UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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NEUROBO PHARMACEUTICALS, INC.
Table of Contents
2
Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024 (this “Report”) to “we,” “us,” “the Company,” “NeuroBo” and “our” refer to NeuroBo Pharmaceuticals, Inc. (the “Company”) and its subsidiaries.
Special Note Regarding Forward-Looking Statements
This Report contains “forward-looking statements” within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation, our expectations regarding our ability to execute on our commercial strategy, the timeline for regulatory submissions, regulatory steps and potential regulatory approval of our current and future product candidates, the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., a related party, (“Dong-A”), including the impact on future financial and operating results of NeuroBo; the cooperation of our contract manufacturers, clinical study partners and others involved in the development of our current and future product candidates; our ability to initiate clinical trials on a timely basis; our ability to recruit subjects for our clinical trials; costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; changes in applicable laws or regulations; effects of changes to our stock price on the terms of the license agreement and any future fundraising and other risks and uncertainties described in our filings with the SEC. Forward-looking statements are based on management’s current expectations and assumptions about future events, which are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict. These statements may be identified by words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. In addition, statements that “we believe,” “we expect,” “we anticipate” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Report and management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made.
Forward-looking statements are based on management’s current expectations and assumptions about future events, which are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict, including without limitation, the risks and uncertainties described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. In some instances, you can identify forward-looking statements by words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. In addition, statements that “we believe,” “we expect,” “we anticipate” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Report and management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. We undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results or expectations, except as required by law.
We operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for us to predict all risk factors and uncertainties. We may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation, the possibility that regulatory authorities do not accept our application or approve the marketing of our products, the possibility we may be unable to raise the funds necessary for the development and commercialization of our products, and those described in this and our other filings with the SEC.
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Part I - Financial Information
Item 1.Financial Statements
NeuroBo Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except per share amounts)
As of | ||||||
March 31, 2024 | December 31, 2023 | |||||
(Unaudited) | ||||||
Assets | ||||||
Current assets: | ||||||
Cash | $ | | $ | | ||
Prepaid expenses and other current assets | | | ||||
Total current assets |
| |
| | ||
Property and equipment, net |
| |
| | ||
Right-of-use asset | | | ||||
Other assets | | | ||||
Total assets | $ | | $ | | ||
Liabilities and stockholders’ equity | ||||||
Current liabilities: | ||||||
Accounts payable (including related party payable of $ | $ | | $ | | ||
Accrued liabilities (including related party payable of $ |
| |
| | ||
Warrant liabilities | | | ||||
Lease liability, short-term | | | ||||
Total current liabilities |
| |
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Lease liability, long-term | | | ||||
Total liabilities |
| |
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Commitments and contingencies (Note 4) | ||||||
Stockholders’ equity | ||||||
Preferred stock, $ | ||||||
Common stock, $ |
| |
| | ||
Additional paid–in capital |
| |
| | ||
Accumulated deficit |
| ( |
| ( | ||
Total stockholders’ equity |
| |
| | ||
Total liabilities and stockholders’ equity | $ | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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NeuroBo Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(Unaudited - In thousands, except share and per share amounts)
Three Months Ended March 31, | ||||||
2024 | 2023 | |||||
Operating expenses: |
|
| ||||
Research and development | $ | | $ | | ||
General and administrative | | | ||||
Total operating expenses |
| |
| | ||
Loss from operations |
| ( |
| ( | ||
Other income (expense): | ||||||
Change in fair value of warrant liabilities | ( | ( | ||||
Interest income | | — | ||||
Total other income | | ( | ||||
Loss before income taxes | ( | ( | ||||
Provision for income taxes | |
| | |||
Net loss and comprehensive net loss |
| ( |
| ( | ||
Loss per share of common stock, basic and diluted | $ | ( | $ | ( | ||
Weighted average shares of common stock, basic and diluted |
| |
| |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
NeuroBo Pharmaceuticals, Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
(Unaudited - In thousands)
Additional | |||||||||||||
Common Stock | Paid–In | Accumulated | Total | ||||||||||
Shares |
| Amount |
| Capital |
| Deficit |
| Equity | |||||
As of January 1, 2023 | | $ | | $ | | $ | ( | $ | | ||||
Issuance of stock from exercise of warrants | | — | | — | | ||||||||
Stock–based compensation | — | — | ( | — | ( | ||||||||
Net loss | — | — | — | ( | ( | ||||||||
As of March 31, 2023 | | | | ( | | ||||||||
As of January 1, 2024 | | $ | | $ | | $ | ( | $ | | ||||
Stock–based compensation | — | — | | — | | ||||||||
Net loss | — | — | — | ( | ( | ||||||||
As of March 31, 2024 | | | | ( | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
NeuroBo Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited - In thousands)
Three Months Ended March 31, | ||||||
2024 | 2023 | |||||
Operating activities | ||||||
Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Stock-based compensation |
| |
| ( | ||
Non-cash lease expense | | — | ||||
Depreciation |
| |
| | ||
Change in fair value of warrant liabilities | | | ||||
Change in operating assets and liabilities: | ||||||
Prepaid expenses and other assets |
| ( |
| ( | ||
Accounts payable |
| |
| | ||
Accrued and other liabilities |
| ( |
| | ||
Net cash used in operating activities |
| ( |
| ( | ||
Investing activities | ||||||
Purchases of property and equipment |
| ( |
| ( | ||
Net cash used in investing activities |
| ( |
| ( | ||
Financing activities | ||||||
Net cash provided by financing activities |
| — |
| — | ||
Net decrease in cash |
| ( |
| ( | ||
Cash at beginning of period |
| |
| | ||
Cash at end of period | $ | | $ | | ||
Supplemental non-cash investing and financing transactions: | ||||||
Reclassification of warrant liabilities upon exercise of warrants | $ | — | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
NeuroBo Pharmaceuticals, Inc.
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 financial statements of the Company as “NeuroBo,” “we,” “our” and “us.” We are a clinical-stage biotechnology company focused primarily on developing 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”). The American Association for the Study of Liver Diseases and its European and Latin American counterparts changed the name to metabolic dysfunction-associated steatohepatitis to reflect the complexity of the disease.
● | 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 GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. DA-1241 has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. |
● | 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. DA-1726 acts as a dual agonist of GLP1R and GCGR. |
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 continue to consider for out-licensing and divestiture opportunities.
