41 unchanged sentences
  All schedules are omitted because they are inapplicable or not required or the required information is shown in the financial statements or notes thereto.
−Removed: EXHIBIT INDEX
+Added: EXHIBIT INDEX 
Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc.
15 unchanged sentences
Form of Placement Agent Warrant Agreement issued in February 2020 offering (incorporated by reference to Exhibit 4.2 of the Form 8-K filed February 6, 2020)
−Removed: Description of Registrant's Securities 
+Added: Description of Registrant's Securities (incorporated by reference to Exhibit 4.10 of the Form 10-K filed March 24, 2022)
Moleculin Biotech, Inc.
9 unchanged sentences
1 to the Patent and Technology License Agreement dated April 2, 2012 by and between The Board of Regents of the University of Texas System and IntertechBio Corporation (incorporated by reference to exhibit 10.6 of the Form S-1/A filed March 21, 2016)
−Removed: Patent and Technology Development and License Agreement June 28, 2012 by and between Annamed, Inc.
−Removed: and Dermin Sp.
−Removed: z.o.o (incorporated by reference to exhibit 10.7 of the Form S-1/A filed April 15, 2016)
−Removed: Patent and Technology Development and License Agreement dated April 15, 2011 by and between IntertechBio Corporation and Dermin Sp.
−Removed: z.o.o (incorporated by reference to exhibit 10.8 of the Form S-1/A filed March 21, 2016)
−Removed: Patent and Technology Development and License Agreement dated October 27, 2010 by and between Moleculin, LLC and Dermin Sp.
−Removed: z.o.o (incorporated by reference to exhibit 10.9 of the Form S-1/A filed March 21, 2016)
Rights Transfer Agreement dated between Moleculin Biotech, Inc.
5 unchanged sentences
(incorporated by reference to exhibit 10.13 of the Form S-1/A filed April 15, 2016)
+Added: 10.10 **
Employment Agreement between Moleculin Biotech, Inc.
1 unchanged sentence
Foster dated August 19, 2016 (incorporated by reference to Exhibit 10.1 of the Form 8-K filed August 25, 2016)
+Added: 10.11 **
Executive Employment Agreement between Moleculin Biotech, Inc.
and Walter Klemp dated October 13, 2016 (incorporated by reference to Exhibit 10.1 of the Form 8-K filed October 13, 2016)
−Removed: Development Collaboration Agreement between Moleculin Biotech, Inc.
−Removed: and Dermin Sp.
−Removed: dated September 30, 2016 (incorporated by reference to Exhibit 10.4 of the Form 10-Q filed November 21, 2016)
Lease Agreement for 5300 Memorial (incorporated by reference to Exhibit 10.1 of the Form 10-Q filed May 14, 2018)
3 unchanged sentences
(incorporated by reference to Exhibit 10.2 of the Form 10-Q filed May 14, 2018)
−Removed: Sublicense Agreement dated as of February 19, 2019 entered into between the Company and WPD Pharmaceuticals.
−Removed: (incorporated by reference to Exhibit 10.21 of the Form 10-K filed February 21, 2019)
Sublicense Agreement dated as of February 19, 2019 entered into between the Company and Animal Life Sciences, LLC (incorporated by reference to Exhibit 10.22 of the Form 10-K filed February 21, 2019) 
4 unchanged sentences
Scientific Advisory Board Agreement, dated February 28, 2020, entered into between the Company and Waldemar Priebe, PhD (incorporated by reference to Exhibit 10.26 of the Form 10-K filed March 19, 2020)   
−Removed: Amended and Restated Sublicense Agreement entered into between the Company and WPD Pharmaceuticals dated December 20, 2021 (incorporated by reference to Exhibit 10.1 of the Form 8-K filed December 27, 2021)
−Removed: Assignment Consent Letter by and between WPD Pharmaceuticals Sp.
−Removed: z o.o and LPC Enterprises, LLC and Moleculin Biotech, Inc.
−Removed: (incorporated by reference to Exhibit 10.2 of the Form 8-K filed December 27, 2021)
−Removed: At Market Issuance Sales Agreement, dated June 25, 2021, by and among the Company and Oppenheimer & Co.
−Removed: (incorporated by reference to Exhibit 1.1 of the Form 8-K filed June 25, 2021)
Purchase Agreement dated June 25, 2021 by and between Moleculin Biotech, Inc.
11 unchanged sentences
Patent And Technology License Agreement dated June 29, 2017 by and between The Board of Regents of The University Of Texas System on behalf of The University Of Texas M.
−Removed: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: Anderson Cancer Center and Moleculin Biotech, Inc. (incorporated by reference to Exhibit 10.30 of the Form 10-K filed March 24, 2022)
Amendment No.
1 to the Patent And Technology License Agreement dated June 29, 2017 by and between The Board of Regents of The University Of Texas System on behalf of The University Of Texas M.
−Removed: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: Anderson Cancer Center and Moleculin Biotech, Inc. (incorporated by reference to Exhibit 10.31 of the Form 10-K filed March 24, 2022)
Patent And Technology License Agreement dated December 2, 2021 by and between The Board of Regents of The University Of Texas System on behalf of The University Of Texas M.
−Removed: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: Anderson Cancer Center and Moleculin Biotech, Inc. (incorporated by reference to Exhibit 10.32 of the Form 10-K filed March 24, 2022)
Patent And Technology License Agreement dated December 3, 2021 by and between The Board of Regents of The University Of Texas System on behalf of The University Of Texas M.
−Removed: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: Anderson Cancer Center and Moleculin Biotech, Inc. (incorporated by reference to Exhibit 10.33 of the Form 10-K filed March 24, 2022)
Patent And Technology License Agreement dated February 3, 2022 by and between The Board of Regents of The University Of Texas System on behalf of The University Of Texas M.
+Added: Anderson Cancer Center and Moleculin Biotech, Inc. (incorporated by reference to Exhibit 10.34 of the Form 10-K filed March 24, 2022)
+Added: 10.27* +
+Added: Patent and Technology License Agreement dated October 21, 2022 by and between The Board of The University Of Texas System on behalf of The University Of Texas M.D.
Anderson Cancer Center and Moleculin Biotech, Inc.
−Removed: Subsidiaries of the Registrant
+Added: Subsidiaries of the Registrant  
Consent of Grant Thornton, LLP
48 unchanged sentences
Report of Independent Registered Public Accounting Firm (PCAOB ID Number 248 )
−Removed: Consolidated Balance Sheets as of December 31, 2021 and 2020
−Removed: Consolidated Statements of Operations and Comprehensive Loss for the Years ended December 31, 2021 and 2020
−Removed: Consolidated Statements of Cash Flows for the Years ended December 31, 2021 and 2020
−Removed: Consolidated Statements of Stockholders' Equity for the Years ended December 31, 2021 and 2020
+Added: Consolidated Balance Sheets as of December 31, 2022 and 2021
+Added: Consolidated Statements of Operations and Comprehensive Loss for the Years ended December 31, 2022 and 2021
+Added: Consolidated Statements of Cash Flows for the Years ended December 31, 2022 and 2021
+Added: Consolidated Statements of Stockholders' Equity for the Years ended December 31, 2022 and 2021
Notes to Consolidated Financial Statements
5 unchanged sentences
(a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, stockholders’
−Removed: equity, and cash flows for each of the two years in the period ended December 31, 2021, and the related notes  (collectively referred to as the “financial statements”).
+Added: equity, and cash flows for each of the two years in the period ended December 31, 2022, and the related notes (collectively referred to as the “financial statements”).
