−Removed: CONTROLS AND PROCEDURES 
+Added: CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
−Removed: Our management has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the end of the period covered by this Form 10-K.
−Removed: The term “disclosure controls and procedures,”
−Removed: as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission's rules and forms and that such information is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding disclosure.
−Removed: Management concluded that our disclosure controls and procedures were effective as of December 31, 2022.
+Added: Our management has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the end of the period covered by this Form 10-K.
+Added: The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission's rules and forms and that such information is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding disclosure.
+Added: Management concluded that our disclosure controls and procedures were effective as of December 31, 2023.
Attestation Report of the Registered Public Accounting Firm
1 unchanged sentence
Management's Report on Internal Control Over Financial Reporting
−Removed: Our principal executive officer and our principal accounting and financial officer, are responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f).
+Added: Our principal executive officer and our principal accounting and financial officer, are responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f).
Management conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2023.
In making this assessment, management used the criteria described in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
−Removed: Our management concluded that our internal controls over financial reporting were effective as of December 31, 2022.
+Added: Our management concluded that our internal control over financial reporting was effective as of December 31, 2023.
Changes in Internal Control Over Financial Reporting
−Removed: 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, 2022, that has materially affected, or is reasonably likely to materially affect, the Company’s 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, 2023, that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
OTHER INFORMATION.
1 unchanged sentence
This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or Securities Act.
−Removed: This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and employees.
+Added: This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and employees.
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: During the three months ended December 31, 2023, no director or officer of the Company adopted or terminated a "Rule 10b5 - 1 trading arrangement” or “non-Rule 10b5 - 1 trading arrangement,” as each term is defined in Item 408 (a) of Regulation S-K.
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
2 unchanged sentences
The information required by this item is incorporated by reference to our proxy statement for the 2024 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2023 and is incorporated into this Annual Report on Form 10-K by reference.
−Removed: Our Board of Directors has adopted a written Code of Business Conduct and Ethics applicable to all officers, directors and employees, which is available on our website (www.moleculin.com) under “Governance Documents”
−Removed: within the “Corporate Governance”
+Added: Our Board of Directors has adopted a written Code of Business Conduct and Ethics applicable to all officers, directors and employees, which is available on our website (www.moleculin.com) under “Governance Documents” within the “Corporate Governance” section.
We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding amendment to, or waiver from, a provision of this Code and by posting such information on the website address and location specified above.
10 unchanged sentences
Financial Statements
−Removed:   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 below. 
+Added: 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.
+Added: See the Index to Financial Statements on page below.
Financial Statement Schedules
−Removed:   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: All schedules are omitted because they are inapplicable or not required or the required information is shown in the financial statements or notes thereto.
+Added: EXHIBIT INDEX
Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc.
4 unchanged sentences
(incorporated by reference to Exhibit 3.1 of the Form 8-K filed January 29, 2021)
+Added: Certificate of Amendment of the Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc.
+Added: (incorporated by reference to Exhibit 3.1 of the Form 8-K filed March 19, 2024)
Amended and Restated Bylaws of Moleculin Biotech., Inc.
(incorporated by reference to exhibit 3.1 of the Form 8-K filed December 17, 2021)
−Removed: 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)
−Removed: Form of Warrant Agreement issued in February 2018 offering (incorporated by reference to Exhibit 4.1 of the Form 8-K filed February 16, 2018)
−Removed: Form of Warrant Agreement issued in June 2018 offering (incorporated by reference to Exhibit 4.1 of the Form 8-K filed June 21, 2018)
Form of Warrant Agreement issued in March 2019 offering (incorporated by reference to Exhibit 4.1 of the Form 8-K filed March 28, 2019)
4 unchanged sentences
Form of Placement Agent Warrant Agreement issued in February 2020 offering (incorporated by reference to Exhibit 4.2 of the Form 8-K filed February 6, 2020)
−Removed: Description of Registrant's Securities (incorporated by reference to Exhibit 4.10 of the Form 10-K filed March 24, 2022)
+Added: Description of Registrant's Securities (incorporated by reference to Exhibit 4.10 of the Form 10-K filed March 24, 2022)
+Added: Form of Pre-Funded Warrant Agreement issued in December 2023 offering (incorporated by reference to Exhibit 4.1 of the Form 8-K filed December 21, 2023)
+Added: Form of Common Warrant Agreement issued in December 2023 offering (incorporated by reference to Exhibit 4.2 of the Form 8-K filed December 21, 2023)
Moleculin Biotech, Inc.
−Removed: Amended and Restated 2015 Stock Plan (incorporated by reference to Exhibit 10.1 of the Form 8-K filed June 21, 2021)
+Added: Amended and Restated 2015 Stock Plan, as amended (incorporated by reference to Exhibit 4.5 of the Form S-8 file number 333-272814)
Rights Transfer Agreement between Moleculin Biotech, Inc.
14 unchanged sentences
(incorporated by reference to exhibit 10.13 of the Form S-1/A filed April 15, 2016)
−Removed: 10.10 **
−Removed: Employment Agreement between Moleculin Biotech, Inc.
−Removed: and Jonathan P.
−Removed: Foster dated August 19, 2016 (incorporated by reference to Exhibit 10.1 of the Form 8-K filed August 25, 2016)
−Removed: 10.11 **
−Removed: Executive Employment Agreement between Moleculin Biotech, Inc.
−Removed: and Walter Klemp dated October 13, 2016 (incorporated by reference to Exhibit 10.1 of the Form 8-K filed October 13, 2016)
Lease Agreement for 5300 Memorial (incorporated by reference to Exhibit 10.1 of the Form 10-Q filed May 14, 2018)
−Removed: 10.13 †
Patent And Technology License Agreement dated February 12, 2018 by and between The Board of Regents of The University Of Texas System on behalf of The University Of Texas M.
1 unchanged sentence
(incorporated by reference to Exhibit 10.2 of the Form 10-Q filed May 14, 2018)
−Removed: Sublicense Agreement dated as of February 19, 2019 entered into between the Company and Animal Life Sciences, LLC (incorporated by reference to Exhibit 10.22 of the Form 10-K filed February 21, 2019) 
+Added: Sublicense Agreement dated as of February 19, 2019 entered into between the Company and Animal Life Sciences, LLC (incorporated by reference to Exhibit 10.22 of the Form 10-K filed February 21, 2019)
Consulting Agreement, dated March 16, 2020, entered into between the Company and Houston Pharmaceuticals, Inc.
−Removed: (HPI) (incorporated by reference to Exhibit 10.24 of the Form 10-K filed March 19, 2020) 
+Added: (HPI) (incorporated by reference to Exhibit 10.24 of the Form 10-K filed March 19, 2020)
Equipment Lab Letter, dated March 16, 2020, entered into between the Company and Houston Pharmaceuticals, Inc.
−Removed: (HPI) (incorporated by reference to Exhibit 10.25 of the Form 10-K filed March 19, 2020) 
−Removed: 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)   
+Added: (HPI) (incorporated by reference to Exhibit 10.25 of the Form 10-K filed March 19, 2020)
+Added: 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)
Purchase Agreement dated June 25, 2021 by and between Moleculin Biotech, Inc.
11 unchanged sentences
Patent And Technology License Agreement dated June 29, 2017 by and between The Board of Regents of The University Of Texas System on behalf of The University Of Texas M.
−Removed: Anderson Cancer Center and Moleculin Biotech, Inc. (incorporated by reference to Exhibit 10.30 of the Form 10-K filed March 24, 2022)
+Added: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: (incorporated by reference to Exhibit 10.30 of the Form 10-K filed March 24, 2022)
Amendment No.
1 to the Patent And Technology License Agreement dated June 29, 2017 by and between The Board of Regents of The University Of Texas System on behalf of The University Of Texas M.
−Removed: Anderson Cancer Center and Moleculin Biotech, Inc. (incorporated by reference to Exhibit 10.31 of the Form 10-K filed March 24, 2022)
+Added: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: (incorporated by reference to Exhibit 10.31 of the Form 10-K filed March 24, 2022)
Patent And Technology License Agreement dated December 2, 2021 by and between The Board of Regents of The University Of Texas System on behalf of The University Of Texas M.
−Removed: Anderson Cancer Center and Moleculin Biotech, Inc. (incorporated by reference to Exhibit 10.32 of the Form 10-K filed March 24, 2022)
+Added: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: (incorporated by reference to Exhibit 10.32 of the Form 10-K filed March 24, 2022)
Patent And Technology License Agreement dated December 3, 2021 by and between The Board of Regents of The University Of Texas System on behalf of The University Of Texas M.
−Removed: Anderson Cancer Center and Moleculin Biotech, Inc. (incorporated by reference to Exhibit 10.33 of the Form 10-K filed March 24, 2022)
+Added: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: (incorporated by reference to Exhibit 10.33 of the Form 10-K filed March 24, 2022)
Patent And Technology License Agreement dated February 3, 2022 by and between The Board of Regents of The University Of Texas System on behalf of The University Of Texas M.
−Removed: Anderson Cancer Center and Moleculin Biotech, Inc. (incorporated by reference to Exhibit 10.34 of the Form 10-K filed March 24, 2022)
−Removed: 10.27* +
+Added: Anderson Cancer Center and Moleculin Biotech, Inc.
+Added: (incorporated by reference to Exhibit 10.34 of the Form 10-K filed March 24, 2022)
Patent and Technology License Agreement dated October 21, 2022 by and between The Board of The University Of Texas System on behalf of The University Of Texas M.D.
Anderson Cancer Center and Moleculin Biotech, Inc.
−Removed: Subsidiaries of the Registrant  
+Added: (incorporated by reference to Exhibit 10.27 of the Form 10-K filed March 22, 2023)
+Added: First Amendment to Commercial Lease Agreement (incorporated by reference to Exhibit 10.1 of the Form 10-Q filed November 13, 2023)
+Added: Form of Securities Purchase Agreement from December 2023 offering (incorporated by reference to Exhibit 10.1 of the Form 8-K filed December 21, 2023)
+Added: Form of Placement Agency Agreement from December 2023 offering (incorporated by reference to Exhibit 10.2 of the Form 8-K filed December 21, 2023)
+Added: Amended and Restated Employment Agreement between Moleculin Biotech, Inc.
+Added: and Walter V.
+Added: Klemp dated January 4, 2024 (incorporated by reference to Exhibit 10.1 of the Form 8-K filed January 5, 2024)
+Added: Amended and Restated Employment Agreement between Moleculin Biotech, Inc.
+Added: and Jonathan P.
+Added: Foster dated January 4, 2024 (incorporated by reference to Exhibit 10.2 of the Form 8-K filed January 5, 2024)
+Added: Employment Agreement between Moleculin Biotech, Inc.
+Added: and Donald Picker dated January 4, 2024 (incorporated by reference to Exhibit 10.3 of the Form 8-K filed January 5, 2024)
+Added: Subsidiaries of the Registrant (incorporated by reference to Exhibit 21 of the Form 10-K filed March 22, 2023)
Consent of Grant Thornton, LLP
5 unchanged sentences
Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
+Added: Moleculin Biotech, Inc.