Our operations have consisted principally of performing research and development (“R&D”) activities, preclinical developments, 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 a -for-eight reverse stock split of our common stock (the “2023 Reverse Stock Split”). As a result, every 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 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 Nasdaq Capital Market LLC (“Nasdaq”) on the last trading day before the 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- to one-for- to be determined at the discretion of our Board of Directors (“Board”). Following the annual meeting, our Board approved a one-for- 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
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NeuroBo Pharmaceuticals, Inc.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
not change; instead, the warrants have an exchange ratio of 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 $
We believe that our existing cash will be sufficient to fund our operations into the fourth quarter of 2024. We plan to continue to fund our operations through a combination of 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. To the extent that we can raise additional funds by issuing equity securities, 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 included in this Report 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 interim financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in this Report should be read in conjunction with the 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 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
9
NeuroBo Pharmaceuticals, Inc.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
not have a material impact on our condensed consolidated financial statements or processes.
Accounting standards issued but not yet adopted
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU amends the guidance in Accounting Standards Codification (“ASC’) 740, Income Taxes, 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. The amendments are effective for fiscal years beginning after December 15, 2024 and should be applied prospectively. Early adoption is permitted. We are currently evaluating the amendments to identify potential impacts 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.
2. Prepaid and other current assets
Prepaid and other current assets consist of the following (in thousands):
As of | ||||||
March 31, 2024 | December 31, 2023 | |||||
Clinical costs | $ | | $ | | ||
Interest receivable | | — | ||||
Other |
| |
| | ||
Total | $ | | $ | |
10
NeuroBo Pharmaceuticals, Inc.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
3. Property and equipment
Property and equipment consist of the following (in thousands):
As of | ||||||
March 31, 2024 | December 31, 2023 | |||||
Office equipment | $ | | $ | | ||
Less accumulated depreciation |
| ( |
| ( | ||
Property and equipment, net | $ | | $ | |
4. Accrued liabilities
Accrued liabilities consist of the following (in thousands):
As of | ||||||
March 31, 2024 | December 31, 2023 | |||||
External R&D costs (including related party payable of $ | $ | | $ | | ||
Employee related costs |
| |
| | ||
Professional service fees | | | ||||
Other |
| |
| | ||
Total | $ | | $ | |
5.Related party
We entered into a license agreement with Dong-A pursuant to which we received an exclusive global license (except for the territory of the Republic of Korea and certain other jurisdictions) to 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 of type 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 $
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.
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NeuroBo Pharmaceuticals, Inc.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
6. Commitments and contingencies
Operating lease
In August 2023, we entered into a non-cancelable operating lease for our new corporate headquarters in Cambridge, Massachusetts. The initial lease term is for
Our lease liability, which represents the net present value of future lease payments, was calculated utilizing a discount rate of
Additionally, we had short-term operating leases for our former corporate headquarters located in Boston, Massachusetts and such lease was terminated in January 2024. For our former corporate headquarters,
7.Stockholders’ equity
Warrants
The following tables summarize our outstanding warrants:
Shares of Common Stock Issuable | ||||||||
for Outstanding Warrants | ||||||||
As of | Exercise | Expiration | ||||||
Warrant Issuance | March 31, 2024 | December 31, 2023 | Price | Date | ||||
July 2018 (1) | | | $ | July 2028 | ||||
April 2020 (1) | | | $ | April 2025 | ||||
January 2021 (1) | | | $ | July 2026 | ||||
October 2021 (1) | | | $ | April 2025 | ||||
November 2022 Series B (2) | | | $ | - | December 2027 | |||
Total | | |
(1) | The number of outstanding 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 warrants was not impacted by the 2023 Reverse Stock Split. Accordingly, the number of outstanding warrants is equal to |
The outstanding warrants are all exercisable as of March 31, 2024 and December 31, 2023. Additionally, the November 2022 Series B warrants have a cashless exercise provision whereby
During the three months ended March 31, 2023,
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NeuroBo Pharmaceuticals, Inc.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
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 March 31, | |||||||
2024 | 2023 | ||||||
General and administrative | $ | | $ | ( | |||
Research and development | | | |||||
Total stock-based compensation | $ | | $ | ( |
For stock options and RSUs granted under the 2019 Equity Incentive Plan, the 2021 Inducement Plan and the 2022 Equity Incentive Plan (the “2022 Plan”), as of March 31, 2024, unrecognized stock-based compensation cost totaled $
Stock-based award plans
As of March 31, 2024, there were (i)
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 | Remaining | Aggregate | Stock | Average | Remaining | Aggregate | |||||||||||||
Issuable | Exercise | Contractual | Intrinsic | Issuable | Exercise | Contractual | Intrinsic | |||||||||||||
for Options | Price | Term (years) | Value | for Options | Price | Term (years) | Value | |||||||||||||
As of January 1, 2024 | | $ | | $ | — | | $ | | $ | — | ||||||||||
Granted | — | — | — | — | ||||||||||||||||
Forfeited/Cancelled | — | — | — | — | ||||||||||||||||
As of March 31, 2024 | | $ | | $ | — | | $ | | $ | — |
The weighted average fair value per share of stock options granted for three months ended March 31, 2023 was $
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NeuroBo Pharmaceuticals, Inc.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
The assumptions used in the Black-Scholes option-pricing model are as follows:
Three Months Ended | ||||
March 31, 2023 | ||||
Expected stock price volatility | % | |||
Expected life of stock options (years) | ||||
Expected dividend yield | — | % | ||
Risk free interest rate | % |
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 | |||||||||||||||
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 | | $ | | $ | | | $ | | $ | | ||||||
Granted | | | ||||||||||||||
Vested | — | — | ||||||||||||||
Released | — | — | — | — | — | |||||||||||
Forfeited/Cancelled | — | — | ||||||||||||||
As of March 31, 2024 | | $ | | $ | | | $ | | $ | |
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 three months ended March 31, 2024 and 2023, (ii) additional losses expected for the remainder of 2024 or losses recorded in 2023, or (iii) net operating loss carry forwards from prior years.
We recorded a full valuation allowance of the net operating losses for the three months ended March 31, 2024 and 2023. Accordingly, there were
14
NeuroBo Pharmaceuticals, Inc.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
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 March 31, | ||||||
2024 | 2023 | |||||
Numerator: | ||||||
Net loss | $ | ( | $ | ( | ||
Denominator: | ||||||
Weighted average shares of common stock, basic | ||||||
Effect of dilutive securities | — | — | ||||
Weighted average shares of common stock, diluted | ||||||
Loss per share of common stock, basic and diluted | $ | ( | $ | ( |
Our basic weighted average shares of common stock for the three months ended March 31, 2024 include the (i) November 2022 Series B warrants since these warrants are exchangeable into common stock for which no additional consideration is required from the holder and (ii) vested RSUs in which their release was deferred in accordance with the respective award agreement. Our basic weighted average shares of common stock for the three months ended March 31, 2023 include both the November 2022 Series A and Series B warrants since these warrants were exchangeable into common stock for which no additional consideration is required from the holder.
