Financial Statements
−Removed: THERAPEUTICS, INC.
−Removed: CONSOLIDATED BALANCE SHEETS
+Added: MARKER THERAPEUTICS, INC.
+Added: CONDENSED CONSOLIDATED BALANCE SHEETS
Current assets:
5 unchanged sentences
Property, plant and equipment, net
+Added: Construction in progress
Right-of-use assets, net
12 unchanged sentences
Stockholders’ equity:
−Removed: Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
−Removed: Common stock, $0.001 par value, 150 million shares authorized, 46.5 million and 45.7 million shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively
+Added: Preferred stock - $ 0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively
+Added: Common stock, $ 0.001 par value, 150 million shares authorized, 46.6 million and 45.7 million shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively
Additional paid-in capital
4 unchanged sentences
Total liabilities and stockholders' equity
−Removed: See accompanying notes to these unaudited
−Removed: condensed consolidated financial statements.
+Added: See accompanying notes to these unaudited condensed consolidated financial statements.
MARKER THERAPEUTICS, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
+Added: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the Three Months Ended
+Added: For the Six Months Ended
+Added: Total revenues
Operating expenses:
3 unchanged sentences
Loss from operations
+Added: ( 6,357,556 )
+Added: ( 5,873,565 )
+Added: ( 13,001,169 )
+Added: ( 11,512,035 )
Other income (expense):
3 unchanged sentences
( 5,570,391 )
+Added: ( 12,827,343 )
+Added: ( 10,889,316 )
Net loss per share, basic and diluted
Weighted average number of common shares outstanding
−Removed: See accompanying notes
−Removed: to these unaudited condensed consolidated financial statements.
+Added: See accompanying notes to these unaudited condensed consolidated financial statements.
MARKER THERAPEUTICS, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: STOCKHOLDERS’
−Removed: Additional Paid-in
−Removed: Total Stockholders'
+Added: CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
+Added: For the Three Months Ended June 30, 2020
+Added: Additional Paid-
+Added: Stockholders’
+Added: Balance at April 1, 2020
+Added: ( 334,019,058 )
+Added: Stock-based compensation
+Added: ( 6,341,699 )
+Added: ( 6,341,699 )
+Added: Balance at June 30, 2020
+Added: ( 340,360,757 )
+Added: For the Six Months Ended June 30, 2020
+Added: Additional Paid-
+Added: Stockholders’
Balance at January 1, 2020
3 unchanged sentences
Stock-based compensation
−Removed: Balance at March 31, 2020
( 12,827,343 )
( 12,827,343 )
−Removed: Additional Paid-in
−Removed: Total Stockholders'
+Added: Balance at June 30, 2020
+Added: ( 340,360,757 )
+Added: For the Three Months Ended June 30, 2019
+Added: Additional Paid-
+Added: Stockholders’
+Added: Balance at April 1, 2019
+Added: ( 311,424,375 )
+Added: Stock-based compensation
+Added: ( 5,570,391 )
+Added: ( 5,570,391 )
+Added: Balance, June 30, 2019
+Added: ( 316,994,766 )
+Added: For the Six Months Ended June 30, 2019
+Added: Additional Paid-
+Added: Stockholders’
Balance at January 1, 2019
3 unchanged sentences
Stock-based compensation
−Removed: Balance, March 31, 2019
( 10,889,316 )
( 10,889,316 )
−Removed: See accompanying notes
−Removed: to these unaudited condensed consolidated financial statements.
+Added: Balance, June 30, 2019
+Added: ( 316,994,766 )
+Added: See accompanying notes to these unaudited condensed consolidated financial statements.
MARKER THERAPEUTICS, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: For the Three Months Ended
+Added: CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
+Added: For the Six Months Ended
Cash Flows from Operating Activities:
8 unchanged sentences
Prepaid expenses and deposits
+Added: ( 1,106,072 )
Interest receivable
2 unchanged sentences
Net cash used in operating activities
+Added: ( 8,401,428 )
+Added: ( 8,059,583 )
Cash Flows from Investing Activities:
Purchase of property and equipment
+Added: ( 1,299,193 )
+Added: Purchase of construction in progress
+Added: ( 2,629,141 )
Net cash used in investing activities
+Added: ( 3,928,334 )
Cash Flows from Financing Activities:
3 unchanged sentences
Net decrease in cash
+Added: ( 11,779,762 )
+Added: ( 8,301,842 )
Cash and cash equivalents at beginning of the period
Cash and cash equivalents at end of the period
−Removed: For the Three Months Ended
+Added: For the Six Months Ended
Supplemental schedule of non-cash financing activities:
Issuance of common stock as commitment fee for future financing
−Removed: See accompanying notes to these unaudited
−Removed: condensed consolidated financial statements.
+Added: Recognition of right-of-use assets and lease liability from new operating lease agreements
+Added: See accompanying notes to these unaudited condensed consolidated financial statements.
MARKER THERAPEUTICS, INC.
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: March 31, 2020
−Removed: Marker Therapeutics,
−Removed: Inc., a Delaware corporation (the “Company”
−Removed: or “we”), is a clinical-stage immuno-oncology company specializing
−Removed: in the development and commercialization of novel T cell-based immunotherapies and innovative peptide-based vaccines for the treatment
−Removed: of hematological malignancies and solid tumor indications.
−Removed: The Company’s MultiTAA T cell technology is based on the selective
−Removed: expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens, which are tumor targets, and kill
−Removed: tumor cells expressing those targets.
−Removed: These T cells are designed to recognize multiple tumor targets to produce broad spectrum
−Removed: anti-tumor activity.
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: June 30, 2020
+Added: NATURE OF OPERATIONS
+Added: 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.
+Added: 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.
+Added: These T cells are designed to recognize multiple tumor targets to produce broad spectrum anti-tumor activity.
BASIS OF PRESENTATION
−Removed: The accompanying unaudited condensed consolidated
−Removed: financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of
−Removed: America (“U.S.
−Removed: GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8
−Removed: of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its
−Removed: annual audited consolidated financial statements.
−Removed: In the opinion of management, the accompanying unaudited condensed consolidated
−Removed: financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation
−Removed: of such interim results.
−Removed: The results for the condensed consolidated
−Removed: statement of operations are not necessarily indicative of results to be expected for the year ending December 31, 2020 or for any
−Removed: future interim period.
−Removed: The condensed consolidated balance sheet at March 31, 2020 has been derived from unaudited financial statements;
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The results for the condensed consolidated statement of operations are not necessarily indicative of results to be expected for the year ending December 31, 2020 or for any future interim period.
+Added: The condensed consolidated balance sheet at June 30, 2020 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.
−Removed: The accompanying
−Removed: condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year
−Removed: ended December 31, 2019 and notes thereto included in the Company’s annual report on Form 10-K filed on March 12, 2020.
+Added: The accompanying condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2019 and notes thereto included in the Company’s annual report on Form 10-K filed on March 12, 2020.
LIQUIDITY AND FINANCIAL CONDITION
−Removed: As of March 31, 2020, the Company had cash
−Removed: and cash equivalents of approximately $40.3 million.
−Removed: The Company’s activities since inception have consisted principally
−Removed: of acquiring product and technology rights, raising capital, and performing research and development.
−Removed: Successful completion of
−Removed: the Company’s development programs and, ultimately, the attainment of profitable operations are dependent on future events,
−Removed: including, among other things, its ability to access potential markets;
+Added: As of June 30, 2020, the Company had cash and cash equivalents of approximately $ 32.1 million.
+Added: The Company’s activities since inception have consisted principally of acquiring product and technology rights, raising capital, and performing research and development.
+Added: 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;
−Removed: successfully progress its product candidates
−Removed: through preclinical and clinical development;
+Added: successfully progress its product candidates through preclinical and clinical development;
obtain regulatory approval of one or more of its product candidates;
−Removed: enforce intellectual property rights;
+Added: maintain and enforce intellectual property rights;
develop a customer base;
attract, retain and motivate qualified personnel;
−Removed: and develop strategic
−Removed: alliances and collaborations.
+Added: and develop strategic alliances and collaborations.
From inception, the Company has been funded by a combination of equity and debt financings.
−Removed: The Company expects to continue to incur
−Removed: substantial losses over the next several years during its development phase.
−Removed: To fully execute its business plan, the Company will
−Removed: need to complete certain research and development activities and clinical trials.
−Removed: Further, the Company’s product candidates
−Removed: will require regulatory approval prior to commercialization.
−Removed: These activities will span many years and require substantial expenditures
−Removed: to complete and may ultimately be unsuccessful.
