6 unchanged sentences
Attestation Report of the Registered Public Accounting Firm
−Removed: Our independent registered public accounting firm will not be required to formally attest to the effectiveness of our internal controls over financial reporting for as long as we are an "emerging growth company" pursuant to the provisions of the Jumpstart Our Business Startups Act.
−Removed: Remediation of a Prior Material Weakness
−Removed: We previously identified and disclosed in our 10-K filed with the SEC on March 19, 2020, as well as in our quarterly reports for March 31, 2020, June 30, 2020, and September 30, 2020, a material weakness related to a lack of segregation of duties associated with the design of our internal controls.
−Removed: With input and oversight from the Audit Committee, we implemented a remediation plan to ensure that control deficiencies contributing to the material weakness were remediated such that these controls will operate effectively.
−Removed: We took the following remediation actions which have facilitated the proper segregation of duties in the initiation of transactions, the recording of transactions, and the custody of assets:
−Removed: Implemented new information technology systems and policies and procedures;
−Removed: Management added additional accounting and IT personnel, including the use of qualified contractors; 
−Removed: Developed formalized accounting procedures and clearly defined authorities;
−Removed: Engaged third party specialists to assess and document the design of our internal controls over financial reporting including the evaluation of proper segregation of duties, and to identify and evaluate any weaknesses in our information systems;
−Removed: Reported regularly to the audit committee on the progress and results of the remediation plan, including the identification, status and resolution of internal control deficiencies.
−Removed: These actions resulted in an improved internal control environment with enhanced segregation of duties that were in place for a period of time to allow for our management to conclude, based on evidence obtained in validating the design and implementation of these controls, that we have fully remediated this material weakness as of December 31, 2020. 
+Added: Our independent registered public accounting firm will not be required to formally attest to the effectiveness of our internal controls over financial reporting for as long as we are a "non-accelerated filer."
Management's Report on Internal Control Over Financial Reporting
4 unchanged sentences
Changes in Internal Control Over Financial Reporting
−Removed: Except for those remedial actions described above, there was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the period covered by this Annual Report on Form 10-K that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
+Added: There was no change in the Company’s internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the year ended December 31, 2021, that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. 
OTHER INFORMATION.
3 unchanged sentences
Alternatively, a court could find these provisions of our certificate of incorporation to be inapplicable or unenforceable in respect of one or more of the specified types of actions or proceedings, which may require us to incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our business and financial.
+Added: DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
+Added: Not applicable.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
15 unchanged sentences
  The financial statements and notes thereto which are attached hereto have been included by reference into Item 8 of this part of the annual report on Form 10-K.
−Removed: See the Index to Financial Statements on page 62. 
+Added: See the Index to Financial Statements on page below. 
Financial Statement Schedules
  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.
5 unchanged sentences
Amended and Restated Bylaws of Moleculin Biotech., Inc.
−Removed: (incorporated by reference to exhibit 3.2 of the Form S-1/A filed March 21, 2016)
+Added: (incorporated by reference to exhibit 3.1 of the Form 8-K filed December 17, 2021)
Form of Series A/B/C Warrant Agreement issued in February 2017 offering (incorporated by reference to Exhibit 4.1 of the Form 8-K filed February 9, 2017)
9 unchanged sentences
Moleculin Biotech, Inc.
−Removed: Amended and Restated 2015 Stock Plan (incorporated by reference to Annex B to the preliminary proxy statement filed March 27, 2020)
+Added: Amended and Restated 2015 Stock Plan (incorporated by reference to Exhibit 10.1 of the Form 8-K filed June 21, 2021)
Rights Transfer Agreement between Moleculin Biotech, Inc.
42 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 March 22, 2021
−Removed: Subsidiaries of the Registrant (incorporated by reference to Exhibit 21 of the Form 10-K filed February 21, 2019) 
+Added: 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)
+Added: Assignment Consent Letter by and between WPD Pharmaceuticals Sp.
+Added: z o.o and LPC Enterprises, LLC and Moleculin Biotech, Inc.
+Added: (incorporated by reference to Exhibit 10.2 of the Form 8-K filed December 27, 2021)
+Added: At Market Issuance Sales Agreement, dated June 25, 2021, by and among the Company and Oppenheimer & Co.
+Added: (incorporated by reference to Exhibit 1.1 of the Form 8-K filed June 25, 2021)
+Added: Purchase Agreement dated June 25, 2021 by and between Moleculin Biotech, Inc.
+Added: and Lincoln Park Capital Fund, LLC.
+Added: (incorporated by reference to Exhibit 10.1 of the Form 8-K filed June 25, 2021)
+Added: Registration Rights Agreement dated June 25, 2021 by and between Moleculin Biotech, Inc.
+Added: and Lincoln Park Capital Fund, LLC.
+Added: (incorporated by reference to Exhibit 10.2 of the Form 8-K filed June 25, 2021)
+Added: Amendment No.
+Added: 3 to Patent and Technology License Agreement between the Parties dated April 2, 2012, dated May 20, 2020, entered into between the Company and the Board of Regents of The University of Texas System, on behalf of The University of Texas M.D.
+Added: Anderson Cancer Center (incorporated by reference to Exhibit 10.1 of the Form 10-Q filed August 12, 2020)
+Added: Amendment No.
+Added: 4 to Patent and Technology License Agreement between the Parties dated April 2, 2012, dated June 15, 2021, entered into between the Company and the Board of Regents of The University of Texas System, on behalf of The University of Texas M.D.
+Added: Anderson Cancer Center (incorporated by reference to Exhibit 10.4 of the Form 10-Q filed August 12, 2021)
+Added: 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.
+Added: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: Amendment No.
+Added: 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.
+Added: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: 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.
+Added: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: 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.
+Added: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: 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.
+Added: Subsidiaries of the Registrant
Consent of Grant Thornton, LLP
15 unchanged sentences
Confidential treatment has been granted as to certain portions of this exhibit pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
+Added: Pursuant to Item 601(b)(10)(iv) of Regulation S-K promulgated by the SEC, certain portions of this exhibit have been redacted.
+Added: The Company hereby agrees to furnish supplementally to the SEC, upon its request, an unredacted copy of this exhibit.
FORM 10-K SUMMARY
25 unchanged sentences
Elizabeth Cermak
+Added: March 24, 2022
Moleculin Biotech, Inc.
Index to Consolidated Financial Statements
−Removed: Report of Independent Registered Public Accounting Firm
+Added: Report of Independent Registered Public Accounting Firm (PCAOB ID Number 248 )
Consolidated Balance Sheets as of December 31, 2021 and 2020
3 unchanged sentences
Notes to Consolidated Financial Statements
−Removed: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Stockholders
2 unchanged sentences
We have audited the accompanying consolidated balance sheets of Moleculin Biotech, Inc.
−Removed: (a Delaware corporation) and subsidiary (the “Company”) as of December 31, 2020 and 2019, 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, 2020, and the related notes (collectively referred to as the “financial statements”).
+Added: (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2021 and 2020, the related consolidated statements of operations and comprehensive loss, stockholders’
+Added: 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”).
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.
10 unchanged sentences
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
We believe that our audits provide a reasonable basis for our opinion.
+Added: Critical audit matters
+Added: Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
+Added: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: We determined that there are no critical audit matters.
/s/ GRANT THORNTON LLP
40 unchanged sentences
74,671  
−Removed: Subscription receivable  
−Removed: ( 129 )  
+Added: Subscription receivable
Accumulated other comprehensive income
11 unchanged sentences
(in thousands, except share and per share data)
+Added: Year Ended December 31,
Operating expenses:
Research and development
+Added: 14,418  
+Added: 12,757  
General and administrative
1 unchanged sentence
Total operating expenses
+Added: 22,968  
+Added: 19,742  
Loss from operations
+Added: ( 22,968 )  
Other income:
2 unchanged sentences
Interest income, net
−Removed: Net loss before taxes
−Removed: Income tax benefit
+Added: $ ( 15,894 )  
Net loss per common share - basic and diluted
+Added: $ ( 0.59 )  
Weighted average common shares outstanding, basic and diluted
+Added: 26,875,927  
+Added: 9,845,685  
Comprehensive loss:
−Removed: Other comprehensive income (loss):
+Added: $ ( 15,894 )  
+Added: Other comprehensive (loss) income:
Foreign currency translation
+Added: ( 24 )  
Comprehensive loss
+Added: $ ( 15,918 )  
See accompanying notes to these consolidated financial statements.
