Marker Therapeutics Inc
For the period ended Dec 31, 2023. Filed Mar 26, 2024.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2023 · Filed Mar 26, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to the Consolidated Financial Statements
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE FISCAL YEARS DECEMBER 31, 2023 AND 2022
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 for the treatment of hematological malignancies and solid tumor indications. The Company’s multiTAA-specific 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. The Company was incorporated in Nevada in 1992 and reincorporated in Delaware in October 2018.
Purchase Agreement with Cell Ready
On June 26, 2023, the Company completed the previously announced transaction with Cell Ready, LLC (“Cell Ready”) pursuant to a Purchase Agreement (the “Cell Ready Purchase Agreement), dated May 1, 2023, by and between the Company and Cell Ready. Mr. John Wilson is a member of the Company’s board of directors and is serving as the CEO of Cell Ready, therefore Cell Ready is a related party. Pursuant to the Cell Ready Purchase Agreement, effective as of the Closing Date, the Company (i) assigned to Cell Ready the leases for the Company’s two manufacturing facilities in Houston, Texas (the “Manufacturing Facilities”), (ii) sold to Cell Ready all of the equipment and leasehold improvements at the Manufacturing Facilities and (iii) assigned to Cell Ready its rights, title and interest in the Company’s Master Services Agreement for Product Supply (the “MSA”), dated April 7, 2023, by and between the Company, Cell Ready and Indapta Therapeutics, Inc., as well as its rights, title and interest in any contracts related to the equipment and Manufacturing Facilities (collectively, the “Purchased Assets”). Cell Ready acquired the Purchased Assets for total consideration of $19.0 million. In connection with the purchase of the Manufacturing Facilities, Cell Ready also extended offers of employment to approximately 50 of the Company’s former employees in its manufacturing, development, quality, and regulatory affairs functions.
The Purchased Assets constituted a significant disposition. Based upon the magnitude of the disposition and because the Company is exiting certain manufacturing operations, the disposition represents a significant strategic shift that will have a material effect on the Company’s operations and financial results. Accordingly, the assets sold meet the definition of a discontinued operation, as defined by Accounting Standards Codification (“ASC”) 205-20 - Discontinued Operations, and prior comparative periods have been retroactively adjusted to reflect the current presentation. See additional discussion at Note 6.
On February 22, 2024, we entered into a Master Services Agreement for Product Supply (the “MSA”) with Cell Ready to provide outsourced services previously performed by the Company prior to its asset sale to Cell Ready. Cell Ready, which is owned by one of our directors and shareholders, Mr. John Wilson, is a contract development and manufacturing organization (CDMO). Under the MSA, it is anticipated Cell Ready will perform a wide variety of services for us, including research and development, and manufacturing in support of our clinical trials. Pursuant to the MSA, the Company may contract with Cell Ready for the provision of various products and services from time to time by entering into work orders with Cell Ready. If the services involve the supply of product, Cell Ready is required to supply such product in conformance with the product requirements set forth in the applicable work order(s). Under the MSA, Cell Ready is to use only personnel with sufficient qualifications and experience to supply the services contemplated by the MSA, provide its personnel with adequate training and assume full responsibility for its personnel’s compliance with the MSA. Further, Cell Ready is required to provide the Company with assistance and cooperation in order for the Company to obtain and maintain all necessary regulatory approvals, at the Company’s expense.
Organizational Changes
In 2023, the Company implemented changes to its organizational structure due to the transaction with Cell Ready and to reduce operational costs. In connection with these changes, the Company reduced headcount, including the separation of its former Chief Executive Officer, Peter Hoang, in May 2023 and its former Chief Accounting Officer, Michael Loiacono, in June 2023. During the second quarter of 2023, the Company recorded $0.9 million of severance and termination-related costs. The payments of these costs were completed in July of 2023. Effective May 1, 2023, the Company’s board of directors appointed Dr. Juan Vera as the Company’s President and Chief Executive Officer.
Effective June 30, 2023, the board of directors appointed Eliot M. Lurier as the Company’s Interim Chief Financial Officer, whereby Mr. Lurier provided consulting services to the Company pursuant to a consulting between the Company and Danforth Advisors, LLC (“Danforth”) and received no compensation directly from the Company. On November 17, 2023, the Company terminated the consulting agreement between the Company and Danforth, effective January 16, 2024.
On November 17, 2023, Mr. Lurier ceased serving as the Company’s Interim Chief Financial Officer and Dr. Vera was appointed as the Company’s Principal Financial and Accounting Officer.
Reverse Stock Split
On January 26, 2023, the Company effected a one-for-ten (1-for-10) reverse stock split of its common stock (the “Reverse Stock Split”) and a corresponding reduction in the total number of authorized shares of its common stock from 300,000,000 to 30,000,000. The Reverse Stock Split, which was approved by stockholders at an annual stockholder meeting on May 24, 2022, was consummated pursuant to a Certificate of Amendment filed with the Secretary of State of Delaware on January 26, 2023. The Reverse Stock Split was effective on January 26, 2023. All references to common stock, warrants to purchase common stock, options to purchase common stock, share data, per share data and related information contained in the consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented.
NOTE 2: FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS
As of December 31, 2023, the Company had cash and cash equivalents of approximately$15.1 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, debt financings and grants.
In August 2021, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “ATM Agreement”) with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (the “Sales Agents”), pursuant to which the Company can offer and sell, from time to time at its sole discretion through the Sales Agents, shares of its common stock having an aggregate offering price of up to $75.0 million. Any shares of its common stock sold will be issued pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-258687), which the SEC declared effective on August 19, 2021, however, our use of the shelf registration statement on Form S-3 will be limited for so long as we are subject to General Instruction I.B.6 of Form S-3, which limits the amounts that we may sell under the registration statement and in accordance with the ATM agreement. The Sales Agents will be entitled to compensation under the Sales Agreement at a commission rate equal to 3.0% of the gross sales price per share sold under the ATM Agreement, and we have provided each of the Sales Agents with indemnification and contribution rights. During the year ended December 31, 2023, the Company sold 265,334 shares of its common stock under the ATM Agreement for proceeds of $1.0 million.
