Marker Therapeutics, Inc. 10-Q

Item 1. Financial Statements MARKER THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ 2021 ​ 2020 ASSETS ​ ​ ​ ​ ​ ​ Current assets: ​ ​ ​ ​ ​ ​ Cash and cash equivalents ​ $ 48,705,297 ​ $ 21,352,382 Prepaid expenses and deposits ​ 2,701,327 ​ 2,057,924 Other receivables ​ ​ 243 ​ ​ 1,000,559 Total current assets ​ 51,406,867 ​ 24,410,865 Non-current assets: ​ ​ ​ ​ ​ ​ Property, plant and equipment, net ​ 9,846,745 ​ 3,570,736 Construction in progress ​ ​ 600,005 ​ ​ 6,789,098 Right-of-use assets, net ​ ​ 10,086,158 ​ ​ 10,844,116 Total non-current assets ​ ​ 20,532,908 ​ ​ 21,203,950 ​ ​ ​ ​ ​ ​ ​ Total assets ​ $ 71,939,775 ​ $ 45,614,815 ​ ​ ​ ​ ​ ​ ​ LIABILITIES AND STOCKHOLDERS' EQUITY ​ ​ Current liabilities: ​ ​ Accounts payable and accrued liabilities ​ $ 7,645,287 ​ $ 6,013,010 Lease liability ​ ​ 581,588 ​ ​ 388,792 Total current liabilities ​ 8,226,875 ​ 6,401,802 Non-current liabilities: ​ ​ ​ ​ ​ ​ Lease liability, net of current portion ​ ​ 11,430,892 ​ ​ 11,868,440 Total non-current liabilities ​ ​ 11,430,892 ​ ​ 11,868,440 ​ ​ ​ ​ ​ ​ ​ Total liabilities ​ 19,657,767 ​ 18,270,242 ​ ​ ​ ​ ​ ​ ​ Commitments and contingencies (see Note 10) ​ — ​ — ​ ​ ​ ​ ​ ​ ​ Stockholders' equity: ​ ​ ​ Preferred stock - $ 0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively ​ ​ — ​ ​ — Common stock, $ 0.001 par value, 150 million shares authorized, 83.1 million and 50.7 million shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively ​ ​ 83,079 ​ ​ 50,731 Additional paid-in capital ​ 440,553,968 ​ 383,533,326 Accumulated deficit ​ ( 388,355,039 ) ​ ( 356,239,484 ) Total stockholders' equity ​ 52,282,008 ​ 27,344,573 ​ ​ ​ ​ ​ ​ ​ Total liabilities and stockholders' equity ​ $ 71,939,775 ​ $ 45,614,815 ​ See accompanying notes to these unaudited condensed consolidated financial statements. ​ 1 Table of Contents ​ MARKER THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three Months Ended For the Nine Months Ended ​ ​ September 30, September 30, ​ 2021 2020 2021 2020 Revenues: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Grant income ​ $ — ​ $ — ​ $ — ​ $ 466,785 Total revenues ​ — ​ — ​ — ​ 466,785 Operating expenses: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Research and development ​ 6,784,390 ​ 4,803,605 ​ ​ 19,777,454 ​ ​ 12,897,275 General and administrative ​ 3,239,148 ​ 2,572,562 ​ 9,936,256 ​ 7,946,846 Total operating expenses ​ 10,023,538 ​ 7,376,167 ​ 29,713,710 ​ 20,844,121 Loss from operations ​ ( 10,023,538 ) ​ ( 7,376,167 ) ​ ( 29,713,710 ) ​ ( 20,377,336 ) Other income: ​ ​ ​ ​ ​ ​ ​ ​ Change in fair value of warrant liabilities ​ — ​ — ​ — ​ 31,000 Arbitration settlement ​ ​ ( 2,406,576 ) ​ ​ — ​ ​ ( 2,406,576 ) ​ ​ — Interest income ​ 791 ​ 4,667 ​ 4,731 ​ 147,493 Net loss ​ $ ( 12,429,323 ) ​ $ ( 7,371,500 ) ​ $ ( 32,115,555 ) ​ $ ( 20,198,843 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss per share, basic and diluted ​ $ ( 0.15 ) ​ $ ( 0.16 ) ​ $ ( 0.43 ) ​ $ ( 0.43 ) Weighted average number of common shares outstanding, basic and diluted ​ 83,078,675 ​ 46,867,119 ​ 74,290,598 ​ 46,509,391 ​ See accompanying notes to these unaudited condensed consolidated financial statements. ​ 2 Table of Contents ​ MARKER THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (UNAUDITED) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three Months Ended September 30, 2021 ​ ​ ​ ​ ​ ​ ​ ​ Total ​ ​ Common Stock ​ Additional Paid- ​ Accumulated ​ Stockholders’ ​ ​ Shares ​ Par value ​ in Capital ​ Deficit ​ Equity Balance at July 1, 2021 83,078,675 ​ $ 83,079 ​ $ 439,085,948 ​ $ ( 375,925,716 ) ​ $ 63,243,311 Stock-based compensation — ​ — ​ 1,468,020 ​ — ​ 1,468,020 Net loss — ​ — ​ — ​ ( 12,429,323 ) ​ ( 12,429,323 ) Balance at September 30, 2021 83,078,675 ​ $ 83,079 ​ $ 440,553,968 ​ $ ( 388,355,039 ) ​ $ 52,282,008 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Nine Months Ended September 30, 2021 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total ​ ​ Common Stock ​ Additional Paid- ​ Accumulated ​ Stockholders’ ​ Shares Par value in Capital Deficit Equity Balance at January 1, 2021 50,731,072 ​ $ 50,731 ​ $ 383,533,326 ​ $ ( 356,239,484 ) ​ $ 27,344,573 Issuance of common stock for cash (net of offering costs of $ 3.9 million) ​ 32,282,857 ​ ​ 32,283 ​ ​ 52,520,475 ​ ​ — ​ ​ 52,552,758 Stock options exercised for cash ​ 1,456 ​ ​ 2 ​ ​ 3,085 ​ ​ — ​ ​ 3,087 