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Table of Contents

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

   Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended June 30, 2021

   Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from _____ to _____.

Commission File Number: 001-37939

Graphic

MARKER THERAPEUTICS, INC.

(Name of registrant in its charter)

DELAWARE

45-4497941

(State or other jurisdiction of incorporation or organization)

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

3200 Southwest Freeway, Suite 2500
Houston, Texas

77027

(Address of principal executive offices)

(Zip Code)

(713) 400-6400

(Issuer’s telephone number)

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, par value $0.001 per share

MRKR

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 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, non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “accelerated filer”, “large 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 August 3, 2021, the Company had 83,078,675 shares of common stock issued and outstanding.

Table of Contents

Table of Contents

Page

PART I – FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets as of June 30, 2021 and December 31, 2020

1

Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2021 and 2020

2

Condensed Consolidated Statement of Stockholders' Equity for the three and six months ended June 30, 2021 and 2020

3

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2021 and 2020

4

Notes to Condensed Consolidated Financial Statements

5

Item 2.

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

14

Item 3.

Quantitative and Qualitative Disclosures About Market Risk.

22

Item 4.

Controls and Procedures.

22

PART II – OTHER INFORMATION

23

Item 1.

Legal Proceedings.

23

Item 1A.

Risk Factors.

23

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

23

Item 3.

Defaults Upon Senior Securities.

23

Item 4.

Mine Safety Disclosure.

23

Item 5.

Other Information.

23

Item 6.

Exhibits.

24

Signatures

25

Table of Contents

PART I.      FINANCIAL INFORMATION

Item 1.        Financial Statements

MARKER THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

    

June 30, 

    

December 31, 

 

2021

2020

ASSETS

Current assets:

Cash and cash equivalents

$

57,221,434

$

21,352,382

Prepaid expenses and deposits

 

2,801,800

 

2,057,924

Other receivables

286

1,000,559

Total current assets

 

60,023,520

 

24,410,865

Non-current assets:

Property, plant and equipment, net

 

10,107,579

 

3,570,736

Construction in progress

6,789,098

Right-of-use assets, net

10,339,884

10,844,116

Total non-current assets

20,447,463

21,203,950

Total assets

$

80,470,983

$

45,614,815

LIABILITIES AND STOCKHOLDERS' EQUITY

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable and accrued liabilities

$

5,100,943

$

6,013,010

Lease liability

558,657

388,792

Total current liabilities

 

5,659,600

 

6,401,802

Non-current liabilities:

Lease liability, net of current portion

11,568,072

11,868,440

Total non-current liabilities

11,568,072

11,868,440

Total liabilities

 

17,227,672

 

18,270,242

Commitments and contingencies (see Note 10)

 

 

Stockholders' equity:

 

 

  

Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively

Common stock, $0.001 par value, 150 million shares authorized, 83.1 million and 50.7 million shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively

83,079

50,731

Additional paid-in capital

 

439,085,948

 

383,533,326

Accumulated deficit

 

(375,925,716)

 

(356,239,484)

Total stockholders' equity

 

63,243,311

 

27,344,573

Total liabilities and stockholders' equity

$

80,470,983

$

45,614,815

See accompanying notes to these unaudited condensed consolidated financial statements.

1

Table of Contents

MARKER THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

    

For the Three Months Ended

 

For the Six Months Ended

June 30, 

 

June 30, 

    

2021

    

2020

    

2021

    

2020

Revenues:

Grant income

$

$

466,785

$

$

466,785

Total revenues

 

 

466,785

 

 

466,785

Operating expenses:

Research and development

 

7,350,035

 

4,277,052

12,993,064

8,093,670

General and administrative

 

3,559,150

 

2,547,289

 

6,697,108

 

5,374,284

Total operating expenses

 

10,909,185

 

6,824,341

 

19,690,172

 

13,467,954

Loss from operations

 

(10,909,185)

 

(6,357,556)

 

(19,690,172)

 

(13,001,169)

Other income:

 

 

 

 

Change in fair value of warrant liabilities

 

 

-

 

-

 

31,000

Interest income

 

2,403

 

15,857

 

3,940

 

142,826

Net loss

$

(10,906,782)

$

(6,341,699)

$

(19,686,232)

$

(12,827,343)

Net loss per share, basic and diluted

$

(0.13)

$

(0.14)

$

(0.28)

$

(0.28)

Weighted average number of common shares outstanding, basic and diluted

 

83,030,470

 

46,572,739

 

69,823,729

 

46,328,561

See accompanying notes to these unaudited condensed consolidated financial statements.