In August 2021, the Company received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas (“CPRIT”) to support the Company’s Phase 2 clinical trial of MT-401. The CPRIT award is intended to support the adjuvant arm of the Company’s Phase 2 clinical trial evaluating MT-401 when given as an adjuvant therapy to patients with acute myeloid leukemia following a hematopoietic stem cell transplant. The primary objectives of the adjuvant arm of the trial are to evaluate relapse-free survival after MT-401 treatment when compared with a randomized control group. Through
the date of this filing, the Company has received $6.8 million of funds from the CPRIT grant. The Company recorded $2.7 million of grant income related to the CPRIT grant as revenue for the year ended December 31, 2023.
In September 2022, the Company received notice from the U.S. Food and Drug Administration (the “FDA”) that it had awarded the Company a $2.0 million grant from the FDA’s Orphan Products Grant program to support the Company’s Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML The Company recorded $0.4 million and $0.1 million of grant income related to the FDA grant as revenue for the year ended December 31, 2023 and December 31, 2022, respectively. As of December 31, 2023, the Company recorded $0.3 million of grant income receivable. In February 2024, the Company received $0.3 million of funds from the FDA grant.
In May 2023, the Company received notice of a $2.0 million grant from the National Institutes of Health Small Business Innovation Research program to support the development and investigation of MT-401 for the treatment of AML patients following standard-of-care therapy with hypomethylating agents. The Company recorded $0.2 million of grant income related to the SBIR grant as revenue for the year ended December 31, 2023. As of December 31, 2023, the Company recorded $0.2 million as other receivable, which represented grant income earned in advance of funds to be received from the SBIR. In February 2024, the Company received $0.2 million of funds from the SBIR grant.
In December 2022, the Company entered into a purchase agreement, or the Purchase Agreement, with Lincoln Park Capital Fund, LLC, or Lincoln Park, which provides that, upon the terms and subject to the conditions of the agreement, the Company has the right, but not the obligation, to sell to Lincoln Park up to $25,000,000 of shares of its common stock, or the Purchase Shares, from time to time over a 24-month term. For the year ended December 31, 2023, the Company sold 12,500 shares of its common stock under the Purchase Agreement for proceeds of approximately $33,000. In January 2023, Lincoln Park was issued 180,410 shares of stock as a commitment fee at a value of $0.5 million. On February 29, 2024, the Company terminated the Purchase Agreement with Lincoln Park effective March 1, 2024.
As described in Note 1, on June 26, 2023, the Company completed the transaction with Cell Ready pursuant to the Cell Ready Purchase Agreement for total consideration of$19.0 million. On February 22, 2024, the Company entered into a Master Services Agreement for Product Supply (the “MSA”) with Cell Ready, a contract development and manufacturing organization (CDMO). Under the MSA, it is anticipated Cell Ready will perform a wide variety of services for us, including research and development, and manufacturing in support of our clinical trials. Pursuant to the MSA, the Company may contract with Cell Ready for the provision of various products and services from time to time by entering into work orders with Cell Ready.
The Company expects to continue to incur substantial losses over the next several years during its development phase.
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 December 31, 2023, including drawdowns of available grant funds, will enable the Company to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025. Prior to the Cell Ready transaction, there was substantial doubt regarding the Company’s ability to continue as a going concern, which was alleviated by the proceeds from the transaction.
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; |
| ● | enters into contract manufacturing arrangements with Cell Ready or other contract manufacturing organizations for clinical manufacturing supply; |
| ● | 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. |
The Company does not have sufficient sources of revenue to provide incoming cash flows to sustain its future operations beyond the fourth quarter of 2025. As outlined above, its ability to pursue its long-term planned business activities is dependent upon its successful efforts to raise additional capital and grant income.
The current macro-economic environment of decades-high inflation and concerns about an economic recession in the United States or other major markets has resulted in, among other things, volatility in the capital markets that may have the effect of 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 due to these factors could materially affect the Company’s business and the value of its common stock.
NOTE 3: SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America and pursuant to the rules and regulations of the Securities Exchange Commission (“SEC”). Any reference in these footnotes to applicable guidance is meant to refer to the authoritative U.S. generally accepted accounting principles (“GAAP”) as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Principles of Consolidation
These consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Marker Cell Therapy, Inc. and GeneMax Pharmaceuticals Inc. – a dormant subsidiary that wholly owns GeneMax Pharmaceuticals Canada, Inc. All significant intercompany balances and transactions are eliminated upon consolidation.
Use of Estimates
Preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Accordingly, actual results may differ materially from those estimates. Management considers many factors in selecting appropriate financial accounting policies, controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: stock-based compensation expense and income taxes.
Cash, Cash Equivalents and Credit Risk
The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents at December 31, 2023 consisted of cash and certificates of deposit in institutions in the United States. Balances at certain institutions have exceeded Federal Deposit Insurance Corporation insured limits and U.S. government agency securities.
The Company maintains cash in accounts which are in excess of the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250,000. As of December 31, 2023 and December 31, 2022, the Company had approximately $1.4. million and $2.3 million, respectively in cash at financial institutions. As of December 31, 2023, the Company had approximately $13.7 million in U.S. government agency securities.
In the event cash is received from grants in advance of incurring qualifying costs, it is recorded as restricted cash until it is earned and recorded to grant income.
The Purchased Assets sold to Cell Ready pursuant to the Cell Ready Purchase Agreement constituted a significant disposition and as such, the Company concluded that the disposition of its Purchased Assets represented a strategic shift that had a major effect on its operations and financial results. Therefore, the Purchased Assets, related party revenue, service revenue and related expenses are classified as discontinued operations for all periods presented herein. See Note 6 for further information.
Patents and Patent Application Costs
Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are, therefore, expensed as incurred.
Stock-Based Compensation
The Company incurs stock-based compensation expense related to the issuance of common stock and stock options. The Company estimates the fair value of stock options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and expected option life:
Expected Term — The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant.
