Moleculin Biotech Inc
For the period ended Jun 30, 2024. Filed Aug 13, 2024.
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Jun 30, 2024 · Filed Aug 13, 2024
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Notes to Condensed Consolidated Financial Statements
Notes to the Condensed Consolidated Financial Statements
1. Nature of Business
The terms “MBI” or “the Company”, “we”, “our” and “us” are used herein to refer to Moleculin Biotech, Inc. 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 hasthree core technologies, each of which have hadone* or more drugs successfully complete a Phase1 clinical trial, based substantially on discoveries made at and licensed from MD Anderson Cancer Center (MD Anderson) in Houston, Texas. The Company hastwo wholly owned subsidiaries, Moleculin Australia Pty. 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. 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. The physician-sponsored trials utilize primarily external funds, such as grant funds, which arenot presented in these financial statements. The Company doesnot have manufacturing facilities, and all manufacturing activities are contracted out tothird parties. Additionally, the Company doesnot have a sales organization. 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.
In2019, the Company sublicensed its technologies to Animal Life Sciences, Inc. (ALI), to enable research and commercialization for non-human use and share development data. As part of this agreement, ALI issued to the Company a 10% equity interest in ALI.
On* May 5, 2023,the Company received a letter from the Nasdaq Capital Market (Nasdaq) notifying the Company that for the prior30* 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 Rule5550(a)(2) (Bid Price Rule). The deficiency letter didnot result in the immediate delisting of the Company's common stock from the Nasdaq. In accordance with Nasdaq Listing Rule5810(c)(3)(A), the Company was provided an initial period of180 calendar days, until* November 1, 2023,to regain compliance with the Bid Price Rule. 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. On March 5, 2024,the Board of Directors approved a reverse1*-for-15 reverse stock split effective11:59 P.M. (Eastern time) on* March 21, 2024,with trading to commence on a split-adjusted basis on March 22, 2024.On April 8, 2024,the Company received a letter from Nasdaq notifying the Company that it had regained compliance with Bid Price Rule5550*(a)(2) as a result of the closing bid price of the Company's common stock being at $1.00 per share or greater for the10 consecutive business days from* March 22, 2024through April 5, 2024.*Accordingly, the Company is in compliance with the Bid Price Rule and Nasdaq considers the matter closed.
2. Basis of presentation, principles of consolidation, and significant accounting policies and liquidity
Reverse Stock Split - On* March 22, 2024,the Company completed a reverse stock split of all the issued and outstanding shares of the Company's common stock at a ratio of1* to 15. 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 previously reported include rounding up of fractional shares as a result of the reverse stock split.
Basis of Presentation – Condensed Consolidated Financial Information - The accompanying condensed consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for financial information, and in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (SEC) with respect to Form10-Q and Article8 of Regulation S-X. Accordingly, they donot include all of the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated financial statements furnished reflect all normal adjustments, which are, in the opinion of management, necessary for a fair statement of results for the interim periods presented. Interim results arenot necessarily indicative of the results for the full year. These condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company as of* December 31, 2023* and for the year then ended, including the notes thereto contained in the Form10-K filed with the SEC on* March 22, 2024.*
Principles of Consolidation - The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP. The Company views its operations and manages its business inone operating segment. All material long-lived assets of the Company reside in the U.S.
Significant Accounting Policies- The Company's significant accounting policies are described in Note2, Basis of Presentation, principles of consolidation and significant accounting policies, to the consolidated financial statements included in the Company's Annual Report on Form10-K for the year ended* December 31, 2023*. There have beenno material changes to the significant accounting policies during thesix months ended* June 30, 2024*.
Use of Estimates - The preparation of these condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors* mayaffect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often mayyield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may*result in actual results differing materially from those estimated amounts used in the preparation of financial statements. Estimates are used in the following areas, among others: fair value estimates on intangible assets, warrants, and stock-based compensation expense, as well as accrued expenses and taxes.
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Intangible Assets – The company evaluates the recoverability of intangible assets periodically and takes into account events or circumstances that warrant revised estimates of useful lives or that indicate that impairment exists. Due to the sustained decline in the Company’s stock price, the Company engaged athird-party valuation firm to complete a quantitative assessment of in-process research and development (IPR&D) asset as of* June 30, 2024.We performed our impairment test by comparing the carrying value of the IPR&D asset to its estimated fair value, which was determined by the income approach, using a discounted cash flow model. Based on our quantitative assessment, the carrying value of the IPR&D asset didnot* exceed its estimated fair value, notingno impairment.
