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b

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______________ to _______________

Commission File Number: 001-41455

 

MAIA BIOTECHNOLOGY, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

83-1495913

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

444 West Lake Street, Suite 1700

Chicago, IL

60606

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (312) 416-8592

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

MAIA

 

NYSE American

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. Yes No

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). Yes No

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

Accelerated filer

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

Emerging growth company

 

 

 

 

 

 

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 7, 2023, the registrant had 14,213,511 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 


 

Table of Contents

 

Page

 

Note About Forward-Looking Statements

1

 

 

 

 

PART I—FINANCIAL INFORMATION

2

Item 1.

Financial Statements

2

Condensed Consolidated Balance Sheets as of September 30, 2023 (Unaudited) and December 31, 2022

2

Condensed Consolidated Statements of Operations (Unaudited) for the three and nine months ended September 30, 2023 and 2022

3

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) for the three and nine months ended September 30, 2023 and 2022

4

 

Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) for the three and nine months ended September 30, 2023 and 2022

5

Condensed Consolidated Statements of Cash Flows (Unaudited) for the nine months ended September 30, 2023 and 2022

7

Notes to Unaudited Condensed Consolidated Financial Statements

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

21

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

29

Item 4.

Controls and Procedures

29

 

PART II—OTHER INFORMATION

30

Item 1.

Legal Proceedings

30

Item 1A.

Risk Factors

30

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

30

Item 3.

Defaults Upon Senior Securities

31

Item 4.

Mine Safety Disclosures

31

Item 5.

Other Information

31

Item 6.

Exhibits

32

Signatures

33

 

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

 

 

September 30,
2023

 

 

December 31,
2022

 

 

 

(unaudited)

 

 

 

 

ASSETS

 

 

 

 

Current assets:

 

 

 

 

Cash

 

$

6,104,587

 

 

$

10,950,927

 

Prepaid expenses and other current assets

 

 

414,120

 

 

 

554,321

 

Australia research and development incentives receivable

 

 

114,426

 

 

 

302,789

 

Total current assets

 

 

6,633,133

 

 

 

11,808,037

 

Deferred offering costs

 

 

365,140

 

 

 

211,203

 

Other assets

 

 

2,800

 

 

 

2,800

 

Total assets

 

$

7,001,073

 

 

$

12,022,040

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

Current liabilities:

 

 

 

 

Accounts payable

 

$

1,226,101

 

 

$

1,165,505

 

Accrued expenses

 

 

2,923,853

 

 

 

2,103,401

 

Total current liabilities

 

 

4,149,954

 

 

 

3,268,906

 

Long term liabilities:

 

 

 

 

 

 

Warrant liability

 

 

103,407

 

 

 

245,341

 

Total liabilities

 

 

4,253,361

 

 

 

3,514,247

 

Commitments and contingencies (Note 6)

 

 

 

 

Stockholders' equity (deficit)

 

 

 

 

Preferred stock, $0.0001 par value, 30,000,000 shares
     authorized at September 30, 2023 and December 31, 2022,
     
0 shares issued and outstanding

 

 

 

 

  Common stock, $0.0001 par value, 70,000,000 shares authorized at
       September 30, 2023 and December 31, 2022,
13,761,123 and 10,955,904 
       shares issued and outstanding at September 30, 2023 and December 31, 2022,
       respectively

 

 

1,377

 

 

 

1,096

 

  Additional paid-in capital

 

 

60,513,616

 

 

 

52,729,942

 

  Accumulated deficit

 

 

(57,723,515

)

 

 

(44,207,272

)

  Accumulated other comprehensive loss

 

 

(43,766

)

 

 

(15,973

)

  Total stockholders' equity

 

 

2,747,712

 

 

 

8,507,793

 

  Total liabilities and stockholders' equity

 

$

7,001,073

 

 

$

12,022,040

 

 

See the accompanying notes to the unaudited condensed consolidated financial statements.

2


 

MAIA Biotechnology, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

 

For the Three Months Ended September 30,

 

 

Nine Months Ended
September 30,

 

 

 

 

 

 

 

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

Research and development expenses

$

2,599,578

 

$

2,343,154

 

 

$

7,394,884

 

 

$

6,539,948

 

General and administrative expenses

 

2,356,065

 

 

1,653,072

 

 

 

6,409,655

 

 

 

4,341,880

 

Ratchet share expense

 

 

 

 

 

1,099,360

 

 

 

 

 

 

1,099,360

 

Total operating expenses

 

4,955,643

 

 

5,095,586

 

 

 

13,804,539

 

 

 

11,981,188

 

Loss from operations

 

(4,955,643

)

 

(5,095,586

)

 

 

(13,804,539

)

 

 

(11,981,188

)

Other (expense) income:

 

 

 

 

 

 

 

 

Interest expense

 

(1

)

 

(1,716

)

 

 

(6,863

)

 

 

(1,820

)

Interest income

 

3,260

 

 

348

 