2

Table of Contents

MARKER THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(UNAUDITED)

For the Three Months Ended June 30, 2021

    

    

    

    

    

Total

Common Stock

Additional Paid-

Accumulated

Stockholders’

Shares

Par value

in Capital

Deficit

Equity

Balance at April 1, 2021

 

83,013,929

$

83,014

$

437,430,839

$

(365,018,934)

$

72,494,919

Stock options exercised for cash

1,456

2

3,085

3,087

Stock-based compensation

 

63,290

 

63

 

1,652,024

 

 

1,652,087

Net loss

 

 

 

 

(10,906,782)

 

(10,906,782)

Balance at June 30, 2021

 

83,078,675

$

83,079

$

439,085,948

$

(375,925,716)

$

63,243,311

For the Six Months Ended June 30, 2021

    

Total

Common Stock

Additional Paid-

Accumulated

Stockholders’

    

Shares

    

Par value

    

in Capital

    

Deficit

    

Equity

Balance at January 1, 2021

 

50,731,072

$

50,731

$

383,533,326

$

(356,239,484)

$

27,344,573

Issuance of common stock for cash (net of offering costs of $3.9 million)

32,282,857

32,283

52,520,475

52,552,758

Stock options exercised for cash

1,456

2

3,085

3,087

Stock-based compensation

63,290

 

63

 

3,029,062

 

 

3,029,125

Net loss

 

 

 

 

(19,686,232)

 

(19,686,232)

Balance at June 30, 2021

 

83,078,675

$

83,079

$

439,085,948

$

(375,925,716)

$

63,243,311

For the Three Months Ended June 30, 2020

Total

Common Stock

Additional Paid-

Accumulated

Stockholders’

    

Shares

    

Par value

    

in Capital

    

Deficit

    

Equity

Balance at April 1, 2020

46,532,522

$

46,532

$

373,467,697

$

(334,019,058)

$

39,495,171

Stock-based compensation

85,110

85

1,360,688

1,360,773

Net loss

(6,341,699)

(6,341,699)

Balance at June 30, 2020

46,617,632

$

46,617

$

374,828,385

$

(340,360,757)

$

34,514,245

For the Six Months Ended June 30, 2020

Total

Common Stock

Additional Paid-

Accumulated

Stockholders’

    

Shares

    

Par value

    

in Capital

    

Deficit

    

Equity

Balance at January 1, 2020

45,728,831

$

45,728

$

371,573,909

$

(327,533,414)

$

44,086,223

Warrants exercised for cash

458,334

459

549,541

550,000

Issuance of common stock as commitment fee for future financing

345,357

345

(345)

Stock-based compensation

85,110

85

2,705,280

2,705,365

Net loss

(12,827,343)

(12,827,343)

Balance at June 30, 2020

46,617,632

$

46,617

$

374,828,385

$

(340,360,757)

$

34,514,245

See accompanying notes to these unaudited condensed consolidated financial statements.

3

Table of Contents

MARKER THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

For the Six Months Ended

June 30, 

    

2021

    

2020

Cash Flows from Operating Activities:

Net loss

$

(19,686,232)

$

(12,827,343)

Reconciliation of net loss to net cash used in operating activities:

 

 

Depreciation and amortization

1,032,971

124,627

Changes in fair value of warrant liabilities

 

 

(31,000)

Stock-based compensation

 

3,029,125

 

2,705,365

Amortization on right-of-use assets

 

504,232

 

96,973

Changes in operating assets and liabilities:

 

  

 

  

Prepaid expenses and deposits

 

(743,876)

 

(1,106,072)

Other receivables

 

1,000,273

 

52,749

Accounts payable and accrued expenses

 

(912,067)

 

2,770,341

Lease liability

(130,503)

(187,068)

Net cash used in operating activities

 

(15,906,077)

 

(8,401,428)

Cash Flows from Investing Activities:

 

 

Purchase of property and equipment

 

(780,716)

 

(1,299,193)

Purchase of construction in progress

(2,629,141)

Net cash used in investing activities

 

(780,716)

 

(3,928,334)

Cash Flows from Financing Activities:

 

 

  

Proceeds from issuance of common stock, net

 

52,552,758

 

Proceeds from exercise of warrants

 

 

550,000

Proceeds from exercise of stock options

 

3,087

 

Net cash provided by financing activities

 

52,555,845

 

550,000

Net increase (decrease) in cash

 

35,869,052

 

(11,779,762)

Cash and cash equivalents at beginning of the period

 

21,352,382

 

43,903,949

Cash and cash equivalents at end of the period

$

57,221,434

$

32,124,187

    

For the Six Months Ended

June 30, 

    

2021

    

2020

Supplemental schedule of non-cash financing activities:

Reclassifications between construction in progress and fixed assets

$

6,789,098

$

Issuance of common stock as commitment fee for future financing

$

$

345

Recognition of right-of-use assets and lease liability from new operating lease agreement

$

$

9,184,027

See accompanying notes to these unaudited condensed consolidated financial statements.

