Monopar Therapeutics

Note1 – Nature of Business and Liquidity**

Nature of Business

Monopar Therapeutics Inc. ("Monopar" or the "Company") is a clinical-stage biotechnology company with late-stage ALXN-1840 for Wilson disease, and radiopharma programs including Phase1-stage MNPR-101-Zr for imaging advanced cancers, and Phase1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers.

Liquidity

The Company has incurred an accumulated deficit of approximately** $64.9 million as of September 30, 2024. To date, the Company has primarily funded its operations with the net proceeds from the Company’s initial public offering of its common stock on Nasdaq, sales of its common stock in the public market through at-the-market sales agreements, private placements of convertible preferred stock and of common stock and cash provided in the camsirubicin asset purchase transaction. In* October 2024,the Company raised approximately $18.7 million in total net proceeds fromtwo* financing events as disclosed under subsequent event section of this Form10-Q. Management estimates that currently available cash will provide sufficient funds to enable the Company to meet its obligationsat least into thefirst half of2026. The Company’s ability to fund its future operations, including the development of ALXN-1840, an investigational drug candidate for Wilson disease, and the continued clinical development of its radiopharmaceutical programs, is dependent upon its ability to execute its business strategy, to obtain additional funding and/or to execute collaborative research agreements. There can beno certainty that future financing or collaborative research agreements will occur in the amounts required or at a time needed to maintain operations, if at all.

Going Concern Assessment

The Company applies Accounting Standards Codification205-40 (“ASC205-40”),Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which the Financial Accounting Standards Board (“FASB”) issued to provide guidance on determining when and how reporting companies must disclose going concern uncertainties in their financial statements. ASC205-40 requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern withinone year of the date of issuance of the entity’s financial statements (or withinone year after the date on which the financial statements are available to be issued, when applicable). Further, a company must provide certain disclosures if there is “substantial doubt about the entity’s ability to continue as a going concern.” In* October 2024,the Company analyzed its cash requirements at least through December 31, 2025and has determined that, based upon the Company’s current available cash, the Company hasno* substantial doubt about its ability to continue as a going concern.

Risks and Uncertainties

Risks Related to the Company's Financial Condition and Capital Requirements

Many, ifnot most, biotechnology companies never become profitable and are acquired, merge, sell major product assets or go out of business before successfully developing any product that generates revenue from commercial sales that enables profitability. The Company has incurred losses since inception, and expects to continue to incur substantial operating losses over the next several years. These losses stem from the clinical development of the Company's current and future licensed and/or purchased product candidates and will continue for the foreseeable future. As a result, the Company anticipates that it will seek to raise additional capital within the next12 months to fund our future operations. The Company's ability to raise sufficient funds in order to support continued clinical, regulatory and commercial development and to make contractual future milestone payments, as well as to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization are uncertain.

The amount of future losses and when, if ever, the Company would become profitable is uncertain. The Company's ability to generate revenue and achieve profitability will depend on, among other things, successful completion of the development of its product candidates; obtaining necessary regulatory approvals from the FDA and international regulatory agencies; establishing manufacturing/quality, sales, and marketing and distribution arrangements withthird parties; obtaining adequate reimbursement bythird-party payers; and raising sufficient funds to finance its activities. If the Company is unsuccessful at some or all of these undertakings, its business, financial condition, and results of operations are expected to be materially and adversely affected.

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Note2 – Significant Accounting Policies

Basis of Presentation

These condensed consolidated financial statements include the financial results of Monopar Therapeutics Inc., its wholly-owned French subsidiary, Monopar Therapeutics, SARL, and its wholly-owned Australian subsidiary, Monopar Therapeutics Australia Pty Ltd, and have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) and include all disclosures required by GAAP for financial reporting. All intercompany accounts have been eliminated. The principal accounting policies applied in the preparation of these condensed consolidated financial statements are set out below and have been consistently applied in all periods presented. The Company has been primarily involved in performing research activities, developing product candidates, and raising capital to support and expand these activities.

The accompanying interim unaudited condensed consolidated financial statements contain all normal, recurring adjustments necessary to present fairly the Company’s condensed consolidated financial position as of* September 30, 2024*, and the Company’s condensed consolidated results of operations and comprehensive loss for thethree andnine months ended* September 30, 2024* and2023, and the Company’s condensed consolidated cash flows for thenine months ended* September 30, 2024* and2023.