Stock-based compensation ​ 63,290 ​ 63 ​ 4,497,082 ​ — ​ 4,497,145 Net loss — ​ — ​ — ​ ( 32,115,555 ) ​ ( 32,115,555 ) Balance at September 30, 2021 83,078,675 ​ $ 83,079 ​ $ 440,553,968 ​ $ ( 388,355,039 ) ​ $ 52,282,008 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three Months Ended September 30, 2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total ​ ​ Common Stock ​ Additional Paid- ​ Accumulated ​ Stockholders’ ​ Shares Par value in Capital Deficit Equity Balance at July 1, 2020 ​ 46,617,632 ​ $ 46,617 ​ $ 374,828,385 ​ $ ( 340,360,757 ) ​ $ 34,514,245 Issuance common stock for cash ​ 1,407,470 ​ ​ 1,408 ​ ​ 2,184,601 ​ ​ — ​ ​ 2,186,009 Stock-based compensation ​ — ​ ​ — ​ ​ 1,269,171 ​ ​ — ​ ​ 1,269,171 Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 7,371,500 ) ​ ​ ( 7,371,500 ) Balance at September 30, 2020 ​ 48,025,102 ​ $ 48,025 ​ $ 378,282,157 ​ $ ( 347,732,257 ) ​ $ 30,597,925 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Nine Months Ended September 30, 2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total ​ ​ Common Stock ​ Additional Paid- ​ Accumulated ​ Stockholders’ ​ Shares Par value in Capital Deficit Equity Balance at January 1, 2020 ​ 45,728,831 ​ $ 45,728 ​ $ 371,573,909 ​ $ ( 327,533,414 ) ​ $ 44,086,223 Issuance common stock for cash ​ 1,407,470 ​ ​ 1,408 ​ ​ 2,184,601 ​ ​ — ​ ​ 2,186,009 Warrants exercised for cash ​ 458,334 ​ ​ 459 ​ ​ 549,541 ​ ​ — ​ ​ 550,000 Issuance of common stock as commitment fee for future financing ​ 345,357 ​ ​ 345 ​ ​ ( 345 ) ​ ​ — ​ ​ — Stock-based compensation ​ 85,110 ​ ​ 85 ​ ​ 3,974,451 ​ ​ — ​ ​ 3,974,536 Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 20,198,843 ) ​ ​ ( 20,198,843 ) Balance at September 30, 2020 ​ 48,025,102 ​ $ 48,025 ​ $ 378,282,157 ​ $ ( 347,732,257 ) ​ $ 30,597,925 ​ See accompanying notes to these unaudited condensed consolidated financial statements. ​ 3 Table of Contents ​ MARKER THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Nine Months Ended ​ ​ September 30, ​ 2021 2020 Cash Flows from Operating Activities: ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 32,115,555 ) ​ $ ( 20,198,843 ) Reconciliation of net loss to net cash used in operating activities: ​ ​ ​ ​ Depreciation and amortization ​ ​ 1,584,495 ​ ​ 272,725 Changes in fair value of warrant liabilities ​ — ​ ( 31,000 ) Stock-based compensation ​ 4,497,145 ​ 3,974,536 Amortization on right-of-use assets ​ 757,958 ​ 337,530 Changes in operating assets and liabilities: ​ ​ Prepaid expenses and deposits ​ ( 643,403 ) ​ ( 840,703 ) Other receivables ​ 1,000,316 ​ 56,054 Accounts payable and accrued expenses ​ 2,742,154 ​ 2,065,929 Lease liability ​ ​ ( 244,752 ) ​ ​ ( 166,723 ) Net cash used in operating activities ​ ( 22,421,642 ) ​ ( 14,530,495 ) Cash Flows from Investing Activities: ​ ​ ​ ​ Purchase of property and equipment ​ ( 1,262,092 ) ​ ( 2,005,160 ) Purchase of construction in progress ​ ​ ( 1,519,196 ) ​ ​ ( 3,147,566 ) Net cash used in investing activities ​ ( 2,781,288 ) ​ ( 5,152,726 ) Cash Flows from Financing Activities: ​ ​ ​ ​ Proceeds from issuance of common stock, net ​ 52,552,758 ​ 2,186,009 Proceeds from exercise of warrants ​ — ​ 550,000 Proceeds from exercise of stock options ​ 3,087 ​ — Net cash provided by financing activities ​ 52,555,845 ​ 2,736,009 Net increase (decrease) in cash ​ 27,352,915 ​ ( 16,947,212 ) ​ ​ ​ ​ ​ ​ ​ Cash and cash equivalents at beginning of the period ​ 21,352,382 ​ 43,903,949 Cash and cash equivalents at end of the period ​ $ 48,705,297 ​ $ 26,956,737 ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Nine Months Ended ​ ​ September 30, ​ 2021 2020 Supplemental schedule of non-cash financing and investing activities: ​ ​ ​ ​ ​ ​ Reclassifications between construction in progress and fixed assets ​ $ 6,789,098 ​ $ — Capital expenditures included in accounts payable ​ $ 70,399 ​ $ 1,894,895 Issuance of common stock as commitment fee for future financing ​ $ — ​ $ 345 Recognition of right-of-use assets and lease liability from new operating lease agreement ​ $ — ​ $ 11,077,636 ​ See accompanying notes to these unaudited condensed consolidated financial statements. ​ 4 Table of Contents ​ MARKER THERAPEUTICS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS September 30, 2021 (Unaudited) NOTE 1: NATURE OF OPERATIONS Marker Therapeutics, Inc., a Delaware corporation (the “Company” or “we”), is a clinical-stage