Exhibit 99.1 CAMBRIDGE, March 28, 2024 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the year ended December 31, 2023 and provided a corporate strategic update. "Throughout 2023 and into the first quarter of 2024, we made remarkable progress advancing the clinical development of our two, next generation cardiometabolic assets, which address the significant metabolic dysfunction-as ...

[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [FINANCIAL STATEMENTS](index=3&type=section&id=ITEM%201%3A%20FINANCIAL%20STATEMENTS) This section presents NeuroBo Pharmaceuticals' unaudited condensed consolidated financial statements, detailing clinical program focus and 'going concern' uncertainty due to recurring losses and funding needs Condensed Consolidated Balance Sheet Data (in thousands) | | September 30, 2023 (unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $25,837 | $33,364 | | Total current assets | $26,145 | $33,532 | | Total assets | $26,425 | $33,534 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $4,722 | $11,784 | | Total liabilities | $4,875 | $11,784 | | Total stockholders' equity | $21,550 | $21,750 | Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | | Three Months Ended Sep 30 | Nine Months Ended Sep 30 | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | Research and development | $2,292 | $571 | $5,293 | $2,473 | | General and administrative | $1,601 | $2,533 | $4,926 | $6,725 | | Loss from operations | $(3,893) | $(3,104) | $(10,219) | $(9,198) | | Net loss | $(3,818) | $(3,113) | $(7,156) | $(9,291) | | Net loss per share, basic and diluted | $(0.09) | $(3.50) | $(0.18) | $(10.45) | Condensed Consolidated Statements of Cash Flows (in thousands) | | For the Nine Months Ended September 30, | | :--- | :--- | :--- | | | **2023** | **2022** | | Net cash used in operating activities | $(7,406) | $(9,905) | | Net cash used in (provided by) investing activities | $(41) | $8 | | Net cash used in financing activities | $(80) | $(134) | | Net decrease in cash | $(7,527) | $(10,031) | | Cash at beginning of period | $33,364 | $16,387 | | Cash at end of period | $25,837 | $6,356 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's strategic shift to DA-1241 and DA-1726, discontinuation of prior programs, a 'going concern' issue with cash into Q4 2024, and unaccrued milestone payment obligations - The company is a clinical-stage biotechnology firm focusing on two primary programs: **DA-1241** for NASH and T2D, and **DA-1726** for obesity and NASH[16](index=16&type=chunk)[21](index=21&type=chunk) - In June 2023, the company discontinued the clinical development of **ANA001** (niclosamide) and **gemcabene** for the treatment of COVID-19[17](index=17&type=chunk) - The company has an accumulated deficit of **$103.0 million** as of September 30, 2023, raising substantial doubt about its ability to continue as a going concern, with existing cash projected to fund operations into the **fourth quarter of 2024**[23](index=23&type=chunk)[24](index=24&type=chunk) - The company has potential future milestone payment obligations related to license agreements with Dong-A ST (up to **$316 million**), the ANA Merger, and Pfizer, but no milestones were achieved or considered probable as of September 30, 2023[40](index=40&type=chunk)[41](index=41&type=chunk)[43](index=43&type=chunk) - The valuation methodology for the **2022 Warrant** liabilities was changed from a Level 3 (Monte Carlo simulation) to a Level 2 input, approximating the underlying stock price due to a cashless exercise provision[70](index=70&type=chunk)[71](index=71&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=ITEM%202%3A%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, strategic focus on DA-1241 and DA-1726, increased R&D expenses, and liquidity challenges, including a 'going concern' disclosure due to limited cash runway into Q4 2024 - The company's primary focus is on developing **DA-1241** for NASH/T2D and **DA-1726** for obesity, having discontinued **ANA001** and **Gemcabene** for COVID-19 in June 2023[87](index=87&type=chunk)[88](index=88&type=chunk) - A Phase 2a clinical trial for **DA-1241** in NASH patients was initiated in **Q3 2023**, with plans to file an IND for **DA-1726** and begin Phase 1 trials in **Q4 2023**[92](index=92&type=chunk)[100](index=100&type=chunk) Comparison of Operating Expenses (in thousands) | | Three Months Ended Sep 30 | Nine Months Ended Sep 30 | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | Research and development | $2,292 | $571 | $5,293 | $2,473 | | General and administrative | $1,601 | $2,533 | $4,926 | $6,725 | - The increase in R&D expenses for **Q3 2023** (**+$1.7 million** YoY) and the nine months ended Sep 30, 2023 (**+$2.8 million** YoY) was primarily driven by **DA-1241** clinical trial costs, including toxicology studies and drug manufacturing[103](index=103&type=chunk)[111](index=111&type=chunk) - The decrease in G&A expenses was mainly due to lower professional fees related to the exploration of business opportunities in **2022** and reduced insurance costs[106](index=106&type=chunk)[114](index=114&type=chunk) - As of September 30, 2023, the company had **$25.8 million** in cash, expected to fund operations into the **fourth quarter of 2024**, raising substantial doubt about its ability to continue as a going concern[131](index=131&type=chunk)[132](index=132&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=31&type=section&id=ITEM%203%3A%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is noted as not applicable for the company - Not applicable[136](index=136&type=chunk) [Controls and Procedures](index=31&type=section&id=ITEM%204%3A%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of September 30, 2023, due to material weaknesses in segregation of duties, logical access, and supervision, with a remediation plan underway - Management concluded that disclosure controls and procedures were not effective as of **September 30, 2023**[141](index=141&type=chunk) - Material weaknesses were identified in internal control over financial reporting, specifically: a lack of segregation of duties, issues with logical access to financial systems, and insufficient supervision and review[142](index=142&type=chunk) - Remediation efforts are underway, including hiring additional accounting personnel, enhancing controls over disbursements, improving review and oversight processes, and restricting system administrator rights[144](index=144&type=chunk)[153](index=153&type=chunk) [PART II OTHER INFORMATION](index=34&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=34&type=section&id=ITEM%201%3A%20Legal%20Proceedings) The company reports no current material legal proceedings expected to adversely affect its business - The company is not currently a party to any material legal proceedings[147](index=147&type=chunk) [Risk Factors](index=34&type=section&id=ITEM%201A%3A%20Risk%20Factors) This section updates the company's risk factors, emphasizing substantial doubt about its going concern ability due to losses and limited cash, alongside