, the Company recorded
Issuance of Options
From October 1 to November 7, 2024, the Company issued
Private Placement
On November 1, 2024, the Company issued and sold
Related Party Participation in Private Placement
The following Company directors participated in the aforementioned November 2024 private placement as follows: (i) Stan Smith purchased
21
price of approximately $
At-The-Market Offering with H.C. Wainwright
Since October 1, 2024, the Company has sold
22
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion together with our financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements that are based on our current expectations, estimates and projections about our business and operations. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors, including those which we discuss under “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q.
Overview
We are a clinical stage biotechnology company engaged in the discovery, development and commercialization of therapies targeting cancer. Our initial disease target is lung cancer, a serious medical condition with an incidence of over 236,000 new cases in the US in 2022, representing 12.3% of all cancers, and over 130,000 deaths, or 21.4% of all cancers. Worldwide, lung cancer incidence is over 2,200,000 per year (ranking second only after breast cancer), and mortality over 1,800,000 (ranking first). Specifically, we are targeting Non-Small Cell Lung Cancer (“NSCLC”), which represents 85% of all lung cancers. THIO (6-thio-dG or 6-thio-2 ‘-deoxyguanosine), our lead asset, is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity.
We have accomplished the following key milestones:
23
24
25
26
27
Impact of the War in Ukraine and War in Israel on Our Operations
The short and long-term implications of war in Ukraine and war in Israel are difficult to predict at this time. The imposition of sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our business, financial condition, and results of operations. Because of the highly uncertain and dynamic nature of these events, the Company terminated any planned research activities in the impacted areas.
28
Results of Operations for the Three and Nine Months Ended September 30, 2024 and 2023
Comparison of Three Months Ended September 30, 2024 and 2023
|
|
Three Months Ended |
|
|
|
|
|
|
||||||
|
|
|
|
|
Change |
|||||||||
|
|
2024 |
|
|
2023 |
|
|
Dollars |
|
|
Percentage |
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
2,667,170 |
|
|
$ |
2,599,578 |
|
|
$ |
67,592 |
|
|
3% |
General and administrative |
|
|
1,521,298 |
|
|
|
2,356,065 |
|
|
|
(834,767 |
) |
|
(35)% |
Total operating costs and expenses |
|
|
4,188,468 |
|
|
|
4,955,643 |
|
|
|
(767,175 |
) |
|
(15)% |
Loss from operations |
|
|
(4,188,468 |
) |
|
|
(4,955,643 |
) |
|
|
767,175 |
|
|
(15)% |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|||
Interest expense |
|
|
(85 |
) |
|
|
(1 |
) |
|
|
(84 |
) |
|
8400% |
Interest income |
|
|
106,082 |
|
|
3260 |
|
|
|
102,822 |
|
|
3154% |
|
Australian research and |
|
|
15,198 |
|
|
|
58,448 |
|
|
|
(43,250 |
) |
|
(74)% |
Change in fair value of warrant |
|
|
1,331,286 |
|
|
|
18,193 |
|
|
|
1,313,093 |
|
|
7218% |
Loss on fair value of warrants over proceeds |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
100% |
Other income, net |
|
|
1,452,481 |
|
|
|
79,900 |
|
|
|
1,372,581 |
|
|
1718% |
Net loss |
|
|
(2,735,987 |
) |
|
|
(4,875,743 |
) |
|
|
2,139,756 |
|
|
(44)% |
Net loss attributable to MAIA |
|
$ |
(2,735,987 |
) |
|
$ |
(4,875,743 |
) |
|
$ |
2,139,756 |
|
|
(44)% |
Operating Costs and Expenses
Research and development expenses
Research and development expenses increased by approximately $67,000 (or approximately 3%), from approximately $2,600,000 for the three months ended September 30, 2023 to approximately $2,667,000 for the three months ended September 30, 2024. The increase was primarily related to an increase in scientific research and clinical research of approximately $293,000, offset by a decrease in payroll expense of approximately $171,000 and a decrease in stock-based compensation costs of approximately $55,000.