Since we reported a net loss for the three months ended March 31, 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 months ended March 31, 2024 and 2023.
The following table sets forth the outstanding securities which were not included in the calculation of diluted earnings per share of common stock for three months ended March 31, 2024 and 2023:
As of March 31, | ||||
| 2024 | 2023 | ||
Stock options | | | ||
RSUs | | — | ||
Warrants (excluding the November 2022 warrants) | | |
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; |
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.
15
NeuroBo Pharmaceuticals, Inc.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
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 March 31, 2024 | As of December 31, 2023 | |||||||||||||||||||||||
Description |
| Total |
| Level 1 |
| Level 2 |
| Level 3 |
| Total |
| Level 1 |
| Level 2 |
| Level 3 | ||||||||
Liabilities: | ||||||||||||||||||||||||
Warrant liabilities | $ | | $ | — | $ | | $ | — | $ | | $ | — | $ | | $ | — | ||||||||
Total liabilities at fair value | $ | | $ | — | $ | | $ | — | $ | | $ | — | $ | | $ | — |
The Series A and Series B warrants, issued in November 2022, 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 the cashless exercise provision of these warrants, which results in an effective per warrant exercise price of
12. Subsequent events
Management has evaluated subsequent events to determine if events or transactions occurring through the filing date of this Report require adjustment to or disclosure in the condensed consolidated financial statements. There were no events that require adjustment to or disclosure in the condensed consolidated financial statements.
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Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and related notes included elsewhere in this Report and the audited financial statements and related notes for the fiscal year ended December 31, 2023 included in our 2023 Form 10-K. This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements. Our actual results may differ materially from those contained in or implied by any forward-looking statements as a result of various factors, including, but not limited to, the risks and uncertainties described under Part II, Item 1A. Risk Factors, elsewhere in this Report.
Certain amounts in the following discussion and analysis may not add due to rounding, and all percentages have been calculated using unrounded amounts.
Overview
We are a clinical-stage biotechnology company focused primarily on developing 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”). The American Association for the Study of Liver Diseases and its European and Latin American counterparts changed the name to metabolic dysfunction-associated steatohepatitis to reflect the complexity of the disease.
● | 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 GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. DA-1241 has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. |
● | 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. DA-1726 acts as a dual agonist of GLP1R and GCGR. |
Our operations have consisted principally of performing research and development (“R&D”) activities, clinical development and raising capital. Our activities are subject to significant risks and uncertainties, such as failing to secure additional funding before sustainable revenues and profit from operations are achieved. For more information on our business and product candidates, see “Part I, Item 1. Business” in our 2023 Form 10-K.
DA-1241
We are currently conducting a Phase 2a trial of DA-1241 for the treatment of MASH in the U.S. The Phase 2a trial has two parts and each of the parts is designed to be a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel clinical study to evaluate the efficacy and safety of DA-1241 in subjects with presumed MASH while we follow the trend for type 2 diabetes mellitus. Part 2 of the Phase 2a trial will also explore the efficacy of DA-1241 in combination with sitagliptin versus placebo. The Phase 2a trial opened enrollment in August 2023 and is expected to enroll a total of 87 subjects, with a planned maximum of 98 subjects to account for early discontinuations, who will be randomized into 4 treatment groups and will be dosed with: DA-1241 50 mg, DA-1241 100 mg, DA-1241 100 mg/Sitagliptin 100 mg, or Placebo in a 1:2:2:2 ratio.
In April 2024, we completed enrollment of Part 1 of the Phase 2a trial in which approximately 49 patients with presumed MASH were randomized into Part 1 with a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo. Part 2 of the Phase 2a trial is currently enrolling and is expected to enroll approximately 37 subjects who will be randomized in a 2:1 ratio into 2 treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo. Currently, we are expecting to report the full trial data in the second half of this year.
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For additional information on DA-1241, see “Part I, Item 1. Business, Our Pipeline, DA-1241 Treatment of MASH” in our 2023 Form 10-K.
DA-1726
We are currently conducting a Phase 1 trial of DA-1726 for the treatment of obesity in the U.S. The Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind, two-part study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Part 1 of the Phase 1 trial opened is a single ascending dose (“SAD “) study and is expected to enroll approximately 45 participants, randomized into one of 5 planned cohorts. Each cohort will be randomized in a 6:3 ratio of DA-1726 or placebo. Part 2 of Phase 1 is designed as a multiple ascending dose (“MAD “) study and is expected to enroll approximately 36 participants, who will be randomized at the same 6:3 ratio into 4 planned cohorts, each to receive 4 weekly administrations of DA-1726 or placebo.
Part 1 of Phase 1 opened enrollment in March 2024 and dosed its first patient in April 2024. Currently, we are expecting to report top-line data from the SAD Part 1 study in the third quarter of 2024 and the MAD Part 2 study in the first quarter of 2025.
For additional information on DA-1726, see “Part I, Item 1. Business, Our Pipeline, DA-1726 Treatment of Obesity” in our 2023 Form 10-K.
Recent developments
● | April 2024: Dosed the first patient in the SAD Part 1 of our two-part Phase 1 clinical trial of DA-1726 for the treatment of obesity. |
● | April 2024: Completed enrollment of Part 1 of our two-part Phase 2a trial evaluating the efficacy and safety of DA-1241 in MASH. Approximately 49 patients with presumed MASH were randomized into Part 1 with a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo. |
● | March 2024: Received SRC approval recommending that the two-part Phase 2a trial of DA-1241 for the treatment of MASH continue without modification following a blinded safety review of the first six months of study conduct. |
● | March 2024: Announced the appointment of Marshall Woodworth as Chief Financial Officer, following his tenure as Acting Chief Financial Officer. |
● | February 2024: Received first site Institutional Review Board (IRB) approval for Alexander Prezioso, M.D., Investigator, Clinical Pharmacology of Miami, in Hialeah, FL, to proceed with the Phase 1 clinical trial of DA-1726 for the treatment of obesity. |
● | February 2024: Announced that the FDA has cleared its Investigational New Drug (IND) application for the Phase 1 trial DA-1726 in obesity. |
● | January 2024: Reported positive pre-clinical safety data of DA-1241 in combination with sitagliptin, a DPP4 inhibitor. The pre-clinical results demonstrated that once daily oral administration in rats, of sitagliptin alone (180 mg/kg/day), DA-1241 alone (100 mg/kg/day), or sitagliptin in combination with DA-1241 (up to 180/100 mg/kg/day sitagliptin+DA-1241) for 13 weeks, was well tolerated with no adverse effects. Additionally, the company announced it had opened enrollment for Part 2 of its Phase 2a clinical trial of DA-1241 when co-administered with sitagliptin for the treatment of MASH. |
Key operating information
Except for the financial amounts for the presented periods in this Report (see financial amounts in the below results of operations and the condensed consolidated balance sheets included elsewhere in this Report), there have been no material
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changes to our key operating information since December 31, 2023. Refer to our 2023 Form 10-K for a complete discussion of our key operating information.