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
26 unchanged sentences
Cash and cash equivalents
−Removed: $ 70,903  
−Removed: $ 15,173  
Prepaid expenses and other current assets
Total current assets
−Removed: 72,497  
−Removed: 17,198  
Furniture and equipment, net of accumulated depreciation of $769 and $638, respectively
Intangible assets
−Removed: 11,148  
−Removed: 11,148  
Operating lease right-of-use asset
−Removed: $ 84,090  
−Removed: $ 29,031  
Liabilities and Stockholders' Equity
1 unchanged sentence
Accounts payable
−Removed: $ 1,364  
−Removed: $ 1,129  
Accrued expenses and other current liabilities
3 unchanged sentences
Total Liabilities
−Removed: 11,271  
Commitments and contingencies (Note 8)
5 unchanged sentences
Additional paid-in capital
−Removed: 151,733  
−Removed: 74,671  
−Removed: Subscription receivable
Accumulated other comprehensive income
Accumulated deficit
−Removed: ( 72,810 )  
Total stockholders' equity
−Removed: 78,993  
−Removed: 17,760  
Total liabilities and stockholders' equity
−Removed: $ 84,090  
−Removed: $ 29,031  
See accompanying notes to these consolidated financial statements.
5 unchanged sentences
Research and development
−Removed: 14,418  
−Removed: 12,757  
General and administrative
1 unchanged sentence
Total operating expenses
−Removed: 22,968  
−Removed: 19,742  
Loss from operations
−Removed: ( 22,968 )  
Other income:
2 unchanged sentences
Interest income, net
−Removed: $ ( 15,894 )  
Net loss per common share - basic and diluted
−Removed: $ ( 0.59 )  
Weighted average common shares outstanding, basic and diluted
−Removed: 26,875,927  
−Removed: 9,845,685  
Comprehensive loss:
−Removed: $ ( 15,894 )  
Other comprehensive (loss) income:
Foreign currency translation
−Removed: ( 24 )  
Comprehensive loss
−Removed: $ ( 15,918 )  
See accompanying notes to these consolidated financial statements.
4 unchanged sentences
Cash flows from operating activities:
−Removed: $ ( 15,894 )  
Adjustments to reconcile net loss to net cash used in operating activities:
1 unchanged sentence
Stock-based compensation
−Removed: Loss from sale of fixed assets
Change in fair value of warrant liability
−Removed: ( 6,728 )  
Operating lease, net
4 unchanged sentences
Net cash used in operating activities
−Removed: ( 18,951 )  
Cash flows from investing activities:
Purchase of fixed assets
−Removed: ( 19 )  
−Removed: Proceeds from sale of fixed assets
Net cash used in investing activities
−Removed: ( 19 )  
Cash flows from financing activities:
1 unchanged sentence
Payment of tax liability for vested restricted stock units
−Removed: ( 23 )  
Proceeds from sale of common stock, net of issuance costs
−Removed: 74,684  
−Removed: 22,561  
−Removed: Net cash provided by financing activities
−Removed: 74,724  
−Removed: 22,549  
+Added: Net cash provided by (used in) financing activities
Effect of exchange rate changes on cash and cash equivalents
−Removed: ( 24 )  
Net change in cash and cash equivalents
−Removed: 55,730  
Cash and cash equivalents, at beginning of year
−Removed: 15,173  
−Removed: 10,735  
Cash and cash equivalents, at end of year
−Removed: $ 70,903  
−Removed: $ 15,173  
−Removed: Supplemental disclosures of cash flow information:
−Removed: Cash paid for interest
−Removed: Cash paid for taxes
−Removed: Non-cash investing and financing activities:
−Removed: Purchases of property and equipment in accounts payable and accrued liabilities
−Removed: Subscription receivable
See accompanying notes to these consolidated financial statements.
15 unchanged sentences
$ ( 56,916 )  
−Removed: Issued for cash - sale of common stock in February 2020, net of issuance costs of $ 709
$ ( 129 )  
−Removed: Issued for cash - sale of common stock pursuant to the 2019 ATM Agreement, net of issuance costs of $ 471
$ 17,760  
+Added: Issued for cash - sale of common stock in Q1 2021, net of issuance costs of $ 6,159
16,883,420  
( 26,966 )  
−Removed: Issued for cash - sale of common stock pursuant to the 2020 ATM Agreement, net of issuance costs of $ 108
74,537  
−Removed: Issued for cash - sale of common stock to Lincoln Park, net of issuance costs of $ 575
74,684  
−Removed: Subscription of common stock in connection with the 2020 ATM Agreement, net of commissions
+Added: Reverse stock split
14,285  
( 60 )  
+Added: Issuance of common stock with equity purchase agreement, net of issuance costs of $ 403
+Added: 107,788  
+Added: Issuance of common stock in connection with Consulting Agreement
Warrants exercised
+Added: 10,000  
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)
21,125  
+Added: ( 23 )  
Stock based compensation
2 unchanged sentences
Cumulative translation adjustment
−Removed: Balance at December 31, 2020
( 24 )  
−Removed: 26,966  
−Removed: $ 74,671  
−Removed: $ ( 56,916 )  
−Removed: $ ( 129 )  
−Removed: $ 17,760  
−Removed: Issued for cash - sale of common stock in Q1 2021, net of issuance costs of $ 6,159
−Removed: 16,883,420  
−Removed: ( 26,966 )  
−Removed: 74,537  
−Removed: 74,684  
−Removed: Reverse stock split
+Added: Balance at December 31, 2021
28,578,338  
$ 151,733  
−Removed: Issuance of common stock with equity purchase agreement, net of issuance costs of $ 403
$ ( 72,810 )  
−Removed: Issuance of common stock in connection with Consulting Agreement
−Removed: Warrants exercised
$ 78,993  
20 unchanged sentences
are used herein to refer to Moleculin Biotech, Inc.
−Removed: MBI is a clinical-stage pharmaceutical company, organized as a Delaware corporation in July 2015, with its focus on the treatment of highly resistant cancers and viruses through the development of its drug candidates, based substantially on discoveries licensed from with The University of Texas System on behalf of the MD Anderson Cancer Center, which the Company refers to as MD Anderson.
+Added: MBI is a clinical-stage pharmaceutical company, organized as a Delaware corporation in July 2015, with clinical programs for hard-to-treat cancers and viruses. The Company has three core technologies, each of which have had one or more drugs successfully complete a Phase 1 clinical trial, based substantially on discoveries made at and licensed from MD Anderson Cancer Center (MD Anderson) in Houston, Texas. 
MBI formed Moleculin Australia Pty.
2 unchanged sentences
In July 2021, MBI formed Moleculin Amsterdam B.V., a wholly owned subsidiary, primarily to act as its legal representative for clinical trials in Europe for Moleculin Biotech, Inc.
−Removed: In 2019, the Company sublicensed essentially all of the rights to its technologies in 29 countries in Europe and Asia to WPD Pharmaceuticals Sp.z o.o.
+Added: In 2019, the Company sublicensed essentially all of the rights to its technologies in over 25  countries in Europe and Asia to WPD Pharmaceuticals Sp.z o.o.
(WPD or WPD Pharmaceuticals) in exchange for a minimum amount of externally funded collaboration on development in Europe over a certain amount of time.
−Removed: This sublicense was last amended in December 2021.
+Added: This sublicense was terminated in March 2023 as described further below.
+Added: As a result to this termination, the Company now has the world-wide rights to its technology. 
Also, in 2019, the Company sublicensed its technologies to Animal Life Sciences, Inc.
1 unchanged sentence
As part of this agreement, ALI issued to the Company a 10 % interest in ALI. 
−Removed: The Company has three core technologies, based substantially on discoveries made at and licensed from MD Anderson.
−Removed: Having six drug candidates, three of which have now shown human activity in clinical trials, the Company believes that success in our lead program, Annamycin, has allowed and will allow further pipeline expansion into multiple high-value oncology indications.
−Removed: The Company’s core technologies consist of the following:
−Removed: a) Annamycin;
−Removed: b) WP1066 Portfolio;
−Removed: and c) the 
−Removed: WP1122 Portfolio.
−Removed: In the US and Europe, the Company has conducted, are currently, or plans in the near term to be conducting clinical trials for its drug candidates –
−Removed: Annamycin, WP1066, WP1220, and WP1122.
−Removed: All trials are or were in the Phase 1 portion except the WP1220 trial, which was a proof-of-concept clinical trial.
−Removed: In 2021 and early 2022, there were also three “right-to-try”
−Removed: (or their foreign equivalent) uses of Annamycin and WP1066.