General and administrative expenses
General and administrative expenses decreased by approximately $835,000 (or approximately 35%) from approximately $2,356,000 for the three months ended September 30, 2023, to approximately $1,521,000 for the three months ended September 30, 2024. The decrease was primarily related to a decrease in professional fees of approximately $507,000, a decrease in other expenses of approximately $258,000, a decrease in stock-based compensation of approximately $60,000, and a decrease of approximately $10,000 payroll expense.
Other income, net
Other income, net increased by approximately $1,373,000 (or approximately 1718%) from other income of approximately $80,000 for the three months ended September 30, 2023, to other income of approximately $1,452,000 for the three months ended September 30, 2024. The increase was primarily related to the change in the fair value of the warrant liability of approximately $1,313,000, a net increase in interest income of approximately $103,000, and a reduction in the Australian research and development incentives of approximately $43,000.
29
Comparison of the Nine Months Ended September 30, 2024 and 2023
|
|
Nine Months Ended |
|
|
|
|
|
|
||||||
|
|
|
|
|
Change |
|||||||||
|
|
2024 |
|
|
2023 |
|
|
Dollars |
|
|
Percentage |
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
7,040,145 |
|
|
$ |
7,394,884 |
|
|
$ |
(354,739 |
) |
|
(5)% |
General and administrative |
|
|
4,912,461 |
|
|
|
6,409,655 |
|
|
|
(1,497,194 |
) |
|
(23)% |
Total operating costs and expenses |
|
|
11,952,606 |
|
|
|
13,804,539 |
|
|
|
(1,851,933 |
) |
|
(13)% |
Loss from operations |
|
|
(11,952,606 |
) |
|
|
(13,804,539 |
) |
|
|
1,851,933 |
|
|
(13)% |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|||
Interest expense |
|
|
(85 |
) |
|
|
(6,863 |
) |
|
|
6,778 |
|
|
(99)% |
Interest income |
|
|
238,583 |
|
|
|
3,768 |
|
|
|
234,815 |
|
|
6232% |
Australian research and |
|
|
51,847 |
|
|
|
149,457 |
|
|
|
(97,610 |
) |
|
(65)% |
Change in fair value of warrant |
|
|
(8,007,505 |
) |
|
|
141,934 |
|
|
|
(8,149,439 |
) |
|
(5742)% |
Loss on fair value of warrants over proceeds |
|
|
(12,952 |
) |
|
|
— |
|
|
|
(12,952 |
) |
|
100% |
Other (expense) income, net |
|
|
(7,730,112 |
) |
|
|
288,296 |
|
|
|
(8,018,408 |
) |
|
(2781)% |
Net loss |
|
|
(19,682,718 |
) |
|
|
(13,516,243 |
) |
|
|
(6,166,475 |
) |
|
46% |
Net loss attributable to MAIA |
|
$ |
(19,682,718 |
) |
|
$ |
(13,516,243 |
) |
|
$ |
(6,166,475 |
) |
|
46% |
Operating Costs and Expenses
Research and development expenses
Research and development expenses decreased by approximately $355,000 (or approximately 5%) from approximately $7,395,000 for the nine months ended September 30, 2023, to approximately $7,040,000 for the nine months ended September 30, 2024. The decrease was primarily related to a decrease in payroll expense of approximately $1,120,000 related to the decreased headcount of research and development employees and the reversal of the accrued bonus, decrease in stock-based compensation costs of approximately $345,000, and a decrease in other expenses of approximately $37,000, offset by an increase in scientific research and clinical research of approximately $1,147,000.
General and administrative expenses
General and administrative expenses decreased by approximately $1,497,000 (or approximately 23%) from approximately $6,409,000 for the nine months ended September 30, 2023, to approximately $4,912,000 for the nine months ended September 30, 2024. The decrease was primarily related to a decrease in payroll expense of approximately $535,000 relating to the reversal of the accrued bonus, a decrease in professional fees of approximately $418,000, a decrease in other expenses of approximately $381,000 related to lower insurance expenses, and a decrease in stock-based compensation of approximately $163,000.