Results of operations
Three months ended March 31, 2024 compared to three months ended March 31, 2023
The following table summarizes our results of operations (in thousands, except share and per share amounts):
Three Months Ended March 31, | |||||||||
| 2024 | 2023 |
| Change | |||||
Operating expenses: | |||||||||
Research and development | $ | 4,904 | $ | 637 | $ | 4,267 | |||
General and administrative | 1,977 | 1,883 | 94 | ||||||
Total operating expenses |
| 6,881 |
| 2,520 |
| 4,361 | |||
Loss from operations |
| (6,881) |
| (2,520) |
| (4,361) | |||
Other income (expense): | |||||||||
Change in fair value of warrant liabilities | (70) | (84) | 14 | ||||||
Interest income | 237 | — | 237 | ||||||
Total other income | 167 | (84) | 251 | ||||||
Loss before income taxes | (6,714) | (2,604) | (4,110) | ||||||
Provision for income taxes | — | — | — | ||||||
Net loss | $ | (6,714) | $ | (2,604) | $ | (4,110) | |||
Loss per share of common stock, basic and diluted | $ | (1.32) | $ | (0.51) | $ | (0.81) | |||
Weighted average shares of common stock, basic and diluted |
| 5,089,408 |
| 5,059,003 | 30,405 |
Operating expenses and loss from operations
Our total operating expenses and loss from operations for the three months ended March 31, 2024 were $6.9 million, an increase of $4.4 million, or 173.1%, compared to the three months ended March 31, 2023. This increase was attributable to (i) $4.3 million in higher R&D expenses and (ii) $0.1 million in higher general and administrative expenses.
Our R&D expenses were $4.9 million for the three months ended March 31, 2024, an increase of $4.3 million, or 669.9%, compared to the three months ended March 31, 2023. This increase was primarily related to increased R&D activities for DA-1241 and DA-1726 for the three months ended March 31, 2024 following commencement of the (i) Phase 2a clinical trial for DA-1241 and (ii) Phase 1 trial for DA-1726 compared to the three months ended March 31, 2023 when R&D activities were starting to ramp up following the acquisition of DA-1241 and DA-1726 in the fourth quarter of 2022. Specifically, the $4.3 million increase in R&D expenses was primarily attributable to (i) $3.9 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting and (ii) $0.4 million in higher employee compensation and benefits. Included in R&D expenses for the three months ended March 31, 2024 was $0.2 million of investigational drug manufacturing costs and non-clinical and preclinical expenses incurred under the Shared Services Agreement with Dong-A as compared to $0.3 million for the three months ended March 31, 2023.
Our general and administrative expenses for the three months ended March 31, 2024 were $2.0 million, an increase of $0.1 million, or 5.0%, compared to the three months ended March 31, 2023. This increase in general and administrative expenses was primarily attributable to $0.2 million in higher non-cash stock-based compensation, partially offset by $0.1 million in lower legal and professional fees.
Other income
Our other income for the three months ended March 31, 2024 was $0.2 million compared to other expense of $0.1 million for the three months ended March 31, 2023. This change was mainly attributable to $0.2 million of interest income earned on our cash balance for the three months ended March 31, 2024, of which there was none for the three months ended
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March 31, 2023.
Provision for income taxes
Our effective tax rate for the three months ended March 31, 2024 and 2023 was zero percent as we have recorded a full valuation allowance for the income tax benefits attributable to our pre-tax losses.
Net loss
For the three months ended March 31, 2024, we had a net loss of $6.7 million, or $1.32 per share of basic and diluted common stock, compared to a net loss of $2.6 million, or $0.51 per share of basic and diluted common stock for the three months ended March 31, 2023.
Liquidity and capital resources
Our primary use of cash is to fund our R&D activities and clinical development activities. We have funded our operations primarily through public offerings of our common stock and private placements of equity. As of March 31, 2024, we had cash totaling $16.0 million. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250 thousand per bank. Our cash balance includes liquid insured deposits, which are obligations of the program banks in which the deposits are held and qualify for FDIC insurance protection per depositor in each recognized legal category of account ownership in accordance with the rules of the FDIC. To date, we have not experienced any losses related to these funds.
We believe that our existing cash will be sufficient to fund our operations into the fourth quarter of 2024. We plan to continue to fund our operations through a combination of 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. To the extent that we can raise additional funds by issuing equity securities, 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.
Cash flows
The principal use of cash in operating activities is to fund our current expenditures in support of our R&D activities and clinical development activities. Financing activities currently represent the principal source of our cash flow.
The following table reflects the major categories of cash flows (in thousands).
Three Months Ended March 31, | ||||||
| 2024 | 2023 | ||||
Net cash used in operating activities | $ | (6,442) | $ | (2,547) | ||
Net cash used in investing activities |
| (5) | (4) | |||
Net cash provided by financing activities |
| — | — | |||
Net decrease in cash | $ | (6,447) | $ | (2,551) |
Operating Activities
Net cash used in operating activities was $6.4 million for the three months ended March 31, 2024, an increase of $3.9 million, or 152.9%, compared to $2.5 million for the three months ended March 31, 2023. Net cash used in operating activities for the three months ended March 31, 2024 consisted of net loss of $6.7 million, partially offset by (i) net non-cash expenses of $0.2 million and (ii) net cash provided by operating assets and liabilities of $0.1 million. Net cash used in operating activities for the three months ended March 31, 2023 consisted primarily of net loss of $2.6 million, partially offset by net cash used by operating assets and liabilities of $0.1 million.
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For additional details, see the condensed consolidated statements of cash flows in the condensed consolidated financial statements included elsewhere in this Report.
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, included elsewhere in this Report, 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 $16.0 million in cash as of March 31, 2024. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $115.0 million as of March 31, 2024. We have incurred a net loss of $6.7 million and used cash of $6.4 million for operating activities for the three months ended March 31, 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.
We believe that our existing cash will be sufficient to fund our operations into the fourth quarter of 2024. We plan to continue to fund our operations through a combination of equity offerings, debt financings, or other sources, potentially including collaborations, licenses 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. To the extent that we can raise additional funds by issuing equity securities, 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.
Critical accounting estimates
Our condensed consolidated financial statements included in this Report have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
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.
There have been no material changes to our critical accounting estimates and judgments since December 31, 2023. Refer to our 2023 Form 10-K for a complete discussion of our critical accounting estimates and judgments.