+Added: Restatement Recoupment Policy
Inline XBRL Instance Document
40 unchanged sentences
Index to Consolidated Financial Statements
−Removed: Report of Independent Registered Public Accounting Firm (PCAOB ID Number 248 )
−Removed: Consolidated Balance Sheets as of December 31, 2022 and 2021
−Removed: Consolidated Statements of Operations and Comprehensive Loss for the Years ended December 31, 2022 and 2021
−Removed: Consolidated Statements of Cash Flows for the Years ended December 31, 2022 and 2021
−Removed: Consolidated Statements of Stockholders' Equity for the Years ended December 31, 2022 and 2021
+Added: Report of Independent Registered Public Accounting Firm (PCAOB ID Number 248 )
+Added: Consolidated Balance Sheets as of December 31, 2023 and 2022
+Added: Consolidated Statements of Operations and Comprehensive Loss for the Years ended December 31, 2023 and 2022
+Added: Consolidated Statements of Cash Flows for the Years ended December 31, 2023 and 2022
+Added: Consolidated Statements of Stockholders' Equity for the Years ended December 31, 2023 and 2022
Notes to Consolidated Financial Statements
4 unchanged sentences
We have audited the accompanying consolidated balance sheets of Moleculin Biotech, Inc.
−Removed: (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, stockholders’
−Removed: equity, and cash flows for each of the two years in the period ended December 31, 2022, and the related notes (collectively referred to as the “financial statements”).
+Added: (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2023, 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, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
+Added: Going concern
+Added: The accompanying financial statements have been prepared assuming that the Company will continue as a going concern.
+Added: As discussed in Note 2 to the financial statements, the Company has incurred an accumulated deficit of $131.6 million since inception and has not generated any revenue from operations.
+Added: These conditions, along with other matters as set forth in Note 2, raise substantial doubt about the Company’s ability to continue as a going concern.
+Added: Management’s plans in regard to these matters are also described in Note 2.
+Added: The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for opinion
−Removed: These financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: These financial statements are the responsibility of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
2 unchanged sentences
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
−Removed: As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
+Added: As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
6 unchanged sentences
(1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: We determined that there are no critical audit matters.
+Added: We determined that there were no critical audit matters.
/s/ GRANT THORNTON LLP
−Removed: We have served as the Company’s auditor since 2017.
−Removed: Houston, Texas
+Added: We have served as the Company’s auditor since 2017.
+Added: Fort Lauderdale, Florida
March 22, 2024
4 unchanged sentences
Cash and cash equivalents
+Added: $ 23,550 $ 43,145
Prepaid expenses and other current assets
Total current assets
+Added: 26,273 45,596
Furniture and equipment, net of accumulated depreciation of $ 896 and $ 769 , respectively
Intangible assets
+Added: 11,148 11,148
Operating lease right-of-use asset
+Added: $ 38,217 $ 57,422
Liabilities and Stockholders' Equity
1 unchanged sentence
Accounts payable
+Added: $ 2,498 $ 2,095
Accrued expenses and other current liabilities
10 unchanged sentences
Additional paid-in capital
−Removed: Accumulated other comprehensive income
+Added: 157,653 153,985
+Added: Accumulated other comprehensive (loss) income
Accumulated deficit
+Added: ( 131,604 ) ( 101,835 )
Total stockholders' equity
+Added: 26,073 52,191
Total liabilities and stockholders' equity
+Added: $ 38,217 $ 57,422
See accompanying notes to these consolidated financial statements.
5 unchanged sentences
Research and development
+Added: 19,487 18,968
General and administrative
+Added: 10,017 11,542
Depreciation and amortization
Total operating expenses
+Added: 29,631 30,640
Loss from operations
+Added: ( 29,631 ) ( 30,640 )
Other income:
−Removed: Gain from change in fair value of warrant liability
+Added: (Loss) gain from change in fair value of warrant liability
+Added: ( 1,044 ) 1,335
+Added: Transaction costs allocated to warrant liabilities
Other income, net
Interest income, net
+Added: $ ( 29,769 ) $ ( 29,025 )
Net loss per common share - basic and diluted
+Added: $ ( 15.07 ) $ ( 15.22 )
Weighted average common shares outstanding, basic and diluted
+Added: 1,975,610 1,906,960
Comprehensive loss:
+Added: $ ( 29,769 ) $ ( 29,025 )
Other comprehensive (loss) income:
Foreign currency translation
+Added: ( 21 ) ( 29 )
Comprehensive loss
+Added: $ ( 29,790 ) $ ( 29,054 )
See accompanying notes to these consolidated financial statements.
4 unchanged sentences
Cash flows from operating activities:
+Added: $ ( 29,769 ) $ ( 29,025 )
Adjustments to reconcile net loss to net cash used in operating activities:
1 unchanged sentence
Stock-based compensation
+Added: License rights expense settled in stock
Change in fair value of warrant liability
+Added: 1,044 ( 1,335 )
Operating lease, net
1 unchanged sentence
Prepaid expenses and other current assets
+Added: ( 272 ) ( 857 )
Accounts payable
1 unchanged sentence
Net cash used in operating activities
+Added: ( 24,101 ) ( 27,639 )
Cash flows from investing activities:
Purchase of fixed assets
+Added: ( 124 ) ( 67 )
Net cash used in investing activities
+Added: ( 124 ) ( 67 )
Cash flows from financing activities:
−Removed: Proceeds from exercise of warrants
Payment of tax liability for vested restricted stock units
−Removed: Proceeds from sale of common stock, net of issuance costs
+Added: ( 25 ) ( 23 )
+Added: Proceeds from sale of common stock, pre-funded and common warrants, net of issuance costs
+Added: Transaction costs allocated to warrant liabilities
Net cash provided by (used in) financing activities
Effect of exchange rate changes on cash and cash equivalents
+Added: ( 21 ) ( 29 )
Net change in cash and cash equivalents
+Added: ( 19,595 ) ( 27,758 )
Cash and cash equivalents, at beginning of year
+Added: 43,145 70,903
Cash and cash equivalents, at end of year
+Added: $ 23,550 $ 43,145
+Added: Supplemental disclosures of cash flow information:
+Added: Non-cash investing and financing activities:
+Added: Purchases of property and equipment in accounts payable and accrued liabilities
+Added: Offering costs included in accounts payable and accrued liabilities
+Added: Issuance of common stock to acquire license rights
See accompanying notes to these consolidated financial statements.
Moleculin Biotech, Inc.
−Removed: Consolidated Statements of Stockholders’
+Added: Consolidated Statements of Stockholders’ Equity
(in thousands except for shares and per unit)
−Removed: Common Stock Subscribed
Par Value Amount
−Removed: Par Value Amount
Additional Paid-In-Capital
Accumulated Deficit
−Removed: Accumulated Other Comprehensive Income
−Removed: Subscription Receivable
+Added: Accumulated Other Comprehensive Income (Loss)
Stockholders' Equity
Balance at December 31, 2021
−Removed: 11,536,720  
−Removed: 26,966  
−Removed: $ 74,671  
−Removed: $ ( 56,916 )  
−Removed: $ ( 129 )  
−Removed: $ 17,760  
−Removed: Issued for cash - sale of common stock in Q1 2021, net of issuance costs of $ 6,159
−Removed: 16,883,420  
−Removed: ( 26,966 )  
−Removed: 74,537  
−Removed: 74,684  
−Removed: Reverse stock split
−Removed: 14,285  
−Removed: ( 60 )  
−Removed: Issuance of common stock with equity purchase agreement, net of issuance costs of $ 403
−Removed: 107,788  
−Removed: Issuance of common stock in connection with Consulting Agreement
−Removed: Warrants exercised
−Removed: 10,000  
+Added: 1,905,223 $ 29 $ 151,733 $ ( 72,810 ) $ 41 $ 78,993
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)
−Removed: 21,125  
−Removed: ( 23 )  
+Added: 3,300 — ( 23 ) — — ( 23 )
Stock based compensation
−Removed: Consolidated net loss
−Removed: ( 15,894 )  
+Added: — — 2,275 2,275
+Added: — — — ( 29,025 ) — ( 29,025 )
Cumulative translation adjustment
−Removed: ( 24 )  
+Added: — — — — ( 29 ) ( 29 )
Balance at December 31, 2022
−Removed: 28,578,338  
−Removed: $ 151,733  
−Removed: $ ( 72,810 )  
−Removed: $ 78,993  
+Added: 1,908,523 $ 29 $ 153,985 $ ( 101,835 ) $ 12 $ 52,191
+Added: Issued for cash - sale of common stock, pre-funded and common warrants, net of allocated issuance costs of $ 57
+Added: 240,151 3 728 — — 731
+Added: Issuance of common stock with equity purchase agreement
+Added: 15,038 — 210 — — 210
+Added: Common stock issued for license rights
+Added: 54,808 1 771 — — 772
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)
−Removed: 49,489  
−Removed: ( 23 )  
+Added: 8,996 — ( 25 ) — — ( 25 )
Stock based compensation
−Removed: Consolidated net loss
−Removed: ( 29,025 )  
+Added: — — 1,984 — — 1,984
+Added: — — — ( 29,769 ) — ( 29,769 )
Cumulative translation adjustment
−Removed: ( 29 )  
+Added: — — — — ( 21 ) ( 21 )
Balance at December 31, 2023
−Removed: 28,627,827  
−Removed: $ 153,985  
−Removed: $ ( 101,835 )  
−Removed: $ 52,191  
+Added: 2,227,516 $ 33 $ 157,653 $ ( 131,604 ) $ ( 9 ) $ 26,073
See accompanying notes to these consolidated financial statements.
1 unchanged sentence
Notes to the Consolidated Financial Statements
−Removed:  Nature of Business 
−Removed: The terms “MBI”
−Removed: or “the Company”, “we”, “our”
−Removed: and “us”
−Removed: 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 clinical programs for hard-to-treat cancers and viruses. The Company has three core technologies, each of which have had one or more drugs successfully complete a Phase 1 clinical trial, based substantially on discoveries made at and licensed from MD Anderson Cancer Center (MD Anderson) in Houston, Texas. 
−Removed: MBI formed Moleculin Australia Pty.
−Removed: Ltd., (MAPL), a wholly owned subsidiary in June 2018, to perform certain preclinical development in Australia.
−Removed: This has enabled the Company to realize the benefits of certain research and development tax credits in Australia.
−Removed: In July 2021, MBI formed Moleculin Amsterdam B.V., a wholly owned subsidiary, primarily to act as its legal representative for clinical trials in Europe for Moleculin Biotech, Inc.
−Removed: In 2019, the Company sublicensed essentially all of the rights to its technologies in over 25  countries in Europe and Asia to WPD Pharmaceuticals Sp.z o.o.
−Removed: (WPD or WPD Pharmaceuticals) in exchange for a minimum amount of externally funded collaboration on development in Europe over a certain amount of time.
−Removed: This sublicense was terminated in March 2023 as described further below.
−Removed: As a result to this termination, the Company now has the world-wide rights to its technology. 
−Removed: Also, in 2019, the Company sublicensed its technologies to Animal Life Sciences, Inc.
−Removed: (ALI), to enable research and commercialization for non-human use and share development data.
−Removed: As part of this agreement, ALI issued to the Company a 10 % interest in ALI. 
−Removed: 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.