Expected Volatility — The Company computes stock price volatility over expected terms based on its historical common stock trading prices.
Risk-Free Interest Rate — The Company bases the risk-free interest rate on the implied yield available on U.S. Treasury zero-coupon issues with an equivalent remaining term.
Expected Dividend — The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models.
The Company amortizes the fair value of the awards expected to vest on a straight-line basis over the requisite service period of the awards. The Company recognizes fair value of stock options granted to nonemployees as stock-based compensation expense over the period in which the related services are received as if the Company had paid cash for those services. Forfeitures are accounted for as incurred.
Research and Development Costs
Research and development expenses consist of costs associated with clinical trial programs. Costs incurred by third parties are expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the clinical trial or project and the invoices received from its external service providers. The Company estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each project and total project spending. The Company adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and development arrangements, the milestone payment obligations are expensed when the milestone events are achieved.
Income Taxes
The Company follows the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax balances. Potential deferred tax assets and liabilities are measured using enacted tax rates expected to apply to the taxable income in the years in which those differences are expected to be recovered or settled. The effect on potential deferred tax assets and liabilities of a change in tax rates is recognized in the statement of operations in the period that includes the date of allowances against deferred tax assets.
Tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement. A liability for “unrecognized tax benefits” is recorded for any tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards. As of December 31, 2023 and 2022, no liability for unrecognized tax benefits was required to be reported. The guidance also discusses the classification of related interest and penalties on income taxes. The Company’s policy is to record interest and penalties on uncertain tax positions as a component of income tax expense. No interest or penalties were recorded during the years ended December 31, 2023 and 2022.
Grant Income
Grant Income represents funding under cost reimbursement programs from government agencies and non-profit foundations for qualified research and development activities performed by the Company. In applying the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company determined that grants and awards are out of the scope of ASC 606 because the funding entities do not meet the definition of a “customer”, as defined by ASC 606, as there is not considered to be a transfer of control of goods or services. With respect to each grant or award, the Company determines if it has a collaboration in accordance with ASC Topic 808, Collaborative Arrangements (“ASC 808”). To the extent the grant or award is within the scope of ASC 808, the Company recognizes the award upon achievement of certain milestones as credits to research and development expenses. For grant and awards outside the scope of ASC 808, the Company applies ASC 606 by analogy, and revenue is recognized when the Company incurs expenses related to the grants for the amount the Company is entitled to under the provisions of the contract.
Loss per Common Share
Basic loss per share includes only the weighted average common shares outstanding, without consideration of potentially dilutive securities. Diluted loss per share includes the weighted average common shares outstanding and any potentially dilutive common stock equivalent shares in the calculation.
New Accounting Standards
From time to time, new accounting pronouncements are issued by the 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.
Recently Issued Accounting Standards Not Yet Adopted
Improvements to Reportable Segment Disclosures
In November 2023, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU requires disclosures to include significant segment expenses that are regularly provided to the chief operating decision maker, among other provisions. The ASU is effective for fiscal year periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the ASU requires retrospective application to all prior periods presented in the financial statements. The Company is currently evaluating the standard to determine the impact of adoption to its consolidated financial statements and disclosures.
Improvements to Income Tax Disclosures
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. Early adoption is permitted. Upon adoption, the guidance can be applied prospectively or retrospectively. We do not expect the adoption of this guidance to have a material impact on its consolidated financial statements.
NOTE 4: NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
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 years ended December 31, 2023 and 2022, respectively:
| | | | | | | |
|---|---|---|---|---|---|---|
| | For the Years Ended | |||||
| · · December 31, | ||||||
| | 2023 | 2022 | ||||
| Numerator: | | | | | | |
| Loss from continuing operations | | $(14,045,895) | | $(19,775,915) | ||
| Income (loss) from discontinued operations | | | 5,809,081 | | | (10,154,779) |
| Net loss | | $(8,236,814) | | $(29,930,694) | ||
| | | | | | | |
| Denominator: | | | | | ||
| Weighted average common shares outstanding, basic | | 8,809,382 | | 8,351,003 | ||
| Weighted average common shares outstanding, diluted | | | 8,809,382 | | | 8,351,003 |
| | | | | | | |
| Net earnings (loss) per share: | | | | | ||
| Loss from continuing operations, basic and diluted | | $(1.59) | | $(2.37) | ||
| Income (loss) from discontinued operations, basic and diluted | | $0.66 | | $(1.22) | ||
| Net loss per share, basic and diluted | | $(0.94) | | $(3.58) | ||
The following securities, rounded to the thousand, were not included in the diluted net loss per share calculation because their effect was anti-dilutive for the periods presented:
| · · · · | ||
|---|---|---|
| | | For the Years Ended |
| | | December 31, |
| | 2023 | 2022 |
| Common stock options | 738,000 | 886,000 |
| Common stock purchase warrants | — | 1,848,000 |
| Potentially dilutive securities | 738,000 | 2,734,000 |
NOTE 5: OTHER RECEIVABLE
Qualifying grant income earned in advance of cash received from grants is recognized as revenue and recorded as other receivable. The Company recorded $2.7 million of grant income related to the CPRIT grant for the year ended December 31, 2023. At December 31, 2023, the Company recorded $0.5 million of grant income receivable related to the CPRIT grant.
Additionally, the Company recorded $0.4 million and $0.2 million of grant income related to the FDA and SBIR grants, respectively, for the year ended December 31, 2023. At December 31, 2023, the Company recorded $0.3 million and $0.2 million of grant income receivable related to the FDA and SBIR grants, respectively.
The Company received $0.3 million and $0.2 million of funds from FDA and SBIR in February 2024, respectively.
NOTE 6: DISCONTINUED OPERATIONS
As discussed in Note 1, on June 26, 2023, the Company completed the previously announced transaction with Cell Ready for cash consideration of $19.0 million, resulting in derecognition of the Purchased Assets and a gain on sale of approximately $8.7 million, net of $63,000 in tax.