−Removed: The Company plans to conduct additional trials and is in the process of obtaining the appropriate regulatory approval.
The Company utilizes its own internal resources and funds to conduct some of these trials and also has trials being conducted via physician-sponsored trials which utilizes primarily external funds, usually grant funds, which are not presented in these financial statements.
3 unchanged sentences
 Basis of presentation, principles of consolidation and significant accounting policies 
−Removed: Reverse Stock Split - On January 29, 2021, the Company filed a Certificate of Amendment to the amended and restated certificate of incorporation with the Secretary of State and the State of Delaware to effect a reverse stock split of all the issued and outstanding shares of the Company's common stock at a ratio of 1 for 6.
+Added: Reverse Stock Split - On January 29, 2021, the Company filed a Certificate of Amendment to its amended and restated certificate of incorporation with the Secretary of State and the State of Delaware to effect a reverse stock split of all the issued and outstanding shares of the Company's common stock at a ratio of 1 for 6 .
The accompanying consolidated financial statements and notes to the consolidated financial statements gives retroactive effect to the reverse stock split for all periods presented.
20 unchanged sentences
S ince inception, the Company has incurred losses and negative cash flows from operating activities.
−Removed: For the years ended December 31, 2021  and 2020 , the Company incurred net losses of $ 15.9  million a nd $ 17.4  million, respectively, and had net cash flows used in operating activities of $ 19.0  million a nd $ 17.8  million, respectively.
+Added: For the years ended December 31, 2022  and 2021 , the Company incurred net losses o f $ 29.0  million a nd $ 15.9  million, respectively, and had net cash flows used in operating activities of $ 27.6  million a nd $ 19.0  million, respectively.
At December 31, 2022 , the Company had an accumulated deficit of$ 101.8  million an d cash of $ 43.1  million.
3 unchanged sentences
If the Company needs to raise additional capital in order to continue to execute its business plan, there is no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to the Company.
−Removed: A failure to raise sufficient capital could adversely impact the Company's ability to achieve its intended business objectives and meet its financial obligations as they become due and payable.
+Added: A failure to raise sufficient capital could adversely impact the Company's ability to achieve its intended business objectives and meet its financial obligations as they become due and payable. In March 2022, the Company received a subpoena from the SEC requesting information and documents, including materials related to certain individuals ( none of which are the Company's officers or directors) and entities, and materials related to the development of and statements regarding the Company's drug candidate for the treatment of COVID- 19.
+Added: The Company has received, and expects to continue to receive, periodic further requests from the SEC staff with respect to this matter.
+Added: The Company is 
+Added: not aware of the specific nature of the underlying investigation by the SEC, and to the extent that this investigation relates to prior public disclosures that it has made, the Company believes in the accuracy and adequacy of such prior disclosures.
+Added: The correspondence from the SEC transmitting the subpoena to the Company states that the SEC is trying to determine whether there have been any violations of federal securities laws, but that its investigation does not mean that the SEC has concluded that anyone has violated the law or that the SEC has a negative opinion of any person, entity, or security.
+Added: The Company cannot predict when this matter will be resolved or what, if any, action the SEC may take following the conclusion of the investigation.
+Added: During the year ended December 31, 2022, the Company has expensed approximately $ 2.4  million in related legal fees and expenses. 
Cash and Cash Equivalents -  Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents.
3 unchanged sentences
Prepaid Expenses and Other Current Assets - Prepaid expenses and other current assets consist of the following (in thousands):
−Removed: Prepaid insurance
−Removed: Vendor prepayments and deposits
Prepaid sponsored research
−Removed: Non-trade receivables
+Added: $ 1,028  
+Added: Vendor prepayments and deposits
+Added: Prepaid insurance
Related party receivables
+Added: Non-trade receivables
Total prepaid expenses and other current assets
1 unchanged sentence
$ 1,594  
−Removed: Vendor prepayments at December 31, 2021  and 2020  includes zero  and $ 1.1  million, respectively, for the expansion of Annamycin production commitments on a commercial scale delivered in 2021 for use in clinical trials.
Property and equipment - Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line depreciation method as follows:
10 unchanged sentences
For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. Intangible assets are tested for impairment on an annual basis, and between annual tests if indicators of potential impairment exist, using a fair-value-based approach.
−Removed: We evaluate the recoverability of intangible assets periodically and take into account events or circumstances that warrant revised estimates of useful lives or that indicate that impairment exists.
+Added: The Company evaluates the recoverability of intangible assets periodically and take into account events or circumstances that warrant revised estimates of useful lives or that indicate that impairment exists.
No impairments of intangible assets have been identified during any of the periods presented.
12 unchanged sentences
The carrying amount of non-trade receivables, accounts payables, and accrued expenses approximates their fair value because of the short-term maturity of such.
−Removed: The Company has categorized its assets and liabilities that are valued at fair value on a recurring basis into three -level fair value hierarchy in accordance with GAAP.
+Added: The Company has categorized its assets and liabilities that are valued at fair value on a recurring basis into three -level fair value hierarchy in accordance with US GAAP.
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
7 unchanged sentences
Unobservable inputs for the asset or liability.
−Removed: The Company’s financial assets and liabilities recorded at fair value on a recurring basis include the fair value of our warrant liability discussed in Note 5.
+Added: The Company’s financial assets and liabilities recorded at fair value on a recurring basis include the fair value of its warrant liability discussed in Note 5.
The following table provides the financial assets and liabilities reported at fair value and measured on a recurring basis at December 31, 2022 and 2021 (in thousands):
5 unchanged sentences
December 31, 2022
−Removed: $ 1,412  
−Removed: $ 1,412  
December 31, 2021
6 unchanged sentences
Exercise of warrants
−Removed: Issuances of warrants
Change in fair value - net
1 unchanged sentence
$ 1,412  
−Removed: Exercise of warrants
Change in fair value - net
December 31, 2022
−Removed: $ 1,412  
The above table of Level 3 liabilities begins with the valuation as of December 31, 2020 and adjusts the balances for changes that occurred during the years.
−Removed: The ending balance of the Level 3 financial instrument presented above represent our best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments.
+Added: The ending balance of the Level 3 financial instrument presented above represent the Company's best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments.
Income Taxes - The Company uses the asset and liability method of accounting for income taxes.
4 unchanged sentences
The Company evaluates and records any uncertain tax positions based on the amount that management deems is more likely than not to be sustained upon examination and ultimate settlement with the tax authorities in the tax jurisdictions in which it operates.
−Removed: Translation of Foreign Currencies - The functional currency for our foreign subsidiaries is the local currency.
−Removed: For our non-US subsidiaries that transact in a functional currency other than the US dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date.
+Added: Translation of Foreign Currencies - The functional currency for the Company's foreign subsidiaries is the local currency.
+Added: For the Company's non-US subsidiaries that transact in a functional currency other than the US dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date.
Income and expense items are translated at the average foreign currency rates for the period.
−Removed: Adjustments resulting from the translation of the financial statements of our foreign operations into US dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of equity.
+Added: Adjustments resulting from the translation of the financial statements of the Company's foreign operations into US dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of equity.
Stock-based Compensation - Stock-based compensation expense includes the estimated fair value of equity awards vested or expected to vest during the reporting period.
10 unchanged sentences
For the years ended December 31, 2022 , and 2021 , approximate ly 5.5  million an d approximately 4.3  million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their antidilutive effect.
−Removed: Research and Development Costs - Research and development costs are expensed as incurred.
+Added: Research and Development Costs - Research and development costs are expensed as incurred. These costs consist primarily of salaries and benefits of research and development personnel, costs related to research activities, preclinical studies, clinical trials, drug manufacturing and allocated overhead and facility-related expenses.
Subsequent Events - The Company’s management reviewed all material events through the date these consolidated financial statements were issued for subsequent event disclosure consideration as described in Note 9 and elsewhere in other notes to the financial statements.
2 unchanged sentences
2020 - 06, Debt with Conversion and Other Options (Subtopic 470 - 20 ) and Derivatives and Hedging - Contracts in Entity's Own Equity (Subtopic 815 - 40 ) (ASU 2020 - 06 ).