 

 

3,768

 

 

 

1,249

 

Australian research and development
   incentives

 

 

58,448

 

 

 

65,111

 

 

 

149,457

 

 

 

230,188

 

Change in fair value of warrant liability

 

18,193

 

 

128,030

 

 

 

141,934

 

 

 

128,030

 

Other income, net

 

79,900

 

 

191,773

 

 

 

288,296

 

 

 

357,647

 

Net loss

 

(4,875,743

)

 

(4,903,813

)

 

 

(13,516,243

)

 

 

(11,623,541

)

Deemed dividend on warrant
   modification

 

 

 

 

 

 

 

 

 

 

 

(450,578

)

Net loss attributable to MAIA
   Biotechnology, Inc. shareholders

$

(4,875,743

)

$

(4,903,813

)

 

$

(13,516,243

)

 

$

(12,074,119

)

Net loss per share

 

 

 

 

 

 

Basic and diluted

$

(0.36

)

$

(0.48

)

 

$

(1.08

)

 

$

(1.39

)

Weighted average common shares
  outstanding basic and diluted

 

13,675,802

 

 

10,165,622

 

 

 

12,521,264

 

 

 

8,713,570

 

 

 

See the accompanying notes to the unaudited condensed consolidated financial statements.

 

3


 

MAIA Biotechnology, Inc. and Subsidiaries

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

 

 

 

 

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 


Net loss

$

(4,875,743

)

$

(4,903,813

)

 

$

(13,516,243

)

 

$

(12,074,119

)

 Foreign currency translation adjustment

 

(17,858

)

 

(47,501

)

 

 

(43,766

)

 

 

(51,646

)

Comprehensive loss

$

(4,893,601

)

$

(4,951,314

)

 

$

(13,560,009

)

 

$

(12,125,765

)

 

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 (Unaudited)

 

For the Three and Nine Months Ended

 

September 30, 2023

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional Paid-In Capital

 

 

Accumulated Deficit

 

 

Accumulated Other Comprehensive Loss

 

 

Total Stockholders' Equity

 

Balance at December 31, 2022

 

 

10,955,904

 

 

$

1,096

 

 

$

52,729,942

 

 

$

(44,207,272

)

 

$

(15,973

)

 

$

8,507,793

 

Issuance of restricted stock

 

 

40,500

 

 

 

4

 

 

 

164,066

 

 

 

 

 

 

 

 

164,070

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

537,522

 

 

 

 

 

 

 

 

 

537,522

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,301

)

 

 

(9,301

)

        Net loss

 

 

 

 

 

 

 

 

 

 

 

(4,116,876

)

 

 

 

 

 

(4,116,876

)

Balance at March 31, 2023

 

 

10,996,404

 

 

 

1,100

 

 

 

53,431,530

 

 

 

(48,324,148

)

 

 

(25,274

)

 

 

5,083,208

 

Issuance of restricted stock

 

 

96,521

 

 

 

9

 

 

 

324,251

 

 

 

 

 

 

 

 

324,260

 

Issuance of common shares in connection with follow-on offering, net of $1,593,016 of issuance costs

 

 

2,555,500

 

 

 

256

 

 

 

4,156,603

 

 

 

 

 

 

 

 

 

4,156,859

 

Issuance of warrants to underwriter in connection with follow-on offering

 

 

 

 

 

 

 

 

241,109

 

 

 

 

 

 

 

 

 

241,109

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

618,932

 

 

 

 

 

 

 

 

 

618,932

 

 Issuance of stock options to satisfy accrued bonus

 

 

 

 

 

 

 

 

974,224

 

 

 

 

 

 

 

 

 

974,224

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(634

)

 

 

(634

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(4,523,624

)

 

 

 

 

 

(4,523,624

)

Balance at June 30, 2023

 

 

13,648,425

 

 

$

1,365

 

 

$

59,746,649

 

 

$

(52,847,772

)

 

$

(25,908

)

 

$

6,874,334

 

Issuance of common shares upon exercise of stock options

 

 

750

 

 

 

1

 

 

 

1,432

 

 

 

 

 

 

 

 

 

1,433

 

Issuance of restricted stock

 

 

111,948

 

 

 

11

 

 

 

194,619

 

 

 

 

 

 

 

 

 

194,630

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

570,916

 

 

 

 

 

 

 

 

 

570,916

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(17,858

)

 

 

(17,858

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(4,875,743

)

 

 

 

 

 

(4,875,743

)

Balance at September 30, 2023

 

 

13,761,123

 

 

$

1,377

 

 

$

60,513,616

 

 

$

(57,723,515

)

 

$

(43,766

)

 

$

2,747,712

 

 

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

 

September 30, 2022

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional Paid-In Capital

 

 

Accumulated Deficit

 

 

Accumulated Other Comprehensive Income (Loss)

 

 

Total Stockholders' Equity

 

Balance at December 31, 2021

 

 

7,584,980

 