+Added: The Company expects to continue to incur substantial losses over the next several years during its development phase.
+Added: To fully execute its business plan, the Company will need to complete certain research and development activities and clinical trials.
+Added: Further, the Company’s product candidates will require regulatory approval prior to commercialization.
+Added: 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.
−Removed: Company plans to meet its capital requirements primarily through issuances of debt and equity securities and, in the longer term,
−Removed: revenue from sales of its product candidates, if approved.
−Removed: Based on the Company’s revised clinical and research and
−Removed: development plans and its revised timing expectations related to the progress of its programs, and buildout of manufacturing and
−Removed: research facilities, and expansion of the Company’s corporate headquarters, discussed in Footnotes #6, #9 and #13 below,
−Removed: the Company expects that its cash and cash equivalents as of March 31, 2020 will enable the Company to fund its operating expenses
−Removed: and capital expenditure requirements into the latter half of the second quarter of 2021.
−Removed: The Company has based this estimate on
−Removed: assumptions that may prove to be wrong, and the Company could utilize its available capital resources sooner than it currently
−Removed: Furthermore, the Company’s operating plan may change, and it may need additional funds sooner than planned in order
−Removed: to meet operational needs and capital requirements for product development and commercialization.
−Removed: Because of the numerous risks
−Removed: and uncertainties associated with the development and commercialization of the Company’s product candidates and the extent
−Removed: to which the Company may enter into additional collaborations with third parties to participate in their development and commercialization,
−Removed: the Company is unable to estimate the amounts of increased capital outlays and operating expenditures associated with its current
−Removed: and anticipated clinical trials.
−Removed: The Company’s future funding requirements will depend on many factors, as it:
−Removed: initiates or continues
−Removed: clinical trials of its product candidates;
−Removed: continues the research
−Removed: and development of its product candidates and seeks to discover additional product candidates;
−Removed: seeks regulatory approvals
−Removed: for any product candidates that successfully complete clinical trials;
−Removed: maintains and enforces
−Removed: intellectual property rights;
−Removed: establishes sales, marketing
−Removed: and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive
−Removed: regulatory approval;
−Removed: evaluates strategic transactions
−Removed: the Company may undertake;
−Removed: enhances operational, financial and information management
−Removed: systems and hires additional personnel, including personnel to support development of product candidates and, if a product candidate
−Removed: is approved, commercialization efforts.
−Removed: In addition to the foregoing, based on
−Removed: the Company’s current assessment, the Company does not expect any material impact on its long-term liquidity due to the
−Removed: COVID-19 pandemic.
−Removed: However, the Company will continue to assess the effect of the pandemic on its operations, including its clinical
−Removed: The extent to which the COVID-19 pandemic will impact the Company’s business and operations will depend on future
−Removed: developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the
−Removed: disease, the duration of the outbreak, the duration and effect of business disruptions and the short-term effects and ultimate
−Removed: effectiveness of the travel restrictions, quarantines, social distancing requirements and business closures in the United States
−Removed: and other countries to contain and treat the disease.
−Removed: While the potential economic impact brought by, and the duration of, COVID-19
−Removed: may be difficult to assess or predict, a widespread pandemic could result in significant disruption of global financial markets,
−Removed: reducing the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity.
−Removed: In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect the Company’s
−Removed: business and the value of its common stock.
−Removed: ACCOUNTING POLICIES
+Added: 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.
+Added: Based on the Company’s revised clinical and research and development plans and its revised timing expectations related to the progress of its programs, and buildout of manufacturing and research facilities, and expansion of the Company’s corporate headquarters, discussed in Footnotes #7 and #10 below, the Company expects that its cash and cash equivalents as of June 30, 2020 will enable the Company to fund its operating expenses and capital expenditure requirements into the second quarter of 2021, as such these factors raise substantial doubt regarding the Company's ability to continue as a going concern.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The Company's future funding requirements will depend on many factors, as it:
+Added: ● initiates or continues clinical trials of its product candidates;
+Added: ● continues the research and development of its product candidates and seeks to discover additional product candidates;
+Added: ● seeks regulatory approvals for any product candidates that successfully complete clinical trials;
+Added: ● maintains and enforces intellectual property rights;
+Added: ● establishes sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive regulatory approval;
+Added: ● evaluates strategic transactions the Company may undertake;
+Added: ● 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.
+Added: These factors raise substantial doubt regarding the Company's ability to continue as a going concern.
+Added: The accompanying 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.
+Added: The condensed consolidated 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.
+Added: 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.
+Added: However, the Company will continue to assess the effect of the pandemic on its operations, including its clinical programs.
+Added: The extent to which the COVID-19 pandemic will impact the Company’s business and operations will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, the duration and effect of business disruptions and the short-term effects and ultimate effectiveness of the travel restrictions, quarantines, social distancing requirements and business closures in the United States and other countries to contain and treat the disease.
+Added: While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a widespread pandemic could result in significant disruption of global financial markets, reducing the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity.
+Added: In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect the Company’s business and the value of its common stock.
+Added: SIGNIFICANT ACCOUNTING POLICIES
+Added: Property and equipment - Construction in Progress
+Added: On June 26, 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas.
+Added: In connection with the manufacturing facility, the Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and eventually install modular cleanrooms in a manufacturing facility.
+Added: $ 2.6 million is recorded in fixed assets - construction in progress on the balance sheet as of June 30, 2020.
+Added: Upon completion of the facility's construction, all costs associated with the buildout will be recorded as manufacturing equipment and amortized over the estimated useful life of the facility.
New Accounting Standards
−Removed: From time to time, new accounting pronouncements
−Removed: are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts
−Removed: as of the specified effective date.
−Removed: Unless otherwise discussed, the Company does not believe that the impact of recently issued
−Removed: standards that are not yet effective will have a material impact on its financial position or results of operations upon adoption.
−Removed: Recent Accounting Standards Not Yet
+Added: 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.
+Added: 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.
+Added: Recent Accounting Standards Not Yet Adopted
In December 2019, the FASB issued ASU No.
−Removed: 2019-12, “Income Taxes (Topic 740):
−Removed: Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended
−Removed: to simplify various aspects related to accounting for income taxes.
−Removed: ASU 2019-12 removes certain exceptions to the general principles
−Removed: in Topic 740 and also clarifies and amends existing guidance to improve consistent application.
−Removed: This guidance is effective for
−Removed: fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted.
−Removed: The Company is currently evaluating the impact of this standard on its condensed consolidated financial statements and related
+Added: 2019-12, “Income Taxes (Topic 740):
+Added: Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes.
+Added: ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application.
+Added: This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted.
+Added: The Company is currently evaluating the impact of this standard on its condensed consolidated financial statements and related disclosures.
NET LOSS PER SHARE
−Removed: Basic loss per common share is computed
−Removed: by dividing net loss by the weighted average number of common shares outstanding during the reporting period.
−Removed: Diluted loss per
−Removed: common share is computed similarly to basic loss per common share except that it reflects the potential dilution that could occur
−Removed: if dilutive securities or other obligations to issue common stock were exercised or converted into common stock.
−Removed: The following table sets forth the computation
−Removed: of net loss per share:
+Added: Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the reporting period.
+Added: 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.
+Added: The following table sets forth the computation of net loss per share for the three and six months ended June 30, 2020 and 2019, respectively:
For the Three Months Ended
+Added: For the Six Months Ended
( 6,341,699 )
( 5,570,391 )
+Added: ( 12,827,343 )
+Added: ( 10,889,316 )
Weighted average common shares outstanding
1 unchanged sentence
Basic and Diluted
−Removed: The following securities, rounded to the
−Removed: nearest thousand, were not included in the diluted net loss per share calculation because their effect was anti-dilutive for the
−Removed: periods presented:
−Removed: For the Three Months Ended
+Added: 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:
+Added: For the Six Months Ended
Common stock options
2 unchanged sentences
Potentially dilutive securities
−Removed: The Company leases office space under agreements
−Removed: classified as operating leases that expire on various dates through 2022.
−Removed: All of the Company’s lease liabilities result from
−Removed: the lease of its corporate headquarters in Houston, Texas, which expires in 2021, and its Jacksonville, Florida office space, which
−Removed: expires in 2022.
−Removed: Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual
−Removed: value guarantees.
−Removed: Certain of the Company’s leases include renewal options and escalation clauses;
−Removed: renewal options have not
−Removed: been included in the calculation of the lease liabilities and right of use assets as the Company is not reasonably certain to exercise
−Removed: Variable expenses generally represent the Company’s share of the landlord’s operating expenses.
−Removed: does not act as a lessor or have any leases classified as financing leases.