2 unchanged sentences
(in thousands)
+Added: Year Ended December 31,
Cash flows from operating activities:
+Added: $ ( 15,894 )  
Adjustments to reconcile net loss to net cash used in operating activities:
1 unchanged sentence
Stock-based compensation
−Removed: License rights expense settled in stock
−Removed: Loss (gain) from sale of fixed assets
+Added: Loss from sale of fixed assets
Change in fair value of warrant liability
−Removed: Operating lease, net of sublease receipts
+Added: ( 6,728 )  
+Added: Operating lease, net
Changes in operating assets and liabilities:
3 unchanged sentences
Net cash used in operating activities
+Added: ( 18,951 )  
Cash flows from investing activities:
Purchase of fixed assets
+Added: ( 19 )  
Proceeds from sale of fixed assets
Net cash used in investing activities
+Added: ( 19 )  
Cash flows from financing activities:
−Removed: Proceeds from exercise of stock options
Proceeds from exercise of warrants
Payment of tax liability for vested restricted stock units
+Added: ( 23 )  
Proceeds from sale of common stock, net of issuance costs
+Added: 74,684  
+Added: 22,561  
Net cash provided by financing activities
+Added: 74,724  
+Added: 22,549  
Effect of exchange rate changes on cash and cash equivalents
+Added: ( 24 )  
Net change in cash and cash equivalents
+Added: 55,730  
Cash and cash equivalents, at beginning of year
+Added: 15,173  
+Added: 10,735  
Cash and cash equivalents, at end of year
+Added: $ 70,903  
+Added: $ 15,173  
Supplemental disclosures of cash flow information:
4 unchanged sentences
Subscription receivable
−Removed: Research and development costs settled in stock
See accompanying notes to these consolidated financial statements.
15 unchanged sentences
$ 15,571  
−Removed: Issued for cash - sale of common stock in March 2019, net of issuance costs of $ 617
+Added: Issued for cash - sale of common stock in February 2020, net of issuance costs of $ 709
1,250,000  
−Removed: Issued to Lincoln Park - sale of common stock, net of $ 59 issuance costs
+Added: Issued for cash - sale of common stock pursuant to the 2019 ATM Agreement, net of issuance costs of $ 471
1,412,017  
−Removed: Issued for cash - sale of common stock in April 2019, net of issuance costs of $ 1,300
11,778  
−Removed: Common stock issued for license rights
11,786  
+Added: Issued for cash - sale of common stock pursuant to the 2020 ATM Agreement, net of issuance costs of $ 108
+Added: 471,405  
+Added: Issued for cash - sale of common stock to Lincoln Park, net of issuance costs of $ 575
+Added: 771,220  
+Added: Subscription of common stock in connection with the 2020 ATM Agreement, net of commissions
+Added: 26,966  
+Added: ( 129 )  
Warrants exercised
+Added: Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)
( 17 )  
−Removed: Stock options exercised
Stock based compensation
7 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  
+Added: Balance at December 31, 2021
28,578,338  
5 unchanged sentences
Notes to the Consolidated Financial Statements
−Removed:  Nature of Business
+Added:  Nature of Business 
The terms “MBI”
2 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 we refer to as MD Anderson.
+Added: 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.
MBI formed Moleculin Australia Pty.
1 unchanged sentence
This has enabled the Company to realize the benefits of certain research and development tax credits in Australia.
−Removed: In February 2019, the Company entered into an agreement with Animal Life Sciences, LLC (ALI), where the Company has granted a sublicense to ALI to research, develop, make, have made, use, offer to sell, sell, export or import and commercialize certain licensed products for non-human use and share development data.
−Removed: ALI issued to the Company a 10 % interest in ALI.
−Removed: ALI converted into a corporation and became Animal Life Sciences, Inc.
−Removed: The Company has three core technologies:
−Removed: 1 ) Annamycin which the Company believes is a "next generation" anthracycline;
−Removed: 2 ) Immune/Transcription Modulators, of which WP1066 is a member;
−Removed: and 3 ) Metabolism/Glycosylation Inhibitors, of which WP1122 is a member. The Company has four drug candidates, representing all three core technologies, and three of which have shown human activity in clinical trials. As of the end of 2020, those three drug candidates accounted for five clinical trials in the US and Europe.
−Removed: Two of those trials are ongoing externally funded studies of WP1066 in brain tumors.
−Removed: Two internally funded Phase 1 clinical trials, Annamycin in acute myeloid leukemia (AML), and WP1220 in cutaneous T-cell lymphoma (CTCL), were successfully concluded.
−Removed: An additional Phase 1/2 clinical trial of Annamycin in AML is also internally funded and is currently ongoing.
−Removed: In 2021, we anticipate the initiation of five new clinical trials in addition to the three trials continuing from 2020.
−Removed: In late 2020, MBI received U.S.
−Removed: Food and Drug Administration (FDA) clearance to proceed with an additional Phase 1b/2 clinical trial of Annamycin for the treatment of sarcoma lung metastases and the Company is preparing to begin this trial in the US.
−Removed: MBI also plans to seek approval to begin a Phase 1/2 clinical trial of Annamycin in combination with Ara-C for the treatment of AML in Europe.
−Removed: MBI expects a second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases to be primarily investigator-funded in Europe and the Company plans to begin a Phase 2 clinical study of WP1220 in CTCL.
−Removed: The Company is also working to initiate a clinical trial of WP1122, in either a Phase 1a/1b clinical trial in COVID- 19 or a physician-sponsored clinical trial for a cancer indication, or both.
−Removed: The ultimate course of action depends on the outcome of additional regulatory and preclinical work.
−Removed: These trials may be internally or externally funded, depending on the timing and nature of the studies.
−Removed: In summary, we had five clinical trials underway or concluded in 2020 and we now expect up to eight clinical trials to be underway or approved in 2021.
+Added: 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.
+Added: 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: (WPD or WPD Pharmaceuticals) in exchange for a minimum amount of externally funded collaboration on development in Europe over a certain amount of time.
+Added: This sublicense was last amended in December 2021.
+Added: Also, in 2019, the Company sublicensed its technologies to Animal Life Sciences, Inc.
+Added: (ALI), to enable research and commercialization for non-human use and share development data.
+Added: As part of this agreement, ALI issued to the Company a 10 % interest in ALI. 
+Added: The Company has three core technologies, based substantially on discoveries made at and licensed from MD Anderson.
+Added: 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.
+Added: The Company’s core technologies consist of the following:
+Added: a) Annamycin;
+Added: b) WP1066 Portfolio;
+Added: and c) the 
+Added: WP1122 Portfolio.
+Added: 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 –
+Added: Annamycin, WP1066, WP1220, and WP1122.
+Added: All trials are or were in the Phase 1 portion except the WP1220 trial, which was a proof-of-concept clinical trial.
+Added: In 2021 and early 2022, there were also three “right-to-try”
+Added: (or their foreign equivalent) uses of Annamycin and WP1066.
+Added: The Company plans to conduct additional trials and is in the process of obtaining the appropriate regulatory approval.
+Added: 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.
The Company does not have manufacturing facilities and all manufacturing activities are contracted out to third parties.
−Removed: Additionally, the Company does not have and does not intend to have a sales organization.
−Removed: The Company’s overall strategy is to seek potential outlicensing opportunities with larger pharmaceutical companies who are better suited for the marketing, sales and distribution of our drugs once approved. 
