What changed in this filing

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Item 5. Market for Registrant’s Common Equity

2021-03-09 compared with 2020-03-12 · 7 added, 384 removed, 5 unchanged (99% of the section changed)

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information

Our common stock is listed for trading

on the Nasdaq Capital Market under the symbol “MRKR”.

As of February 28, 2020, we had 465 stockholders of record whom

are holding shares.

Our common stock is listed for trading on the Nasdaq Capital Market under the symbol “MRKR”.

As of February 26, 2021, we had 412 stockholders of record whom are holding shares.

The price of our common stock on February 26, 2021 was $2.42 per share.

Dividend Policy

No dividends have been declared or paid

on our common stock.

We have incurred recurring losses and do not currently intend to pay any cash dividends in the foreseeable

No dividends have been declared or paid on our common stock.

We have incurred recurring losses and do not currently intend to pay any cash dividends in the foreseeable future.

Recent Sales of Unregistered Securities

We did not record any issuances of unregistered

securities during the fourth quarter of 2019.

We did not record any issuances of unregistered securities during the fourth quarter of 2020.

SELECTED FINANCIAL DATA

We are a smaller reporting company as defined

by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion of our financial

condition, changes in financial condition, plan of operations and results of operations should be read in conjunction with (i)

our audited consolidated financial statements as at December 31, 2019 and December 31, 2018 and (ii) the section entitled “Business”,

included in this annual report.

The discussion contains forward-looking statements that involve risks, uncertainties and assumptions.

Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors.

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, with reduced 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.

The MultiTAA-specific T cell therapy has

been well tolerated in an ongoing Phase 1/2 clinical trial conducted by our strategic partner Baylor College of Medicine, or BCM.

As reported in March 2019, eleven of the thirteen patients in the adjuvant disease setting dosed with the MultiTAA-specific T cell

therapy after receiving an allogeneic stem cell transplant survived, ranging from 6 weeks to 2.5 years post-infusion, with nine

of these remaining patients in continuing complete remission, or CCR.

Survival of the six patients with active disease ranged from

4 to 21 months, as compared to a historical survival rate of approximately 4.5 months for patients who receive the standard of

care post-transplant.

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, in post-allogeneic hematopoietic

stem cell transplant patients with AML in both the adjuvant and active disease setting, which may become pivotal pending the results

of the interim analysis.

The dose administered in this multicenter trial is the current maximum tolerated dose from the ongoing

Phase 1/2 trial.

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.

In February 2020, we announced that the FDA has permitted us to initiate our Phase

2 clinical trial beginning with a safety lead-in portion of the trial.

We recently 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

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.

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 December 2019, 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 CD19 CAR-T therapies.

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 Phase 2 clinical

trials investigating other indications in 2020 in addition to our planned Phase 2 trial in post-transplant AML patients.

Financial Overview

Critical Accounting Policies

The consolidated financial statements are

prepared in conformity with U.S.

GAAP, which require the use of estimates, judgments and assumptions that affect the reported amounts

of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and the reported amounts

of expenses in the periods presented.

We believe that the accounting estimates employed are appropriate and resulting balances

are reasonable;

however, due to inherent uncertainties in making estimates, actual results could differ from the original estimates,

requiring adjustments to these balances in future periods.

The critical accounting estimates that affect the consolidated financial

statements and the judgments and assumptions used are consistent with those described under Note 3 in the Notes to Consolidated

Financial Statements in this Form 10-K.

Research and Development Expenses

To date, our research and development expenses

have related primarily to the development of our clinical platform and the identification and development of our product candidates.

Clinical and research and development expenses consist of expenses incurred in performing research and development activities,

cost of our clinical trials, including compensation, share-based compensation expense and benefits for research and development

employees and consultants, facilities expenses, overhead expenses, cost of supplies, manufacturing expenses, fees paid to third

parties and other outside expenses.

Clinical costs are expensed as incurred.

Costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include,

but are not limited to, the following:

per patient clinical trial costs;

the number of patients that participate in the clinical trials;

the number of sites included in the clinical trials;

the length of time required to enroll eligible patients;

the number of doses that patients receive;

the drop-out or discontinuation rates of patients;

potential additional safety monitoring or other studies requested by regulatory agencies;

the duration of patient follow-up;

the efficacy and safety profile of the product candidates;

the ability to successfully manufacture patient doses.

In addition, the potential for success

of each product candidate will depend on numerous factors, including clinical trial outcomes, acceptance by regulatory authorities,

competition, manufacturing capability and commercial viability.