−Removed: The Company excludes short-term leases
−Removed: having initial terms of 12 months or less from the new accounting guidance as an accounting policy election and recognizes rent
−Removed: expense on a straight-line basis over the lease term.
−Removed: The Company has two lease agreements, an office at the Florida Atlantic Research
−Removed: and Development Authority and laboratory space located at the Texas Medical Center in Houston, which are included in short-term
−Removed: lease expense below.
−Removed: At March 31, 2020, the Company had operating
−Removed: lease liabilities of approximately $0.4 million and right of use assets of approximately $0.4 million, which were included in the
−Removed: condensed consolidated balance sheet.
−Removed: The following summarizes quantitative information about the
−Removed: Company’s operating leases:
+Added: PROPERTY AND EQUIPMENT
+Added: Property and equipment consist of the following as of June 30, 2020 and December 31, 2019, respectively:
+Added: Estimated Useful Lives
+Added: Lab equipment
+Added: Manufacturing equipment
+Added: Computers, equipment and software
+Added: Office furniture
+Added: Leasehold improvements
+Added: Lesser of lease term or estimated useful life
+Added: accumulated depreciation
+Added: Construction in progress
+Added: Total fixed assets, net
+Added: Depreciation expense for the three months ended June 30, 2020 and 2019 was approximately $ 0.09 million and $ 0.03 million, respectively.
+Added: Depreciation expense for the six months ended June 30, 2020 and 2019 was approximately $ 0.1 million and $ 0.04 million, respectively.
+Added: On June 26, 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas.
+Added: In connection with the manufacturing facility, the Company has incurred costs pursuant to an agreement with a vendor to design, engineer, build and eventually install modular cleanrooms in a manufacturing facility.
+Added: $ 2.6 million is recorded in fixed assets - construction in progress on the balance sheet as of June 30, 2020.
+Added: Upon completion of the facility's construction, all costs associated with the buildout will be recorded as manufacturing equipment and amortized over the estimated useful life of the facility.
+Added: In connection with the research facility that the Company opened during the second quarter of 2020, the Company incurred approximately $ 1.0 million of costs acquiring necessary lab equipment to carry out its experiments.
+Added: On March 23, 2020, the Company entered into an agreement to expand its corporate headquarters in Houston, Texas, which is expected to commence in the third or fourth quarter of 2020.
+Added: The initial lease term is ten years with two five-year renewal options.
+Added: Fixed rent payments under the initial term are approximately $ 5.6 million.
+Added: Additionally, the Company is also responsible for its share of operating expenses.
+Added: On April 30, 2020, the Company entered into a lease for a research facility in Houston, Texas.
+Added: The lease term is 71 months .
+Added: Fixed rent payments under the initial term are approximately $ 1.1 million.
+Added: In the second quarter of 2020, the Company recorded right-of use assets and related operating lease liabilities of approximately $ 0.9 million as result of entering into the lease for our research facility.
+Added: On June 26, 2020, the Company entered into a lease for a manufacturing facility in Houston, Texas.
+Added: The initial lease term is ten years from the expected commencement date in the third quarter of 2020 with two five-year renewal options.
+Added: Fixed rent payments under the initial term are approximately $ 11.1 million.
+Added: Additionally, the Company is also responsible for its share of operating expenses.
+Added: In the second quarter of 2020, the Company recorded right-of use assets and related operating lease liabilities of approximately $8.3 million as result of entering into the lease for its manufacturing facility.
+Added: The Company also leases office space under agreements classified as operating leases that expire on various dates through 2022.
+Added: The Company has a remaining lease liability of $ 0.2 million and $ 0.2 million of the related right-of-use asset resulting from the lease of its corporate headquarters in Houston, Texas, which expires in 2021.
+Added: In addition, the Company has a remaining lease liability of $ 0.2 million and $ 0.2 million of the related right-of-use asset from the lease of its Jacksonville, Florida office space, which expires in 2022.
+Added: Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees.
+Added: Certain of the Company’s leases include renewal options and escalation clauses;
+Added: 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.
+Added: Variable expenses generally represent the Company’s share of the landlord’s operating expenses.
+Added: The Company does not act as a lessor or have any leases classified as financing leases.
+Added: The Company excludes short-term leases having initial terms of 12 months or less from the new accounting guidance as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term.
+Added: The Company has two lease agreements, an office at the Florida Atlantic Research and Development Authority and laboratory space located at the Texas Medical Center in Houston, which are included in short-term lease expense below.
+Added: At June 30, 2020, the Company had operating lease liabilities of approximately $ 9.5 million and right-of-use assets of approximately $ 9.5 million, which were included in the condensed consolidated balance sheet.
+Added: The following summarizes quantitative information about the Company’s operating leases for the three and six months ended June 30, 2020 and 2019, respectively:
For the Three Months Ended
+Added: For the Six Months Ended
Operating lease expense summary:
3 unchanged sentences
Other information:
−Removed: Right of use assets exchanged for new operating lease liabilities as of adoption date
−Removed: Weighted-average remaining lease term as of March 31, 2020 –
−Removed: operating leases
−Removed: Weighted-average discount rate as of adoption date –
−Removed: operating leases
−Removed: Maturities of the Company’s operating leases, excluding
−Removed: short-term leases, are as follows:
−Removed: Nine months ended December 31, 2020
+Added: Operating cash flows - operating leases
+Added: Weighted-average remaining lease term as of June 30, 2020 – operating leases
+Added: Weighted-average discount rate as of adoption date – operating leases
+Added: Maturities of the Company's operating leases, excluding short-term leases, are as follows:
+Added: Six months ended December 31, 2020
Year ended December 31, 2021
Year ended December 31, 2022
+Added: Year ended December 31, 2023
+Added: Year ended December 31, 2024
Less present value discount
−Removed: Operating lease liabilities included in the Condensed Consolidated Balance Sheet at March 31, 2020
−Removed: On March 23, 2020, the Company entered
−Removed: into an agreement to expand its corporate headquarters in Houston, Texas, which is expected to commence in the third quarter of
−Removed: The initial lease term is ten years with two five-year renewal options.
−Removed: Fixed rent payments under the initial term are approximately
−Removed: $5.6 million.
−Removed: Additionally, the Company is also responsible for its share of operating expenses.
−Removed: On March 30, 2020, the Company entered
−Removed: into a lease for a manufacturing facility in Houston, Texas.
−Removed: The lease is contingent upon the landlord’s successful acquisition
−Removed: of the property and is expected to commence in the second or third quarter of 2020.
−Removed: The initial lease term is ten years with two
−Removed: five-year renewal options.
−Removed: Fixed rent payments under the initial term are approximately $11.1 million.
−Removed: Additionally, the Company
−Removed: is also responsible for its share of operating expenses.
−Removed: PAYABLE AND ACCRUED LIABILITIES
−Removed: Accounts payable and accrued liabilities consist of the following
−Removed: as of March 31, 2020 and December 31, 2019, respectively:
+Added: ( 3,024,000 )
+Added: Operating lease liabilities included in the Condensed Consolidated Balance Sheet at June 30, 2020
+Added: ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
+Added: Accounts payable and accrued liabilities consist of the following as of June 30, 2020 and December 31, 2019, respectively:
Accounts payable
3 unchanged sentences
Total accounts payable and accrued liabilities
−Removed: WARRANT LIABILITY
−Removed: AND FAIR VALUE MEASUREMENTS
−Removed: During the three months ended March 31,
−Removed: 2020, all of the Company’s common stock purchase warrants previously treated as a liability expired.
−Removed: A summary of quantitative information with
−Removed: respect to valuation methodology and significant unobservable inputs used for the Company’s common stock purchase warrants
−Removed: that are categorized within Level 3 of the fair value hierarchy for the three months ended March 31, 2020 and 2019 is as follows:
+Added: WARRANT LIABILITY AND FAIR VALUE MEASUREMENTS
+Added: During the six months ended June 30, 2020, all of the Company's common stock purchase warrants previously treated as a liability expired.
+Added: A summary of quantitative information with respect to valuation methodology and significant unobservable inputs used for the Company’s common stock purchase warrants that are categorized within Level 3 of the fair value hierarchy for the six months ended June 30, 2020 and 2019 is as follows:
Weighted Average Inputs
−Removed: For the Three Months Ended
+Added: For the Six Months Ended
Exercise price
3 unchanged sentences
Dividend yield (per share)
−Removed: Financial Liabilities Measured at
−Removed: Fair Value on a Recurring Basis
−Removed: Financial liabilities measured at fair
−Removed: value on a recurring basis are summarized below and disclosed on the balance sheet under Warrant liability:
−Removed: Fair value measured at March 31, 2020
+Added: Financial Liabilities Measured at Fair Value on a Recurring Basis
+Added: Financial liabilities measured at fair value on a recurring basis are summarized below and disclosed on the balance sheet under Warrant liability:
+Added: Fair value measured at June 30, 2020
Quoted prices in active
3 unchanged sentences
Fair value at
−Removed: March 31, 2020
+Added: June 30, 2020
Warrant liability
7 unchanged sentences
Warrant liability
−Removed: The fair value accounting standards define
−Removed: fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
−Removed: market participants.