−Removed: ASU 2020 - 06 simplifies the complexity associated with applying US GAAP for certain financial instruments with characteristics of both liabilities and equity, including convertible instruments and contracts in an entity's own equity. The guidance is effective for the Company beginning on January 1, 2022 and prescribes different transition methods for the various provisions. The Company's adoption of this pronouncement effective January 1, 2022 is not expected to have a material impact on the Company's consolidated financial statements.
+Added: ASU 2020 - 06 simplifies the complexity associated with applying US GAAP for certain financial instruments with characteristics of both liabilities and equity, including convertible instruments and contracts in an entity's own equity. The guidance was effective for the Company beginning on January 1, 2022 and prescribes different transition methods for the various provisions. The Company's adoption of this pronouncement did not have a material impact on the Company's consolidated financial statements.
In May 2021, 
3 unchanged sentences
ASU 2021 - 04 clarifies certain aspects of the current guidance to promote consistency among reporting of an issuer's accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange.
−Removed: The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years.
−Removed: Early adoption is permitted for all entities, including adoption in an interim period.
+Added: The amendments in this update were effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years.
The Company’s adoption of this pronouncement effective January 1, 2022 
−Removed: is not expected to have a material impact on the Company’s condensed consolidated financial statements. 
+Added: did not have a material impact on the Company’s condensed consolidated financial statements. 
The Company does not believe that any other recently issued effective pronouncements, or pronouncements issued but not yet effective, if adopted, would have a material effect on the accompanying financial statements.
1 unchanged sentence
In conjunction with its acquisition of Moleculin, LLC in 2016, the Company recognized an intangible asset for acquired in-process research and development (IPR&D) related to the acquired WP1066 portfolio.
−Removed: As our WP1066 portfolio is currently in development, the Company’s IPR&D intangible asset will not be amortized until development is complete.
+Added: As the Company's WP1066 portfolio is currently in development, the Company’s IPR&D intangible asset will not be amortized until development is complete.
If the associated research and development effort is abandoned, the Company’s IPR&D intangible asset will be written-off and the Company will record a noncash impairment loss on its statements of operations.
1 unchanged sentence
IPR&D was $ 11.1 million as of December 31, 2022 and 2021 , respectively.
−Removed: Accrued expenses and other current liabilities 
+Added: Accrued expenses and other current liabilities
Accrued expenses and other current liabilities at December 31, 2022 and 2021 consist of the following components (in thousands):
1 unchanged sentence
$ 1,337  
+Added: $ 1,005  
Accrued payroll and bonuses
Accrued legal, regulatory, professional and other
−Removed: Accrued liabilities due to related party
Operating lease liability - current
+Added: Accrued liabilities due to related party
Total accrued expenses and other current liabilities
1 unchanged sentence
$ 2,258  
−Removed: Additionally, accounts payable includes $ 48,000 as of December 31, 2021  and 2020 , respectively, for a related party payable to HPI. 
+Added: Additionally, accounts payable include s $ 64,000 and $ 48,000 as of December 31, 2022  and 2021 , respectively, for related party payables. 
Warrants 
1 unchanged sentence
Warrants are classified as liabilities when the Company may be required to settle a warrant exercise in cash and classified as equity when the Company settles a warrant exercise in shares of its common stock.
−Removed: Liability classified warrants are valued at fair value at the date of issue and at each reporting date pursuant to FASB ASC 820, Fair Value Measurement, (ASC 820 ) and is reflected as a warrant liability on our consolidated balance sheet with the change in the warrant liability during each reporting period is reflected as a gain (loss) from change in fair value of warrant liability in our consolidated statement of operations.
+Added: Liability classified warrants are valued at fair value at the date of issue and at each reporting date pursuant to FASB ASC 820, Fair Value Measurement, (ASC 820 ) and is reflected as a warrant liability on the Company's consolidated balance sheet with the change in the warrant liability during each reporting period is reflected as a gain (loss) from change in fair value of warrant liability in the Company's consolidated statement of operations.
Equity classified warrants issued to non-employees in exchange for services are accounted for in accordance with ASC 718 which requires all stock-based payments be recognized in the consolidated statements of operations based on their fair value.
10 unchanged sentences
67,349  
−Removed: 67,349  
−Removed: $ 8.42  
Issued February 2018
17 unchanged sentences
Equity Classified Warrants
−Removed: Issued May 2016 - Bonwick
−Removed: 17,970  
−Removed: $ 45.00  
Issued July 2017 - Consulting (3)
1 unchanged sentence
$ 15.64  
−Removed: Issued April 2018 - Consulting
−Removed: 16,667  
Issued August 2019 - Consulting
25,000  
−Removed: 25,000  
Issued April 2020 - Consulting
4 unchanged sentences
71,500  
+Added: 71,500  
Issued August 2021 - Consulting
1 unchanged sentence
250,000  
+Added: Issued June 2022 - Consulting
50,000  
+Added: Issued September 2022 - Consulting
250,000  
+Added: 646,501  
+Added: 396,502  
+Added: $ 2.42  
Balance outstanding
34 unchanged sentences
( 67,349 )  
+Added: 8.10 to 9.00  
+Added: $ 8.42  
Outstanding at December 31, 2022
6 unchanged sentences
$ 9.49  
−Removed: In connection with the Company's stock offering that closed in February 2020, the Company issued warrants to purchase 937,501  shares of its common stock, that are exercisable six months from the date of issuance, at a price of $ 6.30  per share, subject to adjustment in certain circumstances, and expire five years from the date they are first exercisable, and issued Oppenheimer & Co.
−Removed: a warrant (Underwriter Warrant) to purchase up to 87,500 shares of its common stock with an exercise price of $ 6.30  per share, subject to adjustment in certain circumstances, which expires in February 2025.
−Removed: For a summary of the changes in fair value associated with our warrant liability for the years ended December 31, 2021 and 2020 , see Note 2.
+Added: For a summary of the changes in fair value associated with the Company's warrant liability for the years ended December 31, 2022 and 2021 , see Note 2.
Basis of presentation, principles of consolidation and significant accounting policies –
Fair Value of Financial Instruments.
−Removed: Equity Classified Warrants
−Removed: In April 2021, the Company granted equity-classified warrants to purchase 71,500  shares of common stock with a five -year term and an exercise price of $ 3.63  vesting quarterly over five years while services are being performed.
+Added: Equity Classified Warrants 
+Added: In September 2022, the Company entered into a portfolio advisory agreement with a related party entity, associated with Dr.
+Added: Waldemar Priebe, and in connection with the agreement, the Company granted equity-classified warrants to purchase 250,000 shares of common stock with a ten -year term and an exercise price of $ 1.24 .
+Added: The September 2022 warrants vest as follows:
+Added: 50% vests upon execution of the agreement, provided the advisor does not terminate the agreement prior to the first anniversary of the agreement;
+Added: and (b) 50% vests 60 days after the end of the one -year term, subject to the Company's Board of Directors determining that the services provided have been adequately performed. In June 2022, the Company granted equity-classified warrants to purchase 50,000 shares of common stock with a ten -year term and an exercise price of $ 1.49 vesting annually over four years while services are being performed. 
In August 2021, the Company entered into a portfolio development advisory agreement with a related party entity, associated with Dr.
1 unchanged sentence
The August 2021 warrants vest (a) 50% upon execution of the agreement, provided the advisor does not terminate the agreement prior to the end of the one -year term;
−Removed: and (b) 50% 60 days after the end of the one -year term, subject to the Company's Board of Directors determining that the services provided have been adequately performed. Also, both the April 2021 
−Removed: and August 2021 warrants vest in full if there is a change of control event, as defined in the agreement.
−Removed: In December 2020, equity warrants to purchase up to 8,334  shares of common stock were issued to a consultant, with vesting contingent on certain conditions focused on executing licensing arrangements.
−Removed: In April 2020, equity warrants to purchase up to 16,667  shares of common stock were issued to a consultant, with vesting contingent on certain conditions focused on generating up to $ 10.0 million of approved research and development expenditures on the Company's drug portfolio.