Nasdaq non-compliance and potential delisting risks - The company has incurred losses since inception, with an accumulated deficit of **$103.0 million** as of September 30, 2023, raising substantial doubt about its ability to continue as a going concern[149](index=149&type=chunk)[150](index=150&type=chunk)[153](index=153&type=chunk) - Existing cash of **$25.8 million** is expected to fund operations only into the **fourth quarter of 2024**, necessitating additional unsecured financing[151](index=151&type=chunk)[152](index=152&type=chunk) - The company is not in compliance with Nasdaq's minimum bid price rule (**$1.00/share**) and has an extension until **February 5, 2024**, to regain compliance[156](index=156&type=chunk)[158](index=158&type=chunk) - Failure to regain compliance with Nasdaq listing requirements could lead to delisting, adversely affecting stock liquidity, value, and capital raising ability, though a reverse stock split has been approved as a potential remedy[157](index=157&type=chunk)[159](index=159&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=ITEM%202%3A%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - None[164](index=164&type=chunk) [Default upon Senior Securities](index=37&type=section&id=ITEM%203%3A%20Default%20upon%20Senior%20Securities) This section is noted as not applicable - Not applicable[165](index=165&type=chunk) [Mine Safety Disclosures](index=37&type=section&id=ITEM%204%3A%20Mine%20Safety%20Disclosures) This section is noted as not applicable - Not applicable[166](index=166&type=chunk) [Other Information](index=37&type=section&id=ITEM%205%3A%20Other%20Information) The company discloses that no directors or Section 16 officers adopted or terminated a Rule 10b5-1 trading plan during Q3 2023 - During the three months ended **September 30, 2023**, no directors or Section 16 officers adopted or terminated a Rule 10b5-1 trading plan[167](index=167&type=chunk) [Exhibits](index=38&type=section&id=ITEM%206%3A%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, a new lease agreement, and required officer certifications - The report includes a list of filed exhibits, notably a new Lease Agreement dated **August 23, 2023**, and required officer certifications (**302** and **906**)[169](index=169&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 OR Table of Contents ☐ 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 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as specified in its charter) Delaware 47-2389984 (State or oth ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2023 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 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as specified in its charter) Delaware 47-2389984 (State or ot ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-37809 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as specified in its charter) Delaware 47-2389984 (State or ...

[Filing Information](index=1&type=section&id=Filing%20Information) This section details the company's Form 10-Q filing, identifying NeuroBo Pharmaceuticals as a non-accelerated, smaller reporting company with 6.5 million shares outstanding as of November 2022 [Form 10-Q Details](index=1&type=section&id=Form%2010-Q%20Details) NeuroBo Pharmaceuticals filed its Q3 2022 Form 10-Q, identifying as a non-accelerated, smaller reporting company with 6.5 million shares outstanding - NeuroBo Pharmaceuticals, Inc. filed a Quarterly Report on Form 10-Q for the period ended **September 30, 2022**[2](index=2&type=chunk) - The company is classified as a **non-accelerated filer** and a **smaller reporting company**[4](index=4&type=chunk) Common Stock Details | Metric | Value | | :--- | :--- | | Common stock, $0.001 par value | NRBO | | Shares outstanding as of Nov 11, 2022 | 6,503,528 | [PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements, management's discussion and analysis, market risk disclosures, and internal controls assessment [ITEM 1 – FINANCIAL STATEMENTS](index=3&type=section&id=ITEM%201%20FINANCIAL%20STATEMENTS) This section provides NeuroBo's unaudited condensed consolidated financial statements and notes for Q3 2022 and prior periods [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased from **$16.8 million** to **$7.6 million**, driven by reduced cash, with a substantial drop in stockholders' equity Condensed Consolidated Balance Sheets (in thousands) | Metric | September 30, 2022 (unaudited) | December 31, 2021 | | :--- | :--- | :--- | | Cash | $6,356 | $16,387 | | Total current assets | $7,554 | $16,584 | | Total assets | $7,557 | $16,799 | | Total current liabilities | $1,619 | $2,157 | | Total liabilities | $1,619 | $2,202 | | Total stockholders' equity | $5,938 | $14,597 | - Cash decreased by **$10,031 thousand** from December 31, 2021, to September 30, 2022[8](index=8&type=chunk) - Total stockholders' equity decreased by **$8,659 thousand**, from **$14,597 thousand** to **$5,938 thousand**[8](index=8&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss improved to **$3.1 million** (3M) and **$9.3 million** (9M) in 2022, primarily due to reduced research and development expenses Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | 3 Months Ended Sep 30, 2022 | 3 Months Ended Sep 30, 2021 | 9 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $571 | $1,394 | $2,473 | $4,549 | | General and administrative | $2,533 | $2,070 | $6,725 | $6,171 | | Total operating expenses | $3,104 | $3,464 | $9,198 | $10,720 | | Net loss | $(3,113) | $(3,461) | $(9,291) | $(10,706) | | Net loss per share, basic and diluted | $(3.50) | $(4.66) | $(10.45) | $(14.58) | - Net loss decreased by **$348 thousand** for the three months ended September 30, 2022, compared to the same period in 2021[10](index=10&type=chunk) - Net loss decreased by **$1,415 thousand** for the nine months ended September 30, 2022, compared to the same period in 2021[10](index=10&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity declined from **$14.6 million** to **$5.9 million**, mainly due to **$9.3 million** in net losses, partially offset by stock-based compensation Changes in Stockholders' Equity (in thousands) | Metric | Balance at Dec 31, 2021 | Stock-based compensation | Net loss | Balance at Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Total Equity | $14,597 | $636 | $(9,291) | $5,938 | - Accumulated deficit increased from **$(81,828) thousand** at December 31, 2021, to **$(91,119) thousand** at September 30, 2022[12](index=12&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations decreased to **$9.9 million**, while financing shifted from **$9.1 million** inflow to **$0.1 million** outflow, resulting in a **$10.0 million** net cash decrease Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | 9 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,905) | $(12,235) | | Net cash provided by (used in) investing activities | $8 | $(3) | | Net cash (used in) provided by financing activities | $(134) | $9,140 | | Net decrease in cash | $(10,031) | $(3,098) | | Cash at end of period | $6,356 | $6,984 | - Net cash used in operating activities decreased by **$2,330 thousand** year-over-year[15](index=15&type=chunk) - Net cash from financing activities shifted from a **$9,140 thousand** inflow in 2021 to a **$134 thousand** outflow in 2022[15](index=15&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail operations, accounting policies, and recent events, including new license agreements, **$32.3 million** in financing, and a reverse stock split [Note 1. The Company and Basis of Presentation](index=7&type=section&id=Note%201.