The interim condensed consolidated results of operations and comprehensive loss and condensed consolidated cash flows for the periods presented arenot necessarily indicative of the condensed consolidated results of operations or cash flows which* maybe reported for the remainder of2024* or for any future period. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. The accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended* December 31, 2023,included in the Company’s Annual Report on Form10*-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on* March 28, 2024.*

Functional Currency

The Company’s consolidated functional currency is the U.S. Dollar. The Company’s Australian subsidiary and French subsidiary use the Australian Dollar and European Euro, respectively, as their functional currency. At each quarter-end, each foreign subsidiary’s balance sheets are translated into U.S. Dollars based upon the quarter-end exchange rate, while their statements of operations and comprehensive loss and statements of cash flows are translated into U.S. Dollars based upon an average exchange rate during the period.

Comprehensive Loss

Comprehensive loss represents net loss plus any income or lossesnot reported in the condensed consolidated statements of operations and comprehensive loss, such as foreign currency translations gains and losses and unrealized gains and losses on debt security investments that are reflected on the Company’s condensed consolidated statements of stockholders’ equity.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and reported amounts of expenses in the condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates.

Cash Equivalents

The Company considers all highly liquid investments purchased with a maturity ofthree months or less on the date of purchase to be cash equivalents. Cash equivalents as of* September 30, 2024* and* December 31, 2023*, consisted oftwo money market accounts and U.S. Treasury Bills.

Investments

The Company considers all of its investments in debt securities (U.S. Government or Agencies), with maturities at the date of purchase from overthree months toone year to be available-for-sale securities. These investments are recorded at fair value with the unrealized gains and losses reflected in accumulated other comprehensive income (loss) on the Company’s condensed consolidated balance sheets. Realized gains and losses from the sale of investments, if any are determined, are recorded net in the condensed consolidated statements of operations and comprehensive loss. The investments selected by the Company have a low level of inherent credit risk given they are issued by the U.S. government and any changes in their fair value are primarily attributable to changes in interest rates and market liquidity. Investments as of* September**30,* 2024 consisted of U.S. Treasury Bills with maturities of less thanthree months.

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Prepaid Expenses

Prepayments are expenditures for goods or services before the goods are used or the services are received and are charged to operations as the benefits are realized. Prepaid expenses* mayinclude payments to development collaborators in excess of actual expenses incurred by the collaborator measured at the end of each reporting period. Prepayments also include insurance premiums, dues and subscriptions and software costs of $10,000 or more per year that are expensed monthly over the life of the contract, which is typicallyone* year. Prepaid expenses are reflected on the Company’s condensed consolidated balance sheets as other current assets.

Leases

Lease agreements are evaluated to determine whether an arrangement is or contains a lease in accordance with ASC842, Leases. Right-of-use lease assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The right-of-use lease asset on the Company’s condensed consolidated balance sheets includes any lease payments made and excludes lease incentives. The incremental borrowing taking into consideration the Company’s credit quality and borrowing rate for similar assets is used in determining the present value of future payments. Lease expense is recorded as general and administrative expenses on the Company’s condensed consolidated statements of operations and comprehensive loss.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents. The Company maintains cash and cash equivalents attwo reputable financial institutions. As of* September 30, 2024*, the balance atone financial institution was in excess of the $250,000 Federal Deposit Insurance Corporation (“FDIC”) insurable limit. The Company hasnot experienced any losses on its deposits since inception and management believes the Company isnot exposed to significant risks with respect to these financial institutions.

Fair Value of Financial Instruments

For financial instruments consisting of cash and cash equivalents, investments, accounts payable, accrued expenses, and other current liabilities, the carrying amounts are reasonable estimates of fair value due to their relatively short maturities.

The Company adopted ASC820, *Fair Value Measurements and Disclosures,*as amended, which addresses the measurement of the fair value of financial assets and financial liabilities. Under this standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date.

The standard establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs reflect assumptions market participants would use in pricing an asset or liability based on market data obtained from independent sources. Unobservable inputs reflect a reporting entity’s pricing an asset or liability developed based on the best information available under the circumstances. The fair value hierarchy consists of the followingthree levels:

Level1* *- instrument valuations are obtained from real-time quotes for transactions in active exchange markets involving identical assets.