The assets and liabilities classified in discontinued operations as of December 31, 2023 and 2022 are as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| · 2023 · 2022 | ||||||
| Prepaid expenses and other current assets | | $— | | $585,840 | ||
| Total current assets of discontinued operations | | | — | | | 585,840 |
| Fixed Assets | | | — | | | 12,323,143 |
| Right of use assets | | — | | 5,479,786 | ||
| Total non-current assets of discontinued operations | | | — | | | 17,802,929 |
| Total assets of discontinued operations | | $— | | $18,388,769 | ||
| | | | | | | |
| Accounts payable | | $— | | $2,183,418 | ||
| Related party deferred revenue | | | — | | | 2,500,000 |
| Short-term lease liabilities | | | — | | | 577,198 |
| Total current liabilities of discontinued operations | | | — | | | 5,260,616 |
| Long-term lease liabilities | | — | | 7,039,338 | ||
| Total non-current liabilities of discontinued operations | | | — | | | 7,039,338 |
| Total liabilities of discontinued operations | | $— | | $12,299,954 | ||
Net loss from discontinued operations consists of the following for the years ended December 31, 2023 and 2022, respectively, excluding the gain on disposal:
| · · · · · · | ||||
|---|---|---|---|---|
| · · For the Years Ended | ||||
| · · December 31, | ||||
| · 2023 · 2022 | ||||
| Revenues: · · · · · · | ||||
| Service revenue | | $816,641 | $— | |
| Related party service revenue | | 3,500,000 | | 5,500,000 |
| Total revenues | | 4,316,641 | | 5,500,000 |
| Operating expenses: | | | ||
| Research and development | | 6,561,957 | | 14,170,894 |
| General and administrative | | 677,090 | | 1,483,885 |
| Total operating expenses | | 7,239,047 | | 15,654,779 |
| Loss from discontinued operations | | $(2,922,406) | $(10,154,779) | |
The following table summarizes our cash flows for the years ended December 31, 2023 and 2022:
| · · · · · · | ||||
|---|---|---|---|---|
| · · For the Years Ended | ||||
| · · December 31, | ||||
| | | 2023 | | 2022 |
| Continuing operations: · · | ||||
| Net cash used in operating activities | | $(10,341,000) | | $(21,513,000) |
| Net cash provided by financing activities | | 1,105,000 | | 202,000 |
| Discontinued operations | | | ||
| Net cash used in operating activities | | (6,099,000) | | (5,459,000) |
| Net cash provided by (used in) investing activities | | $18,664,000 | | $(4,945,000) |
| Net increase (decrease) in cash and cash equivalents | | $3,329,000 | | $(31,715,000) |
Related Party Service Revenue
In April 2022, the Company entered into a binding services agreement (“Wilson Wolf Agreement”) with Wilson Wolf Manufacturing Corporation (“Wilson Wolf”). Mr. John Wilson is a member of the Company’s board of directors and is serving as the CEO of Wilson Wolf. Wilson Wolf is in the business of creating products and services intended to simplify and expedite the transition of cell therapies and gene-modified cell therapies to mainstream society (the “Wilson Wolf Mission”). Pursuant to the Wilson Wolf Agreement, Wilson Wolf made a cash payment to the Company in the amount of $8.0 million, as consideration for certain training and research services.
In March 2023, the Company recognized the final $2.5 million of revenue pursuant to this $8.0 million agreement and an additional $1.0 million because the Work Direction was completed within one year from the onset of the Wilson Wolf Agreement, achieving the agreed milestone. The Wilson Wolf Agreement and related service obligations were completed upon achievement of this final milestone, and no obligations remain.
Service Revenue
In April 2023, the Company signed the Indapta Master Services Agreement, pursuant to which the Company provided services to Indapta. Under an executed work order of that agreement, now complete, the Company recognized $0.8 million for the services during the period ended June 30, 2023. Effective as of the closing date of the Purchase Agreement with Cell Ready, the rights and obligations to the Indapta Agreement were transferred to Cell Ready, and as such the revenues and expenses are reflected in discontinued operations.
NOTE 7: PROPERTY AND EQUIPMENT
Substantially all of the previously reported property and equipment was disposed of as a result of the Cell Ready transaction. See Note 6: Discontinued Operations for details.
NOTE 8: LEASES
Substantially all of the previously reported leases were disposed of as a result of the Cell Ready transaction. See Note 6: Discontinued Operations for details.
NOTE 9: ACCOUNTS PAYABLE, ACCRUED LIABILITIES, AND RELATED PARTY PAYABLE
Accounts payable, accrued liabilities, and related party payable consist of the following as of December 31, 2023 and 2022, respectively:
| | | | | | | |
|---|---|---|---|---|---|---|
| · December 31, · December 31, | ||||||
| · · 2023 · · 2022 | ||||||
| Accounts payable | | $961,000 | | $1,101,000 | ||
| Compensation and benefits | | 57,000 | | 750,000 | ||
| Professional fees | | | 303,000 | | | 518,000 |
| Related party payable | | 1,330,000 | | — | ||
| Arbitration settlement fees | | — | | 114,000 | ||
| Tax fees | | 219,000 | | — | ||
| Other | | 205,000 | | 38,000 | ||
| Total accounts payable and accrued liabilities | | | 3,075,000 | | | 2,521,000 |
The $1.3 million related-party payable reflects amounts payable to Cell Ready for outsourced product development and manufacturing services. This amount was paid during February 2024. See Note 14: Related Party Transactions.
NOTE 10: STOCKHOLDERS’ EQUITY
Increase in Authorized Shares
During June 2022, the Company’s board of directors and stockholders approved a Certificate of Amendment (the “Amendment”) to the Company’s Certificate of Incorporation to increase the authorized shares of common stock of the Company from 15,000,000 shares to 30,000,000 shares. The Company filed the Amendment with the Secretary of State of Delaware on May 25, 2022.