%20The%20Company%20and%20Basis%20of%20Presentation) NeuroBo is a clinical-stage biotech focused on NASH, obesity, and T2D, with **$32.3 million** in recent financing addressing going concern doubts after a reverse stock split - NeuroBo is a clinical-stage biotechnology company with primary programs for **NASH, obesity, and T2D** (DA-1241, DA-1726) and other programs for **viral, neurodegenerative, and cardiometabolic diseases** (ANA001, NB-01, NB-02, Gemcabene)[17](index=17&type=chunk)[18](index=18&type=chunk) - The company has an accumulated deficit of **$91.1 million** as of September 30, 2022, and has experienced net losses and negative cash flows since inception[28](index=28&type=chunk) - Subsequent to September 30, 2022, the company raised approximately **$32.3 million** in gross proceeds from a public offering and private placement, expected to provide adequate liquidity for at least twelve months[29](index=29&type=chunk) - A **one-for-thirty reverse stock split** became effective on **September 12, 2022**, retroactively adjusting all common stock and per share amounts[26](index=26&type=chunk)[27](index=27&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=9&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note details significant accounting policies, including expensing R&D and G&A costs, stock-based compensation, and assessing ASU 2016-13 impact - Research and development costs are expensed as incurred, including **clinical trial costs, manufacturing costs, and license fees**[33](index=33&type=chunk) - Stock-based compensation is recognized at the **grant-date fair value** in accordance with ASC 718[34](index=34&type=chunk) - The company is assessing the impact of **ASU 2016-13, 'Financial Instruments – Credit Losses,'** effective for smaller reporting companies after December 15, 2022[37](index=37&type=chunk) [Note 3. Balance Sheet Detail](index=11&type=section&id=Note%203.%20Balance%20Sheet%20Detail) Property and equipment, net, decreased from **$110 thousand** to **$3 thousand** due to equipment sales, and accrued liabilities also declined Property and Equipment, Net (in thousands) | Metric | September 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Research and development equipment | $0 | $158 | | Office equipment | $30 | $63 | | Total property and equipment, net | $3 | $110 | - A loss on sale of property and equipment of **$75 thousand** was recognized during the nine months ended September 30, 2022, due to the termination of the Korea lease[38](index=38&type=chunk) Accrued Liabilities (in thousands) | Metric | September 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | External research and development expenses | $356 | $854 | | Payroll related | $0 | $376 | | Total accrued liabilities | $544 | $1,301 | [Note 4. Commitments and Contingencies](index=11&type=section&id=Note%204.%20Commitments%20and%20Contingencies) The company has operating lease commitments and significant contingent liabilities for milestone and royalty payments, with no current recognition due to uncertainty - The Korea Lease was terminated effective **April 30, 2022**, with no gain or loss recognized[44](index=44&type=chunk) Operating Lease Expenses (in thousands) | Lease | 3 Months Ended Sep 30, 2022 | 3 Months Ended Sep 30, 2021 | 9 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Corporate headquarters | $3 | $7 | $11 | $41 | | Korea Lease (non-cash) | N/A | N/A | $8 | $18 | | Korea Lease (cash payments) | N/A | N/A | $11 | $24 | - Potential milestone payments for Niclosamide Product (ANA Merger) total up to **$175.5 million**, plus a **2.5% royalty** on annual worldwide net sales[47](index=47&type=chunk) - Potential milestone payments under the YourChoice Agreement total **$19.5 million**, plus a **0.5% royalty** on annual worldwide net sales of Niclosamide Product[50](index=50&type=chunk) - Under the CVR Agreement, CVR Holders are entitled to **80% of proceeds** from Gemcabene for cardiovascular conditions and **10% for other indications**[52](index=52&type=chunk) - Milestone payments under the Pfizer Agreement for Gemcabene total up to **$37 million**, plus tiered royalties on net sales[55](index=55&type=chunk)[57](index=57&type=chunk) [Note 5. License and Collaboration Agreement](index=15&type=section&id=Note%205.%20License%20and%20Collaboration%20Agreement) The Beijing SL Agreement grants exclusive rights to Gemcabene in Asia, with potential milestone and royalty payments, but no revenue recognized to date - The Beijing SL Agreement grants Beijing SL an exclusive royalty-bearing license to **Gemcabene** in mainland China, Hong Kong, Macau, and Taiwan[60](index=60&type=chunk) - No revenue has been recognized under the Beijing SL Agreement as of **September 30, 2022**[60](index=60&type=chunk) [Note 6. Stockholders' Equity](index=15&type=section&id=Note%206.%20Stockholders'%20Equity) As of September 30, 2022, **228,235 warrants** were outstanding, primarily from 2021 issuances, with various exercise prices and expiration dates Outstanding Warrants (in thousands) | Warrant Issuance | Number of Warrants (Sep 30, 2022) | Number of Warrants (Dec 31, 2021) | Exercise Price | | :--- | :--- | :--- | :--- | | March 2017 | - | 1,315 | $7,800.00 | | July 2018 | 48 | 48 | $5,602.50 | | April 2020 | 1,252 | 1,252 | $375.00 | | January 2021 | 83,338 | 83,338 | $180.90 | | October 2021 | 143,597 | 143,597 | $112.50 | | Total | 228,235 | 229,550 | | [Note 7. Stock-based Compensation](index=16&type=section&id=Note%207.%20Stock-based%20Compensation) Stock-based compensation expense increased to **$218 thousand** (3M) and **$636 thousand** (9M), with **$0.7 million** unrecognized cost remaining Stock-based Compensation Expense (in thousands) | Period | 2022 | 2021 | | :--- | :--- | :--- | | Three Months Ended Sep 30 | $218 | $107 | | Nine Months Ended Sep 30 | $636 | $474 | Stock Option Activity (9 Months Ended Sep 30, 2022) | Metric | Number of Options | Weighted Average Exercise Price | | :--- | :--- | :--- | | Outstanding at Dec 31, 2021 | 32,498 | $119.72 | | Granted | 5,995 | $17.83 | | Forfeited/Cancelled | (2,000) | $181.20 | | Outstanding at Sep 30, 2022 | 36,493 | $99.62 | - Unrecognized stock-based compensation cost was **$0.7 million** as of September 30, 2022, with a weighted average recognition period of **1.1 years**[70](index=70&type=chunk) [Note 8. Net Loss Per Common Share](index=17&type=section&id=Note%208.