Level2* *- instrument valuations are obtained from readily available pricing sources for comparable instruments.

Level3* *- instrument valuations are obtained without observable market values and require a high-level of judgment to determine the fair value.

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Determining which category an asset or liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each reporting period. There wereno transfers between Level1, 2 or3 of the fair value hierarchy during thethree andnine months ended* September 30, 2024* and2023. The following table presents the assets that are reported at fair value on the Company's condensed consolidated balance sheets on a recurring basis.No values were recorded in Level2 or Level3 as of* September 30, 2024* and* December 31, 2023*. The Company hasno liabilities reported at fair value on a recurring basis

Assets Measured at Fair Value on a Recurring Basis

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Net Loss per Share

Net loss per share for thethree andnine months ended* September 30, 2024* and2023, is calculated by dividing net loss by the weighted-average shares of common stock outstanding during the periods. Diluted net loss per share for thethree andnine months ended* September 30, 2024* and2023, is calculated by dividing net loss by the weighted-average shares of the sum of a) weighted average common stock outstanding (3,520,398 and 2,823,680 shares for thethree months ended* September 30, 2024and2023* respectively,3,419,321 and 2,710,356 shares for thethree andnine months ended* September 30, 2024* and2023 respectively) and b) potentially dilutive shares of common stock (such as stock options and restricted stock units) outstanding during the period determined using the treasury stock method. As of* September 30, 2024* and2023, potentially dilutive securities included stock-based awards to purchase upto 476,758 and 516,166 sharesof the Company’s common stock, respectively. For thethree andnine months ended* September 30, 2024* and2023, potentially dilutive securities are excluded from the computation of fully diluted net loss per share as their effect is anti-dilutive.

Research and Development Expenses

Research and development (“R&D”) costs are expensed as incurred. Major components of R&D expenses include salaries and benefits paid to the Company’s R&D staff, compensation expenses of G&A personnel performing R&D, fees paid to consultants and to the entities that conduct certain R&D activities on the Company’s behalf and costs of materials and supplies which were used in R&D activities during the reporting period.

Clinical Trials Accruals

The Company accrues and expenses the costs for clinical trial activities performed bythird parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with contract research organizations, service providers, and clinical trial sites. The Company estimates the amounts to accrue based upon discussions with internal clinical personnel and external service providers as to progress or stage of completion of trials or services and the agreed upon fees to be paid for such services. Costs of setting up clinical trial sites for participation in the trials are expensed immediately as R&D expenses. Clinical trial site costs related to patient screening and enrollment are accrued as patients are screened/entered into the trial.

Collaborative Agreements

The Company and its collaborative partners are active participants in collaborative agreements and all parties would be exposed to significant risks and rewards depending on the technical and commercial success of the activities. Contractual payments to the other parties in collaboration agreements and costs incurred by the Company when the Company is deemed to be the principal participant for a given transaction are recognized on a gross basis in R&D expenses. Royalties and license payments are recorded as earned.

During thethree andnine months ended* September 30, 2024* and2023,no milestones were met, andno royalties were earned; therefore, the Company didnot pay or accrue/expense any license or royalty payments.

Licensing Agreements

The Company has various agreements licensing technology utilized in the development of its product or technology programs. The licenses contain success milestone obligations and royalties on future sales. During thethree andnine months ended* September 30, 2024* and2023,no milestones were met, andno royalties were earned; therefore, the Company didnot pay or accrue/expense any license or royalty payments under any of its license agreements.

See Note8 for additional discussion regarding the Company’s Licensing Agreements.

Patent Costs

The Company expenses costs relating to issued patents and patent applications, including costs relating to legal, renewal and application fees, as a component of general and administrative expenses in its condensed consolidated statements of operations and comprehensive loss.

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Income Taxes

The Company uses an asset and liability approach for accounting for deferred income taxes, which requires recognition of deferred income tax assets and liabilities for the expected future tax consequences of events that have been recognized in its financial statements but havenot been reflected in its taxable income. Estimates and judgments are required in the calculation of certain tax liabilities and in the determination of the recoverability of certain deferred income tax assets, which arise from temporary differences and carryforwards. Deferred income tax assets and liabilities are measured using the currently enacted tax rates that apply to taxable income in effect for the years in which those tax assets and liabilities are expected to be realized or settled.

