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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

Form 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2024

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from          to          

Commission file number 001-37809

Graphic

NeuroBo Pharmaceuticals, Inc.

(Exact name of Registrant as specified in its charter)

Delaware

47-2389984

(State or other jurisdiction of incorporation or organization)

(IRS Employer Identification No.)

545 Concord Avenue, Suite 210

Cambridge, Massachusetts

02138

(Address of principal executive offices)

(Zip Code)

(857) 702-9600

(Registrant’s telephone number, including area code)

Not applicable

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

Trading Symbol(s)

Name of Each Exchange On Which Registered

Common stock, $0.001 par value

NRBO

The Nasdaq Stock Market LLC

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. Yes      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer  

Accelerated filer  

Non-accelerated filer  

Smaller reporting company  

Emerging growth company  

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes    No  

As of August 9, 2024, the registrant had 8,459,196 shares of common stock, $0.001 par value per share, issued and outstanding.

NEUROBO PHARMACEUTICALS, INC.

Table of Contents

Part I

Financial Information

4

Item 1.

Financial Statements (Unaudited)

4

Condensed Consolidated Balance Sheets as of June 30, 2024 (Unaudited) and December 31, 2023

4

Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2024 and 2023 (Unaudited)

5

Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2024 and 2023 (Unaudited)

6

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023 (Unaudited)

7

Notes to the Condensed Consolidated Financial Statements (Unaudited)

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

19

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

26

Item 4.

Controls and Procedures

26

Part II

Other Information

27

Item 1.

Legal Proceedings

27

Item 1A.

Risk Factors

27

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

27

Item 3.

Default upon Senior Securities

27

Item 4.

Mine Safety Disclosures

28

Item 5.

Other Information

28

Item 6.

Exhibits

28

Signatures

30

2

Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q for the quarterly period ended June 30, 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 our future financial and operating results; the ability to integrate the product candidates into our business in a timely and cost-efficient manner; 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; the 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; the 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (2023 Form 10-K), and in our other filings with the Securities and Exchange Commission (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. 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.

3

Part I - Financial Information

Item 1.Financial Statements

NeuroBo Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except per share amounts)

As of

June 30, 2024

December 31, 2023

(Unaudited)

Assets

Current assets:

Cash

$

27,934

$

22,435

Prepaid expenses and other current assets

583

77

Total current assets

 

28,517

 

22,512

Property and equipment, net

 

44

 

46

Right-of-use asset

169

202

Other assets

21

21

Total assets

$

28,751

$

22,781

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$

2,632

$

821

Clinical trial accrued liabilities

2,066

3,033

Accrued expenses and other current liabilities

 

463

 

592

Warrant liabilities

861

658

Related party payable

3,617

789

Lease liability, short-term

72

67

Total current liabilities

 

9,711

 

5,960

Lease liability, long-term

98

136

Total liabilities

 

9,809

 

6,096

Commitments and contingencies (Note 7)

Stockholders’ equity

Preferred stock, $0.001 par value per share; 10,000 shares authorized as of June 30, 2024 and December 31, 2023; no shares issued or outstanding as of June 30, 2024 and December 31, 2023

Common stock, $0.001 par value per share, 100,000 shares authorized as of June 30, 2024 and December 31, 2023; 8,221 and 4,906 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively

 

8

 

5

Additional paid–in capital

 

143,966

 

124,945

Accumulated deficit

 

(125,032)

 

(108,265)

Total stockholders’ equity

 

18,942

 

16,685

Total liabilities and stockholders’ equity

$

28,751

$

22,781

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4

NeuroBo Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(Unaudited - In thousands, except share and per share amounts)

Three Months Ended June 30,

Six Months Ended June 30,

2024

2023

2024

2023

Operating expenses:

    

    

    

    

Research and development

$

8,074

$

2,364

$

12,978

$

3,001

General and administrative

2,010

1,442

3,987

3,325

Total operating expenses

 

10,084

 

3,806

 

16,965

 

6,326

Loss from operations

 

(10,084)

 

(3,806)

 

(16,965)

 

(6,326)

Other income (expense):

Change in fair value of warrant liabilities

(133)

3,072

(203)

2,988

Interest income

164

401

Total other income

31

3,072

198

2,988

Loss before income taxes

(10,053)

(734)

(16,767)

(3,338)

Provision for income taxes

 

 

Net loss and comprehensive net loss

 

(10,053)

 

(734)

 

(16,767)

 

(3,338)

Loss per share of common stock, basic and diluted

$

(1.85)

$

(0.15)

$

(3.19)

$

(0.66)

Weighted average shares of common stock, basic and diluted

 

5,428,906

5,059,003

 

5,259,939

5,059,003

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

3,179

$

3

$

117,542

$

(95,795)

$

21,750

Issuance of stock from exercise of warrants

218

1,436

1,436

Stock–based compensation 

(74)

(74)

Net loss

(2,604)

(2,604)

As of March 31, 2023

3,397

3

118,904

(98,399)

20,508

Issuance of stock from exercise of warrants

1,383

2

5,396

5,398

Stock–based compensation 

24

24

Net loss

(734)

(734)

As of June 30, 2023

4,780

$

5

$

124,324

$

(99,133)

$

25,196

As of January 1, 2024

4,906

$

5

$

124,945

$

(108,265)

$

16,685

Stock–based compensation 

105

105

Net loss

(6,714)

(6,714)

As of March 31, 2024

4,906

5

125,050

(114,979)

10,076

Issuance of common stock and warrants (Pre-funded, Series A and Series B), net of issuance costs of $1,522

3,308

3

18,473

18,476

Issuance of Placement Agent warrants

309

309

Issuance of stock for vested restricted stock units

7

Stock–based compensation 

134

134

Net loss

(10,053)

(10,053)

As of June 30, 2024

8,221

$

8

$

143,966

$

(125,032)

$

18,942

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)

Six Months Ended June 30,

2024

2023

Operating activities

Net loss

$

(16,767)

$

(3,338)

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation

 

239

 

(50)

Non-cash lease expense

1

Depreciation

 

10

 

1

Change in fair value of warrant liabilities

203

(2,988)

Change in operating assets and liabilities:

Prepaid expenses and other assets

 

(507)

 

(318)

Accounts payable

 

1,396

 

260

Accrued and other liabilities

 

1,732

 

1,841

Net cash used in operating activities

 

(13,693)

 

(4,592)

Investing activities

Purchases of property and equipment

 

(8)

 

(4)

Net cash used in investing activities

 

(8)

 

(4)

Financing activities

Proceeds from issuance of common stock and pre-funded warrants

19,998

Payments of issuance costs

(798)

(80)

Net cash provided by (used in) financing activities

 

19,200

 

(80)

Net increase (decrease) in cash

 

5,499

 

(4,676)

Cash at beginning of period

 

22,435

 

33,364

Cash at end of period

$

27,934

$

28,688

Supplemental non-cash investing and financing transactions:

Unpaid issuance costs

$

415

$

Reclassification of warrant liabilities upon exercise of warrants

$

$

6,833

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

7

Table of Contents

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 condensed consolidated 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. 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, glucagon-like peptide 1 (“GLP-1”), glucagon-dependent insulinotropic polypeptide receptor, and peptide YY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. DA-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, which includes preclinical developments and clinical trials, and raising capital. Our activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved.

Common stock reverse stock splits

In December 2023, we completed a one-for-eight reverse stock split of our common stock (the “2023 Reverse Stock Split”). As a result, every eight shares of our issued and outstanding common stock were combined, converted and changed into one share of our common stock. Any fraction of a share of our common stock that was created as a result of the 2023 Reverse Stock Split was rounded down to the next whole share and our stockholders received cash equal to the market value of the fractional share, determined by multiplying such fraction by the closing sales price of our common stock as reported on the Nasdaq Capital Market LLC (“Nasdaq”) on the last trading day before the 2023 Reverse Stock Split. The 2023 Reverse Stock Split was initially approved by our stockholders at the annual meeting of stockholders in June 2023. At the annual meeting, the stockholders approved a proposal to amend our certificate of incorporation to affect a reverse split of our outstanding common stock at a ratio in the range of one-for-five to one-for-eight to be determined at the discretion of our Board of Directors (“Board”). Following the annual meeting, our Board approved a one-for-eight reverse stock split of our issued and outstanding shares of common stock.

The 2023 Reverse Stock Split did not impact the number of authorized shares of common stock of 100,000,000 shares. For the 2023 Reverse Stock Split, a proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options, and warrants to purchase shares of our common stock, the number of shares issuable upon vesting of restricted stock units (“RSUs”) and the number of shares reserved for issuance pursuant to our equity incentive compensation plans. Specifically, for the Series A Warrants and Series B

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Notes to the Condensed Consolidated Financial Statements

(Unaudited)

Warrants issued in November 2022 that were outstanding on the effective date of the 2023 Reverse Stock Split, the number of outstanding warrants did not change; instead, the warrants have an exchange ratio of eight 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 $27.9 million in cash as of June 30, 2024. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $125.0 million as of June 30, 2024. We have incurred a net loss of $16.8 million and net cash used of $13.7 million for operating activities for the six months ended June 30, 2024. Due in large part to the ongoing Phase 2a clinical trial for DA-1241 and Phase 1 clinical trial for DA-1726, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern.

We believe that our existing cash will be sufficient to fund our operations into the second quarter of 2025. Our existing cash includes gross proceeds of $20.0 million, of which $10.0 million was received from Dong-A ST Co., Ltd., a related party (“Dong-A”), in connection with the closing of the Offering (as defined below) in June 2024. We plan to continue to fund our operations through a combination of proceeds of (i) up to $20.0 million from the potential future exercise of Series A Warrants issued in the Offering before deducting for certain issuance costs, such as placement agent fees and expenses and (ii) from equity offerings, debt financings, or other sources, potentially including collaborations, out-licensing and other similar arrangements. If the Series A Warrants issued in the June 2024 Offering are exercised, we believe that the additional gross proceeds to us from such exercises would be sufficient to fund our operations into 2026. There can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all, or that the Series A Warrants will be exercised. To the extent that we can raise additional funds by issuing equity securities or in the event our existing warrants are exercised, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business. If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on us.

A.Basis of presentation

We prepared the condensed consolidated financial statements following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“GAAP”) for complete financial statements can be condensed or omitted. However, except as disclosed herein, there has been no material change in the information disclosed in the notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (“2023 Form 10-K”).

Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these condensed consolidated financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the condensed consolidated financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in the condensed

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Notes to the Condensed Consolidated Financial Statements

(Unaudited)

consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in our 2023 Form 10-K. Certain amounts in the condensed consolidated financial statements and accompanying notes may not add due to rounding, and all percentages have been calculated using unrounded amounts.

B.New accounting standards

Adoption of new accounting standards

New accounting standards or accounting standards updates were assessed and determined to be either not applicable or did not have a material impact on our condensed consolidated financial statements or processes.

Accounting standards issued but not yet adopted

In December 2023, the Financial Accounting Standards Board issued Accounting Standard Update (“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.

E.Reclassification of prior year presentation

Certain prior year amounts have been reclassified for consistency with the current year presentation. Adjustments have been made to the condensed consolidated balance sheets to reclassify the presentation of certain current liabilities related to clinical trial accrued liabilities of $3.0 million and related party payable of $0.8 million from accrued expenses and other current liabilities. These reclassifications had no effect on the reported total current liabilities in the condensed consolidated balance sheets.

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NeuroBo Pharmaceuticals, Inc.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

2. Prepaid expenses and other current assets 

Prepaid expenses and other current assets consist of the following (in thousands):

As of

June 30, 2024

December 31, 2023

Insurance

$

313

$

Deposits

111

39

Other prepaid expenses

 

159

 

38

Total

$

583

$

77

3. Property and equipment, net

Property and equipment, net consist of the following (in thousands):

As of

June 30, 2024

December 31, 2023

Office equipment

$

88

$

80

Less accumulated depreciation

 

(44)

 

(34)

Property and equipment, net

$

44

$

46

4. Accrued expenses and other current liabilities

Accrued expenses and other current liabilities consist of the following (in thousands):

As of

June 30, 2024

December 31, 2023

Employee related costs

$

403

$

118

Professional service fees

45

308

Other

 

15

 

166

Total

$

463

$

592

5. Warrant liabilities

Changes to our warrant liabilities are summarized as follows (in thousands):

Total

As of January 1, 2024

$

658

Fair value changes

203

As of June 30, 2024

$

861

Our warrant liabilities relate to the 2022 Series A Warrants and 2022 Series B Warrants, which were issued in November 2022. These warrants are considered to be derivative instruments; accordingly, we recorded their estimated fair value as warrant liabilities. We estimated the fair value of these warrants using the trading market price of our common stock due to a cashless exercise provision of these warrants whereby eight warrants can be exchanged for one share of common stock for no additional consideration, which results in an effective per warrant exercise price of zero.

6.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) for two proprietary compounds for specified indications (the “2022 License

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NeuroBo Pharmaceuticals, Inc.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

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 $3.4 million and $3.6 million for the three and six months ended June 30, 2024, respectively, and $1.5 million and $1.8 million for the three and six months ended June 30, 2023, respectively, under the Shared Services Agreement, which are included in operating expenses: research and development in the accompanying condensed consolidated statements of operations. We have an aggregate payable to Dong-A of $3.6 million and $0.8 million as of June 30, 2024 and December 31, 2023, respectively, under the Shared Services Agreement, which are included in related party payable in the accompanying condensed consolidated balance sheets.

