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) |
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Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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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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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 May 14, 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 March 31, 2024 (Unaudited) and December 31, 2023 |
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3 |
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4 |
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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. |
31 |
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Item 4. |
31 |
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32 |
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Item 1. |
32 |
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Item 1A. |
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Item 2. |
33 |
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Item 3. |
33 |
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Item 4. |
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Item 5. |
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Item 6. |
35 |
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36 |
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i
NOTE ABOUT FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements. 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," 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").
We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward‑looking statements.
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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March 31, |
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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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Deferred offering costs |
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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 (deficit) |
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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 (deficit) |
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( |
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Total liabilities and stockholders' equity (deficit) |
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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 March 31, |
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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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General and administrative expenses |
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Total operating expenses |
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Loss from operations |
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Other (expense) income: |
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Interest expense |
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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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Other income, net |
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Net loss |
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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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Net loss per share |
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Basic and diluted |
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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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2024 |
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2023 |
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Net loss |
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$ |
( |
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$ |
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Foreign currency translation adjustment |
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( |
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Comprehensive loss |
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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 Months Ended March 31, |
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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 Income (Loss) |
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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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Issuance of warrants in connection with the Private Placement Offering #1 |
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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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( |
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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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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 Months Ended March 31, |
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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 Income (Loss) |
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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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$ |
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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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( |
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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 |
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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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See the accompanying notes to the unaudited condensed consolidated financial statements.
6
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Three Months Ended |
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2024 |
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2023 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
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$ |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation |
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Consulting expense for restricted shares issued |
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Change in fair value of warrant liability |
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Change in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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Australia research and development incentives receivable |
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( |
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( |
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Other receivables |
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( |
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— |
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Accounts payable |
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( |
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Accrued expenses |
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( |
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Net cash used in operating activities |
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Cash flows from financing activities: |
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Proceeds from sale of common stock in private placement offering #1 |
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— |
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Proceeds from sale of common stock in private placement offering #2 |
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— |
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Proceeds from At-The-Market offering |
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— |
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Payment of offering transactions costs |
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— |
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Net cash provided by financing activities |
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— |
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Net effect of foreign currency exchange on cash |
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Net increase (decrease) in cash |
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Cash at beginning of period |
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Cash at end of period |
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$ |
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$ |
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Supplemental disclosure of cash flow information: |
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Warrants issued in connection with private placement offering #1 |
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$ |
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— |
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Warrants issued in connection with private placement offering #2 |
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$ |
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— |
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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.
8
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 on March 21, 2024. The condensed consolidated balance sheet as of December 31, 2023 was derived from the 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. 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 common stock, stock options and warrants, the embedded features in convertible notes, and accruals for outsourced research and development activities. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
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, 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.
9
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. At March 31, 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.
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 March 31, 2024 and December 31, 2023 cash includes cash in a 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 three months ended March 31, 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 three months ended March 31, 2024. The estimated fair value of warrants issued to underwriters represented Level 3 measurements.
10
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 adjustments if necessary. The estimates in the Company’s accrued research and development expenses are related to expenses incurred with respect to CROs, 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.
11
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, 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 are selected, 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. 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 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 three months ended March 31, 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.
12
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 1) the underlying shares are classified as liabilities or 2) 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.
Deferred Offering Costs
Deferred offering costs are included in other assets and consist of legal, accounting, underwriting fees and other costs. There are no deferred offering costs as of the December 31, 2023 balance sheet date. Deferred offering costs incurred through the March 31, 2024 balance sheet are directly related to at-the-market offering and will be charged to additional paid-in capital upon the completion of the offering.
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, 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:
|
|
Three Months Ended |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Shares issuable upon exercise of stock options |
|
|
|
|
|
|
||
Shares issuable upon exercise of warrants |
|
|
|
|
|
|
||
Recent Accounting Standards
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting – Improvements to Reportable Segment Disclosures, 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
13
applied retrospectively. We do not expect the amendments in this ASU 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, 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 this ASU to have a material impact on our consolidated financial statements.
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board 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.
Reclassification of Prior Year Presentation
Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported statement of cash flows.
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 have 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 Report. Our directors and executive officers may also adopt future 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 when entering into the plan, 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.