The Company regularly assesses the likelihood that its deferred income tax assets will be realized from recoverable income taxes or recovered from future taxable income. To the extent that the Company believes any amounts arenot “more likely thannot” to be realized, the Company records a valuation allowance to reduce the deferred income tax assets. In the event the Company determines that all or part of the net deferred tax assets arenot realizable in the future, an adjustment to the valuation allowance would be charged to earnings in the period such determination is made. Similarly, if the Company subsequently determines deferred income tax assets that were previously determined to be unrealizable are now realizable, the respective valuation allowance would be reversed, resulting in an adjustment to earnings in the period such determination is made.

Internal Revenue Code Sections382 and383 (“Sections382 and383”) limit the use of net operating loss (“NOL”) carryforwards and R&D credits, after an ownership change. To date, the Company hasnot conducted a Section382 or383 study, however, because the Company will continue to raise significant amounts of equity in the coming years, the Company expects that Sections382 and383 will limit the Company’s usage of NOLs and R&D credits in the future.

ASC740, Income Taxes, requires that the tax benefit of net operating losses, temporary differences, and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely thannot.” Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carryforward period. The Company has reviewed the positive and negative evidence relating to the realizability of the deferred tax assets and has concluded that the deferred tax assets arenot “more likely thannot” to be realized. As a result, the Company recorded a full valuation allowance as of* September 30, 2024* and* December 31, 2023*. U.S. Federal R&D tax credits from2016 to2019 were utilized to reduce payroll taxes in future periods and were recorded as other current assets (anticipated to be received within12 months), on the Company’s condensed consolidated balance sheets. The Company intends to maintain the valuation allowance until sufficient evidence exists to support its reversal. The Company regularly reviews its tax positions. For a tax benefit to be recognized, the related tax position must be “more likely thannot” to be sustained upon examination. Any amount recognized is generally the largest benefit that is “more likely thannot” to be realized upon settlement. The Company’s policy is to recognize interest and penalties related to income tax matters as an income tax expense. For thethree andnine months ended* September 30, 2024* and2023, the Company didnot have any interest or penalties associated with unrecognized tax benefits.

The Company is subject to U.S. Federal, Illinois and California state income taxes. In addition, the Company is subject to local tax laws of France and Australia. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. Monopar was originally formed as an LLC in* December 2014,then incorporated on December 16, 2015.The Company is subject to U.S. Federal, state and local tax examinations by tax authorities for the tax years2015* through2023. The Company doesnot anticipate significant changes to its current uncertain tax positions through* September 30, 2024*.

Stock-Based Compensation

The Company accounts for stock-based compensation arrangements with employees, non-employee directors and consultants using a fair value method, which requires the recognition of compensation expense for costs related to all stock-based awards, including stock option and restricted stock unit (“RSU”) grants. The fair value method requires the Company to estimate the fair value of stock-based payment awards on the date of grant using an option pricing model or the closing stock price on the date of grant in the case of RSUs.

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Stock-based compensation expense for awards granted to employees, non-employee directors and consultants are based on the fair value of the underlying instrument calculated using the Black-Scholes option-pricing model on the date of grant for stock options and using the closing stock price on the date of grant for RSUs and recognized as expense on a straight-line basis over the requisite service period, which is the vesting period. Determining the appropriate fair value model and related assumptions requires judgment, including estimating the future stock price volatility and expected terms. For stock options granted in2023, the expected volatility rates are estimated based on the Company’s historical actual volatility over thethree-year period from its initial public offering on* December 18, 2019through December 31, 2022.For awards granted during thethree* months ended* September 30, 2024*, the expected volatility rates were estimated based on the Company’s historical actual volatility over thefour-year period from its initial public offering on* December 18, 2019,through December 31, 2023.The expected term for options granted to date is estimated using the simplified method. Forfeitures only include known forfeitures to-date as the Company accounts for forfeitures as they occur due to a limited history of forfeitures. The Company hasnot* paid dividends and doesnot anticipate paying a cash dividend in the future vesting period and, accordingly, uses an expected dividend yield of zero. The risk-free interest rate is based on the rate of U.S. Treasury securities with maturities consistent with the estimated expected term of the awards.