For additional information on the 2022 License Agreement, the Shared Service Agreement and other agreements with Dong-A, refer to “Note 5. Related party” in the audited consolidated financial statements and notes thereto for the year ended December 31, 2023, which is included in our 2023 Form 10-K.

7. 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 three years with an option to renew for an additional two-year term. The lease commenced in September 2023 and expires in August 2026. We recorded lease rental expense of $22 thousand and $44 thousand for the three and six months ended June 30, 2024, respectively, and we made cash lease payments of $21 thousand and $43 thousand during the three and six months ended June 30, 2024.

Our lease liability, which represents the net present value of future lease payments, was calculated utilizing a discount rate of 11%, which corresponds to our estimated incremental borrowing rate.

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, no rental expenses were recorded for the three months and six months ended June 30, 2024, and we recorded rental expense of $6 thousand and $11 thousand for the three and six months ended June 30, 2023, respectively.

8.Stockholders’ equity

June 2024 offering

Securities purchase agreements

In June 2024, we entered into and closed on two securities purchase agreements (the “Offering”) with an institutional accredited investor and Dong-A, and received aggregate gross proceeds of $20.0 million, of which $10.0 million was received from Dong-A. The Offering was comprised of (i) 3,307,889 shares of common stock at a purchase price of $3.93 per share, (ii) pre-funded warrants to purchase up to 1,781,171 shares of common (the “Pre-Funded Warrants”) at a purchase price of $3.929 per warrant, (iii) Series A warrants to purchase 5,089,060 shares of common stock (the “Series A Warrants”), and (iv) Series B warrants to purchase up to 7,633,591 shares of common stock (the “Series B Warrants”). Collectively, the Series A Warrants and the Series B Warrants are referred to as “PIPE Common Warrants.” Of the total shares of common stock issued in the Offering, 763,359 shares were sold to an institutional investor pursuant to our

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NeuroBo Pharmaceuticals, Inc.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

effective shelf registration statement on Form S-3 (Registration No. 333-278646), initially filed with and declared effective by the SEC in April 2024, and a prospectus supplement filed with the SEC in June 2024.

The Pre-Funded Warrant has an exercise price of $0.001 per share and is immediately exercisable and will expire when exercised in full and the PIPE Common Warrants have an exercise price of $3.93 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the warrants (the “Stockholder Approval”). We are currently planning to hold a Special Meeting of Stockholders in September 2024 to seek Stockholder Approval for certain warrants issued in connection with the Offering. Additionally, prior to the closing of the Offering in June 2024, we received a letter agreement from Dong-A whereby Dong-A irrevocably agreed to vote all of the shares of Company’s voting stock over which Dong-A have voting control in favor of any resolution presented to the stockholders of the Company related to the Stockholder Approval.

The Series A Warrants will expire on the earlier of the twelve month anniversary of the Stockholder Approval and within 60 days following the public announcement of the Company receiving positive Phase 1 multiple ascending dose (“MAD”) data readout for DA-1726, and the Series B Warrants will expire on the earlier of the five years anniversary of the Stockholder Approval and within six months following the public announcement of the Company receiving positive Phase 1 Part 3 data readout for DA-1726. Based on the terms of the PIPE Common Warrants, we have concluded that the accounting classification of the PIPE Common Warrants is to be stockholders’ equity

Under the terms of the Pre-Funded Warrants and the PIPE Common Warrants issued to the institutional accredited investor, we may not affect the exercise of any such Pre-Funded Warrant or PIPE Common Warrants, and the holder will not be entitled to exercise any portion of any Pre-Funded Warrant or PIPE Common Warrants, if, upon giving effect to such exercise, the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates, other persons acting or who could be deemed to be acting as a group together with the holder or any of the holder’s affiliates, and any other persons whose beneficial ownership of common stock would or could be aggregated with the holder’s or any of the holder’s affiliates) would exceed 9.99% (in the case of the Pre-Funded Warrants) or 4.99% (in the case of the PIPE Common Warrants) of the number of shares of the Company’s outstanding common stock immediately after giving effect to the exercise (the “Beneficial Ownership Limitation”), as such percentage ownership is calculated in accordance with Section 13(d) of the Exchange Act and the applicable regulations of the SEC. A holder of the Pre-Funded Warrant or PIPE Common Warrants that were issued to the institutional accredited investor may increase or decrease the Beneficial Ownership Limitation to a higher or lower percentage (not to exceed 9.99%), effective 61 days after written notice to us. Any such increase or decrease will apply only to that holder and not to any other holder of the Pre-Funded Warrants or PIPE Common Warrants.

Placement agent

We paid to the placement agent a cash fee equal to 7.0% of the gross proceeds of the Offering received from a certain institutional investor and $0.1 million for non-accountable expenses and clearing costs. In addition, we issued warrants to the placement agent’s designees (“Placement Agent Warrants”) to purchase up to 127,227 shares of common stock (which represents 5% of the sum of the shares of common stock and Pre-Funded Warrants sold to the institutional investor in the Offering) at an exercise price of $4.9125 per share (which represents a premium of 25% of the offering price per share of common stock in the Offering). The Placement Agent Warrants will be exercisable beginning on the effective date of the Stockholder Approval and will expire on the earlier of (i) two years after the date that the shares of common stock underlying the Placement Agent Warrants are registered pursuant to an effective registration statement filed pursuant to the Securities Act of 1933, as amended, which occurred on July 24, 2024, and (ii) June 23, 2029. The fair value of the Placement Agent Warrants was $0.3 million, which represents a non-cash issuance cost. The weighted average fair value per share of these Placement Agent Warrants was $2.73, and was determined using the Black-Scholes option pricing model with the following assumptions: expected stock price volatility of 140.0%, expected term of 2.1 years, expected dividend yield of 0%, and risk-free interest rate of 4.63%. Based on the terms of the Placement Agreement Warrants, we have concluded that the accounting classification of the Placement Agent Warrants is stockholders’ equity in the accompanying condensed consolidated balance sheets.

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Notes to the Condensed Consolidated Financial Statements

(Unaudited)

Upon the exercise for cash of any PIPE Common Warrants issued to a certain institutional investor, we shall pay the placement agent (i) a cash fee of 7.0% of the aggregate gross exercise price paid in cash with respect thereto and (ii) a non-cash fee in the form of additional warrants to purchase the number of shares of common stock equal to 5.0% of the aggregate number of such shares of common stock underlying such warrants. The cash fee payable to the placement agent for any PIPE Common Warrants exercised by the institutional investor is accounted for as a contingent commitment and will be recorded as an offset to any gross proceeds received from any future exercises of PIPE Common Warrants by the institutional investor. The non-cash fee payable to the placement agent for any PIPE Common Warrants exercised by the institutional investor is accounted for as contingent warrants (“Placement Agent Contingent Warrants”) to purchase up to 318,067 shares of common stock, which is subject to performance criteria of the institutional investor regarding any exercise for cash of any PIPE Common Warrants with an assumed grant date of the Offering closing date, and an exercise price of $4.9125 per share. The weighted average fair value per share of these Placement Agent Contingent Warrants was $3.43 and was determined using the Black-Scholes option pricing model with the following assumptions: expected stock price volatility of 127.0%, expected term of 5.7 years, expected dividend yield of 0%, and risk-free interest rate of 4.31%. Based on the terms of the placement agent engagement letter, we have concluded that the accounting classification of the Placement Agent Contingent Warrants is to be stockholders’ equity. On each balance sheet reporting date, we will need to assess whether it is probable for us to issue warrants to the placement agent based on whether it is probable for any PIPE Common Warrants to be exercised by the institutional investor. As of June 30, 2024, we determined that the issuance of additional warrants to the placement agent is not yet probable; accordingly, the Placement Agent Contingent Warrants had no impact on the condensed consolidated balance sheets.

Warrants

The following tables summarize our outstanding warrants:

Shares of Common Stock Issuable

for Outstanding Warrants

As of

Exercise

Expiration

Warrant Issuance

June 30, 2024

December 31, 2023

Price

Date

July 2018 (1)

6

6

$

44,820.0000

July 2028

April 2020 (1)

159

159

$

3,000.0000

April 2025

January 2021 (1)

10,421

10,421

$

1,447.2000

July 2026

October 2021 (1)

15,390

15,390

$

900.0000

April 2025

November 2022 Series B (2)

177,938

177,938

$

0.0000

December 2027

June 2024 Placement Agent (3)

127,227

$

4.9125

July 2026

June 2024 Pre-Funded (4)

1,781,171

$

0.0010

no expiration date

June 2024 Series A (5)

5,089,060

$

3.9300

September 2025 (latest date)

June 2024 Series B (6)

7,633,591

$

3.9300

September 2029 (latest date)

Total

14,834,963

203,914

(1)The number of outstanding and exercisable warrants was adjusted for the impact of each of the common stock reverse stock splits completed in 2023 and 2022. Accordingly, the number of outstanding warrants is equal to the number of shares of common stock issuable for outstanding warrants.
(2)The number of outstanding and exercisable warrants was not impacted by the 2023 Reverse Stock Split. Accordingly, the number of outstanding warrants is equal to eight times the number of shares of common stock issuable for outstanding warrants. Additionally, during the six months ended June 30, 2023, 6,460,333 Series B warrants were exchanged for 807,541 shares of our common stock.
(3)These warrants are exercisable at any time on or after the Stockholder Approval, which is currently planned to be in September 2024, and expire two years after a resale registration statement covering the shares of common stock issuable upon the exercise of the warrants hereunder becomes effective

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Notes to the Condensed Consolidated Financial Statements

(Unaudited)

with the SEC. In July 2024, a resale registration statement was filed with the SEC and became effective.
(4)These warrants are exercisable immediately upon their issuance in June 2024 and are considered to be perpetual warrants without any expiration date.
(5)These warrants are exercisable at any time on or after the Stockholder Approval, which is currently planned to be in September 2024, and expire on the earlier of (i) the twelve months anniversary of the stockholder approval date, and (ii) the 60th day following the date on which the Company publicly announce the receiving of positive Phase 1 MAD data readout for DA-1726.
(6)These warrants are exercisable at any time on or after the Stockholder Approval, which is currently planned to be in September 2024, and expire on the earlier of (i) the five years anniversary of the stockholder approval date and (ii) the six months anniversary following the date on which the Company publicly announce the receiving of positive Phase 1, Part 3 data readout for DA-1726.

Additionally, during the six months ended June 30, 2023, 6,345,333 Series A warrants issued in November 2022 were exchanged for 793,167 shares of our common stock. Furthermore, as of December 31, 2023, the Series A warrants issued in November 2022 were fully exchanged for shares of our common stock.

9. Stock-based compensation

Stock-based compensation expense was included in general and administrative and research and development as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

2024

2023

2024

2023

General and administrative

$

99

$

24

$

170

$

(61)

Research and development

36

69

11

Total stock-based compensation

$

135

$

24

$

239

$

(50)

For stock options and RSUs granted under the 2019 Equity Incentive Plan (the “2019 Plan”), the 2021 Inducement Plan and (the “Inducement Plan”) the 2022 Equity Incentive Plan, as amended (the “2022 Plan”), as of June 30, 2024, unrecognized stock-based compensation cost totaled $0.8 million. The unrecognized stock-based expense is expected to be recognized over a weighted average period of 1.8 years.

Stock-based award plans

In June 2024, in connection with the 2024 Annual Meeting of Stockholders, our stockholders approved an amendment to our 2022 Plan (the “Amendment”). Pursuant to the terms and conditions of the Amendment, the 2022 Plan was amended to:

automatically increase on January 1st of each year for a period of eight years commencing on January 1, 2025 and ending on (and including) January 1, 2032, the aggregate number of shares of common stock that may be issued pursuant to Awards (as defined in the 2022 Plan) to an amount equal to 10% of the Fully Diluted Shares (as defined in the 2022 Plan) as of the last day of the preceding calendar year, provided, however that the Board may act prior to the effective date of any such annual increase to provide that the increase for such year will be a lesser number of shares of common stock; and
increase the aggregate maximum number of shares of common stock that may be issued pursuant to the exercise of Incentive Stock Options (as defined in the 2022 Plan) to 1 million shares of the common stock plus the amount of any increase in the number of shares that may be available for issuance pursuant to the annual increase

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Notes to the Condensed Consolidated Financial Statements

(Unaudited)

described above, but in no event more than 15 million shares of the common stock issued as incentive stock options.

As of June 30, 2024, there were (i) 1,575 outstanding stock options under the 2019 Plan, and (ii) 3,125 outstanding stock options and 218,113 outstanding RSUs under the 2022 Plan. As of June 30, 2024, we had an aggregate of 385,921 shares available for future issuance, of which 4,166 shares were available under the Inducement Plan and 381,755 shares were available under the 2022 Plan.

Stock options

The following table summarizes the status of our outstanding and exercisable options and related transactions for the period presented (in thousands, except share and per share amounts):

Outstanding

Exercisable

Shares of

Weighted

Shares of

Weighted

Common

Weighted

Average

Common

Weighted

Average

Stock

Average

Aggregate

Remaining

Stock

Average

Aggregate

Remaining

Issuable

Exercise

Intrinsic

Contractual

Issuable

Exercise

Intrinsic

Contractual

for Options

Price

Value

Term (years)

for Options

Price

Value

Term (years)

As of January 1, 2024

4,700

$

398.30

$

8.6

4,577

$

391.04

$

8.6

Vested

59

689.72

As of June 30, 2024

4,700

$

398.30

$

8.0

4,636

$

394.84

$

8.0

During the six months ended June 30 2023, we granted 3,125 stock options and the weighted average fair value per share of these stock options was $3.63. We estimated the grant date fair value of stock options granted to employees, consultants, and directors using the Black-Scholes option pricing model. The assumptions used in the Black-Scholes option-pricing model were as follows: expected stock price volatility of 82.9%, expected term of 5.0 year, expected dividend yield of 0%, and risk-free interest rate of 3.54%.