−Removed: COVID- 19 - In March 2020, the World Health Organization declared the outbreak of a novel Coronavirus (COVID- 19 ) as a pandemic, which continues to spread throughout the world.
−Removed: The spread of COVID- 19 has caused significant volatility in US and international markets, including Poland, where MBI conducts some of its clinical trials and Italy, where its drug supply is produced.
−Removed: There has been limited interruption of its drug supply, and most Polish clinics where the Company is conducting trials are limiting access for monitoring activities.
−Removed: Additionally, MBI believes COVID- 19 has materially slowed the recruitment of patients for its trials.
−Removed: This could worsen or be alleviated at any time.
−Removed: Furthermore, there is significant uncertainty around the breadth and duration of business disruptions related to COVID- 19, as well as its impact on the US and international economies and, as such, the Company is unable to determine if it will have a material impact to its operations. Additionally, the Company believes that the potential for impact to its supply chain due to COVID- 19 will be reduced as vaccine production normalizes throughout the industry.
−Removed: In light of current US trends with respect to COVID- 19, MBI does not expect COVID- 19 to materially impact recruitment for current or future US based trials as COVID- 19 hospitalizations have recently decreased.
−Removed: However, the Company cannot be certain that these trends will continue and there is the possibility they may reverse. 
−Removed:  Basis of presentation, principles of consolidation and significant accounting policies
−Removed: Reverse Stock Split - On January 29, 2021, pursuant to authority granted by our stockholders, our board of directors approved a one -for- six reverse stock split of our common stock and the filing of an amendment to our amended and restated certificate of incorporation to effectuate the reverse stock split.
−Removed: The amendment was filed with the Secretary of State of the State of Delaware and the reverse stock split became effective in accordance with the terms of the amendment at 5:00 p.m.
−Removed: Eastern Time on January 29, 2021 ( the “Effective Time”).
−Removed: The amendment provides that, at the Effective Time, every six shares of our issued and outstanding common stock will automatically be combined into one issued and outstanding share of common stock, without any change in par value per share, which will remain $ 0.001 .
+Added: Additionally, the Company does not have a sales organization.
+Added: The Company’s overall strategy is to seek potential outlicensing or outsourcing opportunities with development/commercialization strategic partners who are better suited for the marketing, sales and distribution of its drugs, if approved. 
+Added:  Basis of presentation, principles of consolidation and significant accounting policies 
+Added: 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.
The accompanying consolidated financial statements and notes to the consolidated financial statements gives retroactive effect to the reverse stock split for all periods presented.
Certain amounts in the financial statements, the notes thereto, and elsewhere in the Form 10 -K may be slightly different than previously reported due to rounding up of fractional shares as a result of the reverse stock split.
−Removed: Basis of Presentation - The accompanying consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S.
−Removed: GAAP) for financial information, and in accordance with the rules and regulations of the United States Securities and Exchange Commission (the SEC).
−Removed: Principles of consolidation - The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiary.
+Added: Basis of Presentation - The accompanying consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (US GAAP), and in accordance with the rules and regulations of the United States Securities and Exchange Commission (the SEC).
+Added: Principles of consolidation - The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries.
All intercompany balances and transactions have been eliminated in consolidation.
1 unchanged sentence
All material long-lived assets of the Company reside in the United States.
−Removed: In accordance with FASB ASC Topic 280, Segment Reporting, we view our operations and manage our business as one segment.
−Removed: As a result, the financial information disclosed herein represents all of the material financial information related to our principal operating segment.
+Added: In accordance with FASB ASC Topic 280, Segment Reporting, the Company views its operations and manages its business as one segment.
+Added: As a result, the financial information disclosed herein represents all of the material financial information related to its principal operating segment.
Use of Estimates - The preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.
8 unchanged sentences
Liquidity and Financial Condition 
−Removed: - The Company is an early stage and emerging growth company (EGC) and has not generated any revenues to date.
−Removed: As such, the Company is subject to all of the risks associated with early stage and emerging growth companies.
−Removed: Since inception, the Company has incurred losses and negative cash flows from operating activities.
−Removed: For the years ended December 31, 2020  and 2019 , the Company incurred net losses of $ 17.4  million and $ 13.2  million, respectively, and had net cash flows used in operating activities of $ 17.8  million and $ 17.2  million, respectively.
−Removed: At December 31, 2020 , the Company had an accumulated deficit of $ 56.9  million and cash of $ 15.2  million.
−Removed: Subsequent to December 31, 2020 , we issued equity and received gross proceeds of $ 80.9  million, described more fully below.
−Removed: The Company expects its cash on hand as of December 31, 2020 plus the cash received subsequent to year-end will be sufficient to fund the Company's operations beyond the near term.
+Added: - The Company is an early stage company an d has not generated any revenues to date.
+Added: As such, the Company is subject to all of the risks associated with early stag e companies.
+Added: S ince inception, the Company has incurred losses and negative cash flows from operating activities.
+Added: 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: At December 31, 2021 , the Company had an accumulated deficit of $ 72.8  million an d cash of $ 70.9  million.
+Added: T he Company expects its cash on hand as of December 31, 2021  will be sufficient to fund the Company's operations beyond the near term.
Such projections are subject to changes in the Company’s internally funded preclinical and clinical activities, including unplanned preclinical and clinical activity.
The Company does not expect to experience positive cash flows from operating activities in the near future and anticipates incurring operating losses for the next few years as it supports the development of its core technologies to the point of generating revenue, most likely via outlicensing, and continues to invest in research and development for additional applications of the Company's core technologies and potentially increase its pipeline of drug candidates.
−Removed: The Company anticipates incurring operating losses for the next several years. If we need to raise additional capital in order to continue to execute our 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 us.
−Removed: A failure to raise sufficient capital could adversely impact our ability to achieve our intended business objectives and meet our financial obligations as they become due and payable.
−Removed: Cash and Cash Equivalents - The Company considers all highly liquid accounts with original maturities of three months or less at the date of acquisition to be cash equivalents. Periodically in the ordinary course of business, the Company may carry cash balances at financial institutions in excess of the insured limits of $250,000.
+Added: 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.
+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.
+Added: Cash and Cash Equivalents -  Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents.
+Added: The Company maintains cash accounts principally at one  financial institution in the US, which at times, may exceed the Federal Deposit Insurance Corporation's limit.
+Added: The Company has not experienced any losses from cash balances in excess of the insurance limit.
+Added: The Company’s management does not believe the Company is exposed to significant credit risk at this time due to the financial condition of the financial institution where its cash is held.
Prepaid Expenses and Other Current Assets - Prepaid expenses and other current assets consist of the following (in thousands):
−Removed: Vendor prepayments and deposits
−Removed: $ 1,281  
−Removed: $ 1,857  
Prepaid insurance
−Removed: Other current assets
−Removed: Related party receivables
+Added: Vendor prepayments and deposits
+Added: Prepaid sponsored research
Non-trade receivables
+Added: Related party receivables
Total prepaid expenses and other current assets
1 unchanged sentence
$ 2,025  
−Removed: Vendor prepayments at December 31, 2020 and 2019 includes approximately $ 1.1  million and $ 1.5 million, respectively, for the expansion of Annamycin production commitments on a commercial scale currently expected to be delivered in the first half of 2021 for use in clinical trials.
+Added: 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:
−Removed: Leasehold improvement
+Added: Leasehold improvements
Shorter of estimated useful lives or the term of the lease
−Removed: Computer equipment  
−Removed: 2 years  
−Removed: Software  
−Removed: 3 years  
+Added: Computer equipment
Machinery and equipment
−Removed: 2 to 5 years  
+Added: 2 to 5  
Furniture and office equipment
−Removed: 2 to 7 years  
+Added: 2 to 7  
Intangible assets - Intangible assets with finite lives are amortized using the straight-line method over their estimated period of benefit.
