Marker Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 14, 2024.
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Sep 30, 2024 · Filed Nov 14, 2024
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Notes to Condensed Consolidated Financial Statements
September 30, 2024
(Unaudited)
NOTE 1: NATURE OF OPERATIONS
Marker Therapeutics, Inc., a Delaware corporation (the “Company” or “we”), is a clinical-stage immuno-oncology company specializing in the development and commercialization of novel T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. The Company’s multi tumor associated antigen (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 7.
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 agreement 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: BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results (see Note 7 for information on discontinued operations).
The results for the unaudited condensed consolidated statement of operations are not necessarily indicative of results to be expected for the year ending December 31, 2024, or for any future interim period. The condensed consolidated balance sheet at December 31, 2023 has been derived from audited financial statements, however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2023 and notes thereto included in the Company’s annual report on Form 10-K filed on March 26, 2024.
Certain amounts presented in prior periods have been reclassified to conform to the current period presentation.
NOTE 3: LIQUIDITY AND FINANCIAL CONDITION
As of September 30, 2024, the Company had cash and cash equivalents of approximately $9.0 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 are 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 nine months ended
September 30, 2024, the Company sold 8,178 shares of its common stock under the ATM Agreement for proceeds of $0.04 million. On June 10, 2024, the Company provided notice of its termination of the ATM Agreement with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC. The Company is not subject to any termination penalties related to the termination of the ATM Agreement. The Company is currently considering more effective ways to improve market access to its equity.
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 clinical investigation of MT-401. Through the date of this filing, the Company has received $9.7 million of funds from the CPRIT grant. The Company recorded $0.9 million and $2.4 million of grant income related to the CPRIT grant as revenue for the three and nine months ended September 30, 2024, respectively. As of September 30, 2024, the Company recorded $0.1 million of grant income receivable, which represented grant income earned in advance of funds to be received from CPRIT.
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 clinical investigation of MT-401 for the treatment of post-transplant AML. Through the date of this filing, the Company has received $1.0 million from the FDA grant. The Company recorded $0.02 million and $0.5 million of grant income related to the FDA grant as revenue for the three and nine months ended September 30, 2024, respectively. As of September 30, 2024, the Company recorded $0.02 million of grant income receivable, which represented grant income earned in advance of funds to be received from the FDA. In October 2024, the Company received $0.02 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 (“SBIR”) program to support the development and investigation of MT-401 for the treatment of AML patients following standard-of-care therapy with hypomethylating agents. Through the date of this filing, the Company has received $0.9 million from SBIR. The Company recorded $0.3 million and $0.7 million of grant income related to the SBIR grant as revenue for the three and nine months ended September 30, 2024. As of September 30, 2024, the Company recorded $0.3 million as other receivable, which represented grant income earned in advance of funds to be received from the SBIR. In October 2024, the Company received $0.3 million of funds from the SBIR grant.
In June 2024, the Company received notice of a $2.0 million grant over a 2 - year period from the National Institutes of Health - National Cancer Institute to support control over tumor immune escape in pancreatic cancer using a dual T cell product strategy. Through the date of this filing, the Company has not received any funds from this grant.
In August 2024, the Company received notice of a $2.0 million grant from the National Institutes of Health Small Business Innovation Research Program to support the clinical investigation of MT-601 in patients with non-Hodgkin’s lymphoma (NHL) who have relapsed following anti-CD19 chimeric antigen receptor (CAR) T cell therapy. Through the date of this filing, the Company has received $0.7 million of funds from this grant. The Company recorded $0.7 million of grant income related to this grant as revenue for the three and nine months ended September 30, 2024. As of September 30, 2024, the Company recorded $0.3 million as other receivable, which represented grant income earned in advance of funds to be received from the SBIR. In October 2024, the Company received $0.3 million of funds from the SBIR lymphoma grant.
In August 2024, the Company received another $2.0 million grant from the National Institutes of Health SBIR Program to support the advancement of MT-601 in patients with pancreatic cancer. Through the date of this filing, the Company has received an immaterial amount of funds from this grant.
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 (See Note 13).
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 anticipates that its cash and cash equivalents as of September 30, 2024, including drawdowns of available grant funds, will enable the Company to fund its operating expenses and capital expenditure requirements into October 2025. This estimate is subject to the Company’s ability to effectively manage its costs, raise additional capital, and utilize drawdowns of anticipated grant funds.