Reverse Stock Split
On January 26, 2023, the Company effected the Reverse Stock Split and a corresponding reduction in the total number of authorized shares of its common stock from 300,000,000 to 30,000,000. The Reverse Stock Split, which was approved by stockholders at an annual stockholder meeting on May 24, 2022, was consummated pursuant to a Certificate of Amendment filed with the Secretary of State of Delaware on January 26, 2023. The Reverse Stock Split was effective on January 26, 2023. All historical share and per share amounts reflected in this report have been adjusted to reflect the Reverse Stock Split.
Preferred Stock
The Company has authorized up to 5,000,000 shares of preferred stock, $0.001 par value per share, for issuance. The preferred stock will have such rights, privileges and restrictions, including voting rights, dividend conversion rights, redemption privileges and liquidation preferences, as shall be determined by the Company’s board of directors upon its issuance. To date, the Company has not issued any preferred shares.
Common Stock
The Company has authorized up to 30,000,000 shares of common stock, $0.001 par value per share, for issuance. Significant 2023 and 2022 common stock transactions were as follows:
2023 Common Stock Transactions
Issuance of Stock Pursuant to ATM Agreement
During the year ended December 31, 2023, the Company sold 265,334 shares of its common stock under the ATM Agreement for net proceeds of $1.0 million.
Stock Purchase Agreement with Lincoln Park
In December 2022, the Company entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park which provides that, upon the terms and subject to the conditions of the agreement, the Company has the right, but not the obligation, to sell to Lincoln Park up to $25,000,000 of shares of its common stock (the “Purchase Shares”) from time to time over a 24-month term, at a variable price with certain market-based terms as defined in the Purchase Agreement. The Purchase Agreement does not exhibit any of the characteristics for liability classification under ASC Topic 480,Distinguishing Liabilities from Equity. Instead, the purchase agreement is indexed to the Company’s own stock under ASC Subtopic 815-40,Contracts in Entity’s Own Equity, and classified as equity. In January 2023, Lincoln Park was issued 180,410 shares of stock as a commitment fee at a value of $0.5 million. During the year ended December 31, 2023, the Company sold 12,500 shares of its common stock under the Purchase Agreement for proceeds of approximately $33,000. The Company terminated the Purchase Agreement with Lincoln Park on February 29, 2024 effective March 1, 2024.
Exercise of Stock Options
During the year ended December 31, 2023, certain outstanding options were exercised for 27,518 shares of common stock providing aggregate proceeds to the Company of approximately $0.1 million.
2022 Common Stock Transactions
Issuance of Restricted Stock Units to Executives
During the year ended December 31, 2022, upon the recommendation of the compensation committee of the Company’s board of directors, and pursuant to the Company’s 2020 Equity Incentive Plan, the Company’s board of directors approved the issuance of a total of 37,252 shares of common stock, valued at a total of approximately $180,200, subject to restricted stock units, which were immediately vested upon grant, to certain executives as performance bonuses for performance during the year ended December 31, 2021.
Issuance of Stock Pursuant to ATM Agreement
During the year ended December 31, 2022, the Company issued and sold 60,651 shares of its common stock under the ATM Agreement for net proceeds of $202,100.
Stock Purchase Agreement with Lincoln Park
During the year ended December 31, 2022, the Company did not sell any shares of its common stock under the Purchase Agreement.
Share Purchase Warrants
A summary of the Company’s share purchase warrants as of December 31, 2023 and 2022, respectively, 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, 2022 | 1,983,000 | | $44.20 | 1.70 | | $— | |
| Expired or cancelled | (135,000) | | 39.70 | — | | — | |
| Balance - December 31, 2022 | 1,848,000 | | | 44.51 | 0.79 | | $— |
| Expired or cancelled | (1,848,000) | | 44.51 | — | | — | |
| Balance - December 31, 2023 | — | | $— | — | | $— | |
All warrants outstanding at December 31, 2022 expired according to their terms on October 16, 2023. As of December 31, 2023, the Company hadno outstanding warrants.
NOTE 11: STOCK BASED COMPENSATION
Stock Options
On May 19, 2020, the Board adopted the 2020 Equity Incentive Plan (“2020 Equity Incentive Plan”) which replaced the 2014 Omnibus Stock Option Plan. The 2020 Plan was further amended effective May 2022 to increase the number of shares of common stock authorized for issuance under the plan by 850,000 shares. The 2020 Plan allows for grants of stock options, restricted shares, stock bonuses and other equity-based awards to employees and non-employee directors of the Company. Awards under the 2020 Plan may be at prices and for terms as determined by the Company’s board of directors and may have vesting requirements as determined by the Board, provided that the exercise price for any stock option must be at least equal to the fair market value (as defined in the 2020 Plan) of a share of the stock on the grant date. Once granted, the exercise price of an option may not be reduced without the approval of the Company’s stockholders, other than under certain limited circumstances such as a stock split or take any other action with respect to a stock option that would be treated as a repricing under the rules and regulations of the Nasdaq Stock Exchange.
Options granted under the 2020 Plan have a maximum term often years from the date of grant and generally vest over four years.
2023 Equity Incentive Awards
On February 27, 2023, pursuant to the Company’s 2020 Equity Incentive Plan, the compensation committee of the Company’s board of directors approved a total of 316,855 options to purchase the Company’s common stock as equity-based incentive awards to the Company’s executive officers and management team. Each option award was granted with an exercise price of $2.14 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 27, 2023, with the option award vesting in 48 equal monthly installments over afour-year period, subject to such executive officer’s continued service on the applicable vesting date. Additionally, on February 27, 2023, the compensation committee of the Company’s board of directors approved a total of 87,677 options to purchase the Company’s common stock to non-executive employees and management team of the Company as equity-based incentive awards. Each option award was granted with an exercise price of $2.14 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 27, 2023, with the option award vesting in 48 equal monthly installments over afour-year period, subject to such employee’s continued service on the applicable vesting date.
The above awards were in addition to 7,000 stock option awards issued during the three months ended March 31, 2023 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $2.769 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on January 3, 2023, with 25% of the option award vesting inone year and the remaining 75% vesting in 36 equal monthly installments thereafter over athree-year period, subject to such employee’s continued service on the applicable vesting date.