1 unchanged sentence
If the associated research and development effort is abandoned, the related IPR&D assets will be written-off and the Company will record a noncash impairment loss on its statements of operations.
−Removed: For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives.
+Added: 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.
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.
No impairments of intangible assets have been identified during any of the periods presented.
−Removed: 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.
Operating Lease Right-of-Use Asset - The Company determines if an arrangement is a lease at contract inception or during modifications or renewal of an existing lease.
1 unchanged sentence
Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term.
−Removed: The lease payments used to determine the Company's operating lease assets may include lease incentives, stated rent increases and escalation clauses linked to rates of inflation when determinable and are recognized in the Company's operating lease assets in the Company's condensed consolidated balance sheet.
+Added: The lease payments used to determine the Company's operating lease assets may include lease incentives, stated rent increases and escalation clauses linked to rates of inflation when determinable and are recognized in the Company's operating lease assets in the Company's consolidated balance sheet.
The Company has elected the practical expedient and does not separate lease components from nonlease components for its leases.
3 unchanged sentences
Refer to Note 8 - Commitments and Contingencies - Lease Obligations Payable for additional information related to the Company’s operating leases.
−Removed: Cost Method Investment - The Company's cost method investment consists of an investment in a corporation in which it does not have the ability to exercise significant influence over its operating and financial activities.
+Added: Sublicense Arrangement - The Company has a sublicense arrangement which consists of an investment in ALI in which it does not have the ability to exercise significant influence over its operating and financial activities.
Management evaluates this investment for possible impairment quarterly.
25 unchanged sentences
 The following table provides a summary of changes in fair value associated with the Level 3 liabilities for the years ended December 31, 2021 and 2020 (in thousands):
−Removed: Warrant Liability Current  
−Removed: Warrant Liability Long-Term  
−Removed: Warrant Liability Total  
+Added: Warrant Liability Long-Term
December 31, 2019
$ 5,818  
−Removed: $ 1,508  
−Removed: Reclass of liability between long-term and current
−Removed: ( 4,490 )  
Exercise of warrants
−Removed: ( 3,174 )  
Issuances of warrants
−Removed: 11,546  
−Removed: 11,546  
Change in fair value - net
−Removed: ( 4,062 )  
December 31, 2020
$ 8,192  
−Removed: $ 5,818  
Exercise of warrants
−Removed: Issuances of warrants
Change in fair value - net
−Removed: ( 2,346 )  
December 31, 2021
$ 1,412  
−Removed: $ 8,192  
The above table of Level 3 liabilities begins with the valuation as of December 31, 2019 and adjusts the balances for changes that occurred during the years.
6 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 subsidiary is the local currency.
−Removed: For our non-U.S.
−Removed: subsidiary that transacts in a functional currency other than the U.S.
−Removed: 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 our foreign subsidiaries is the local currency.
+Added: 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.
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 U.S.
−Removed: 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 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.
Stock-based Compensation - Stock-based compensation expense includes the estimated fair value of equity awards vested or expected to vest during the reporting period.
1 unchanged sentence
ASC 718 requires all stock-based payments to employees, including grants of employee stock options, restricted stock units, modifications to existing stock options, and equity classified warrants to be recognized in the consolidated statements of operations based on their fair values.
−Removed: The grant date fair value of stock options is determined using the Black-Scholes option pricing model and the grant date fair value of restricted stock awards is determined using the closing price of the Company’s common stock on the date of grant (or if the date of grant is not a business day, on the business day prior to the date of the grant).
+Added: The grant date fair value of stock options and equity classified warrants are calculated using the Black-Scholes option pricing model and the grant date fair value of restricted stock awards is determined using the closing price of the Company’s common stock on the date of grant (or if the date of grant is not a business day, on the business day prior to the date of the grant).
The awards are subject to service vesting conditions.
Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term, net of forfeitures which are recognized as they occur.
−Removed: In 2019, compensation expense related to awards to non-employees with service-based vesting conditions was recognized based on the then-current fair value at each financial reporting date prior to the measurement date over the associated service period of the award, which is generally the vesting term.
−Removed: In 2020, compensation expense related to awards to non-employees with performance-based vesting conditions is recognized based on the grant date fair value. Effective January 1, 2020, the Company began using the volatility of its own stock since it now has sufficient historic data in its stock price.
+Added: Compensation expense related to awards to non-employees with performance-based vesting conditions is recognized based on the grant date fair value. Effective January 1, 2020, the Company began using the volatility of its own stock since it now has sufficient historic data in its stock price.
Loss Per Common Share - Basic net loss per common share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period.
2 unchanged sentences
In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive.
−Removed: For the years ended December 31, 2020 , and 2019 , approximately 3.6  million and approximately 2.0  million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their antidilutive effect.
+Added: For the years ended December 31, 2021 , and 2020 , approximate ly 4.3  million an d approximately 3.6  million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their antidilutive effect.
Research and Development Costs - Research and development costs are expensed as incurred.
1 unchanged sentence
Recent Accounting Pronouncements
−Removed: In August 2018, the FASB issued ASU No.
−Removed: 2018 - 13, Fair Value Measurement (Topic 820 ) (ASU 2018 - 13 ).
−Removed: ASU 2018 - 13 modifies the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, based on the concepts in the Concepts Statement, including the consideration of costs and benefits.
−Removed: The amendments in this ASU are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019.
−Removed: The Company adoption of this pronouncement effective January 1, 2020 
−Removed: did not have a material impact on the Company's consolidated financial statements.
−Removed: In December 2019, the FASB issued ASU No.
−Removed: 2019 - 12, Income Taxes (Topic 740 ) (ASU 2019 - 12 ).
−Removed: ASU 2019 - 12 modifies the requirements for the timing of adoption of enacted change in tax law.
−Removed: The effects of changes on taxes currently payable or refundable for the current year must be reflected in the computation of annual effective tax rate in the first interim period that includes the enactment date of the new legislation, beginning after December 15, 2020.
−Removed: Early adoption is permitted upon issuance of this ASU.
−Removed: The Company adoption of this pronouncement effective December 15, 2020 did not have a material impact on the Company's consolidated financial statements. 
−Removed: In August 2020, the FASB issued ASU No.
+Added: In August 2020, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU No.
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 amends the guidance for the derivatives scope exception for contracts in an entity's own equity to reduce form-over-substance-based accounting conclusions.
−Removed: The Board observed that the application of the derivatives scope exception guidance results in accounting for some contracts as derivatives while accounting for economically similar contracts as equity.
−Removed: The Board also decided to improve and amend the related EPS guidance.
−Removed: The amendments in this Update are effective for public business entities that meet the definition of a Securities and Exchange Commission (SEC) filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years.
−Removed: Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years.
−Removed: The Company is currently evaluating the impact that this standard will have, if any, on its 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 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: In May 2021, 
+Added: the FASB issued ASU No.
+Added: 2021 - 04, Earnings Per Share (Topic 260 ), Debt - Modifications and Extinguishments (Subtopic 470 - 50 ), Compensation - Stock Compensation (Topic 718 ), and Derivatives and Hedging - Contracts in Entity's Own Equity (Subtopic 815 - 40 ):
+Added: Issuer's Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.
+Added: 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.
+Added: 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.
+Added: Early adoption is permitted for all entities, including adoption in an interim period.
+Added: The Company’s adoption of this pronouncement effective January 1, 2022 
+Added: is not expected to 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.
7 unchanged sentences
Accrued expenses and other current liabilities at December 31, 2021 and 2020 consist of the following components (in thousands):
−Removed: Accrued chemistry manufacturing and control costs
+Added: Accrued research and development
+Added: $ 1,005  
Accrued payroll and bonuses
−Removed: Accrued clinical activities
−Removed: Accrued legal, regulatory, and professional
−Removed: Accrued license fees and sponsored research agreements
+Added: Accrued legal, regulatory, professional and other
+Added: Accrued liabilities due to related party
Operating lease liability - current
−Removed: Accrued other
−Removed: Related party payable
Total accrued expenses and other current liabilities
−Removed: Additionally, Accounts payable includes $ 48,000 and zero as of December 31, 2020 and 2019, respectively, for a related party payable to HPI. 