+Added: Nature of Business
+Added: The terms “MBI” or “the Company”, “we”, “our” and “us” are used herein to refer to Moleculin Biotech, Inc.
+Added: MBI is a clinical-stage pharmaceutical company, organized as a Delaware corporation in July 2015, with clinical programs for hard-to-treat cancers and viruses.
+Added: The Company has three core technologies, each of which have had one or more drugs successfully complete a Phase 1 clinical trial, based substantially on discoveries made at and licensed from MD Anderson Cancer Center (MD Anderson) in Houston, Texas.
+Added: The Company has two wholly owned subsidiaries, Moleculin Australia Pty.
+Added: Ltd., which was set up to perform certain preclinical development and Moleculin Amsterdam B.V., which acts as its legal representative for clinical trials in Europe.
+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.
+Added: The physician-sponsored trials utilize primarily external funds, such as 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 a sales organization.
−Removed: 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. 
−Removed:  Basis of presentation, principles of consolidation and significant accounting policies 
−Removed: Reverse Stock Split - On January 29, 2021, the Company filed a Certificate of Amendment to its amended and restated certificate of incorporation with the Secretary of State and the State of Delaware to effect a reverse stock split of all the issued and outstanding shares of the Company's common stock at a ratio of 1 for 6 .
+Added: Additionally, the Company does not have a sales organization.
+Added: The Company’s overall strategy is to seek potential out-licensing or outsourcing opportunities with development/commercialization strategic partners who are better suited for the marketing, sales and distribution of its drugs, if approved.
+Added: I n 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 % equity interest in ALI.
+Added: On May 5, 2023, the Company received a letter from the Nasdaq Capital Market (Nasdaq) notifying the Company that for the prior 30 consecutive business days the bid price for the Company's common stock had closed below the minimum $ 1.00 per share requirement for continued inclusion on Nasdaq pursuant to Nasdaq Listing Rule 5550 (a)( 2 ) (Bid Price Rule).
+Added: The deficiency letter did not result in the immediate delisting of the Company's common stock from the Nasdaq.
+Added: In accordance with Nasdaq Listing Rule 5810 (c)( 3 )(A), the Company was provided an initial period of 180 calendar days, until November 1, 2023, to regain compliance with the Bid Price Rule.
+Added: On November 2, 2023, the Company received a 180 -calendar day extension, until April 29, 2024, from the Nasdaq to regain compliance with Bid Price Rule.
+Added: On October 3, 2023, the Company held a Special Meeting of Stockholders (special meeting).
+Added: The Company's stockholders granted the Board of Directors the authority to effect an amendment to the Company’s amended and restated certificate of incorporation to effect a reverse stock split of the outstanding shares of the Company’s common stock, at a reverse stock split ratio of between 1 -for- 5 and 1 -for- 20 as determined by the Board in its sole discretion, prior to the one -year anniversary of the Special Meeting.
+Added: On March 5, 2024, the Board of Directors approved a reverse 1 -for- 15 reverse stock split effective 11:59 P.M.
+Added: (Eastern time) on March 21, 2024, with trading to commence on a split-adjusted basis on March 22, 2024.
+Added: If, at any time before April 29, 2024, the bid price for the Company's common stock closes at $ 1.00 or more for a minimum of 10 consecutive business days, the Nasdaq Staff will provide written notification to the Company that it complies with the Bid Price Rule, unless the Staff exercises its discretion to extend this 10 day period pursuant to Nasdaq Listing Rule 5810 (c)( 3 )(G).
+Added: If the Company does not regain compliance with the Bid Price Rule by April 29, 2024, the Nasdaq Staff will provide written notification to the Company that its common stock may be delisted.
+Added: The Company would then be entitled to appeal the Nasdaq Staff’s determination to a NASDAQ Listing Qualifications Panel and request a hearing.
+Added: There can be no assurance that, if the Company does appeal a delisting determination by the Nasdaq Staff to the NASDAQ Listing Qualifications Panel, that such appeal would be successful.
+Added: There can be no assurance that the Company will be able to regain compliance with the Bid Price Rule.
+Added: Basis of presentation, principles of consolidation and significant accounting policies
+Added: Reverse Stock Split - On March 22, 2024, pursuant to authority granted by our stockholders, the Company effected a one -for- fifteen 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.
+Added: 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 11:59 P.M.
+Added: (Eastern time) on March 21, 2024, with trading to commence on a split-adjusted basis on March 22, 2024.
+Added: The amendment provides that, at the effective time, every fifteen 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 at $ 0.001 .
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 (US GAAP), and in accordance with the rules and regulations of the United States Securities and Exchange Commission (the SEC).
+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).
Principles of consolidation - The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries.
13 unchanged sentences
fair value estimates on intangible assets, warrants, and stock-based compensation expense, as well as accrued expenses and taxes.
−Removed: Liquidity and Financial Condition 
−Removed: - The Company is an early stage company an d has not generated any revenues to date.
−Removed: As such, the Company is subject to all of the risks associated with early stag e companies.
−Removed: S ince inception, the Company has incurred losses and negative cash flows from operating activities.
−Removed: For the years ended December 31, 2022  and 2021 , the Company incurred net losses o f $ 29.0  million a nd $ 15.9  million, respectively, and had net cash flows used in operating activities of $ 27.6  million a nd $ 19.0  million, respectively.
−Removed: At December 31, 2022 , the Company had an accumulated deficit of$ 101.8  million an d cash of $ 43.1  million.
−Removed: T he Company expects its cash on hand as of December 31, 2022  will be sufficient to fund the Company's operations beyond the near term.
−Removed: Such projections are subject to changes in the Company’s internally funded preclinical and clinical activities, including unplanned preclinical and clinical activity.
−Removed: 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: If the Company needs to raise additional capital in order to continue to execute its business plan, there is no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to the Company.
−Removed: A failure to raise sufficient capital could adversely impact the Company's ability to achieve its intended business objectives and meet its financial obligations as they become due and payable. In March 2022, the Company received a subpoena from the SEC requesting information and documents, including materials related to certain individuals ( none of which are the Company's officers or directors) and entities, and materials related to the development of and statements regarding the Company's drug candidate for the treatment of COVID- 19.
−Removed: The Company has received, and expects to continue to receive, periodic further requests from the SEC staff with respect to this matter.
−Removed: The Company is 
−Removed: not aware of the specific nature of the underlying investigation by the SEC, and to the extent that this investigation relates to prior public disclosures that it has made, the Company believes in the accuracy and adequacy of such prior disclosures.
+Added: Going Concern and Liquidity - These consolidated financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and discharge its liabilities in the normal course of business.
+Added: The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain necessary financing to continue operations and the attainment of profitable operations.
+Added: As of December 31, 2023 , the Company had an accumulated defic it of $ 131.6 million since inception and had not yet generated any revenues from operations.
+Added: Additionally, management anticipates that its cash on hand of $ 23.6 million a s of December 31, 2023 is not sufficient to fund its planned operations for a period of at least one year from when these consolidated financial statements are issued.
+Added: These factors raise substantial doubt regarding the Company's ability to continue as a going concern.
+Added: These consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
+Added: The Company intends to seek additional funding through one or more of the following:
+Added: a combination of equity offerings, debt financings, government or other third -party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof.
+Added: There can be no assurance that such events or a combination thereof can be achieved.
+Added: In March 2022, the Company received a subpoena from the SEC requesting information and documents, including materials related to certain individuals ( none of which are the Company's officers or directors) and entities, and materials related to the development of and statements regarding the Company's drug candidate for the treatment of COVID- 19.
+Added: The Company has received, and expects to continue to receive, periodic further requests from the SEC staff with respect to this matter.
+Added: The Company is not aware of the specific nature of the underlying investigation by the SEC, and to the extent that this investigation relates to prior public disclosures that it has made, the Company believes in the accuracy and adequacy of such prior disclosures.
The correspondence from the SEC transmitting the subpoena to the Company states that the SEC is trying to determine whether there have been any violations of federal securities laws, but that its investigation does not mean that the SEC has concluded that anyone has violated the law or that the SEC has a negative opinion of any person, entity, or security.
−Removed: The Company cannot predict when this matter will be resolved or what, if any, action the SEC may take following the conclusion of the investigation.
−Removed: During the year ended December 31, 2022, the Company has expensed approximately $ 2.4  million in related legal fees and expenses. 
−Removed: Cash and Cash Equivalents -  Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents.
−Removed: 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.
−Removed: The Company has not experienced any losses from cash balances in excess of the insurance limit.
−Removed: 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.
+Added: The Company cannot predict when this matter will be resolved or what, if any, action the SEC may take following the conclusion of the investigation.
+Added: The Company expensed approximately $ 1.5 million and $ 2.4 million in related general and administrative fees and expenses for the twelve months ended December 31, 2023 and 2022 respectively, which has impacted and may continue to impact our liquidity.
+Added: The Company is in the process of filing a claim with its insurance carriers related to this loss which may cover a portion of the related expenses but not all.
+Added: The claim is currently under review by the insurance company.
+Added: The claim has not yet been approved nor has a reimbursement amount been determined.
+Added: Accordingly, the Company has not recorded any provision for insurance reimbursement as of December 31, 2023 .
+Added: The Company expects to record any potential insurance reimbursement at the time that the amount to be reimbursed is determined and approved by the insurance carrier.
+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 of $250,000.
+Added: The Company considers all highly liquid accounts with original maturities of three months or less to be cash equivalents.
+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.
+Added: As of December 31, 2023 , there was $ 0.3 million of cash on hand in a bank account in Australia and there is no known limitations impacting the Company's liquidity in Australia.
Prepaid Expenses and Other Current Assets - Prepaid expenses and other current assets consist of the following (in thousands):
Prepaid sponsored research
−Removed: $ 1,028  
−Removed: Vendor prepayments and deposits
+Added: $ 1,515 $ 1,028
Prepaid insurance
−Removed: Related party receivables
+Added: Vendor prepayments and deposits
Non-trade receivables
+Added: Related-party receivables
Total prepaid expenses and other current assets
−Removed: $ 2,451  
−Removed: $ 1,594  
+Added: $ 2,723 $ 2,451
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:
3 unchanged sentences
Machinery and equipment
−Removed: 2 to 5  
Furniture and office equipment
−Removed: 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. 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.
+Added: For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives.
+Added: 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.
The Company evaluates the recoverability of intangible assets periodically and take into account events or circumstances that warrant revised estimates of useful lives or that indicate that impairment exists.
8 unchanged sentences
Short-term leases, defined as leases that have a lease term of 12 months or less at the commencement date, are excluded from this treatment and are recognized on a straight-line basis over the term of the lease.
−Removed: Refer to Note 8 - Commitments and Contingencies - Lease Obligations Payable for additional information related to the Company’s operating leases.
+Added: Refer to Note 8 - Commitments and Contingencies - Lease Obligations Payable for additional information related to the Company’s operating leases.
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.
6 unchanged sentences
Assets and liabilities recorded in the balance sheets at fair value are categorized based on a hierarchy of inputs as follows:
−Removed: Level 1 –
−Removed: Unadjusted quoted prices in active markets of identical assets or liabilities.
−Removed: Level 2 –
−Removed: Quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
−Removed: Level 3 –
−Removed: Unobservable inputs for the asset or liability.