Going Concern and Liquidity - These condensed 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. The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain necessary equity financing to continue operations and the attainment of profitable operations. As of * June 30, 2024*, the Company had an accumulated deficit of$140.9 million since inception and hadnot yet generated any revenues from operations. Additionally, management anticipates that its cash on hand of$10.8 million as of* June 30, 2024* isnot sufficient to fund its planned operations for a period of at leastone year from when these consolidated financial statements are issued. These factors raise substantial doubt regarding the Company's ability to continue as a going concern. These unaudited condensed consolidated financial statements donot 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. The Company intends to seek additional funding throughone or more of the following: a combination of equity offerings, debt financings, government or otherthird-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof. There can beno assurance that such events or a combination thereof can be achieved.
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. The Company has received, and expects to continue to receive, periodic further requests from the SEC staff with respect to this matter. The Company isnot* 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 doesnot 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. The Company cannot predict when this matter will be resolved or what, if any, action the SEC* maytake following the conclusion of the investigation. The company expensed approximately $0.1 million and $0.4 million in related general and administrative fees and expenses for thethree* months ended* June 30, 2024and2023*, respectively, and $0.1 million and $0.9 million for thesix months ended* June 30, 2024and2023*, respectively. The Company is in the process of filing a claim with its insurance carriers related to this loss which* maycover a portion of the related expenses butnot* all. The claim is currently under review by the insurance company. The claim hasnot yet been approved nor has a reimbursement amount been determined which, if any, would be limited by the applicable retention as defined under the policy. Accordingly, the Company hasnot recorded any provision for insurance reimbursement. The Company expects to record the insurance reimbursement at the time that the amount to be reimbursed is determined and approved by the insurance carrier. Any insurance reimbursement receivable will be recorded at an amountnot to exceed the recorded loss and only if the terms of the legally enforceable insurance contracts support that the insurance recovery willnot be disputed and is deemed collectible, or if recovery of the loss is probable.
Cash and Cash Equivalents - Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company maintains cash accounts principally atone financial institution in the U.S., which at times,* mayexceed the Federal Deposit Insurance Corporation’s limit. The Company hasnot* experienced any losses from cash balances in excess of the insurance limit. The Company’s management doesnot believe the Company is exposed to significant credit risk at this time due to the financial condition of the financial institution where its cash is held.
Prepaid Expenses and Other Current Assets- Prepaid expenses and other current assets consist of the following (in thousands):
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Prepaid sponsored research | $1,277 | $1,515 |
| Prepaid insurance | 1,143 | 564 |
| Vendor prepayments and deposits | 457 | 545 |
| Non-trade receivables | 5 | 95 |
| Related party receivables | 4 | 4 |
| Total prepaid expenses and other current assets | $2,886 | $2,723 |
**Fair Value of Financial Instruments -**The Company's financial instruments consist primarily of non-trade receivables, accounts payable, accrued expenses and its warrant liability. The carrying amount of non-trade receivables, accounts payable, and accrued expenses approximates their fair value because of the short-term maturity of such.
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The Company has categorized its assets and liabilities that are valued at fair value on a recurring basis into athree-level fair value hierarchy in accordance with U.S. GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level1) and lowest priority to unobservable inputs (Level3).
Assets and liabilities recorded in the balance sheets at fair value are categorized based on a hierarchy of inputs as follows:
Level1 – Unadjusted quoted prices in active markets of identical assets or liabilities.
Level2 – 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.
Level3 – Unobservable inputs for the asset or liability.
The Company’s financial assets and liabilities recorded at fair value on a recurring basis include the fair value of warrant liability discussed in Note4.