+Added: $ 2,258  
+Added: $ 1,791  
+Added: Additionally, accounts payable includes $ 48,000 as of December 31, 2021  and 2020 , respectively, for a related party payable to HPI. 
Warrants 
−Removed: Upon its issuance of warrants to purchase shares of common stock, the Company evaluates the terms of the warrant issue to determine the appropriate accounting and classification of the warrant issue pursuant to FASB ASC Topic 480, Distinguishing Liabilities from Equity, FASB ASC Topic 505, Equity, FASB ASC 815, Derivatives and Hedging, and ASC 718.
+Added: Upon its issuance of warrants to purchase shares of common stock, the Company evaluates the terms of the warrant issue to determine the appropriate accounting and classification of the warrant issue pursuant to FASB ASC Topic 480, Distinguishing Liabilities from Equity, FASB ASC Topic 505, Equity, FASB ASC 815, Derivatives and Hedging, and ASC 718, Compensation - Stock Compensation.
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.
26 unchanged sentences
875,001  
−Removed: Issued February 2020  
+Added: Issued February 2020
1,015,001  
2 unchanged sentences
2,733,645  
+Added: $ 9.46  
Equity Classified Warrants
2 unchanged sentences
$ 45.00  
−Removed: $ 45.00  
Issued July 2017 - Consulting (3)
3 unchanged sentences
16,667  
−Removed: 16,667  
Issued August 2019 - Consulting
1 unchanged sentence
25,000  
−Removed: Issued April 2020 - Consulting  
+Added: Issued April 2020 - Consulting
16,667  
−Removed: Issued December 2020 - Consulting  
16,667  
+Added: Issued December 2020 - Consulting
+Added: Issued April 2021 - Consulting
71,500  
+Added: Issued August 2021 - Consulting
250,000  
+Added: 396,502  
+Added: 109,639  
+Added: $ 4.59  
Balance outstanding
9 unchanged sentences
The Company uses the Black-Scholes option pricing model (BSM) to determine the fair value of its warrants at the date of issue and outstanding at each reporting date.
−Removed: The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S.
−Removed: Treasury bonds linearly interpolated to obtain a maturity period commensurate with the term of the warrants.
+Added: The risk-free interest rate assumption is based upon observed interest rates on zero coupon US Treasury bonds linearly interpolated to obtain a maturity period commensurate with the term of the warrants.
Estimated volatility is a measure of the amount by which the Company's stock price is expected to fluctuate each year during the expected life of the warrants.
−Removed: Beginning in 2020, only the volatility of the Company's own stock is used in the BSM as it now has sufficient historic data in its stock price.
−Removed: In 2019, the Company used the volatility of its own stock blended with the volatility of peer entities due to the lack of sufficient historical data of its stock price.
+Added: Beginning in 2020, only the volatility of the Company's own stock is used in the BSM as it now has sufficient historic data in its stock price. 
The assumptions used in determining the fair value of the Company’s outstanding liability classified warrants are as follows:
19 unchanged sentences
( 10,000 )  
−Removed: 6.30 0 to 6.30 30
$ 6.60  
−Removed: ( 750 )  
−Removed: 6.60 0 to 6.60 60
−Removed: $ 6.60  
−Removed: Outstanding at December 31, 2020  
+Added: Outstanding at December 31, 2021
2,723,645  
1 unchanged sentence
$ 9.46  
−Removed: Vested and Exercisable at December 31, 2020  
+Added: Vested and Exercisable at December 31, 2021
2,723,645  
7 unchanged sentences
Equity Classified Warrants
+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: In August 2021, the Company entered into a portfolio development 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 $ 3.08 .
+Added: 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;
+Added: 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 
+Added: and August 2021 warrants vest in full if there is a change of control event, as defined in the agreement.
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.
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, 2020  the Company had 109,639  equity classified warrants outstanding and 85,472 warrants were exercisable.
−Removed: At December 31, 2019 , the Company had 84,638  equity classified warrants outstanding and all were exercisable.
−Removed: The Company recorded stock compensation expense for the non-employee consulting agreements of $ 5,000 and $ 94,000  for the years ended December 31, 2020 and 2019 , respectively.
+Added: At December 31, 2021  the Company had 396,502 equity classified warrants outstanding and 186,560 warrants were exercisable.
+Added: At December 31, 2020 , the Company had 109,639 equity classified warrants outstanding and 85,472 were exercisable.
+Added: 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.
At December 31, 2021 , there was $ 548,000 o f unrecognized stock compensation expense related to the Company's equity-classified warrants.
 Equity 
−Removed: The Company is authorized to issue 105,000,000 shares of which 5,000,000 shares of preferred stock are authorized and 100,000,000 shares of common stock are authorized.
Preferred Stock
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.
−Removed: As of December 31, 2020 , the Company has not issued any preferred stock.
+Added: No preferred stock was issued or outstanding as of 
+Added: December 31, 2021 .
Common Stock 
+Added: February 2021 Stock Offering
+Added: 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.
+Added: The Company received total proceeds of $ 78.0  million, prior to deducting the underwriting discount and other estimated offering expenses. 
February 2020 
3 unchanged sentences
See Note 5  - Warrants for equity classified warrants granted during the year ended December 31, 2020.
−Removed: Lincoln Park Transaction 
−Removed: In October 2018, the Company entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC (Lincoln Park).
−Removed: Pursuant to the terms of the Purchase Agreement, Lincoln Park agreed to purchase from us up to $ 20.0 million of our common stock (subject to certain limitations) from time to time during the term of the Purchase Agreement.
−Removed: Pursuant to the terms of the Registration Rights Agreement, we filed with the SEC a registration statement to register for resale under the Securities Act the shares that have been or may be issued to Lincoln Park under the Purchase Agreement.
−Removed: Pursuant to the terms of the Purchase Agreement, at the time we signed the Purchase Agreement and the Registration Rights Agreement, we issued 40,503 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the Purchase Agreement and agreed to issue an additional 20,252  commitment shares pro-rata when and if Lincoln Park purchased (at the Company's discretion) the $ 20.0 million aggregate commitment.
−Removed: The commitment shares were valued at $ 0.3 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. During the year ended 2019, the Company issued 117,674 shares to Lincoln Park which included 1,007  commitment shares for $ 1.0  million.
−Removed: In November 2020, the Company terminated its purchase agreement dated October 2018 with Lincoln Park.
−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).
+Added: Lincoln Park Equity Line  
+Added: In June 2021, the Company entered into a Purchase Agreement (the 2021 Purchase Agreement) with Lincoln Park Capital Fund.
+Added: 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.
+Added: 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: 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.
+Added: There have been no additional shares issued to date under this agreement.
+Added: 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).
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.
4 unchanged sentences
At Market Issuance Sales Agreements (ATM) 
−Removed: In July 2019, the Company entered into an At Market Issuance Sales Agreement (the “2019 ATM Agreement”) with Oppenheimer & Co.
−Removed: (the “Agent”).
−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 “Shares”). 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. 
+Added: In June 2021, the Company entered into an At Market Issuance Sales Agreement (the 2021 ATM Agreement) with Oppenheimer & Co.
+Added: 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.
+Added: As of the date of this report, there have been no issuances under the 2021 ATM Agreement.
+Added: 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.
+Added: The Company terminated the 2020 ATM Agreement on February 2, 2021. 
July 2020, we entered into a new At Market Issuance Sales Agreement with Oppenheimer & Co.
5 unchanged sentences
The Company terminated the 2020 ATM Agreement on February 2, 2021. 
+Added: In July 2019, the Company entered into an At Market Issuance Sales Agreement (the 2019 ATM Agreement) with Oppenheimer & Co.
+Added: 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.