−Removed: As such, fair value is determined based upon assumptions that market participants would use in pricing an
−Removed: asset or liability.
+Added: The fair value accounting standards define fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants.
+Added: As such, fair value is determined based upon assumptions that market participants would use in pricing an asset or liability.
Fair value measurements are rated on a three-tier hierarchy as follows:
5 unchanged sentences
Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions.
−Removed: There were no transfers between Level 1,
−Removed: 2 or 3 during the three months ended March 31, 2020.
−Removed: The following table presents changes in
−Removed: Level 3 liabilities measured at fair value for the three months ended March 31, 2020:
−Removed: Balance –
−Removed: January 1, 2020
+Added: There were no transfers between Level 1, 2 or 3 during the six months ended June 30, 2020.
+Added: The following table presents changes in Level 3 liabilities measured at fair value for the six months ended June 30, 2020:
+Added: Balance - January 1, 2020
Change in fair value of warrant liability
−Removed: Balance –
−Removed: March 31, 2020
−Removed: AND CONTINGENCIES
−Removed: An arbitration proceeding was brought against
−Removed: the Company before the Financial Industry Regulatory Authority, Inc.
−Removed: by a broker seeking to be paid approximately $1 million as
−Removed: compensation for two 2018 transactions, a warrant conversion and a private placement brokered by another broker.
−Removed: The broker’s
−Removed: claims are based on a placement agent agreement for a private placement it brokered in 2017, under which it alleges it is entitled
−Removed: to compensation for the 2018 transactions.
−Removed: The Company believes it has defenses to all of the allegations and intends to vigorously
−Removed: defend itself in this matter.
−Removed: On March 26, 2020 the Company entered
−Removed: into an agreement with a vendor to design, engineer, build and eventually install modular cleanrooms in a manufacturing facility,
−Removed: which the Company expects to lease with a commencement date in the second or third quarter of 2020.
−Removed: The total fees for this project
−Removed: to be substantially completed by December 31, 2020 are estimated to be $6.0 million.
−Removed: STOCKHOLDERS’
+Added: Balance - June 30, 2020
+Added: COMMITMENTS AND CONTINGENCIES
+Added: An arbitration proceeding was brought against the Company before the Financial Industry Regulatory Authority, Inc.
+Added: by a broker seeking to be paid approximately $ 1 million as compensation for two 2018 transactions, a warrant conversion and a private placement brokered by another broker.
+Added: The broker’s claims are based on a placement agent agreement for a private placement it brokered in 2017, under which it alleges it is entitled to compensation for the 2018 transactions.
+Added: The Company believes it has defenses to all of the allegations and intends to vigorously defend itself in this matter.
+Added: As discussed in Footnotes #6 and #7, on March 26, 2020 the Company entered into an agreement with a vendor to design, engineer, build and eventually install modular cleanrooms in a manufacturing facility in Houston, Texas, which the Company expects to lease with a commencement date in the third quarter of 2020.
+Added: The total fees for this project to be substantially completed by December 31, 2020 are estimated to be $ 6.0 million.
+Added: As of June 30, 2020, the Company has recorded $ 2.6 million of construction in progress costs associated with the building of the cleanrooms.
+Added: STOCKHOLDERS’ EQUITY
Common Stock Transactions
Exercise of Stock Warrants
−Removed: During the three months ended March 31,
−Removed: 2020, certain outstanding warrants were exercised for 458,334 shares of common stock providing aggregate proceeds to the Company
−Removed: of approximately $0.6 million.
+Added: During the six months ended June 30, 2020, certain outstanding warrants were exercised for 458,334 shares of common stock providing aggregate proceeds to the Company of approximately $ 0.6 million.
+Added: Board Compensation
+Added: During the six months ended June 30, 2020, the Company issued an aggregate of 85,110 shares of common stock to its non-employee directors.
+Added: 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.
Aspire Capital
−Removed: On February 28, 2020, the Company entered
−Removed: into a common stock purchase agreement (the “Purchase Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”)
−Removed: which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed
−Removed: to purchase up to an aggregate of $30.0 million of shares of the Company’s common stock over the 30-month term of the purchase
−Removed: In consideration for entering into the purchase agreement, the Company issued to Aspire Capital 345,357 shares of the
−Removed: Company’s common stock as a commitment fee.
+Added: On February 28, 2020, the Company entered into a common stock purchase agreement (the “Purchase Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”) which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $ 30.0 million of shares of the Company’s common stock over the 30 -month term of the purchase agreement.
+Added: In consideration for entering into the purchase agreement, the Company issued to Aspire Capital 345,357 shares of the Company’s common stock as a commitment fee.
The Company recorded the commitment fee to additional paid in capital.
−Removed: March 31, 2020, Aspire Capital had not purchased any shares under the Purchase Agreement.
−Removed: The Company may request daily up to 0.1
−Removed: million shares to be purchased with a maximum purchase commitment of 9.2 million shares over the term of the arrangement.
−Removed: price will generally be 97% of the stock price on the date of purchase.
+Added: As of June 30, 2020, Aspire Capital had not purchased any shares under the Purchase Agreement.
+Added: The Company may request daily up to 0.1 million shares to be purchased with a maximum purchase commitment of 9.2 million shares over the term of the arrangement.
+Added: The purchase price will generally be 97% of the stock price on the date of purchase.
Share Purchase Warrants
−Removed: A summary of the Company’s share
−Removed: purchase warrants as of March 31, 2020 and changes during the period is presented below:
+Added: A summary of the Company’s share purchase warrants as of June 30, 2020 and changes during the period is presented below:
Weighted Average
7 unchanged sentences
Expired or cancelled
−Removed: Balance - March 31, 2020
+Added: Balance - June 30, 2020
STOCK-BASED COMPENSATION
Stock Options
−Removed: Award of 2019 Performance Bonuses and
−Removed: 2020 Equity Incentive Awards
−Removed: On March 10, 2020, upon the recommendation
−Removed: of the compensation committee and pursuant to the Company’s 2014 Omnibus Stock Ownership Plan, the Company’s board
−Removed: of directors approved a total of 1,170,000 options to purchase the Company’s common stock as (i) performance bonuses for
−Removed: 2019 performance and (ii) equity-based incentive awards to the Company’s executive officers.
−Removed: Each option award was granted
−Removed: with an exercise price of $2.12 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on
−Removed: March 10, 2020, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such executive
−Removed: officer’s continued service on the applicable vesting date.
−Removed: Additionally, on March 10, 2020, the Company issued 111,000 options
−Removed: to purchase the Company’s common stock to other employees of the Company as equity-based incentive awards.
−Removed: Each option award
−Removed: was granted with an exercise price of $2.12 per share, the closing price of the Company’s common stock on the Nasdaq Global
−Removed: Market on March 10, 2020, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such
−Removed: executive officer’s continued service on the applicable vesting date.
−Removed: The above awards were in addition to stock option awards issued
−Removed: during the three months ended March 31, 2020 to new employees upon their commencement of employment with the Company.
−Removed: A summary of the Company’s stock option activity is as
−Removed: Number of Shares
−Removed: Weighted Average Exercise Price
−Removed: Total Intrinsic Value
−Removed: Weighted Average Remaining Contractual Life
+Added: Award of 2019 Performance Bonuses and 2020 Equity Incentive Awards
+Added: On March 10, 2020, upon the recommendation of the compensation committee and pursuant to the Company’s 2014 Omnibus Stock Ownership Plan, the Company’s board of directors approved a total of 1,170,000 options to purchase the Company’s common stock as (i) performance bonuses for 2019 performance and (ii) equity-based incentive awards to the Company’s executive officers.
+Added: Each option award was granted with an exercise price of $ 2.12 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on March 10, 2020, 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.
+Added: Additionally, on March 10, 2020, the Company issued 111,000 options to purchase the Company’s common stock to other employees of the Company as equity-based incentive awards.
+Added: Each option award was granted with an exercise price of $ 2.12 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on March 10, 2020, 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.
+Added: The above awards were in addition to stock option awards issued during the six months ended June 30, 2020 to new employees upon their commencement of employment with the Company.