4

Table of Contents

MARKER THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2021

(Unaudited)

NOTE 1: NATURE OF OPERATIONS

Marker Therapeutics, Inc., a Delaware corporation (the “Company” or “we”), is a clinical-stage immuno-oncology company specializing in the development and commercialization of novel T cell-based immunotherapies and innovative peptide-based vaccines for the treatment of hematological malignancies and solid tumor indications. The Company’s MultiTAA T cell technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens, which are tumor targets, and kill tumor cells expressing those targets. These T cells are designed to recognize multiple tumor targets to produce broad spectrum anti-tumor activity. 

NOTE 2: BASIS OF PRESENTATION

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results.

The results for the condensed consolidated statement of operations are not necessarily indicative of results to be expected for the year ending December 31, 2021 or for any future interim period. The condensed consolidated balance sheet at June 30, 2021 has been derived from unaudited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2020 and notes thereto included in the Company’s annual report on Form 10-K filed on March 9, 2021.

NOTE 3: LIQUIDITY AND FINANCIAL CONDITION

As of June 30, 2021, the Company had cash and cash equivalents of approximately $57.2 million. The Company’s activities since inception have consisted principally of acquiring product and technology rights, raising capital, and performing research and development. Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to access potential markets; secure financing; successfully progress its product candidates through preclinical and clinical development; obtain regulatory approval of one or more of its product candidates; maintain and enforce intellectual property rights; develop a customer base; attract, retain and motivate qualified personnel; and develop strategic alliances and collaborations. From inception, the Company has been funded by a combination of equity and debt financings.

On March 16, 2021, the Company issued an aggregate of 32,282,857 shares of its common stock, for net proceeds of $52.6 million.

The Company expects to continue to incur substantial losses over the next several years during its development phase. To fully execute its business plan, the Company will need to complete certain research and development activities and clinical trials. Further, the Company’s product candidates will require regulatory approval prior to commercialization. These activities will span many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in completing these activities could adversely impact the Company. The Company plans to meet its capital requirements primarily through issuances of debt and equity securities and, in the longer term, revenue from sales of its product candidates, if approved.

5

Table of Contents

Based on the Company’s clinical and research and development plans and its timing expectations related to the progress of its programs, the Company expects that its cash and cash equivalents as of June 30, 2021 will enable the Company to fund its operating expenses and capital expenditure requirements into the first quarter of 2023. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could utilize its available capital resources sooner than it currently expects. Furthermore, the Company’s operating plan may change, and it may need additional funds sooner than planned in order to meet operational needs and capital requirements for product development and commercialization. Because of the numerous risks and uncertainties associated with the development and commercialization of the Company's product candidates and the extent to which the Company may enter into additional collaborations with third parties to participate in their development and commercialization, the Company is unable to estimate the amounts of increased capital outlays and operating expenditures associated with its current and anticipated clinical trials. The Company’s future funding requirements will depend on many factors, as it:

initiates or continues clinical trials of its product candidates;
continues the research and development of its product candidates and seeks to discover additional product candidates;
seeks regulatory approvals for any product candidates that successfully complete clinical trials;
maintains and enforces intellectual property rights;
establishes sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive regulatory approval;
evaluates strategic transactions the Company may undertake; and
enhances operational, financial and information management systems and hires additional personnel, including personnel to support development of product candidates and, if a product candidate is approved, commercialization efforts.

In addition to the foregoing, based on the Company’s current assessment, the Company does not expect any material impact on its long-term liquidity due to the COVID-19 pandemic. However, the Company will continue to assess the effect of the pandemic on its operations, including its clinical programs. The extent to which the COVID-19 pandemic will impact the Company’s business and operations will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, the duration and effect of business disruptions and the short-term effects and ultimate effectiveness of the travel restrictions, quarantines, social distancing requirements and business closures in the United States and other countries to contain and treat the disease. While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a widespread pandemic could result in significant disruption of global financial markets, reducing the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect the Company’s business and the value of its common stock.

NOTE 4: SIGNIFICANT ACCOUNTING POLICIES

New Accounting Standards

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed, the Company does not believe that the impact of recently issued standards that are not yet effective will have a material impact on its financial position or results of operations upon adoption.

Recent Accounting Standards Adopted in the Year

Income Taxes

In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes  (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company has adopted the new standard effective January 1, 2021 and has concluded that the adoption of this standard did not have a material impact on its condensed consolidated financial statements and related disclosures.

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NOTE 5: NET LOSS PER SHARE

Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period. Diluted loss per common share is computed similarly to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock.

