NeuroBo Pharmaceuticals Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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Sep 30, 2024 · Filed Nov 7, 2024
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Notes to the Condensed Consolidated Financial Statements (Unaudited)
**1.**Business, basis of presentation, new accounting standards and summary of significant accounting policies
General
NeuroBo Pharmaceuticals, Inc. (the “Company”), a Delaware corporation, and its subsidiaries are referred to collectively in these notes to the condensed consolidated financial statements of the Company as “NeuroBo,” “we,” “our” and “us.”We are a clinical-stage biotechnology company focused primarily ondeveloping and commercializing novel pharmaceuticals to treat cardiometabolic diseases. NeuroBo has two programs currently focused on treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity. MASH was formerly known as non-alcoholic steatohepatitis (“NASH”).
| ● | DA-1241 is a novel G-Protein-Coupled Receptor 119 (“GPR119”) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes. Agonism of GPR119 in the gut promotes the release of key gut peptides, glucagon-like peptide 1 (“GLP-1”), glucagon-dependent insulinotropic polypeptide receptor, and peptide YY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. |
| ● | DA-1726 is a novel oxyntomodulin analogue functioning as a GLP-1 receptor (“GLP1R”) and glucagon receptor (“GCGR”) dual agonist for the treatment of obesity that is to be administered once weekly subcutaneously. |
While we primarily focus our financial resources and management’s attention on the development of DA-1241 and DA-1726, we also have four legacy therapeutic programs designed to impact a range of indications in viral, neurodegenerative and cardiometabolic diseases which we have, or continue to consider for, out-licensing and divestiture opportunities. In July 2024, we entered into an exclusive out-license agreement with MThera Pharma Co., LTD. (“MThera”) to provide MThera with the rights to NB-01 for the treatment of painful diabetic neuropathy.
Our operations have consisted principally of performing research and development (“R&D”) activities, which includes preclinical developments and clinical trials, and raising capital. Our activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved.
Common stock reverse stock splits
In December 2023, we completed aone-for-eight reverse stock split of our common stock (the “2023 Reverse Stock Split”). As a result, every eight shares of our issued and outstanding common stock were combined, converted and changed into one share of our common stock. Any fraction of a share of our common stock that was created as a result of the 2023 Reverse Stock Split was rounded down to the next whole share and our stockholders received cash equal to the market value of the fractional share, determined by multiplying such fraction by the closing sales price of our common stock as reported on the Nasdaq Capital Market LLC (“Nasdaq”)on the last trading day before the 2023 Reverse Stock Split. The 2023 Reverse Stock Split was initially approved by our stockholders at the annual meeting of stockholders in June 2023. At the annual meeting, the stockholders approved a proposal to amend our certificate of incorporation to affect a reverse split of our outstanding common stock at a ratio in the range of one-for-five to one-for-eight to be determined at the discretion of our Board of Directors (“Board”). Following the annual meeting, our Board approved a one-for-eight reverse stock split of our issued and outstanding shares of common stock.
The 2023 Reverse Stock Split did not impact the number of authorized shares of common stock of 100,000,000 shares. For the 2023 Reverse Stock Split, a proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options, and warrants to purchase shares of our common stock, the number of shares issuable upon vesting of restricted stock units (“RSUs”) and the number of shares reserved for issuance pursuant to our equity incentive compensation plans. Specifically, for the Series A warrants and Series B warrants issued in November 2022 that were outstanding on the effective date of the 2023 Reverse Stock Split, the number of outstanding warrants did not change; instead, the warrants have anexchange ratio ofeight warrants for one share of our
common stock.
In the accompanying condensed consolidated financial statements and these notes to the condensed consolidated financial statements, all historical numbers of shares of common stock and per share data have been adjusted to give effect to the 2023 Reverse Stock Split. Additionally, since the common stock par value was unchanged, historical amounts for common stock and additional paid-in capital have been adjusted to give effect to the 2023 Reverse Stock Split.