Other expense, net
Other expense, net increased by approximately $8,018,000 (or approximately 2781%) from other income, net of approximately $288,000 for the nine months ended September 30, 2023, to other expense, net of approximately $7,730,000 for the nine months ended September 30, 2024. The increase was primarily related to the change in the fair value of the warrant liability of approximately $8,149,000, a loss on fair value of warrants over proceeds of approximately $13,000, a reduction in the Australia research and development incentives of approximately $98,000 and a net increase of interest income of approximately $242,000.
30
Liquidity and Capital Resources
Our Ability to Continue as a Going Concern
As of September 30, 2024, our cash totaled approximately $8,691,000 which represented an increase of approximately $1,540,000 compared to December 31, 2023. As of September 30, 2024, we had working capital of approximately $5,631,000 which represents an increase of approximately $3,004,000 compared to December 31, 2023. We have generated no revenues as of September 30, 2024. Our current operating plan indicates that we will continue to incur losses from operations and generate negative cash flows from operating activities given ongoing expenditures related to the completion of its ongoing clinical trials and our lack of revenue generating activities. Based on our cash reserves as of September 30, 2024 of $8,691,000 and current financial condition as of the date of this Quarterly Report, the accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
To meet the Company’s future working capital needs, we will need to raise additional equity or enter into debt financing. While we have historically been able to raise additional capital through issuance of equity and/or debt financing, and we have implemented a plan to control its expenses in order to satisfy its obligations due within one year from the date of issuance of these financial statements, we cannot guarantee that it will be able to raise additional equity, raise debt, or contain expenses. Accordingly, there is substantial doubt about our ability to continue as a going concern within one year after these financial statements are issued.
Sales of Common Stock
On March 14, 2024, we issued and sold 2,496,318 shares of our Common Stock and warrants to purchase 2,496,318 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated March 11, 2024 at a price $1.17 per share, for which we received gross proceeds of approximately $2.92 million. The securities sold to our directors participating in the March 14, 2024 private placement were issued pursuant to the MAIA 2021 Plan.
On March 28, 2024, we issued and sold 578,643 shares of our Common Stock and warrants to purchase 578,643 shares of our Common Stock in a private placement to certain accredited investors pursuant to securities purchase agreements dated March 25, 2024 at a price of $2.295 per share, for which we received gross proceeds of approximately $1.33 million.
Between February 14, 2024 and March 31, 2024, we sold 507,754 shares of Common Stock at an average price of approximately $1.47 per share, resulting in aggregate gross proceeds of approximately $745,251 under the ATM Agreement dated February 14, 2024, for which we paid Wainwright approximately $22,357 in commissions resulting in net proceeds to us of approximately $722,894. Between April 1, 2024 and June 30, 2024, we sold 2,015,122 shares of our Common Stock at an average price of $3.53 per share, resulting in aggregate gross proceeds of approximately $7,116,978 under the ATM Agreement dated February 14, 2024 with Wainwright, for which we paid Wainwright $213,509 in commissions, resulting in net proceeds of approximately $6,903,469. Between July 1, 2024 and September 30, 2024, we sold 177,606 shares of Common Stock at an average price of approximately $3.72 per share, resulting in aggregate gross proceeds of approximately $660,437 under the ATM Agreement dated May 15, 2024, for which we paid Wainwright approximately $19,813 in commissions, resulting in net proceeds to us of approximately $640,624.
On April 25, 2024, we issued and sold 494,096 shares of our Common Stock and warrants to purchase 494,096 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated April 25, 2024 at a price of $2.034 per share, for which we received gross proceeds of approximately $1.0 million. The securities sold to our directors participating in the April 25, 2024 private placement were issued pursuant to the MAIA 2021 Plan.
We will need to raise additional capital to fund our operations, to develop and commercialize THIO, and to develop, acquire or in-license other products. We may seek to fund our operations through public equity, private equity, or
31
debt financings, as well as other sources. We cannot make any assurances that additional financings will be available to us and, if available, on acceptable terms or at all. This could negatively impact our business and operations and could also lead to the reduction of our operations.