Restricted Stock Units

The following table summarizes the status of our RSUs and related transactions for the period presented (in thousands, except share and per share amounts):

Outstanding

Vested and Deferred Release

Shares of

Average

Shares of

Average

Common Stock

Grant Date

Aggregate

Common Stock

Grant Date

Aggregate

Issuable

Fair Value

Intrinsic

Issuable

Fair Value

Intrinsic

for RSUs

Price

Value

for RSUs

Price

Value

As of January 1, 2024

141,361

$

4.55

$

523

5,469

$

4.02

$

20

Granted

83,899

5.41

Vested and Deferred Release

1,563

4.12

Vested and Released

(7,147)

4.05

29

As of June 30, 2024

218,113

$

4.90

$

1,056

7,032

$

4.04

$

34

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.

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Notes to the Condensed Consolidated Financial Statements

(Unaudited)

10.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 and six months ended June 30, 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 and six months ended June 30, 2024 and 2023. Accordingly, there were no benefits for income taxes recorded for the three and six months ended June 30, 2024 and 2023. Additionally, as of June 30, 2024 and December 31, 2023, we maintain a full valuation allowance for all deferred tax assets.

11.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 June 30,

Six Months Ended June 30,

2024

2023

2024

2023

Numerator:

Net loss

$

(10,053)

$

(734)

$

(16,767)

$

(3,338)

Denominator:

Weighted average shares of common stock, basic

5,428,906

5,059,003

5,259,939

5,059,003

Effect of dilutive securities

Weighted average shares of common stock, diluted

5,428,906

5,059,003

5,259,939

5,059,003

Loss per share of common stock, basic and diluted

$

(1.85)

$

(0.15)

$

(3.19)

$

(0.66)

For each of the periods presented in the above table, our basic weighted average shares of common stock include any outstanding (i) November 2022 Series A warrants and Series B warrants, (ii) June 2024 Pre-Funded Warrants and (iii) vested RSUs in which their release was deferred in accordance with the respective award agreement during the respective period.

Since we reported a net loss for the three and six months ended June 30, 2024 and 2023, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and diluted loss per share of common stock and our basic and diluted weighted average shares of common stock are the same for three and six months ended June 30, 2024 and 2023. The following table sets forth the potentially dilutive securities which were not included in the calculation of diluted earnings per share of common stock for three and six months ended June 30, 2024 and 2023:

As of June 30,

    

2024

2023

Stock options

4,700

5,034

RSUs

211,081

Warrants

12,875,854

28,529

12.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;

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(Unaudited)

Level 2:

Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the asset or liability; and

Level 3: Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.

The following table sets forth our financial assets and liabilities, subject to fair value measurements on a recurring basis, by level within the fair value hierarchy (in thousands):

As of June 30, 2024

As of December 31, 2023

Description

    

Total

    

Level 1

    

Level 2

    

Level 3

    

Total

    

Level 1

    

Level 2

    

Level 3

Liabilities:

Warrant liabilities

$

861

$

$

861

$

$

658

$

$

658

$

Total

$

861

$

$

861

$

$

658

$

$

658

$

13.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. Except for the following events, there were no other events that require adjustment to or disclosure in the condensed consolidated financial statements.

In August 2024, we issued 229,171 shares of common stock in connection with an exercise of Pre-Funded Warrants.

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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. We have two programs currently focused on treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity. MASH was formerly known as non-alcoholic steatohepatitis. 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, glucagon-like peptide 1 (“GLP-1”), glucagon-dependent insulinotropic polypeptide receptor, and peptide YY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. DA-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. In July 2024, we entered into an exclusive out-license agreement with MThera Pharma Co., LTD. (“MThera”) to provide MThera with the rights to NB-01 for the treatment of painful diabetic neuropathy.

Our operations have consisted principally of performing research and development (“R&D”) activities, which includes preclinical developments and clinical trials, and raising capital. Our activities are subject to significant risks and uncertainties, 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 United States. 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. Phase 2a trial enrollment began in August 2023 and we have completed enrollment of Part 1 of the Phase 2a trial in which patients with presumed MASH were randomized with a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo. Additionally, we also completed enrollment of Part 2

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of the Phase 2a trial in which patients with presumed MASH were randomized with a 2:1 ratio into 2 treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo. Currently, we are expecting to have top line result in the fourth quarter of 2024.

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 United States. The Phase 1 trial is 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 is a single ascending dose (“SAD”) study and enrollment began in March 2024. In August 2024, we completed enrollment with a total of 45 participants, randomized into one of five cohorts, with each cohort having been randomized in a 6:3 ratio of DA-1726 to placebo. Part 2 of Phase 1 is a multiple ascending dose (“MAD”) study, enrollment began in June 2024, and is expected to enroll approximately 36 participants, who will be randomized at the same 6:3 ratio into four planned cohorts, each to receive four weekly administrations of DA-1726 or placebo. 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

August 2024: Completed enrollment in the SAD Part 1 of our Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity.
August 2024: Signed a joint research agreement, along with Dong-A, with ImmunoForge to develop a long-acting, once-monthly, formulation of DA-1726 utilizing ImmunoForge’s long-lasting half-life extension Elastin-Like Polypeptide (“ELP”) platform technology.
July 2024: Signed an exclusive out-license agreement, providing MTHERA with the rights to develop and commercialize NB-01, one of four legacy assets, for the treatment of painful diabetic neuropathy, allowing MTHERA to conduct research and clinical trials, including, but not limited to, a potential Phase 3 clinical trial in the United States and South Korea, for the future commercialization of NB-01.
July 2024: Engaged veteran biotech and pharmaceutical professional, Chris Fang, MD, as Advisor/Consulting Chief Medical Officer, effective July 2, 2024.
June 2024: Completed enrollment of Part 2 of our two-part Phase 2a trial evaluating the efficacy and safety of DA-1241 in MASH.
June 2024: Dosed the first patient in the MAD Part 2 of our two-part Phase 1 clinical trial of DA-1726 a novel, dual oxyntomodulin (“OXM”) analog agonist that functions as a GLP1R and GCGR, for the treatment of obesity.
June 2024: Closed a concurrent placement and registered direct offering priced at-the-market under the Nasdaq Capital Market’s rules, with aggregate gross proceeds of $20.0 million up front with up to an additional $50.0 million of aggregate gross proceeds upon the exercise in full of clinical milestone-linked Series A Warrants and Series B Warrants.
June 2024: Presented preclinical data at the American Diabetes Association 84th Scientific Sessions, showing that DA-1726 demonstrated superiority in weight loss, retention of lean body mass, and lipid-lowering effects compared to survodutide.

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June 2024: Presented preclinical data that suggests DA-1241, a novel GPR119 agonist, in combination with semaglutide (Wegovy®), a GLP1R agonist, improves liver fibrosis and demonstrates additive hepatoprotective effects in preclinical MASH models compared to either treatment alone. The new data, presented at the European Association for the Study of Liver Congress, suggests, for the first time, a beneficial combination effect of DA-1241 and semaglutide in the treatment of liver fibrosis, which may be attributed to augmented inhibition of fibrogenesis and inflammation in the liver. The data also demonstrated more than additive effects on metabolic, biochemical, and histological endpoints in GAN DIO-MASH mice, highlighting the therapeutic potential of dual targeting GPR119 and GLP1R function in MASH with liver fibrosis.
April 2024: Dosed the first patient in the SAD Part 1 of our 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.

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 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 June 30, 2024 compared to three months ended June 30, 2023

The following table summarizes our results of operations (in thousands, except share and per share amounts):

Three Months Ended June 30,

    

2024

2023

Operating expenses:

Research and development

$

8,074

$

2,364

General and administrative

2,010

1,442

Total operating expenses

 

10,084

 

3,806

Loss from operations

 

(10,084)

 

(3,806)

Other income (expense):

Change in fair value of warrant liabilities

(133)

3,072

Interest income

164

Total other income

31

3,072

Loss before income taxes

(10,053)

(734)

Provision for income taxes

Net loss

$

(10,053)

$

(734)

Loss per share of common stock, basic and diluted

$

(1.85)

$

(0.15)

Weighted average shares of common stock, basic and diluted

 

5,428,906

 

5,059,003

Operating expenses and loss from operations

Our total operating expenses and loss from operations for the three months ended June 30, 2024 were $10.0 million, an increase of $6.3 million, or 165.0%, compared to the three months ended June 30, 2023. This increase was attributable to $5.7 million in higher R&D expenses and $0.6 million in higher general and administrative expenses.

Our R&D expenses were $8.1 million for the three months ended June 30, 2024, an increase of $5.7 million, or 241.5%, compared to the three months ended June 30, 2023. This increase was primarily related to increased R&D activities for DA-1241 and DA-1726 for the three months ended June 30, 2024 following commencement of the Phase 2a clinical trial

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for DA-1241 and Phase 1 trial for DA-1726 compared to the three months ended June 30, 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 $5.7 million increase in R&D expenses was primarily attributable to (i) $5.4 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting and (ii) $0.3 million in higher employee compensation and benefits. Included in R&D expenses for the three months ended June 30, 2024 was $3.4 million of investigational drug manufacturing costs and non-clinical and preclinical expenses incurred under the Shared Services Agreement with Dong-A as compared to $1.5 million for the three months ended June 30, 2023.

Our general and administrative expenses for the three months ended June 30, 2024 were $2.0 million, an increase of $0.6 million, or 39.4%, compared to the three months ended June 30, 2023. This increase was primarily attributable to $0.4 million in higher employee compensation and benefits and $0.1 million in higher non-cash stock-based compensation.

Other income

Our other income for the three months ended June 30, 2024 was $31 thousand, a decrease of $3.0 million, or 99.0%, compared to the three months ended June 30, 2023. This decrease was attributable to the recording of a loss of $0.1 million related to the change in fair value of warrant liabilities for the three months ended June 30, 2024 compared to a gain of $3.1 million for three months ended June 30, 2023, partially offset by $0.2 million of interest income earned on our cash balance for the three months ended June 30, 2024, of which there was none for the three months ended June 30, 2023.

Provision for income taxes

Our effective tax rate for the three months ended June 30, 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 June 30, 2024, we had a net loss of $10.1 million, or $1.85 per share of basic and diluted common stock, compared to a net loss of $0.7 million, or $0.15 per share of basic and diluted common stock for the three months ended June 30, 2023.

Six months ended June 30, 2024 compared to six months ended June 30, 2023

The following table summarizes our results of operations (in thousands, except share and per share amounts):

Six Months Ended June 30,

    

2024

2023

Operating expenses:

Research and development

$

12,978

$

3,001

General and administrative

3,987

3,325

Total operating expenses

 

16,965

 

6,326

Loss from operations

 

(16,965)

 

(6,326)

Other income (expense):

Change in fair value of warrant liabilities

(203)

2,988

Interest income

401

Total other income

198

2,988

Loss before income taxes

(16,767)

(3,338)

Provision for income taxes

Net loss

$

(16,767)

$

(3,338)

Loss per share of common stock, basic and diluted

$

(3.19)

$

(0.66)

Weighted average shares of common stock, basic and diluted

 

5,259,939

 

5,059,003

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Operating expenses and loss from operations

Our total operating expenses and loss from operations for the six months ended June 30, 2024 were $17.0 million, an increase of $10.6 million, or 168.2%, compared to the six months ended June 30, 2023. This increase was attributable to (i) $10.0 million in higher R&D expenses and (ii) $0.7 million in higher general and administrative expenses.

Our R&D expenses were $13.0 million for the six months ended June 30, 2024, an increase of $10.0 million, or 332.5%, compared to the six months ended June 30, 2023. This increase was primarily related to increased R&D activities for DA-1241 and DA-1726 for the six months ended June 30, 2024 following commencement of the Phase 2a clinical trial for DA-1241 and Phase 1 trial for DA-1726 compared to the six months ended June 30, 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 $10.0 million increase in R&D expenses was primarily attributable to (i) $9.3 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting and (ii) $0.7 million in higher employee compensation and benefits. Included in R&D expenses for the six months ended June 30, 2024 was $3.6 million of investigational drug manufacturing costs and non-clinical and preclinical expenses incurred under the Shared Services Agreement with Dong-A as compared to $1.8 million for the six months ended June 30, 2023.

Our general and administrative expenses for the six months ended June 30, 2024 were $4.0 million, an increase of $0.7 million, or 19.9%, compared to the six months ended June 30, 2023. This increase was primarily attributable to $0.4 million in higher employee compensation and benefits and $0.2 million in higher non-cash stock-based compensation.

Other income

Our other income for the six months ended June 30, 2024 was $0.2 million, a decrease of $2.8 million, or 93.4%, compared to the six months ended June 30, 2023. This decrease was attributable to the recording of a loss of $0.2 million related to the change in fair value of warrant liabilities for the six months ended June 30, 2024 compared to a gain of $3.0 million for six months ended June 30, 2023, partially offset by $0.4 million of interest income earned on our cash balance for the six months ended June 30, 2024, of which there was none for the six months ended June 30, 2023.

Provision for income taxes

Our effective tax rate for the six months ended June 30, 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 six months ended June 30, 2024, we had a net loss of $16.8 million, or $3.19 per share of basic and diluted common stock, compared to a net loss of $3.3 million, or $0.66 per share of basic and diluted common stock for the six months ended June 30, 2023.