On May 10, 2023, the Company’s board of directors approved a one-time share option grant of 100,000 shares of common stock to Dr. Vera for his appointment as the Company’s Chief Executive Officer. The option has a term often years and will vest in equal annual
installments on May 10, 2024, May 10, 2025, May 10, 2026, and May 10, 2027, subject to Mr. Vera’s continued service to the Company as of the applicable vesting date. Each option award was granted with an exercise price of $1.42 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on May 10, 2023.
On June 6, 2023, pursuant to the Company’s Non-Employee Director Compensation Policy, which had previously been approved by the Company’s board of directors, a total of 32,000 stock option awards were issued to independent members of the board of directors of the Company. Each option award was granted with an exercise price of $1.72 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on June 6, 2023. Each Option award will vest inone year subject to the director’s continuance of service through June 6, 2024.
For the year ended December 31, 2023, the Company recorded incremental stock-based compensation expense of approximately $0.3 million pertaining to the modification of stock options in connection with the termination of certain employees that were hired by Cell Ready or transitioned as independent consultants. The modification provided for an acceleration of unvested options, resulting in a change in compensation expense that was immediately recognized. $0.2 million is reflected in loss from discontinued operations.
2022 Equity Incentive Awards
On February 17, 2022, pursuant to the Company’s 2020 Equity Incentive Plan, the compensation committee of the Company’s board of directors approved a total of 125,000 options to purchase the Company’s common stock as equity-based incentive awards to the Company’s executive officers. Each option award was granted with an exercise price of $4.60 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 17, 2022, with the option award vesting in 48 equal monthly installments over afour-year period, subject to such executive officer’s continued service on the applicable vesting date. Additionally, on February 17, 2022, the compensation committee of the Company’s board of directors approved a total of 39,500 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 $4.60 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 17, 2022, with the option award vesting in 48 equal monthly installments over afour-year period, subject to such employee’s continued service on the applicable vesting date.
The above awards were in addition to 17,500 stock option awards issued during the three months ended March 31, 2022 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $10.00 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on January 3, 2022, with 25% of the option award vesting inone year and the remaining 75% vesting in 36 equal monthly installments thereafter over athree-year period, subject to such employee’s continued service on the applicable vesting date.
21,000 stock option awards were issued during the three months ended June 30, 2022 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $4.30 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on April 1, 2022, with 25% of the option award vesting inone year and the remaining 75% vesting in 36 equal monthly installments thereafter over athree-year period, subject to such employee’s continued service on the applicable vesting date.
10,000 stock option awards were issued during the three months ended September 30, 2022 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $3.50 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on July 1, 2022, with 25% of the option award vesting inone year and the remaining 75% vesting in 36 equal monthly installments thereafter over athree-year period, subject to such employee’s continued service on the applicable vesting date.
Additionally,7,000 stock option awards were issued during the three months ended December 31, 2022 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $3.73 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on October 3, 2022, with 25% of the option award vesting inone year and the remaining 75% vesting in 36 equal monthly installments thereafter over athree-year period, subject to such employee’s continued service on the applicable vesting date.
Also, pursuant to the Company’s Non-Employee Director Compensation Policy, which had previously been approved by the Company’s board of directors,40,000 stock option awards were issued during the year ended December 31, 2022 to independent members of the
board of directors of the Company. Each option award was granted on May 24, 2022 with an exercise price of $3.377 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on May 24, 2022. Each option award vested overone year subject to the director’s continuance of service through May 24, 2023.
As of December 31, 2023, approximately 1.1 million shares of common stock are available to be issued under the 2020 Plan.
Stock Options
A summary of the Company’s stock option activity for the years ended December 31, 2023 and December 31, 2022, is as follows:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · · Weighted Average | ||||||||||
| | | | | | | | | | | Remaining |
| · · · · Weighted Average · · · · · Contractual | ||||||||||
| · Number of Shares · Exercise Price · Total Intrinsic Value · Life (in years) | ||||||||||
| Outstanding as of January 1, 2022 | 768,623 | | $54.69 | | $— | | 7.7 | |||
| Granted | 260,000 | | | 4.68 | | | — | | 7.8 | |
| Canceled/Expired | | (142,450) | | | 36.78 | | | — | | — |
| Outstanding as of December 31, 2022 | 886,173 | | | 42.90 | | | — | | 7.3 | |
| Granted | 544,532 | | | 1.99 | | | — | | 5.6 | |
| Exercised | (27,518) | | 3.29 | | — | | — | |||
| Canceled/Expired | (665,292) | | 30.41 | | — | | — | |||
| Outstanding as of December 31, 2023 | 737,895 | | $25.42 | | $1,317,000 | | 7.6 | |||
| Options vested and exercisable | 404,343 | | $43.53 | | $244,000 | | 6.6 | |||
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 years ended December 31, 2023 and 2022, respectively, were as follows:
| · · · · · · · | |||||
|---|---|---|---|---|---|
| · · For the Years Ended · | |||||
| · · December 31, · | |||||
| · 2023 · 2022 · | |||||
| Exercise price | | $1.99 | | $4.70 | |
| Expected term (years) | | 6.0 | | 5.9 | |
| Expected stock price volatility | | 91% | 85% | ||
| Risk-free rate of interest | | 4% | 2% | ||
| Expected dividend rate | | 0% | 0% | ||
The following table sets forth stock-based compensation expenses recorded during the respective periods:
| | | | | | | |
|---|---|---|---|---|---|---|
| | For the Years Ended | |||||
| · · December 31, | ||||||
| · 2023 · 2022 | ||||||
| Stock Compensation expenses: · · | ||||||
| Research and development | | $338,000 | | $783,000 | ||
| General and administrative | | | 520,000 | | | 2,522,000 |
| Stock compensation in continuing operations | | | 858,000 | | | 3,305,000 |
| Stock compensation in discontinued operations | | 725,000 | | 2,039,000 | ||
| Total stock compensation expenses | | $1,583,000 | | $5,344,000 | ||
At December 31, 2023, the total stock-based compensation cost related to unvested awards not yet recognized was $0.4 million. The expected weighted average period compensation costs to be recognized was 1.8 years. Future option grants will impact the compensation expense recognized.