immuno-oncology company specializing in the development and commercialization of novel T cell-based immunotherapies and innovative peptide-based vaccines for the treatment of hematological malignancies and solid tumor indications. The Company’s MultiTAA T cell technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens, which are tumor targets, and kill tumor cells expressing those targets. These T cells are designed to recognize multiple tumor targets to produce broad spectrum anti-tumor activity. ​ NOTE 2: BASIS OF PRESENTATION The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. The results for the condensed consolidated statement of operations are not necessarily indicative of results to be expected for the year ending December 31, 2021 or for any future interim period. The condensed consolidated balance sheet at September 30, 2021 has been derived from unaudited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2020 and notes thereto included in the Company’s annual report on Form 10-K filed on March 9, 2021. ​ NOTE 3: LIQUIDITY AND FINANCIAL CONDITION As of September 30, 2021, the Company had cash and cash equivalents of approximately $ 48.7 million. The Company’s activities since inception have consisted principally of acquiring product and technology rights, raising capital, and performing research and development. Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to access potential markets; secure financing; successfully progress its product candidates through preclinical and clinical development; obtain regulatory approval of one or more of its product candidates; maintain and enforce intellectual property rights; develop a customer base; attract, retain and motivate qualified personnel; and develop strategic alliances and collaborations. From inception, the Company has been funded by a combination of equity and debt financings. 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. 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 the Company has provided each of the Sales Agents with indemnification and contribution rights. To date, the Company has not sold any shares of its common stock under the ATM Agreement. On March 16, 2021, the Company issued an aggregate of 32,282,857 shares of its common stock, for net proceeds of $ 52.6 million. 5 Table of Contents ​ The Company expects to continue to incur substantial losses over the next several years during its development phase. To fully execute its business plan, the Company will need to complete certain research and development activities and clinical trials. Further, the Company’s product candidates will require regulatory approval prior to commercialization. These activities will span many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in completing these activities could adversely impact the Company. The Company plans to meet its capital requirements primarily through issuances of debt and equity securities and, in the longer term, revenue from sales of its product candidates, if approved. 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 its lead MultiTAA-specific T cell product 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. To date, the Company has not received any funds from the CPRIT grant. 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 September 30, 2021 will enable the Company to fund its operating expenses and capital expenditure requirements into the first quarter of 2023. This expectation does not account for any future funds that the Company may receive from the CPRIT award. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could utilize its available capital resources sooner than it currently expects. Furthermore, the Company’s operating plan may change, and it may need additional funds sooner than planned in order to meet operational needs and capital requirements for product development and commercialization. Because of the numerous risks and uncertainties associated with the development and commercialization of the Company's product candidates and the extent to which the Company may enter into additional collaborations with third parties to participate in their development and commercialization, the Company is unable to estimate the amounts of increased capital outlays and operating expenditures associated with its current and anticipated clinical trials. The Company’s future funding requirements will depend on many factors, as it: ● initiates or