−Removed: The Company’s financial assets and liabilities recorded at fair value on a recurring basis include the fair value of its warrant liability discussed in Note 5.
+Added: Level 1 – Unadjusted quoted prices in active markets of identical assets or liabilities.
+Added: Level 2 – Quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
+Added: Level 3 – Unobservable inputs for the asset or liability.
+Added: The Company’s financial assets and liabilities recorded at fair value on a recurring basis include the fair value of its warrant liability discussed in Note 5.
The following table provides the financial assets and liabilities reported at fair value and measured on a recurring basis at December 31, 2023 and 2022 (in thousands):
5 unchanged sentences
December 31, 2023
+Added: $ 4,855 $ — $ — $ 4,855
December 31, 2022
−Removed: $ 1,412  
−Removed: $ 1,412  
−Removed:  The following table provides a summary of changes in fair value associated with the Level 3 liabilities for the years ended December 31, 2022 and 2021 (in thousands):
+Added: $ 77 $ — $ — $ 77
+Added: The following table provides a summary of changes in fair value associated with the Level 3 liabilities for the years ended December 31, 2023 and 2022 (in thousands):
Warrant Liability Long-Term
December 31, 2021
−Removed: $ 8,192  
−Removed: Exercise of warrants
Change in fair value - net
December 31, 2022
−Removed: $ 1,412  
+Added: Issuances of warrants
Change in fair value - net
8 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 the Company's foreign subsidiaries is the local currency.
−Removed: For the Company's non-US subsidiaries that transact in a functional currency other than the US dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date.
+Added: Translation of Foreign Currencies - The functional currency for the Company's foreign subsidiaries is the local currency.
+Added: For the Company's non-US subsidiaries that transact in a functional currency other than the US dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date.
Income and expense items are translated at the average foreign currency rates for the period.
−Removed: Adjustments resulting from the translation of the financial statements of the Company's foreign operations into US dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of equity.
+Added: Adjustments resulting from the translation of the financial statements of the Company's foreign operations into US dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of equity.
Stock-based Compensation - Stock-based compensation expense includes the estimated fair value of equity awards vested or expected to vest during the reporting period.
−Removed: The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation (ASC 718 ).
−Removed: 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 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).
+Added: The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation (ASC 718 ).
+Added: 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 grant date fair values.
+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: 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.
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.
For purposes of this calculation, options to purchase common stock, restricted stock units subject to vesting and warrants to purchase common stock were considered to be common stock equivalents.
+Added: Shares of the Company's common stock underlying pre-funded warrants are included in the calculation of basic and diluted earnings per share.
Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents.
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, 2022 , and 2021 , approximate ly 5.5  million an d approximately 4.3  million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their antidilutive effect.
−Removed: Research and Development Costs - Research and development costs are expensed as incurred. These costs consist primarily of salaries and benefits of research and development personnel, costs related to research activities, preclinical studies, clinical trials, drug manufacturing and allocated overhead and facility-related expenses.
−Removed: Subsequent Events - The Company’s management reviewed all material events through the date these consolidated financial statements were issued for subsequent event disclosure consideration as described in Note 9 and elsewhere in other notes to the financial statements.
+Added: For the years ended December 31, 2023 , and 2022 , approximate ly 0.5 million and 0.4 million ( t aking into account the reverse stock splits we have completed) of potentially dilutive shares were excluded from the computation of diluted loss per share due to their antidilutive effect.
+Added: Research and Development Costs - Research and development costs are expensed as incurred.
+Added: These costs consist primarily of salaries and benefits of research and development personnel, costs related to research activities, preclinical studies, clinical trials, drug manufacturing and allocated overhead and facility-related expenses.
+Added: Subsequent Events - The Company’s management reviewed all material events through the date these consolidated financial statements were issued for subsequent event disclosure consideration as described in Note 9 and elsewhere in other notes to the financial statements.
Recent Accounting Pronouncements
−Removed: In August 2020, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU No.
−Removed: 2020 - 06, Debt with Conversion and Other Options (Subtopic 470 - 20 ) and Derivatives and Hedging - Contracts in Entity's Own Equity (Subtopic 815 - 40 ) (ASU 2020 - 06 ).
−Removed: ASU 2020 - 06 simplifies the complexity associated with applying US GAAP for certain financial instruments with characteristics of both liabilities and equity, including convertible instruments and contracts in an entity's own equity. The guidance was effective for the Company beginning on January 1, 2022 and prescribes different transition methods for the various provisions. The Company's adoption of this pronouncement did not have a material impact on the Company's consolidated financial statements.
−Removed: In May 2021, 
−Removed: the FASB issued ASU No.
−Removed: 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 ):
−Removed: Issuer's Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.
−Removed: ASU 2021 - 04 clarifies certain aspects of the current guidance to promote consistency among reporting of an issuer's accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange.
−Removed: The amendments in this update were effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years.
−Removed: The Company’s adoption of this pronouncement effective January 1, 2022 
−Removed: did not have a material impact on the Company’s condensed consolidated financial statements. 
−Removed: 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.
−Removed:  Intangible Assets
+Added: In December 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU 2023 - 09, Income Taxes (Topic 740 ):
+Added: Improvements to Income Tax Disclosures.
+Added: ASU 2023 - 09 improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction.
+Added: It also includes certain other amendments to improve the effectiveness of income tax disclosures.
+Added: This guidance will be effective for the annual periods beginning the year ended December 31, 2025.
+Added: Early adoption is permitted.
+Added: The Company is currently assessing the impact of ASU 2023 - 09 on its disclosures.
+Added: There are no other effective pronouncements, or pronouncements issued but not yet effective, if adopted, would have a material effect on the accompanying financial statements.
+Added: Intangible Assets
In conjunction with its acquisition of Moleculin, LLC in 2016, the Company recognized an intangible asset for acquired in-process research and development (IPR&D) related to the acquired WP1066 portfolio.
−Removed: As the Company's WP1066 portfolio is currently in development, the Company’s IPR&D intangible asset will not be amortized until development is complete.
−Removed: If the associated research and development effort is abandoned, the Company’s IPR&D intangible asset will be written-off and the Company will record a noncash impairment loss on its statements of operations.
+Added: As the Company's WP1066 portfolio is currently in development, the Company’s IPR&D intangible asset will not be amortized until development is complete.
+Added: If the associated research and development effort is abandoned, the Company’s IPR&D intangible asset will be written-off and the Company will record a noncash impairment loss on its statements of operations.
For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives.
−Removed: IPR&D was $ 11.1 million as of December 31, 2022 and 2021 , respectively.
+Added: IPR&D wa s $ 11.1 million as of December 31, 2023 and 2022 , respectively.
Accrued expenses and other current liabilities
1 unchanged sentence
Accrued research and development
−Removed: $ 1,337  
−Removed: $ 1,005  
+Added: $ 2,845 $ 1,337
Accrued payroll and bonuses
3 unchanged sentences
Total accrued expenses and other current liabilities
−Removed: $ 2,724  
−Removed: $ 2,258  
−Removed: Additionally, accounts payable include s $ 64,000 and $ 48,000 as of December 31, 2022  and 2021 , respectively, for related party payables. 
−Removed: Warrants 
+Added: $ 4,317 $ 2,724
+Added: Additionally, accounts payable includ es $ 67,000 an d $ 64,000 as of December 31, 2023 and 2022 , respectively, for related party payables (operating costs reimbursements).
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.
−Removed: Liability classified warrants are valued at fair value at the date of issue and at each reporting date pursuant to FASB ASC 820, Fair Value Measurement, (ASC 820 ) and is reflected as a warrant liability on the Company's consolidated balance sheet with the change in the warrant liability during each reporting period is reflected as a gain (loss) from change in fair value of warrant liability in the Company's consolidated statement of operations.
+Added: Liability classified warrants are valued at fair value at the date of issue and at each reporting date pursuant to FASB ASC 820, Fair Value Measurement, (ASC 820 ) and are reflected as a warrant liability on the Company's consolidated balance sheet.
+Added: The change in the warrant liability during each reporting period is reflected as a gain (loss) from change in fair value of warrant liability in the Company's consolidated statement of operations.
Equity classified warrants issued to non-employees in exchange for services are accounted for in accordance with ASC 718 which requires all stock-based payments be recognized in the consolidated statements of operations based on their fair value.
For further information, see Note 2.
−Removed: Basis of presentation, principles of consolidation and significant accounting policies –
−Removed: Stock-based Compensation.
+Added: Basis of presentation, principles of consolidation and significant accounting policies – Stock-based Compensation.
At December 31, 2023 and 2022 , the Company has the following warrants outstanding:
−Removed: Number of Shares Under Outstanding Warrants at December 31, 2022  
−Removed: Number of Shares Under Outstanding Warrants at December 31, 2021  
−Removed: Weighted Average Exercise Price at December 31, 2022  
−Removed: Remaining Contractual Life at December 31, 2022 (Years)
+Added: Number of Shares Under Outstanding Warrants at December 31, 2023 Number of Shares Under Outstanding Warrants at December 31, 2022 Weighted Average Exercise Price at December 31, 2023 Remaining Contractual Life at December 31, 2023 (Years)
Liability Classified Warrants (1)
Issued February 2018
−Removed: 67,349  
−Removed: Issued February 2018
−Removed: 378,951  
−Removed: 378,951  
+Added: — 25,264 $ — —
Issued June 2018 (2)
−Removed: 123,836  
−Removed: 123,836  
Issued March 2019
−Removed: 263,507  
−Removed: 263,507  
+Added: 17,568 17,568 99.00 0.2
Issued April 2019
−Removed: 875,001  
−Removed: 875,001  
+Added: 58,334 58,334 157.50 0.3
Issued February 2020
−Removed: 1,015,001  
−Removed: 1,015,001  
−Removed: 2,656,296  
−Removed: 2,723,645  
−Removed: $ 9.49  
+Added: 67,667 67,667 94.50 1.6
+Added: Issued December 2023
+Added: 939,312 — 9.60 5.0
+Added: 1,082,881 177,089 $ 24.30
Equity Classified Warrants
−Removed: Issued July 2017 - Consulting (3)
−Removed: 25,001  
−Removed: $ 15.64  
−Removed: Issued August 2019 - Consulting
−Removed: 25,000  
Issued April 2020 - Consulting
−Removed: 16,667  
−Removed: 16,667  
+Added: 1,112 1,112 $ 102.60 1.3
Issued December 2020 - Consulting
+Added: 556 556 70.80 2.0
Issued April 2021 - Consulting
−Removed: 71,500  
−Removed: 71,500  
+Added: 4,767 4,767 54.45 2.3
Issued August 2021 - Consulting
−Removed: 250,000  
−Removed: 250,000  
+Added: 16,667 16,667 46.20 7.6
Issued June 2022 - Consulting
−Removed: 50,000  
+Added: 3,334 3,334 22.35 8.5
Issued September 2022 - Consulting
−Removed: 250,000  
−Removed: 646,501  
−Removed: 396,502  
−Removed: $ 2.42  
+Added: 16,667 16,667 18.60 8.7
+Added: Issued June 2023 - Consulting
+Added: 10,000 — 9.00 9.5
+Added: Issued August 2023 - Consulting
+Added: 6,667 — 9.30 4.6
+Added: Issued December 2023 - Pre-Funded Warrants
+Added: 229,506 — 0.001 5.0
+Added: 289,276 43,103 $ 6.00
Balance outstanding
−Removed: 3,302,797  
−Removed: 3,120,147  
−Removed: $ 8.10  
+Added: 1,372,157 220,192 $ 23.55
( 1 ) If the Company subdivides (by any stock split, stock dividend, recapitalization or otherwise) its outstanding shares of its common stock into a smaller number of shares, the warrant exercise price is proportionately reduced and the number of shares under outstanding warrants is proportionately increased.