Recent accounting pronouncements
Information regarding (i) adoption of new accounting standards and (ii) accounting standards issued but not yet adopted is included in "Note 1. Business, basis of presentation, new accounting standards and summary of significant accounting policies " to the condensed consolidated financial statements included in this Report.
Item 3.Quantitative and Qualitative Disclosures about Market Risk
Not applicable.
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Item 4.Controls and Procedures
Evaluation of disclosure controls and procedures
As required by Rules 13a-15(b) and 15d-15(b) under the Exchange Act, our management, with the participation of our principal executive officer (“PEO”) and principal financial officer (“PFO”), evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Report. Based upon that evaluation, our PEO and PFO concluded that our disclosure controls and procedures were not effective as of the end of the period covered by this Report, as a result of material weaknesses in our internal control over financial reporting, which are discussed further below.
Previously identified material weaknesses in internal control over financial reporting
In connection with the preparation of the financial statements included in our 2023 Form 10-K, management identified the following material weaknesses: (i) lack of segregation of duties over cash disbursements and financial reporting, (ii) logical access over computer applications, and (iii) lack of supervision and review over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Specifically, there was a lack of segregation of duties involved in the execution of wire transfers, preparing journal entries, and review over clinical trial accruals, and certain individuals in the accounting department have administrative access to the financial reporting systems. See “Remediation efforts to address the material weaknesses” below for steps we are taking to correct these material weaknesses.
Remediation efforts to address the material weaknesses
We are in the process of remediating, but have not yet remediated, the material weaknesses, as described above, related to lack of segregation of duties over cash disbursements and financial reporting, logical access over computer applications, and lack of supervision and review over financial reporting. Under the oversight of the audit committee, management has developed a detailed plan and timetable for the implementation of appropriate remedial measures to address the material weaknesses. As of the date of this report, we have taken the following actions:
● | we have added additional personnel to the accounting department to allow for increased segregation of duties; |
● | we have implemented a change management review process for access to systems used for financial reporting systems; |
● | we have enhanced the controls over disbursements, separating the functions of initiating and approving to two separate individuals; and |
● | we have implemented enhanced controls relating to the review and oversight of financial reporting, including the preparation of journal entries, and clinical trial accruals. |
Management believes that we have made considerable progress toward remediation of these material weaknesses and anticipates a full remediation during 2024.
Inherent limitations of disclosure controls and procedures
Our management, including our PEO and PFO, does not expect that our disclosure controls and procedures will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls is also based in part upon certain assumptions about the likelihood of
22
future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Changes in internal control Over financial reporting
Other than the remediation activities listed above, there have been no changes in our internal control over financial reporting during the quarter ended March 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Part II - Other Information
Item 1.Legal Proceedings
From time to time, we may be involved in various claims and legal proceedings arising out of our ordinary course of business. We are not currently a party to any claims or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business and condensed consolidated financial statements. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A.Risk Factors
Ou business, financial condition and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those described in Part I, Item 1A of the 2023 Form 10-K under the heading “Risk Factors,” any one or more of which could, directly or indirectly, cause our actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating results. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating results and stock price. There have been no material changes to our risk factors since the 2023 Form 10-K.
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3.Defaults upon Senior Securities
None.
Item 4.Mine Safety Disclosures
None.
Item 5.Other Information
Non-Employee Director Compensation Policy
As part of a regular review of the corporate governance practices of the Company and in an effort to continue to attract and retain qualified members of the Board of Directors of the Company (the “Board”), after consultation with compensation experts and upon recommendation of the Compensation Committee, the Board approved an Amended and Restated Non-Employee Director Compensation Policy (the “A&R Non-Employee Director Compensation Policy”), which provides annual cash and equity compensation for non-employee directors of the Board, on the terms and conditions contained therein. The A&R Non-Employee Director Compensation Policy is intended to enable the Company to attract qualified directors, provide them with compensation at a level that is consistent with the Company’s compensation
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objectives, and in the case of equity-based compensation, align our directors’ interests with those of our stockholders. The A&R Non-Employee Director Compensation Policy was effective as of May 7, 2024.
Annual Cash Retainer
Under the A&R Non-Employee Director Compensation Policy, each of our non-employee directors of the Board is entitled to receive the following cash compensation for services on the Board and committees thereof, as follows:
Position |
| Amount |
| |
Base Board Retainer |
| $ | 40,000 |
|
Non-Executive Chair of the Board (in addition to above Base Retainer) |
| $ | 35,000 | |
Chair of Audit Committee |
| $ | 18,000 |
|
Chair of Compensation Committee |
| $ | 12,000 |
|
Chair of Nominating and Corporate Governance Committee |
| $ | 10,000 |
|
Member of Audit Committee (non-Chair) |
| $ | 9,000 |
|
Member of Compensation Committee (non-Chair) |
| $ | 6,000 |
|
Member of Nominating and Corporate Governance Committee (non-Chair) |
| $ | 5,000 |
|
The annual cash compensation amounts are payable in equal quarterly installments, in arrears following the end of each quarter in which the service occurred, pro-rated for any partial quarters.
Equity Compensation
Initial Grant
For each non-employee director who is first elected or appointed to the Board in 2024 prior to the effective date of the A&R Non-Employee Director Compensation Policy or on or following the effective date of the A&R Non-Employee Director Compensation Policy, at the close of business on the date of such non-employee director’s initial election or appointment to the Board, each such non-employee director will be automatically, and without further action by the Board or the Compensation Committee, granted a restricted stock unit award (an “RSU Award”) covering a number of restricted stock units equal to (a) $40,000 divided by (b) the average Fair Market Value (as defined in the Company’s 2022 Equity Incentive Plan, as amended) of a share of the Company’s common stock (the “Common Stock”) for the 30 consecutive market trading days ending on and including the last market trading day prior to the grant date of such RSU Award, rounded down to the nearest whole unit (each, an “Initial Grant”). 50% of each Initial Grant will be vested as of the date of grant and the remainder will vest in two equal installments on each subsequent anniversary of the date of grant, subject to such non-employee director’s continuous service with the Company on each vesting date.
Annual Grant and Prorated Annual Grant
At the close of business after the first Annual Meeting following the effective date of the A&R Non-Employee Director Compensation Policy and on the date of each subsequent annual meeting of the Company’s stockholders held following the initial Annual Meeting (each, an “Annual Meeting”), each person who is then a non-employee director will be automatically, and without further action by the Board or the Compensation Committee, granted an RSU Award covering a number of restricted stock units equal to (i) $20,000 divided by (ii) the average Fair Market Value of a share of Common Stock for the 30 consecutive market trading days ending on and including the last market trading day prior to the grant date of such RSU Award, rounded down to the nearest whole unit (each, an “Annual Grant”).