−Removed: At December 31, 2021  the Company had 396,502 equity classified warrants outstanding and 186,560 warrants were exercisable.
+Added: and (b) 50% vests 60 days after the end of the one -year term, subject to the Company's Board of Directors determining that the services provided have been adequately performed.
+Added: The Company's Board of Directors determined that the services had been adequately performed, and as such, the August 2021 warrants are fully vested.
+Added: In April 2021, the Company granted equity-classified warrants to purchase 71,500  shares of common stock with a five -year term and an exercise price of $ 3.63  vesting quarterly over five years while services are being performed.
+Added: Additionally, both the April 2021 
+Added: and August 2021 warrants vest in full if there is a change of control event, as defined in the agreements.
+Added: At December 31, 2022  the Company had 646,501 equity classified warrants outstanding and 400,859  warrants were exercisable.
At December 31, 2021 , the Company had 396,502 equity classified warrants outstanding and 186,560 were exercisable.
−Removed: The Company recorded stock compensation expense for the non-employee consulting agreements o f $ 516,000 and $ 5,000  for the years ended December 31, 2021 and 2020 , respectively.
−Removed: At December 31, 2021 , there was $ 548,000 o f unrecognized stock compensation expense related to the Company's equity-classified warrants.
+Added: The Company recorded stock compensation expense for the non-employee consulting agreements of $ 398,000 and $ 516,000  for the years ended December 31, 2022 and 2021 , respectively.
+Added: At December 31, 2022 , there was $ 437,000 of unrecognized stock compensation expense related to the Company's equity-classified warrants.
 Equity 
Preferred Stock
−Removed: Our certificate of incorporation authorizes the Company to issue these shares in one or more series, to determine the designations and the powers, preferences and relative, participating, optional or other special rights and the qualifications, limitations and restrictions thereof, including the dividend rights, conversion or exchange rights, voting rights (including the number of votes per share), redemption rights and terms, liquidation preferences, sinking fund provisions and the number of shares constituting the series.
+Added: The Company's certificate of incorporation authorizes the Company to issue these shares in one or more series, to determine the designations and the powers, preferences and relative, participating, optional or other special rights and the qualifications, limitations and restrictions thereof, including the dividend rights, conversion or exchange rights, voting rights (including the number of votes per share), redemption rights and terms, liquidation preferences, sinking fund provisions and the number of shares constituting the series.
No preferred stock was issued or outstanding as of 
1 unchanged sentence
Common Stock 
−Removed: February 2021 Stock Offering
+Added: 2022 Stock Issuances
+Added: During the year ended December 31, 2022 , the Company did not enter into any public offerings.
+Added: 2021 Stock Issuances
In February 2021, the Company entered into an underwritten public offering for the sale by the Company of 14,273,684 shares of its common stock at a public offering price of $ 4.75 per share and granted the underwriters a 30 -day option to purchase up to an additional 2,141,052 shares of common stock offered in the public offering, which was exercised.
The Company received total proceeds of $ 78.0  million, prior to deducting the underwriting discount and other estimated offering expenses. 
−Removed: February 2020 
−Removed: Stock Offering
−Removed: In February 2020, the Company entered into subscription agreements with certain institutional investors for the sale by the Company of 1,250,000 shares of its common stock and warrants to purchase 937,501  shares of common stock at a combined public offering price of $ 4.80 per share and related warrant.
−Removed: The Company received total proceeds of $ 6.0 million, net of $ 0.7 million in transaction expenses.
−Removed: See Note 5  - Warrants for equity classified warrants granted during the year ended December 31, 2020.
Lincoln Park Equity Line  
1 unchanged sentence
Pursuant to the terms of the Purchase Agreement, Lincoln Park agreed to purchase from the Company up to $ 20.0 million of common stock (subject to certain limitations) from time to time during the term of the Purchase Agreement.
−Removed: Pursuant to the terms of the Purchase Agreement, at the time the Company signed the Purchase Agreement, the Company issued 107,788 shares of common stock to Lincoln Park as an initial fee for its commitment to purchase shares of the Company's common stock under the Purchase Agreement, and has agreed to issue Lincoln Park up to an additional 53,893 shares of common stock as commitment shares pro-rata when and if Lincoln Park purchases (at our discretion) the $ 20.0 million aggregate commitment.
+Added: Pursuant to the terms of the 2021 Purchase Agreement, at the time the Company signed the Purchase Agreement, the Company issued 107,788 shares of common stock to Lincoln Park as an initial fee for its commitment to purchase shares of the Company's common stock under the Purchase Agreement, and has agreed to issue Lincoln Park up to an additional 53,893 shares of common stock as commitment shares pro-rata when and if Lincoln Park purchases (at the Company's discretion) the $ 20.0 million aggregate commitment.
The initial commitment shares issued in June 2021 were valued at $ 0.4 million, recorded as an addition to equity for the issuance of common stock and treated as a reduction to equity as a cost of capital to be raised under the Purchase Agreement.
There have been no additional shares issued to date under this agreement.
−Removed: In November 2020, the Company entered into a purchase agreement (the 2020 Purchase Agreement) and a registration rights agreement (the 2020 Registration Rights Agreement) with Lincoln Park Capital Fund, LLC (Lincoln Park).
−Removed: Pursuant to the terms of the 2020 Purchase Agreement, Lincoln Park agreed to purchase from the Company up to $ 22.0 million of the Company’s common stock (subject to certain limitations) from time to time during the term of the 2020 Purchase Agreement.
−Removed: Pursuant to the terms of the 2020 Registration Rights Agreement, the Company filed with the SEC a registration statement to register the shares that have been or may be issued to Lincoln Park under the 2020 Purchase Agreement.
−Removed: Pursuant to the terms of the 2020 Purchase Agreement, at the time the Company signed the 2020 Purchase Agreement and the 2020 Registration Rights Agreement, the Company issued 126,699 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the 2020 Purchase Agreement and agreed to issue an additional 50,680  shares pro-rata when and if Lincoln Park purchases (at the Company’s discretion) the $22.0 million aggregate commitment. The commitment shares were valued at $ 0.5  million, recorded as an addition to equity for the issuance of common stock and treated as a reduction to equity as a cost of capital to be raised under the Purchase Agreement.
−Removed: During the year ended December 31, 2020, the Company issued 771,220 shares, which included 133,017  commitment shares for net proceeds of $ 2.2  million.
−Removed: The Company terminated the 2020 Purchase Agreement on February 2, 2021.
At Market Issuance Sales Agreements (ATM) 
1 unchanged sentence
Pursuant to the terms of the 2021 ATM Agreement, the Company may offer and sell, from time to time through Oppenheimer shares of the Company's common stock with an aggregate sales price of up to $ 50.0 million.
−Removed: As of the date of this report, there have been no issuances under the 2021 ATM Agreement.
+Added: There were no issuances under the 2021 ATM Agreement.
+Added: The Company terminated the 2021 ATM Agreement on February 3, 2023.
In January 2021 the Company issued 468,684 shares for gross proceeds of $ 2.9 million using the Company's 2020 At Market Agreement (the 2020 ATM Agreement) with Oppenheimer & Co., Inc.
The Company terminated the 2020 ATM Agreement on February 2, 2021. 
−Removed: July 2020, we entered into a new At Market Issuance Sales Agreement with Oppenheimer & Co.
−Removed: (the 2020 ATM Agreement).
−Removed: Pursuant to the terms of the 2020 ATM Agreement, the Company was able to sell from time to time through Oppenheimer shares of the Company’s common stock with an aggregate sales price of up to $ 15.0 million.
−Removed: During the year ended December 31, 2020, pursuant to the 2020 ATM Agreement, the Company issued 471,405  shares of common stock at an average price of $ 6.11 per share, resulting in net proceeds of $ 2.8 million. 
−Removed: In addition, at December 31, 2020, we had 26,966  shares of our common stock subscribed in ATM transactions under the 2020 ATM Agreement for net proceeds, after deducting commissions and other transaction costs, of approximately $ 0.1 million at an average selling price of $ 4.96  per share.