%20Net%20Loss%20Per%20Common%20Share) Basic and diluted net loss per share are identical due to antidilutive securities, with **36,493 stock options** and **228,235 warrants** excluded - There is no difference between basic and diluted net loss per share as all potentially dilutive securities were **antidilutive**[71](index=71&type=chunk) Anti-Dilutive Securities Excluded from EPS Calculation | Security | 3 Months Ended Sep 30, 2022 | 3 Months Ended Sep 30, 2021 | 9 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Stock options | 36,493 | 18,801 | 36,493 | 18,801 | | Warrants | 228,235 | 85,953 | 228,235 | 85,953 | [Note 9. Income Taxes](index=18&type=section&id=Note%209.%20Income%20Taxes) The effective tax rate was **zero percent** for all periods, with a full valuation allowance on net deferred tax assets resulting in no income tax benefit - The effective tax rate was **zero percent** for the three and nine months ended September 30, 2022 and 2021[73](index=73&type=chunk) - A **full valuation allowance** was recorded on net deferred tax assets, leading to no income tax benefit[73](index=73&type=chunk) [Note 10. Related Party Transactions](index=18&type=section&id=Note%2010.%20Related%20Party%20Transactions) NeuroBo entered an exclusive license agreement with Dong-A ST for DA-1241 and DA-1726, including a **$22 million** upfront payment and significant milestone potential - The company has manufacturing and supply agreements with **Dong-A ST** for NB-01 and NB-02, with no manufacturing costs incurred in the reported periods[75](index=75&type=chunk)[76](index=76&type=chunk) - An exclusive License Agreement with **Dong-A ST** for DA-1241 and DA-1726 became effective on **November 8, 2022**[77](index=77&type=chunk) - The License Agreement includes an upfront payment of **$22 million** in Series A Convertible Preferred Stock, single-digit royalties, and potential regulatory milestone payments of up to **$178 million** for DA-1726 and **$138 million** for DA-1241[78](index=78&type=chunk) - A Securities Purchase Agreement with **Dong-A ST** involves the purchase of **$15 million** in Series A Preferred Stock and warrants, contingent on a Qualified Financing[80](index=80&type=chunk) [Note 11. Subsequent Events](index=20&type=section&id=Note%2011.%20Subsequent%20Events) Post-quarter, NeuroBo closed a public offering raising **$17.3 million**, and Dong-A ST completed a **$15 million** private placement, activating the License Agreement - On **November 8, 2022**, the company closed a public offering, raising approximately **$17.3 million** in gross proceeds[81](index=81&type=chunk) - The public offering included **Class A Units** (common stock + Series A & B Warrants) and **Class B Units** (Series B Convertible Preferred Stock + Series A & B Warrants)[81](index=81&type=chunk) - In a concurrent private placement, **Dong-A ST** purchased **$15 million** of Series A Convertible Preferred Stock and warrants, triggering the effectiveness of the License Agreement[82](index=82&type=chunk)[83](index=83&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operational results, strategic shift to new programs, recent financing, COVID-19 impact, and future funding needs [Forward-Looking Statements](index=21&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements subject to risks and uncertainties regarding business operations, clinical activities, and funding needs - The report contains **forward-looking statements** regarding business operations, cash flow, business development, clinical activities, product development, and commercialization efforts[87](index=87&type=chunk) - These statements are subject to **risks and uncertainties**, including regulatory approvals, funding needs, and competitive product offerings[89](index=89&type=chunk) [Overview](index=21&type=section&id=Overview) NeuroBo is a clinical-stage biotech focused on NASH, obesity, and T2D with lead programs DA-1241 and DA-1726, plus other therapeutic programs - NeuroBo is a clinical-stage biotechnology company with two primary programs: **DA-1241 for NASH and T2D**, and **DA-1726 for NASH and obesity**[90](index=90&type=chunk)[92](index=92&type=chunk) - Additional therapeutic programs include **ANA001 for moderate COVID-19**, **NB-01 for painful diabetic neuropathy**, **NB-02 for neurodegenerative diseases**, and **Gemcabene** for cardiometabolic diseases and potentially COVID-19[92](index=92&type=chunk)[95](index=95&type=chunk) [Recent Developments](index=23&type=section&id=Recent%20Developments) NeuroBo entered an exclusive license agreement with Dong-A ST for DA-1241 and DA-1726, including a **$22 million** upfront payment and significant milestone potential - An exclusive license agreement with **Dong-A ST** for DA-1241 and DA-1726 became effective on **November 8, 2022**[94](index=94&type=chunk) - The license agreement includes an upfront payment of **$22 million** in Series A Convertible Preferred Stock and potential milestone payments up to **$178 million** for DA-1726 and **$138 million** for DA-1241[95](index=95&type=chunk)[97](index=97&type=chunk) - A public offering closed on **November 8, 2022**, raising approximately **$17.3 million** in gross proceeds[101](index=101&type=chunk) - **Dong-A ST** purchased **$15 million** of Series A Convertible Preferred Stock and warrants in a concurrent private placement[99](index=99&type=chunk) [COVID-19 Impact](index=26&type=section&id=COVID-19%20Impact) COVID-19 continues to pose uncertainties and risks to operations, though no significant negative financial impacts have occurred to date, future effects remain unpredictable - The global COVID-19 pandemic continues to present **uncertainty and unforeseeable new risks** to the company's operations and business plan[103](index=103&type=chunk) - To date, the company has not experienced significant negative impacts on its consolidated statements of operations or cash flows, except for adjustments to scientific activity[104](index=104&type=chunk) - The extent of the future impact of COVID-19 on the company's financial condition, liquidity, or results of operations is **uncertain**[105](index=105&type=chunk) [Current Scientific Activity](index=26&type=section&id=Current%20Scientific%20Activity) NeuroBo focuses on DA-1241 and DA-1726 development, ceased NB-01's prior pathway, closed ANA001 enrollment, and postponed NB-02 due to macroeconomic conditions - Primary programs are **DA-1241 for NASH and T2D** (Phase 2a study planned) and **DA-1726 for NASH and obesity** (IND application and human clinical trials planned)[106](index=106&type=chunk)[107](index=107&type=chunk) - Enrollment in the Phase 2 clinical trial of **ANA001 for moderate COVID-19** closed in **July 2022**, with data analysis expected in **Q4 2022**[110](index=110&type=chunk) - Development of **NB-01** on its prior regulatory pathway has ceased; alternatives like **orphan drug or nutraceutical** are being explored[111](index=111&type=chunk)[114](index=114&type=chunk) - Work on **NB-02's IND application** and first human clinical trials is postponed due to global health and macroeconomic conditions, with strategic partnerships being considered[112](index=112&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Net