Private Placement
The following Company directors participated in the March 2024 private placement as follows: (i) Stan Smith purchased
14
3. ACCRUED EXPENSES
As of March 31, 2024 and December 31, 2023 accrued expenses consisted of the following:
|
|
March 31, |
|
|
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 December 31, 2023 |
|
|||||||||||||
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
|
|
Fair value at March 31, 2024 |
|
|||||||||||||
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
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 |
|
|||||
Warrant liabilities: |
2024 |
|
|
2023 |
|
||
Balance, beginning of period |
$ |
|
|
$ |
|
||
Issuance of warrants |
|
|
|
|
— |
|
|
Loss (Gain) on fair value of warrant liability |
|
|
|
|
( |
) |
|
Balance, end of period |
$ |
|
|
$ |
|
||
Upon the closing of the Company’s initial public offering, the Company’s shareholders agreement terminated pursuant to its terms. In connection with the closing of the Company’s initial public offering, 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
15
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 $
Effective March 25, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $
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
On March 28, 2024, the Company issued and sold (i)
MAIA Biotechnology, Inc. Restricted Stock Awards
During the three months ended March 31, 2023, the company expensed $
During the three months ended March 31, 2024, the company expensed $
MAIA Stock Warrants
16
Concurrently with the closing of the Company’s initial public offering, 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
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
17
remeasured the warrant liability resulting in a value of $
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
|
|
Warrants |
|
|
Weighted |
|
|
Weighted |
|
|||
Balance at January 1, 2024 |
|
|
|
|
$ |
|
|
|
|
|||
Issued |
|
|
|
|
|
|
|
|
|
|||
Exercised |
|
|
|
|
|
|
|
|
|
|||
Expired |
|
|
|
|
|
|
|
|
|
|||
Balance at March 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|||
MAIA Biotechnology, Inc. Stock Award 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 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 to govern the
On August 1, 2022 the Company approved the MAIA Biotechnology, Inc. 2021 Equity Incentive Plan (the “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
18
share on the date of grant, and the contractual term shall be
As of March 31, 2024, only stock options have been awarded pursuant to the MAIA stock award plans.
The following table summarizes the activity and information regarding MAIA’s outstanding and exercisable options for the three months ended March 31, 2024:
|
|
Options Outstanding |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Balance at January 1, 2024 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Cancelled/forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Balance at March 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Options exercisable at March 31, 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 three months ended March 31, 2024 and 2023:
|
|
2024 |
|
|
2023 |
|
||
Risk-free interest rate |
|
|
|
|
||||
Expected term (in years) |
|
|
|
|
||||
Expected volatility |
|
|
|
|
||||
Expected dividend yield |
|
|
- |
|
|
|
— |
|
The weighted-average grant date fair value of stock options issued during the three months ended March 31, 2024 and 2023 was $
Stock based compensation related to the Company’s stock plans are as follows:
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
General and administrative |
|
$ |
|
|
$ |
|
||
Research and development |
|
|
|
|
|
|
||
Total stock-based compensation |
|
$ |
|
|
$ |
|
||
19
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 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 agreement has a term of
The agreement requires royalties of
The Company will also pay UTSW running royalties on a yearly basis as a percentage of Net Sales of the Company or its sublicensee.
Regeneron – In February 2021, the Company reached an 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
20
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 March 31, 2024, and December 31, 2023, the Company had a full valuation allowance against its deferred tax assets.
For the three months ended March 31, 2024 and 2023, the Company recorded
Issuance of Options
From April 1 to May 14, 2024, the Company issued
On May 10, 2024, the Company issued
At-The-Market Offering with H.C. Wainwright
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 $
Private Placement
On April 25, 2024, the Company issued and sold
Related Party Participation in Private Placement
The following Company directors participated in the aforementioned April 2024 private placement as follows: (i) Stan Smith purchased
21
stock for an aggregate purchase price of approximately $
Amendments to Common Stock Purchase Warrants
On May 11, 2024, the Company entered into amendments to certain of those common stock purchase warrants originally issued on March 14, 2024 with an exercise price of $
On May 11, 2024, the Company entered into amendments to certain of those common stock purchase warrants originally issued on March 28, 2024 with an exercise price of $
On May 11, 2024, the Company entered into amendments to certain of those common stock purchase warrants originally issued on April 25, 2024 with an exercise price of $
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 accomplished the following key milestones:
23
24
25
26
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.