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 $27.9 million in cash as of June 30, 2024. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $125.0 million as of June 30, 2024. We have incurred a net loss of $16.8 million and net cash used of $13.7 million for operating activities for the six months ended June 30, 2024. Due in large part to the ongoing Phase 2a clinical trial for DA-1241 and Phase 1 clinical trial for DA-1726, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern.

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We believe that our existing cash will be sufficient to fund our operations into the second quarter of 2025. Our existing cash includes gross proceeds of $20.0 million, of which $10.0 million was received from Dong-A, in connection with the closing of the Offering (as defined below) in June 2024. We plan to continue to fund our operations through a combination of proceeds of (i) up to $20.0 million from the potential future exercise of Series A Warrants issued in the Offering (as defined below) before deducting for certain issuance costs, such as placement agent fees and expenses and (ii) from equity offerings, debt financings, or other sources, potentially including collaborations, out-licensing and other similar arrangements. If the Series A Warrants issued in the June 2024 Offering are exercised, we believe that the additional gross proceeds to us from such exercises would be sufficient to fund our operations into 2026. There can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all, or that the Series A Warrants will be exercised. To the extent that we can raise additional funds by issuing equity securities or in the event our existing warrants are exercised, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business. If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on us.

Liquidity and capital resources

Our primary use of cash is to fund our R&D activities. We have funded our operations primarily through public offerings of our common stock and private placements of equity. As of June 30, 2024, we had cash totaling $27.9 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.

Registered direct offering and private placement

In June 2024, we closed on a registered direct offering of 763,359 shares of common stock at a purchase price of $3.93 per share for gross proceeds of $3.0 million (the “Registered Direct Offering”) with an institutional investor. The offering of the shares was made pursuant to our effective shelf registration statement on Form S-3 (Registration No. 333-278646), initially filed with and declared effective by the SEC in April 2024, and a prospectus supplement filed with the SEC in June 2024.

In June 2024, we closed on a private placement offering (the “Private Placement,” and together with the Registered Direct Offering, the “Offering”) with an institutional accredited investor and Dong-A, and received aggregate gross proceeds of $17.0 million, of which $10.0 million was received from Dong-A. The Private Placement was comprised of (i) 2,544,530 shares of common stock, (ii) pre-funded warrants to purchase up to 1,781,171 shares of common (the “Pre-Funded Warrants”), (iii) Series A warrants to purchase 5,089,060 shares of common stock (the “Series A Warrants”), and (iv) Series B warrants to purchase up to 7,633,591 shares of common stock (the “Series B Warrants”). For additional information, see “Note 8. Stockholders’ equity” to the condensed consolidated financial statements included elsewhere in this Report.

Cash flows

The principal use of cash in operating activities is to fund our current expenditures in support of our R&D activities. Financing activities currently represent the principal source of our cash flow.

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The following table reflects the major categories of cash flows (in thousands).

Six Months Ended June 30,

    

2024

2023

Net cash used in operating activities

$

(13,693)

$

(4,592)

Net cash used in investing activities

 

(8)

(4)

Net cash provided by (used in) financing activities

 

19,200

(80)

Net increase (decrease) in cash

$

5,499

$

(4,676)

Net cash used in operating activities was $13.7 million for the six months ended June 30, 2024 and consisted of net loss of $16.8 million, partially offset by net cash provided by change in operating assets and liabilities of $2.6 million and non-cash charges totaling $0.5 million, which was primarily related to stock-based compensation and change in fair value of warrant liabilities. Net cash used in operating activities was $4.6 million for the six months ended June 30, 2023 and consisted of net loss of $3.3 million and non-cash credits totaling $3.0 million, which was primarily related to change in fair value of warrant liabilities, partially offset by net cash provided by changes in operating assets and liabilities of $1.8 million.

Net cash used in investing activities, related to the purchases of property equipment, was less than $0.1 million for the six months ended June 30, 2024 and 2023.

Net cash provided by financing activities was $19.2 million for the six months ended June 30, 2024 compared to net cash used in financing activities of $0.1 million for the six months ended June 30, 2023. Net cash provided by financing activities for the six months ended June 30, 2024 consisted of gross proceeds from the Offering of $20.0 million, net of payment of issuance cost of $0.8 million. Net cash used in financing activities of $0.1 million for the six months ended June 30, 2023 was attributable to payment of financing costs related to a prior financing transaction.

For additional details, see the condensed consolidated statements of cash flows in the condensed consolidated financial statements included elsewhere in this Report.

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.

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Item 3.Quantitative and Qualitative Disclosures about Market Risk

Not applicable.

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

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 described above. We have taken the following actions to address the material weaknesses:

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.

As of the date of this Report, we have remediated the material weaknesses related to logical access over certain computer applications. We are in the process of remediating, but have not yet remediated, the material weaknesses related to (i) lack of segregation of duties over cash disbursements and financial reporting, (ii) logical access over one computer application, and (iii) lack of supervision and review over financial reporting.

Management believes that we have made considerable progress toward remediation of the remaining material weaknesses and anticipates a full remediation during 2024.

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Form 10-Q

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 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 June 30, 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

Our 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

During the three months ended June 30, 2024, we did not issue or sell any unregistered securities that were not otherwise previously disclosed in a Current Report on Form 8-K.

Item 3.Defaults upon Senior Securities

None.

27

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NeuroBo Pharmaceuticals, Inc.

Form 10-Q

Item 4.Mine Safety Disclosures

None.

Item 5.Other Information

None.

Item 6.Exhibits

Exhibit Number

    

Description of Document

3.1

Third Amended and Restated Certificate of Incorporation of Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed on August 10, 2016).

3.2

Third Amended and Restated Bylaws of Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on May 9, 2024).

4.1

Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K on June 25, 2024).

4.2

Form of Series A Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K on June 25, 2024).

4.3

Form of Series B Warrant (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K on June 25, 2024).

4.4

Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.4 to the Registrant’s Current Report on Form 8-K on June 25, 2024).

10.1˄

First Amendment to the Registrant’s 2022 Equity Incentive Plan, effective as of June 7, 2024 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on June 7, 2024).

10.2

Amended and Restated Non-Employee Director Compensation Policy, dated May 7, 2024 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on May 5, 2024).

10.3

Form of Securities Purchase Agreement, dated as of June 23, 2024, by and among the Registrant and the Purchaser identified on the signature page thereto (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K on June 25, 2024).

10.4

Form of Securities Purchase Agreement, dated as of June 23, 2024, by and among the Registrant and the Purchasers identified on the signature pages thereto (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K on June 25, 2024).

10.5

Form of Registration Rights Agreement, dated as of June 23, 2024, by and among the Registrant and the Purchasers identified on the signature pages thereto (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K on June 25, 2024).

31.1*

Certification of Principal Executive Officer Pursuant to Exchange Act Rule 13a-14(a) or 15d-14(a), as Adopted Pursuant to Section 302 of The Sarbanes Oxley Act of 2002.

31.2*

Certification of Principal Financial Officer Pursuant to Exchange Act Rule 13a-14(a) or 15d-14(a), as Adopted Pursuant to Section 302 of The Sarbanes Oxley Act of 2002.

32.1**

Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2**

Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS*

Inline XBRL Instance Document

101.SCH*

Inline XBRL Taxonomy Extension Schema Document

28

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NeuroBo Pharmaceuticals, Inc.

Form 10-Q

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 Report are deemed furnished and not filed with the SEC and are not to be incorporated by reference into any filing of NeuroBo Pharmaceuticals, Inc. under the Securities Act or the Exchange Act, whether made before or after the date of this Report, irrespective of any general incorporation language contained in such filing.

˄

Indicates management contract or compensatory plan.

29

Table of Contents

NeuroBo Pharmaceuticals, Inc.

Form 10-Q

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 August 14, 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

30

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 June 30, 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: August 14, 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 June 30, 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: August 14, 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 June 30, 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: August 14, 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 June 30, 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: August 14, 2024

/s/ Marshall H. Woodworth

Chief Financial Officer

(Principal Financial Officer)


v3.24.2.u1
Document and Entity Information - shares
6 Months Ended
Jun. 30, 2024
Aug. 09, 2024
Cover [Abstract]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Jun. 30, 2024  
Document Transition Report false  
Entity File Number 001-37809  
Entity Registrant Name NeuroBo Pharmaceuticals, Inc.  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 47-2389984  
Entity Address, Address Line One 545 Concord Avenue, Suite 210  
Entity Address, City or Town Cambridge,  
Entity Address, State or Province MA  
Entity Address, Postal Zip Code 02138  
City Area Code 857  
Local Phone Number 702-9600  
Title of 12(b) Security Common stock, $0.001 par value  
Trading Symbol NRBO  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   8,459,196
Entity Central Index Key 0001638287  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2024  
Document Fiscal Period Focus Q2  
Amendment Flag false  
v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Current assets:    
Cash $ 27,934 $ 22,435
Prepaid expenses and other current assets 583 77
Total current assets 28,517 22,512
Property and equipment, net 44 46
Right-of-use asset 169 202
Other assets 21 21
Total assets 28,751 22,781
Current liabilities:    
Accounts payable 2,632 821
Clinical trial accrued liabilities 2,066 3,033
Accrued expenses and other current liabilities 463 592
Warrant liabilities 861 658
Related party payable $ 3,617 $ 789
Other Liability, Current, Related Party [Extensible Enumeration] us-gaap:RelatedPartyMember us-gaap:RelatedPartyMember
Lease liability, short-term $ 72 $ 67
Total current liabilities 9,711 5,960
Lease liability, long-term 98 136
Total liabilities 9,809 6,096
Commitments and contingencies (Note 7)
Stockholders' equity    
Preferred stock, $0.001 par value per share; 10,000 shares authorized as of June 30, 2024 and December 31, 2023; no shares issued or outstanding as of June 30, 2024 and December 31, 2023
Common stock, $0.001 par value per share, 100,000 shares authorized as of June 30, 2024 and December 31, 2023; 8,221 and 4,906 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 8 5
Additional paid-in capital 143,966 124,945
Accumulated deficit (125,032) (108,265)
Total stockholders' equity 18,942 16,685
Total liabilities and stockholders' equity $ 28,751 $ 22,781
v3.24.2.u1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
shares in Thousands
Jun. 30, 2024
Dec. 31, 2023
Condensed Consolidated Balance Sheets    
Preferred stock, par value (in dollar per share) $ 0.001 $ 0.001
Preferred stock, shares authorized 10,000 10,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Common stock, par value (in dollar per share) $ 0.001 $ 0.001
Common stock, shares authorized 100,000 100,000
Common stock, shares issued 8,221 4,906
Common stock, shares outstanding 8,221 4,906
v3.24.2.u1
Condensed Consolidated Statements of Operations - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Operating expenses:        
Research and development $ 8,074 $ 2,364 $ 12,978 $ 3,001
General and administrative 2,010 1,442 3,987 3,325
Total operating expenses 10,084 3,806 16,965 6,326
Loss from operations (10,084) (3,806) (16,965) (6,326)
Other income (expense):        
Change in fair value of warrant liabilities (133) 3,072 (203) 2,988
Interest income 164   401  
Total other income 31 3,072 198 2,988
Loss before income taxes (10,053) (734) (16,767) (3,338)
Provision for income taxes 0 0 0 0
Net loss (10,053) (734) (16,767) (3,338)
Comprehensive net loss $ (10,053) $ (734) $ (16,767) $ (3,338)
Loss per share:        
Loss per share of common stock, basic (in dollars per share) $ (1.85) $ (0.15) $ (3.19) $ (0.66)
Loss per share of common stock, diluted (in dollars per share) $ (1.85) $ (0.15) $ (3.19) $ (0.66)
Weighted average shares of common stock outstanding:        
Basic (in shares) 5,428,906 5,059,003 5,259,939 5,059,003
Diluted (in shares) 5,428,906 5,059,003 5,259,939 5,059,003
v3.24.2.u1
Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($)
shares in Thousands, $ in Thousands
Series A and Series B Pre-funded Warrant
Common Stock
Series A and Series B Pre-funded Warrant
Additional Paid-in Capital
Series A and Series B Pre-funded Warrant
Common Stock
Additional Paid-in Capital
Private Placement
Additional Paid-in Capital
Accumulated Deficit
Private Placement
Total
Balance at beginning of period at Dec. 31, 2022       $ 3   $ 117,542 $ (95,795)   $ 21,750
Balance at beginning of period (shares) at Dec. 31, 2022       3,179          
Increase (Decrease) in Stockholders' Equity                  
Issuance of stock from exercise of warrants           1,436     1,436
Issuance of stock from exercise of warrants (in shares)       218          
Stock-based compensation           (74)     (74)
Net loss             (2,604)   (2,604)
Balance at end of period at Mar. 31, 2023       $ 3   118,904 (98,399)   20,508
Balance at end of period (shares) at Mar. 31, 2023       3,397          
Balance at beginning of period at Dec. 31, 2022       $ 3   117,542 (95,795)   21,750
Balance at beginning of period (shares) at Dec. 31, 2022       3,179          
Increase (Decrease) in Stockholders' Equity                  
Issuance of stock from exercise of warrants                 6,833
Net loss                 (3,338)
Balance at end of period at Jun. 30, 2023       $ 5   124,324 (99,133)   25,196
Balance at end of period (shares) at Jun. 30, 2023       4,780          
Balance at beginning of period at Mar. 31, 2023       $ 3   118,904 (98,399)   20,508
Balance at beginning of period (shares) at Mar. 31, 2023       3,397          
Increase (Decrease) in Stockholders' Equity                  
Issuance of stock from exercise of warrants       $ 2   5,396     5,398
Issuance of stock from exercise of warrants (in shares)       1,383          
Stock-based compensation           24     24
Net loss             (734)   (734)
Balance at end of period at Jun. 30, 2023       $ 5   124,324 (99,133)   25,196
Balance at end of period (shares) at Jun. 30, 2023       4,780          
Balance at beginning of period at Dec. 31, 2023       $ 5   124,945 (108,265)   16,685
Balance at beginning of period (shares) at Dec. 31, 2023       4,906          
Increase (Decrease) in Stockholders' Equity                  
Stock-based compensation           105     105
Net loss             (6,714)   (6,714)
Balance at end of period at Mar. 31, 2024       $ 5   125,050 (114,979)   10,076
Balance at end of period (shares) at Mar. 31, 2024       4,906          
Balance at beginning of period at Dec. 31, 2023       $ 5   124,945 (108,265)   16,685
Balance at beginning of period (shares) at Dec. 31, 2023       4,906          
Increase (Decrease) in Stockholders' Equity                  
Net loss                 (16,767)
Balance at end of period at Jun. 30, 2024       $ 8   143,966 (125,032)   18,942
Balance at end of period (shares) at Jun. 30, 2024       8,221          
Balance at beginning of period at Mar. 31, 2024       $ 5   125,050 (114,979)   10,076
Balance at beginning of period (shares) at Mar. 31, 2024       4,906          
Increase (Decrease) in Stockholders' Equity                  
Issuance of common stock and warrants (Pre-funded, Series A and Series B), net of issuance costs $ 3 $ 18,473 $ 18,476            
Issuance of common stock and warrants (Pre-funded, Series A and Series B), net of issuance costs (in shares) 3,308                
Issuance of Placement Agent warrants         $ 309     $ 309  
Issuance of stock for vested restricted stock units (in shares)       7          
Stock-based compensation           134     134
Net loss             (10,053)   (10,053)
Balance at end of period at Jun. 30, 2024       $ 8   $ 143,966 $ (125,032)   $ 18,942
Balance at end of period (shares) at Jun. 30, 2024       8,221          
v3.24.2.u1
Condensed Consolidated Statements of Changes in Stockholders' Equity (Parenthetical)
$ in Thousands
3 Months Ended
Jun. 30, 2024
USD ($)
Series A and Series B Pre-funded Warrant  
Stock and warrants issuance costs $ 1,522
v3.24.2.u1
Condensed Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Operating activities      
Net loss $ (734) $ (16,767) $ (3,338)
Adjustments to reconcile net loss to net cash used in operating activities:      
Stock-based compensation   239 (50)
Non-cash lease expense   1  
Depreciation   10 1
Change in fair value of warrant liabilities (3,072) 203 (2,988)
Change in operating assets and liabilities:      
Prepaid expenses and other assets   (507) (318)
Accounts payable   1,396 260
Accrued and other liabilities   1,732 1,841
Net cash used in operating activities   (13,693) (4,592)
Investing activities      
Purchases of property and equipment   (8) (4)
Net cash used in investing activities   (8) (4)
Financing activities      
Proceeds from issuance of common stock and pre-funded warrants   19,998  
Payments of issuance costs   (798) (80)
Net cash provided by (used in) financing activities   19,200 (80)
Net increase (decrease) in cash   5,499 (4,676)
Cash at beginning of period   22,435 33,364
Cash at end of period 28,688 27,934 28,688
Supplemental non-cash investing and financing transactions:      
Unpaid issuance costs   $ 415  
Reclassification of warrant liabilities upon exercise of warrants $ 5,398   $ 6,833
v3.24.2.u1
Business, basis of presentation, new accounting standards and summary of significant accounting policies
6 Months Ended
Jun. 30, 2024
Business, basis of presentation, new accounting standards and summary of significant accounting policies  
Business, basis of presentation, new accounting standards and summary of significant accounting policies