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, continues, or accelerates 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. As outlined above, the Company’s ability to pursue its long-term planned business activities is dependent upon its successful efforts to raise additional capital and grant income.
These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. The Company’s condensed consolidated financial statements have been prepared on a going concern basis, which implies that the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The Company’s financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
In addition to the foregoing, the current macro-economic environment of decades-high inflation and concerns about an economic recession in the United States or other major markets have 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 4: SIGNIFICANT ACCOUNTING POLICIES
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 September 30, 2024 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 September 30, 2024, the Company had approximately $4.1 million in cash at financial institutions and approximately $4.9 million in U.S. government agency securities, for aggregate cash and cash equivalents of $9.0 million. As of December 31, 2023, the Company had approximately $1.4 million in cash at financial institutions and approximately $13.7 million in U.S. government agency securities, for aggregate cash and cash equivalents of $15.1 million.
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.
Discontinued Operations
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 7 for further information.
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. Public entities with a single reportable segment, such as the Company, are required to provide the new disclosures and all the disclosures required under ASC 280. The ASU is effective for fiscal year periods beginning after December15, 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 the Company’s consolidated financial statements.
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed, the Company does not believe that the impact of recently issued standards that are not yet effective will have a material impact on its consolidated financial position or results of operations upon adoption.
There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2023 filed on March 26, 2024.
NOTE 5: NET LOSS PER SHARE
Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period. Diluted loss per common share is computed similarly to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock.
The following table sets forth the computation of net loss per share for the three and nine months ended September 30, 2024 and 2023, respectively:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · For the Three Months Ended · For the Nine Months Ended | ||||||||||||
| · · September 30, · September 30, | ||||||||||||
| | 2024 | 2023 | 2024 | 2023 | ||||||||
| Numerator: | | | | | | | | | | | | |
| Loss from continuing operations | | $(2,308,192) | | $(2,981,961) | | $(6,893,691) | | $(11,305,768) | ||||
| Income from discontinued operations | | $— | | $— | | $— | | $5,872,020 | ||||
| Net loss | | $(2,308,192) | | $(2,981,961) | | $(6,893,691) | | $(5,433,748) | ||||
| | | | | | | | | | | | | |
| Denominator: | | | | | | | | | ||||
| Weighted average common shares outstanding, basic | | 8,923,170 | | 8,825,881 | | 8,914,487 | | 8,782,340 | ||||
| Weighted average common shares outstanding, diluted | | 8,923,170 | | 8,825,881 | | 8,914,487 | | 8,834,512 | ||||
| | | | | | | | | | | | | |
| Net earnings (loss) per share: | | | | | | | | | ||||
| Loss from continuing operations, basic and diluted | | $(0.26) | | $(0.34) | | $(0.77) | | $(1.29) | ||||
| Income from discontinued operations, basic | | $— | | $— | | $— | | $0.67 | ||||
| Income from discontinued operations, diluted | | $— | | $— | | $ | | | $0.66 | |||
| Net loss per share, basic and diluted | | $(0.26) | | $(0.34) | | $(0.77) | | $(0.62) | ||||
The following securities, rounded to the nearest thousand, were not included in the diluted net loss per share calculation because their effect was anti-dilutive for the periods presented:
| · · · · · · · · | |||||
|---|---|---|---|---|---|
| · · For the Three Months Ended · · For the Nine Months Ended | |||||
| · · September 30, · · September 30, | |||||
| · 2024 · 2023 · 2024 · 2023 | |||||
| Common stock options | | 596,000 | 800,000 | 596,000 | 748,000 |
| Common stock purchase warrants | | — | 1,848,000 | — | 1,848,000 |
| Potentially dilutive securities | | 596,000 | 2,648,000 | 596,000 | 2,596,000 |
NOTE 6: 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 $0.9 million and $2.4 million of grant income related to the CPRIT grant for the three and nine months ended September 30, 2024, respectively. At September 30, 2024, the Company recorded $0.1 million of grant income receivable related to the CPRIT grant.
Additionally, the Company recorded $0.02 million and $1.0 million of grant income related to the FDA and SBIR grants, respectively, for the three months ended September 30, 2024. The Company recorded $0.5 million and $1.4 million of grant income related to the FDA and SBIR grants, respectively, for the nine months ended September 30, 2024. At September 30, 2024, the Company recorded $0.02 million and $0.6 million of grant income receivable related to the FDA and SBIR grants, respectively.
In October 2024, the Company received payments of $0.02 million and $0.6 million from the FDA grant and all SBIR grants, respectively.