Going concern
The determination as to whether we can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our condensed consolidated financial statements have been prepared assuming that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business.
As reflected in the condensed consolidated financial statements, we had$21.7 million in cash as of September 30, 2024. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of$130.7 million as of September 30, 2024. We have incurred a net loss of$22.4 million and net cash used in operating activities of $19.3 million for the nine months ended September 30, 2024. Due in large part to the ongoing Phase 2a clinical trial for DA-1241 and Phase 1 clinical trial for DA-1726, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern within one year from the issuance of these condensed consolidated financial statements.
We believe that our existing cash will be sufficient to fund our operations into the third quarter of 2025. We plan to continue to fund our operations from equity offerings, debt financings, or other sources, potentially including collaborations, out-licensing and other similar arrangements. There can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all, or that the Series A Warrants will be exercised. To the extent that we can raise additional funds by issuing equity securities or in the event our existing warrants are exercised, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business. If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on us.
**A.**Basis of presentation
We prepared the condensed consolidated financial statements following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“GAAP”) for complete financial statements can be condensed or omitted. However, except as disclosed herein, there has been no material change in the information disclosed in the notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (“2023 Form 10-K”).
Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these condensed consolidated financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the condensed consolidated financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in the condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in our 2023 Form 10-K. Certain amounts in the condensed consolidated financial statements and accompanying notes may not add up due to rounding, and all percentages have been calculated using unrounded amounts.
**B.**New accounting standards
Adoption of new accounting standards
New accounting standards or accounting standards updates were assessed and determined to be either not applicable or did not have a material impact on our condensed consolidated financial statements or processes.
Accounting standards issued but not yet adopted
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures to improve disclosure requirements about reportable segments and address requests from investors for additional, more detailed information about a reportable segment’s expenses. This ASU requires that a public entity that has a single reportable segment provide all the disclosures required by the amendments in this ASU and all existing segment disclosures in Topic 280. Additionally, this ASU requires disclosures of significant segment expenses provided to the Chief Operating Decision Maker ("CODM") and included in reported measures of segment profit and loss. Disclosure of the title and position of the CODM is required. This ASU requires interim and annual disclosures about a reportable segment's profit or loss and assets. Furthermore, this ASU requires disclosure of other segment items by reportable segment including a description of its composition. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, on a retrospective basis. The disclosures will be implemented as required for the year-ended December 31, 2024. We are currently evaluating the impact of adopting this ASU to our notes to the consolidated financial statements and processes.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures to improve the transparency of income tax disclosures by amending the required rate reconciliation disclosures as well as requiring disclosure of income taxes paid disaggregated by jurisdiction. As amended, the rate reconciliation disclosure will be required to be presented in both percentages and reporting currency amounts, with consistent categories and greater disaggregation of information. This ASU also includes amendments intended to improve the effectiveness of income tax disclosures and eliminate certain existing disclosure requirements related to uncertain tax positions and unrecognized deferred tax liabilities. This ASU is effective for fiscal years beginning after December 15, 2024 and should be applied prospectively. Early adoption is permitted. We are currently evaluating the impact of adopting this ASU to our notes to the consolidated financial statements and processes.
In November 2024, the FASB issued ASU 2024-03, Accounting Standards Update 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses to improve financial reporting by requiring that public business entities disclose additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. The amendments in this ASU do not change or remove current expense disclosure requirements; however, the amendments affect where such information appears in the notes to financial statements because entities are required to include certain current disclosures in the same tabular format disclosure as the other disaggregation requirements in the amendments. This ASU is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating the impact of adopting this ASU to our notes to the consolidated financial statements and processes.
Other recently issued accounting standards not yet adopted by us are not expected, upon adoption, to have a material impact on our condensed consolidated financial statements.
**C.**Estimates and assumptions
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in our consolidated financial statements relate to accrued expenses and the fair value of stock-based compensation and warrants. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.