1.Business, basis of presentation, new accounting standards and summary of significant accounting policies

General

NeuroBo Pharmaceuticals, Inc. (the “Company”), a Delaware corporation, and its subsidiaries are referred to collectively in these notes to the condensed consolidated financial statements of the Company as “NeuroBo,” “we,” “our” and “us.” We are a clinical-stage biotechnology company focused primarily 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. 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, glucagon-like peptide 1 (“GLP-1”), glucagon-dependent insulinotropic polypeptide receptor, and peptide YY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. DA-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, which includes preclinical developments and clinical trials, and raising capital. Our activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved.

Common stock reverse stock splits

In December 2023, we completed a one-for-eight reverse stock split of our common stock (the “2023 Reverse Stock Split”). As a result, every eight shares of our issued and outstanding common stock were combined, converted and changed into one share of our common stock. Any fraction of a share of our common stock that was created as a result of the 2023 Reverse Stock Split was rounded down to the next whole share and our stockholders received cash equal to the market value of the fractional share, determined by multiplying such fraction by the closing sales price of our common stock as reported on the Nasdaq Capital Market LLC (“Nasdaq”) on the last trading day before the 2023 Reverse Stock Split. The 2023 Reverse Stock Split was initially approved by our stockholders at the annual meeting of stockholders in June 2023. At the annual meeting, the stockholders approved a proposal to amend our certificate of incorporation to affect a reverse split of our outstanding common stock at a ratio in the range of one-for-five to one-for-eight to be determined at the discretion of our Board of Directors (“Board”). Following the annual meeting, our Board approved a one-for-eight reverse stock split of our issued and outstanding shares of common stock.

The 2023 Reverse Stock Split did not impact the number of authorized shares of common stock of 100,000,000 shares. For the 2023 Reverse Stock Split, a proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options, and warrants to purchase shares of our common stock, the number of shares issuable upon vesting of restricted stock units (“RSUs”) and the number of shares reserved for issuance pursuant to our equity incentive compensation plans. Specifically, for the Series A Warrants and Series B

Warrants issued in November 2022 that were outstanding on the effective date of the 2023 Reverse Stock Split, the number of outstanding warrants did not change; instead, the warrants have an exchange ratio of eight 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 $27.9 million in cash as of June 30, 2024. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $125.0 million as of June 30, 2024. We have incurred a net loss of $16.8 million and net cash used of $13.7 million for operating activities for the six months ended June 30, 2024. Due in large part to the ongoing Phase 2a clinical trial for DA-1241 and Phase 1 clinical trial for DA-1726, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern.

We believe that our existing cash will be sufficient to fund our operations into the second quarter of 2025. Our existing cash includes gross proceeds of $20.0 million, of which $10.0 million was received from Dong-A ST Co., Ltd., a related party (“Dong-A”), in connection with the closing of the Offering (as defined below) in June 2024. We plan to continue to fund our operations through a combination of proceeds of (i) up to $20.0 million from the potential future exercise of Series A Warrants issued in the Offering before deducting for certain issuance costs, such as placement agent fees and expenses and (ii) from equity offerings, debt financings, or other sources, potentially including collaborations, out-licensing and other similar arrangements. If the Series A Warrants issued in the June 2024 Offering are exercised, we believe that the additional gross proceeds to us from such exercises would be sufficient to fund our operations into 2026. There can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all, or that the Series A Warrants will be exercised. To the extent that we can raise additional funds by issuing equity securities or in the event our existing warrants are exercised, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business. If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on us.

A.Basis of presentation

We prepared the condensed consolidated financial statements following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“GAAP”) for complete financial statements can be condensed or omitted. However, except as disclosed herein, there has been no material change in the information disclosed in the notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (“2023 Form 10-K”).

Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these condensed consolidated financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the condensed consolidated financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in the condensed

consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in our 2023 Form 10-K. Certain amounts in the condensed consolidated financial statements and accompanying notes may not add due to rounding, and all percentages have been calculated using unrounded amounts.

B.New accounting standards

Adoption of new accounting standards

New accounting standards or accounting standards updates were assessed and determined to be either not applicable or did not have a material impact on our condensed consolidated financial statements or processes.

Accounting standards issued but not yet adopted

In December 2023, the Financial Accounting Standards Board issued Accounting Standard Update (“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.

E.Reclassification of prior year presentation

Certain prior year amounts have been reclassified for consistency with the current year presentation. Adjustments have been made to the condensed consolidated balance sheets to reclassify the presentation of certain current liabilities related to clinical trial accrued liabilities of $3.0 million and related party payable of $0.8 million from accrued expenses and other current liabilities. These reclassifications had no effect on the reported total current liabilities in the condensed consolidated balance sheets.

v3.24.2.u1
Prepaid expenses and other current assets
6 Months Ended
Jun. 30, 2024
Prepaid expenses and other current assets  
Prepaid expenses and other current assets

2. Prepaid expenses and other current assets 

Prepaid expenses and other current assets consist of the following (in thousands):

As of

June 30, 2024

December 31, 2023

Insurance

$

313

$

Deposits

111

39

Other prepaid expenses

 

159

 

38

Total

$

583

$

77

v3.24.2.u1
Property and equipment, net
6 Months Ended
Jun. 30, 2024
Property and equipment, net  
Property and equipment, net

3. Property and equipment, net

Property and equipment, net consist of the following (in thousands):

As of

June 30, 2024

December 31, 2023

Office equipment

$

88

$

80

Less accumulated depreciation

 

(44)

 

(34)

Property and equipment, net

$

44

$

46

v3.24.2.u1
Accrued expenses and other current liabilities
6 Months Ended
Jun. 30, 2024
Accrued expenses and other current liabilities  
Accrued expenses and other current liabilities

4. Accrued expenses and other current liabilities

Accrued expenses and other current liabilities consist of the following (in thousands):

As of

June 30, 2024

December 31, 2023

Employee related costs

$

403

$

118

Professional service fees

45

308

Other

 

15

 

166

Total

$

463

$

592

v3.24.2.u1
Warrant liabilities
6 Months Ended
Jun. 30, 2024
Warrant liabilities  
Warrant liabilities

5. Warrant liabilities

Changes to our warrant liabilities are summarized as follows (in thousands):

Total

As of January 1, 2024

$

658

Fair value changes

203

As of June 30, 2024

$

861

Our warrant liabilities relate to the 2022 Series A Warrants and 2022 Series B Warrants, which were issued in November 2022. These warrants are considered to be derivative instruments; accordingly, we recorded their estimated fair value as warrant liabilities. We estimated the fair value of these warrants using the trading market price of our common stock due to a cashless exercise provision of these warrants whereby eight warrants can be exchanged for one share of common stock for no additional consideration, which results in an effective per warrant exercise price of zero.

v3.24.2.u1
Related party
6 Months Ended
Jun. 30, 2024
Related party  
Related party

6.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) for two proprietary compounds for specified indications (the “2022 License

Agreement”) upon meeting certain financing milestones. The 2022 License Agreement covers the rights to DA-1241 for treatment of MASH and DA-1726 for treatment of obesity and MASH. The 2022 License Agreement also provides that we may develop DA-1241 for the treatment 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 $3.4 million and $3.6 million for the three and six months ended June 30, 2024, respectively, and $1.5 million and $1.8 million for the three and six months ended June 30, 2023, respectively, under the Shared Services Agreement, which are included in operating expenses: research and development in the accompanying condensed consolidated statements of operations. We have an aggregate payable to Dong-A of $3.6 million and $0.8 million as of June 30, 2024 and December 31, 2023, respectively, under the Shared Services Agreement, which are included in related party payable in the accompanying condensed consolidated balance sheets.

For additional information on the 2022 License Agreement, the Shared Service Agreement and other agreements with Dong-A, refer to “Note 5. Related party” in the audited consolidated financial statements and notes thereto for the year ended December 31, 2023, which is included in our 2023 Form 10-K.

v3.24.2.u1
Commitments and Contingencies
6 Months Ended
Jun. 30, 2024
Commitments and Contingencies  
Commitments and Contingencies

7. 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 three years with an option to renew for an additional two-year term. The lease commenced in September 2023 and expires in August 2026. We recorded lease rental expense of $22 thousand and $44 thousand for the three and six months ended June 30, 2024, respectively, and we made cash lease payments of $21 thousand and $43 thousand during the three and six months ended June 30, 2024.

Our lease liability, which represents the net present value of future lease payments, was calculated utilizing a discount rate of 11%, which corresponds to our estimated incremental borrowing rate.

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, no rental expenses were recorded for the three months and six months ended June 30, 2024, and we recorded rental expense of $6 thousand and $11 thousand for the three and six months ended June 30, 2023, respectively.

v3.24.2.u1
Stockholders' Equity
6 Months Ended
Jun. 30, 2024
Stockholders' Equity  
Stockholders' Equity

8.Stockholders’ equity

June 2024 offering

Securities purchase agreements

In June 2024, we entered into and closed on two securities purchase agreements (the “Offering”) with an institutional accredited investor and Dong-A, and received aggregate gross proceeds of $20.0 million, of which $10.0 million was received from Dong-A. The Offering was comprised of (i) 3,307,889 shares of common stock at a purchase price of $3.93 per share, (ii) pre-funded warrants to purchase up to 1,781,171 shares of common (the “Pre-Funded Warrants”) at a purchase price of $3.929 per warrant, (iii) Series A warrants to purchase 5,089,060 shares of common stock (the “Series A Warrants”), and (iv) Series B warrants to purchase up to 7,633,591 shares of common stock (the “Series B Warrants”). Collectively, the Series A Warrants and the Series B Warrants are referred to as “PIPE Common Warrants.” Of the total shares of common stock issued in the Offering, 763,359 shares were sold to an institutional investor pursuant to our

effective shelf registration statement on Form S-3 (Registration No. 333-278646), initially filed with and declared effective by the SEC in April 2024, and a prospectus supplement filed with the SEC in June 2024.