Recent Accounting Pronouncements

In* October 2023,the FASB issued Accounting Standards Update ("ASU")2023-06, Disclosure Improvements, Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. The ASU incorporates certain U.S. Securities and Exchange Commission (SEC) disclosure requirements and are expected to clarify or improve disclosure and presentation requirements of a variety of Codification Topics, allow users to more easily compare entities subject to the SEC's existing disclosures with those entities that werenot* previously subject to the requirements, and align the requirements in the Codification with the SEC's regulations. The effective date for each amendment will be the date on which the SEC's removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective with early adoption prohibited. For all other entities, the amendments will be effectivetwo years later. In accordance with ASU2023-06, the Company has added Note7 – Net Loss per Share.

In* November 2023,the FASB issued ASUNo.* 2023-07, Segment Reporting (Topic280*): Improvements to Reportable Segment Disclosures*. The ASU is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The purpose of the amendment is to enable investors to better understand an entity’s overall performance and assess potential future cash flows. The guidance is effective for fiscal years beginning after* December 15, 2023**,* and interim periods within fiscal years beginning after* December 15, 2024**,* with early adoption permitted. The Company is currently evaluating the effect the amendments in ASU2023-07 will have on its segment disclosures.

In* December 2023,the FASB issued ASUNo.* 2023-09, Income Taxes (Topic740*): Improvements to Income Tax Disclosures*. The ASU improves income tax disclosure requirements and will require more detailed information on several income tax disclosures, such as income taxes paid and the income tax rate reconciliation table. The standard is effective for public business entities with annual periods beginning after* December 15, 2024,and early adoption is permitted. The Company is currently evaluating the impact of this new standard on its condensed consolidated financial statements and related disclosures. The Company doesnot* expect a material impact to its condensed consolidated financial statements based on adoption of this ASU.

Note3 - Investments

As of* September 30, 2024*, the Company hadtwo money market accounts and available-for-sale investments with contractual maturities ofthree months or less categorized as cash and cash equivalents as follows:

As of* September 30, 2024*, there wereno available-for-sale securities in an unrealized-loss position. There wereno U.S. Treasury Bills classified as investments on the condensed consolidated balance sheet as of* September 30, 2024*.

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As of* December 31, 2023* the Company hadtwo money market accounts and available-for-sale investments with contractual maturities ofthree months or less categorized as cash and cash equivalents as follows:

As of* December 31, 2023*, there wereno available-for-sale securities in an unrealized-loss position. There wereno U.S. Treasury Bills classified as investments on the condensed consolidated balance sheet as of* December 31, 2023*.

See Note2 for additional discussion regarding the Company’s fair value measurements.

Note4 - Capital Stock

Holders of the common stock are entitled to receive such dividends as* maybe declared by the Board of Directors out of funds legally available therefor. To dateno* dividends have been declared. Upon dissolution and liquidation of the Company, holders of the common stock are entitled to a ratable share of the net assets of the Company remaining after payments to creditors of the Company. The holders of shares of common stock are entitled toone vote per share for the election of each director nominated to the Board andone vote per share on all other matters submitted to a vote of stockholders.

The Company’s amended and restated certificate of incorporation authorizes the Company to issue 40,000,000 shares of common stock with a par value of $0.001 per share.

Reverse Stock Split

On* August 5, 2024,the Company conducted its Annual Meeting of Stockholders in which the stockholders approved among other items, a proposal to amend the Company's Second Amended and Restated Certificate of Incorporation to effect a reverse stock split of the outstanding shares, which provided the Board of Directors with authority to effect a reverse split within a specified range of ratios. Subsequently, the Board of Directors approved a reverse stock split of1* for 5 shares of the Company's common stock in an attempt to regain compliance with the Nasdaq's continued listing requirements, which the reverse stock split did end up successfully accomplishing. The reverse stock split became effective at5:00 pm on Monday* August 12, 2024,and the Company's common stock commenced trading on a split-adjusted basis at the open of trading on Tuesday, August 13, 2024.*

Furthermore, at the Annual Meeting of Stockholders, a proposal to amend the2016 Stock Incentive Plan was approved. As a result, the total number of shares reserved for issuance under the Amended2016 Plan would increase from 5,100,000 to 7,100,000 (pre-split). As a result of the above mentioned stock split, the total number of shares reserved for issuance was adjusted to 1,420,000.