The following table sets forth the computation of net loss per share for the three and six months ended June 30, 2021 and 2020, respectively:

    

For the Three Months Ended

 

For the Six Months Ended

June 30, 

 

June 30, 

    

2021

    

2020

     

2021

    

2020

Numerator:

Net loss

$

(10,906,782)

$

(6,341,699)

$

(19,686,232)

$

(12,827,343)

Denominator:

 

 

 

 

Weighted average common shares outstanding

 

83,030,470

 

46,572,739

 

69,823,729

 

46,328,561

Net loss per share:

 

 

 

 

Basic and diluted

$

(0.13)

$

(0.14)

$

(0.28)

$

(0.28)

The following securities, rounded to the nearest thousand, were not included in the diluted net loss per share calculation because their effect was anti-dilutive for the periods presented:

For the Six Months Ended

June 30, 

    

2021

    

2020

Common stock options

 

7,461,000

 

5,842,000

Common stock purchase warrants

 

20,830,000

 

21,381,000

Potentially dilutive securities

 

28,291,000

 

27,223,000

NOTE 6: OTHER RECEIVABLES

Pursuant to the Company’s lease agreement for its manufacturing facility, the Company incurred and paid for the construction invoices directly for both the structural improvements of the facility and the building of the manufacturing modular cleanroom (i.e. leasehold improvements and manufacturing equipment).  In accordance with the agreement, upon completion of the facility’s construction, the Company was owed up to $1.0 million as reimbursement, and as such a landlord receivable was recorded, which provides for a legal right to receive construction reimbursements from the landlord for tenant improvement allowances. During the fiscal year ended 2020, the Company recorded a $1.0 million receivable in its condensed consolidated financial statements.  The Company received the $1.0 million reimbursement in April 2021.

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NOTE 7: PROPERTY AND EQUIPMENT

Property and equipment consist of the following as of June 30, 2021 and December 31, 2020, respectively:

June 30, 

December 31, 

    

Estimated Useful Lives

    

2021

    

2020

Lab and manufacturing equipment

5 Years

$

6,840,000

$

2,360,000

Computers, equipment and software

 

3-5 Years

909,000

835,000

Office furniture

 

5 Years

 

820,000

 

678,000

Leasehold improvements

Lesser of lease term or estimated useful life

3,163,000

289,000

Total  

 

  

11,732,000

4,162,000

Less: accumulated depreciation

 

  

 

(1,624,000)

 

(591,000)

Construction in progress

6,789,000

Total fixed assets, net

 

  

$

10,108,000

$

10,360,000

In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas. In connection with the manufacturing facility, the Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and eventually install modular cleanrooms in a manufacturing facility. $6.8 million was recorded in fixed assets - construction in progress on the balance sheet as of December 31, 2020. The completion of the facility’s construction occurred during December 2020 and the Company received its certificate of occupancy in January 2021, and as such was placed into service in January 2021. During January 2021, $4.0 million of the costs previously recorded as construction in progress were recorded to lab and manufacturing equipment and $2.8 million were recorded to leasehold improvements.

Depreciation expense for the three months ended June 30, 2021 and 2020 was approximately $0.5 million and $0.1 million, respectively.

Depreciation expense for the six months ended June 30, 2021 and 2020 was approximately $1.0 million and $0.1 million, respectively.

NOTE 8: LEASES

The Company leases manufacturing, research and administrative facilities under operating leases. The Company evaluates its contracts to determine if an arrangement is a lease at inception and classify it as a finance or operating lease. Currently, all of the Company’s leases are classified as operating leases. Leased assets and corresponding liabilities are recognized based on the present value of the lease payments over the lease term. The lease terms may include options to extend when it is reasonably certain that the Company will exercise that option.

Topic ASC 842 requires the Company to recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. Right-of-use assets are recorded in other assets on the Company’s condensed consolidated balance sheets. Current and non-current lease liabilities are recorded in other accruals within current liabilities and other non-current liabilities, respectively, on its condensed consolidated balance sheets. Costs associated with operating leases are recognized on a straight-line basis within operating expenses over the term of the lease.

As of June 30, 2021, the Company had total operating lease liabilities of approximately $12.1 million and right-of-use assets of approximately $10.3 million, which were included in the condensed consolidated balance sheet.  

Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees.  Certain of the Company’s leases include renewal options and escalation clauses; renewal options have not been included in the calculation of the lease liabilities and right-of-use assets as the Company is not reasonably certain to exercise the options.  Variable expenses generally represent the Company’s share of the landlord’s operating expenses.  The Company does not act as a lessor or have any leases classified as financing leases.  

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The following summarizes quantitative information about the Company’s operating leases for the three and six months ended June 30, 2021 and 2020, respectively:

    

For the Three Months Ended

 

For the Six Months Ended

 

June 30

June 30

    

2021

    

2020

    

2021

    

2020

 

Operating lease expense summary:

 

  

  

  

  

Operating lease expense

$

425,000

$

103,000

$

850,000

$

158,000

Short-term lease expense

 

 

3,000

 

 

22,000

Variable lease expense

 

129,000

 

5,000

 

262,000

 

16,000

Total

$

554,000

$

111,000

$

1,112,000

$

196,000

    

For the Six Months Ended

June 30

2021

2020

Other information:

 

  

 

  

Operating cash flows - operating leases

$

477,000

$

248,000

The weighted-average remaining lease term as of June 30, 2021 and December 31, 2020 was approximately 8.9 years and 9.3 years, respectively. The weighted-average discount rate used to determine the operating lease liability as of June 30, 2021 and December 31, 2020 was approximately 5.7% and 5.7%, respectively.