In addition, for each non-employee director who is first elected or appointed to the Board after the first Annual Meeting of the Company’s stockholders following the effective date of the A&R Non-Employee Director Compensation Policy on a date other than the date of an Annual Meeting of the Company’s stockholders, at the close of business on the thirtieth (30th) day following such non-employee director’s initial election or appointment to the Board, such non-employee director will be automatically, and without further action by the Board or the Compensation Committee, granted an RSU Award covering a number of restricted stock units equal to (i) $20,000 divided by (ii) the average Fair Market Value of a share of Common Stock for the 30 consecutive market trading days ending on and including the last market trading day prior to the
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grant date of such RSU Award, multiplied by a fraction, the numerator of which equals 365 minus the total number of days, as of the grant date of such RSU Award, that have occurred since the last Annual Meeting and the denominator of which equals 365, rounded down to the nearest whole unit (each, a “Prorated Annual Grant”).
Each Annual Grant and Prorated Annual Grant will vest in full on the earlier of (i) the one-year anniversary of the grant date of the Annual Grant or Prorated Annual Grant, as applicable, and (ii) the date immediately prior to the date of the Annual Meeting following the grant date of such Annual Grant or Prorated Annual Grant, as applicable, subject to such non-employee director’s continuous service with the Company on each vesting date.
Retainer Grant
Each non-employee director may elect to forego receiving payment of all (but not less than all) of the annual cash retainers described above that he or she is otherwise eligible to receive for the period during the Company’s fiscal year that the election applies commencing on the first day of such fiscal year (or if the non-employee director makes the election in the Company’s fiscal year that the election applies, on the first day of the Company’s fiscal quarter following the Company’s fiscal quarter in which the election is made) and ending on the last day of such fiscal year and instead receive an RSU Award (the “Retainer Grant”), provided such election is timely made and complies with certain other requirements specified in the A&R Non-Employee Director Compensation Policy. If a non-employee director timely makes the election described above in accordance with the A&R Non-Employee Director Compensation Policy, on the first day of the Company’s fiscal year that the election applies (or if the non-employee director makes the election in the Company’s fiscal year that the election applies, on the first day of the Company’s fiscal quarter following the Company’s fiscal quarter in which the election is made), the non-employee director will be automatically granted a Retainer Grant covering a number of RSUs equal to the (i) aggregate amount of the annual cash retainers that the non-employee director is eligible to receive under the A&R Non-Employee Director Compensation Policy for the applicable period to which the election applies divided by (ii) the average Fair Market Value of a share of Common Stock for the 30 consecutive market trading days ending on and including the last market trading day prior to the grant date of such Retainer Grant, rounded down to the nearest whole unit. Each Retainer Grant will vest in equal quarterly installments over the period commencing on the grant date of the Retainer Grant and ending on the last day of the fiscal year in which the Retainer Grant is granted, subject to the non-employee director’s continuous service on each vesting date.
Deferral of Settlement of RSU Awards
Each non-employee director may elect to defer the delivery of shares in settlement of any RSU Award granted under the A&R Non-Employee Director Compensation Policy that would otherwise be delivered to such non-employee director on or following the date such award vests pursuant to the terms of a deferral election such non-employee director makes in accordance with the A&R Non-Employee Director Compensation Policy.
Change of Control; Death; Disability
Each RSU Award held by a non-employee director that is granted under the A&R Non-Employee Director Compensation Policy, including the awards described above, will fully vest upon such non-employee director’s death or disability (as defined in the Company’s 2022 Equity Incentive Plan, as amended), or immediately prior to the consummation of a change in control (as defined in the Company’s 2022 Equity Incentive Plan, as amended), in each case to extent such award is outstanding immediately prior to the occurrence of such event.
Non-Employee Director Compensation Limit
The aggregate value of all compensation granted or paid, to any non-employee director with respect to any fiscal year of the Company, including awards granted and cash fees paid by the Company to such non-employee director, will not exceed the limits set forth in the Company’s 2022 Equity Incentive Plan, as amended, currently, (1) $750,000 in total value or (2) if such non-employee director first joins the Board during such fiscal year, $1,500,000 in total value.
All RSU Awards shall be issued pursuant to the terms of the Company’s 2022 Equity Incentive Plan, as amended.
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The foregoing description of the A&R Non-Employee Director Compensation Policy is not complete and is subject to and qualified in its entirety by reference to the A&R Non-Employee Director Compensation Policy, a copy of which is attached hereto as Exhibit 10.1 and is incorporated herein by reference.
Item 6.Exhibits
Exhibit Number |
| Description of Document |
3.1* | ||
10.1* | Amended and Restated Non-Employee Director Compensation Policy, dated May 7, 2024. | |
31.1* | ||
31.2* | ||
32.1** | ||
32.2** | ||
101.INS* | Inline XBRL Instance Document | |
101.SCH* | Inline XBRL Taxonomy Extension Schema Document | |
101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | |
* | Filed herewith | |
** | Furnished herewith. The certifications attached as Exhibit 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are deemed furnished and not filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of NeuroBo Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing. |
26
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized, on May 9, 2024.
NEUROBO PHARMACEUTICALS, INC. | |||||||
|
|
| |||||
/s/ Hyung Heon Kim | |||||||
Hyung Heon Kim |
| ||||||
President and Chief Executive Officer |
| ||||||
/s/ Marshall H. Woodworth | |||||||
Marshall H. Woodworth | |||||||
Chief Financial Officer |
27
Exhibit 3.1
THIRD AMENDED AND RESTATED
BYLAWS
OF
NEUROBO PHARMACEUTICALS, INC.
1
2
3
4
(1) | the value of which is derived in whole or in part from the value of any class or series of shares or other securities of the corporation; |
(2) | which otherwise provides any direct or indirect opportunity to gain or share in any gain derived from a change in the value of securities of the corporation; |
(3) | the effect or intent of which is to mitigate loss, manage risk or benefit of security value or price changes; or |
(4) | which provides the right to vote or increase or decrease the voting power of, such Proponent or nominee, as applicable, or any of its affiliates or associates, with respect to any securities of the corporation, |
which agreement, arrangement, contract, interest or understanding may include, without limitation, any option, warrant, debt position, note, bond, convertible security, swap, stock appreciation right, short position, repurchase, profit interest, hedge, right to dividends, voting agreement, performance-related fee or arrangement to borrow or lend shares (whether or not subject to payment, settlement, exercise or conversion in any such class or series), and any proportionate interest of such Proponent or nominee, as applicable, in the securities of the corporation held by any general or limited partnership, or any limited liability company, of which such Proponent or nominee, as applicable is, directly or indirectly, a general partner or managing member.