+Added: A summary of the Company’s stock option activity is as follows:
+Added: Total Intrinsic
+Added: Exercise Price
+Added: Life (in years)
Outstanding as of January 1, 2020
−Removed: Outstanding as of March 31, 2020
+Added: Outstanding as of June 30, 2020
Options vested and exercisable
−Removed: The Black-Scholes option pricing model
−Removed: is used to estimate the fair value of stock options granted under the Company’s share-based compensation plans.
−Removed: average assumptions used in calculating the fair values of stock options that were granted during the three months ended March
−Removed: 31, 2020 was as follows:
−Removed: For the Three Months Ended
−Removed: March 31, 2020
+Added: 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.
+Added: The weighted average assumptions used in calculating the fair values of stock options that were granted during the six months ended June 30, 2020 was as follows:
+Added: For the Six Months Ended
+Added: June 30, 2020
Exercise price
3 unchanged sentences
Expected dividend rate
−Removed: The following table sets forth stock-based
−Removed: compensation expenses recorded during the respective periods:
+Added: The following table sets forth stock-based compensation expenses recorded during the respective periods:
For the Three Months Ended
+Added: For the Six Months Ended
Stock Compensation expenses:
2 unchanged sentences
Total stock compensation expenses
−Removed: At March 31, 2020, the total stock-based
−Removed: compensation cost related to unvested awards not yet recognized was $15.9 million.
−Removed: The expected weighted average period compensation
−Removed: costs to be recognized was approximately 3.0 years.
+Added: At June 30, 2020, the total stock-based compensation cost related to unvested awards not yet recognized was $ 12.9 million.
+Added: The expected weighted average period compensation costs to be recognized was approximately 3.0 years.
Future option grants will impact the compensation expense recognized.
+Added: During the six months ended June 30, 2020, the Company received $ 0.5 million of a grant awarded to the Mayo Foundation from the U.S.
+Added: Department of Defense to fund the Phase 2 clinical trial of TPIV100 for the treatment of HER2/neu breast cancer.
+Added: The portion of the grant the Company received compensated the Company for clinical supplies manufactured by the Company for the clinical trial.
+Added: In accordance with Accounting Standards Update No.
+Added: 2014-09, "Revenue from Contracts with Customers (Topic 606)"
+Added: issued by the Financial Accounting Standards Board, the Company recorded the $ 0.5 million of grant income as revenue.
+Added: The Company did not record any grant income during the six months ended June 30, 2019.
RELATED PARTY TRANSACTIONS
−Removed: The following table sets forth related
−Removed: party transaction expenses recorded during the respective periods:
+Added: The following table sets forth related party transaction expenses recorded for the three and six months ended June 30, 2020 and 2019, respectively.
For the Three Months Ended
+Added: For the Six Months Ended
Research and development
−Removed: Sponsored Research Agreements with
−Removed: The Baylor College of Medicine (“BCM”) .
−Removed: On November 16, 2018 and February 1, 2020, in furtherance of the BCM
−Removed: License Agreement and as contemplated by the terms thereof, the Company entered in Sponsored Research Agreements (“SRAs”)
−Removed: with BCM, which provided for the conduct of research for the Company by credentialed personnel at BCM’s Center for Cell and
−Removed: Gene Therapy.
−Removed: During the quarters ended March 31, 2020
−Removed: and 2019, the Company incurred approximately $35,000 and $7,500, respectively, of expenses to BCM under the two SRAs.
+Added: The detailed information for the table above is below.
+Added: Sponsored Research Agreements with The Baylor College of Medicine (“BCM”) .
+Added: On November 16, 2018 and February 1, 2020, in furtherance of the BCM License Agreement and as contemplated by the terms thereof, the Company entered in Sponsored Research Agreements (“SRAs”) with BCM, which provided for the conduct of research for the Company by credentialed personnel at BCM’s Center for Cell and Gene Therapy.
+Added: The following table sets forth related party transaction expenses recorded in connection with the SRAs for the three and six months ended June 30, 2020 and 2019, respectively.
+Added: For the Three Months Ended
+Added: For the Six Months Ended
+Added: Research and development
Clinical Supply Agreement with BCM .
−Removed: On September 9, 2019, in furtherance of the BCM License Agreement and as contemplated by the terms thereof, the Company entered
−Removed: in a Clinical Supply Agreement (“CSA”) with BCM, which provided for BCM to provide to the Company multi tumor antigen
−Removed: specific products.
−Removed: During the quarter ended March 31, 2020, the Company incurred
−Removed: approximately $200,000 of expenses to BCM under the CSA.
−Removed: Consulting Agreement with Dr.
−Removed: On October 19, 2018, after the closing of the Company’s merger, the Company entered into a consulting agreement
−Removed: Juan Vera, a member of the Company’s board of directors, to serve as the Company’s Chief Development Officer.
−Removed: On September 1, 2019, Dr.
−Removed: Vera became an employee of the Company and his consulting agreement was terminated.
−Removed: During the quarter ended March 31, 2019,
−Removed: the Company incurred approximately $81,000 of expenses under Dr.
−Removed: Vera’s consulting agreement.
−Removed: On April 30, 2020, the Company entered into a lease for a research
−Removed: facility in Houston, Texas.
−Removed: The lease term is 71 months.
−Removed: Fixed rent payments under the initial term are approximately $1.1 million.
−Removed: Additionally, the Company is also responsible for its share of operating expenses.
−Removed: Management’s Discussion
−Removed: and Analysis of Financial Condition and Results of Operations
−Removed: This Quarterly Report on Form 10-Q contains
−Removed: forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, that involve
−Removed: risks and uncertainties.
−Removed: All statements other than statements relating to historical matters including statements to the effect
−Removed: that we “believe”, “expect”, “anticipate”, “plan”, “target”, “intend”
−Removed: and similar expressions should be considered forward-looking statements.
−Removed: Our actual results could differ materially from those
−Removed: discussed in the forward-looking statements as a result of a number of important factors, including factors discussed in this section
−Removed: and elsewhere in this Quarterly Report on Form 10-Q, and the risks discussed in our other filings with the SEC.
−Removed: Such risks and
−Removed: uncertainties may be amplified by the COVID-19 pandemic and its potential impact on our business and the global economy.
−Removed: are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis, judgment,
−Removed: belief or expectation only as the date hereof.
−Removed: We assume no obligation to update these forward-looking statements to reflect events
−Removed: or circumstance that arise after the date hereof.
−Removed: As used in this quarterly report:
−Removed: the terms “we”, “us”, “our”, “Marker”
−Removed: and the “Company”
−Removed: Therapeutics, Inc.
−Removed: and its wholly owned subsidiaries, Marker Cell Therapy, Inc.
−Removed: and GeneMax Pharmaceuticals Inc.
−Removed: which wholly owns
−Removed: GeneMax Pharmaceuticals Canada Inc., unless the context otherwise requires;
−Removed: (ii) “SEC”
−Removed: refers to the Securities and
−Removed: Exchange Commission;
−Removed: (iii) “Securities Act”
−Removed: refers to the Securities Act of 1933, as amended;
−Removed: (iv) “Exchange
−Removed: refers to the Securities Exchange Act of 1934, as amended;
−Removed: and (v) all dollar amounts refer to United States dollars
−Removed: unless otherwise indicated.
−Removed: The following should be read in conjunction
−Removed: with our unaudited condensed consolidated interim financial statements and related notes for the three months ended March 31, 2020
−Removed: included in this Quarterly Report.
−Removed: Company Overview
−Removed: We are a clinical-stage immuno-oncology
−Removed: company specializing in the development and commercialization of novel T cell-based immunotherapies and innovative peptide-based
−Removed: vaccines for the treatment of hematological malignancies and solid tumor indications.
−Removed: We developed our lead product candidates
−Removed: from our MultiTAA-specific T cell technology, which is based on the selective expansion of non-engineered, tumor-specific T cells
−Removed: that recognize tumor associated antigens, or TAAs, which are tumor targets, and then kill tumor cells expressing those targets.
−Removed: These T cells are designed to recognize multiple tumor targets to produce broad spectrum anti-tumor activity.
−Removed: We are advancing
−Removed: two pipelines of product candidates as part of our MultiTAA-specific T cell program:
−Removed: the autologous T cells for the treatment of
−Removed: lymphoma, multiple myeloma, or MM, and selected solid tumors and the allogeneic T cells for the treatment of acute myeloid leukemia,
−Removed: or AML, and acute lymphoblastic leukemia, or ALL.