Maturities of our operating leases, excluding short-term leases, are as follows:

Six months ended December 31, 2021

    

$

600,000

Year ended December 31, 2022

 

1,278,000

Year ended December 31, 2023

 

1,542,000

Year ended December 31, 2024

 

1,826,000

Year ended December 31, 2025

1,874,000

Thereafter

8,772,000

Total

15,892,000

Less present value discount

 

(3,765,000)

Operating lease liabilities included in the Condensed Consolidated Balance Sheet at June 30, 2021

$

12,127,000

NOTE 9: ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

Accounts payable and accrued liabilities consist of the following as of June 30, 2021 and December 31, 2020, respectively:

    

June 30, 

    

December 31, 

2021

2020

Accounts payable

$

2,042,000

$

2,935,000

Compensation and benefits

 

1,105,000

 

1,694,000

Process development expenses

777,000

277,000

Professional fees

 

445,000

 

875,000

Technology license fees

 

300,000

 

105,000

Other

 

432,000

 

127,000

Total accounts payable and accrued liabilities

$

5,101,000

$

6,013,000

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NOTE 10: COMMITMENTS AND CONTINGENCIES

An arbitration proceeding was brought against the Company before the Financial Industry Regulatory Authority, Inc. by a broker seeking to be paid approximately $1.6 million as compensation for two financing transactions that occurred in 2018, a warrant conversion and a private placement brokered by another broker. The broker further claims approximately $335,000 in interest, and approximately $600,000 in attorney’s fees, which are recoverable in the arbitration by the prevailing party. The broker’s claims are based on a placement agent agreement for a private placement it brokered in 2017, under which it alleges it is entitled to compensation for the 2018 transactions.   The arbitration hearing has occurred, and the parties have filed post-hearing briefs, and are awaiting a decision from the arbitrators.

NOTE 11: STOCKHOLDERS’ EQUITY

Common Stock Transactions

Exercise of Stock Options

During the six months ended June 30, 2021, certain outstanding options were exercised for 1,456 shares of common stock providing aggregate proceeds to the Company of approximately $3,100.

Board Compensation

During the six months ended June 30, 2021, the Company issued an aggregate of 63,290 shares of common stock to its non-employee directors. The fair value of the common stock of approximately $0.2 million was recognized as a component of stock-based compensation expense in general and administrative expenses.

Underwritten Public Offering

On March 11, 2021, the Company entered into an underwriting agreement with Piper Sandler & Co., as representative of the several underwriters, to issue and sell 28,572,000 shares of common stock of the Company in an underwritten public offering. The offering price to the public was $1.75 per share.  In addition, the Company granted the underwriters an option to purchase, for a period of 30 days, up to an additional 4,285,800 shares of common stock, which such option was partially exercised with respect to 3,710,857 shares.  An aggregate of 32,282,857 shares of the Company’s common stock was issued for net proceeds of $52.6 million.

Share Purchase Warrants

A summary of the Company’s share purchase warrants as of June 30, 2021 and changes during the period is presented below:

    

    

Weighted Average

 

Number of

Weighted Average

Remaining Contractual

Total Intrinsic

    

Warrants

    

Exercise Price

    

Life (in years)

    

Value

Balance - January 1, 2021

 

20,830,000

$

4.47

2.60

$

Balance - June 30, 2021

20,830,000

$

4.47

2.11

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NOTE 12: STOCK-BASED COMPENSATION

Stock Options

2021 Equity Incentive Awards

On February 10, 2021, pursuant to the Company’s 2020 Equity Incentive Plan, the compensation committee of the Company’s board of directors approved a total of 740,000 options to purchase the Company’s common stock as equity-based incentive awards to the Company’s executive officers, other than the Chief Executive Officer. Each option award was granted with an exercise price of $3.29 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 10, 2021, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such executive officer’s continued service on the applicable vesting date.  Additionally, on February 10, 2021, the compensation committee of the Company’s board of directors approved a total of 260,000 options to purchase the Company’s common stock to non-executive employees of the Company as equity-based incentive awards.  Each option award was granted with an exercise price of $3.29 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 10, 2021, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such employee’s continued service on the applicable vesting date.

On February 11, 2021, upon the recommendation of the compensation committee and pursuant to the Company’s 2020 Equity Incentive Plan, the Company’s board of directors approved a total of 430,000 options to purchase the Company’s common stock as (equity-based incentive awards to the Company’s Chief Executive Officer. The option award was granted with an exercise price of $3.06 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 11, 2021, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such Chief Executive Officer’s continued service on the applicable vesting date.

The above awards were in addition to 90,000 stock option awards issued during the three months ended March 31, 2021 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $1.47 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on January 4, 2021, with 25% of the option award vesting in one year and the remaining 75% vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee's continued service on the applicable vesting date. Also, 100,000 stock option awards were issued during the three months ended June 30, 2021 to new employees upon their commencement of employment with the Company.  Each option award was granted with an exercise price of $2.19 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on April 1, 2021, with 25% of the option award vesting in one year and the remaining 75% vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee’s continued service on the applicable vesting date.