−Removed: Accordingly, we have recorded a subscription receivable of $ 0.1 million as a reduction of stockholders' equity in our consolidated balance sheet as of December 
−Removed: The Company terminated the 2020 ATM Agreement on February 2, 2021. 
−Removed: In July 2019, the Company entered into an At Market Issuance Sales Agreement (the 2019 ATM Agreement) with Oppenheimer & Co.
−Removed: Pursuant to the terms of the 2019 ATM Agreement, the Company was able to sell from time to time through the Agent shares of the Company’s common stock, with an aggregate sales price of up to $ 15 million. The Company agreed to pay a commission to the Agent of 3.0 % of the gross proceeds of the sale of the Shares sold under the Agreement and reimburse the Agent for certain expenses.
−Removed: The Company also provided the Agent with customary indemnification rights.
−Removed: During the year ended December 31, 2020, pursuant to the 2019 ATM Agreement, the Company issued 1,412,017 shares of common stock at an average price of $ 8.68  per share, resulting in net proceeds of $ 11.9 million.
−Removed: In the third quarter of 2020, the 2019 ATM Agreement expired and was terminated. 
Adoption of 2015 Stock Plan
1 unchanged sentence
2015, the Board of Directors of the Company approved the Company’s 2015 Stock Plan, which was amended in April 
−Removed: 2016, April 2018, and June 2020.
+Added: 2016, April 2018, June 2020, and May 2022.
The expiration date of the plan is December 
The awards under the 2015 Stock Plan can be in the form of stock options, stock awards, stock unit awards, or stock appreciation rights.
−Removed: On June 15, 2020, the stockholders approved an amendment to the 2015 Plan to, among other things, increase the number of shares of common stock authorized for issuance under the 2015 Plan by 1,000,000 shares.
+Added: In May 2022, the stockholders approved an amendment to the 2015 Plan to, among other things, increase the number of shares of common stock authorized for issuance under the 2015 Plan by 2,000,000 shares.
Stock-based Compensation and Outstanding Awards
−Removed: Under the terms of the Company’s 2015 Stock Plan, as amended, and approved by its stockholders in June 2020, 1,750,001 shares of the Company’s common stock are available for grant to employees, non-employee directors and consultants.
+Added: Under the terms of the Company’s 2015 Stock Plan, as amended, and approved by its stockholders in May 2022, 3,750,001 shares of the Company’s common stock are available for grant to employees, non-employee directors and consultants.
The 2015 Stock Plan provides for the grant of stock options, stock awards, stock unit awards, or stock appreciation rights.
−Removed: As of December 31, 2021 , there wer e 41,628  s hares remaining to be issued under the 2015 Stock Plan.
+Added: As of December 31, 2022 , there wer e 752,296  shares re maining to be issued under the 2015 Stock Plan.
Stock-based compensation expense for the years ended December 31, 2022 and 2021 is as follows (in thousands):
41 unchanged sentences
$ 1.49  
+Added: ( 5,834 )  
+Added: $ 15.57  
+Added: $ 24.39  
Outstanding, December 31, 2022
6 unchanged sentences
$ 10.38  
−Removed: Options granted during 2021  and 2020  have an aggregated fair value of $ 1.7  million and $ 1.3 million, respectively, tha t was calculated using the Black-Scholes option-pricing model.
−Removed: At December 31, 2021 , total compensation cost not yet recognized was $ 2.8  million an d the weighted average period over which this amount is expected to be recognized is 2.7  years.
−Removed: T he aggregate fair value of options vesting was $ 1.5 million in the years ended December 31, 2021 and 2020 , respectively.
−Removed: Subsequent to December 31, 2021, the Company granted 21,667 options.
+Added: Options granted during 2022  and 2021  have an aggregated fair value of $ 1.1  million and $ 1.7  million, respectively, tha t was calculated using the Black-Scholes option-pricing model.
+Added: At December 31, 2022 , total compensation cost not yet recognized was $ 2.5  million and the weighted average period over which this amount is expected to be recognized is 2.4  years.
+Added: T he aggregate fair value of options vesting was $ 1.5 million in the years ended December 31, 2022 and 2021 , respectively. 
Restricted Stock
18 unchanged sentences
As of December 31, 2022 , total compensation cost not yet recognized was $ 1.1  million a nd the weighted average period over which this amount is expected to be recognized is 2.8  years.
+Added: In June 2022, the Company granted 452,334 shares of restricted stock units with a weighted average fair value of $ 1.49  per share at the date of grant, which vest annually in four equal installments.
In J une 2021, the Company granted 150,000 shares of restricted stock units with a weighted average fair value of $ 3.73 per share at the date of grant, which vest annually in four equal installments.
33 unchanged sentences
( 0.2 )%  
+Added: ( 37 )  
Uncertain tax provision
15 unchanged sentences
11,024  
+Added: 10,866  
+Added: 174 R&D Carryforward
State tax loss carryforwards
11 unchanged sentences
( 86 )  
−Removed: ( 23 )  
Total deferred tax liabilities
3 unchanged sentences
As of December 31, 2022 , the Company had total US federal operating loss carry forwards of approximately $ 52  million.
−Removed: Of thi s, $ 6.1  million will expire commencing i n 2035, with the rest having no set expiration date.
+Added: O f thi s, $ 6.1  million will expire commencing i n 2035, with the rest having no set expiration date.
The value of these carryforwards depends on the Company’s ability to generate taxable income.
10 unchanged sentences
The Company has cumulative losses and there is no assurance of future taxable income, therefore, valuation allowances have been recorded to fully offset the deferred tax asset at December 31, 2022 .
−Removed: Management has determined that it is more likely than not that the Company will not recognize the benefits of its federal and state deferred tax assets, and as a result, a valuation allowance of $ 18.8  million a nd $ 13.9  million has been established at December 31, 2021 and 2020 , respectively.
+Added: Management has determined that it is more likely than not that the Company will not recognize the benefits of its federal and state deferred tax assets, and as a result, a valuation allowance of $ 25.7  million an d $ 18.8  million has been established at December 31, 2022 and 2021 , respectively.
The change in the valuation allowance for the year ended December 31, 2022 was primarily due to additional operating losses and capitalized research costs.
1 unchanged sentence
The Company has a full valuation allowance against its US federal R&D tax credits. For the 2022 tax year, the potential US and Australian research and development tax credits are not expected to be significant.
+Added: The federal research credits will begin to expire in the years 2037 through 2041, if not utilized.
The Company has a liability for unrecognized tax benefits o f $ 0.2  million (excluding accrued interest and penalties) as of December 31, 2022 .
9 unchanged sentences
The Company does not believe that its tax positions will significantly change due to any settlement and/or expiration of statutes of limitations prior to 
−Removed: December 31, 2021 within the next year.
+Added: December 31, 2022 within the next year. 
+Added: Starting in 2022, changes to Internal Revenue Code Section 174 made by the Tax Cuts and Jobs Act of 2017 no longer permit an immediate deduction for research and development expenditures in the tax year that such costs are incurred.
+Added: As a result the Company capitalized such costs in its 2022 income tax provision, resulting in an increase in deferred tax assets. 
 Commitments and Contingencies  
9 unchanged sentences
The corporate office lease is classified as an operating lease.
−Removed: In August 2019, the Company entered into an Amended Lease Agreement (the "Lab Lease") which it uses for lab space.
−Removed: The term of the Lease began in September 2019 and will continue for an initial term of 35 months, with no further right or option to renew.
+Added: In June 2022, the Company entered into a Second Amendment to its Lease Agreement (the "Lab Lease") which it uses for lab space.
+Added: The term of the Lease will continue through September 30, 2027, with no further right or option to renew.
The Company is required to remit base monthly rent which will increase at an average approximate rate of 3 % each year.
The Lab Lease is classified as an operating lease.
−Removed: In August 2019, the Company entered into a sublease with a related party, Houston Pharmaceuticals, Inc.