**D.**Significant accounting policies
Our significant accounting policies are described in “Note 1. Business, basis of presentation, new accounting standards and summary of significant accounting policies” in the audited consolidated financial statements and notes thereto for the year ended December 31, 2023, which is included in our 2023 Form 10-K.
E.Reclassification of prior year presentation
Certain prior year amounts have been reclassified for consistency with the current year presentation. Adjustments have been made to the condensed consolidated balance sheets to reclassify the presentation of (i) clinical trial accrued liabilities of $3.0 million from accrued expenses and other current liabilities to clinical trial accrued liabilities (ii) related party payable of $0.8 million from accrued expenses and other current liabilities to related party payable. These reclassifications had no effect on the reported total current liabilities in the condensed consolidated balance sheets.
**2.**Prepaid expenses and other current assets
Prepaid expenses and other current assets consist of the following (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · As of | ||||||
| · · September 30, 2024 · · December 31, 2023 | ||||||
| Insurance | | $159 | | $— | ||
| Deposits | | | 12 | | | 39 |
| Other prepaid expenses | | 95 | | 38 | ||
| Total | | $266 | | $77 | ||
**3.**Property and equipment, net
Property and equipment, net consist of the following(in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| · · As of | ||||
| | | September 30, 2024 | | December 31, 2023 |
| Office equipment | | $88 | | $80 |
| Less accumulated depreciation | | (49) | | (34) |
| Property and equipment, net | | $39 | | $46 |
We recorded depreciation expense of $5 thousand and $15 thousand for the three and nine months ended September 30, 2024, respectively. For the three and nine months ended September 30, 2023, we recorded depreciation expense of $1 thousand and $2 thousand, respectively.
**4.**Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consist of the following(in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · As of | ||||||
| · · September 30, 2024 · · December 31, 2023 | ||||||
| Employee related costs | | $600 | | $118 | ||
| Professional service fees | | | 39 | | | 308 |
| Other | | 15 | | 166 | ||
| Total | | $654 | | $592 | ||
**5.**Warrant liabilities
Changes to our warrant liabilities are summarized as follows (in thousands):
| | | | |
|---|---|---|---|
| · · Total | |||
| As of January 1, 2024 | | $658 | |
| Fair value changes | | | (94) |
| As of September 30, 2024 | | $564 | |
Our warrant liabilities relate to the 2022 Series A warrants and 2022 Series B warrants, which were issued in November 2022. These warrants are considered to be derivative instruments; accordingly, we recorded their estimated fair value as warrant liabilities. We estimated the fair value of these warrants using the trading market price of our common stock due to a cashless exercise provision of these warrants whereby eight warrants can be exercised for one share of common stock forno additional consideration, which results in an effective per warrant exercise price ofzero.
6**.**Related party
We entered into a license agreement with Dong-A ST Co., Ltd. (“Dong-A”) pursuant to which we received an exclusive global license (except for the territory of the Republic of Korea) for two proprietary compounds for specified indications (the “2022 License Agreement”) upon meeting certain financing milestones. The 2022 License Agreement covers the rights to DA-1241 for treatment of MASH and DA-1726 for treatment of obesity and MASH. The 2022 License Agreement also provides that we may develop DA-1241 for the treatment oftype 2 diabetes mellitus.
In connection with the 2022 License Agreement, we entered into a shared services agreement with Dong-A (the “Shared Services Agreement”), relating to DA-1241 and DA-1726, pursuant to which Dong-A may provide technical support, preclinical development, and clinical trial support services on terms and conditions acceptable to both parties. In addition, the Shared Services Agreement provides that Dong-A will manufacture all of our clinical requirements of DA-1241 and DA-1726 under the terms provided in the Shared Services Agreement.
We incurred R&D expenses of$0.7 million and$4.3 million for the three and nine months ended September 30, 2024, respectively, and$0.4 million and$2.2 million for the three and nine months ended September 30, 2023, respectively, under the Shared Services Agreement, which are included in operating expenses: research and development in the accompanying condensed consolidated statements of operations. Theaggregate amount payable to Dong-A is$3.5 million and$0.8 million as of September 30, 2024 and December 31, 2023, respectively, under the Shared Services Agreement, which are included in related party payable in the accompanying condensed consolidated balance sheets.