continues clinical trials of its product candidates; ● continues the research and development of its product candidates and seeks to discover additional product candidates; ● seeks regulatory approvals for any product candidates that successfully complete clinical trials; ● maintains and enforces intellectual property rights; ● establishes sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive regulatory approval; ● evaluates strategic transactions the Company may undertake; and ● enhances operational, financial and information management systems and hires additional personnel, including personnel to support development of product candidates and, if a product candidate is approved, commercialization efforts. In addition to the foregoing, based on the Company’s current assessment, the Company does not expect any material impact on its long-term liquidity due to the COVID-19 pandemic. However, the Company will continue to assess the effect of the pandemic on its operations, including its clinical programs. The extent to which the COVID-19 pandemic will impact the Company’s business and operations will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, the emergence of any new variant strains of COVID-19, the duration and effect of business disruptions and the short-term effects and ultimate effectiveness of the travel restrictions, quarantines, social distancing requirements, the timing, distribution, rate of public acceptance and efficacy of vaccines and other treatments, and business closures in the United States and other countries to contain and treat the disease. While the potential economic impact brought by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict, it could result in significant disruption of global financial markets, reducing the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 and any variant strains thereof could materially affect the Company’s business and the value of its common stock. ​ 6 Table of Contents ​ NOTE 4: SIGNIFICANT ACCOUNTING POLICIES Prior Period Reclassification Certain reclassifications have been made to reclass certain non-cash capital expenditures on the consolidated statements of cash flows from a cash outflow from investing activity to a non-cash investing activity. The Company has evaluated the materiality of this adjustment and concluded it was not material to the previously issued consolidated financial statements and had no impact to the reported consolidated balance sheets, consolidated statements of operations or net loss per share. For the year ended December 31, 2020, this immaterial adjustment had the effect of increasing net cash used in operating activities and decreasing net cash used in investing activities by $ 1.2 million from what was previously reported. For the nine months ended September 30, 2020, this immaterial adjustment had the effect of increasing net cash used in operating activities and decreasing net cash used in investing activities by $ 1.9 million from was previously reported. Property and equipment - Construction in Progress During the third quarter of 2021, and in connection with the Company’s manufacturing facility in Houston, Texas, the Company incurred $ 0.6 million of costs pursuant to an agreement with a vendor to build and eventually install a second modular cleanroom. Such costs were recorded in fixed assets – construction in progress on the balance sheet as of September 30, 2021. Upon completion and installation of the modular cleanroom, all costs associated with the buildout will be recorded as manufacturing equipment and amortized over the estimated useful life. Grant Income The Company recognizes grant income in accordance with the terms stipulated under the grant awarded to the Company’s collaborators at the Mayo Foundation from the U. S. Department of Defense. In various situations, the Company receives certain payments from the Mayo Foundation for reimbursement of clinical supplies. These payments are non-refundable and are not dependent on the Company’s ongoing future performance. The Company has adopted a policy of recognizing these payments when received and as revenue in accordance with Accounting Standards Update No. 2014 09, “Revenue from Contracts with Customers (Topic 606)” issued by the Financial Accounting Standards Board (“FASB”). Cash received from grants in advance of incurring qualifying costs is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred. New