+Added: The Company also provided the Agent with customary indemnification rights.
+Added: 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.
+Added: In the third quarter of 2020, the 2019 ATM Agreement expired and was terminated. 
Adoption of 2015 Stock Plan
3 unchanged sentences
The expiration date of the plan is December 
−Removed: 5, 2025 and the total number of underlying shares of the Company’s common stock available for grant to employees, directors and consultants under the plan is currently 1,750,001  shares, including the amendments.
The awards under the 2015 Stock Plan can be in the form of stock options, stock awards, stock unit awards, or stock appreciation rights.
3 unchanged sentences
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, 2020 , there were 726,493  shares remaining to be issued under the 2015 Stock Plan.
+Added: As of December 31, 2021 , there wer e 41,628  s hares remaining to be issued under the 2015 Stock Plan.
Stock-based compensation expense for the years ended December 31, 2021 and 2020 is as follows (in thousands):
13 unchanged sentences
Additionally, the Company’s stock options provide for full vesting of unvested outstanding options, in the event of a change of control of the Company.
−Removed: The fair value of each stock option is estimated on the date of grant using the Black-Scholes option valuation model that uses the assumptions noted below.
+Added: The fair value of each stock option is estimated on the date of grant using the BSM model that uses the assumptions noted below.
The expected term of the stock option awards was computed using the “plain vanilla”
method as prescribed by the Securities and Exchange Commission Staff Accounting Bulletin 107 because the Company does not have sufficient data regarding employee exercise behavior to estimate the expected term.
−Removed: Beginning in 2020, the Company used the volatility of its own stock in the BSM as it now has sufficient historic data in its stock price.
−Removed: Prior to 2020, the volatility was determined by referring to the average historical volatility of a peer group of public companies combined with its own due to the lack of sufficient historical data of its stock price.
−Removed: The risk-free rate for periods within the contractual life of the option is based on the U.S.
−Removed: Treasury yield curve in effect at the time of grant.
+Added: Beginning in 2020, the Company used the volatility of its own stock in the BSM as it now has sufficient historic data in its stock price. The risk-free rate for periods within the contractual life of the option is based on the US Treasury yield curve in effect at the time of grant.
The fair value of the option grants has been estimated, with the following weighted-average assumptions:
22 unchanged sentences
$ 3.74  
−Removed: Exercised  
−Removed: ( 3,334 )  
−Removed: $ 5.34  
−Removed: $ 6.36  
Outstanding, December 31, 2021
6 unchanged sentences
$ 13.39  
−Removed: Options granted during 2020 have an aggregated fair value of $ 1.3  million that was calculated using the Black-Scholes option-pricing model.
−Removed: At December 31, 2020 , total compensation cost not yet recognized was $ 2.6  million and the weighted average period over which this amount is expected to be recognized is 2.5  years.
−Removed: The aggregate fair value of options vesting in the years ended December 31, 2020 and 2019 was $ 1.5  million and $ 1.3  million, respectively.
−Removed: In July 2020, the Company granted 224,964 employee stock options.
−Removed: In August 2020, the Company issued 16,667 options to Dr.
−Removed: Waldemar Priebe, one of the Company's founders and chair of the Company's Scientific Advisory Board.
−Removed: In October 2020, the Company granted 6,667 stock options, with 3 -year annual vesting upon appointment of Elizabeth Cermak to the Company's Board of Director's. 
+Added: 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.
+Added: 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.
+Added: T he aggregate fair value of options vesting was $ 1.5 million in the years ended December 31, 2021 and 2020 , respectively.
+Added: Subsequent to December 31, 2021, the Company granted 21,667 options.
Restricted Stock
17 unchanged sentences
$ 4.59  
−Removed: As of December 31, 2020 , total compensation cost not yet recognized was $ 0.5  million and the weighted average period over which this amount is expected to be recognized is 3.0  years.
+Added: As of December 31, 2021 , total compensation cost not yet recognized was $ 0.8  million a nd the weighted average period over which this amount is expected to be recognized is 2.9  years.
+Added: 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.
 Income Taxes 
31 unchanged sentences
( 37 )  
−Removed: Research and development tax credits
−Removed: Uncertain tax provision
( 0.2 )%  
+Added: Uncertain tax provision
( 57 )  
13 unchanged sentences
Federal net operating loss carryforwards
+Added: 10,866  
State tax loss carryforwards
11 unchanged sentences
$ ( 6 )  
−Removed: ROU Asset  
( 23 )  
3 unchanged sentences
The Company has incurred net operating losses since inception.
−Removed: As of December 31, 2020 , the Company had total U.S.
−Removed: federal operating loss carry forwards of approximately $ 38  million.
−Removed: Of this, $ 6.0 million will expire commencing in 2035, with the rest having no set expiration date.
+Added: As of December 31, 2021 , the Company had total US federal operating loss carry forwards of approximately $ 52  million.
+Added: Of 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.
5 unchanged sentences
However, the Company believes that this matter is not material to the overall tax position within the financial statements due to the full valuation allowance against the net operating losses and the lack of utilization of the net operating losses during tax years open under statute.
−Removed: The Company conducts business in various locations and, as a result, files income tax returns in the United States Federal jurisdiction and in multiple state jurisdictions.
−Removed: As of December 31, 2020 , the Company had state operating losses of approximately $ 1.2  million which expire commencing in 2032.
−Removed: Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S.
−Removed: federal, state and local income tax authorities for all tax years in which a loss carryforward is available.
+Added: The Company conducts business in various locations and, as a result, files income tax returns in the United States federal jurisdiction, in multiple state jurisdictions, and internationally as required.
+Added: As of December 31, 2021 , the Company had state operating losses of approximate ly $ 1.9  million which expire commencing in 2032.
+Added: Since the Company is in a loss carryforward position, the Company is generally subject to examination by the US federal, state and local income tax authorities for all tax years in which a loss carryforward is available.
Management has evaluated the positive and negative evidence for the realizability of its deferred tax assets.
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, 2021 .
−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 $ 13.9  million and $ 9.4  million has been established at December 31, 2020 and 2019 , 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 $ 18.8  million a nd $ 13.9  million has been established at December 31, 2021 and 2020 , respectively.
The change in the valuation allowance for the year ended December 31, 2021 was primarily due to additional operating losses and capitalized research costs.
The Company undertakes research and development (R&D) activities that qualify for certain tax credits for US and Australian income tax purposes.
−Removed: The Company has a full valuation allowance against its U.S.
−Removed: federal R&D tax credits.
−Removed: For the 2018 tax year, the Company claimed an Australian credit of approximately $ 0.2 million on its 2018 Australian tax return.
−Removed: For the 2020 tax year, the potential U.S.
−Removed: and Australian research and development tax credits are not expected to be significant.
−Removed: The company has a liability for unrecognized tax benefits of $ 0.1 million (excluding accrued interest and penalties) as of December 31, 2020 .
+Added: The Company has a full valuation allowance against its US federal R&D tax credits. For the 2021 tax year, the potential US and Australian research and development tax credits are not expected to be significant.
+Added: The Company has a liability for unrecognized tax benefits o f $ 0.2  million (excluding accrued interest and penalties) as of December 31, 2021 .
+Added: The Company's policy is to record interest and penalties related to income taxes as part of its income tax provision.
A reconciliation of the beginning and ending unrecognized tax benefits excluding interest and penalties is as follows (in thousands): 
8 unchanged sentences
December 31, 2021 within the next year.
−Removed:  Commitments and Contingencies 
−Removed: In addition to the commitments and contingencies described elsewhere in these notes, see below for a discussion of the Company's commitments and contingencies as of December 31, 2020 . 
+Added:  Commitments and Contingencies  
+Added: In addition to the commitments and contingencies described elsewhere in these notes, see below for a discussion of the Company's commitments and contingencies for the years ended 
+Added: December 31, 2021 , and December 31, 2020 , respectively. 