For additional information on the 2022 License Agreement, the Shared Service Agreement and other agreements with Dong-A, refer to “Note 5. Related party” in the audited consolidated financial statements and notes thereto for the year ended December 31, 2023, which is included in our 2023 Form 10-K.
**7.**Stockholders’ equity
The Offering
Securities purchase agreements
In June 2024, we entered into and closed ontwo securities purchase agreements (the “Offering”)with an institutional investor and Dong-A, andreceived aggregate gross proceeds of $20.0 million, of which $10.0 million was received from Dong-A. The Offering was comprised of (i)3,307,889 shares of common stock at a purchase price of $3.93 per share, (ii) pre-funded warrants to purchase up to 1,781,171 shares of common(the “Pre-Funded Warr ants”) at a purchase price of $3.929 per warrant, (iii) Series A warrants to purchase 5,089,060 shares of common stock (the “Series A Warrants”), and (iv) Series B warrants to purchase up to 7,633,591 shares of common stock (the “Series B Warrants”). Collec tively, the Series A Warrants and the Series B Warrants are referred to as “PIPE Common Warrants.” Of the total shares of common stock issued in the Offering,763,359 shares were sold to an institutional investor pursuant to our effective shelf registration statement on Form S-3 (Registration No. 333-278646), initially filed with and declared effective by the SEC in April 2024, and a prospectus supplement filed with the SEC in June 2024.
The Pre-Funded Warrants have an exercise price of $0.001 per share and are immediately exercisable and will expire when exercised in full and the PIPE Common Warrants have an exercise price of $3.93 per share and are exercisable as of September 18, 2024, which is the effective date of the stockholder approval received at the Special Meeting of Stockholders for the issuance of the shares upon exercise of the warrants (the “Stockholder Approval Date”).
The Series A Warrants will expire on the earlier of thetwelve month anniversary of the Stockholder Approval Date and within 60 days following the public announcement of the Company receiving positive Phase 1 multiple ascending dose (“MAD”) data readout for DA-1726, and the Series B Warrants will expire on the earlier of thefive-year anniversary of the Stockholder Approval Date and within nine months following the public announcement of the Company receiving positive Phase 1 Part 3 data readout for DA-1726. Based on the terms of the PIPE Common Warrants, we have concluded that the accounting classification of the PIPE Common Warrants is to be stockholders’ equity
Under the terms of the Pre-Funded Warrants and the PIPE Common Warrants issued to the institutional investor, we may not affect the exercise of any such Pre-Funded Warrants or PIPE Common Warrants, and the holder will not be entitled to exercise any portion of any Pre-Funded Warrants or PIPE Common Warrants, if, upon giving effect to such exercise, the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates, other persons acting or who could be deemed to be acting as a group together with the holder or any of the holder’s affiliates, and any other persons whose beneficial ownership of common stock would or could be aggregated with the holder’s or any of the holder’s affiliates) would exceed 9.99% (in the case of the Pre-Funded Warrants) or 4.99% (in the case of the PIPE Common Warrants) of the number of shares of the Company’s outstanding common stock immediately after giving effect to the exercise (the “Beneficial Ownership Limitation”), as such percentage ownership is calculated in accordance with Section 13(d) of the Exchange Act and the applicable regulations of the SEC. A holder of the Pre-Funded Warrants or PIPE Common Warrants that were issued to the institutional investor may increase or decrease the Beneficial Ownership Limitation to a higher or lower percentage (not to exceed 9.99%), effective 61 days after written notice to us. Any such increase or decrease will apply only to that holder and not to any other holder of the Pre-Funded Warrants or PIPE Common Warrants.