−Removed: Because we do not genetically engineer the MultiTAA-specific T cell therapies,
−Removed: we believe that our product candidates are easier and less expensive to manufacture, have lower toxicities than current engineered
−Removed: chimeric antigen receptor, or CAR-T, and T cell receptor-based therapies and may provide patients with meaningful clinical benefit.
−Removed: We are also developing innovative peptide-based immunotherapeutic vaccines for the treatment of metastatic solid tumors.
−Removed: We are pursuing post-transplant AML as
−Removed: the lead indication for our first company-sponsored MultiTAA-specific T cell program.
−Removed: The MultiTAA-specific T cell therapy has
−Removed: been well tolerated in an ongoing Phase 1/2 clinical trial conducted by our strategic partner Baylor College of Medicine, or BCM.
−Removed: As reported in March 2019, eleven of the thirteen patients in the adjuvant disease setting dosed with the MultiTAA-specific T cell
−Removed: therapy after receiving an allogeneic stem cell transplant survived, ranging from 6 weeks to 2.5 years post-infusion, with nine
−Removed: of these remaining patients in continuing complete remission, or CCR.
−Removed: Survival of the six patients with active disease ranged from
−Removed: 4 to 21 months, as compared to a historical survival rate of approximately 4.5 months for patients who receive the standard of
−Removed: care post-transplant.
−Removed: We submitted an investigational new drug,
−Removed: or IND, application to the United States Food and Drug Administration, or the FDA to initiate a Phase 2 clinical trial of MultiTAA-specific
−Removed: T cell therapy, which we refer to as MT-401, in post-allogeneic hematopoietic stem cell transplant patients with AML in both the
−Removed: adjuvant and active disease setting, which may become pivotal pending the results of the interim analysis.
−Removed: The dose administered
−Removed: in this multicenter trial is the current maximum tolerated dose from the ongoing Phase 1/2 trial.
−Removed: In the adjuvant setting, patients
−Removed: will be randomized to either MultiTAA-specific T cell therapy at approximately 90 days post-transplant versus standard of care
−Removed: observation, while the active disease patients will receive MT-401 following relapse post-transplant as part of a single-arm group.
−Removed: In February 2020, we announced that the FDA has permitted us to initiate our Phase 2 clinical trial beginning with a safety lead-in
−Removed: portion of the trial.
−Removed: We expect that we will be delayed in initiating this trial per previously communicated timelines due to the
−Removed: COVID-19 pandemic.
−Removed: See “—Clinical Program Updates.”
−Removed: In April 2020, the FDA granted orphan drug designation to
−Removed: MT-401 for the treatment of AML after receiving an allogenic stem cell transplant.
−Removed: We reported interim data for an ongoing
−Removed: Phase 1/2 clinical trial of the MultiTAA-specific T cell therapy for the treatment of pancreatic adenocarcinoma being conducted
−Removed: In this trial, we have observed a clinical benefit correlated with the post-infusion detection of tumor-reactive T cells
−Removed: in patient peripheral blood and within tumor biopsy samples in patients in the tumor-resection arm of the trial.
−Removed: These T cells
−Removed: exhibited activity against both targeted antigens and non-targeted TAAs, indicating induction of antigen spreading.
−Removed: have not observed any drug-related systemic toxicity or neurotoxicity in this trial.
−Removed: We are also evaluating the MultiTAA-specific T cell therapies
−Removed: in a Phase 2 clinical trial for the treatment of breast cancer and in Phase 1 clinical trials for the treatment of ALL, lymphoma,
−Removed: MM and sarcoma, all of which are being conducted by BCM.
−Removed: As of December 2019, the MultiTAA-specific T cell therapies have been
−Removed: generally well tolerated by all of the patients enrolled in clinical trials in hematological and solid tumor indications with no
−Removed: incidents of cytokine release syndrome or neurotoxicity, which are frequently associated with CAR-T therapies.
−Removed: Our ongoing clinical
−Removed: trials may be also affected by the COVID-19 pandemic.
−Removed: Based on our observations in clinical trials in AML, pancreatic cancer, lymphoma,
−Removed: ALL and MM, we believe that the MultiTAA-specific T cell therapies have the potential to mediate a meaningful anti-tumor effect,
−Removed: as well as significant in vivo expansion of T cells.
−Removed: We may initiate additional Phase 2 clinical trials investigating other indications
−Removed: in addition to our planned Phase 2 trial in post-transplant AML patients.
−Removed: Our clinical-stage pipeline, including
−Removed: clinical trials being conducted by BCM and other partners, is set forth below:
−Removed: Clinical Program Updates
−Removed: MT-401 for the Treatment of Post-Transplant AML
−Removed: In February 2020, we announced that the FDA lifted the clinical
−Removed: hold on the Phase 2 clinical trial investigating the safety and efficacy of MT-401 for the treatment of patients with AML post-transplant
−Removed: permitting us to initiate the trial with the safety lead-in portion that is expected to enroll approximately six patients.
−Removed: patients will be dosed with MT-401 manufactured using the legacy reagent used in the Phase 1 trial, and three patients will be
−Removed: dosed with MT-401 manufactured using a new reagent from an alternative supplier.
−Removed: We anticipate using this supplier for clinical
−Removed: and commercial manufacturing of MT-401.
−Removed: The FDA placed a partial clinical hold on the trial for the use of the MT-401 product manufactured
−Removed: using one of the reagents supplied by the alternative supplier until the final data and certificate of analysis for the reagent
−Removed: are reviewed and accepted by the FDA.
−Removed: As a result of the COVID-19 pandemic, we may be delayed in our ability to enroll the first
−Removed: three patients in the safety lead-in portion of the trial, but we continue to work to identify clinical trial sites.
−Removed: alternate supplier has notified us that they will also be delayed in providing the new reagent for MT-401, along with the final
−Removed: data and certificate of analysis required by the FDA to satisfy the requirements for lifting the partial hold.
−Removed: Accordingly, we
−Removed: expect that we will be delayed in initiating the Phase 2 trial per previously communicated timelines.
−Removed: Results of Operations
−Removed: In this discussion
−Removed: of our results of operations and financial condition, amounts, other than per-share amounts, have been rounded to the nearest thousand
−Removed: Comparison of the Three Months Ended March 31, 2020 and
−Removed: March 31, 2019
−Removed: The following table summarizes the results
−Removed: of our operations for the three months ended March 31, 2020 and 2019:
+Added: On September 9, 2019, in furtherance of the BCM License Agreement and as contemplated by the terms thereof, the Company entered in a Clinical Supply Agreement ("CSA") with BCM, which provided for BCM to provide to the Company multi tumor antigen specific products.
+Added: The following table sets forth related party transaction expenses recorded in connection with the CSA for the three and six months ended June 30, 2020 and 2019, respectively.
For the Three Months Ended
−Removed: Operating expenses:
+Added: For the Six Months Ended
Research and development
−Removed: General and administrative
−Removed: Total operating expenses
−Removed: Loss from operations
−Removed: Other income (expense):
−Removed: Change in fair value of warrant liabilities
−Removed: Interest income
−Removed: $ (6,486,000 )
−Removed: $ (5,319,000 )
−Removed: $ (1,168,000 )
−Removed: Net loss per share, basic and diluted
−Removed: Weighted average number of common shares outstanding
−Removed: Operating Expenses
−Removed: Operating expenses incurred
−Removed: during the three months ended March 31, 2020 were $6.6 million compared to $5.6 million during the three months ended March 31,
−Removed: Significant changes and
−Removed: expenditures in operating expenses are outlined as follows:
−Removed: Research and Development Expenses
−Removed: Research and development expenses increased
−Removed: by 35% to $3.8 million for the three months ended March 31, 2020, compared to $2.8 million for the three months ended March
−Removed: The increase of $1.0 million in 2020 was primarily attributable
−Removed: to the following:
−Removed: increase of $0.8 million in headcount-related expenses as we increased the number of research and development personnel,
−Removed: increase of $0.2 million in clinical consulting and professional expenses,
−Removed: increase of $0.1 million in research and
−Removed: development stock-based compensation expenses,
−Removed: increase of $0.7 million in process development expenses,
−Removed: decrease of $0.2 million in other expenses,
−Removed: decrease of $0.6 million in our peptide vaccine clinical trial expenses due to the stages of ongoing clinical trials and the decreased number of active patients in such trials.
−Removed: General and Administrative Expenses
−Removed: General and administrative expenses were $2.8 million for the
−Removed: three months ended March 31, 2020 and 2019.
−Removed: General and administrative expenses were comprised of the following
−Removed: changes year over year:
−Removed: decrease of $0.1 million in general and administrative stock-based compensation expenses,
−Removed: increase of $0.2 million in legal and professional fees, and
−Removed: decrease of $0.1 million in office-related expenses, insurance and other general and administrative expenses.