Additionally, if the Company combines (by combination, reverse stock split or otherwise) its outstanding shares of common stock into a smaller number of shares, the warrant exercise price is proportionately increased and the number of shares under outstanding warrants is proportionately decreased.
−Removed: Also, the Company may voluntarily reduce the warrant exercise price for its warrants issued in March 2019 and February 2017 and may voluntarily extend the contractual term of its warrants issued in February 2017. 
−Removed: ( 2 ) Includes warrants to purchase 118,372  shares at an exercise price of $ 12.12 , expiring December 22, 2023, and warrants to purchase 5,464  shares at an exercise price of $ 13.92 , expiring June 21, 2023.
−Removed: ( 3 ) Includes warrants to purchase 16,667  shares at an exercise price of $ 14.46  and warrants to purchase 8,334  shares at an exercise price of $ 18.00 .
+Added: Also, the Company may voluntarily reduce the warrant exercise price for its warrants issued in March 2019.
+Added: ( 2 ) Taking into account the reverse stock splits we have completed, includes warrants to purchase 7,892 shares at an exercise price of $ 181.80 , expiring December 22, 2023, and warrants to purchase 365 shares at an exercise price of $ 208.80 , expiring June 21, 2023.
+Added: In March 2024, the Company issued a consultant a ten -year warrant to purchase up to 3,334 shares of common stock (taking into account the reverse stock splits we have completed).
+Added: The warrants vest annually over a four -year term.
Liability Classified Warrants
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 US 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: The assumptions used in determining the fair value of the Company’s outstanding liability classified warrants are as follows:
+Added: The assumptions used in determining the fair value of the Company’s outstanding liability classified warrants are as follows:
Year Ended December 31,
Risk-free interest rate
−Removed: 4.2 % to 4.8 %  
−Removed: 0.1 % to 1.1 %  
−Removed: 63.1 % to 76.3 %  
−Removed: 71.8 % to 114.5 %  
+Added: 3.8 % to 5.4 % 4.2 % to 4.8 %
+Added: 79.5 % to 108.7 % 63.1 % to 76.3 %
Expected life (years)
−Removed: 0.1 to 2.6  
−Removed: 0.1 to 3.6  
+Added: 0.3 to 5.0 0.1 to 2.6
Dividend yield
A summary of the Company's liability classified warrant activity during the year ended December 31, 2023 and related information follows:
−Removed: Number of Shares Under Warrant  
−Removed: Range of Warrant Exercise Price per Share  
−Removed: Weighted Average Exercise Price  
−Removed: Weighted Average Remaining Contractual Life (Years)
+Added: Number of Shares Under Warrant Range of Warrant Exercise Price per Share Weighted Average Exercise Price Weighted Average Remaining Contractual Life (Years)
Outstanding at December 31, 2022
−Removed: 2,723,645  
177,089 94.50 0 to 252.00 00
−Removed: $ 9.46  
−Removed: $ 6.60  
−Removed: ( 67,349 )  
−Removed: 8.10 to 9.00  
−Removed: $ 8.42  
+Added: 939,312 9.60 0 to 9.60 60
+Added: ( 33,520 ) 208.80 0 to 252.00 00 $ 243.30 —
Outstanding at December 31, 2023
−Removed: 2,656,296  
−Removed: 6.30 to 16.80  
−Removed: $ 9.49  
+Added: 1,082,881 9.60 0 to 181.80 80 $ — 5.1
Vested and Exercisable at December 31, 2023
−Removed: 2,656,296  
−Removed: 6.30 to 16.80  
−Removed: $ 9.49  
+Added: 143,568 94.50 0 to 181.80 80 $ 120.60 0.9
For a summary of the changes in fair value associated with the Company's warrant liability for the years ended December 31, 2023 and 2022 , see Note 2.
−Removed: Basis of presentation, principles of consolidation and significant accounting policies –
−Removed: Fair Value of Financial Instruments.
−Removed: Equity Classified Warrants 
+Added: Basis of presentation, principles of consolidation and significant accounting policies – Fair Value of Financial Instruments.
+Added: Equity Classified Warrants
+Added: In December 2023, the Company entered into a Securities Purchase Agreement with an institutional investor and certain of the Company's executive officers, employees, advisors and a member of its board of directors for the sale by the Company of 240,151 shares ( t aking into account the reverse stock splits we have completed) of the Company's common stock, and pre-funded warrants to purchase 229,506 shares of common stock ( t aking into account the reverse stock splits we have completed) in lieu thereof in a registered direct offering (Pre-Funded Warrants).
+Added: In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of 939,312 shares of common stock.
+Added: Subject to certain ownership limitations, each of the Common Warrants will become exercisable on the effective date of such stockholder approval as may be required by the applicable rules and regulations of the Nasdaq Stock Market with respect to issuance of all of the Common Warrants and the common stock upon the exercise thereof.
+Added: Subject to certain ownership limitations, each Common Warrant will have an exercise price of $ 9.60 per share, expire five years from the date of stockholder approval and will become exercisable beginning on the effective date of stockholder approval for the shares issuable upon the exercise of the Common Warrants.
+Added: Subject to certain ownership limitations, each Pre-Funded Warrant is exercisable into one share of common stock at a price per share of $ 0.001 (as adjusted from time to time in accordance with the terms thereof).
+Added: The combined purchase price of one share of common stock (or pre-funded warrant in lieu thereof) and accompanying Common Warrant was $ 9.60 for the institutional investor, and $ 10.35 for the executive officers, employees, advisors and the member of the Company's board of directors who participated in the offering.
+Added: The Company received gross proceeds of $ 4.5 million, before deducting the placement agent's fees and other offering expenses payable by the Company.
+Added: Proceeds of the December 2023 Offering were allocated between common shares and warrants first by allocating proceeds to the warrants classified as a liability based on their fair value and then allocating the residual to the equity instruments, which includes the Pre-Funded Warrants.
+Added: Transaction costs related to the issuance of shares were recognized in stockholder's equity (deficit), while costs of $ 510,000 allocated to warrant liabilities were expensed for the year ended December 31, 2023 .
+Added: In August 2023, the Company granted equity-classified warrants to a consultant to purchase up to 6,667 shares ( t aking into account the reverse stock splits we have completed) of Company common stock with a five -year term and an exercise price of $ 9.30 .
+Added: The warrants vest based on performance of certain services.
+Added: As of December 31, 2023 , no related vesting criteria were met.
+Added: In June 2023, the Company granted equity-classified warrants to purchase 10,000 shares of common stock with a ten -year term and an exercise price of $ 9.00 vesting annually over four years while services are being performed.
In September 2022, the Company entered into a portfolio advisory agreement with a related party entity, associated with Dr.
−Removed: Waldemar Priebe, and in connection with the agreement, the Company granted equity-classified warrants to purchase 250,000 shares of common stock with a ten -year term and an exercise price of $ 1.24 .
+Added: Waldemar Priebe, and in connection with the agreement, the Company granted equity-classified warrants to purchase 16,667 shares of common stock ( t aking into account the reverse stock splits we have completed) with a ten -year term and an exercise price of $ 18.60 .
The September 2022 warrants vest as follows:
−Removed: 50% vests upon execution of the agreement, provided the advisor does not terminate the agreement prior to the first anniversary of the agreement;
−Removed: and (b) 50% vests 60 days after the end of the one -year term, subject to the Company's Board of Directors determining that the services provided have been adequately performed. In June 2022, the Company granted equity-classified warrants to purchase 50,000 shares of common stock with a ten -year term and an exercise price of $ 1.49 vesting annually over four years while services are being performed. 
−Removed: In August 2021, the Company entered into a portfolio development advisory agreement with a related party entity, associated with Dr.
−Removed: 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 .
−Removed: 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: (a) 50% vests upon execution of the agreement, provided the advisor does not terminate the agreement prior to the first anniversary of the agreement;
and (b) 50% vests 60 days after the end of the one -year term, subject to the Company's Board of Directors determining that the services provided have been adequately performed.
−Removed: The Company's Board of Directors determined that the services had been adequately performed, and as such, the August 2021 warrants are fully vested.
−Removed: In April 2021, the Company granted equity-classified warrants to purchase 71,500  shares of common stock with a five -year term and an exercise price of $ 3.63  vesting quarterly over five years while services are being performed.
−Removed: Additionally, both the April 2021 
−Removed: and August 2021 warrants vest in full if there is a change of control event, as defined in the agreements.
−Removed: At December 31, 2022  the Company had 646,501 equity classified warrants outstanding and 400,859  warrants were exercisable.
−Removed: At December 31, 2021 , the Company had 396,502 equity classified warrants outstanding and 186,560 were exercisable.
−Removed: The Company recorded stock compensation expense for the non-employee consulting agreements of $ 398,000 and $ 516,000  for the years ended December 31, 2022 and 2021 , respectively.
−Removed: At December 31, 2022 , there was $ 437,000 of unrecognized stock compensation expense related to the Company's equity-classified warrants.
−Removed:  Equity 
+Added: In June 2022, the Company granted equity-classified warrants to purchase 3,334 shares of common stock with a ten -year term and an exercise price of $ 22.35 vesting annually over four years while services are being performed.
+Added: At December 31, 2023 the Company had 289,276 equity classified warrants outstanding of which 266,350 w arrants were exercisable ( t aking into account the reverse stock splits we have completed).
+Added: At December 31, 2022 , the Company had 43,103 equity classified warrants outstanding of which 26,724 were exercisable ( t aking into account the reverse stock splits we have completed).
+Added: The Company recorded stock compensation expense for the non-employee consulting agreements of $ 196,000 a nd $ 398,000 for the years ended December 31, 2023 and 2022 , respectively.
+Added: At December 31, 2023 , there wa s $ 353,000 of u nrecognized stock compensation expense related to the Company's equity-classified warrants.
Preferred Stock
The Company's certificate of incorporation authorizes the Company to issue these shares in one or more series, to determine the designations and the powers, preferences and relative, participating, optional or other special rights and the qualifications, limitations and restrictions thereof, including the dividend rights, conversion or exchange rights, voting rights (including the number of votes per share), redemption rights and terms, liquidation preferences, sinking fund provisions and the number of shares constituting the series.
−Removed: No preferred stock was issued or outstanding as of 
−Removed: December 31, 2022 .
−Removed: Common Stock 
−Removed: 2022 Stock Issuances
−Removed: During the year ended December 31, 2022 , the Company did not enter into any public offerings.
+Added: No preferred stock was issued or outstanding as of December 31, 2023 .
2023 Stock Issuances
−Removed: 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.
−Removed: The Company received total proceeds of $ 78.0  million, prior to deducting the underwriting discount and other estimated offering expenses. 