The reverse stock split reduced the number of shares of the Company's common stock outstanding on* August 12, 2024from 17,601,827 to 3,520,427. Proportional adjustments were made to the Company's outstanding stock options, and restricted stock units.No fractional shares were issued in connection with the reverse stock split. Stockholders who would otherwise have held a fractional share of common stock were rounded up and issuedone* whole share.

The par value of the Company's common stock was unchanged at $0.001 per share. The number of authorized shares of common stock was also unchanged at 40,000,000 shares.

The reverse stock split didnot modify the rights or preferences of the underlying common stock. The Company's stockholders' equity reflects the par value for all shares of common stock at $0.001 per share, with a corresponding increase in additional paid-in capital. All per-share amounts and numbers of shares in the accompanying financial statements and related notes have been retroactively adjusted to reflect the reverse stock split.

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Sales of Common Stock

On* April 20, 2022,the Company entered into a Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC (“JonesTrading”), pursuant to which Monopar mayoffer and sell, from time to time, through or to JonesTrading, as sales agent or principal, shares of Monopar’s common stock. On January 4, 2023,the Company filed a a prospectus related to the offer and sale of shares of common stock under this agreement of up to an aggregate amount of $6,505,642, under which $5,446,975 had been sold through September 30, 2024*and $1,058,667 was remaining on that date. Expenses related to these financing activities were recorded as offering costs (a reduction of additional paid in capital) on the Company’s condensed consolidated statement of stockholders’ equity for the period.

During thenine months ended* September 30, 2024*, the Company sold 509,061 shares of its common stock at an average gross price per share of $6.45 for net proceeds of $3,194,310, after fees and commissions of $81,932.

During thenine months ended* September 30, 2023*, the Company sold 173,124 shares of its common stock at an average gross price per share of $8.85 for net proceeds of $1,493,205, after fees and commissions of $38,312. In addition, the Company incurred legal, accounting and other fees totaling $25,872 for net proceeds after fees, commissions and expenses of $1,467,333.

Note5 - Stock Incentive Plan

In* April 2016,the Company’s Board of Directors and stockholders representing a majority of the Company’s outstanding stock at that time, approved the Monopar Therapeutics Inc.2016 Stock Incentive Plan, as amended (the “Plan”), allowing the Company to grant up to an aggregate 140,000 shares of stock-based awards in the form of stock options, restricted stock units, stock appreciation rights and other stock-based awards to employees, non-employee directors and consultants. In October 2017,the Company’s Board of Directors voted to increase the stock award pool to 320,000 shares of common stock, which subsequently was approved by the Company’s stockholders. In April 2020,the Company’s Board of Directors voted to increase the stock award pool to 620,000 (an increase of 300,000 shares of common stock), which was approved by the Company’s stockholders in June 2020.In April 2021,the Company’s Board of Directors voted to approve an amendment to the2016* Stock Incentive Plan to remove certain individual award limits and other provisions related to I.R.C. Section162(m) and to update the limit on Incentive Stock Options tono more that100% of the maximum aggregate number of shares which* maybe granted under the plan, which was approved by the Company’s stockholders in June 2021.In March 2022,the Company’s Board of Directors voted to increase the stock award pool to 1,020,000 (an increase of 400,000 shares of common stock), which was approved by the Company’s stockholders in June 2022.On August 5, 2024,the Company's Stockholders approved a proposal to amend the2016* Stock Incentive Plan and a Reverse Stock Split. As a result of the proposal to amend the2016 Stock Incentive Plan the total number of shares reserved for issuance under the Amended2016 Plan would increase from 1,020,000 to 1,420,000. In* August 2024the Company’s Board of Directors voted to approve the Reverse Stock Split at a ratio of1*-for-5.

During thenine months ended* September 30, 2024*, the Board of Directors granted to a consultant aggregate stock options for the purchase of 2,000 shares of the Company’s common stock with an exercise price of $1.271 per share vesting monthly over 12 months and to officers aggregate stock options for the purchase of 30,001 shares of the Company's common stock with exercise prices ranging from $2.450 to $2.956 per share vesting over 4 years. In addition, during thenine months ended* September**30,* 2024, the Company’s Plan Administrator Committee granted to non-officer employees and a new employee aggregate stock options for the purchase of 11,522 shares of the Company’s common stock with exercise prices ranging from $1.899 to $2.751 per share which vest over 4 years. All stock option grants have a 10-year term.