We determine which programs to pursue and how much to fund each

program in response to ongoing scientific assessments, competitive developments, clinical trial results, as well as an assessment

of each product candidate's commercial potential.

We anticipate our research and development costs will continue to increase over

the next several years due to increased spending on the clinical development and manufacturing of our product candidates.

General and Administrative Expenses

General and administrative expenses consist

primarily of salaries and other related costs, including share-based compensation, for personnel in executive, finance, accounting,

business development, legal and human resources functions.

Other significant costs include facility costs not otherwise included

in research and development expenses, legal fees relating to patent and corporate matters, insurance costs and professional fees

for consultancy, accounting, audit and investor relations.

We anticipate that our general and administrative

expenses will increase in the future to support our continued research and development activities, and the potential commercialization

of our product candidates.

We did not recognize any income tax expense

for the years ended December 31, 2019 and 2018.

Other Income (Expense)

Other income (expense), net consists of

interest income and change in fair value of warrant liabilities.

Results of Operations For the Years Ended December 31, 2019

The following table summarizes the results of our operations

(rounded to the thousand except for per share amounts) for the years ended December 31, 2019 and 2018, together with the changes

to those items:

For the Years Ended

Total revenues

Operating expenses:

Research and development - intellectual property acquired

(116,045,000 )

Research and development

General and administrative

(14,403,000 )

Total operating expenses

(125,636,000 )

Loss from operations

(22,529,000 )

(148,172,000 )

Other income (expense):

Change in fair value of warrant liabilities

Interest income

$ (21,428,000 )

$ (147,958,000 )

$ 126,530,000

Net loss per share, basic and diluted

Weighted average number of common shares outstanding

We did not generate any revenue during

the years ended December 31, 2019 and 2018, respectively from the sales or licensing of our product candidates.

During the year

ended December 31, 2019, we recognized $213,000 of revenue associated with a grant awarded to Mayo Foundation from the US Department

of Defense for the Phase 2 Clinical Trial of TPIV200 which Mayo paid to us for clinical supplies manufactured by us and provided

for the clinical trial funded by the grant.

We refer to this grant as the Mayo Grant.

During the year ended December 31, 2018,

we also recognized $206,000 of grant income from the Mayo Grant.

Operating Expenses

Operating expenses incurred during the

fiscal year ended December 31, 2019 were $22.7 million compared to $148.4 million in the prior year.

Significant changes and expenditures

in operating expenses are outlined as follows:

Research and Development Expense-Intellectual

Property Acquired

Research and development –

Property Acquired, decreased $116.0 million in the year ended December 31, 2018 to $0 in the year ended December 31, 2019, representing

the fair market value of assets acquired by us in connection with the merger we completed in October 2018, or the Merger.

the Merger was accounted for as an asset acquisition and the assets acquired consisted of intellectual property that had not received

regulatory approval, the total purchase price was immediately expensed as in process research and development or intellectual property

Research and Development Expense

Research and development expenses increased

by 61% to $12.8 million for the year ended December 31, 2019, compared to $8.0 million for the year ended December 31,

The increase of $4.8 million in 2019 was primarily attributable

to the following:

increase of $1.9 million in headcount-related expenses as we increased the number of research and development personnel,

increase of $1.9 million in clinical consulting and professional expenses,

increase of $1.4 million in research

and development stock-based compensation expenses,

increase of $1.1 million in process development expenses,

increase of $0.1 million in other

expenses, and

decrease of $1.6 million in clinical trial expenses due to the stages of ongoing clinical trials and the decreased number of active patients in such trials.

General and Administrative Expenses

General and administrative expenses

decreased by 59% to $10.0 million for the year ended December 31, 2019 from $24.4 million during the prior period.

decrease of $14.4 million was primarily attributable to a decrease of $12.8 million in stock-based compensation expenses due

to executive stock option grants issued in fiscal year 2018, as well as the following:

increase of $0.8 million in headcount-related expenses as we increased the number of administrative personnel and also incurred a full year of expenses during fiscal year 2019 for personnel hired during the second half of fiscal year 2018,

increase of $1.0 million in legal and professional fees,

increase of $0.3 million in office-related expenses, insurance and other general and administrative expenses, and

decrease of $3.7 million in merger-related expenses during fiscal year 2019.

Other Income (Expense)

Change in Fair Value of Warrant Liabilities

Change in fair value of warrant liabilities

for the year ended December 31, 2019 was $18,000 as compared to ($40,000) for the fiscal year ended December 31, 2018.