During the six months ended June 30, 2021, 1,456 stock options were exercised for net proceeds of $3,100.

A summary of the Company’s stock option activity for the six months ended June 30, 2021 is as follows:

    

    

    

Weighted Average

Remaining

Weighted Average 

Total Intrinsic

Contractual

    

Number of Shares

    

Exercise Price

    

Value

    

Life (in years)

Outstanding as of January 1, 2021

 

6,001,814

$

6.22

$

8.3

Granted

 

1,620,000

3.06

9.3

Exercised

(1,456)

2.12

Canceled/Expired

 

(159,581)

3.42

Outstanding as of June 30, 2021

 

7,460,777

$

5.59

$

1,178,000

8.1

Options vested and exercisable

 

3,396,723

$

6.91

$

299,000

7.5

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The Black-Scholes option pricing model is used to estimate the fair value of stock options granted under the Company’s share-based compensation plans. The weighted average assumptions used in calculating the fair values of stock options that were granted during the six months ended June 30, 2021 was as follows:  

For the Six Months Ended

    

June 30, 2021

  

Exercise price

$

3.06

Expected term (years)

 

6.0

Expected stock price volatility

 

95

%

Risk-free rate of interest

 

1

%

Expected dividend rate

 

0

%

The following table sets forth stock-based compensation expenses recorded during the respective periods:

    

For the Three Months Ended

 

For the Six Months Ended

June 30, 

 

June 30, 

    

2021

    

2020

    

2021

    

2020

Stock Compensation expenses:

 

  

 

  

  

 

  

Research and development

$

709,000

$

528,000

$

1,405,000

$

1,309,000

General and administrative

 

943,000

 

833,000

 

1,624,000

 

1,396,000

Total stock compensation expenses

$

1,652,000

$

1,361,000

$

3,029,000

$

2,705,000

As of June 30, 2021, the total stock-based compensation cost related to unvested awards not yet recognized was $11.2 million. The expected weighted average period compensation costs to be recognized was approximately 2.3 years. Future option grants will impact the compensation expense recognized.

NOTE 13: RELATED PARTY TRANSACTIONS

The following table sets forth related party transaction expenses recorded for the three and six months ended June 30, 2021 and 2020, respectively.

For the Three Months Ended

 

For the Six Months Ended

June 30, 

 

June 30, 

    

2021

    

2020

    

2021

    

2020

Baylor College of Medicine

$

841,000

$

158,000

$

1,263,000

$

393,000

Bio-Techne Corporation

114,000

35,000

160,000

54,000

Total Research and development

$

955,000

 

$

193,000

$

1,423,000

 

$

447,000

Agreements with The Baylor College of Medicine (“BCM”).

In November 2018 and February 2020, the Company entered in Sponsored Research Agreements with BCM, which provided for the conduct of research for the Company by credentialed personnel at BCM’s Center for Cell and Gene Therapy.

In September 2019, the Company entered in a Clinical Supply Agreement with BCM, which provided for BCM to provide to the Company multi tumor antigen specific products.

In October 2019, the Company entered in a Workforce Grant Agreement with BCM, which provided for BCM to provide to the Company manpower costs of projects for manufacturing, quality control testing and validation run activities.

In August 2020, the Company entered in a Clinical Trial Agreement with BCM, which provided for BCM to provide to the Company investigator-initiated research studies.

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Purchases from Bio-Techne Corporation.

The Company is currently utilizing Bio-Techne Corporation and two of its brands for the purchases of reagents, primarily cytokines.  Mr. David Eansor is a member of the Company’s board of directors and is serving as the President of the Protein Sciences Segment of Bio-Techne Corporation.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, that involve risks and uncertainties. All statements other than statements relating to historical matters including statements to the effect that we “believe”, “expect”, “anticipate”, “plan”, “target”, “intend” and similar expressions should be considered forward-looking statements. Our actual results could differ materially from those discussed in the forward-looking statements as a result of a number of important factors, including factors discussed in this section and elsewhere in this Quarterly Report on Form 10-Q, and the risks discussed in our other filings with the SEC. Such risks and uncertainties may be amplified by the COVID-19 pandemic and its potential impact on our business and the global economy. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis, judgment, belief or expectation only as the date hereof. We assume no obligation to update these forward-looking statements to reflect events or circumstance that arise after the date hereof.

As used in this quarterly report: (i) the terms “we”, “us”, “our”, “Marker” and the “Company” mean Marker Therapeutics, Inc. and its wholly owned subsidiaries, Marker Cell Therapy, Inc. and GeneMax Pharmaceuticals Inc. which wholly owns GeneMax Pharmaceuticals Canada Inc., unless the context otherwise requires; (ii) “SEC” refers to the Securities and Exchange Commission; (iii) “Securities Act” refers to the Securities Act of 1933, as amended; (iv) “Exchange Act” refers to the Securities Exchange Act of 1934, as amended; and (v) all dollar amounts refer to United States dollars unless otherwise indicated.