Under the Plan, the per share exercise price for the shares to be issued upon exercise of an option shall be determined by the Plan Administrator, except that the per share exercise price shall beno less than100% of the fair market value per share on the grant date. Fair market value is the Company’s closing price on the grant date on Nasdaq. Stock options generally expire after 10 years.

Stock option activity under the Plan was as follows:

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A summary of options outstanding as of* September 30, 2024*, is shown below:

Restricted stock unit activity under the Plan was as follows:

(1) There were 5,997 restricted stock units granted during thenine months ended* September 30, 2024*. These units vest6/48ths on thesix-month anniversary of vesting commencement date and3/48ths per quarter thereafter.

Stock option grants and fair values under the Plan were as follows:

As of* September 30, 2024*, the aggregate intrinsic value of outstanding vested and unvested stock options was approximately $553,205 and $131,509 respectively. The weighted-average exercise price in aggregate was $19.35 which includes $21.92 for fully vested stock options and $11.38 for stock options expected to vest. As of* September 30, 2024*, unamortized unvested balance of stock-based compensation was $1.4 million, to be amortized over the following 2 years.

During thethree months ended* September 30, 2024* and2023, the Company recognized $13,512 and $256,670 of employee, non-employee director and consultant stock-based compensation expense as general and administrative expenses, respectively, and $185,609 and $217,468 as research and development expenses, respectively. During thenine months ended* September 30, 2024* and2023, the Company recognized $325,589 and $757,303 of employee, non-employee director and consultant stock-based compensation expense as general and administrative expenses, respectively, and $536,584 and $666,340 as research and development expenses, respectively. The stock-based compensation expense is allocated on a departmental basis, based on the classification of the stock-based award holder. No income tax benefits have been recognized in the condensed consolidated statements of operations and comprehensive loss for stock-based compensation arrangements.

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Note6 - Related Party Transactions

As of* September 30, 2024*, Tactic Pharma, LLC (“Tactic Pharma”), the Company’s initial investor, beneficially owned 24.3% of Monopar’s common stock. During thethree andnine months ended* September 30, 2024*, there wereno transactions between Tactic Pharma and Monopar.

None of the related parties discussed in this paragraph received compensation other than market-based salary, market-based stock-based compensation and benefits and performance-based incentive bonus or in the case of non-employee directors, market-rate Board fees and market-rate stock-based compensation. The Company considers the following individuals as related parties: Two of the Company’s board members were also Managing Members of Tactic Pharma as of* September 30, 2024*. Chandler D. Robinson is a Company Co-Founder, Chief Executive Officer, common stockholder, Managing Member of Tactic Pharma, former Manager of the predecessor LLC, Manager of CDR Pharma, LLC and Board member of Monopar as a C Corporation. Michael Brown is a Managing Member of Tactic Pharma (as of* February 1, 2019,withno* voting power as it relates to Monopar), a previous managing member of Monopar as an LLC, common stockholder and Board member of Monopar as a C Corporation.

Note7 - Net Loss Per Share

Basic and diluted net loss per common share was calculated as follows:

Information pertaining to number of shares outstanding gives retroactive effect to a1 for 5 reverse stock split that became effective on August 12, 2024.

Note8 – Commitments and Contingencies

License, Development and Collaboration Agreements

XOMA Ltd.

Pursuant to a non-exclusive license agreement with XOMA Ltd. for the humanization technology used in the development of MNPR-101, the Company is obligated to pay XOMA Ltd. clinical, regulatory and sales milestones which could reach up to $14.925 million if the Company achieves all milestones for MNPR-101. The agreement doesnot require the payment of sales royalties. There can beno assurance that the Company will achieve any milestones. As of* September 30, 2024*, the Company hadnot reached any milestones and hasnot been required to pay XOMA Ltd. any funds under this license agreement. Thefirst milestone payment is payable uponfirst dosing of a human patient in a Phase2 clinical trial. The Company's MNPR-101 radiopharma program is in Phase1 and the Company cannot reliably predict when the program will enter Phase2 if at all.