−Removed: Other Income (Expense)
−Removed: Change in Fair Value of Warrant Liabilities
−Removed: Change in fair
−Removed: value of warrant liabilities for the three months ended March 31, 2020 was $31,000 as compared to ($9,000) for the three months
−Removed: ended March 31, 2019.
−Removed: Interest Income
−Removed: Interest income was $0.1 million and $0.3
−Removed: million for the three months ended March 31, 2020 and 2019, respectively, and was attributable to interest income relating to funds
−Removed: that are held in U.S.
−Removed: Treasury notes and U.S.
−Removed: government agency-backed securities.
−Removed: We recorded a net loss of $6.5 million,
−Removed: or a net loss per share, basic and diluted of ($0.14), during the three months ended March 31, 2020, compared to a net loss of
−Removed: $5.3 million, or a net loss per share, basic and diluted of ($0.12), during the three months ended March 31, 2019.
−Removed: in our net loss during the three months ended March 31, 2020 compared to during the three months ended March 31, 2019 was due to
−Removed: the continued expansion of our research and development activities, increased expenses relating to current and future clinical
−Removed: trials, and the overall growth of our corporate infrastructure.
−Removed: We anticipate that we will continue to incur net losses in the
−Removed: future as we continue to invest in research and development activities, including clinical development of our MultiTAA T cell product
−Removed: Liquidity and Capital Resources
−Removed: We have not generated any revenues from
−Removed: product sales since inception.
−Removed: We have financed our operations primarily through public and private offerings of our debt and equity
−Removed: The following table sets forth our cash
−Removed: and cash equivalents and working capital as of March 31, 2020 and December 31, 2019:
−Removed: Cash and cash equivalents
−Removed: Working capital
−Removed: The following table summarizes our cash
−Removed: flows for the three months ended March 31, 2020 and 2019:
+Added: Workforce Grant Agreement with BCM .
+Added: On October 5, 2019, in furtherance of the BCM Clinical Supply Agreement and as contemplated by the terms thereof, the Company entered in a Workforce Grant Agreement ("WGA") with BCM, which provided for BCM to provide to the Company manpower costs of projects for manufacturing, quality control testing and validation run activities.
+Added: The following table sets forth related party transaction expenses recorded in connection with the WGA for the three and six months ended June 30, 2020 and 2019, respectively.
For the Three Months Ended
−Removed: Net Cash provided by (used in):
−Removed: Operating activities
−Removed: $ (4,099,000 )
−Removed: $ (3,880,000 )
−Removed: Investing activities
−Removed: Financing activities
−Removed: Net decrease in cash and cash equivalents
−Removed: $ (3,649,000 )
−Removed: $ (4,040,000 )
−Removed: Operating Activities
−Removed: Net cash used in operating activities during
−Removed: the three months ended March 31, 2020 was $4.1 million.
−Removed: The use of cash primarily related to our net loss of $6.5 million, in addition
−Removed: to the effect of changes in asset and liability accounts, including an increase in prepaid expenses and deposits of $0.2 million,
−Removed: an increase in accounts payable and accrued liabilities of $1.2 million, a decrease in interest receivable of $32,000 and a decrease
−Removed: in lease liabilities of $49,000.
−Removed: Net cash used in operating activities during the three months
−Removed: ended March 31, 2019 was $3.9 million.
−Removed: The use of cash primarily related to our net loss of $5.3 million, in addition to the effect
−Removed: of changes in asset and liability accounts, including an increase in prepaid expenses and deposits of $75,000, a decrease in accounts
−Removed: payable and accrued liabilities of $61,000, a decrease in lease liabilities of $45,000 and an increase in interest receivable of
−Removed: Investing Activities
−Removed: Net cash used in investing activities was
−Removed: $0.1 million and $0.2 million for the purchase of property and equipment during the three months ended March 31, 2020 and 2019,
−Removed: respectively.
−Removed: Financing Activities
−Removed: Net cash provided
−Removed: by financing activities was $550,000 during the three months ended March 31, 2020, due to the exercise of stock warrants.
−Removed: provided by financing activities was $63,000 during the three months ended March 31, 2019, due to the exercise of stock warrants
−Removed: and stock options.
−Removed: Future Capital Requirements
−Removed: To date, we have not generated any revenues
−Removed: from the commercial sale of approved drug products, and we do not expect to generate substantial revenue for at least the next
−Removed: several years.
−Removed: If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory
−Removed: approval, our ability to generate future revenue will be compromised.
−Removed: We do not know when, or if, we will generate any revenue
−Removed: from our product candidates, and we do not expect to generate significant revenue unless and until we obtain regulatory approval
−Removed: of, and commercialize, our product candidates.
−Removed: We expect our expenses to increase in connection with our ongoing activities, particularly
−Removed: as we continue the research and development of, continue or initiate clinical trials of and seek marketing approval for our product
−Removed: In addition, if we obtain approval for any of our product candidates, we expect to incur significant commercialization
−Removed: expenses related to sales, marketing, manufacturing and distribution.
−Removed: We anticipate that we will need substantial additional funding
−Removed: in connection with our continuing operations.
−Removed: If we are unable to raise capital when needed or on attractive terms, we could be
−Removed: forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
−Removed: As of March 31, 2020, we had working capital of $38.8 million,
−Removed: compared to working capital of $43.5 million as of December 31, 2019.
−Removed: Based on our revised clinical and research and development
−Removed: plans and our revised timing expectations related to the progress of our programs, and buildout of manufacturing and research facilities,
−Removed: and expansion of our corporate headquarters, we expect that our cash and cash equivalents as of March 31, 2020 will enable us to
−Removed: fund our operating expenses and capital expenditure requirements into the latter half of the second quarter of 2021.
−Removed: We have based
−Removed: this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently
−Removed: Furthermore, our operating plan may change, and we may need additional funds sooner than planned in order to meet operational
−Removed: needs and capital requirements for product development and commercialization.
−Removed: Because of the numerous risks and uncertainties associated
−Removed: with the development and commercialization of our product candidates and the extent to which we may enter into additional collaborations
−Removed: with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased
−Removed: capital outlays and operating expenditures associated with our current and anticipated clinical trials.
−Removed: Our future funding requirements
−Removed: will depend on many factors, as we:
−Removed: initiate or continue clinical
−Removed: trials of our product candidates;
−Removed: continue the research and development of our product
−Removed: candidates and seek to discover additional product candidates;seek regulatory approvals for our product candidates if they successfully
−Removed: complete clinical trials;
−Removed: establish sales, marketing
−Removed: and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive
−Removed: regulatory approval;
−Removed: evaluate strategic transactions
−Removed: we may undertake;
−Removed: enhance operational, financial
−Removed: and information management systems and hire additional personnel, including personnel to support development of our product candidates
−Removed: and, if a product candidate is approved, our commercialization efforts.
−Removed: Because all of our product candidates are
−Removed: in the early stages of clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the
−Removed: actual amounts necessary to successfully complete the development and commercialization of product candidates or whether, or when,
−Removed: we may achieve profitability.
−Removed: Until such time, if ever, that we can generate substantial product revenue, we expect to finance
−Removed: our cash needs through a combination of equity or debt financings and collaboration arrangements.
−Removed: During fiscal 2020, we have entered into
−Removed: agreements to buildout a manufacturing facility, to lease a research lab and to expand our corporate headquarters in Houston, Texas.
−Removed: A summary of these future capital requirements is below:
−Removed: On March 23, 2020, we entered into an agreement to expand our corporate headquarters in Houston,
−Removed: Texas, which is expected to commence in the third quarter of 2020.
−Removed: The initial lease term is ten years with two five-year renewal
−Removed: Fixed rent payments under the initial term are approximately $5.6 million.
−Removed: Additionally, we are also responsible for our
−Removed: share of operating expenses.
−Removed: On March 26, 2020 we entered into an agreement with a vendor to design, engineer, build and eventually
−Removed: install modular cleanrooms in a manufacturing facility, which we expect to lease with a commencement date in the second or third
−Removed: quarter of 2020.
−Removed: The total fees for this project to be substantially completed by December 31, 2020 are estimated to be $6.0 million.
−Removed: On March 30, 2020, we entered into a lease for a manufacturing facility in Houston, Texas.
−Removed: lease is contingent upon the landlord’s successful acquisition of the property and is expected to commence in the second
−Removed: or third quarter of 2020.
−Removed: The initial lease term is ten years with two five-year renewal options.