−Removed: Lincoln Park Equity Line  
−Removed: In June 2021, the Company entered into a Purchase Agreement (the 2021 Purchase Agreement) with Lincoln Park Capital Fund.
−Removed: Pursuant to the terms of the Purchase Agreement, Lincoln Park agreed to purchase from the Company up to $ 20.0 million of common stock (subject to certain limitations) from time to time during the term of the Purchase Agreement.
−Removed: Pursuant to the terms of the 2021 Purchase Agreement, at the time the Company signed the Purchase Agreement, the Company issued 107,788 shares of common stock to Lincoln Park as an initial fee for its commitment to purchase shares of the Company's common stock under the Purchase Agreement, and has agreed to issue Lincoln Park up to an additional 53,893 shares of common stock as commitment shares pro-rata when and if Lincoln Park purchases (at the Company's discretion) the $ 20.0 million aggregate commitment.
−Removed: 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.
−Removed: There have been no additional shares issued to date under this agreement.
−Removed: At Market Issuance Sales Agreements (ATM) 
−Removed: In June 2021, the Company entered into an At Market Issuance Sales Agreement (the 2021 ATM Agreement) with Oppenheimer & Co.
−Removed: Pursuant to the terms of the 2021 ATM Agreement, the Company may offer and sell, from time to time through Oppenheimer shares of the Company's common stock with an aggregate sales price of up to $ 50.0 million.
−Removed: There were no issuances under the 2021 ATM Agreement.
−Removed: The Company terminated the 2021 ATM Agreement on February 3, 2023.
−Removed: 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.
−Removed: The Company terminated the 2020 ATM Agreement on February 2, 2021. 
−Removed: Adoption of 2015 Stock Plan
−Removed: In December 
−Removed: 2015, the Board of Directors of the Company approved the Company’s 2015 Stock Plan, which was amended in April 
−Removed: 2016, April 2018, June 2020, and May 2022.
−Removed: The expiration date of the plan is December 
+Added: In December 2023, the Company entered into a Securities Purchase Agreement with an institutional investor and certain of the Company's executive officers, employees, advisors and a member of its board of directors for the sale by the Company of 240,151 shares of the Company's common stock, and pre-funded warrants to purchase 229,506 shares of common stock in lieu thereof in a registered direct offering.
+Added: In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of 939,312 shares of common stock.
+Added: Subject to certain ownership limitations, each of the Common Warrants will become exercisable on the effective date of such stockholder approval as may be required by the applicable rules and regulations of the Nasdaq Stock Market with respect to issuance of all of the Common Warrants and the common stock upon the exercise thereof.
+Added: Subject to certain ownership limitations, each Common Warrant will have an exercise price of $ 9.60 per share, expire five years from the date of stockholder approval and will become exercisable beginning on the effective date of stockholder approval for the shares issuable upon the exercise of the Common Warrants.
+Added: Subject to certain ownership limitations, each Pre-Funded Warrant is exercisable into one share of common stock at a price per share of $ 0.001 (as adjusted from time to time in accordance with the terms thereof).
+Added: The combined purchase price of one share of common stock (or pre-funded warrant in lieu thereof) and accompanying Common Warrant was $ 9.60 for the institutional investor, and $ 10.35 for the executive officers, employees, advisors and the member of the Company's board of directors who participated in the offering.
+Added: The Company received gross proceeds of $ 4.5 million, before deducting the placement agent's fees and other offering expenses payable by the Company.
+Added: All figures herein are taking into account the one -for- fifteen reverse stock split completed March 22, 2024.
+Added: Lincoln Park Equity Line
+Added: During the year ended December 31, 2023 , pursuant to the 2021 Lincoln Park purchase agreement, the Company issued to Lincoln Park 15,038 shares of common stock ( t aking into account the reverse stock splits we have completed) for gross proceeds of $ 0.2 million.
+Added: The 2021 Lincoln Park Agreement, which has $ 19.8 million available as of December 31, 2023 , terminates on July 1, 2024.
+Added: The Company is in discussions with Lincoln Park Capital to effect the extension of this agreement.
+Added: The Company intends to seek an extension of this agreement prior to termination, however no agreement has been reached through to the date that these consolidated financial statements were issued.
+Added: In the December 2023 Offering, the Company agreed not to utilize the Lincoln Park Agreement or any such extension thereof, until after June 26, 2024.
+Added: 2015 Stock Plan, Stock-based Compensation and Outstanding Awards
+Added: In December 2015, the Board of Directors of the Company approved the Company’s 2015 Stock Plan, which was amended in April 2016, April 2018, June 2020, May 2022, and May 2023.
+Added: The expiration date of the plan is December 5, 2025.
The awards under the 2015 Stock Plan can be in the form of stock options, stock awards, stock unit awards, or stock appreciation rights.
−Removed: In May 2022, the stockholders approved an amendment to the 2015 Plan to, among other things, increase the number of shares of common stock authorized for issuance under the 2015 Plan by 2,000,000 shares.
−Removed: Stock-based Compensation and Outstanding Awards
−Removed: Under the terms of the Company’s 2015 Stock Plan, as amended, and approved by its stockholders in May 2022, 3,750,001 shares of the Company’s common stock are available for grant to employees, non-employee directors and consultants.
+Added: In May 2023 and 2022, the 2015 Stock Plan (Plan) was amended to authorize an additional 116,667 shares and 133,334 shares, respectively, such that 366,667 total shares may be issued under the Plan.
+Added: In March 2024, the Company issued 3,334 shares of common stock to a consultant.
+Added: All figures herein are taking into account the one -for- fifteen reverse stock split completed March 22, 2024.
+Added: Under the terms of the Company’s 2015 Stock Plan, as amended, and approved by its stockholders in May 2023, 366,667 shares of the Company’s common stock ( t aking into account the reverse stock splits we have completed) are available for grant to employees, non-employee directors and consultants.
The 2015 Stock Plan provides for the grant of stock options, stock awards, stock unit awards, or stock appreciation rights.
−Removed: As of December 31, 2022 , there wer e 752,296  shares re maining to be issued under the 2015 Stock Plan.
+Added: As of December 31, 2023 , there wer e 3,794 shares ( t aking into account the reverse stock splits we have completed) re maining to be granted under the 2015 Stock Plan.
Stock-based compensation expense for the years ended December 31, 2023 and 2022 is as follows (in thousands):
1 unchanged sentence
General and administrative
−Removed: $ 1,467  
−Removed: $ 1,461  
+Added: $ 1,439 $ 1,467
Research and development
Total stock-based compensation
−Removed: $ 2,275  
−Removed: $ 2,373  
−Removed: Each of the Company’s stock-based compensation arrangements are discussed below.
+Added: $ 1,984 $ 2,275
+Added: Each of the Company’s stock-based compensation arrangements are discussed below.
Stock Options
−Removed: Stock option awards are generally granted with an exercise price equal to the market price of the Company’s stock at the date of grant.
+Added: Stock option awards are generally granted with an exercise price equal to the market price of the Company’s stock at the date of grant.
Stock option awards generally have a 10 -year contractual term and vest over a 4 -year period for employees and over a 1 to 3 -year period for directors from the grant date on a straight-line basis over the requisite service period.
The grant-date fair value of stock options is determined using the Black-Scholes option-pricing model.
−Removed: 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.
+Added: 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.
The fair value of each stock option is estimated on the date of grant using the BSM model that uses the assumptions noted below.
−Removed: The expected term of the stock option awards was computed using the “plain vanilla”
−Removed: 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. 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.
+Added: 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.
+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.
+Added: 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:
1 unchanged sentence
Risk-free interest rate
−Removed: 1.6 % to 3.3 %  
−Removed: 0.9 % to 1.4 %  
−Removed: 107.0 % to 113.2 %  
−Removed: 114.8 % to 118.8 %  
+Added: 3.9 % to 4.6 % 1.6 % to 3.3 %
+Added: 96.0 % to 101.2 % 107.0 % to 113.2 %
Expected life (years)
−Removed: 5.3 to 6.3  
−Removed: 5.3 to 6.2  
+Added: 5.5 to 6.3 5.3 to 6.3
Expected dividend yield
Stock option activity for the year ended December 31, 2023 is as follows:
−Removed: Number of Shares  
−Removed: Weighted Average Grant Date Fair Value  
−Removed: Weighted Average Exercise Price
+Added: Number of Shares Weighted Average Grant Date Fair Value Weighted Average Exercise Price
Weighted Average Remaining Contractual Term (years)
−Removed: Aggregate Intrinsic Value  
+Added: Aggregate Intrinsic Value
Outstanding, December 31, 2022
−Removed: 1,438,352  
−Removed: $ 6.35  
−Removed: $ 8.45  
−Removed: 842,832  
−Removed: $ 1.26  
−Removed: $ 1.49  
−Removed: ( 5,834 )  
−Removed: $ 15.57  
−Removed: $ 24.39  
+Added: 151,690 $ 66.60 $ 87.45 7.8 $ —
+Added: 101,400 $ 7.35 $ 9.00
+Added: ( 3,610 ) $ 9.15 $ 11.10
+Added: ( 56 ) $ 157.50 $ 224.10
Outstanding, December 31, 2023
−Removed: 2,275,350  
−Removed: $ 4.44  
−Removed: $ 5.83  
+Added: 249,424 $ 43.35 $ 56.70 7.9 $ 378,606
Exercisable, December 31, 2023
−Removed: 927,723  
−Removed: $ 7.53  
−Removed: $ 10.38  
−Removed: Options granted during 2022  and 2021  have an aggregated fair value of $ 1.1  million and $ 1.7  million, respectively, tha t was calculated using the Black-Scholes option-pricing model.
−Removed: At December 31, 2022 , total compensation cost not yet recognized was $ 2.5  million and the weighted average period over which this amount is expected to be recognized is 2.4  years.
−Removed: T he aggregate fair value of options vesting was $ 1.5 million in the years ended December 31, 2022 and 2021 , respectively. 
+Added: 93,337 $ 88.65 $ 119.40 6.1 $ —
+Added: Options granted during 2023 and 2022 have an aggregated grant date fair value of $ 0.7 million and $ 1.1 million, respectively, that was calculated using the Black-Scholes option-pricing model.
+Added: At December 31, 2023 , total compensation cost not yet recognized was $ 1.9 million and the weighted average period over which this amount is expected to be recognized is 2.3 years.
+Added: The aggregate fair value of options vested was $ 1.3 milli on and $ 1.5 million in the years ended December 31, 2023 and 2022 , respectively.
Restricted Stock
1 unchanged sentence
Restricted stock units vest annually in four equal installments.
−Removed: Additionally, the Company's restricted stock unit agreements provide for full vesting of the restricted stock award in the event of a change of control of the Company. 
−Removed: Restricted stock unit activity for the year ended 
−Removed: December 31, 2022  is as follows:
+Added: Additionally, the Company's restricted stock unit agreements provide for full vesting of the restricted stock award in the event of a change of control of the Company.