NorthStar Medical Radioisotopes, LLC ("NorthStar")

In* June 2024,*the Company entered into a long-term, non-exclusive master supply agreement for NorthStar to provide Monopar with the therapeutic radioisotope actinium-225 ("Ac-225"). The original collaboration agreement was amended at that time to clarify certain economic terms and those related to jointly developed intellectual property rights for Monopar’s MNPR-101 for radiopharmaceutical use. Monopar has acquired those rights from NorthStar, together with certain broad, jointly developed intellectual property pertaining to MNPR-101, giving Monopar full ownership and title to its lead MNPR-101 radiopharmaceutical platform. Both companies will share ownership of the filed patent application on the use of PCTA as a linker with Ac-225, which has shown with MNPR-101 superior binding and yield with Ac-225 over the current industry-leading linker, DOTA.

Legal Contingencies

The Company* may*be subject to claims and assessments from time to time in the ordinary course of business.No claims have been asserted to date.

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Indemnification

In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that* maybe made against the Company in the future, but that havenot* yet been made. To date, the Company hasnot paid any claims nor been required to defend any action related to its indemnification obligations. However, the Company* may*record charges in the future as a result of future claims against these indemnification obligations.

In accordance with itssecond amended and restated certificate of incorporation, amended and restated bylaws and the indemnification agreements entered into with each officer and non-employee director, the Company has indemnification obligations to its officers and non-employee directors for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacities. There have beenno indemnification claims to date.

Note9 – Subsequent Events

On* October 23, 2024,the Company executed a License Agreement effective October 23, 2024with Alexion Pharmaceuticals, Inc. (“Alexion, AstraZeneca Rare Disease” or “Alexion”), pursuant to which Alexion, AstraZeneca Rare Disease granted the Company an exclusive worldwide license for the development and commercialization of ALXN-1840, a drug candidate for Wilson disease that has progressed through a Phase3* clinical trial that met its primary endpoint.

As initial upfront consideration for the License Agreement, the Company issued Alexion 387,329 shares of common stock (representing a 9.9% beneficial ownership interest in the Company upon issuance) and the Company has agreed to make an upfront cash payment of $4.0 million, which shall be payable intwo installments, including a $1.0 million cash payment at the time of signing and a $3.0 million cash payment withinninety (90) days. The Company made the initial $1 million payment on* October 24, 2024.*

Additionally, pursuant to the license agreement, Alexion is eligible to receive milestones and royalties, as further described below.

The shares issued to Alexion were issued pursuant to a separate Common Stock Investment Agreement, also dated* October 23, 2024,between the Company and Alexion (the “Equity Agreement”). Pursuant to the Equity Agreement, the Company agreed to anti-dilution provisions that entitle Alexion to additional shares of common stock so that the total number of shares issued thereunder continue to represent 9.9% of outstanding shares after any subsequent issuances of common stock through the next $25.0 million of common equity capital raised by the Company, subject to a maximum of 705,015 Shares (inclusive of the shares initially issued) unless the Company obtains stockholder approval. As of October 31, 2024,the Company has issued Alexion an additional 135,172 shares under these anti-dilution provisions (bringing the total number of shares issued to Alexion to 522,501) as a result of the financing transactions discussed below. The Equity Agreement also entitles Alexion to customary registration rights and the Company agreed to file a resale registration statement withinforty-five* (45) days of* October 23, 2024.*

As additional consideration, the Company will be obligated to pay Alexion aggregate milestone payments of up to $94.0 million, including regulatory approval and sales related milestone payments. Alexion is also entitled to receive tiered royalties based on net sales in the low to mid-double digit range. Alexion has a right offirst negotiation regarding any rights that the Company intends to sublicense, and will receive a percentage in the mid-double digits of sublicensing income received by Company until the Licensed Product achieves sales. The Company also assumed athird party agreement from Alexion under which the Company will owe athird-party a single digit millions cash milestone payment upon regulatory approval in Europe and a single digit percentage royalty on net sales in Europe.

Subsequent to* September 30, 2024,*the Company sold 48,700 shares of its common stock at an average gross price per share of $21.22 for net proceeds of $1,007,934, after fees, commissions and expenses of $25,874 through an-at-the market offering,

On* October 28, 2024,the Company entered into and executed a placement agent agreement with Rodman & Renshaw LLC in connection with registered public offering of 1,181,540 shares of the Company’s common stock, par value $0.001 per share, at an offering price of $16.25 per Share. In connection with this offering, the Company entered into a securities purchase agreement with certain of the purchasers in the offering. The offering closed on October 30, 2024*and yielded net proceeds to the Company of approximately $17.7 million, after deducting placement agent fees and other estimated offering expenses.