Accounting Standards From time to time, new accounting pronouncements are issued by FASB or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed, the Company does not believe that the impact of recently issued standards that are not yet effective will have a material impact on its financial position or results of operations upon adoption. Recent Accounting Standards Adopted in the Year Income Taxes In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company has adopted the new standard effective January 1, 2021 and has concluded that the adoption of this standard did not have a material impact on its condensed consolidated financial statements and related disclosures. ​ 7 Table of Contents ​ 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, 2021 and 2020, respectively: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three Months Ended For the Nine Months Ended ​ ​ September 30, September 30, ​ 2021 2020 2021 2020 Numerator: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 12,429,323 ) ​ $ ( 7,371,500 ) ​ $ ( 32,115,555 ) ​ $ ( 20,198,843 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Denominator: ​ ​ ​ ​ ​ ​ ​ ​ Weighted average common shares outstanding ​ 83,078,675 ​ 46,867,119 ​ 74,290,598 ​ 46,509,391 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss per share: ​ ​ ​ ​ ​ ​ ​ ​ Basic and diluted ​ $ ( 0.15 ) ​ $ ( 0.16 ) ​ $ ( 0.43 ) ​ $ ( 0.43 ) ​ 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 Nine Months Ended ​ ​ September 30, ​ 2021 2020 Common stock options 7,544,000 5,882,000 Common stock purchase warrants 19,830,000 20,964,000 Potentially dilutive securities 27,374,000 26,846,000 ​ ​ NOTE 6: OTHER RECEIVABLES Pursuant to the Company’s lease agreement for its manufacturing facility, the Company incurred and paid for the construction invoices directly for both the structural improvements of the facility and the building of the manufacturing modular cleanroom (i.e. leasehold improvements and manufacturing equipment). In accordance with the agreement, upon completion of the facility’s construction, the Company was owed up to $ 1.0 million as reimbursement, and as such a landlord receivable was recorded, which provides for a legal right to receive construction reimbursements from the landlord for tenant improvement allowances. During the fiscal year ended 2020, the Company recorded a $ 1.0 million receivable in its condensed consolidated financial statements. The Company received the $ 1.0 million reimbursement in April 2021. ​ 8 Table of Contents ​ NOTE 7: PROPERTY AND EQUIPMENT Property and equipment consist of the following as of September 30, 2021 and December 31, 2020, respectively: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, ​ December 31, ​ Estimated Useful Lives 2021 2020 Lab and manufacturing equipment ​ 5 Years ​ $ 7,050,000 ​ $ 2,360,000 Computers, equipment and software 3 - 5 Years ​ ​ 967,000 ​ ​ 835,000 Office furniture 5 Years ​ 834,000 ​ 678,000 Leasehold improvements ​ Lesser of lease term or estimated useful life ​ ​ 3,171,000 ​ ​ 289,000 Total ​ ​ 12,022,000 ​ ​ 4,162,000 Less: accumulated depreciation ​ ( 2,175,000 ) ​ ( 591,000 ) Construction in progress ​ ​ ​ ​ 600,000 ​ ​ 6,789,000 Total fixed assets, net ​ $ 10,447,000 ​ $ 10,360,000 ​ In June 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas. The Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and eventually install modular cleanrooms in a manufacturing facility. $ 6.8 million was recorded in fixed assets - construction in progress on the balance sheet as of December 31, 2020. The completion of the facility’s construction occurred during December 2020 and the Company received its certificate of occupancy in January 2021, and as such was placed into service in January 2021 and became fully operational in July 2021. During January 2021, $ 4.0 million of the costs previously recorded as construction in progress were recorded to lab and manufacturing equipment and $ 2.8 million were recorded to leasehold improvements. During the third quarter of 2021, and in connection with the opening of the Company’s manufacturing facility in Houston, Texas, the Company incurred $ 0.6 million of costs pursuant to an agreement with a vendor to build and eventually install a second modular cleanroom. Such costs were recorded in fixed assets – construction in progress on the balance sheet as of September 30, 2021. Depreciation expense for the three