Interest Income

Interest income was approximately $1.1

million for the year ended December 31, 2019 and was attributable to interest income relating to funds that are held in U.S.

notes and U.S.

government agency-backed securities.

Interest income for the year ended December 31, 2018 was approximately $0.3

We recorded a net loss of $21.4 million,

or a net loss per share, basic and diluted of ($0.47) during the year ended December 31, 2019 compared to a net loss of $148.0

million, or a net loss per share, basic and diluted of ($7.75) during the year ended December 31, 2018.

The weighted average number

of shares outstanding, basic and diluted, was 45.6 million for the year ended December 31, 2019 compared to 19.1 million for the

year ended December 31, 2018.

The decrease in our net loss in 2019, as compared to 2018, was due to research and development intellectual

property acquired in 2018 in connection with the Merger and a decrease in stock-based compensation in 2019, offset in 2019 by increased

spending due to the continued expansion of our research and development activities, increased clinical trials and manufacturing

activities, and the overall growth of our corporate infrastructure.

We anticipate that we will continue to incur net losses in

the future as we further invest in our research and development activities, including our clinical development of MultiTAA-specific

T cell product candidates.

In addition, our general and administrative expenses decreased in 2019 mainly due to the decrease in

stock-based equity awards related to existing and new executives and key consultants.

Liquidity and Capital Resources

We have not generated any revenues from

the sales or licensing of our product candidates since inception and only have limited revenue associated with grants.

financed our operations primarily through public and private offerings of our stock and debt including warrants and the exercise

The following table sets forth our cash

and cash equivalents and working capital as of December 31, 2019 and 2018:

Cash and cash equivalents

Working capital

The following table summarizes our cash flows for the years

ended December 31, 2019 and 2018:

For the Years Ended

Net Cash provided by (used in):

Operating activities

$ (18,284,000 )

$ (14,480,000 )

Investing activities

Financing activities

Net (decrease) increase in cash and cash equivalents

$ (17,843,000 )

Operating Activities

Net cash used in operating activities during

the year ended December 31, 2019 was $18.3 million.

The use of cash primarily related to our net loss of $21.4 million, in addition

to the effect of changes in asset and liability accounts, including an increase in prepaid expenses and deposits of $1.4 million,

a decrease in accounts payable and accrued liabilities of $1.0 million, a decrease in interest receivable of $52,000 and a net

increase in lease liabilities of $0.2 million.

Net cash used in operating activities during

the year ended December 31, 2018 was $14.5 million.

The use of cash primarily related to our net loss of $148.0 million, in addition

to the effect of changes in asset and liability accounts, including an increase in prepaid expenses and deposits of $0.1 million,

an increase in accounts payable and accrued liabilities of $1.2 million and an increase in interest receivable of $0.1 million.

Investing Activities

Net cash used in investing activities was

$0.4 million and $0.1 million for the purchase of property and equipment during the years ended December 31, 2019 and 2018, respectively.

Financing Activities

Net cash provided

by financing activities was $816,000 during the year December 31, 2019, due primarily to the exercise of stock warrants and stock

Net cash provided by financing activities

was $71.2 million during the year December 31, 2018, due primarily to the following:

May 2018 Private Placement Transaction

Common Stock Purchase Agreement

On May 18, 2018, we closed on the sale

of 1,300,000 shares of common stock for $2.40 per share pursuant to a common stock purchase agreement with an existing accredited

investor in a private placement under Rule 506 of Regulation D.

Aggregate gross proceeds were approximately $3.1 million.

Exercise of Warrants Held by Existing Institutional Investors

On May 18, 2018,

certain existing institutional investors agreed to exercise existing warrants for which we agreed to reduce the exercise price

for a portion of such warrants from $6.00, $9.00, $15.00 and $7.20, respectively, per share to $2.50 per share, provided that the

investors exercise such warrants for cash immediately.

Such investors exercised warrants to purchase 782,506 shares.

proceeds of approximately $2.0 million.

October 2018 Private Placement Transaction

On October 17, 2018, concurrent with

the completion of the Merger, we issued to certain accredited investors in a private placement transaction an aggregate of

17,500,000 shares of our common stock and warrants to purchase 13,437,500 shares of common stock at an exercise price of

$5.00 per share with a five-year term.

Aggregate proceeds were approximately $70.0 million.

Future Capital Requirements

To date, we have not generated any revenues

from the commercial sale of approved drug products, and we do not expect to generate substantial revenue for at least the next

several years.

If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory

approval, our ability to generate future revenue will be compromised.