The Pre-Funded Warrant has an exercise price of $0.001 per share and is immediately exercisable and will expire when exercised in full and the PIPE Common Warrants have an exercise price of $3.93 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the warrants (the “Stockholder Approval”). We are currently planning to hold a Special Meeting of Stockholders in September 2024 to seek Stockholder Approval for certain warrants issued in connection with the Offering. Additionally, prior to the closing of the Offering in June 2024, we received a letter agreement from Dong-A whereby Dong-A irrevocably agreed to vote all of the shares of Company’s voting stock over which Dong-A have voting control in favor of any resolution presented to the stockholders of the Company related to the Stockholder Approval.

The Series A Warrants will expire on the earlier of the twelve month anniversary of the Stockholder Approval and within 60 days following the public announcement of the Company receiving positive Phase 1 multiple ascending dose (“MAD”) data readout for DA-1726, and the Series B Warrants will expire on the earlier of the five years anniversary of the Stockholder Approval and within six months following the public announcement of the Company receiving positive Phase 1 Part 3 data readout for DA-1726. Based on the terms of the PIPE Common Warrants, we have concluded that the accounting classification of the PIPE Common Warrants is to be stockholders’ equity

Under the terms of the Pre-Funded Warrants and the PIPE Common Warrants issued to the institutional accredited investor, we may not affect the exercise of any such Pre-Funded Warrant or PIPE Common Warrants, and the holder will not be entitled to exercise any portion of any Pre-Funded Warrant or PIPE Common Warrants, if, upon giving effect to such exercise, the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates, other persons acting or who could be deemed to be acting as a group together with the holder or any of the holder’s affiliates, and any other persons whose beneficial ownership of common stock would or could be aggregated with the holder’s or any of the holder’s affiliates) would exceed 9.99% (in the case of the Pre-Funded Warrants) or 4.99% (in the case of the PIPE Common Warrants) of the number of shares of the Company’s outstanding common stock immediately after giving effect to the exercise (the “Beneficial Ownership Limitation”), as such percentage ownership is calculated in accordance with Section 13(d) of the Exchange Act and the applicable regulations of the SEC. A holder of the Pre-Funded Warrant or PIPE Common Warrants that were issued to the institutional accredited investor may increase or decrease the Beneficial Ownership Limitation to a higher or lower percentage (not to exceed 9.99%), effective 61 days after written notice to us. Any such increase or decrease will apply only to that holder and not to any other holder of the Pre-Funded Warrants or PIPE Common Warrants.

Placement agent

We paid to the placement agent a cash fee equal to 7.0% of the gross proceeds of the Offering received from a certain institutional investor and $0.1 million for non-accountable expenses and clearing costs. In addition, we issued warrants to the placement agent’s designees (“Placement Agent Warrants”) to purchase up to 127,227 shares of common stock (which represents 5% of the sum of the shares of common stock and Pre-Funded Warrants sold to the institutional investor in the Offering) at an exercise price of $4.9125 per share (which represents a premium of 25% of the offering price per share of common stock in the Offering). The Placement Agent Warrants will be exercisable beginning on the effective date of the Stockholder Approval and will expire on the earlier of (i) two years after the date that the shares of common stock underlying the Placement Agent Warrants are registered pursuant to an effective registration statement filed pursuant to the Securities Act of 1933, as amended, which occurred on July 24, 2024, and (ii) June 23, 2029. The fair value of the Placement Agent Warrants was $0.3 million, which represents a non-cash issuance cost. The weighted average fair value per share of these Placement Agent Warrants was $2.73, and was determined using the Black-Scholes option pricing model with the following assumptions: expected stock price volatility of 140.0%, expected term of 2.1 years, expected dividend yield of 0%, and risk-free interest rate of 4.63%. Based on the terms of the Placement Agreement Warrants, we have concluded that the accounting classification of the Placement Agent Warrants is stockholders’ equity in the accompanying condensed consolidated balance sheets.

Upon the exercise for cash of any PIPE Common Warrants issued to a certain institutional investor, we shall pay the placement agent (i) a cash fee of 7.0% of the aggregate gross exercise price paid in cash with respect thereto and (ii) a non-cash fee in the form of additional warrants to purchase the number of shares of common stock equal to 5.0% of the aggregate number of such shares of common stock underlying such warrants. The cash fee payable to the placement agent for any PIPE Common Warrants exercised by the institutional investor is accounted for as a contingent commitment and will be recorded as an offset to any gross proceeds received from any future exercises of PIPE Common Warrants by the institutional investor. The non-cash fee payable to the placement agent for any PIPE Common Warrants exercised by the institutional investor is accounted for as contingent warrants (“Placement Agent Contingent Warrants”) to purchase up to 318,067 shares of common stock, which is subject to performance criteria of the institutional investor regarding any exercise for cash of any PIPE Common Warrants with an assumed grant date of the Offering closing date, and an exercise price of $4.9125 per share. The weighted average fair value per share of these Placement Agent Contingent Warrants was $3.43 and was determined using the Black-Scholes option pricing model with the following assumptions: expected stock price volatility of 127.0%, expected term of 5.7 years, expected dividend yield of 0%, and risk-free interest rate of 4.31%. Based on the terms of the placement agent engagement letter, we have concluded that the accounting classification of the Placement Agent Contingent Warrants is to be stockholders’ equity. On each balance sheet reporting date, we will need to assess whether it is probable for us to issue warrants to the placement agent based on whether it is probable for any PIPE Common Warrants to be exercised by the institutional investor. As of June 30, 2024, we determined that the issuance of additional warrants to the placement agent is not yet probable; accordingly, the Placement Agent Contingent Warrants had no impact on the condensed consolidated balance sheets.

Warrants

The following tables summarize our outstanding warrants:

Shares of Common Stock Issuable

for Outstanding Warrants

As of

Exercise

Expiration

Warrant Issuance

June 30, 2024

December 31, 2023

Price

Date

July 2018 (1)

6

6

$

44,820.0000

July 2028

April 2020 (1)

159

159

$

3,000.0000

April 2025

January 2021 (1)

10,421

10,421

$

1,447.2000

July 2026

October 2021 (1)

15,390

15,390

$

900.0000

April 2025

November 2022 Series B (2)

177,938

177,938

$

0.0000

December 2027

June 2024 Placement Agent (3)

127,227

$

4.9125

July 2026

June 2024 Pre-Funded (4)

1,781,171

$

0.0010

no expiration date

June 2024 Series A (5)

5,089,060

$

3.9300

September 2025 (latest date)

June 2024 Series B (6)

7,633,591

$

3.9300

September 2029 (latest date)

Total

14,834,963

203,914

(1)The number of outstanding and exercisable warrants was adjusted for the impact of each of the common stock reverse stock splits completed in 2023 and 2022. Accordingly, the number of outstanding warrants is equal to the number of shares of common stock issuable for outstanding warrants.
(2)The number of outstanding and exercisable warrants was not impacted by the 2023 Reverse Stock Split. Accordingly, the number of outstanding warrants is equal to eight times the number of shares of common stock issuable for outstanding warrants. Additionally, during the six months ended June 30, 2023, 6,460,333 Series B warrants were exchanged for 807,541 shares of our common stock.
(3)These warrants are exercisable at any time on or after the Stockholder Approval, which is currently planned to be in September 2024, and expire two years after a resale registration statement covering the shares of common stock issuable upon the exercise of the warrants hereunder becomes effective
with the SEC. In July 2024, a resale registration statement was filed with the SEC and became effective.
(4)These warrants are exercisable immediately upon their issuance in June 2024 and are considered to be perpetual warrants without any expiration date.
(5)These warrants are exercisable at any time on or after the Stockholder Approval, which is currently planned to be in September 2024, and expire on the earlier of (i) the twelve months anniversary of the stockholder approval date, and (ii) the 60th day following the date on which the Company publicly announce the receiving of positive Phase 1 MAD data readout for DA-1726.
(6)These warrants are exercisable at any time on or after the Stockholder Approval, which is currently planned to be in September 2024, and expire on the earlier of (i) the five years anniversary of the stockholder approval date and (ii) the six months anniversary following the date on which the Company publicly announce the receiving of positive Phase 1, Part 3 data readout for DA-1726.

Additionally, during the six months ended June 30, 2023, 6,345,333 Series A warrants issued in November 2022 were exchanged for 793,167 shares of our common stock. Furthermore, as of December 31, 2023, the Series A warrants issued in November 2022 were fully exchanged for shares of our common stock.

v3.24.2.u1
Stock-based Compensation
6 Months Ended
Jun. 30, 2024
Stock-based compensation  
Stock-based compensation

9. Stock-based compensation

Stock-based compensation expense was included in general and administrative and research and development as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

2024

2023

2024

2023

General and administrative

$

99

$

24

$

170

$

(61)

Research and development

36

69

11

Total stock-based compensation

$

135

$

24

$

239

$

(50)

For stock options and RSUs granted under the 2019 Equity Incentive Plan (the “2019 Plan”), the 2021 Inducement Plan and (the “Inducement Plan”) the 2022 Equity Incentive Plan, as amended (the “2022 Plan”), as of June 30, 2024, unrecognized stock-based compensation cost totaled $0.8 million. The unrecognized stock-based expense is expected to be recognized over a weighted average period of 1.8 years.

Stock-based award plans

In June 2024, in connection with the 2024 Annual Meeting of Stockholders, our stockholders approved an amendment to our 2022 Plan (the “Amendment”). Pursuant to the terms and conditions of the Amendment, the 2022 Plan was amended to:

automatically increase on January 1st of each year for a period of eight years commencing on January 1, 2025 and ending on (and including) January 1, 2032, the aggregate number of shares of common stock that may be issued pursuant to Awards (as defined in the 2022 Plan) to an amount equal to 10% of the Fully Diluted Shares (as defined in the 2022 Plan) as of the last day of the preceding calendar year, provided, however that the Board may act prior to the effective date of any such annual increase to provide that the increase for such year will be a lesser number of shares of common stock; and
increase the aggregate maximum number of shares of common stock that may be issued pursuant to the exercise of Incentive Stock Options (as defined in the 2022 Plan) to 1 million shares of the common stock plus the amount of any increase in the number of shares that may be available for issuance pursuant to the annual increase
described above, but in no event more than 15 million shares of the common stock issued as incentive stock options.

As of June 30, 2024, there were (i) 1,575 outstanding stock options under the 2019 Plan, and (ii) 3,125 outstanding stock options and 218,113 outstanding RSUs under the 2022 Plan. As of June 30, 2024, we had an aggregate of 385,921 shares available for future issuance, of which 4,166 shares were available under the Inducement Plan and 381,755 shares were available under the 2022 Plan.

Stock options

The following table summarizes the status of our outstanding and exercisable options and related transactions for the period presented (in thousands, except share and per share amounts):

Outstanding

Exercisable

Shares of

Weighted

Shares of

Weighted

Common

Weighted

Average

Common

Weighted

Average

Stock

Average

Aggregate

Remaining

Stock

Average

Aggregate

Remaining

Issuable

Exercise

Intrinsic

Contractual

Issuable

Exercise

Intrinsic

Contractual

for Options

Price

Value

Term (years)

for Options

Price

Value

Term (years)

As of January 1, 2024

4,700

$

398.30

$

8.6

4,577

$

391.04

$

8.6

Vested

59

689.72

As of June 30, 2024

4,700

$

398.30

$

8.0

4,636

$

394.84

$

8.0

During the six months ended June 30 2023, we granted 3,125 stock options and the weighted average fair value per share of these stock options was $3.63. We estimated the grant date fair value of stock options granted to employees, consultants, and directors using the Black-Scholes option pricing model. The assumptions used in the Black-Scholes option-pricing model were as follows: expected stock price volatility of 82.9%, expected term of 5.0 year, expected dividend yield of 0%, and risk-free interest rate of 3.54%.

Restricted Stock Units

The following table summarizes the status of our RSUs and related transactions for the period presented (in thousands, except share and per share amounts):

Outstanding

Vested and Deferred Release

Shares of

Average

Shares of

Average

Common Stock

Grant Date

Aggregate

Common Stock

Grant Date

Aggregate

Issuable

Fair Value

Intrinsic

Issuable

Fair Value

Intrinsic

for RSUs

Price

Value

for RSUs

Price

Value

As of January 1, 2024

141,361

$

4.55

$

523

5,469

$

4.02

$

20

Granted

83,899

5.41

Vested and Deferred Release

1,563

4.12

Vested and Released

(7,147)

4.05

29

As of June 30, 2024

218,113

$

4.90

$

1,056

7,032

$

4.04

$

34

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.

v3.24.2.u1
Income taxes
6 Months Ended
Jun. 30, 2024
Income taxes  
Income taxes

10.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 and six months ended June 30, 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 and six months ended June 30, 2024 and 2023. Accordingly, there were no benefits for income taxes recorded for the three and six months ended June 30, 2024 and 2023. Additionally, as of June 30, 2024 and December 31, 2023, we maintain a full valuation allowance for all deferred tax assets.

v3.24.2.u1
Loss per share of common stock
6 Months Ended
Jun. 30, 2024
Loss per share of common stock  
Loss per share of common stock

11.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 June 30,

Six Months Ended June 30,

2024

2023

2024

2023

Numerator:

Net loss

$

(10,053)

$

(734)

$

(16,767)

$

(3,338)

Denominator:

Weighted average shares of common stock, basic

5,428,906

5,059,003

5,259,939

5,059,003

Effect of dilutive securities

Weighted average shares of common stock, diluted

5,428,906

5,059,003

5,259,939

5,059,003

Loss per share of common stock, basic and diluted

$

(1.85)

$

(0.15)

$

(3.19)

$

(0.66)

For each of the periods presented in the above table, our basic weighted average shares of common stock include any outstanding (i) November 2022 Series A warrants and Series B warrants, (ii) June 2024 Pre-Funded Warrants and (iii) vested RSUs in which their release was deferred in accordance with the respective award agreement during the respective period.