months ended September 30, 2021 and 2020 was approximately $ 0.6 million and $ 0.1 million, respectively. Depreciation expense for the nine months ended September 30, 2021 and 2020 was approximately $ 1.6 million and $ 0.3 million, respectively. ​ NOTE 8: LEASES The Company leases manufacturing, research and administrative facilities under operating leases. The Company evaluates its contracts to determine if an arrangement is a lease at inception and classify it as a finance or operating lease. Currently, all of the Company’s leases are classified as operating leases. Leased assets and corresponding liabilities are recognized based on the present value of the lease payments over the lease term. The lease terms may include options to extend when it is reasonably certain that the Company will exercise that option. Topic ASC 842 requires the Company to recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. Right-of-use assets are recorded in other assets on the Company’s condensed consolidated balance sheets. Current and non-current lease liabilities are recorded in other accruals within current liabilities and other non-current liabilities, respectively, on its condensed consolidated balance sheets. Costs associated with operating leases are recognized on a straight-line basis within operating expenses over the term of the lease. As of September 30, 2021, the Company had total operating lease liabilities of approximately $ 12.0 million and right-of-use assets of approximately $ 10.1 million, which were included in the condensed consolidated balance sheet. Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees. Certain of the Company’s leases include renewal options and escalation clauses; renewal options have not been included in the calculation of the lease liabilities and right-of-use assets as the Company is not reasonably certain to exercise the options. Variable expenses generally represent the Company’s share of the landlord’s operating expenses. The Company does not act as a lessor or have any leases classified as financing leases. 9 Table of Contents ​ The following summarizes quantitative information about the Company’s operating leases for the three and nine months ended September 30, 2021 and 2020, respectively: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three Months Ended For the Nine Months Ended ​ ​ September 30, ​ September 30, ​ ​ 2021 2020 2021 2020 Operating lease expense summary: ​ ​ ​ ​ ​ ​ ​ ​ Operating lease expense ​ $ 425,000 ​ $ 375,000 ​ $ 1,275,000 ​ $ 533,000 ​ Short-term lease expense ​ — ​ — ​ — ​ 22,000 ​ Variable lease expense ​ 168,000 ​ 69,000 ​ 430,000 ​ 85,000 ​ Total ​ $ 593,000 ​ $ 444,000 ​ $ 1,705,000 ​ $ 640,000 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Nine Months Ended ​ ​ September 30, ​ ​ 2021 ​ 2020 Other information: ​ ​ Operating cash flows - operating leases ​ $ 763,000 ​ $ 362,000 ​ The weighted-average remaining lease term as of September 30, 2021 and December 31, 2020 was approximately 8.7 years and 9.3 years, respectively. The weighted-average discount rate used to determine the operating lease liability as of September 30, 2021 and December 31, 2020 was approximately 5.7 % and 5.7 %, respectively. Maturities of our operating leases, excluding short-term leases, are as follows: ​ ​ ​ ​ ​ Three months ended December 31, 2021 $ 314,000 Year ended December 31, 2022 ​ 1,278,000 Year ended December 31, 2023 ​ 1,542,000 Year ended December 31, 2024 ​ 1,826,000 Year ended December 31, 2025 ​ ​ 1,874,000 Thereafter ​ ​ 8,772,000 Total ​ ​ 15,606,000 Less present value discount ​ ( 3,594,000 ) Operating lease liabilities included in the Condensed Consolidated Balance Sheet at September 30, 2021 ​ $ 12,012,000 ​ ​ ​ NOTE 9: ACCOUNTS PAYABLE AND ACCRUED LIABILITIES Accounts payable and accrued liabilities consist of the following as of September 30, 2021 and December 31, 2020, respectively: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ ​ 2021 ​ 2020 Accounts payable ​ $ 2,326,000 ​ $ 2,935,000 Compensation and benefits ​ 1,468,000 ​ 1,694,000 Process development expenses ​ ​ 461,000 ​ ​ 277,000 Professional fees ​ 374,000 ​ 875,000 Technology license fees ​ 250,000 ​ 105,000 Arbitration settlement fees ​ 2,407,000 ​ — Other ​ 359,000 ​ 127,000 Total accounts payable and accrued liabilities ​ $ 7,645,000 ​ $ 6,013,000 ​ ​ 10 Table of Contents ​ NOTE 10: COMMITMENTS AND CONTINGENCIES ​ An