+Added: Restricted stock unit activity for the year ended December 31, 2023 is as follows:
Number of Shares
2 unchanged sentences
Unvested Shares, December 31, 2022
−Removed: 220,559  
−Removed: $ 4.59  
−Removed: 452,334  
−Removed: $ 1.49  
−Removed: ( 65,421 )  
−Removed: $ 4.98  
+Added: 40,499 $ 33.60 3.1
+Added: 65,292 $ 9.00
+Added: ( 11,901 ) $ 41.55
Unvested Shares, December 31, 2023
−Removed: 607,472  
−Removed: $ 2.24  
−Removed: As of December 31, 2022 , total compensation cost not yet recognized was $ 1.1  million a nd the weighted average period over which this amount is expected to be recognized is 2.8  years.
−Removed: In June 2022, the Company granted 452,334 shares of restricted stock units with a weighted average fair value of $ 1.49  per share at the date of grant, which vest annually in four equal installments.
−Removed: 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.
−Removed:  Income Taxes 
−Removed: The provision for income taxes consists of the following components (in thousands):  
+Added: 93,890 $ 15.45 7.3
+Added: As of December 31, 2023 , total compensation cost not yet recognized was $ 1.2 million and the weighted average period over which this amount is expected to be recognized is 2.7 years.
+Added: In June 2023, the Company granted 65,292 shares of restricted stock units with a weighted average fair value of $ 9.00 per share at the date of grant (t aking into account the reverse stock splits we have completed ), which vest annually in four installments.
+Added: In June 2022, the Company granted 30,156 shares of restricted stock units with a weighted average fair value of $ 22.35 per share (t aking into account the reverse stock splits we have completed ) at the date of grant, which vest annually in four equal installments.
+Added: In December 2023, the Company granted to the Company's executive officers 73,334 performance-based restricted stock units (t aking into account the reverse stock splits we have completed ) (PSU).
+Added: Each PSU will vest upon both (A) the approval of a plan amendment by the Company's stockholders;
+Added: and (B) the first of the following to occur:
+Added: (a) a licensing transaction with a valuation, at the time, in excess of $150 million, which valuation shall be determined by the Board;
+Added: (b) the filing of a new drug application;
+Added: or (c) upon a Change in Control (as defined in the Plan), in each case subject to the respective executive officer's continued service with the Company as of each such vesting date.
+Added: Recognition of stock-based compensation expense associated with these performance-based stock options commences when the performance condition is considered probable of achievement, using management’s best estimates, which consider the inherent risk and uncertainty regarding the future outcomes of the milestones.
+Added: As of the date of issuance and through December 31, 2023 , none of the performance goals were deemed probable, and as a result, no expense was recognized for these performance-based vesting awards.
+Added: The provision for income taxes consists of the following components (in thousands):
Year Ended December 31,
3 unchanged sentences
Deferred income tax expense
−Removed: The following summarizes activity related to the Company’s valuation allowance (in thousands): 
+Added: The following summarizes activity related to the Company’s valuation allowance (in thousands):
Year Ended December 31,
Valuation allowance at beginning of period
−Removed: $ 18,823  
−Removed: $ 13,867  
−Removed: Income tax benefit
+Added: $ 25,696 $ 18,823
+Added: Change charged to expense (income)
Release of valuation allowance
Valuation allowance at end of period
−Removed: $ 25,696  
−Removed: $ 18,823  
−Removed: A reconciliation of the income tax benefit computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows (in thousands):
+Added: $ 32,308 $ 25,696
+Added: A reconciliation of the income tax benefit computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows (in thousands):
Year Ended December 31,
Federal tax benefit at statutory rate
−Removed: $ 6,096  
−Removed: 21.0 %  
−Removed: $ 3,338  
+Added: $ 6,251 21.0 % $ 6,096 21.0 %
State tax benefit net of federal
+Added: 118 0.4 % 347 1.2 %
Foreign rate differential
+Added: 59 0.2 % 10 0.0 %
Stock warrant costs
+Added: ( 219 ) ( 0.8 )% 280 1.0 %
Other permanent differences
−Removed: ( 145 )  
−Removed: ( 0.5 )%  
−Removed: ( 77 )  
+Added: ( 73 ) ( 0.2 )% ( 145 ) ( 0.5 )%
Permanent provision to return items
+Added: 662 2.3 % 395 1.4 %
Stock compensation change
−Removed: ( 49 )  
−Removed: ( 0.2 )%  
−Removed: ( 37 )  
+Added: ( 82 ) ( 0.3 )% ( 49 ) ( 0.2 )%
Uncertain tax provision
−Removed: ( 61 )  
−Removed: ( 0.2 )%  
−Removed: ( 57 )  
+Added: ( 103 ) ( 0.4 )% ( 61 ) ( 0.2 )%
Increase in valuation allowance
−Removed: ( 6,873 )  
−Removed: ( 23.7 )%  
−Removed: ( 4,956 )  
+Added: ( 6,613 ) ( 22.2 )% ( 6,873 ) ( 23.7 )%
Total tax (expense) benefit
−Removed: The principal components of the Company’s deferred tax assets and liabilities consist of the following (in thousands):
+Added: $ — — % $ — — %
+Added: The principal components of the Company’s deferred tax assets and liabilities consist of the following (in thousands):
Year Ended December 31,
1 unchanged sentence
Start-up costs
−Removed: $ 7,727  
−Removed: $ 5,618  
+Added: $ 9,621 $ 7,727
Federal net operating loss carryforwards
−Removed: 11,024  
−Removed: 10,866  
+Added: 11,598 11,024
174 R&D Carryforward
5 unchanged sentences
Total deferred tax assets
−Removed: $ 25,782  
−Removed: $ 18,852  
+Added: $ 32,420 $ 25,782
Less valuation allowance
−Removed: ( 25,696 )  
+Added: ( 32,308 ) ( 25,696 )
Net deferred tax assets
Deferred tax liabilities:
−Removed: ( 86 )  
+Added: $ ( 112 ) $ ( 86 )
Total deferred tax liabilities
−Removed: $ ( 86 )  
+Added: $ ( 112 ) $ ( 86 )
Net deferred taxes
The Company has incurred net operating losses since inception.
−Removed: As of December 31, 2022 , the Company had total US federal operating loss carry forwards of approximately $ 52  million.
−Removed: O f thi s, $ 6.1  million will expire commencing i n 2035, with the rest having no set expiration date.
−Removed: The value of these carryforwards depends on the Company’s ability to generate taxable income.
+Added: As of December 31, 2023 , the Company had total US federal operating loss carry forwards of approximately $ 52 million.
+Added: O f thi s, $ 6.1 million will expire commencing i n 2035, with the rest having no set expiration date.
+Added: The value of these carryforwards depends on the Company’s ability to generate taxable income.
Additionally, because federal tax laws limit the time during which the net operating loss carryforwards may be applied against future taxes, if the Company fails to generate taxable income prior to the expiration dates of the carry forwards the Company may not be able to fully utilize the net operating loss carryforwards to reduce future income taxes.
1 unchanged sentence
However, these net operating losses will only be able to offset 80% of future taxable income.
−Removed: However, with the signing of the CARES Act net operating loss carryforwards created in 2018, 2019, and 2020 are able to offset 100% of future taxable income.
Finally, the Company has not undertaken a detailed analysis of the application of IRC Section 382 with respect to limitations on the utilization of net operating loss carryforwards and other deferred tax assets.
1 unchanged sentence
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.
−Removed: As of December 31, 2022 , the Company had state operating losses of approximate ly $ 2.5  million which expire commencing in 2036.
−Removed: 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.
+Added: As of December 31, 2023 , the Company had state operating losses of approximate ly $ 2.7 million which expire commencing in 2036.
+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, 2023 .
−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 $ 25.7  million an d $ 18.8  million has been established at December 31, 2022 and 2021 , respectively.
+Added: A valuation allowance o f $ 32.3 million an d $ 25.7 million has been established at December 31, 2023 and 2022 , respectively.
The change in the valuation allowance for the year ended December 31, 2023 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 US federal R&D tax credits. For the 2022 tax year, the potential US and Australian research and development tax credits are not expected to be significant.
+Added: The Company has a full valuation allowance against its US federal R&D tax credits.
+Added: For the 2023 tax year, there may be a potential Australian research and development tax credit, as the Company is increasing research and development activities in Australia.
+Added: The Company estimates the amount of cash refund it expects to receive related to the Australian research and development tax incentive program and records the incentives when it is probable that 1 ) the Company will comply with relevant conditions of the program and 2 ) there is reasonable assurance the claim will be recovered.
+Added: During the years ended December 31, 2023 and 2022 , respectively, the Company has not recorded the Australian tax incentive as it is not yet probable that the terms and claim will be recovered.
The federal research credits will begin to expire in the years 2037 through 2041, if not utilized.
−Removed: The Company has a liability for unrecognized tax benefits o f $ 0.2  million (excluding accrued interest and penalties) as of December 31, 2022 .
+Added: The Company has a liability for unrecognized tax benefits o f $ 0.3 million (excluding accrued interest and penalties) as of December 31, 2023 .
The Company's policy is to record interest and penalties related to income taxes as part of its income tax provision.
−Removed: A reconciliation of the beginning and ending unrecognized tax benefits excluding interest and penalties is as follows (in thousands): 
+Added: A reconciliation of the beginning and ending unrecognized tax benefits excluding interest and penalties is as follows (in thousands):
Year Ended December 31,
5 unchanged sentences
Balance, end of year
−Removed: The Company does not believe that its tax positions will significantly change due to any settlement and/or expiration of statutes of limitations prior to 
−Removed: December 31, 2022 within the next year. 
+Added: The Company does not believe that its tax positions will significantly change due to any settlement and/or expiration of statutes of limitations prior to December 31, 2023 within the next year.
Starting in 2022, changes to Internal Revenue Code Section 174 made by the Tax Cuts and Jobs Act of 2017 no longer permit an immediate deduction for research and development expenditures in the tax year that such costs are incurred.
−Removed: As a result the Company capitalized such costs in its 2022 income tax provision, resulting in an increase in deferred tax assets. 
−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 for the years ended 
−Removed: December 31, 2022 , and December 31, 2021 , respectively. 
+Added: As a result the Company capitalized such costs in its 2023 and 2022 income tax provision, resulting in an increase in deferred tax assets.
+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 December 31, 2023 , and December 31, 2022 , respectively.
Lease Obligations Payable
−Removed: Effective January 1, 2019, the Company adopted ASC 842, which requires recognition of a right-of use asset and a lease liability for all leases at the commencement date based on the present value of the lease payment over the lease term.
−Removed: In March 2018, the Company entered into a Lease Agreement (the “Lease”) which it uses for its corporate office space and headquarters.
−Removed: The term of the Lease began in August 2018 and will continue for an initial term of 66 months, which may be renewed for an additional 5 years.
−Removed: The Company is required to remit base monthly rent which will increase at an average approximate rate of 3 % each year.
−Removed: The Company is also required to pay additional rent in the form of its pro-rata share of certain specified operating expenses of the Landlord.
+Added: In September 2023, the Company executed an amendment to extend the corporate office lease until August 31, 2029, with an option to renew.
+Added: The Company is required to remit base monthly rent of approximately $ 4,700 which will increase at an average approximate rate of 2 % each year.
+Added: The Company is also required to pay additional rent in the form of its pro-rata share of certain specified operating expenses of the building.
The leased space is located in Houston, Texas.