loss decreased for both three and nine months ended September 30, 2022, primarily due to reduced R&D expenses, despite a slight increase in G&A Operating Results (in thousands) | Metric | 3 Months Ended Sep 30, 2022 | 3 Months Ended Sep 30, 2021 | Change (3M) | 9 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2021 | Change (9M) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Research and development | $571 | $1,394 | $(823) | $2,473 | $4,549 | $(2,076) | | General and administrative | $2,533 | $2,070 | $463 | $6,725 | $6,171 | $554 | | Total operating expenses | $3,104 | $3,464 | $(360) | $9,198 | $10,720 | $(1,522) | | Net loss | $(3,113) | $(3,461) | $348 | $(9,291) | $(10,706) | $1,415 | - Research and development expenses decreased by **$0.8 million** for the three months and **$2.1 million** for the nine months ended September 30, 2022, primarily due to reduced clinical trial activity and drug manufacturing costs for ANA001[118](index=118&type=chunk)[124](index=124&type=chunk) - General and administrative expenses increased by **$0.5 million** for both the three and nine months ended September 30, 2022, mainly due to higher legal and professional fees[120](index=120&type=chunk)[125](index=125&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) Cash decreased to **$6.4 million**, with **$9.9 million** used in operations; **$32.3 million** raised post-quarter is expected to fund operations for 12 months Cash Flows Summary (in thousands) | Activity | 9 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,905) | $(12,235) | | Net cash provided by (used in) investing activities | $8 | $(3) | | Net cash (used in) provided by financing activities | $(134) | $9,140 | | Net decrease in cash | $(10,031) | $(3,098) | - Cash used in operating activities decreased by **$2.3 million** year-over-year, primarily due to lower net loss and changes in working capital[130](index=130&type=chunk)[131](index=131&type=chunk) - Subsequent to September 30, 2022, the company raised approximately **$32.3 million** in gross proceeds from equity offerings, expected to fund operations for at least **12 months**[138](index=138&type=chunk) - The company expects to continue incurring significant operating losses and will need to raise additional funds to support its development activities[135](index=135&type=chunk)[138](index=138&type=chunk) [Critical Accounting Policies and Estimates](index=32&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) No material changes were made to critical accounting policies or estimates during the three and nine months ended September 30, 2022 - No material changes to critical accounting policies or estimates were made during the three and nine months ended **September 30, 2022**[140](index=140&type=chunk) [Recent Accounting Pronouncements](index=32&type=section&id=Recent%20Accounting%20Pronouncements) This section refers to Note 2 for a discussion of recently issued accounting pronouncements and their ongoing impact assessment - Refer to **Note 2** for a discussion of recently issued accounting pronouncements[141](index=141&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures about Market Risk](index=32&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) There are no applicable quantitative and qualitative disclosures about market risk for the company - The company has no applicable quantitative and qualitative disclosures about market risk[142](index=142&type=chunk) [ITEM 4. Controls and Procedures](index=32&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Disclosure controls were ineffective as of **September 30, 2022**, due to material weaknesses in segregation of duties and logical access, with remediation efforts underway - Disclosure controls and procedures were not effective as of **September 30, 2022**, due to material weaknesses[147](index=147&type=chunk) - Material weaknesses include a lack of **segregation of duties** over financial reporting and inadequate **logical access controls** over computer applications[148](index=148&type=chunk) - Remediation efforts include enhancing controls over wire disbursements, improving clinical site expense monitoring, and restricting administrator rights to financial reporting systems[150](index=150&type=chunk) [PART II – OTHER INFORMATION](index=36&type=section&id=PART%20II%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and a list of exhibits [ITEM 1. Legal Proceedings](index=36&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not currently involved in material legal proceedings, but acknowledges litigation risks including costs and diversion of resources - The company is not currently a party to any legal proceedings likely to have a **material adverse effect** on its business[153](index=153&type=chunk) - Litigation can have an adverse impact due to **defense and settlement costs**, and **diversion of management resources**[153](index=153&type=chunk) [ITEM 1A. Risk Factors](index=36&type=section&id=ITEM%201A.%20Risk%20Factors) This section details business risks, including NASH development, milestone payments, and regulatory approvals, plus common stock risks related to Dong-A ST's potential control [Risks Related to the Business](index=36&type=section&id=Risks%20Related%20to%20the%20Business) Business risks include challenges in NASH development, significant milestone payments, uncertain regulatory approvals, intense market competition, and difficult patient enrollment - Developing **DA-1241 for NASH** is difficult due to the lack of approved products and evolving regulatory pathways, making timing and costs unpredictable[155](index=155&type=chunk) - The company may be required to make **significant milestone and royalty payments** under the 2022 License Agreement, potentially impacting financial condition[156](index=156&type=chunk) - Successfully obtaining regulatory approval for product candidates is a **complex, lengthy, expensive, and uncertain process**, with a high risk of delay or denial[163](index=163&type=chunk)[164](index=164&type=chunk) - The company faces **substantial competition** in the development and commercialization of new products for T2D, NASH, obesity, and COVID-19 from larger, more experienced pharmaceutical and biotechnology companies[172](index=172&type=chunk)[175](index=175&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk)[181](index=181&type=chunk) - Enrollment and retention of patients in clinical trials, particularly for **NASH**, is an expensive, time-consuming process and can be hindered by various factors[170](index=170&type=chunk)[171](index=171&type=chunk) [Risks Relating to Our Common Stock and Ownership](index=44&type=section&id=Risks%20Relating%20to%20Our%20Common%20Stock%20and%20Ownership) Dong-A ST's potential majority ownership could grant significant control, leading to 'controlled company' status and potential conflicts, while warrants may cause dilution - If stockholder approval is received, **Dong-A ST** may own more than **50% of common stock**, leading to significant control and potential conflicts of interest with other shareholders[185](index=185&type=chunk)[188](index=188&type=chunk) - **Dong-A ST's significant ownership** could result in NeuroBo being a **'controlled company'** under Nasdaq rules, allowing exemptions from certain corporate governance requirements[190](index=190&type=chunk) - The terms of **Series B Convertible Preferred Stock and warrants** could impede the company's ability to enter into certain transactions or obtain additional financing[191](index=191&type=chunk)[194](index=194&type=chunk) - The exercise of **Series A and Series B Warrants** on a 'cashless' basis could result in additional dilution without providing additional proceeds to the company[196](index=196&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=48&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - No unregistered sales of equity securities or use of proceeds to report[197](index=197&type=chunk) [ITEM 3. Default upon Senior Securities](index=48&type=section&id=ITEM%203.