The following should be read in conjunction with our unaudited condensed consolidated interim financial statements and related notes for the six months ended June 30, 2021 included in this Quarterly Report.

Company Overview

We are a clinical-stage immuno-oncology company specializing in the development and commercialization of novel T cell-based immunotherapies and innovative peptide-based vaccines for the treatment of hematological malignancies and solid tumor indications. We developed our lead product candidates from our MultiTAA-specific T cell technology, which is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens, or TAAs, which are tumor targets, and then kill tumor cells expressing those targets. These T cells are designed to recognize multiple tumor targets to produce broad spectrum anti-tumor activity. We are advancing two pipelines of product candidates as part of our MultiTAA-specific T cell program: the autologous T cells for the treatment of lymphoma, multiple myeloma, or MM, and selected solid tumors and the allogeneic T cells for the treatment of acute myeloid leukemia, or AML, and acute lymphoblastic leukemia, or ALL. Because we do not genetically engineer the MultiTAA-specific T cell therapies, we believe that our product candidates are easier and less expensive to manufacture, have lower toxicities than current engineered chimeric antigen receptor, or CAR-T, and T cell receptor-based therapies and may provide patients with meaningful clinical benefit. We are also developing innovative peptide-based immunotherapeutic vaccines for the treatment of metastatic solid tumors.

We are pursuing post-transplant AML as the lead indication for our first company-sponsored MultiTAA-specific T cell program. In April 2020, the FDA granted orphan drug designation to MT-401 for the treatment of AML after receiving an allogeneic stem cell transplant.  The MultiTAA-specific T cell therapy has been well tolerated in an ongoing Phase 1 clinical trial in AML and myelodysplastic syndrome, or MDS, conducted by our strategic partner Baylor College of Medicine, or BCM. As reported in a recent publication by Lulla et al., 11 of the 17 patients in the adjuvant disease setting dosed with the MultiTAA-specific T cell therapy after receiving an allogeneic hematopoietic stem cell transplant, or HSCT, never relapsed [median leukemia-free survival, or LFS, not reached at a median follow-up of 1.9 years], with 11 of 15 patients remaining alive (estimated two-year overall survival of 77%) at a median follow-up of 1.9 years post-infusion, which compares favorably with HSCT outcomes for risk-matched AML/MDS patients post-HSCT [median LFS of nine to 15 months and two-year survival probability of 42%].  Additionally, eight patients were treated for active disease that was resistant to salvage therapy post-HSCT with a median of five prior lines of therapy (range: four to 10).  One of the eight patients crossed over from the adjuvant group, while two patients enrolled twice, but all three patients had active AML that failed another line of salvage therapy after their first MultiTAA-specific T cell infusion.  Two of the eight patients achieved objective responses, with one complete response and one partial response, with six patients continuing with stable disease.

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We submitted an investigational new drug, or IND, application to the United States Food and Drug Administration, or the FDA, to initiate a Phase 2 clinical trial of MultiTAA-specific T cell therapy, which we refer to as MT-401 (zedenoleucel), in post-allogeneic HSCT patients with AML in both the adjuvant and active disease setting. The dose administered in this multicenter trial is currently 100 million cells every two weeks for three doses. In the adjuvant setting, patients will be randomized to either MultiTAA-specific T cell therapy at approximately 90 days post-transplant versus standard of care observation, while the active disease patients will receive MT-401 following relapse post-transplant as part of a single-arm group. We have completed the safety lead-in portion of the trial in June 2021. We initiated the remainder of the Phase 2 trial in July 2021 and plan to complete enrollment of approximately 20 patients and activate additional clinical sites across the United States in the fourth quarter of 2021 in order to report results from the active disease arm of the trial in the first quarter of 2022. We expect to begin manufacturing MT-401 for the Phase 2 trial at our cGMP manufacturing facility in the third quarter of 2021.

We reported interim data for an ongoing Phase 1/2 clinical trial of the MultiTAA-specific T cell therapy for the treatment of pancreatic adenocarcinoma being conducted by BCM. In this trial, we have observed a clinical benefit correlated with the post-infusion detection of tumor-reactive T cells in patient peripheral blood and within tumor biopsy samples in patients in the tumor-resection arm of the trial. These T cells exhibited activity against both targeted antigens and non-targeted TAAs, indicating induction of antigen spreading. To date, we have not observed any cytokine release syndrome or neurotoxicity in this trial.