The following table provides the financial liabilities reported at fair value and measured on a recurring basis at* June 30, 2024* and* December 31, 2023* (table in thousands):
| Description | Fair Value | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Fair value of warrant liability as of June 30, 2024: | $1,704 | $— | $— | $1,704 |
| Fair value of warrant liability as of December 31, 2023: | $4,855 | $— | $— | $4,855 |
The table below of Level3 liabilities (table in thousands) begins with the valuation as of the beginning of thesecond quarter and then is adjusted for changes in fair value that occurred during thesecond quarter. The ending balance of the Level3 financial instrument presented above represents the Company's best estimates and* may**not* be substantiated by comparison to independent markets and, in many cases, couldnot be realized in immediate settlement of the instruments.* *
| Three Months Ended June 30, 2024 | Warrant Liability Long-Term |
|---|---|
| Balance, March 31, 2024 | $3,400 |
| Change in fair value - net | (1,696) |
| Balance, June 30, 2024 | $1,704 |
The table below of Level3 liabilities (table in thousands) begins with the valuation as of* December 31, 2023and then is adjusted for changes in fair value that occurred during thesix* months ended* June 30, 2024*. The ending balance of the Level3 financial instrument presented above represents the Company's best estimates and* may**not* be substantiated by comparison to independent markets and, in many cases, couldnot be realized in immediate settlement of the instruments.* *
| Six Months Ended June 30, 2024 | Warrant Liability Long-Term |
|---|---|
| Balance, December 31, 2023 | $4,855 |
| Change in fair value - net | (3,151) |
| Balance, June 30, 2024 | $1,704 |
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 are considered to be common stock equivalents. 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. For thethree andsix months ended* June 30, 2024and2023*, approximately 1.6 million and 0.4 million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their anti-dilutive effect.
Subsequent Events - The Company’s management reviewed all material events through the date of these unaudited condensed consolidated financial statements.
Recent Accounting Pronouncements- There areno recently issued accounting standards updates that are currently expected to have a material impact on the Company.
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3. Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consist of the following components (in thousands):
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Accrued payroll and bonuses | $1,157 | $765 |
| Accrued research and development | 1,060 | 2,845 |
| Accrued legal, regulatory, professional and other | 540 | 547 |
| Operating lease liability - current | 112 | 100 |
| Accrued liabilities due to related party | 44 | 60 |
| Total accrued expenses and other current liabilities | $2,913 | $4,317 |
Additionally, accounts payable includes $20,000 and $67,000 as of* June 30, 2024* and* December 31, 2023*, respectively, for related party payables.
4. Warrants
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. The risk-free interest rate assumption is based upon observed interest rates onzero coupon U.S. 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. Only the volatility of the Company's own stock is used in the Black-Scholes option pricing model.
The assumptions used in determining the fair value of the Company's outstanding liability classified warrants are as follows:
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Risk-free interest rate | 4.3% to 5.2% | 3.8% to 5.4% |
| Volatility | 87.9% to 94.9% | 79.5% to 108.7% |
| Expected life (years) | 0.6 to 4.5 | 0.3 to 5.0 |
| Dividend yield | —% | —% |
A summary of the Company's liability classified warrant activity during thesix months ended* June 30, 2024* and related information follows:
| Number of Shares · Range of Warrant Exercise · Weighted Average · Weighted Average Remaining Contractual | |||||
|---|---|---|---|---|---|
| Under Warrant · Price per Share · Exercise Price · Life (Years) | |||||
| Balance at January 1, 2024 | 1,082,895 | $9.60 | $157.50 | $24.32 | 5.1 |
| Expired warrants | (75,909) | $99.00 | $99.00 | $99.00 | — |
| Balance at June 30, 2024 | 1,006,986 | $9.60 | $94.50 | $— | 4.4 |
| Exercisable at June 30, 2024 | 1,006,986 | $9.60 | $94.50 | $15.31 | 4.4 |
For a summary of the changes in fair value associated with the Company's warrant liability for thesix months ended* June 30, 2024*, see Note2 - Basis of presentation, principles of consolidation and significant accounting policies - Fair Value of Financial Instruments.
Equity Classified Warrants
In* March 2024,the Company granted equity-classified warrants to purchase up to 3,334 shares of Company common stock with aten-year term and an exercise price of $9.15. The warrants vest annually overfour* years while services are being performed.
At* June 30, 2024*, the Company had 63,105 equity classified warrants outstanding and 40,658 warrants were exercisable. At* December 31, 2023*, the Company had 289,276 equity classified warrants outstanding and 266,350 warrants were exercisable.
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The Company recorded stock compensation expense for the non-employee consulting agreements of $35,000 and $46,000 for thethree months ended* June 30, 2024and2023*, respectively, and $68,000 and $92,000 for thesix months ended* June 30, 2024and2023* , respectively. At* June 30, 2024*, there was $309,000 of unrecognized stock compensation expense related to the Company's equity classified warrants.