NOTE 7: 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. There were no remaining assets and liabilities classified in discontinued operations as of September 30, 2024 or December 31, 2023.
The Company had no activity related to discontinued operations for the three and nine months ended September 30, 2024. Net loss from discontinued operations for the three and nine months ended September 30, 2023, was as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · For the Three Months · For the Nine Months | ||||||
| · · Ended September 30, · · Ended September 30, | ||||||
| · · 2023 · · 2023 | ||||||
| Revenues: | | | | | | |
| Service Revenue | | $— | | $816,641 | ||
| Related party service revenue | | | — | | | 3,500,000 |
| Total revenues | | — | | 4,316,641 | ||
| Operating expenses: | | | | | ||
| Research and development | | — | | 6,561,957 | ||
| General and administrative | | | — | | | 677,090 |
| Total operating expenses | | | — | | | 7,239,048 |
| Loss from discontinued operations | | $— | | $(2,922,406) | ||
The following table summarizes our cash flows related to discontinued operations for the nine months ended September 30, 2023:
| · · · | ||
|---|---|---|
| | | For the Nine Months |
| | | Ended September 30, |
| | 2023 | |
| Discontinued operations: | | |
| Net cash used in operating activities | | (6,036,000) |
| Net cash provided by investing activities | | 18,664,000 |
| Net increase (decrease) in cash and cash equivalents | | $12,628,000 |
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 certain agreed milestones were met. Payment of the additional $1.0 million was received in May 2023.
NOTE 8: ACCOUNTS PAYABLE, ACCRUED LIABILITIES AND RELATED PARTY PAYABLE
Accounts payable, accrued liabilities, and related party payable consist of the following as of September 30, 2024 and December 31, 2023, respectively:
| | | | | | | |
|---|---|---|---|---|---|---|
| · September 30, · December 31, | ||||||
| · · 2024 · · 2023 | ||||||
| Accounts payable | | $1,904,000 | | $961,000 | ||
| Compensation and benefits | | 39,000 | | 57,000 | ||
| Professional fees | | | 359,000 | | | 303,000 |
| Related party payable | | 903,000 | | 1,330,000 | ||
| Tax fees | | 52,000 | | 219,000 | ||
| Other | | 204,000 | | 205,000 | ||
| Total accounts payable, accrued liabilities and related party payable | | $3,461,000 | | $3,075,000 | ||
The $0.9 million and $1.3 million related-party payable as of September 30, 2024 and December 31, 2023, respectively, primarily reflects amounts payable to Cell Ready for outsourced product development and manufacturing services. See Note 13: Related Party Transactions.
NOTE 9: STOCKHOLDERS’ EQUITY
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.
Common Stock Transactions
Issuance of Stock Pursuant to ATM Agreement
During the nine months ended September 30, 2024, the Company sold 8,178 shares of its common stock under the ATM Agreement for gross proceeds of $37,000. During the nine months ended September 30, 2023, the Company sold 265,334 shares of its common stock under the ATM Agreement for gross proceeds of $1.0 million. On June 10, 2024, the Company provided notice of its termination of the ATM Agreement with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC. The Company is currently considering more effective ways to improve market access to its equity.
Stock Purchase Agreement
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 had 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 was 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 nine months ended September 30, 2023, the Company sold 12,500 shares of its common stock under the Purchase Agreement for gross 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 nine months ended September 30, 2024, certain outstanding options were exercised for 23,892 shares of common stock, providing aggregate proceeds to the Company of approximately $59,000.
NOTE 10: STOCK-BASED COMPENSATION
Stock Options
2024 Equity Incentive Awards
There wereno equity incentive awards issued during the three and nine months ended September 30, 2024.