Lease Obligations Payable
13 unchanged sentences
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  and $ 14,000  in sublease income from the related party for the year ended December 31, 2020  and December 31, 2019 , respectively.
−Removed: Sublease income is recorded as other income on the Company's condensed consolidated statement of operations and comprehensive loss.
+Added: 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: Sublease income is recorded as other income on the Company's consolidated statement of operations and comprehensive loss.
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.
11 unchanged sentences
Operating cash flows from operating leases
−Removed: Right-of-use assets obtained in exchange for lease liabilities:
−Removed: Operating leases
As of December 31, 2021 , future minimum leases under ASC 842 under the Company's operating leases were as follows (in thousands):
6 unchanged sentences
As of December 31, 2021 , the weighted average remaining lease term for operating leases is 1.7  years , and the weighted average discount rate is 9.6 %.
−Removed: The 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: 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. 
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.
3 unchanged sentences
Not all of these payments are applicable to every drug.
−Removed: Total expenses under these agreements were $ 255,000  and $ 240,000 , respectively, for the years ended December 31, 2020 and 2019 .
−Removed: On June 29, 2017, the Company entered into an agreement with MD Anderson licensing certain technology related to the method of preparing Liposomal Annamycin. On March 22, 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 dated February 12, 2018 with MD Anderson related to WP1732.
+Added: 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.
+Added: Total expenses under these agreements were $ 267,000  
+Added: and $ 255,000 , respectively, for the years ended 
+Added: December 31, 2021  and 
+Added: On June 29, 2017, the Company entered into a Patent and Technology License Agreement with MD Anderson licensing certain technology related to the method of preparing Liposomal Annamycin and on December 17, 2021 the Company entered into an amendment to this agreement to include certain technology related to the method of reconstituting Liposomal Annamycin.
+Added: On December 2, 2021, the Company entered into a Patent and Technology License Agreement with MD Anderson licensing certain technology related to lung targeted therapies with Annamycin.
+Added: The terms and payments of these agreements are included in the summary above under “Commitments and Contingencies –
+Added: Licenses –
+Added: MD Anderson”.
+Added: The terms of these agreements extend until the later of 20 years from the effective date of the agreements, or the expiration of the last-to-expire licensed patent.
+Added: In addition, commencing on the four -year anniversary of each agreement, MD Anderson has the right to remove any jurisdiction from such agreement, upon 90 days’
+Added: notice, if the Company has not commercialized or is not using commercially reasonable efforts actively and effectively to attempt to commercialize a licensed invention in such jurisdiction.
WP1122 Portfolio
−Removed: The rights and obligations to an April 2012 Patent and Technology License Agreement entered into by and between IntertechBio and MD Anderson (the “IntertechBio Agreement”) have been assigned to MBI.
+Added: 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.
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.
−Removed: This agreement was amended in May 2020 to allow for the extension of certain milestones.
+Added: 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.
+Added: The 2012 Agreement was amended in May 2020 to allow for the extension of certain milestones.
The initial milestone required the Company to file an IND with the FDA for a Phase I study by February 20, 2021.
−Removed: The Company extended the deadline for this milestone by six months by making the required extension payment, and the Company has the right to receive two additional six -month extensions in the future by making additional extension payments.
+Added: The Company extended the deadline for this milestone by six months by making the required extension payment, and the Company has the right to receive two additional six -month extensions in the future by making additional extension payments. On August 3, 2021, the Company filed a CTA for the application of WP1122 in the United Kingdom to commence a Phase 1a clinical trial of WP1122.
+Added: MD Anderson agreed that this CTA filing would further extend the deadline to file an IND with the FDA for a Phase I study until February 2022.
+Added: In December 2021, the Company submitted an IND for the treatment of GBM with WP1122 to the FDA, thus meeting the IND filing milestone.
+Added: 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.
+Added: 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;
+Added: or if the Company fails to commence a Phase 2 study for licensed product prior to November 20, 2024.
+Added: 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.
+Added: 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: or if the Company fails to commence a Phase 1 study for licensed product prior to December 3, 2026.
+Added: 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.
WP1066 Portfolio
−Removed: The rights and obligations to a June 2010 Patent and Technology License Agreement entered into by and between Moleculin LLC and MD Anderson (the “Moleculin Agreement”) have been assigned MBI.
+Added: The rights and obligations to a June 2010 Patent and Technology License Agreement entered into by and between Moleculin LLC and MD Anderson (the “2010 Agreement”) have been assigned MBI.
Therefore, MBI has obtained a royalty-bearing, worldwide, exclusive license to intellectual property rights, including patent rights, related to its WP1066 drug product candidate.
−Removed: In consideration, the Company must make payments to MD Anderson including an up-front payment, milestone payments and minimum annual royalty payments for sales of products developed under the license agreement.
−Removed: Annual Maintenance fee payments will no longer be due upon marketing approval in any country of a licensed product.
+Added: On February 3, 2022, the Company entered into a new patent and technology license agreement (the “2022 Agreement”) with MD Anderson licensing certain technology related to WP1066 checkpoint inhibitors.
+Added: In consideration for these agreements, the Company must make payments to MD Anderson including an up-front payment, milestone payments and minimum annual royalty payments for sales of products developed under the license agreement.
+Added: Annual Maintenance fee payments will no longer be due upon marketing approval in any country of a licensed product under the 2010 Agreement.
One-time milestone payments are due upon commencement of the first Phase III study for a licensed product within the United States, Europe, China or Japan;
1 unchanged sentence
and upon receipt of the first marketing approval for sale of a licensed product in the United States.
−Removed: The rights the Company has obtained pursuant to the assignment of the Moleculin Agreement are made subject to the rights of the U.S.
−Removed: government to the extent that the technology covered by the licensed intellectual property was developed under a funding agreement between MD Anderson and the U.S.
+Added: The term of the 2010 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.
+Added: The term of the 2022 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.
+Added: 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.
+Added: The Company believes that to 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).
−Removed: Under the HPI Out-Licensing Agreement the Company was required to make quarterly payments totaling $ 0.75 million for the first twelve quarters following the effective date of the HPI Out-Licensing Agreement, or May 2, 2016, in consideration for the right to development data related to the development of licensed products.
−Removed: Notwithstanding the Company's obligation to make the foregoing payments, the HPI Out-Licensing Agreement did not obligate HPI to conduct any research or to meet any milestones.
−Removed: Upon payment in the amount of $ 1.0 million to HPI within three years of the effective date of the HPI Out-Licensing Agreement (HPI Option Repurchase Payment) 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 other than the aforementioned quarterly payments.
−Removed: The option repurchase payment was paid on April 30, 2019 for $ 1.0  million and, accordingly, the HPI Out-Licensing Agreement was terminated.
−Removed: The $ 1.0  million payment was accrued and expensed under research and development in 2018.
−Removed: Total expenses related to HPI were $ 284,000  and $ 75,000 , for the years ended December 31, 2020 and 2019 , respectively. On March 16, 2020, the Company entered into two agreements with HPI.
+Added: 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.
+Added: In March 2020, the Company entered into two agreements with HPI.
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.
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.
+Added: Total expenses related to HPI were $ 234,000  
+Added: and $ 284,000 , for the years ended December 31, 2021 and 2020 , respectively. 
Sponsored Research Agreements with MD Anderson
−Removed: In January 2017, MBI amended its Sponsored Laboratory Study Agreement with MD Anderson where it was extended to the end of October 2018.
−Removed: In December 2017, MBI extended this Agreement until the end of October 2019 for total payment amount of $ 347,000  spread over that period of time.
−Removed: In September 2018, the Company extended this Agreement until the end of October 2020 for total payment amount of $ 395,000  spread over that period of time.
−Removed: In June 2019, the Company amended the Agreement to support the continuation of the project for total payment amount of $ 438,000 .
−Removed: In October 2019, the Company amended the agreement until the end of October 2021 for a total additional payment amount of $ 395,000 .