arbitration proceeding was brought against the Company before the Financial Industry Regulatory Authority, Inc. (“FINRA”) by a broker seeking to be paid compensation for two financing transactions that occurred in 2018, a warrant conversion and a private placement brokered by another broker. The broker’s claims were based on a placement agent agreement for a private placement it brokered in 2017, under which it alleged it was entitled to compensation for the 2018 transactions. The FINRA panel found in favor of the broker and awarded the broker $ 2.4 million for compensation, interest and attorney fees. As of September 30, 2021, the Company recorded an accrual of $ 2.4 million in accrued liabilities on its condensed consolidated balance sheet and a $ 2.4 million charge to other expenses. On September 17, 2021, the broker filed a petition to confirm the FINRA arbitration award in the Supreme Court of New York for the County of New York. The Company removed the case to the United States District Court for the Southern District of New York on September 27, 2021. On October 22, 2021, the Company filed a motion in federal court to vacate the award. ​ NOTE 11: STOCKHOLDERS’ EQUITY Common Stock Transactions Exercise of Stock Options During the nine months ended September 30, 2021, certain outstanding options were exercised for 1,456 shares of common stock providing aggregate proceeds to the Company of approximately $ 3,100 . Board Compensation During the nine months ended September 30, 2021, the Company issued an aggregate of 63,290 shares of common stock to its non-employee directors. The fair value of the common stock of approximately $ 0.2 million was recognized as a component of stock-based compensation expense in general and administrative expenses. Underwritten Public Offering On March 11, 2021, the Company entered into an underwriting agreement with Piper Sandler & Co., as representative of the several underwriters, to issue and sell 28,572,000 shares of common stock of the Company in an underwritten public offering. The offering price to the public was $ 1.75 per share. In addition, the Company granted the underwriters an option to purchase, for a period of 30 days , up to an additional 4,285,800 shares of common stock, which such option was partially exercised with respect to 3,710,857 shares. An aggregate of 32,282,857 shares of the Company’s common stock was issued for net proceeds of $ 52.6 million. Share Purchase Warrants A summary of the Company’s share purchase warrants as of September 30, 2021 and changes during the period is presented below: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ ​ ​ ​ Number of ​ Weighted Average ​ Remaining Contractual ​ Total Intrinsic ​ Warrants Exercise Price Life (in years) Value Balance - January 1, 2021 20,830,000 ​ $ 4.47 ​ 2.60 ​ $ — Expired or cancelled ​ ( 1,000,000 ) ​ ​ 5.50 ​ — ​ — Balance - September 30, 2021 ​ 19,830,000 ​ $ 4.42 ​ 1.95 ​ $ — ​ ​ 11 Table of Contents ​ NOTE 12: STOCK-BASED COMPENSATION Stock Options 2021 Equity Incentive Awards On February 10, 2021, pursuant to the Company’s 2020 Equity Incentive Plan, the compensation committee of the Company’s board of directors approved a total of 740,000 options to purchase the Company’s common stock as equity-based incentive awards to the Company’s executive officers, other than the Chief Executive Officer. Each option award was granted with an exercise price of $ 3.29 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 10, 2021, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such executive officer’s continued service on the applicable vesting date. Additionally, on February 10, 2021, the compensation committee of the Company’s board of directors approved a total of 260,000 options to purchase the Company’s common stock to non-executive employees of the Company as equity-based incentive awards. Each option award was granted with an exercise price of $ 3.29 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 10, 2021, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such employee’s continued service on the applicable vesting date. On February 11, 2021, upon the recommendation of the compensation committee and pursuant to the Company’s 2020 Equity Incentive Plan, the Company’s board of directors approved a total of 430,000 options to purchase the Company’s common stock as (equity-based incentive awards to the Company’s Chief Executive Officer. The