Placement agent
We paid to the placement agent a cash fee equal to 7.0% of the gross proceeds of the Offering received from a certain institutional investor and$0.1 million for non-accountable expenses and clearing costs. In addition, we issued warrants to the placement agent’s designees (“Placement Agent Warrants”) to purchase up to 127,227 shares of common stock (which represents 5% of the sum of the shares of common stock and Pre-Funded Warrants sold to the institutional investor in the Offering) at an exercise price of$4.9125 per share (which represents a premium of 25% of the offering price per share of common stock in the Offering). The Placement Agent Warrants will be exercisable beginning on the effective date of the Stockholder Approval Date and will expire on the earlier of (i)two years after the date that the shares of common stock
underlying the Placement Agent Warrants are registered pursuant to an effective registration statement filed pursuant to the Securities Act of 1933, as amended, which occurred on July 24, 2024, and (ii) June 23, 2029. The grant date fair value of the Placement Agent Warrants was$0.3 million, which represents a non-cash issuance cost. The weighted average grant date fair value per share of these Placement Agent Warrants was$2.73, which was determined using the Black-Scholes option pricing model Based on the terms of the Placement Agreement Warrants, we have concluded that the accounting classification of the Placement Agent Warrants is stockholders’ equity in the accompanying condensed consolidated balance sheets.
Upon the exercise for cash of any PIPE Common Warrants issued to a certain institutional investor, we shall pay the placement agent (i) a cash fee of 7.0% of the aggregate gross exercise price paid in cash with respect thereto and (ii) a non-cash fee in the form of additional warrants to purchase the number of shares of common stock equal to 5.0% of the aggregate number of such shares of common stock underlying such warrants. The cash fee payable to the placement agent for any PIPE Common Warrants exercised by the institutional investor is accounted for as a contingent commitment and will be recorded as an offset to any gross proceeds received from any future exercises of PIPE Common Warrants by the institutional investor. The non-cash fee payable to the placement agent for any PIPE Common Warrants exercised by the institutional investor is accounted for as contingent warrants (“Placement Agent Contingent Warrants”) to purchase up to 318,067 shares of common stock, which is subject to performance criteria of the institutional investor regarding any exercise for cash of any PIPE Common Warrants with an assumed grant date of the Offering closing date, and an exercise price of $4.9125 per share. The weighted average grant date fair value per share of these Placement Agent Contingent Warrants was $3.43, which was determined using the Black-Scholes option pricing model. Based on the terms of the placement agent engagement letter, we have concluded that the accounting classification of the Placement Agent Contingent Warrants is to be stockholders’ equity. On each balance sheet reporting date, we will need to assess whether it is probable for us to issue warrants to the placement agent based on whether it is probable for any PIPE Common Warrants to be exercised by the institutional investor. As of September 30, 2024, we determined that the issuance of additional warrants to the placement agent is not yet probable; accordingly, the Placement Agent Contingent Warrants had no impact on the condensed consolidated balance sheets.