%20Default%20upon%20Senior%20Securities) No defaults upon senior securities were reported for the period - No defaults upon senior securities to report[198](index=198&type=chunk) [ITEM 4. Mine Safety Disclosures](index=48&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[199](index=199&type=chunk) [ITEM 5. Other Information](index=48&type=section&id=ITEM%205.%20Other%20Information) No other information is reported for the period - No other information to report[200](index=200&type=chunk) [ITEM 6. Exhibits](index=49&type=section&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, key agreements, and executive certifications - Exhibits include **corporate governance documents** (Certificate of Incorporation, Bylaws, Certificates of Designation for Preferred Stock)[202](index=202&type=chunk) - Key agreements filed as exhibits include the **License Agreement and Securities Purchase Agreement with Dong-A ST**, and the **Underwriting Agreement** for the public offering[202](index=202&type=chunk)[204](index=204&type=chunk) - Certifications from the **Principal Executive Officer** and **Principal Financial Officer** are included[204](index=204&type=chunk) [SIGNATURES](index=51&type=section&id=SIGNATURES) This section contains the official signatures for the report, confirming its submission by authorized personnel [Report Signatures](index=51&type=section&id=Report%20Signatures) The report was signed by **Gil Price, M.D.**, President and CEO (Principal Financial Officer), on **November 14, 2022** - The report was signed by **Gil Price, M.D.**, President and Chief Executive Officer (Principal Financial Officer), on **November 14, 2022**[207](index=207&type=chunk)[208](index=208&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2022 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 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as specified in its charter) Delaware 47-2389984 (State or oth ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Form 10-Q Commission file number 001-37809 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2022 NeuroBo Pharmaceuticals, Inc. OR (Exact name of Registrant as specified in its charter) Delaware 47-2389984 (State or ot ...

Part I [Business](index=7&type=section&id=Item%201.%20Business) NeuroBo Pharmaceuticals is a clinical-stage biotech company developing treatments for neurodegenerative, infectious, and cardiometabolic diseases [Overview and Strategy](index=7&type=section&id=Overview%20and%20Strategy) NeuroBo is a clinical-stage biotech company with four therapeutic programs, acquired through ANA Therapeutics and Gemphire mergers - The company's current pipeline consists of four therapeutic programs: ANA001 (COVID-19), NB-01 (painful diabetic neuropathy), NB-02 (neurodegenerative diseases), and Gemcabene (cardiometabolic/COVID-19)[26](index=26&type=chunk)[28](index=28&type=chunk) - Key strategic elements include prioritizing the development of ANA001 for COVID-19, exploring alternative pathways for NB-01 such as an orphan drug or nutraceutical, seeking out-licensing for NB-02, and exploring new indications for Gemcabene[29](index=29&type=chunk) [Product Candidates](index=9&type=section&id=Product%20Candidates) The company's pipeline features ANA001 (COVID-19), NB-01 (painful diabetic neuropathy), NB-02 (neurodegenerative), and Gemcabene (cardiometabolic/COVID-19) NeuroBo Product Candidate Pipeline | Product Candidate | Indication | Development Stage | Key Notes | | :--- | :--- | :--- | :--- | | **ANA001** | Moderate COVID-19 | Phase 2/3 Clinical Trial | Lead drug candidate; proprietary oral niclosamide formulation. | | **NB-01** | Painful Diabetic Neuropathy (PDN) | Phase 2 Completed | Development on prior pathway ceased; exploring orphan drug or nutraceutical alternatives. | | **NB-02** | Neurodegenerative Diseases (e.g., Alzheimer's) | Preclinical | Assessing strategic alternatives, including out-licensing. | | **Gemcabene** | COVID-19 / Other Indications | Phase 2 Completed (for dyslipidemia) | Partial clinical hold for dyslipidemia; assessing new indications including COVID-19. - ANA001 (niclosamide) is being studied in a 60-subject Phase 2 clinical trial in the U.S. for moderate COVID-19, with a potential Phase 3 component[31](index=31&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk) - Development of NB-01 for painful diabetic neuropathy will not advance to Phase 3 trials on its prior regulatory pathway[103](index=103&type=chunk) - **Development of Gemcabene for dyslipidemia remains on a partial clinical hold** from the FDA[116](index=116&type=chunk)[123](index=123&type=chunk) [Licensing Agreements](index=42&type=section&id=Licensing%20Agreements) NeuroBo's operations are supported by key licensing agreements for ANA001, NB-01, and Gemcabene, involving milestone payments and royalties Key Licensing Agreement Terms | Product | Licensor/Partner | Key Financial Terms | | :--- | :--- | :--- | | **ANA001** | YourChoice Therapeutics | Aggregate milestone payments of $19.5 million and single-digit royalties. | | **NB-01** | Dong-A ST | Development milestones up to $98 million, sales milestones up to $80 million, and single to low-double digit royalties. | | **Gemcabene** | Pfizer | Milestone payments up to $37 million and tiered royalties from high-single digits to mid-teens. | | **Gemcabene (China)** | Beijing SL (Licensee) | Upfront payment of $2.5 million, developmental milestones up to $6 million, sales milestones up to $20 million, and tiered royalties from mid-teens to 20%. [Manufacturing](index=46&type=section&id=Manufacturing) The company relies on third-party contract manufacturers for all product candidates, which include small molecules and botanical drug products - The company outsources all manufacturing to contract manufacturers and does not own any production facilities[154](index=154&type=chunk)[162](index=162&type=chunk) - ANA001 and Gemcabene are small molecule drug candidates synthesized using readily available raw materials under cGMP standards[154](index=154&type=chunk)[162](index=162&type=chunk) - NB-01 and NB-02 are considered "botanical