We are also evaluating the MultiTAA-specific T cell therapies in a Phase 2 clinical trial for the treatment of breast cancer and in Phase 1 clinical trials for the treatment of ALL, lymphoma, MM and sarcoma, all of which are being conducted by BCM. As of June 2021, the MultiTAA-specific T cell therapies have been generally well tolerated by all of the patients enrolled in clinical trials in hematological and solid tumor indications with no incidents of cytokine release syndrome or neurotoxicity, which are frequently associated with CAR-T therapies. Our ongoing clinical trials may be also affected by the COVID-19 pandemic.  Based on our observations in clinical trials in AML, pancreatic cancer, lymphoma, ALL and MM, we believe that the MultiTAA-specific T cell therapies have the potential to mediate a meaningful anti-tumor effect, as well as significant in vivo expansion of T cells.  We may initiate additional clinical trials investigating other indications in addition to our planned Phase 2 trial in post-transplant AML patients.

Pipeline

Our clinical-stage pipeline, including clinical trials being conducted by BCM and other partners, is set forth below:

Graphic

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Results of Operations

In this discussion of our results of operations and financial condition, amounts in financial tables, other than per-share amounts, have been rounded to the nearest thousand.

Comparison of the Three Months Ended June 30, 2021 and 2020

The following table summarizes the results of our operations for the three months ended June 30, 2021 and 2020:

    

For the Three Months Ended

    

  

    

  

 

June 30, 

    

 

    

2021

    

2020

    

Change

 

Revenues:

Grant income

$

$

467,000

$

(467,000)

(100)

%

Total revenues

 

 

467,000

 

(467,000)

 

(100)

%

Operating expenses:

 

 

 

 

  

Research and development

 

7,350,000

 

4,277,000

 

3,073,000

 

72

%

General and administrative

 

3,559,000

 

2,547,000

 

1,012,000

 

40

%

Total operating expenses

 

10,909,000

 

6,824,000

 

4,085,000

 

60

%

Loss from operations

 

(10,909,000)

 

(6,358,000)

 

(4,551,000)

 

72

%

Other income (expense):

 

 

 

 

Change in fair value of warrant liabilities

 

 

 

 

Interest income

 

2,000

 

16,000

 

(14,000)

 

(88)

%

Net loss

$

(10,907,000)

$

(6,342,000)

$

(4,565,000)

 

72

%

Net loss per share, basic and diluted

$

(0.13)

$

(0.14)

$

0.01

 

(7)

%

Weighted average number of common shares outstanding, basic and diluted

 

83,030,000

 

46,573,000

 

36,457,000

 

78

%

Revenue

Grant income

We did not receive any grant income during the three months ended June 30, 2021.

During the three months ended June 30, 2020, we received $0.5 million of a grant awarded to the Mayo Foundation from the U.S. Department of Defense to fund the Phase 2 clinical trial of TPIV100 for the treatment of HER2/neu breast cancer. The portion of the grant we received compensated us for clinical supplies manufactured by us for the clinical trial.  

Operating Expenses

Operating expenses incurred during the three months ended June 30, 2021 were $10.9 million compared to $6.8 million during the three months ended June 30, 2020.

Significant changes and expenditures in operating expenses are outlined as follows:

Research and Development Expenses

Research and development expenses increased by 72% to $7.4 million for the three months ended June 30, 2021, compared to $4.3 million for the three months ended June 30, 2020.

The increase of $3.1 million in 2021 was primarily attributable to the following:

oincrease of $0.8 million in expenses related to our AML clinical trial,

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oincrease of $0.7 million in headcount-related expenses,
oincrease of $0.5 million in process development expenses,
oincrease of $0.7 million in sponsored research expenses from BCM agreements,
oincrease of $0.3 million in rent and utilities,
oincrease of $0.2 million in other expenses, and
oincrease of $0.4 million in depreciation expenses primarily attributable to our manufacturing facility and related expenses, offset by
odecrease of $0.5 million in expenses related to our vaccine clinical trials.

General and Administrative Expenses

General and administrative expenses were $3.6 million and $2.5 million for the three months ended June 30, 2021 and 2020, respectively.

The increase of $1.1 million in 2021 was primarily attributable to the following:

oincrease of $0.3 million in legal fees,
oincrease of $0.3 million in headcount-related expenses,
oincrease of $0.2 million in rent and utilities, and
oincrease of $0.3 million in other expenses.

Other Income (Expense)

Interest Income

Interest income was $2,000 and $16,000 for the three months ended June 30, 2021 and 2020, respectively, and was attributable to interest income relating to funds that are held in U.S. Treasury notes and U.S. government agency-backed securities.

Net Loss

The increase in our net loss during the three months ended June 30, 2021 compared to the three months ended June 30, 2020 was due to the continued expansion of our research and development activities, increased expenses relating to future clinical trials, and the overall growth of our corporate infrastructure. We anticipate that we will continue to incur net losses in the future as we continue to invest in research and development activities, including clinical development of our MultiTAA T cell product candidates.

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Table of Contents

Comparison of the Six Months Ended June 30, 2021 and 2020

The following table summarizes the results of our operations for the six months ended June 30, 2021 and 2020:

For the Six Months Ended

June 30, 

    

 

    

2021

    

2020

    

Change