The corporate office lease is classified as an operating lease.
−Removed: In June 2022, the Company entered into a Second Amendment to its Lease Agreement (the "Lab Lease") which it uses for lab space.
−Removed: The term of the Lease will continue through September 30, 2027, with no further right or option to renew.
+Added: In June 2022, the Company entered into a Second Amendment to its Lease Agreement (Lab Lease) which it uses for lab space.
+Added: The term of the Lease will continue through September 30, 2027, with no further right or option to renew.
The Company is required to remit base monthly rent which will increase at an average approximate rate of 3 % each year.
The Lab Lease is classified as an operating lease.
−Removed: In August 2019, the Company entered into a sublease (which was extended in 2022 in connection with the lease extension) with a related party, Houston Pharmaceuticals, Inc.
+Added: In August 2019, the Company entered into a sublease (which was extended in 2022 in connection with the lease extension) with a related party, Houston Pharmaceuticals, Inc.
The Company has granted HPI access to all of its Lab Lease space and HPI has agreed to pay the Company 50 % of the Company's rent payable under the Lab Lease less 50 % of any benefits from any sublease or other lab service agreement the Company may receive from its Lab Lease.
Although HPI has access to the Company's Lab Lease space, it is the intent of the parties that they equally share the Lab Lease space for research purposes.
−Removed: The Company recorded approximately $ 45,000  and $ 42,000 in sublease income from the related party for the years ended December 31, 2022  and December 31, 2021 , respectively.
+Added: The Company recorded approximately $ 49,000 a nd $ 45,000 in sublease income from the related party for the years ended December 31, 2023 and December 31, 2022 , respectively.
Sublease income is recorded as other income on the Company's consolidated statement of operations and comprehensive loss.
−Removed: During the year ended December 31, 2022 , the Company did not enter into any new lease arrangements requiring any additional right-of-use assets or liabilities to be recorded, other than the extension discussed above.
−Removed: The Company made an accounting policy election not to apply the recognition requirements to short-term leases.
−Removed: The Company recognizes the lease payments for short-term leases in profit or loss on a straight-line basis over the lease term, and variable lease payments in the period in which the obligation for those payments is incurred.
−Removed: The following summarizes quantitative information about the Company's operating leases for the years ended 
−Removed: December 31, 2022 , and December 31, 2021 , respectively (in thousands): 
+Added: The following summarizes quantitative information about the Company's operating leases for the years ended December 31, 2023 , and December 31, 2022 , respectively (in thousands):
Year Ended December 31,
Operating lease cost
−Removed: Short-term lease cost
Variable lease cost
10 unchanged sentences
Present value of operating lease liabilities
−Removed: As of December 31, 2022 , the weighted average remaining lease term for operating leases is 4.2 5  years , and the weighted average discount rate is 9.6 %.
−Removed: Th e interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses an incremental borrowing rate based on a peer analysis using information available at the commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. 
−Removed: MD Anderson 
−Removed: Under agreements associated with Annamycin, the WP1122 Portfolio and the WP1066 Portfolio all described below, the Company is responsible for certain license, milestone and royalty payments over the course of the agreements.
−Removed: Annual license fees can cost as high as $ 0.1 million depending upon the anniversary, milestone payments for the commencement of phase II and phase III clinical trials, for the submission of an NDA to the FDA and for the receipt of marketing approval for sale of a license product can cost as high as $ 0.6 million, depending upon certain terms and conditions.
+Added: As of December 31, 2023 , the weighted average remaining lease term for operating leases i s 4.6 years, and the weighted average discount rate is 9.6 %.
+Added: 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: 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.
+Added: Annual license fees can cost as high as $ 0.1 million depending upon the anniversary, milestone payments for the commencement of phase II and phase III clinical trials, for the submission of an NDA to the FDA and for the receipt of marketing approval for sale of a license product can cost as high as $ 0.6 million, depending upon certain terms and conditions.
Not all of these payments are applicable to every drug.
−Removed: In March 2021, after a determination that the Company did not intend to pursue development of WP1732, the Company entered into a termination of the license agreement related to WP1732 dated February 12, 2018 with MD Anderson.
−Removed: Total expenses under these agreements were $ 264,000  an d $ 267,000 , respectively, for the years ended 
−Removed: December 31, 2022  and 
+Added: Total expenses under these agreements we re $ 258,000 and $ 264,000 , respectively, for the years ended December 31, 2023 and 2022 .
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.
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.
−Removed: The terms and payments of these agreements are included in the summary above under “Commitments and Contingencies –
−Removed: Licenses –
−Removed: MD Anderson”.
+Added: The terms and payments of these agreements are included in the summary above under Commitments and Contingencies – Licenses – MD Anderson.
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.
−Removed: 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’
−Removed: 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.
+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’ 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 “2012 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 ( 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 its WP1122 Portfolio and to its drug product candidate, WP1122.
−Removed: On October 21, 2022, the Company entered into a new patent and technology license agreement (the "2022 Agreement") with MD Anderson for an additional molecule under the WP1122 Portfolio.
−Removed: 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: On October 21, 2022, the Company entered into a new patent and technology license agreement ( 2022 Agreement) with MD Anderson for an additional molecule under the WP1122 Portfolio.
+Added: On December 3, 2021, the Company entered into a new patent and technology license agreement ( 2021 Agreement) with MD Anderson licensing certain technology related to WP1122 anti-viral treatments.
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. 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: 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: 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.
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.
1 unchanged sentence
The term of the 2012 agreement extends until the later of 15 years from the effective date of the agreement, or the expiration of the last-to-expire licensed patent.
−Removed: MD Anderson had the right terminate the 2012 agreement if the Company failed to commence a Phase 1 study for a licensed product prior to November 20, 2022, which Phase 1 study occurred in the United Kingdom during 2022 prior to the deadline.
In addition, MD Anderson may terminate the 2012 agreement if the Company fails to commence a Phase 2 study for licensed product prior to November 20, 2024.
The term of the 2021 agreement extends until the later of 20 years from the effective date of the agreement, or the expiration of the last-to-expire licensed patent.
−Removed: 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;
−Removed: or if the Company fails to commence a Phase 1 study for licensed product prior to December 3, 2026.
−Removed: The Company believes that the Phase 1 study that occurred in the United Kingdom during 2022 met 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 “2010 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 ( 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: 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: On February 3, 2022, the Company entered into a new patent and technology license agreement ( 2022 Agreement) with MD Anderson licensing certain technology related to WP1066 checkpoint inhibitors.
+Added: In January 2024 the Company notified MD Anderson that it was terminating this license.
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.
4 unchanged sentences
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.
−Removed: 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.
−Removed: In addition, MD Anderson may terminate the 2022 Agreement if the Company fails to file for an IND for a Phase 1 study before February 2, 2025 in the United States, France, Germany, Italy, Spain, the United Kingdom or China.
−Removed: The Company believes that 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).
1 unchanged sentence
The Company has two current agreements with HPI.
−Removed: The first agreement, which was renewed in May 2022, continues a prior consulting arrangement with HPI and requires payments for $ 43,500  per quarter.
+Added: The first agreement, which was renewed in May 2022, continues a prior consulting arrangement with HPI and requires payments for $ 43,500 per quarter.
The second agreement, which can be cancelled with sixty days notice by either party, allows the Company's employees access to laboratory equipment owned by HPI and this requires a payment of $ 15,000 per quarter to HPI.
−Removed: Total expenses related to HPI were $ 234,000  for the years ended December 31, 2022 and 2021 . 
+Added: Total expenses related to HPI were $ 234,000 f or the years ended December 31, 2023 and 2022 .
Sponsored Research Agreements with MD Anderson
−Removed: MBI has a Sponsored Laboratory Study Agreement with MD Anderson expiring December 31, 2024.
−Removed: In June 
−Removed: 2022, the Company entered into a new Sponsored Research Agreement with MD Anderson for total payment of $ 1.3 million to support the continuation of the project. In addition, the Company also has Sponsored Research Agreements with other universities, one in the US and one in Europe. The expenses recognized under the agreements w ere $ 1,133,000  a nd $ 697,000 , respectively for the years ended December 31, 2022 and 2021 .
+Added: MBI has a Sponsored Laboratory Study Agreement with MD Anderson expiring December 31, 2025.
+Added: In October 2023, the Company entered into an amendment to the Sponsored Research Agreement with MD Anderson for total payments to MD Anderson of $ 0.8 million to support the continuation of the project.
+Added: In addition, the Company also has Sponsored Research Agreements with other universities, one in the US and one in Europe.
+Added: The expenses recognized under the agreements were $ 775,000 and $ 1,133,000 , respectively for the years ended December 31, 2023 and 2022 .
Other Licenses
−Removed: WPD Pharmaceuticals 
−Removed: Since February 2019, 
−Removed: the Company was party to a sublicense agreement with WPD Pharmaceuticals (WPD), pursuant to which it sublicensed to WPD certain intellectual property rights, including rights to Annamycin, its WP1122 portfolio, and its WP1066 portfolio (as amended, the “WPD Agreement”).
+Added: WPD Pharmaceuticals
+Added: Since February 2019, the Company was party to a sublicense agreement with WPD Pharmaceuticals (WPD), pursuant to which it sublicensed to WPD certain intellectual property rights, including rights to Annamycin, its WP1122 portfolio, and its WP1066 portfolio (as amended, WPD Agreement).
WPD is affiliated with Dr.
6 unchanged sentences
Animal Life Sciences
−Removed: In February 2019, the Company sublicensed certain intellectual property rights, including rights to Annamycin, its WP1122 portfolio, and its WP1066 portfolio in the field of non-human animals to ALI (the “ALI Agreement”).
+Added: In February 2019, the Company sublicensed certain intellectual property rights, including rights to Annamycin, its WP1122 portfolio, and its WP1066 portfolio in the field of non-human animals to ALI (ALI Agreement).
ALI is affiliated with Dr.
−Removed: Waldemar Priebe, one of its founders and its largest shareholder.
+Added: Waldemar Priebe, one of its founders.
Under the ALI Agreement, the Company granted ALI a worldwide royalty-bearing, exclusive license to research, develop, manufacture, have manufactured, use, import, offer to sell and/or sell products in the field of non-human animals under the licensed intellectual property.
This license is subject to the terms in the prior agreements entered into by the Company and MDA.
+Added: Other Guarantees
+Added: Bank Guarantee and Letter of Credit
+Added: In December 2023, the Company entered into a letter of credit with its primary banking relationship in the US, or bank guarantee, in the amount of $ 0.2 million, in connection to a value-added tax (VAT) registration in Poland.
+Added: To date, there have been no draws or claims against this bank guarantee.
Employment Agreements
−Removed: 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 
−Removed: using the rate of compensation in effect at December 31, 2022 .
−Removed:  Subsequent Events 
−Removed: Subsequent events occurring after December 31, 2022  are discussed elsewhere in these notes.
+Added: The Company has agreements with certain executive and other employees to provide benefits in the event of termination.
+Added: The base salary and certain other benefits would aggregate approximately $ 5.5 million using the rate of compensation in effect at December 31, 2023 .
+Added: Subsequent Events
+Added: Subsequent events occurring after December 31, 2023 are discussed elsewhere in these notes.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.