A summary of the Company’s stock option activity for the nine months ended September 30, 2024 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, 2024 | 737,895 | | $25.42 | | $1,317,000 | | 7.6 | |||
| Exercised | | (23,892) | | | 2.45 | | | — | | — |
| Canceled/Expired | (117,670) | | | 43.37 | | | — | | — | |
| Outstanding as of September 30, 2024 | 596,333 | | $22.80 | | $291,000 | | 7.1 | |||
| Options vested and exercisable | 386,062 | | $33.76 | | $109,000 | | 6.4 | |||
The following table sets forth stock-based compensation expenses recorded during the respective periods:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · For the Three Months Ended · For the Nine Months Ended | ||||||||||||
| · · September 30, · September 30, | ||||||||||||
| · 2024 · 2023 · 2024 · 2023 | ||||||||||||
| Stock Compensation expenses: · · · · · | ||||||||||||
| Research and development | | $3,000 | | $106,000 | | $13,000 | | $299,000 | ||||
| General and administrative | | 50,000 | | 69,000 | | 182,000 | | 416,000 | ||||
| Stock compensation in continuing operations | | | 53,000 | | | 175,000 | | | 195,000 | | | 715,000 |
| Stock compensation in discontinued operations | | | — | | | — | | | — | | | 725,000 |
| Total stock compensation expenses | | $53,000 | | $175,000 | | $195,000 | | $1,440,000 | ||||
As of September 30, 2024, the total stock-based compensation cost related to unvested awards not yet recognized was $0.2 million. The expected weighted average period for compensation costs to be recognized was approximately 1.8 years. Future option grants will impact the compensation expense recognized.
NOTE 11: 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 clinical investigation of MT-401.
If restricted cash is 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 September 30, 2024, and December 31, 2023. 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 $0.9 million and $2.4 million of grant income related to the CPRIT grant as revenue for the three and nine months ended September 30, 2024, respectively. As of September 30, 2024, the Company recorded $0.1 million as other receivable, which represented grant income earned in advance 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 clinical investigation of MT-401 for the treatment of post-transplant AML. The Company recorded $0.02 million and $0.5 million of grant income related to the FDA grant as revenue for the three and nine months ended September 30, 2024, respectively. As of September 30, 2024, the Company recorded $0.02 million as other receivable, which represented grant income earned in advance of funds to be received from the FDA. In October 2024, the Company received $0.02 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 $0.3 million and $0.7 million of grant income related to this grant as revenue for the three and nine months ended September 30, 2024, respectively. As of September 30, 2024, the Company recorded $0.3 million as other receivable, which represented grant income earned in advance of funds to be received from the SBIR. In October 2024, the Company received $0.3 million of funds from the SBIR grant.
In August 2024, the Company received notice of a $2.0 million grant from the National Institutes of Health Small Business Innovation Research Program to support the clinical investigation of MT-601 in patients with non-Hodgkin’s lymphoma (NHL) who have relapsed following anti-CD19 chimeric antigen receptor (CAR) T cell therapy. The Company recorded $0.7 million of grant income related to this grant as revenue for the three and nine months ended September 30, 2024. As of September 30, 2024, the Company recorded $0.3 million as other receivable, which represented grant income earned in advance of funds to be received from the SBIR. In October 2024, the Company received $0.3 million of funds from the SBIR lymphoma grant.
NOTE 12: 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 13: RELATED PARTY EXPENSES
The following table sets forth related party transaction expenses recorded for the three and nine months ended September 30, 2024 and 2023, respectively.
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · For the Three Months Ended · For the Nine Months Ended | ||||||||||||
| · · September 30, · September 30, | ||||||||||||
| · 2024 · 2023 · 2024 · 2023 | ||||||||||||
| Baylor College of Medicine | | $— | | $— | | $6,000 | | $13,000 | ||||
| Cell Ready | | | 1,235,000 | | | 368,000 | | | 3,071,000 | | | 368,000 |
| Wilson Wolf Manufacturing Corporation | | | — | | | — | | | — | | | 277,000 |
| Total Research and development | | $1,235,000 | $368,000 | | $3,077,000 | $658,000 | ||||||
$0.9 million of related party transactions are included in accounts payable and accrued liabilities as of September 30, 2024. See Note 8 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 into a Clinical Trial Agreement with BCM, which provided for BCM to provide to the Company investigator-initiated research studies.
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.
BCM owns shares of the Company’s common stock.
Purchases from Wilson Wolf
In 2023, the Company utilized 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 3–year 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.
During the nine months ended September 30, 2024, the Company entered into Work Order #1 under the MSA, pursuant to which Cell Ready agreed to 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. During the three and nine months ended September 30, 2024, the Company incurred $1.2 million and $3.1 million, respectively, in expenses related to the services and manufacturing costs and paid $0.5 million and $3.4 million, respectively, for invoices received. Additional Work Orders are expected to be generated for the remainder of 2024.
NOTE 14: SUBSEQUENT EVENTS
The Company has evaluated subsequent events and transactions that occurred up to the date unaudited condensed consolidated financial statements were issued. Based upon this review, the Company did not identify any subsequent events that would have required adjustment to or disclosure in the unaudited condensed consolidated financial statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.