drug products" by the FDA, derived from plant species cultivated under GAP-compliant conditions[159](index=159&type=chunk)[161](index=161&type=chunk) [Competition](index=50&type=section&id=Competition) NeuroBo faces intense competition from major pharmaceutical and biotechnology companies with greater financial and technical resources - The company faces competition from large, well-resourced pharmaceutical and biotech companies[165](index=165&type=chunk)[166](index=166&type=chunk) Competitive Landscape by Product Candidate | Product Candidate | Indication | Key Competitors / Existing Therapies | | :--- | :--- | :--- | | **ANA001** | COVID-19 | Remdesivir (VEKLURY®), Nirmatrelvir/ritonavir (PAXLOVID™), Molnupiravir, various monoclonal antibodies. | | **NB-01** | Painful Diabetic Neuropathy | Pregabalin (LYRICA®), Duloxetine (CYMBALTA®), Tapentadol HCl (NUCYNTA®). | | **NB-02** | Alzheimer's Disease | Aducanumab (ADUHELM®), Donepezil (ARICEPT®), Rivastigmine (EXELON®), Memantine (NAMENDA®). [Intellectual Property](index=52&type=section&id=Intellectual%20Property) The company's IP strategy combines patents, trade secrets, and know-how across its product candidates, with varying expiration dates Intellectual Property Portfolio Summary (as of Dec 31, 2021) | Product Candidate | U.S. Patents/Applications | Foreign Patents/Applications | Estimated Expiration Range | | :--- | :--- | :--- | :--- | | **ANA001** | 4 provisional applications | PCT application filed | ~2041 | | **NB-01** | 4 issued patents, 2 pending | 65 granted patents, 1 pending | 2026 - 2033 | | **NB-02** | 2 issued patents, 2 pending | 24 granted patents, 9 pending | ~2035 | | **Gemcabene** | 8 issued patents, 7 pending | 36 granted patents, 46 pending | 2021 - 2039 | [Government Regulation](index=56&type=section&id=Government%20Regulation) The company's products are subject to extensive FDA regulation, including preclinical, clinical trials, and post-approval requirements - Pharmaceutical products require extensive regulation by the FDA, including preclinical studies, an effective IND application, and multi-phase clinical trials before an NDA can be submitted for marketing approval[187](index=187&type=chunk)[188](index=188&type=chunk) - Botanical drug products like NB-01 and NB-02 face specific FDA guidance, focusing on a "totality of the evidence" approach to ensure therapeutic consistency across batches[188](index=188&type=chunk)[237](index=237&type=chunk) - Nutraceuticals are regulated as "dietary supplements" under the Dietary Supplement, Health and Education Act (DSHEA), which does not require pre-market FDA approval for safety and efficacy, but mandates manufacturers to ensure their products are safe and claims are substantiated[208](index=208&type=chunk)[210](index=210&type=chunk) - The company's commercial success will depend on coverage and reimbursement from third-party payers like government programs (Medicare, Medicaid) and private insurers, which are increasingly focused on cost-containment[264](index=264&type=chunk)[266](index=266&type=chunk) [Risk Factors](index=83&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including going concern doubt, clinical trial delays, FDA holds, and internal control weaknesses - The company has a history of net losses (**$81.8 million accumulated deficit** as of Dec 31, 2021) and requires additional financing to continue operations, raising **substantial doubt about its ability to continue as a going concern**[284](index=284&type=chunk)[285](index=285&type=chunk)[289](index=289&type=chunk) - The **Phase 2 clinical trial for ANA001 is likely to be delayed** due to the suspension of trial sites in Ukraine and Poland following the Russian invasion, which may impact the timeline for potential Phase 3 progression[328](index=328&type=chunk) - The company is **not currently in compliance with Nasdaq's minimum bid price requirement** of $1.00 per share, which could lead to delisting if not resolved[459](index=459&type=chunk)[460](index=460&type=chunk) - **Material weaknesses in internal control over financial reporting** have been identified, specifically a **lack of segregation of duties** and issues with logical access to financial systems[480](index=480&type=chunk)[742](index=742&type=chunk) - **Development of Gemcabene for dyslipidemia remains on a partial clinical hold** by the FDA, creating significant uncertainty around its future[301](index=301&type=chunk)[309](index=309&type=chunk) [Properties](index=155&type=section&id=Item%202.%20Properties) The company leases corporate headquarters in Boston and research facilities in South Korea, deemed adequate for current needs - The company leases office space in Boston, MA (approx 40 sq ft) and research/lab facilities in Seoul, South Korea (approx 574 sq ft)[503](index=503&type=chunk) [Legal Proceedings](index=155&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - As of the report date, NeuroBo is not involved in any material legal proceedings[504](index=504&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=155&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under 'NRBO', with **26.66 million shares outstanding** and no plans for future dividends - The company's common stock is listed on The Nasdaq Capital Market under the ticker symbol "NRBO"[506](index=506&type=chunk) - As of March 25, 2022, there were **26,661,771 shares of common stock outstanding**[506](index=506&type=chunk) - The company has **never declared or paid dividends** and does not plan to in the foreseeable future[507](index=507&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=155&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) NeuroBo reported a $15.3 million net loss in 2021, with $16.4 million cash, raising going concern doubt and needing more financing [Results of Operations](index=167&type=section&id=Results%20of%20Operations) NeuroBo's net loss decreased to **$15.3 million** in 2021 from $29.7 million in 2020, primarily due to the absence of a one-time IPR&D charge Comparison of Operating Results (in thousands) | | For the Year Ended December 31, | Change | | :--- | :--- | :--- | :--- | | | **2021** | **2020** | **($)** | | Research and development | $6,546 | $4,531 | $2,015 | | Acquired in-process R&D | $0 | $17,339 | ($17,339) | | General and administrative | $8,752 | $7,846 | $906 | | **Total operating expenses** | **$15,298** | **$29,716** | **($14,418)** | | **Net loss** | **($15,284)** | **($29,678)** | **$14,394** | - The **$2.0 million increase in R&D expenses** in 2021 was primarily driven by a $1.9 million increase in clinical trial costs and a $0.4 million increase in drug manufacturing for the ANA001 program[551](index=551&type=chunk) - The **$17.3 million IPR&D expense** in 2020 was a one-time charge related to the acquisition of Niclosamide projects from the ANA merger[552](index=552&type=chunk) [Liquidity and Capital Resources](index=169&type=section&id=Liquidity%20and%20Capital%20Resources) As of Dec 31, 2021, the company had **$16.4 million** in cash, expected to fund operations into Q4 2022, raising