+Added: In August 2019, the Company entered into a sublease (which was extended in 2022 in connection with the lease extension) with a related party, Houston Pharmaceuticals, Inc.
The Company has granted HPI access to all of its Lab Lease space and HPI has agreed to pay the Company 50 % of the Company's rent payable under the Lab Lease less 50 % of any benefits from any sublease or other lab service agreement the Company may receive from its Lab Lease.
Although HPI has access to the Company's Lab Lease space, it is the intent of the parties that they equally share the Lab Lease space for research purposes.
−Removed: The Company recorded approximately $ 42,000  in sublease income from the related party for the years ended December 31, 2021  and December 31, 2020 , respectively.
+Added: The Company recorded approximately $ 45,000  and $ 42,000 in sublease income from the related party for the years ended December 31, 2022  and December 31, 2021 , respectively.
Sublease income is recorded as other income on the Company's consolidated statement of operations and comprehensive loss.
−Removed: During the year ended December 31, 2021 , the Company did not enter into any lease arrangements requiring any additional right-of-use assets or liabilities to be recorded.
+Added: During the year ended December 31, 2022 , the Company did not enter into any new lease arrangements requiring any additional right-of-use assets or liabilities to be recorded, other than the extension discussed above.
The Company made an accounting policy election not to apply the recognition requirements to short-term leases.
18 unchanged sentences
As of December 31, 2022 , the weighted average remaining lease term for operating leases is 4.2 5  years , and the weighted average discount rate is 9.6 %.
−Removed: T he interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses an incremental borrowing rate based on a peer analysis using information available at the commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. 
+Added: Th e interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses an incremental borrowing rate based on a peer analysis using information available at the commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. 
+Added: MD Anderson 
Under agreements associated with Annamycin, the WP1122 Portfolio and the WP1066 Portfolio all described below, the Company is responsible for certain license, milestone and royalty payments over the course of the agreements.
−Removed: Annual license fees can cost as high as $ 0.1 million depending upon the anniversary, milestone payments for the commencement of phase II and phase III clinical trials can cost as high as $ 0.5 million.
−Removed: Other milestone payments for submission of an NDA to the FDA and receipt of first marketing approval for sale of a license product can be as high as $ 0.6 million.
−Removed: Royalty payments can range in the single digits as a percent of net sales on drug products or flat fees as high as $ 0.6 million, depending upon certain terms and conditions.
+Added: Annual license fees can cost as high as $ 0.1 million depending upon the anniversary, milestone payments for the commencement of phase II and phase III clinical trials, for the submission of an NDA to the FDA and for the receipt of marketing approval for sale of a license product can cost as high as $ 0.6 million, depending upon certain terms and conditions.
Not all of these payments are applicable to every drug.
In March 2021, after a determination that the Company did not intend to pursue development of WP1732, the Company entered into a termination of the license agreement related to WP1732 dated February 12, 2018 with MD Anderson.
−Removed: Total expenses under these agreements were $ 267,000  
−Removed: and $ 255,000 , respectively, for the years ended 
+Added: Total expenses under these agreements were $ 264,000  an d $ 267,000 , respectively, for the years ended 
December 31, 2022  and 
9 unchanged sentences
The rights and obligations to an April 2012 Patent and Technology License Agreement entered into by and between IntertechBio and MD Anderson (the “2012 Agreement”) have been assigned to MBI.
−Removed: Therefore, MBI has obtained a royalty-bearing, worldwide, exclusive license to intellectual property, including patent rights, related to our WP1122 Portfolio and to our drug product candidate, WP1122.
+Added: Therefore, MBI has obtained a royalty-bearing, worldwide, exclusive license to intellectual property, including patent rights, related to its WP1122 Portfolio and to its drug product candidate, WP1122.
+Added: On October 21, 2022, the Company entered into a new patent and technology license agreement (the "2022 Agreement") with MD Anderson for an additional molecule under the WP1122 Portfolio.
On December 3, 2021, the Company entered into a new patent and technology license agreement (the “2021 Agreement”) with MD Anderson licensing certain technology related to WP1122 anti-viral treatments.
5 unchanged sentences
The term of the 2012 agreement extends until the later of 15 years from the effective date of the agreement, or the expiration of the last-to-expire licensed patent.
−Removed: In addition, MD Anderson may terminate the 2012 agreement if the Company fails to commence a Phase 1 study for a licensed product prior to November 20, 2022;
−Removed: or if the Company fails to commence a Phase 2 study for licensed product prior to November 20, 2024.
+Added: MD Anderson had the right terminate the 2012 agreement if the Company failed to commence a Phase 1 study for a licensed product prior to November 20, 2022, which Phase 1 study occurred in the United Kingdom during 2022 prior to the deadline.
+Added: In addition, MD Anderson may terminate the 2012 agreement if the Company fails to commence a Phase 2 study for licensed product prior to November 20, 2024.
The term of the 2021 agreement extends until the later of 20 years from the effective date of the agreement, or the expiration of the last-to-expire licensed patent.
−Removed: In addition, MD Anderson may terminate the 2021 agreement if the Company fails to file an IND for a Phase 1 study for a licensed product prior to December 3, 2024;
+Added: MD Anderson may terminate the 2021 agreement if the Company fails to file an IND for a Phase 1 study for a licensed product prior to December 3, 2024;
or if the Company fails to commence a Phase 1 study for licensed product prior to December 3, 2026.
−Removed: The Company believes that the recent approval for its clinical trial application for a WP1122 Phase 1 clinical trial for COVID- 19 will meet these required milestones.
+Added: The Company believes that the Phase 1 study that occurred in the United Kingdom during 2022 met these required milestones.
WP1066 Portfolio
10 unchanged sentences
In addition, MD Anderson may terminate the 2022 Agreement if the Company fails to file for an IND for a Phase 1 study before February 2, 2025 in the United States, France, Germany, Italy, Spain, the United Kingdom or China.
−Removed: The Company believes that to the clinical trial application in China filed prior to 2016 meets this milestone.
+Added: The Company believes that the clinical trial application in China filed prior to 2016 meets this milestone. 
MBI entered into an outlicensing agreement with HPI, pursuant to which it granted certain intellectual property rights to HPI, including rights covering the potential drug candidate, WP1066 (HPI Out-Licensing Agreement).
Upon payment of the option repurchase payment in 2019, the HPI Out-Licensing Agreement was terminated and MBI regained all rights to the licensed subject matter and rights to any and all development data and any regulatory submissions including any IND, NDA or ANDA related to the licensed subject matter and can end the license without any other obligation.
−Removed: In March 2020, the Company entered into two agreements with HPI.
−Removed: The first agreement, which has a term of two years, continues a prior consulting arrangement with HPI on the Company's licensed molecules and requires payments for $ 43,500  per quarter to HPI.
+Added: The Company has two current agreements with HPI.
+Added: The first agreement, which was renewed in May 2022, continues a prior consulting arrangement with HPI and requires payments for $ 43,500  per quarter.
The second agreement, which can be cancelled with sixty days notice by either party, allows the Company's employees access to laboratory equipment owned by HPI and this requires a payment of $ 15,000 per quarter to HPI.
−Removed: Total expenses related to HPI were $ 234,000  
−Removed: and $ 284,000 , for the years ended December 31, 2021 and 2020 , respectively. 
+Added: Total expenses related to HPI were $ 234,000  for the years ended December 31, 2022 and 2021 . 
Sponsored Research Agreements with MD Anderson
MBI has a Sponsored Laboratory Study Agreement with MD Anderson expiring December 31, 2024.
−Removed: In July 2021, the Company amended its Sponsored Laboratory Study Agreement with MD Anderson for total payment of $ 175,000 to support the continuation of the project.
−Removed: The expenses recognized under the MD Anderson agreement with regards to the Sponsored Laboratory Study were $ 697,000  a nd $ 629,000 , respectively for the years ended December 31, 2021 and 2020 .