−Removed: Fixed rent payments under the
−Removed: initial term are approximately $11.1 million.
−Removed: Additionally, we are also responsible for our share of operating expenses.
−Removed: On April 30, 2020, we entered into a lease for a research facility in Houston, Texas.
−Removed: term is 71 months.
−Removed: Fixed rent payments under the initial term are approximately $1.1 million.
−Removed: Additionally, we are also responsible
−Removed: for our share of operating expenses.
−Removed: We plan to continue to fund our operations
−Removed: and capital funding needs through equity and/or debt financing.
−Removed: We may also consider new collaborations or selectively partner
−Removed: our technology.
−Removed: To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership
−Removed: interests of our stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect
−Removed: the rights of our existing stockholders’
−Removed: common stock.
−Removed: The incurrence of indebtedness would result in increased fixed payment
−Removed: obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations
−Removed: on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact
−Removed: our ability to conduct our business.
−Removed: If we raise additional funds through strategic partnerships and alliances and licensing arrangements
−Removed: with third parties, we may have to relinquish valuable rights to our technologies or product candidates or grant licenses on terms
−Removed: unfavorable to us.
−Removed: We may also be required to pay damages or have liabilities associated with litigation or other legal proceedings
−Removed: involving our company.
−Removed: In addition to the foregoing, based on
−Removed: our current assessment, we do not expect any material impact on our long-term liquidity due to the COVID-19 pandemic.
−Removed: we will continue to assess the effect of the pandemic on our operations.
−Removed: The extent to which the COVID-19 pandemic will impact
−Removed: our business and operations will depend on future developments that are highly uncertain and cannot be predicted with confidence,
−Removed: such as the ultimate geographic spread of the disease, the duration of the outbreak, the duration and effect of business disruptions
−Removed: and the short-term effects and ultimate effectiveness of the travel restrictions, quarantines, social distancing requirements and
−Removed: business closures in the United States and other countries to contain and treat the disease.
−Removed: While the potential economic impact
−Removed: brought by, and the duration of, COVID-19 may be difficult to assess or predict, a widespread pandemic could result in significant
−Removed: disruption of global financial markets, reducing our ability to access capital, which could in the future negatively affect our
−Removed: In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect our business
−Removed: and the value of our common stock.
−Removed: Aspire Common Stock Purchase Agreement
−Removed: In February 2020, we entered into a common
−Removed: stock purchase agreement, or the Purchase Agreement, with Aspire Capital Fund, LLC, or Aspire Capital, which provides that, upon
−Removed: the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate
−Removed: of $30.0 million of shares of our common stock over the 30-month term of the Purchase Agreement.
−Removed: As of March 31, 2020, Aspire Capital
−Removed: had not purchased any shares under the Purchase Agreement.
−Removed: In consideration for entering into the
−Removed: Purchase Agreement, concurrently with the execution of the Purchase Agreement, we issued to Aspire Capital 345,357 shares of our
−Removed: common stock, or the Commitment Shares.
−Removed: Under the Purchase Agreement, on any trading day selected by the Company, the Company has
−Removed: the right, in its sole discretion, to present Aspire Capital with a Purchase Notice directing Aspire Capital (as principal) to
−Removed: purchase up to 100,000 shares of our common stock per business day, up to $30.0 million of our common stock in the aggregate at
−Removed: a Purchase Price equal to the lesser of:
−Removed: the lowest sale price of our common stock on the purchase date;
−Removed: the arithmetic average of the three lowest closing sale prices for our common stock during the
−Removed: ten consecutive trading days ending on the trading day immediately preceding the purchase date.
−Removed: We and Aspire Capital also may mutually
−Removed: agree to increase the number of shares that may be sold to as much as an additional 2,000,000 shares per business day.
−Removed: In addition, on any date on which we submit
−Removed: a Purchase Notice to Aspire Capital in an amount equal to at least 100,000 shares, we also have the right, in our sole discretion,
−Removed: to present Aspire Capital with a volume-weighted average price purchase notice, or a VWAP Purchase Notice, directing Aspire Capital
−Removed: to purchase an amount of stock equal to up to 30% of the aggregate shares of our common stock traded on its principal market on
−Removed: the next trading day, which we refer to as the VWAP Purchase Date, subject to a maximum number of shares we may determine.
−Removed: purchase price per share pursuant to such VWAP Purchase Notice is generally 97% of the volume-weighted average price for our common
−Removed: stock traded on its principal market on the VWAP.
−Removed: We may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire
−Removed: Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed.
−Removed: The Purchase Agreement provides that we
−Removed: and Aspire Capital shall not effect any sales under the Purchase Agreement on any purchase date where the closing sale price of
−Removed: our common stock is less than $0.25.
−Removed: There are no trading volume requirements or restrictions under the Purchase Agreement, and
−Removed: we will control the timing and amount of sales of our common stock to Aspire Capital.
−Removed: Aspire Capital has no right to require any
−Removed: sales by us but is obligated to make purchases from us as directed by us on future fundings, rights of first refusal, participation
−Removed: rights, penalties or liquidated damages in the Purchase Agreement.
−Removed: The Purchase Agreement may be terminated by us at any time,
−Removed: at its discretion, without any cost to us.
−Removed: Aspire Capital has agreed that neither it nor any of its agents, representatives and
−Removed: affiliates shall engage in any direct or indirect short-selling or hedging of our common stock during any time prior to the termination
−Removed: of the Purchase Agreement.
−Removed: We expect to use any proceeds under the Purchase Agreement for working capital and general corporate
−Removed: The Purchase Agreement provides that the
−Removed: number of shares that may be sold pursuant to the Purchase Agreement will be limited to 9,232,814 shares, including the Commitment
−Removed: Shares, or the Exchange Cap, which represents 19.99% of our outstanding shares of common stock as of the date of the Purchase Agreement,
−Removed: unless stockholder approval is obtained to issue more than 19.99%.
−Removed: This limitation will not apply if, at any time the Exchange
−Removed: Cap is reached and at all times thereafter, the average price paid for all shares issued under the Purchase Agreement is equal
−Removed: to or greater than $2.41, which was the closing price of our shares on The Nasdaq Global Market immediately preceding the execution
−Removed: of the Purchase Agreement.
−Removed: We are not required or permitted to issue any shares of common stock under the Purchase Agreement if
−Removed: such issuance would breach our obligations under the rules or regulations of The Nasdaq Global Market.
−Removed: Critical Accounting Policies
−Removed: The condensed consolidated financial statements
−Removed: are prepared in conformity with U.S.
−Removed: GAAP, which require the use of estimates, judgments and assumptions that affect the reported
−Removed: amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and the reported
−Removed: amounts of expenses in the periods presented.
−Removed: We believe that the accounting estimates employed are appropriate and resulting
−Removed: balances are reasonable;
−Removed: however, due to inherent uncertainties in making estimates, actual results could differ from the original
−Removed: estimates, requiring adjustments to these balances in future periods.
−Removed: The critical accounting estimates that affect the consolidated
−Removed: financial statements and the judgments and assumptions used are consistent with those described under Part II, Item 7 of our Annual
−Removed: Report on Form 10-K for the year ended December 31, 2019.
−Removed: Off-Balance Sheet Arrangements
−Removed: We have not entered into any off-balance
−Removed: sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes of
−Removed: financial condition, revenues, expenses, results of operations, liquidity, capital expenditures or capital resources that are material
−Removed: to investors.
−Removed: Quantitative and Qualitative Disclosures About Market Risk
−Removed: We are a smaller reporting company as defined
−Removed: by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
+Added: For the Six Months Ended
+Added: Research and development
+Added: Purchases from Bio-Techne Corporation .
+Added: The Company is currently utilizing Bio-Techne Corporation and one of its brands for the purchases of reagents, primarily cytokines.
+Added: 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.
+Added: The following table sets forth related party transaction expenses recorded in connection with Bio-Techne Corporation for the three and six months ended June 30, 2020 and 2019, respectively.
+Added: For the Three Months Ended
+Added: For the Six Months Ended
+Added: Research and development
+Added: Consulting Agreement with Dr.
+Added: On October 19, 2018, after the closing of the Company’s merger, the Company entered into a consulting agreement with Dr.
+Added: Juan Vera, a member of the Company’s board of directors, to serve as the Company’s Chief Development Officer.
+Added: On September 1, 2019, Dr.
+Added: Vera became an employee of the Company and his consulting agreement was terminated.
+Added: During the three and six months ended June 30, 2019, the Company incurred approximately $ 88,000 and $ 175,000 , respectively, of expenses under Dr.
+Added: Vera’s consulting agreement.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.