option award was granted with an exercise price of $ 3.06 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on February 11, 2021, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such Chief Executive Officer’s continued service on the applicable vesting date. The above awards were in addition to 90,000 stock option awards issued during the three months ended March 31, 2021 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $ 1.47 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on January 4, 2021, with 25 % of the option award vesting in one year and the remaining 75 % vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee's continued service on the applicable vesting date. Also, 100,000 stock option awards were issued during the three months ended June 30, 2021 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $ 2.19 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on April 1, 2021, with 25 % of the option award vesting in one year and the remaining 75 % vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee’s continued service on the applicable vesting date. Additionally, 130,000 stock option awards were issued during the three months ended September 30, 2021 to new employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of $ 2.88 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on July 1, 2021, with 25 % of the option award vesting in one year and the remaining 75 % vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee’s continued service on the applicable vesting date. During the nine months ended September 30, 2021, 1,456 stock options were exercised for net proceeds of $ 3,100 . A summary of the Company’s stock option activity for the nine months ended September 30, 2021 is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Remaining ​ ​ ​ ​ Weighted Average ​ Total Intrinsic ​ Contractual ​ Number of Shares Exercise Price Value Life (in years) Outstanding as of January 1, 2021 6,001,814 ​ $ 6.22 ​ $ — ​ 8.3 Granted 1,750,000 ​ ​ 3.05 ​ ​ — ​ 9.1 Exercised ​ ( 1,456 ) ​ ​ 2.12 ​ ​ — ​ — Canceled/Expired ( 206,312 ) ​ ​ 3.61 ​ ​ — ​ — Outstanding as of September 30, 2021 7,544,046 ​ $ 5.55 ​ $ 32,000 ​ 7.9 Options vested and exercisable 3,814,160 ​ $ 6.75 ​ $ 5,000 ​ 7.4 ​ 12 Table of Contents ​ 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 nine months ended September 30, 2021 was as follows: ​ ​ ​ ​ ​ ​ ​ ​ For the Nine Months Ended ​ ​ September 30, 2021 Exercise price ​ $ 3.05 ​ Expected term (years) ​ 6.0 ​ Expected stock price volatility ​ 95 % Risk-free rate of interest ​ 1 % Expected dividend rate ​ 0 % ​ The following table sets forth stock-based compensation expenses recorded during the respective periods: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three Months Ended For the Nine Months Ended ​ ​ September 30, September 30, ​ 2021 2020 2021 2020 Stock Compensation expenses: ​ ​ ​ ​ ​ Research and development ​ $ 727,000 ​ $ 636,000 ​ $ 2,132,000 ​ $ 1,945,000 General and administrative ​ 741,000 ​ 634,000 ​ 2,365,000 ​ 2,030,000 Total stock compensation expenses ​ $ 1,468,000 ​ $ 1,270,000 ​ $ 4,497,000 ​ $ 3,975,000 ​ As of September 30, 2021, the total stock-based compensation cost related to unvested awards not yet recognized was $ 9.9 million. The expected weighted average period compensation costs to be recognized was approximately 2.1 years. Future option grants will impact the compensation expense recognized. ​ NOTE 13: RELATED PARTY TRANSACTIONS The following table sets forth related party transaction expenses recorded for the three and nine months ended September 30, 2021 and 2020, respectively. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three Months Ended For the Nine Months Ended ​ ​ September 30, September 30, ​ 2021 2020 2021 2020 Baylor College of Medicine ​ $ 789,000 ​ $ 355,000 ​ $ 2,052,000 ​ $ 759,000 Bio-Techne Corporation ​ ​ 54,000 ​ ​ 50,000 ​ ​ 215,000 ​ ​ 105,000 Total Research and development ​ $ 843,000 $ 405,000 ​ $ 2,267,000 $ 864,000 ​ 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. 13 Table of Contents ​ Purchases from Bio-Techne Corporation . The Company is currently utilizing Bio-Techne Corporation and two of its brands for the purchases of reagents, primarily cytokines. Mr. David Eansor is a member of the Company’s board of directors and is serving as the President of the Protein Sciences Segment of Bio-Techne Corporation. ​ ​ ​ 14 Table of Contents ​