Warrants
The following tables summarize our outstanding warrants:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · Shares of Common Stock Issuable · · · · · | ||||||||
| · for Outstanding Warrants · · · · · | ||||||||
| · As of · · Exercise · · Expiration | ||||||||
| Warrant Issuance · September 30, 2024 · · December 31, 2023 · · Price · · Date | ||||||||
| July 2018 (1) | 6 | | 6 | | $44,820.0000 | | July 2028 | |
| April 2020 (1) | 159 | | 159 | | $3,000.0000 | | April 2025 | |
| January 2021 (1) | 10,421 | | 10,421 | | $1,447.2000 | | July 2026 | |
| October 2021 (1) | 15,390 | | 15,390 | | $900.0000 | | April 2025 | |
| November 2022 Series B (2) | 177,938 | | 177,938 | | $0.0000 | | December 2027 | |
| June 2024 Placement Agent (3) | 127,227 | | — | | $4.9125 | | July 2026 | |
| June 2024 Pre-Funded (4) | 1,430,000 | | — | | $0.0010 | | no expiration date | |
| June 2024 Series A (5) | 5,089,060 | | — | | $3.9300 | | September 2025 (latest date) | |
| June 2024 Series B (6) | 7,633,591 | | — | | $3.9300 | | September 2029 (latest date) | |
| Total | 14,483,792 | | 203,914 | | | | | |
| (1) | The number of outstanding and exercisable warrants was adjusted for the impact of each of the common stock reverse stock splits completed in 2023 and 2022. Accordingly, the number of outstanding warrants is equal to the number of shares of common stock issuable for outstanding warrants. |
| (2) | The number of outstanding and exercisable warrants was not impacted by the 2023 Reverse Stock Split. Accordingly, the number of outstanding warrants is equal to eight times the number of shares of common stock issuable for outstanding warrants. Additionally, during the nine months ended September 30, 2023, 807,541 shares of our common stock were issued upon the exercise of 6,460,333 Series B warrants. |
| (3) | These warrants are exercisable at any time from the Stockholder Approval Date and expire two years after a resale registration statement covering the shares of common stock issuable upon the exercise of the warrants hereunder becomes effective with the SEC. In July 2024, a resale registration statement was filed with the SEC and became effective. |
| (4) | These warrants are exercisable immediately upon their issuance in June 2024 and are considered to be perpetual warrants without any expiration date. |
| (5) | These warrants are exercisable at any time from the Stockholder Approval Date and expire on the earlier of (i) the twelve months anniversary of the Stockholder Approval Date, and (ii) the 60th day following the date on which the Company publicly announce the receiving of positive Phase 1 MAD data readout for DA-1726. |
(6)These warrants are exercisable at any time from the Stockholder Approval Date and expire on the earlier of (i) thefive-year anniversary of the Stockholder Approval Date and (ii) thesix months anniversary following the date on which the Company publicly announce the receiving of positive Phase 1, Part 3 data readout for DA-1726.
During the three months ended September 30, 2024,351,171 Pre-Funded Warrants issued in June 2024 were exercised for an equivalent number of shares of our common stock. Additionally, during the nine months ended September 30, 2023,6,345,333 Series A warrants issued in November 2022 were exercised for 793,167 shares of our common stock. Furthermore, as of December 31, 2023, all Series A warrants issued in November 2022 were fully exercised for shares of our common stock.
**8.**Stock-based compensation
Stock-based compensation expense was included in general and administrative and research and development as follows(in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||||||
| · · September 30, · · September 30, | ||||||||||||
| · · 2024 · · 2023 · · 2024 · · 2023 | ||||||||||||
| General and administrative | | $103 | | $172 | | $273 | | $111 | ||||
| Research and development | | | 36 | | | — | | | 105 | | | 11 |
| Total stock-based compensation | | $139 | | $172 | | $378 | | $122 | ||||
Stock-based award plans
In June 2024, in connection with the 2024 Annual Meeting of Stockholders, our stockholders approved an amendment (the “Amendment”) to the NeuroBo Pharmaceuticals, Inc. 2022 Equity Incentive Plan (the “2022 Plan”). Pursuant to the terms and conditions of the Amendment, the 2022 Plan was amended to:
| ● | automatically increase on January 1st of each year for a period of eight years commencing on January 1, 2025 and ending on (and including) January 1, 2032, the aggregate number of shares of common stock that may be issued pursuant to Awards (as defined in the 2022 Plan) to an amount equal to 10% of the Fully Diluted Shares (as defined in the 2022 Plan) as of the last day of the preceding calendar year, provided, however that the Board may act prior to the effective date of any such annual increase to provide that the increase for such year will be a lesser number of shares of common stock; and |
| ● | increase the aggregate maximum number of shares of common stock that may be issued pursuant to the exercise of Incentive Stock Options (as defined in the 2022 Plan) to 1 million shares of the common stock plus the amount of any increase in the number of shares that may be available for issuance pursuant to the annual increase described above, but in no event more than 15 million shares of the common stock issued as incentive stock options. |
The following table summarizes the outstanding awards issued pursuant to our stock-based award plans and inducement grants as of September 30, 2024 and the remaining shares of common stock available for future issuance:
| | | | | | | |
|---|---|---|---|---|---|---|
| | | | | | | Remaining shares of |
| | | Stock | | | | common stock available |
| Plan Name | | Options | | RSUs | | for future issuance |
| 2019 Equity Incentive Plan (the “2019 Plan”) | | 1,575 | | — | | — |
| 2022 Plan | | 3,125 | | 170,059 | | 393,222 |
| 2021 Inducement Plan | | — | | — | | 4,166 |
| Total | | 4,700 | | 170,059 | | 397,388 |
For stock options and RSUs granted under the 2019 Plan and 2022 Plan as of September 30, 2024, unrecognized stock-based compensation costs totaled $0.8 million. The unrecognized stock-based costs are expected to be recognized as an expense over a weighted average period of 1.7 years.