Since we reported a net loss for the three and six months ended June 30, 2024 and 2023, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and diluted loss per share of common stock and our basic and diluted weighted average shares of common stock are the same for three and six months ended June 30, 2024 and 2023. The following table sets forth the potentially dilutive securities which were not included in the calculation of diluted earnings per share of common stock for three and six months ended June 30, 2024 and 2023:

As of June 30,

    

2024

2023

Stock options

4,700

5,034

RSUs

211,081

Warrants

12,875,854

28,529

v3.24.2.u1
Fair value of financial instruments
6 Months Ended
Jun. 30, 2024
Fair value of financial instruments  
Fair value of financial instruments

12.Fair value of financial instruments

Fair value is a market-based measurement, not an entity specific measurement and is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy:

Level 1:

Unadjusted quoted prices for identical assets or liabilities in active markets;

Level 2:

Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the asset or liability; and

Level 3: Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.

The following table sets forth our financial assets and liabilities, subject to fair value measurements on a recurring basis, by level within the fair value hierarchy (in thousands):

As of June 30, 2024

As of December 31, 2023

Description

    

Total

    

Level 1

    

Level 2

    

Level 3

    

Total

    

Level 1

    

Level 2

    

Level 3

Liabilities:

Warrant liabilities

$

861

$

$

861

$

$

658

$

$

658

$

Total

$

861

$

$

861

$

$

658

$

$

658

$

v3.24.2.u1
Subsequent events
6 Months Ended
Jun. 30, 2024
Subsequent events  
Subsequent events

13.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. Except for the following events, there were no other events that require adjustment to or disclosure in the condensed consolidated financial statements.

In August 2024, we issued 229,171 shares of common stock in connection with an exercise of Pre-Funded Warrants.

v3.24.2.u1
Pay vs Performance Disclosure - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Jun. 30, 2023
Mar. 31, 2023
Jun. 30, 2024
Jun. 30, 2023
Pay vs Performance Disclosure            
Net Income (Loss) $ (10,053) $ (6,714) $ (734) $ (2,604) $ (16,767) $ (3,338)
v3.24.2.u1
Insider Trading Arrangements
3 Months Ended
Jun. 30, 2024
Trading Arrangements, by Individual  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.24.2.u1
Business, basis of presentation, new accounting standards and summary of significant accounting policies(Policies)
6 Months Ended
Jun. 30, 2024
Business, basis of presentation, new accounting standards and summary of significant accounting policies  
Basis of presentation

A.Basis of presentation

We prepared the condensed consolidated financial statements following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“GAAP”) for complete financial statements can be condensed or omitted. However, except as disclosed herein, there has been no material change in the information disclosed in the notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (“2023 Form 10-K”).

Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these condensed consolidated financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the condensed consolidated financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in the condensed

consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in our 2023 Form 10-K. Certain amounts in the condensed consolidated financial statements and accompanying notes may not add due to rounding, and all percentages have been calculated using unrounded amounts.

New accounting standards

B.New accounting standards

Adoption of new accounting standards

New accounting standards or accounting standards updates were assessed and determined to be either not applicable or did not have a material impact on our condensed consolidated financial statements or processes.

Accounting standards issued but not yet adopted

In December 2023, the Financial Accounting Standards Board issued Accounting Standard Update (“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.

Estimates and assumptions

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.

Reclassification of prior year presentation

E.Reclassification of prior year presentation

Certain prior year amounts have been reclassified for consistency with the current year presentation. Adjustments have been made to the condensed consolidated balance sheets to reclassify the presentation of certain current liabilities related to clinical trial accrued liabilities of $3.0 million and related party payable of $0.8 million from accrued expenses and other current liabilities. These reclassifications had no effect on the reported total current liabilities in the condensed consolidated balance sheets.

v3.24.2.u1
Prepaid expenses and other current assets (Tables)
6 Months Ended
Jun. 30, 2024
Prepaid expenses and other current assets  
Schedule of prepaid expenses and other current assets

Prepaid expenses and other current assets consist of the following (in thousands):

As of

June 30, 2024

December 31, 2023

Insurance

$

313

$

Deposits

111

39

Other prepaid expenses

 

159

 

38

Total

$

583

$

77

v3.24.2.u1
Property and equipment, net (Tables)
6 Months Ended
Jun. 30, 2024
Property and equipment, net  
Schedule of property and equipment, net

Property and equipment, net consist of the following (in thousands):

As of

June 30, 2024

December 31, 2023

Office equipment

$

88

$

80

Less accumulated depreciation

 

(44)

 

(34)

Property and equipment, net

$

44

$

46

v3.24.2.u1
Accrued expenses and other current liabilities (Tables)
6 Months Ended
Jun. 30, 2024
Accrued expenses and other current liabilities  
Schedule of Accrued expenses and other current liabilities

Accrued expenses and other current liabilities consist of the following (in thousands):

As of

June 30, 2024

December 31, 2023

Employee related costs

$

403

$

118

Professional service fees

45

308

Other

 

15

 

166

Total

$

463

$

592

v3.24.2.u1
Warrant liabilities (Tables)
6 Months Ended
Jun. 30, 2024
Warrant liabilities  
Schedule of warrant liabilities

Changes to our warrant liabilities are summarized as follows (in thousands):

Total

As of January 1, 2024

$

658

Fair value changes

203

As of June 30, 2024

$

861

v3.24.2.u1
Stockholders Equity (Tables)
6 Months Ended
Jun. 30, 2024
Stockholders' Equity  
Schedule of outstanding warrants

Shares of Common Stock Issuable

for Outstanding Warrants

As of

Exercise

Expiration

Warrant Issuance

June 30, 2024

December 31, 2023

Price

Date

July 2018 (1)

6

6

$

44,820.0000

July 2028

April 2020 (1)

159

159

$

3,000.0000

April 2025

January 2021 (1)

10,421

10,421

$

1,447.2000

July 2026

October 2021 (1)

15,390

15,390

$

900.0000

April 2025

November 2022 Series B (2)

177,938

177,938

$

0.0000

December 2027

June 2024 Placement Agent (3)

127,227

$

4.9125

July 2026

June 2024 Pre-Funded (4)

1,781,171

$

0.0010

no expiration date

June 2024 Series A (5)

5,089,060

$

3.9300

September 2025 (latest date)

June 2024 Series B (6)

7,633,591

$

3.9300

September 2029 (latest date)

Total

14,834,963

203,914

(1)The number of outstanding and exercisable warrants was adjusted for the impact of each of the common stock reverse stock splits completed in 2023 and 2022. Accordingly, the number of outstanding warrants is equal to the number of shares of common stock issuable for outstanding warrants.
(2)The number of outstanding and exercisable warrants was not impacted by the 2023 Reverse Stock Split. Accordingly, the number of outstanding warrants is equal to eight times the number of shares of common stock issuable for outstanding warrants. Additionally, during the six months ended June 30, 2023, 6,460,333 Series B warrants were exchanged for 807,541 shares of our common stock.
(3)These warrants are exercisable at any time on or after the Stockholder Approval, which is currently planned to be in September 2024, and expire two years after a resale registration statement covering the shares of common stock issuable upon the exercise of the warrants hereunder becomes effective
with the SEC. In July 2024, a resale registration statement was filed with the SEC and became effective.
(4)These warrants are exercisable immediately upon their issuance in June 2024 and are considered to be perpetual warrants without any expiration date.
(5)These warrants are exercisable at any time on or after the Stockholder Approval, which is currently planned to be in September 2024, and expire on the earlier of (i) the twelve months anniversary of the stockholder approval date, and (ii) the 60th day following the date on which the Company publicly announce the receiving of positive Phase 1 MAD data readout for DA-1726.
(6)These warrants are exercisable at any time on or after the Stockholder Approval, which is currently planned to be in September 2024, and expire on the earlier of (i) the five years anniversary of the stockholder approval date and (ii) the six months anniversary following the date on which the Company publicly announce the receiving of positive Phase 1, Part 3 data readout for DA-1726.
v3.24.2.u1
Stock-based Compensation (Tables)
6 Months Ended
Jun. 30, 2024
Stock-based compensation  
Schedule of stock-based compensation expense

Stock-based compensation expense was included in general and administrative and research and development as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

2024

2023

2024

2023

General and administrative

$

99

$

24

$

170

$

(61)

Research and development

36

69

11

Total stock-based compensation

$

135

$

24

$

239

$

(50)

Schedule of the status of outstanding and exercisable options and related transactions

The following table summarizes the status of our outstanding and exercisable options and related transactions for the period presented (in thousands, except share and per share amounts):

Outstanding

Exercisable

Shares of

Weighted

Shares of

Weighted

Common

Weighted

Average

Common

Weighted

Average

Stock

Average

Aggregate

Remaining

Stock

Average

Aggregate

Remaining

Issuable

Exercise

Intrinsic

Contractual

Issuable

Exercise

Intrinsic

Contractual

for Options

Price

Value

Term (years)

for Options

Price

Value

Term (years)

As of January 1, 2024

4,700

$

398.30

$

8.6

4,577

$

391.04

$

8.6

Vested

59

689.72

As of June 30, 2024

4,700

$

398.30

$

8.0

4,636

$

394.84

$

8.0

Schedule of RSUs and related transactions

The following table summarizes the status of our RSUs and related transactions for the period presented (in thousands, except share and per share amounts):

Outstanding

Vested and Deferred Release

Shares of

Average

Shares of

Average

Common Stock

Grant Date

Aggregate

Common Stock

Grant Date

Aggregate

Issuable

Fair Value

Intrinsic

Issuable

Fair Value

Intrinsic

for RSUs

Price

Value

for RSUs

Price

Value

As of January 1, 2024

141,361

$

4.55

$

523

5,469

$

4.02

$

20

Granted

83,899

5.41

Vested and Deferred Release

1,563

4.12

Vested and Released

(7,147)

4.05

29

As of June 30, 2024

218,113

$

4.90

$

1,056

7,032

$

4.04

$

34

v3.24.2.u1
Loss per share of common stock (Tables)
6 Months Ended
Jun. 30, 2024
Loss per share of common stock  
Schedule of computation of basic and diluted 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 June 30,

Six Months Ended June 30,

2024

2023

2024

2023

Numerator:

Net loss

$

(10,053)

$

(734)

$

(16,767)

$

(3,338)

Denominator:

Weighted average shares of common stock, basic

5,428,906

5,059,003

5,259,939

5,059,003

Effect of dilutive securities

Weighted average shares of common stock, diluted

5,428,906

5,059,003

5,259,939

5,059,003

Loss per share of common stock, basic and diluted

$

(1.85)

$

(0.15)

$

(3.19)

$

(0.66)

Schedule of outstanding securities which were not included in the calculation of diluted earnings per share of common stock

As of June 30,

    

2024

2023

Stock options

4,700

5,034

RSUs

211,081

Warrants

12,875,854

28,529

v3.24.2.u1
Fair value of financial instruments (Tables)
6 Months Ended
Jun. 30, 2024
Fair value of financial instruments  
Schedule of fair value of financial instruments measured on recurring basis

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 June 30, 2024

As of December 31, 2023

Description

    

Total

    

Level 1

    

Level 2

    

Level 3

    

Total

    

Level 1

    

Level 2

    

Level 3

Liabilities:

Warrant liabilities

$

861

$

$

861

$

$

658

$

$

658

$

Total

$

861

$

$

861

$

$

658

$

$

658

$

v3.24.2.u1
Business, basis of presentation, new accounting standards and summary of significant accounting policies (Details) - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Jun. 30, 2023
Mar. 31, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Sale of Stock              
Common stock, shares authorized 100,000       100,000   100,000
Cash $ 27,934       $ 27,934   $ 22,435
Accumulated deficit 125,032       125,032   108,265
Net losses 10,053 $ 6,714 $ 734 $ 2,604 16,767 $ 3,338  
Net cash used in operating activities         13,693 $ 4,592  
Consideration received         19,998    
Clinical trial accrued liabilities 2,066       2,066   3,033
Accrued expenses and other current liabilities 463       463   $ 592
Reclassification adjustment              
Sale of Stock              
Clinical trial accrued liabilities 3,000       3,000    
Accrued expenses and other current liabilities $ 800       $ 800    
v3.24.2.u1
Prepaid expenses and other current assets (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Prepaid expenses and other current assets    
Insurance $ 313  
Deposits 111 $ 39
Other prepaid expenses 159 38
Total $ 583 $ 77
v3.24.2.u1
Property and equipment, net (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Property and equipment, net    
Office equipment $ 88 $ 80
Less accumulated depreciation (44) (34)
Property and equipment, net $ 44 $ 46
v3.24.2.u1
Accrued expenses and other current liabilities (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Accrued expenses and other current liabilities    
Employee related costs $ 403 $ 118
Professional service fees 45 308
Other 15 166
Total $ 463 $ 592
v3.24.2.u1
Warrant liabilities (Details)
$ in Thousands
6 Months Ended
Jun. 30, 2024
USD ($)
Warrant liabilities  
As of beginning balance $ 658
Fair value changes 203
As of ending balance $ 861
v3.24.2.u1
Warrant liabilities - Additional Information (Details) - November 2022 Series A and B
$ / shares in Units, $ in Thousands
Nov. 30, 2022
USD ($)
$ / shares
shares
Class of Warrant or Right [Line Items]  
Number of warrants per unit | shares 8
Consideration received | $ $ 0
Warrants exercise price | $ / shares $ 0
v3.24.2.u1
Related parties (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Related Party Transactions          
Research and development $ 8,074 $ 2,364 $ 12,978 $ 3,001  
Related party payable $ 3,617   $ 3,617   $ 789
Other Liability, Current, Related Party [Extensible Enumeration] us-gaap:RelatedPartyMember   us-gaap:RelatedPartyMember   us-gaap:RelatedPartyMember
Other Liability, Current, Related Party, Name [Extensible Enumeration] nrbo:DongStMember   nrbo:DongStMember   nrbo:DongStMember
Shared Services Agreement          
Related Party Transactions          
Research and development $ 3,400 $ 1,500 $ 3,600 $ 1,800  
v3.24.2.u1
Commitments and Contingencies - Operating Leases - (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Aug. 31, 2023
New Corporate Headquarters Lease          
Commitments and Contingencies          
Term of contract         3 years
Renewal term         2 years
Rental expense $ 22   $ 44    
Operating lease cash payments 21   43    
Operating lease discount rate         11.00%
Former Corporate Headquarters Lease          
Commitments and Contingencies          
Rental expense $ 0 $ 6 $ 0 $ 11  
v3.24.2.u1
Stockholders' equity - June 2024 registered direct offering and private placement (Details)
$ / shares in Units, $ in Thousands
1 Months Ended 6 Months Ended
Jun. 30, 2024
USD ($)
security
$ / shares
shares
Jun. 30, 2024
USD ($)
$ / shares
shares
Consideration received | $   $ 19,998
Series A warrant    
Shares of common stock issuable for Issued and outstanding warrants 793,167 793,167
Series B warrants    
Shares of common stock issuable for Issued and outstanding warrants 807,541 807,541
June 2024 Offering    
Number of Securities | security 2  
Shares issued (in shares) 3,307,889  
Offering shares (Per share) | $ / shares $ 3.93 $ 3.93
Consideration received | $ $ 20,000  
Percentage of placement agent fee 7.00%  
Non-accountable expenses and clearing costs | $ $ 100  
Percentage of common stock sold 5.00%  
June 2024 Offering | Pre-Funded Warrants    
Offering shares (Per share) | $ / shares $ 3.929 $ 3.929
Shares of common stock issuable for Issued and outstanding warrants 1,781,171 1,781,171
Exercise Price | $ / shares $ 0.001 $ 0.001
Maximum percentage of outstanding common stock 9.99% 9.99%
Number of days written notice 61 days  
June 2024 Offering | Series A warrant    
Shares of common stock issuable for Issued and outstanding warrants 5,089,060 5,089,060
Expired terms 12 months  
Threshold period following the public announcement of receiving positive phase 1 multiple ascending dose data for expiry of warrants 60 days  
June 2024 Offering | Series B warrants    
Shares of common stock issuable for Issued and outstanding warrants 7,633,591 7,633,591
Expired terms 5 years  
Threshold period following the public announcement of receiving positive phase 1 multiple ascending dose data for expiry of warrants 6 months  
June 2024 Offering | PIPE common warrants    
Shares issued (in shares) 763,359  
Exercise Price | $ / shares $ 3.93 $ 3.93
Maximum percentage of outstanding common stock 4.99% 4.99%
June 2024 Offering | Placement agent warrants    
Shares of common stock issuable for Issued and outstanding warrants 127,227 127,227
Exercise Price | $ / shares $ 4.9125 $ 4.9125
Premium of offering price per share (as a percent) 25.00%  
Terminate of common stock 2 years  
Non-cash issuance cost | $ $ 300 $ 300
Weighted average fair value of warrants | $ / shares $ 2.73  
June 2024 Offering | Placement agent warrants | Expected stock price volatility    
Warrant measurement 1.400 1.400
June 2024 Offering | Placement agent warrants | Expected Term    
Warrant measurement 0.021 0.021
June 2024 Offering | Placement agent warrants | Expected Dividend Rate    
Warrant measurement 0 0
June 2024 Offering | Placement agent warrants | Risk Free Interest Rate    
Warrant measurement 0.0463 0.0463
June 2024 Offering | Placement Agent Contingent Warrants    
Shares of common stock issuable for Issued and outstanding warrants 318,067 318,067
Exercise Price | $ / shares $ 4.9125 $ 4.9125
Weighted average fair value of warrants | $ / shares $ 3.43  
June 2024 Offering | Placement Agent Contingent Warrants | Expected stock price volatility    
Warrant measurement 1.270 1.270
June 2024 Offering | Placement Agent Contingent Warrants | Expected Term    
Warrant measurement 0.057 0.057
June 2024 Offering | Placement Agent Contingent Warrants | Expected Dividend Rate    
Warrant measurement 0 0
June 2024 Offering | Placement Agent Contingent Warrants | Risk Free Interest Rate    
Warrant measurement 0.0431 0.0431
June 2024 Offering | Dong-A    
Consideration received | $ $ 10,000  
v3.24.2.u1
Stockholders Equity - Warrants (Details) - $ / shares
Jun. 30, 2024
Dec. 31, 2023
Warrants    
Number of Warrants 14,834,963 203,914
Warrants Exercise Price 44,820.00    
Warrants    
Number of Warrants 6 6
Exercise Price $ 44,820.0000  
Warrants Exercise Price 3,000.00    
Warrants    
Number of Warrants 159 159
Exercise Price $ 3,000.0000  
Warrants Exercise Price 1,447.20    
Warrants    
Number of Warrants 10,421 10,421
Exercise Price $ 1,447.2000  
Warrants Exercise Price 900.00    
Warrants    
Number of Warrants 15,390 15,390
Exercise Price $ 900.0000  
November 2022 Series B    
Warrants    
Number of Warrants 177,938 177,938
Exercise Price $ 0.0000  
June 2024 Placement Agent    
Warrants    
Number of Warrants 127,227  
Exercise Price $ 4.9125  
June 2024 Pre-funded    
Warrants    
Number of Warrants 1,781,171  
Exercise Price $ 0.0010  
June 2024 Series A    
Warrants    
Number of Warrants 5,089,060  
Exercise Price $ 3.9300  
June 2024 Series B    
Warrants    
Number of Warrants 7,633,591  
Exercise Price $ 3.9300  
v3.24.2.u1
Stockholders Equity - Warrants - Narrative (Details)
6 Months Ended
Jun. 30, 2024
shares
Number of warrants exchanged 8
Warrants term 2 years
Series B Warrant  
Number of warrants exchanged 6,460,333
Warrants to purchase shares of common stock 807,541
June 2024 Series A  
Expired terms 12 months
Threshold period following the public announcement of receiving positive phase 1 multiple ascending dose data for expiry of warrants 60 days
June 2024 Series B  
Expired terms 5 years
Threshold period following the public announcement of receiving positive phase 1 multiple ascending dose data for expiry of warrants 6 months
Series A warrant  
Number of warrants exchanged 6,345,333
Warrants to purchase shares of common stock 793,167
v3.24.2.u1
Stock-based Compensation - Expense, unrecognized cost, awards o/s (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Number of Options          
Stock-based compensation $ 135 $ 24 $ 239 $ (50)  
Stock options outstanding (in shares) 4,700   4,700   4,700
Shares available for future issuance 385,921   385,921    
2021 Inducement Plan          
Number of Options          
Shares available for future issuance 4,166   4,166    
2022 Plan          
Number of Options          
Period of automatic increase in shares reserved     8 years    
Percentage of the common shares outstanding (as a percent)     10.00%    
Number of shares authorized 1,000,000   1,000,000    
Shares available for future issuance 381,755   381,755    
2022 Plan | Maximum          
Number of Options          
Number of shares authorized 15,000,000   15,000,000    
Stock Plan 2022,2021 And 2019 Plans          
Number of Options          
Unrecognized share-based compensation cost $ 800   $ 800    
Unrecognized share-based compensation - Weighted average period     1 year 9 months 18 days    
Employee Stock Option | 2019 Plan          
Number of Options          
Stock options outstanding (in shares) 1,575   1,575    
Employee Stock Option | 2022 Plan          
Number of Options          
Stock options outstanding (in shares) 3,125   3,125    
Restricted stock units | 2022 Plan          
Number of Options          
RSUs outstanding 218,113   218,113    
General and administrative          
Number of Options          
Stock-based compensation $ 99 $ 24 $ 170 (61)  
Research and development          
Number of Options          
Stock-based compensation $ 36   $ 69 $ 11  
v3.24.2.u1
Stock-based Compensation - Stock Options (Details) - $ / shares
6 Months Ended 12 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Stock Options, Additional Disclosures      
Outstanding, Number, Beginning Balance (in shares) 4,700    
Granted (in shares)   3,125  
Outstanding, Number, Ending Balance (in shares) 4,700   4,700
Options Exercisable, Number, Beginning 4,577    
Vested and exercisable (in shares) 59    
Options Exercisable, Number, Ending 4,636   4,577
Outstanding, Weighted Average Exercise Price, Beginning Balance (in dollars per share) $ 398.30    
Outstanding, Weighted Average Exercise Price, Ending Balance (in dollars per share) 398.30   $ 398.30
Options Exercisable, Exercise price, beginning (in dollars per share) 391.04    
Vested and exercisable (in dollars per share) 689.72    
Options Exercisable, Exercise price, ending (in dollars per share) $ 394.84   $ 391.04
Options, Outstanding, Remaining Contractual Term 8 years   8 years 7 months 6 days
Options Exercisable, Remaining Contractual Term 8 years   8 years 7 months 6 days
Weighted average fair value per share of options granted   $ 3.63  
v3.24.2.u1
Stock-based Compensation - Assumptions (Details)
6 Months Ended
Jun. 30, 2024
Stock-based compensation  
Expected stock price volatility 82.90%
Expected life of stock options (years) 5 years
Expected dividend yield 0.00%
Risk free interest rate 3.54%
v3.24.2.u1
Stock based compensation RSU (Details)
$ / shares in Units, $ in Thousands
6 Months Ended
Jun. 30, 2024
USD ($)
$ / shares
shares
Stock-based compensation  
RSU's Fair value, Beginning balance (in shares) | shares 141,361
RSU's, Number grants (in shares) | shares 83,899
RSU's, Number Vested and Released (in shares) | shares (7,147)
RSU's Fair value, Ending balance (in shares) | shares 218,113
RSU's Fair value, Opening balance (per share) | $ / shares $ 4.55
RSU's Fair value, grants in period (per share) | $ / shares 5.41
RSU's Fair value, vested in period (per share) | $ / shares 4.05
RSU's Fair value, Ending balance (per share) | $ / shares $ 4.90
Intrinsic value, opening balance | $ $ 523
Intrinsic value vested | $ 29
Intrinsic value, ending balance | $ $ 1,056
RSU's Vested and Deferred Release, Beginning balance (in shares) | shares 5,469
RSUs, Vested and Deferred Release (in shares) | shares 1,563
RSU's Vested and Deferred Release, Ending balance (in shares) | shares 7,032
RSU's Vested Fair value, Opening balance (per share) | $ / shares $ 4.02
RSUs, Vested and Deferred Release (per share) | $ / shares 4.12
RSU's Vested Fair value, Ending balance (per share) | $ / shares $ 4.04
Vested intrinsic value, beginning balance | $ $ 20
Vested intrinsic value, ending balance | $ $ 34
v3.24.2.u1
Income Taxes (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Income taxes        
Provision for income taxes $ 0 $ 0 $ 0 $ 0
v3.24.2.u1
Loss per share of common stock - Computation of basic and diluted loss per share of common stock (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Jun. 30, 2023
Mar. 31, 2023
Jun. 30, 2024
Jun. 30, 2023
Loss per share of common stock            
Net loss $ (10,053) $ (6,714) $ (734) $ (2,604) $ (16,767) $ (3,338)
Weighted average shares of common stock, basic (in shares) 5,428,906   5,059,003   5,259,939 5,059,003
Weighted average shares of common stock, diluted (in shares) 5,428,906   5,059,003   5,259,939 5,059,003
Loss per share of common stock, basic (in dollars per share) $ (1.85)   $ (0.15)   $ (3.19) $ (0.66)
Loss per share of common stock, diluted (in dollars per share) $ (1.85)   $ (0.15)   $ (3.19) $ (0.66)
v3.24.2.u1
Loss per share of common stock - Antidilutive Securities (Details) - shares
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Employee Stock Option        
Loss per share of common stock        
Outstanding securities not included in the calculation of diluted earnings per share of common stock (in shares) 4,700 5,034 4,700 5,034
RSUs        
Loss per share of common stock        
Outstanding securities not included in the calculation of diluted earnings per share of common stock (in shares) 211,081   211,081  
Warrants - issued        
Loss per share of common stock        
Outstanding securities not included in the calculation of diluted earnings per share of common stock (in shares) 12,875,854 28,529 12,875,854 28,529
v3.24.2.u1
Fair value of financial instruments - Recurring basis (Details) - Recurring - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Fair value of financial instruments    
Warrant liabilities $ 861 $ 658
Total 861 658
Level 2    
Fair value of financial instruments    
Warrant liabilities 861 658
Total $ 861 $ 658
v3.24.2.u1
Subsequent events (Details)
Aug. 31, 2024
shares
Subsequent Event | Pre-Funded Warrants  
Subsequent Events  
Shares issued 229,171

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