27
Financial Operations Overview and Analysis for the Three Months Ended March 31, 2024 and 2023
Comparison of three months ended March 31, 2024 and 2023
|
|
Three Months Ended |
|
|
|
|
|
|
||||||
|
|
|
|
|
Change |
|||||||||
|
|
2024 |
|
|
2023 |
|
|
Dollars |
|
|
Percentage |
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
2,320,742 |
|
|
$ |
2,195,991 |
|
|
$ |
124,751 |
|
|
6% |
General and administrative |
|
|
1,628,134 |
|
|
|
1,988,259 |
|
|
|
(360,125 |
) |
|
(18)% |
Total operating costs and expenses |
|
|
3,948,876 |
|
|
|
4,184,250 |
|
|
|
(235,374 |
) |
|
(6)% |
Loss from operations |
|
|
(3,948,876 |
) |
|
|
(4,184,250 |
) |
|
|
235,374 |
|
|
(6)% |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|||
Interest expense |
|
|
— |
|
|
|
(5,147 |
) |
|
|
5,147 |
|
|
(100)% |
Interest income |
|
|
44,118 |
|
|
|
336 |
|
|
|
43,782 |
|
|
13030% |
Australian research and |
|
|
18,601 |
|
|
|
51,243 |
|
|
|
(32,642 |
) |
|
(64)% |
Change in fair value of warrant |
|
|
(4,181,298 |
) |
|
|
20,942 |
|
|
|
(4,202,240 |
) |
|
(20066)% |
Other income, net |
|
|
(4,118,579 |
) |
|
|
67,374 |
|
|
|
(4,185,953 |
) |
|
(6213)% |
Net loss |
|
|
(8,067,455 |
) |
|
|
(4,116,876 |
) |
|
|
(3,950,579 |
) |
|
96% |
Net loss attributable to MAIA |
|
$ |
(8,067,455 |
) |
|
$ |
(4,116,876 |
) |
|
$ |
(3,950,579 |
) |
|
96% |
Operating Expenses
Research and development expenses
Research and development expenses increased by approximately $125,000 or 6%, from approximately $2,196,000 for the three months ended March 31, 2023 to approximately $2,321,000 for the three months ended March 31, 2024. The increase was primarily related to an increase in scientific research and clinical research of approximately $603,000, offset by a decrease in payroll and bonus expenses of approximately $316,000 related to the decreased headcount of research and development employees, and decrease in stock-based compensation costs of approximately $162,000.
General and administrative expenses
General and administrative expenses decreased by approximately $360,000, or 18% from approximately $1,988,000 for the three months ended March 31, 2023 to approximately $1,628,000 for the three months ended March 31, 2024. The decrease was primarily related to a decrease in other expenses of approximately $172,000 related to lower investor relations and communication expenses, a decrease in payroll expense of approximately $112,000, a decrease in professional fees of approximately $50,000 relating to lower usage of consultants, and a decrease in stock-based compensation of approximately $26,000.
Other expense, net
Other expense, net increased by approximately 4,186,000 or 6213% from other income of approximately $67,000 for the three months ended March 31, 2023 to other expense of approximately $4,119,000 for the three months ended March 31, 2024. The increase was primarily related to the change in the fair value of the warrant liability of approximately $4,202,000, a reduction in the Australia research and development incentives of approximately $33,000 and a net increase of interest income of approximately $49,000.
28
Liquidity and Capital Resources
Our Ability to Continue as a Going Concern
As of March 31, 2024, our cash totaled approximately $8,271,000 which represented an increase of approximately $1,121,000 compared to December 31, 2023. As of March 31, 2024, we had working capital of approximately $3,792,000 which represents an increase of approximately $1,165,000 compared to December 31, 2023. We have generated no revenues as of March 31, 2024. Our current operating plan indicates that it 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 March 31, 2024 of $8,271,000 and current financial condition as of the date of the Quarterly Report on Form 10-Q, 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
Between February 14, 2024 and March 31, 2024, we have sold 507,754 shares of our common stock at an average price of $1.47 per share, resulting in aggregate gross proceeds of approximately $745,000 under the initial ATM Agreement with H.C. Wainwright & Co., LLC.
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 private placement were issued pursuant to our 2021 Equity Incentive 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.
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 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.
29
Cash Flows
Cash Flows for three months ended March 31, 2024 and 2023
|
|
Three Months Ended |
|
|||||
|
|
|
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Net cash flows used in operating activities |
|
$ |
(3,586,800 |
) |
|
$ |
(3,360,649 |
) |
Net cash flows provided by financing activities |
|
|
4,717,048 |
|
|
|
- |
|
Effect of foreign currency exchange rate changes on cash |
|
|
(9,494 |
) |
|
|
(3,966 |
) |
Net increase in cash and cash equivalents |
|
$ |
1,120,754 |
|
|
$ |
(3,364,615 |
) |
Operating Activities
For the three months ended March 31, 2024, net cash used in operating activities was approximately $3,587,000, which consisted of a consolidated net loss of approximately $8,067,000 offset by non-cash charges of approximately $350,000 in stock-based compensation, approximately $12,000 of non-cash expense to issue stock to consultants, and the remeasurement of the warrant liability of approximately $4,181,000. Total changes in operating assets and liabilities of approximately $63,000 were driven by an approximate $39,000 net decrease in accounts payable and accrued expenses, an approximate $19,000 decrease in the Australia research and development incentives receivable, and an approximate $5,000 decrease in prepaid expense and other assets.