NOTE 12: GRANT INCOME
CPRIT
In August 2021, the Company received notice of a Product Development Research award totaling approximately $13.1 million from CPRIT to support the Company’s Phase 2 clinical trial of MT-401. The CPRIT award is intended to support the adjuvant arm of the Company’s Phase 2 clinical trial evaluating MT-401 when given as an adjuvant therapy to patients with acute myeloid leukemia following a hematopoietic stem cell transplant. The primary objectives of the adjuvant arm of the trial are to evaluate relapse-free survival after MT-401 treatment when compared with a randomized control group.
If restricted cash received from grants in advance of incurring qualifying costs, it is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred. There wasno restricted cash recorded as of December 31, 2023 and December 31, 2022. If qualifying grant income is earned in advance of cash received from grants, it is recognized as revenue and recorded as other receivable.
The Company recorded $2.7 million and $3.4 million of grant income related to the CPRIT grant as revenue for the years ended December 31, 2023 and 2022, respectively. At December 31, 2023, the Company had recorded $0.5 million as other receivable, which represented grant income earned in advance of the next tranche of funds to be received from CPRIT.
FDA
In September 2022, the Company received notice from the FDA that it had awarded the Company a $2.0 million grant from the FDA’s Orphan Products Grant program to support the Company’s Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML. The Company recorded $0.4 million and $0.1 million of grant income related to the FDA grant as revenue for the years ended December 31, 2023 and December 31, 2022, respectively. As of December 31, 2023, the Company recorded $0.3 million as other receivable, which represented grant income earned in advance of funds to be received from the FDA. In February 2024, the Company received $0.3 million of funds from the FDA grant.
SBIR
In May 2023, the Company announced it had received a $2.0 million grant from the National Institutes of Health Small Business Innovation Research program to support the development and investigation of MT-401 for the treatment of AML patients following standard-of-care therapy with hypomethylating agents. The Company recorded $0.2 million of grant income related to the SBIR grant as revenue for the year ended December 31, 2023. As of December 31, 2023, the Company recorded $0.2 million as other receivable, which represented grant income earned in advance of funds to be received from the SBIR. In February 2024, the Company received $0.2 million of funds from the SBIR grant.
NOTE 13: LEGAL PROCEEDINGS
From time to time, the Company may be party to ordinary, routine litigation incidental to their business. The Company knows of no material, active or pending legal proceedings against the Company, nor is the Company involved as a plaintiff in any material proceeding or pending litigation. There are no proceedings in which any of the Company’s directors, officers or affiliates, or any registered or beneficial shareholder, is an adverse party or has a material interest adverse to the Company’s interest.
NOTE 14: RELATED PARTY TRANSACTIONS
The following table sets forth related party transaction expenses recorded for the years ended December 31, 2023 and 2022, respectively.
| | | | | | | |
|---|---|---|---|---|---|---|
| · · For the Years Ended | ||||||
| · · December 31, | ||||||
| · 2023 · 2022 | ||||||
| Baylor College of Medicine | | $13,000 | $1,142,000 | |||
| Bio-Techne Corporation | | | — | | | 101,000 |
| Cell Ready | | | 1,330,000 | | — | |
| Wilson Wolf Manufacturing Corporation | | | 277,000 | | | 265,000 |
| Total Research and development | | $1,620,000 | $1,508,000 | |||
$1.3 million of related party transactions are included in accounts payable and accrued liabilities as of December 31, 2023. See Note 9 for additional information.
Agreements with The Baylor College of Medicine (“BCM”)**.
In November 2018, January 2020 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, May 2020 and July 2021, the Company entered into Clinical Supply Agreements 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.
BCM is also a shareholder of the Company’s common stock.
The Company has also entered into a Clinical Site Agreement with BCM, which provided for BCM to conduct clinical trials for the Company and is a part of continuing operations.
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 was serving as the President of the Protein Sciences Segment of Bio-Techne Corporation. Mr. Eansor resigned from Bio-Techne Corporation on March 1, 2022, and as such, two months of transactions in 2022 are included in the table above.
Purchases from Wilson Wolf*.*
The Company is currently utilizing Wilson Wolf for the purchases of cell culture devices called G-Rexes. Mr. John Wilson is a member of the Company’s board of directors and is serving as the CEO of Wilson Wolf Manufacturing Corporation.
Purchases from Cell Ready, LLC.
The Company is currently utilizing Cell Ready, LLC for its clinical manufacturing supply and product development. Mr. John Wilson is a member of the Company’s board of directors and is serving as the CEO of Cell Ready, LLC. On February 22, 2024, we entered into a Master Services Agreement for Product Supply (the “MSA”) with Cell Ready. Cell Ready, which is owned by one of our directors and shareholders, Mr. John Wilson, is a contract development and manufacturing organization (CDMO). Under the MSA, it is anticipated Cell Ready will perform a wide variety of services for us, including research and development, and manufacturing in support
of our clinical trials. Pursuant to the MSA, the Company may contract with Cell Ready for the provision of various products and services from time to time by entering into work orders with Cell Ready. If the services involve the supply of product, Cell Ready is required to supply such product in conformance with the product requirements set forth in the applicable work order(s). Under the MSA, Cell Ready is to use only personnel with sufficient qualifications and experience to supply the services contemplated by the MSA, provide its personnel with adequate training and assume full responsibility for its personnel’s compliance with the MSA. Further, Cell Ready is required to provide the Company with assistance and cooperation in order for the Company to obtain and maintain all necessary regulatory approvals, at the Company’s expense. Also on February 22, 2024, the Company entered into Work Order #1 under the MSA, pursuant to which Cell Ready will provide the Company with GMP drug product for Marker MT-401 and/or MT-601. The services include the delivery of final drug product and quality control testing. The Company also requested Cell Ready to provide general support services in connection therewith. The total projected sum (inclusive of taxes) for the services under Work Order #1 are not anticipated to exceed $750,000. The services will cover the anticipated manufacturing costs for the first quarter of 2024. Additional Work Orders are expected to be generated for the remainder of 2024.