5. Equity
Lincoln Park Equity Line
The Company didnot utilize the2021 Lincoln Park purchase agreement during thesix months ended* June 30, 2024*. The2021 Lincoln Park Agreement terminated in* June 2024.*
Other Components of Equity
In* March 2024,the Company issued 6,834 shares of common stock to consultants in exchange for services to be provided. In addition, during thesix* months ended* June 30, 2024*, the Company issued 19,743 shares of common stock related to the vesting of restricted stock units.
Stock-Based Compensation and Outstanding Awards
The2015 Stock Plan provides for the grant of stock options, stock awards, stock unit awards, and stock appreciation rights to employees, non-employee directors and consultants. In* May 2023and2022,* the2015 Stock Plan (the Plan) was amended to authorize an additional 116,667 shares and 133,334 shares, respectively, such that 366,667 total shares* maybe issued under the Plan. As of June 30, 2024*, there were 1,053 shares remaining to be issued under the2015 Stock Plan.
Stock-based compensation expense for thethree andsix months ended* June 30, 2024and2023*, respectively, is as follows (table in thousands):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| General and administrative | $340 | $379 | $721 | $748 |
| Research and development | 113 | 134 | 225 | 264 |
| Total stock-based compensation expense | $453 | $513 | $946 | $1,012 |
On* May 8, 2024the Company issued 1,000 options to purchase the company stock under the2015* Stock Plan to a Science Advisory Board member.
6. Income Taxes
Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.
The Company doesnot expect to pay any significant federal, state, or foreign income taxes in2024 as a result of the losses recorded during thethree andsix months ended* June 30, 2024* and the additional losses expected for the remainder of2024 and cumulative net operating loss carryforwards. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is “more likely thannot” that some component or all of the benefits of deferred tax assets willnot be realized. As a result, as of* June 30, 2024* and* December 31, 2023* the Company maintained a full valuation allowance for all deferred tax assets.
The Company recordedno income tax provision for thethree andsix months ended* June 30, 2024and2023*, respectively. The effective tax rate for thesix months ended* June 30, 2024and2023* isnil. The income tax rates vary from the federal and state statutory rates primarily due to the change in fair value of the stock warrants, Internal Revenue Code Section162(m) limitations and ISO activity, as well as the valuation allowances on the Company’s deferred tax assets. The Company estimates its annual effective tax rate at the end of each quarterly period. Jurisdictions with a projected loss for the year whereno tax benefit can be recognized due to the valuation allowance could result in a higher or lower effective tax rate during a particular quarter depending on the mix and timing of actual earnings versus annual projections.
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7. Commitments and Contingencies
In addition to the commitments and contingencies described elsewhere in these notes, see below for a discussion of the Company's commitments and contingencies as of* June 30, 2024*.
Lease Obligations Payable
The following summarizes quantitative information about the Company's operating leases for thethree andsix months ended* June 30, 2024and2023*, respectively (table in thousands):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Lease cost: | ||||
| Operating lease cost | $38 | $33 | $75 | $65 |
| Variable lease cost | 7 | 7 | 10 | 14 |
| Total | $45 | $40 | $85 | $79 |
In* September 2023,the Company executed an amendment to extend the corporate office lease until August 31, 2029,*with an option to renew. 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. 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.
In* June 2022,the Company extended the lab lease until September 30, 2027,withno* further right or option to renew. The Company recorded approximately $12,000 in sublease income from a related party for thethree months ended* June 30, 2024and2023*, respectively, and $24,000 and $25,000 for thesix months ended* June 30, 2024and2023*. Sublease income is recorded as other income, net on the Company's condensed consolidated statement of operations and comprehensive loss. Operating cash flows from operating leases was $38,000 for thethree months ended* June 30, 2024and2023*, respectively, and $68,000 and $75,000 for thesix months ended* June 30, 2024and2023*, respectively.
Licenses
MD Anderson -Total expenses related to the Company's license agreements with MD Anderson were $63,000 and $64,000 for thethree months ended June 30, 2024and2023, respectively, and $117,000 and $129,000 for thesix months ended* June 30, 2024and2023*, respectively.
HPI -The Company hastwo agreements with a related party, Houston Pharmaceuticals, Inc. (HPI) with total expenses of $59,000 for each of thethree months ended June 30, 2024and2023, respectively, and $117,000 for thesix months ended* June 30, 2024and2023*, respectively.
Sponsored Research Agreements - The expenses recognized under the agreements were $377,000 and $176,000 for thethree months ended* June 30, 2024and2023*, respectively, and $533,000 and $331,000 for thesix months ended* June 30, 2024and2023*, respectively.
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