−Removed: In February 2021, the Company amended the agreement until the end of December 2022 for a total additional payment amount of $ 1.0  million.
−Removed: The expenses recognized under the MD Anderson agreement with regards to the Sponsored Laboratory Study were $ 629,000  and $ 544,000 , respectively for the years ended December 31, 2020 and 2019 .
+Added: MBI has a Sponsored Laboratory Study Agreement with MD Anderson expiring December 31, 2022.
+Added: 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.
+Added: 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 .
Other Licenses
1 unchanged sentence
Zoo (Dermin).
−Removed: In connection with such agreements, certain intellectual property rights related to Annamycin, our WP1122 portfolio, and our WP1066 portfolio have been licensed to Dermin and Dermin has been 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.
−Removed: With respect to Annamycin, the license is limited to the countries of Poland, Ukraine, Czech Republic, Hungary, Romania, Slovakia, Belarus, Lithuania, Latvia, Estonia, Netherlands, Turkey, Belgium, Switzerland, Austria, Sweden, Greece, Portugal, Norway, Denmark, Ireland, Finland, Luxembourg, Iceland, Kazakhstan, Russian Federation, Uzbekistan, Georgia, Armenia, Azerbaijan and Germany;
−Removed: provided that we have the right to remove Germany from the list of covered territories with a $ 0.5 million payment.
−Removed: With respect to WP1122, the license is limited to the countries of Belarus, Russia, Kazakhstan, Uzbekistan, Turkmenistan, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia and Ukraine.
−Removed: With respect to WP1066, the license is limited to the countries of Belarus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia and Ukraine.
−Removed: In each case, Dermin will pay a royalty for the sale of any licensed product in the licensed territories and will pay all out-of-pocket expenses incurred in filing, prosecuting and maintaining the licensed patents for which the license has been granted in the licensed territories.
−Removed: Dermin also agreed to provide a percentage of certain consideration that Dermin receives pursuant to sublicense agreements.
−Removed: In July 2019, Dermin assigned its rights under the foregoing license agreements to an affiliated entity, Exploration Invest Pte Ltd.
+Added: 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.
+Added: In July 2019, Dermin assigned its rights under the foregoing license agreements to an affiliated entity of Dermin, Exploration Invest Pte Ltd.
(Exploration).
−Removed: On July 30, 2019, the Company and Exploration entered into a License Modification 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:
+Added: 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:
(i) limit the licensed territory solely to Poland;
1 unchanged sentence
In August 2019, the Company issued 71,663  shares of Company common stock to Exploration to satisfy this commitment.
−Removed: WPD Pharmaceuticals
+Added: 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.
+Added: The Company paid $ 0.4 million to Exploration in February 2022 to satisfy this commitment.
+Added: As such, all of the above licenses have been terminated.
+Added: WPD Pharmaceuticals 
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 amended on March 22, 2021 ( such agreement as amended, the “WPD Agreement”).
+Added: (WPD), which sublicense was last amended on December 20, 2021 ( such agreement 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”).
+Added: Waldemar Priebe, one of the Company’s founders and largest shareholder.
+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).
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.
For purposes of the WPD Agreement, the term “Commercially Reasonable Development Efforts”
−Removed: 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 on the research, development and commercialization of products in the licensed territories;
−Removed: and (ii) $ 1.0  million annually for the four years thereafter on the research and development of products in the licensed territories.
−Removed: This license is subject to the terms in the prior agreements entered into by the Company with Dermin and MDA.
−Removed: WPD is actively seeking Polish government grants for research involving licensed drug candidates.
−Removed: Prior to approval of the original WPD Agreement, the Company's board of directors received a fairness opinion from Roth Capital Partners, LLC that stated that it was their opinion that the consideration the Company will receive from WPD pursuant to the WPD Agreement is fair, from a financial point of view, to the Company.
−Removed: Prior to approval of the amendment to the WPD Agreement, the Company's board of directors received a fairness opinion from Maxim Group LLC that stated that it was their opinion that the consideration the Company will receive from WPD pursuant to the amended WPD Agreement is fair, from a financial point of view, to the Company.
+Added: (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:
+Added: (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;
+Added: and (ii) $ 2.1  million annually for the five years thereafter on the research and development of products in the licensed territories.
+Added: The total CRDE required by the sublicense is $ 14.0 million.
+Added: 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.
+Added: 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:
+Added: (i) more than $14.0 million in Commercially Reasonable Development Efforts, the override royalty percentage will decrease to 0.75% of net sales;
+Added: or (ii) more than $17.0 million in Commercially Reasonable Development Efforts, the override royalty percentage will decrease to 0.5% of net sales.
+Added: With certain exceptions, the WPD Agreement will remain in full force and effect until the expiration of the last patent within the sublicensed patents.
+Added: 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.
Animal Life Sciences
4 unchanged sentences
This license is subject to the terms in the prior agreements entered into by the Company and MDA.
−Removed: Under the ALI Agreement, the Company has the right to name an observer to ALI's board of directors.
−Removed: In August 2019, the Company named its Chairman and CEO Walter V.
−Removed: Klemp to that position.
−Removed: Since ALI and WPD are beginning the process to develop and commercialize products using the sublicensed intellectual property rights, the Company is currently unable to predict whether ALI and WPD will be successful in developing such products or when the Company may recognize royalty revenues related to such products.
Employment Agreements
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, 2020 .
+Added: The base salary and certain other benefits would aggregate approximately $ 0.9  million  using the rate of compensation in effect at December 31, 2021 .
 Subsequent Events 
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: Reverse Stock Split 
−Removed: On January 29, 2021, pursuant to authority granted by our stockholders, the Company's board of directors approved a one -for- six reverse stock split of our common stock and the filing of an amendment to the Company's amended and restated certificate of incorporation to effectuate the reverse stock split.
−Removed: The amendment was filed with the Secretary of State of the State of Delaware and the reverse stock split became effective in accordance with the terms of the amendment at 5:00 p.m.
−Removed: Eastern Time on January 29, 2021 ( the “Effective Time”).
−Removed: The amendment provides that, at the Effective Time, every six shares of the Company's issued and outstanding common stock will automatically be combined into one issued and outstanding share of common stock, without any change in par value per share, which will remain $ 0.001 .
−Removed: The accompanying consolidated financial statements and notes to the consolidated financial statements gives retroactive effect to the reverse stock split for all periods presented.
−Removed: Certain amounts in the financial statements, the notes thereto, and elsewhere in the Form 10 -K may be slightly different than previously reported due to rounding of fractional shares as a result of the Reverse Stock Split.
−Removed: Issuances of Equity and Warrant Exercises
−Removed: Subsequent to December 31, 2020, the Company issued equity and received gross proceeds of $ 80.9  million.
−Removed: During January 2021 it issued approximately 469,000 shares for gross proceeds of $ 2.9  million using its At The Market Agreement with Oppenheimer & Co., Inc., discussed above.
−Removed: Additionally, on February 3, 2021, MBI announced the pricing of an underwritten public offering of an aggregate of 14,273,684 shares of common stock at a public offering price of $ 4.75 per share.
−Removed: The Company 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.
−Removed: The offering closed on February 5, 2021 and gross proceeds of the offering were approximately $ 67.8 million, prior to deducting the underwriting discount and other estimated offering expenses.
−Removed: On February 10, 2021, the underwriters of the public offering exercised in full their option to purchase an additional 2,141,052 shares of common stock at the public offering price of $ 4.75 per share, bringing total gross proceeds to approximately $ 78.0 million before underwriting discount.
−Removed: Subsequent to December 31, 2020 and through the date of filing of these financial statements, 10,000 shares were issued due to the exercise of various warrants related to past public offerings.
−Removed: Gross proceeds due to these exercises approximated $ 63,000 .   
+Added: In February 2022, the Company and Exploration Invest Pte Ltd.
+Added: (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.
+Added: The Company paid $ 0.4 million to Exploration in February 2022 to satisfy this commitment.
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.