5
6
7
8
9
10
11
12
13
14
15
16
Notwithstanding the foregoing, unless otherwise determined pursuant to paragraph (e) of this Section 43, no advance shall be made by the corporation to an officer of the corporation (except by reason of the fact that such officer is or was a director of the corporation in which event this paragraph shall not apply) in any action, suit or proceeding, whether civil, criminal, administrative or investigative, if a determination is reasonably and promptly made (i) by a majority vote of directors who were not parties to the proceeding, even if not a quorum, or (ii) by a committee of such directors designated by a majority vote of such directors, even though less than a quorum, or (iii) if there are no such directors, or such directors so direct, by independent legal counsel in a written opinion, that the facts known to the decision-making party at the time such determination is made demonstrate clearly and convincingly that such person acted in bad faith or in a manner that such person did not believe to be in or not opposed to the best interests of the corporation.
17
18
19
20
If any action the subject matter of which is within the scope of this Section 46 is filed in a court other than a court located within the State of Delaware (a “Foreign Action”) in the name of any stockholder, such stockholder shall be deemed to have consented to: (i) the personal jurisdiction of the state and federal courts located within the State of Delaware in connection with any action brought in any such court to enforce this Section 46 (an “Enforcement Action”); and (ii) having service of process made upon such stockholder in any such Enforcement Action by service upon such stockholder’s counsel in the Foreign Action as agent for such stockholder. This Section 46 shall not apply to actions brought to enforce a duty or liability created by the 1934 Act or the Securities Act of 1933, as amended, or any claim for which the federal courts have exclusive jurisdiction.
Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the corporation shall be deemed to have notice of and consented to the provisions of this Section 46.
21
NeuroBo Pharmaceuticals, Inc.
Amended and Restated
Non-Employee Director Compensation Policy
Effective Date: May 7, 2024
Each member of the Board of Directors (the “Board”) of NeuroBo Pharmaceuticals, Inc., a Delaware corporation (the “Company”) who is not also serving as an employee of the Company or any of its subsidiaries (each such member, an “Non-Employee Director”) will receive the compensation described in this Amended and Restated Non-Employee Director Compensation Policy (this “Policy”). A Non-Employee Director may decline all or any portion of his or her compensation by giving notice to the Company prior to the date cash is to be paid or equity awards are to be granted, as the case may be. This Policy will be effective as of May 7, 2024 (the “Effective Date”). This Policy may be amended at any time in the sole discretion of the Board, or by the Compensation Committee of the Board (the “Compensation Committee”) at the recommendation of the Board. Unless otherwise defined herein, capitalized terms used in this Policy will have the meaning given to such terms in the Company’s 2022 Equity Incentive Plan, as amended, or if such plan is no longer in use, the meaning given to such terms or any similar terms in the primary successor to such plan (in either case, the “Plan”).
Position |
| Amount |
| |
Base Board Retainer |
| $ | 40,000 |
|
Non-Executive Chair of the Board (in addition to above Base Retainer) |
| $ | 35,000 |
|
Chair of Audit Committee |
| $ | 18,000 |
|
Chair of Compensation Committee |
| $ | 12,000 |
|
Chair of Nominating and Corporate Governance Committee |
| $ | 10,000 |
|
Member of Audit Committee (non-Chair) |
| $ | 9,000 |
|
Member of Compensation Committee (non-Chair) |
| $ | 6,000 |
|
Member of Nominating and Corporate Governance Committee (non-Chair) |
| $ | 5,000 |
|
For the avoidance of doubt, the Annual Retainers in the table above are additive and a Non-Employee Director shall be eligible to earn an Annual Retainer for each position in which he or she serves. In addition, the Annual Retainers will be prorated for the first calendar quarter in which the Effective Date occurs, which proration will be based on the number of days of the
calendar quarter remaining in such quarter after the Effective Date. The Board may adopt a program that allows Non-Employee Directors to defer Annual Retainers.
Approved by the Board of Directors: May 7, 2024
Exhibit A
NEUROBO PHARMACEUTICALS, INC.
AMENDED AND RESTATED
NON-EMPLOYEE DIRECTOR COMPENSATION POLICY
Restricted Stock Unit Deferral and Retainer Grant Election Form
For Non-Employee Directors
Please complete and return this Restricted Stock Unit Deferral and Retainer Grant Election Form (the “Election Form”), as described below, [for existing non-employee directors making elections for 2024: within 30 days after the Effective Date of the Policy][for existing non-employee directors making elections for 2025 or any year thereafter: on or before December 31 of each year] [for new non-employee directors: within 30 days following the date you join the Board] (the “Submission Deadline”), to the Chief Financial Officer of the Company, with a copy to the Company’s counsel, NeuroBo Pharmaceuticals, Inc., 545 Concord Avenue, Suite 210, Cambridge, Massachusetts 02138.
Neither the provision of this Election Form nor your completion of this Election Form represents a commitment by the Company to grant an Award to you. The grant of an Award remains subject to the terms of the Company’s Amended and Restated Non-Employee Director Compensation Policy as may be hereinafter amended (the “Policy”). Terms not otherwise defined herein shall have the meaning set forth in the Policy or the Plan, as applicable.
I understand that my Election Form will become irrevocable effective as of the Submission Deadline.
2. | Personal Information: |
(Please print)
Participant Name: (the “Participant”)
1 Applicate Retainer Grant Measurement Date
2 Last day of the fiscal year of the Company to which the Retainer Gant Election applies
Exhibit A-1
(a) | By signing below, I elect to defer in accordance with this Section 3 100% of my [ ]3 that may be granted to me, if any, under the Plan and pursuant to the Policy in the calendar year following the calendar year in which I tender this election (or if I first became eligible to participate in the Policy in the calendar year in which I tender this election, in the calendar year in which I tender this election). If I do not timely submit a properly completed Election Form, then my [ ]4 will vest and settle in accordance with the terms of the Policy, the Plan, and the applicable RSU Award Agreement. |
(b) | All Awards that are deferred pursuant to this Section 3 are referred to as “Deferred Awards” in this Election Form. |
(c) | By signing below, I elect to have my Deferred Awards settled as follows: |
(1) | Subject to the following paragraph, my Deferred Awards will be settled in a single lump sum installment in whole shares on the earlier of (y) immediately prior to a Change in Control, provided that, for the avoidance of doubt, a transaction will not be deemed a Change in Control unless the transaction qualifies as a “change in control event” within the meaning of Treasury Regulation Section 1.409A-3(i)(5); or (z) within 60 days following my Separation Date or my death, whichever is earlier. |
For the purposes of the foregoing, “Separation Date” means the date of my retirement or other separation from service with the Company and all of its Affiliates (as determined in accordance with Section 409A(2)(A)(i) of the Code and Treasury Regulation Section 1.409A-1(h)).