+Added: In June 
+Added: 2022, the Company entered into a new Sponsored Research Agreement with MD Anderson for total payment of $ 1.3 million to support the continuation of the project. In addition, the Company also has Sponsored Research Agreements with other universities, one in the US and one in Europe. The expenses recognized under the agreements w ere $ 1,133,000  a nd $ 697,000 , respectively for the years ended December 31, 2022 and 2021 .
Other Licenses
−Removed: In 2015, we obtained the rights and obligations for certain patent and technology development and license agreements with Dermin Sp.
−Removed: Zoo (Dermin).
−Removed: In connection with such agreements, certain intellectual property rights related to Annamycin, our WP1122 portfolio, and our WP1066 portfolio were licensed to Dermin and Dermin was granted a royalty-bearing, exclusive license to manufacture, have manufactured, use, import, offer to sell and/or sell products in the field of human therapeutics under the licensed intellectual property in certain countries in Europe and Asia.
−Removed: In July 2019, Dermin assigned its rights under the foregoing license agreements to an affiliated entity of Dermin, Exploration Invest Pte Ltd.
−Removed: (Exploration).
−Removed: On July 30, 2019, the Company and Exploration entered into an agreement pursuant to which the Company agreed to issue Exploration shares of Company common stock valued at $ 0.5  million (based on the greater of the closing price of the common stock on the date of the agreement or the 10 -day average closing price prior to the date of the agreement) in exchange for the modifying the license agreements to:
−Removed: (i) limit the licensed territory solely to Poland;
−Removed: and (ii) limit the patent rights and technology rights licensed to Exploration to the patent rights and technology rights that existed on the date the original license agreements were entered into with Dermin.
−Removed: In August 2019, the Company issued 71,663  shares of Company common stock to Exploration to satisfy this commitment.
−Removed: In February 2022, the Company and Exploration entered into a license termination agreement pursuant to which the Company agreed to pay Exploration $0.4 million to terminate each of the License Agreements, and extend its confidentiality requirements until the 10 -year anniversary of the license termination agreement.
−Removed: The Company paid $ 0.4 million to Exploration in February 2022 to satisfy this commitment.
−Removed: As such, all of the above licenses have been terminated.
WPD Pharmaceuticals 
−Removed: In February 2019, the Company sublicensed certain intellectual property rights, including rights to Annamycin, its WP1122 portfolio, and its WP1066 portfolio to WPD Pharmaceuticals sp.
−Removed: (WPD), which sublicense was last amended on December 20, 2021 ( such agreement as amended, the “WPD Agreement”).
+Added: Since February 2019, 
+Added: the Company was party to a sublicense agreement with WPD Pharmaceuticals (WPD), pursuant to which it sublicensed to WPD certain intellectual property rights, including rights to Annamycin, its WP1122 portfolio, and its WP1066 portfolio (as amended, the “WPD Agreement”).
WPD is affiliated with Dr.
−Removed: Waldemar Priebe, one of the Company’s founders and largest shareholder.
−Removed: Under the WPD Agreement, the Company granted WPD a royalty-bearing, exclusive license to research, develop, manufacture, have manufactured, use, import, offer to sell and/or sell products in the field of human therapeutics under the licensed intellectual property in the countries of Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Moldova, Romania, Armenia, Azerbaijan, Georgia, Slovakia, Czech Republic, Hungary, Uzbekistan, Kazakhstan, Greece, Austria, Russia, Netherlands, Turkey, Belgium, Switzerland, Sweden, Portugal, Norway, Denmark, Ireland, Finland, Luxembourg, Iceland (licensed territories).
−Removed: In consideration for entering into the WPD Agreement, WPD agreed that it must use Commercially Reasonable Development Efforts to develop and commercialize products in the licensed territories.
−Removed: For purposes of the WPD Agreement, the term “Commercially Reasonable Development Efforts”
−Removed: (CRDE) means the expenditure, either directly or through the guarantees of grants, by or on behalf of WPD or any of its affiliates of at least:
−Removed: (i) $ 2.5  million during the first four years of the agreement (or prior to February 2023) on the research, development and commercialization of products in the licensed territories;
−Removed: and (ii) $ 2.1  million annually for the five years thereafter on the research and development of products in the licensed territories.
−Removed: The total CRDE required by the sublicense is $ 14.0 million.
−Removed: During the term of the WPD Agreement, to the extent the Company is required to make any payments to MD Anderson pursuant to its license agreements with MD Anderson, whether a milestone or royalty payment, as a result of the research and development or sale of a sublicensed product, WPD shall be required to advance or reimburse the Company for such payments.
−Removed: In further consideration for the rights granted by the Company to WPD under the WPD Agreement, WPD agreed to pay us a royalty percentage at a rate equal to the royalty rate owed MD Anderson under the Company’s license agreements with MD Anderson plus an additional royalty (the “override royalty percentage”) equal to 1.0% of net sales of any sublicensed products, provided, however, if WPD spends:
−Removed: (i) more than $14.0 million in Commercially Reasonable Development Efforts, the override royalty percentage will decrease to 0.75% of net sales;
−Removed: or (ii) more than $17.0 million in Commercially Reasonable Development Efforts, the override royalty percentage will decrease to 0.5% of net sales.
−Removed: With certain exceptions, the WPD Agreement will remain in full force and effect until the expiration of the last patent within the sublicensed patents.
−Removed: Notwithstanding the foregoing, the Company has the right, in its sole discretion, to terminate the WPD Agreement in whole, or to materially amend the agreement by removing a portion of the sublicensed subject matter, in connection with certain fundamental transactions or in connection with the granting to an unaffiliated third party of a license or sublicense to all or to a material portion of the sublicensed subject matter within all or substantially all of the licensed territories (such event, the “buyback event”) by making a payment to WPD based on the percentage of licensed territories involved in the buyback event as compared to the overall world healthcare spend and the extent to which WPD has satisfied its Commercially Reasonable Development Efforts requirements.
+Added: Waldemar Priebe, the Company's founder.
+Added: Under the WPD Agreement, the Company granted WPD a royalty-bearing, exclusive license to research, develop, manufacture, have manufactured, use, import, offer to sell and/or sell products in the field of human therapeutics under the licensed intellectual property in the countries of Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Moldova, Romania, Armenia, Azerbaijan, Georgia, Slovakia, Czech Republic, Hungary, Uzbekistan, Kazakhstan, Greece, Austria, Russia, Netherlands, Turkey, Belgium, Switzerland, Sweden, Portugal, Norway, Denmark, Ireland, Finland, Luxembourg, Iceland (licensed territories).
+Added: In March 2023, the Company and WPD agreed to terminate the WPD Agreement.
+Added: Pursuant to the termination, the Company agreed to pay WPD (or its designees) $ 700,000 in cash and shares of its common stock valued at $ 800,000 .
+Added: In connection with the termination, WPD agreed to assign all of its rights and obligations related to the Phase 1b/2 clinical trial of Annamycin for the treatment of STS lung metastases being conducted at Maria Sklodowska-Curie National Research Institute.
+Added: With the termination of the WPD Agreement, the Company now holds the worldwide rights to all of its licensed intellectual property, other than the rights related to non-human animals.
Animal Life Sciences
6 unchanged sentences
The Company has agreements with certain executive and other employees to provide benefits in the event of termination.
−Removed: The base salary and certain other benefits would aggregate approximately $ 0.9  million  using the rate of compensation in effect at December 31, 2021 .
+Added: The base salary and certain other benefits would aggregate approximately $ 0.9  million 
+Added: using the rate of compensation in effect at December 31, 2022 .
 Subsequent Events 
−Removed: In addition to the subsequent events discussed elsewhere in these notes, see below for a discussion of our subsequent events occurring after December 31, 2021 .
−Removed: In February 2022, the Company and Exploration Invest Pte Ltd.
−Removed: (Exploration) entered into a license termination agreement pursuant to which the Company agreed to pay Exploration $0.4 million to terminate certain License Agreements and extend its confidentiality requirements until the 10 -year anniversary of the license termination agreement.
−Removed: The Company paid $ 0.4 million to Exploration in February 2022 to satisfy this commitment.
+Added: Subsequent events occurring after December 31, 2022  are discussed elsewhere in these notes.
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.