For the three months ended March 31, 2023, net cash used in operating activities was approximately $3,361,000, which consisted of a net loss of approximately $4,117,000 offset by non-cash charges of approximately $538,000 in stock-based compensation, approximately $164,000 of non-cash expense to issue stock to consultants, and the remeasurement of the warrant liability of approximately $21,000. Total changes in operating assets and liabilities of approximately $76,000 were driven by an approximate $27,000 decrease in accounts payable and accrued liabilities, an approximate $154,000 increase in prepaid expenses and other assets and an approximate decrease of $51,000 in Australia research and development incentives receivables.
For the three months ended March 31, 2024 the effect of foreign currency exchange rate changes on cash decreased the cash balance as of March 31, 2024 by approximately $9,000 versus approximately $4,000 for the three months ended March 31, 2023.
Financing Activities
Net cash provided by financing activities was approximately $4,717,000 and $0 for the three months ended March 31, 2024 and 2023, respectively. Total net cash provided by financing activities for the three months ended March 31, 2024 consisted primarily of approximately $4,249,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $745,000, and offset by an approximate $277,000 of offering costs.
Critical Accounting Policies and Significant Judgments and Estimates
Our condensed consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (U.S. 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.
30
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 March 31, 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, or 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 March 31, 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 on Form 10-Q 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 our Annual Report on Form 10-K filed under the heading “Risk Factors” and filed with the SEC 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’ deficit was approximately $5.76 million as of March 31, 2024, and 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 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 rules 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:
32
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Recent sales of unregistered securities
On March 18, 2024, we issued 12,500 shares of restricted common stock pursuant to an agreement the Company entered into on August 15, 2023 with Laidlaw & Company for investor services. We did not receive any proceeds from this issuance.
On May 10, 2024, the Company issued 4,678 shares of Common Stock upon exercise of an existing warrant on a net-exercise basis. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) and/or 3(a)(9) of the Securities Act of 1933, as amended.
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.
Amendments to Common Stock Purchase Warrants
On May 11, 2024, the Company entered into amendments to certain of those common stock purchase warrants originally issued on March 14, 2024 with an exercise price of $1.30 per share with holders of such warrants to
33
purchase 1,794,882 shares of common stock (out of warrants to purchase an aggregate of 2,043,587 shares of common stock issued to non-affiliated investors on March 14, 2024) to amend and restate the “Fundamental Transaction” adjustment provision in such warrants to facilitate such warrants being accounted for on the Company’s balance sheet as equity in future periods as opposed to a warrant liability.
On May 11, 2024, the Company entered into amendments to certain of those common stock purchase warrants originally issued on March 28, 2024 with an exercise price of $2.55 per share with holders of such warrants to purchase 349,886 shares of common stock (out of warrants to purchase an aggregate of 578,643 shares of common stock issued to non-affiliated investors on March 28, 2024) to amend and restate the “Fundamental Transaction” adjustment provision in such warrants to facilitate such warrants being accounted for on the Company’s balance sheet as equity in future periods as opposed to a warrant liability.
On May 11, 2024, the Company entered into amendments to certain of those common stock purchase warrants originally issued on April 25, 2024 with an exercise price of $2.26 per share with holders of such warrants to purchase 263,027 shares of common stock (out of warrants to purchase an aggregate of 326,939 shares of common stock issued to non-affiliated investors on April 25, 2024) to amend and restate the “Fundamental Transaction” adjustment provision in such warrants to facilitate such warrants being accounted for on the Company’s balance sheet as equity in future periods as opposed to a warrant liability.
The foregoing descriptions of terms and conditions of the amendments to common stock purchase warrants originally issued on each of March 14, 2024, March 28, 2024 and April 25, 2024 do not purport to be complete and are qualified in their entirety by the full text of the form of such amendments, which are attached hereto as Exhibits 4.1, 4.2, and 4.3, respectively, to this Quarterly Report on Form 10-Q and are incorporated by reference herein.
10b5-1 Trading Plans
During the fiscal quarter ended March 31, 2024,
There were
34
Item 6. Exhibits.
4.1* |
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4.2* |
|
|
4.3* |
|
|
31.1* |
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|
31.2* |
|
|
32.1** |
|
|
32.2** |
|
|
101.INS* |
|
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* |
|
Inline XBRL Taxonomy Extension Schema Document |
101.CAL* |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF* |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB* |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE* |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
104 |
|
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.
35
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, 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: May 14, 2024 |
|
By: |
/s/ Vlad Vitoc |
|
|
|
Vlad Vitoc |
|
|
|
Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
|
|
|
|
Date: May 14, 2024 |
|
By: |
/s/ Jeffrey C. Himmelreich |
|
|
|
Jeffrey C. Himmelreich |
|
|
|
Head of Finance |
|
|
|
(Principal Financial Officer) |
36