NOTE 15: INCOME TAXES
The Company hasno federal income tax expense due to operating losses incurred for the years ended December 31, 2023 and 2022. The Company recognized $4,000 in state tax expense for the year ended December 31, 2023.
The effects of temporary differences that give rise to significant portions of the deferred tax assets as of December 31, 2023 and 2022 are as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · For the Years Ended | ||||||
| · · December 31, | ||||||
| | 2023 | 2022 | ||||
| Deferred Tax Assets | | | | | | |
| Net Operating Loss Carryforward | | $29,352,000 | | $30,072,000 | ||
| Stock Compensation | | | 2,598,000 | | | 5,642,000 |
| Capitalized R&E | | | 7,026,000 | | | 4,818,000 |
| Research and Development | | | 733,000 | | | 733,000 |
| | | | 39,709,000 | | | 41,265,000 |
| Less: Valuation Allowance | | | (39,709,000) | | | (41,265,000) |
| Total Deferred Tax Assets | | $— | | $— | ||
| | | | | | | |
| Total Deferred Tax Liabilities | | $— | | $— | ||
| | | | | | | |
| Net Deferred Tax Assets/(Liabilities) | | $— | | $— | ||
The Company assesses the likelihood that deferred tax assets will be realized. To the extent that realization is not likely, a valuation allowance is established. Based upon the history of losses, management believes that it is more likely than not, that future benefits of deferred tax assets will not be realized and has established a full valuation allowance for the years ended December 31, 2023 and 2022. The Company has research and development tax credit carryforwards of $733,000 available to offset future federal income taxes. The research and development tax credit carryforwards begin to expire in 2030.
The Company has approximately $131.8 million of federal and $38.4 million of state Net Operating Losses (“NOL”s) that may be available to offset future taxable income, if any. The federal net operating loss carryforwards of $38.0 million, if not utilized, will expire between 2030 and 2037. The federal net operating loss carryforwards of $93.8 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 $21.7 million, if not utilized, will begin to expire in 2035. The state net operating loss carryforwards of $16.6 million generated in 2018 and thereafter are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely.
In accordance with Section 382 of the Internal Revenue code, the usage of the Company’s net operating loss carryforwards may be limited in the event of a change in ownership. A full Section 382 analysis has not been prepared and NOLs could be subject to limitation under Section 382.
Effective for tax years beginning after December 31, 2021, taxpayers are required to capitalize any expenses incurred that are considered incidental to research and experimentation (R&E) activities under IRC Section 174. While taxpayers historically had the option of deducting these expenses under IRC Section 174, the December 2017 Tax Cuts and Jobs Act mandates capitalization and amortization of R&E expenses for tax years beginning after December 31, 2021. Expenses incurred in connection with R&E activities in the US must be amortized over a 5-year period if incurred, and R&E expenses incurred outside the US must be amortized over a 15-year period. R&E activities are broader in scope than qualified research activities considered under IRC Section 41 (relating to the research tax credit). For the year ended December 31, 2023 and 2022, the Company performed an analysis based on available guidance and determined that it will continue to be in a loss position even after the required capitalization and amortization of its R&E expenses. The Company will continue to monitor this issue for future developments, but it does not expect R&E capitalization and amortization to require it to pay cash taxes now or in the near future.
The Company’s income tax returns for 2019 to 2023 are still open and subject to audit. In addition, net operating losses arising from prior years are also subject to examination at the time they are utilized in future years.
For the years ended December 31, 2023 and 2022, the expected tax expense (benefit) from continuing operations based on the U. S. federal statutory rate is reconciled with the actual tax provision (benefit) as follows:
| · · · · · · · · · · · | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| | For the Years Ended December 31, | ||||||||
| · · 2023 · · 2022 | |||||||||
| · · · · · Percent of · · · · · Percent of · | |||||||||
| · Amount · Pretax Loss · Amount · Pretax Loss | |||||||||
| U.S. federal statutory rate | | $(2,948,000) | 21.00% | $(4,153,000) | 21.00% | ||||
| State taxes, net of federal benefit | | | (20,000) | 0.14% | | (28,000) | 0.14% | ||
| Tax rate change | | | (9,000) | 0.06% | | 10,000 | (0.05)% | ||
| Permanent Differences | | | | | | | |||
| - Other permanent differences | | | 25,000 | (0.18)% | | 288,000 | (1.46)% | ||
| Change in valuation allowance | | | (1,556,000) | 11.08% | | 2,864,000 | (14.48)% | ||
| Deferred true-up | | | 4,512,000 | (32.14)% | | 1,019,000 | (5.15)% | ||
| Income tax provision/(benefit) | | $4,000 | (0.04)% | $— | 0.00% | ||||
The Company recognized approximately $4,000 in state tax expense for the year ended December 31, 2023.
ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. As of December 31, 2023, and 2022, there wereno unrecognized tax benefits. The Company recognizes accrued interest and penalties as income tax expense. No amounts were accrued for the payment of interest and penalties at December 31, 2023 and 2022. The Company is currently not aware of any issues under review that could result in significant payments, accruals or material deviation from its position in the next year.
**NOTE 16:**SUBSEQUENT EVENTS
On February 22, 2024, the Company entered into a Master Services Agreement for Product Supply (the “Agreement”) with Cell Ready, a contract development and manufacturing organization (CDMO). Cell Ready is owned by one of the Company’s directors and shareholders, Mr. John Wilson. See Note 1 and Note 14.** **
On February 29, 2024, Marker Therapeutics, Inc. (the “Company”) delivered notice to Lincoln Park Capital Fund, LLC, an Illinois limited liability company (“LPC”), terminating the Purchase Agreement, dated December 12, 2022 (the “Purchase Agreement”), with LPC effective March 1, 2024 (the “Termination Date”). The Company projects a financial runway through the fourth quarter of 2025 and does not anticipate an immediate need for capital acquisition.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.