Stock options
The following table summarizes the status of our outstanding and exercisable options and related transactions for the period presented (in thousands, except share and per share amounts):
| | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Outstanding · · Exercisable | ||||||||||||||||||||
| | | Shares of | | | | | | | | Weighted | | Shares of | | | | | | | | Weighted |
| · · Common · · Weighted · · · · Average · · Common · · Weighted · · · · Average | ||||||||||||||||||||
| · · Stock · · Average · · Aggregate · · Remaining · · Stock · · Average · · Aggregate · · Remaining | ||||||||||||||||||||
| · · Issuable · · Exercise · · Intrinsic · · Contractual · · Issuable · · Exercise · · Intrinsic · · Contractual | ||||||||||||||||||||
| · · for Options · · Price · · Value · · Term (years) · · for Options · · Price · · Value · · Term (years) | ||||||||||||||||||||
| As of January 1, 2024 | | 4,700 | | $398.30 | | $— | | 8.6 | | 4,577 | | $391.04 | | $— | | 8.6 | ||||
| Vested | | | | | | | | | | | | 104 | | | 747.38 | | | | | |
| As of September 30, 2024 | | 4,700 | | $398.30 | | $— | | 7.8 | | 4,681 | | $398.93 | | $— | | 7.8 | ||||
Restricted Stock Units
The following table summarizes the status of our RSUs and related transactions for the period presented (in thousands, except share and per share amounts):
| | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Outstanding · · Vested and Deferred Release | ||||||||||||||||
| · · Shares of · · Average · · · · Shares of · · Average · · | ||||||||||||||||
| · · Common Stock · · Grant Date · · Aggregate · · Common Stock · · Grant Date · · Aggregate | ||||||||||||||||
| · · Issuable · · Fair Value · · Intrinsic · · Issuable · · Fair Value · · Intrinsic | ||||||||||||||||
| · · for RSUs · · Price · · Value · · for RSUs · · Price · · Value | ||||||||||||||||
| As of January 1, 2024 | | 141,361 | | $4.55 | | $523 | | 5,469 | | $4.02 | | $20 | ||||
| Granted | | 83,899 | | | 5.41 | | | | | | | | | | | |
| Vested and Deferred Release | | | | | | | | | | 14,768 | | | 4.29 | | | |
| Vested and Released | | (55,201) | | | 4.68 | | | 207 | | | | | | | | |
| As of September 30, 2024 | | 170,059 | | $4.93 | | $539 | | 20,237 | | $4.21 | | $64 | ||||
Grant date fair value of stock options, warrants and restricted stock units
We estimated the grant date fair value of stock options and warrants granted to employees, consultants (including placement agents for the offerings), and directors using the Black-Scholes option pricing model. The following assumptions used in the Black-Scholes option pricing model for stock options and warrants granted in 2024 and 2023 are as follows:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · Contingent · · Stock | ||||||||||||
| · · Warrants Granted · · Warrants Granted · · Options Granted | ||||||||||||
| · · in June 2024 · · in June 2024 · · in March 2023 | ||||||||||||
| Weighted average fair value | | $2.73 | | | $3.43 | | | $3.63 | | |||
| Expected stock price volatility | | | 140.0% | | | 127.0% | | | 82.9% | |||
| Expected term (years) | | | 2.1 | | | | 5.7 | | | | 5.0 | |
| Expected dividend yield | | | —% | | | —% | | | —% | |||
| Risk-free interest rate | | | 463% | | | 4.31% | | | 3.54% | |||
We estimated the grant date fair value of restricted stock units granted to employees, consultants and directors based on the closing sales price of our common stock as reported on Nasdaq on the date of grant.