going concern doubt - The company had cash and cash equivalents of **$16.4 million** as of December 31, 2021, which is expected to fund operations into the fourth quarter of 2022[520](index=520&type=chunk)[569](index=569&type=chunk) - These conditions raise **substantial doubt about the company's ability to continue as a going concern**, and additional capital will be needed to continue operations beyond Q4 2022[521](index=521&type=chunk)[525](index=525&type=chunk)[571](index=571&type=chunk) Cash Flow Summary (in thousands) | | For the Year Ended December 31, | | :--- | :--- | :--- | | | **2021** | **2020** | | Net cash used in operating activities | $(15,134) | $(10,764) | | Net cash (used in) provided by investing activities | $(586) | $69 | | Net cash provided by financing activities | $22,026 | $6,858 | - In 2021, the company raised a **total of $24.0 million in gross proceeds** from two equity offerings: a $10.0 million private placement in January and a $14.0 million registered direct offering in October[556](index=556&type=chunk)[557](index=557&type=chunk) [Financial Statements and Supplementary Data](index=179&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited financial statements for 2021 and 2020, with the auditor expressing **substantial doubt about going concern** - The report from the independent auditor, BDO USA, LLP, highlights a "**Going Concern Uncertainty**" due to the company's recurring losses and negative cash flows[597](index=597&type=chunk) Key Balance Sheet Data (in thousands) | | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash | $16,387 | $10,089 | | Total Assets | $16,799 | $10,968 | | Total Liabilities | $2,202 | $3,765 | | Total Stockholders' Equity | $14,597 | $7,203 | Key Income Statement Data (in thousands, except per share) | | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Total operating expenses | $15,298 | $29,716 | | Net loss | $(15,284) | $(29,678) | | Net loss per share | $(0.66) | $(1.83) | [Controls and Procedures](index=216&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls were **ineffective as of December 31, 2021** due to material weaknesses in segregation of duties and logical access controls - Management concluded that disclosure controls and procedures were **not effective as of December 31, 2021**[739](index=739&type=chunk) - Two material weaknesses were identified: a **lack of segregation of duties** over financial reporting (e.g., wire transfers, journal entries) and **inadequate logical access controls** over computer applications[742](index=742&type=chunk) - Remediation efforts are underway, including enhancing controls over wire disbursements, improving oversight of clinical trial expense accounting, and restricting administrator rights to financial systems[743](index=743&type=chunk)[745](index=745&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=218&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's Board of Directors is staggered, with key executive officers and an independent audit committee, adhering to a code of ethics - The Board of Directors is divided into three classes with staggered three-year terms[749](index=749&type=chunk) - Ben Gil Price, M.D. serves as the President and Chief Executive Officer[751](index=751&type=chunk) - The Audit Committee is composed of independent directors D. Gordon Strickland (Chair), Andrew Koven, and Jason Groves, with Mr. Strickland qualifying as an "audit committee financial expert"[768](index=768&type=chunk) [Executive Compensation](index=226&type=section&id=Item%2011.%20Executive%20Compensation) The 2021 summary compensation table details payments to named executive officers, including Dr. Ben Gil Price's inducement stock option award 2021 Summary Compensation Table | Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | All Other Comp. ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Ben Gil Price (President & CEO) | 2021 | 66,154 | — | 854,122 | — | 920,276 | | Richard Kang (Former President & CEO) | 2021 | 260,769 | 130,680 | — | 160,000 | 551,449 | | Akash Bakshi (Former COO) | 2021 | 250,000 | — | — | 125,000 | 375,000 | - Dr. Ben Gil Price's employment agreement includes an **annual base salary of $400,000** and a **target bonus of 50% of base salary**[776](index=776&type=chunk)[777](index=777&type=chunk) - He received an **inducement stock option award to purchase 616,666 shares**[777](index=777&type=chunk) - In connection with his resignation, former CEO Dr. Richard Kang received a **severance package including $150,000 in cash**, a **prorated 2021 bonus of $130,680**, and a one-year consulting agreement[782](index=782&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=232&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Significant beneficial ownership is concentrated among E&Investment, Dong-A ST, and other entities, with management owning **27.9%** Security Ownership of Major Shareholders (as of March 25, 2022) | Name of Beneficial Owner | Shares Beneficially Owned | Percentage | | :--- | :--- | :--- | | E&Investment, Inc. | 7,321,789 | **27.5%** | | Dong-A ST Co., Ltd. | 2,880,612 | **10.8%** | | JK BioPharma Solutions, Inc. | 1,817,842 | **6.8%** | | Roy Lester Freeman | 1,456,160 | **5.5%** | | All current executive officers and directors as a group (8 persons) | 7,473,455 | **27.9%** | [Certain Relationships and Related Transactions, and Director Independence](index=238&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company has **related party transactions with Dong-A ST** and has determined a **majority of its directors are independent** under Nasdaq rules - The company has a **manufacturing and supply agreement with Dong-A ST**, a shareholder with over 5% beneficial ownership, for the production of NB-01 drug substance[808](index=808&type=chunk) - The Board has determined that a **majority of its directors are independent** as defined by Nasdaq listing rules[816](index=816&type=chunk) [Principal Accountant Fees and Services](index=240&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) BDO USA, LLP provided audit services for 2021 and 2020, with all fees pre-approved by the Audit Committee Audit Fees Paid to BDO USA, LLP | Fee Category | Fiscal Year 2021 | Fiscal Year 2020 | | :--- | :--- | :--- | | Audit fees | $343,034 | $535,691 | | **Total fees** | **$343,034** | **$535,691** | - **All audit and permissible non-audit services provided by the independent auditor were pre-approved** by the company's audit committee[822](index=822&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=242&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the Form 10-K, including material contracts and certifications, with no financial statement schedules - This section contains a list of all exhibits filed with the Form 10-K, including material contracts and certifications[823](index=823&type=chunk)

Table of Contents 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 September 30, 2021 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 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Delaware 47-23899 ...