We do not know when, or if, we will generate any revenue

from our product candidates, and we do not expect to generate significant revenue unless and until we obtain regulatory approval

of, and commercialize, our product candidates.

We expect our expenses to increase in connection with our ongoing activities, particularly

as we continue the research and development of, continue or initiate clinical trials of and seek marketing approval for our product

In addition, if we obtain approval for any of our product candidates, we expect to incur significant commercialization

expenses related to sales, marketing, manufacturing and distribution.

We anticipate that we will need substantial additional funding

in connection with our continuing operations.

If we are unable to raise capital when needed or on attractive terms, we could be

forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

As of December 31, 2019, we had cash and

cash equivalents of approximately $43.9 million.

Based on our revised clinical and research and development plans and our

revised timing expectations related to the progress of our programs, we expect that our cash and cash equivalents as of December 31,

2019 will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2021.

based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than

we currently expect.

Furthermore, our operating plan may change, and we 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 our product candidates and the extent to which we may

enter into additional collaborations with third parties to participate in their development and commercialization, we are unable

to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical

Our future funding requirements will depend on many factors, as we:

initiate or continue clinical trials of our product candidates;

continue the research and development of our product candidates, seek to discover additional product candidates;

seek regulatory approvals for our product candidates if they successfully complete clinical trials;

establish sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive regulatory approval;

evaluate strategic transactions we may undertake;

enhance operational, financial and information management systems and hire additional personnel, including personnel to support development of our product candidates and, if a product candidate is approved, our commercialization efforts.

Because all of our product candidates are

in the early stages of clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the

actual amounts necessary to successfully complete the development and commercialization of product candidates or whether, or when,

we may achieve profitability.

Until such time, if ever, that we can generate substantial product revenue, we expect to finance

our cash needs through a combination of equity or debt financings and collaboration arrangements.

We plan to continue to fund our

operations and capital funding needs through equity and/or debt financing.

We may also consider new collaborations or

selectively partner our technology.

To the extent that we raise additional capital through the sale of equity or convertible

debt securities, the ownership interests of our stockholders will be diluted, and the terms may include liquidation or other

preferences that adversely affect the rights of our existing stockholders’

common stock.

The incurrence of indebtedness

would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on

our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other

operating restrictions that could adversely impact our ability to conduct our business.

If we raise additional funds through

strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights

to our technologies or product candidates or grant licenses on terms unfavorable to us.

We may also be required to pay

damages or have liabilities associated with litigation or other legal proceedings involving our company.

Off-Balance Sheet Arrangements

We have not entered into any off-balance

sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in

financial condition, revenues, expenses, results of operations, liquidity, capital expenditures or capital resources that is material

to investors.

Tax Loss and Credit Carryforwards

As of December 31, 2019, we have approximately

$73.8 million of federal and $47.4 million of state net operating loss carryforwards that may be available to offset future taxable

income, if any.

The federal net operating loss carryforwards of $41.9 million, if not utilized, will expire between 2029 and 2037.

The federal net operating loss carryforwards of $31.9 million generated in 2018 and thereafter are subject to an 80% limitation

on taxable income, do not expire and will carry forward indefinitely.

The state net operating loss carryforwards of $21.9 million,

if not utilized, will begin to expire in 2035.

The state net operating loss carryforwards of $25.5 million generated in 2018 and

thereafter are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely.

Any change in

ownership greater than 50% under Section 382 of the Internal Revenue Code places significant annual limitations on the use of such

net operating loss carryforwards.

At December 31, 2019 and 2018, we recorded

a 100% valuation allowance against our deferred tax assets of approximately $24.6 million and $20.0 million, respectively, as our

management believes it is uncertain that they will be fully realized.

If we determine in the future that we will be able to realize

all or a portion of our net operating loss carryforwards, an adjustment to valuation allowance against our deferred tax assets

would increase net income in the period in which we make such a determination.

Inflation affects the cost of raw materials,

goods and services that we use.

In recent years, inflation has been modest.

However, fluctuations in energy costs and commodity

prices can affect the cost of all raw materials and components.

The competitive environment somewhat limits our ability to recover

higher costs resulting from inflation by raising prices.

Although we cannot precisely determine the effects of inflation on our

business, it is management’s belief that the effects on future revenues and operating results will not be significant.

do not believe that inflation has had a material impact on our results of operations for the periods presented, except with respect

to payroll-related costs and other costs arising from or related to government-imposed regulations.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are a smaller reporting company as defined

by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 5. Market for Registrant’s Common Equity