Cash Flows
Cash Flows for the Nine Months ended September 30, 2024 and 2023
|
|
Nine Months Ended |
|
|||||
|
|
|
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Net cash flows used in operating activities |
|
$ |
(11,796,286 |
) |
|
$ |
(9,078,570 |
) |
Net cash flows provided by financing activities |
|
|
13,331,146 |
|
|
|
4,245,463 |
|
Effect of foreign currency exchange rate changes on cash |
|
|
5,229 |
|
|
|
(13,233 |
) |
Net increase in cash and cash equivalents |
|
$ |
1,540,089 |
|
|
$ |
(4,846,340 |
) |
Operating Activities
For the nine months ended September 30, 2024, net cash used in operating activities was approximately $11,796,000, which consisted of a consolidated net loss of approximately $19,683,000 offset by non-cash charges of approximately $1,219,000 in stock-based compensation, approximately $112,000 of non-cash expense to issue stock to consultants, the remeasurement of the warrant liability of approximately $8,008,000, and the loss on fair value of warrants over proceeds of approximately $13,000. Total changes in operating assets and liabilities of approximately $1,465,000 were driven by an approximate $1,330,000 net decrease in accounts payable and accrued expenses, an approximate $93,000 increase in the Australia research and development incentives receivable, and an approximate $227,000 decrease in prepaid expense and other assets.
For the nine months ended September 30, 2023, net cash used in operating activities was approximately $9,079,000, which consisted of a net loss of approximately $13,516,000 offset by non-cash charges of approximately $1,727,000 in stock-based compensation, approximately $683,000 of non-cash expense to issue stock to consultants, and the remeasurement of the warrant liability of approximately $142,000. Total changes in operating assets and liabilities of approximately $2,169,000 were driven by an approximate $1,861,000 increase in accounts payable and accrued liabilities, an approximate increase of $134,000 in prepaid expenses and other assets and an approximate increase of $134,000 in Australia research and development incentives receivables.
For the nine months ended September 30, 2024 the effect of foreign currency exchange rate changes on cash increased the cash balance as of September 30, 2024 by approximately $5,000 versus a decrease of approximately $13,000 for the nine months ended September 30, 2023.
Investing Activities
For the nine months ended September 30, 2024 and 2023, we did not have any cash provided by or used in investing activities.
Financing Activities
Net cash provided by financing activities was approximately $13,331,000 and $4,245,000 for the nine months ended September 30, 2024 and 2023, respectively. Total net cash provided by financing activities for the nine months ended September 30, 2024 consisted primarily of approximately $5,254,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $8,523,000, proceeds from the exercise of stock options of $216,000, and were offset by approximately $661,000 of offering costs.
Net cash provided by financing activities for the nine months ended September 30, 2023 consisted primarily of approximately $5,750,000 of gross proceeds from the sales of Common Stock in a follow-on offering, offset by approximately $1,352,000 of offering costs and approximately $154,000 of deferred offering costs.
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Off-Balance Sheet Arrangements
None.
Critical Accounting Policies and Significant Judgments and Estimates
Our condensed consolidated financial statements are prepared in accordance with GAAP. These accounting principles require us to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements. We believe that the estimates, judgments and assumptions are reasonable based upon information available to us at the time that these estimates, judgments and assumptions are made. To the extent there are material differences between these estimates, judgments or assumptions and actual results, our financial statements will be affected. For a discussion of our critical accounting estimates, please read Part II, Item 7 — Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 21, 2024. There have been no material changes to the critical accounting estimates previously disclosed in such report.
Recently Issued Accounting Standards Not Yet Effective or Adopted
Management does not believe that any recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying unaudited condensed consolidated financial statements.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company and are not required to provide the information otherwise required under this item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Under the supervision of and with the participation of our management, including our Chief Executive Officer, who is our principal executive officer, and our Head of Finance, who is our principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of September 30, 2024, the end of the period covered by this Quarterly Report. The term “disclosure controls and procedures,” as set forth in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) means controls and other procedures of a company that are designed to provide reasonable assurance that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms promulgated by the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected. Based on the evaluation of our disclosure controls and procedures as of September 30, 2024, our Chief Executive Officer and Head of Finance concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in management's evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings
We are not party to any material legal proceedings. From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.
Item 1A. Risk Factors.
Factors that could cause our actual results to differ materially from those in this Quarterly Report are any of the risks described in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 21, 2024. Any of these factors could result in a significant or material adverse effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations. As of the date of this Quarterly Report, except as set forth below, there are no additional risk factors added to the risk factors disclosed in our Annual Report on Form 10-K.