 

$

758

 

 

$

37,618,438

 

 

$

(28,437,993

)

 

$

 

 

$

9,181,203

 

Issuance of common shares upon exercise of stock options

 

 

26,500

 

 

 

3

 

 

 

47,697

 

 

 

 

 

 

 

 

 

47,700

 

Issuance of common shares upon exercise of warrants

 

 

61,111

 

 

 

6

 

 

 

109,994

 

 

 

 

 

 

 

 

 

110,000

 

Issuance of common shares in connection with Equity Financing

 

 

263,729

 

 

 

27

 

 

 

2,373,534

 

 

 

 

 

 

 

 

 

2,373,561

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

713,330

 

 

 

 

 

 

 

 

 

713,330

 

Modification of warrant in equity

 

 

 

 

 

 

 

 

450,478

 

 

 

 

 

 

 

 

 

 

Deemed dividend on modification of warrant

 

 

 

 

 

 

 

 

(450,478

)

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,721

 

 

 

1,721

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(3,413,845

)

 

 

 

 

 

(3,413,845

)

Balance at March 31, 2022

 

 

7,936,320

 

 

 

794

 

 

 

40,862,993

 

 

 

(31,851,838

)

 

 

1721

 

 

 

9,013,670

 

Issuance of common shares upon exercise of warrants

 

 

468,601

 

 

 

47

 

 

 

275,353

 

 

 

 

 

 

 

 

 

275,400

 

Issuance of common shares in connection with Equity Financing

 

 

11,111

 

 

 

1

 

 

 

99,998

 

 

 

 

 

 

 

 

 

99,999

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

584,768

 

 

 

 

 

 

 

 

 

584,768

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,866

)

 

 

(5,866

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(3,305,883

)

 

 

 

 

 

(3,305,883

)

Balance at June 30, 2022

 

 

8,416,032

 

 

$

842

 

 

$

41,823,112

 

 

$

(35,157,721

)

 

$

(4,145

)

 

$

6,662,088

 

Issuance of common shares upon exercise of stock options

 

 

10,000

 

 

 

1

 

 

 

17,999

 

 

 

 

 

 

 

 

 

18,000

 

Issuance of common shares in connection with initial public offering, net of $2,749,905 issuance cost

 

 

2,300,000

 

 

 

230

 

 

 

8,749,865

 

 

 

 

 

 

 

 

 

8,750,095

 

Issuance of ratchet share

 

 

219,872

 

 

 

22

 

 

 

1,099,338

 

 

 

 

 

 

 

 

 

1,099,360

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

532,438

 

 

 

 

 

 

 

 

 

532,438

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(47,501

)

 

 

(47,501

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(4,903,813

)

 

 

 

 

 

(4,903,813

)

Balance at September 30, 2022

 

 

10,945,904

 

 

$

1,095

 

 

$

52,222,752

 

 

$

(40,061,534

)

 

$

(51,646

)

 

$

12,110,667

 

 

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
September 30,

 

 

 

 

2023

 

2022

 

Cash flows from operating activities:

 

 

 

Net loss

 

$

(13,516,243

)

 

$

(11,623,541

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

Stock-based compensation

 

 

1,727,369

 

 

1,830,536

 

Issuance of ratchet shares

 

 

 

 

 

1,099,360

 

Consulting expense for restricted shares issued

 

 

682,962

 

 

 

 

Change in fair value of warrant liability

 

 

(141,934

)

 

(128,030

)

Change in operating assets and liabilities:

 

 

 

 

 

Prepaid expenses and other current assets

 

 

134,145

 

 

 

(412,124

)

Australia research and development incentives receivable

 

 

174,613

 

 

 

(230,188

)

Other assets

 

 

 

 

 

322

 

Accounts payable

 

 

64,016

 

 

64,788

 

Accrued expenses

 

 

1,796,502

 

 

252,487

 

Net cash used in operating activities

 

 

(9,078,570

)

 

(9,146,390

)

Cash flows from financing activities:

 

 

 

Proceeds from issuance of common stock, net of transaction costs

 

 

 

 

2,473,560

 

Deferred offering costs

 

 

(153,937

)

 

 

Proceeds from exercise of stock options

 

 

1,432

 

 

 

65,700

 

Proceeds from exercise of warrants

 

 

 

 

385,400

 

Proceeds from sale of common stock in initial public offering

 

 

 

 

 

11,500,000

 

Payment of initial public offering transaction costs

 

 

 

 

 

(1,754,586

)

Proceeds from sale of common stock in follow-on offering

 

 

5,749,875

 

 

 

 

Payment of follow-on offering transactions costs

 

 

(1,351,907

)

 

 

 

Net cash provided by financing activities

 

 

4,245,463

 

 

12,670,074

 

Net effect of foreign currency exchange on cash

 

 

(13,233

)

 

(34,334

)

Net decrease in cash

 

 

(4,846,340

)

 

 

3,489,350

 

Cas