**9.**Income taxes
We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during the nine months ended September 30, 2024, (ii) additional losses expected for the remainder of 2024, or (iii) net operating loss carry forwards from prior years.
We recorded a full valuation allowance of the net operating losses for the three and nine months ended September 30, 2024 and 2023. Accordingly, there wereno benefits for income taxes recorded for the three and nine months ended September 30, 2024 and 2023. Additionally, as of September 30, 2024 and December 31, 2023, we maintain a full valuation allowance for all deferred tax assets.
**10.**Loss per share of common stock
The following table sets forth the computation of basic and diluted loss per share of common stock(in thousands, except share and per share amounts):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||||||
| · · September 30, · · September 30, | ||||||||||||
| · · 2024 · · 2023 · · 2024 · · 2023 | ||||||||||||
| Numerator: | | | | | | | | | | | | |
| Net loss | | $(5,652) | | $(3,818) | | $(22,419) | | $(7,156) | ||||
| Denominator: | | | | | | | | | | | | |
| Weighted average shares of common stock, basic | | | 10,214,087 | | | 5,075,817 | | | 6,922,338 | | | 5,064,670 |
| Effect of dilutive securities | | | — | | | — | | | — | | | — |
| Weighted average shares of common stock, diluted | | | 10,214,087 | | | 5,075,817 | | | 6,922,338 | | | 5,064,670 |
| Loss per share of common stock, basic and diluted | | $(0.55) | | $(0.75) | | $(3.24) | | $(1.41) | ||||
For each of the periods presented in the above table, our basic weighted average shares of common stock include any outstanding (i) November 2022 Series A warrants and Series B warrants, (ii) June 2024 Pre-Funded Warrants and (iii) vested RSUs in which their release was deferred in accordance with the respective award agreement during the respective period.
Since we reported a net loss for the three and nine months ended September 30, 2024 and 2023, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and diluted loss per share of common stock and our basic and diluted weighted average shares of common stock are the same for three and nine months ended September 30, 2024 and 2023.
The following table sets forth the potentially dilutive securities that were not included in the calculation of diluted earnings per share of common stock for the three and nine months ended September 30, 2024 and 2023:
| | | | | |
|---|---|---|---|---|
| · · As of September 30, | ||||
| · 2024 · 2023 | ||||
| Stock options | | 4,700 | | 5,034 |
| RSUs | | 149,822 | | 138,899 |
| Warrants | | 12,875,854 | | 28,529 |
**11.**Fair value of financial instruments
Fair value is a market-based measurement, not an entity specific measurement and is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy:
| Level 1: | Unadjusted quoted prices for identical assets or liabilities in active markets; |
| Level 2: | Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the asset or liability; and |
Level 3: Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.
The following table sets forth our financial assets and liabilities, subject to fair value measurements on a recurring basis, by level within the fair value hierarchy(in thousands):
| · · · · · · · · · · · · · · · · · · · · · · · · | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · As of September 30, 2024 · · As of December 31, 2023 | ||||||||||||||||
| Description · Total · Level 1 · Level 2 · Level 3 · Total · Level 1 · Level 2 · Level 3 | ||||||||||||||||
| Liabilities: · · · · · · · · · · · · · · · · · · · · · · · · | ||||||||||||||||
| Warrant liabilities | | $564 | | $— | | $564 | | $— | | $658 | | $— | | $658 | | $— |
| Total | | $564 | | $— | | $564 | | $— | | $658 | | $— | | $658 | | $— |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.