If we are unable to comply with the continued listing requirements of the NYSE American, then our Common Stock would be delisted from the NYSE American, which would limit investors’ ability to effect transactions in our Common Stock and subject us to additional trading restrictions.
Our Common Stock is currently listed on the NYSE American and the continued listing of our Common Stock on the NYSE American is contingent on our continued compliance with a number of listing requirements. If we are unable to comply with the continued listing requirements of the NYSE American, our Common Stock would be delisted from the NYSE American, which would limit investors’ ability to effect transactions in our Common Stock and subject us to additional trading restrictions. In order to maintain our listing, we must maintain certain share prices, financial and share distribution targets, including maintaining a minimum amount of stockholders’ equity and a minimum number of public stockholders, as well as satisfy other listing requirements of the NYSE American. In addition to these objective standards, NYSE American may delist the securities of any issuer for other reasons involving the judgment of NYSE American.
While our stockholders’ equity was approximately $1.62 million as of September 30, 2024, and while we have had losses from continuing operations and/or net losses in each of our fiscal years ended December 31, 2021, 2022 and 2023, we are nevertheless currently in compliance with the NYSE American continued listing standards as we satisfy alternate compliance standards provided in Section 1003(a) of the NYSE American Company Guide since: (i) the total value of our market capitalization is at least $50,000,000; and (ii) we have at least 1,100,000 shares publicly held, a market value of publicly held shares of at least $15,000,000 and 400 round lot shareholders. There is no assurance that we will be able to maintain compliance with the NYSE American continued listing standards and/or continue our listing on the NYSE American in the future.
If the NYSE American delists our Common Stock from trading on its exchange and we are not able to list our securities on another national securities exchange, we expect the Common Stock would qualify to be quoted on an over-the-counter market. If this were to occur, we could face significant material adverse consequences, including:
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Recent sales of unregistered securities
On September 20, 2024, the Company entered into a Services Agreement with IRTH Communications LLC (“IRTH”) pursuant to which IRTH will provide investor relations, communications and consulting services. In consideration of IRTH's undertaking of the services agreement and provision of services thereunder, the Company agreed to issue IRTH shares of its Common Stock having a value of $100,000 with the number of shares (the “Shares”) determined by dividing $100,000 by the Company's closing price on the date of execution of the agreement, or 34,602 shares based on the $2.89 closing price for the Company's common stock on September 20, 2024. The Shares are to be issued based on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”).
No underwriters were involved in the foregoing issuance of securities. The securities described above were issued in reliance upon the exemption from the registration requirements of the Securities Act, as set forth in Section 4(a)(2) under the Securities Act relative to transactions by an issuer not involving any public offering, to the extent an exemption from such registration was required. The recipient of securities in the transaction described above represented that it was an accredited investor and was acquiring the securities for its own account for investment purposes only, and not with a view to, or for sale in connection with, any distribution thereof and that they could bear the risks of the investment and could hold the securities for an indefinite period of time and appropriate legends were affixed to the instruments representing such securities issued in such transactions
Purchases of equity securities by the issuer and affiliated purchasers.
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
10b5-1 Trading Plans
During the fiscal quarter ended September 30, 2024,
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There were
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Item 6. Exhibits.
3.1 |
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3.2 |
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31.1* |
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31.2* |
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32.1** |
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32.2** |
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101.INS*** |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH*** |
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Inline XBRL Taxonomy Extension Schema Document |
101.CAL*** |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF*** |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB*** |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE*** |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
104*** |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith.
** These certifications are furnished to the SEC pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.
*** Furnished herewith. Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act or Section 18 of the Exchange Act and otherwise are not subject to liability under those sections.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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MAIA Biotechnology Inc. |
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Date: November 12, 2024 |
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By: |
/s/ Vlad Vitoc |
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Vlad Vitoc |
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Chief Executive Officer |
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(Principal Executive Officer) |
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Date: November 12, 2024 |
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By: |
/s/ Jeffrey C. Himmelreich |
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Jeffrey C. Himmelreich |
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Head of Finance |
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(Principal Financial Officer) |
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