(2) | If a distribution hereunder is triggered because of my Separation Date and I am a “specified employee” within the meaning of Section 409A at the time of my Separation Date, then the distribution that I would otherwise be entitled to receive upon the Separation Date will not be settled until the date that is 6 months and 1 day following the Separation Date, unless I die following my Separation Date, in which case, my distribution will commence as soon as practicable following my death. |
5. | Participant Acknowledgements and Signatures: |
(a) | I agree to all of the terms and conditions of this Election Form. |
(b) | I acknowledge that I have received and read a copy of the Plan’s prospectus and that I am familiar with the terms and provisions of the Plan. |
3 Awards with respect to which the Non-Employee Director is making a deferral election to be included.
4 Awards with respect to which the Non-Employee Director is making a deferral election to be included.
Exhibit A-2
(c) | I agree to the right of the Board or the Compensation Committee to amend or terminate my election under Section 3 at any time and for any reason, with or without notice; provided that such termination or amendment is performed in compliance with Section 409A (as determined by Company legal counsel in its sole and absolute discretion). |
(d) | I understand that the obligation of the Company to settle any Deferred Awards is unfunded and that no assets of any kind have been segregated in a trust or otherwise set aside to satisfy any obligation under this Election Form. I also understand that any election to defer the settlement of any Awards pursuant to this Election Form will make me only a general, unsecured creditor of the Company. |
(e) | I understand that any amounts deferred will be taxable as ordinary income in the year settled. Notwithstanding, I agree and understand that the Company does not guarantee in any way whatsoever the tax treatment of any deferrals or payments made under the Policy or this Election Form. I understand that I will be responsible for all taxes and any other costs owed with respect to any deferrals or payments made with respect to my Awards. |
(f) | I understand that the Company will be under no obligation to settle any Deferred Awards until any applicable tax withholding obligations are satisfied and that if I fail to satisfy any such tax withholding obligations I will forfeit my right to receive the shares subject to my Deferred Award. I understand that the Company has the right (but not the obligation) to withhold taxes from my Deferred Awards (including pursuant to net share withholding) in any amount and through such procedure as the Company deems necessary or desirable to satisfy any income or other tax obligations incurred with respect to my Awards. |
(g) | I understand that, upon receipt of any Deferred Awards, in addition to federal taxes, I may owe taxes to the state where I resided at the time of vesting in the Deferred Awards and/or to the state where I reside when the Deferred Awards are settled, if different. |
(h) | I understand, acknowledge and agree that the Board or the Compensation Committee has the discretion to make all determinations and decisions regarding any elections set forth on this Election Form. |
(i) | I understand that this Election Form and the elections made hereunder are intended to comply with the requirements of Section 409A so that none of [the Deferred Awards or the Retainer Grant] issuable will be subject to the tax acceleration and additional penalty taxes imposed under Section 409A, and any ambiguities herein will be interpreted to so comply. If applicable, I understand that I am solely responsible for any accelerated income taxes and additional taxes and tax penalties imposed by Section 409A. |
Exhibit A-3
(j) | I also understand that this Election Form and the elections made hereunder will in all respects be subject to the terms and conditions of the Policy, the applicable Award Agreement and the Plan, as applicable. Should any inconsistency exist between this Election Form, the Policy, the Plan, the Award Agreement under which an Award was granted, and/or any applicable law, then the provisions of either the applicable law (including, but not limited to, Section 409A) or the Plan will control, with the Plan subordinated to the applicable law and the Award Agreement and the Policy subordinated to this Election Form. |
By signing this Election Form, I authorize the implementation of the above elections. I understand that my [deferral election and retainer grant election] are irrevocable effective as of the Submission Deadline and may not be changed in the future, except in accordance with the requirements of Section 409A and the procedures specified by the Board or the Compensation Committee.
| | | ||
Signed: Participant Name: | Date: | |||
| | |||
Agreed to and accepted: | ||||
| | |||
NeuroBo Pharmaceuticals, Inc. By: Name: Title: | Date: |
IMPORTANT DEADLINE: Please remember that if you wish to make any election set forth on this Election Form, then the properly completed Election Form must be signed by you and returned ON OR BEFORE THE SUBMISSION DEADLINE to the Chief Financial Officer of the Company, with a copy to the Company’s counsel (or such other individual as the Company designates).
Exhibit A-4
Exhibit 31.1
Certification of Chief Executive Officer
pursuant to Rule 13a-14(a) or Rule 15d-14(a)
I, Hyung Heon Kim, certify that:
(1) | I have reviewed this quarterly report on Form 10-Q for the quarterly period ended March 31, 2024 of NeuroBo Pharmaceuticals, Inc.; |
(2) | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
(3) | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
(4) | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
(5) | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: May 9, 2024 | /s/ Hyung Heon Kim |
| President and Chief Executive Officer |
| (Principal Executive Officer) |
|
Exhibit 31.2
Certification of Chief Financial Officer
pursuant to Rule 13a-14(a) or Rule 15d-14(a)
I, Marshall Woodworth, certify that:
(1) | I have reviewed this quarterly report on Form 10-Q for the quarterly period ended March 31, 2024 of NeuroBo Pharmaceuticals, Inc.; |
(2) | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
(3) | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
(4) | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
(5) | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: May 9, 2024 | /s/ Marshall Woodworth |
| Chief Financial Officer |
| (Principal Financial Officer) |
|
Exhibit 32.1
Certification of Chief Executive Officer
under Section 906 of the Sarbanes-Oxley Act of 2002
(18 U.S.C. § 1350)
In connection with the quarterly report on Form 10-Q for the quarterly period ended March 31, 2024 of NeuroBo Pharmaceuticals, Inc. (the “Company”) as filed with the Securities and Exchange Commission (the “Report”), I, Hyung Heon Kim, President and Chief Executive Officer, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
(1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: May 9, 2024 | /s/ Hyung Heon Kim |
| President and Chief Executive Officer |
| (Principal Executive Officer) |
|
Exhibit 32.2
Certification of Chief Financial Officer
under Section 906 of the Sarbanes-Oxley Act of 2002
(18 U.S.C. § 1350)
In connection with the quarterly report on Form 10-Q for the quarterly period ended March 31, 2024 of NeuroBo Pharmaceuticals, Inc. (the “Company”) as filed with the Securities and Exchange Commission (the “Report”), I, Marshall H. Woodworth, Chief Financial Officer, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
(1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: May 9, 2024 | /s/ Marshall H. Woodworth |
| Chief Financial Officer |
| (Principal Financial Officer) |
|