Dosed First Patient in the Single Ascending Dose Part 1 of the Phase 1 Clinical Trial of DA-1726 in Obesity, With Top-Line Data Readout Expected in the Third Quarter of 2024 Anticipate First Patient to be Dosed in the Multiple Ascending Dose Part 2 of the Phase 1 Clinical Trial of DA-1726 in the Third Quarter of 2024 Part 2 of the Phase 2a Trial of DA-1241 for the Treatment of MASH Underway After Enrollment of Part 1 Completed, With Data Expected in the Fourth Quarter of 2024 Cash of $16.0 Million, Expected ...

CAMBRIDGE, Mass., April 30, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced the acceptance of poster presentations for its promising cardiometabolic assets, DA-1241 and DA-1726, at the EASL Congress 2024 and the American Diabetes Association (ADA) 84th Scientific Sessions in June. "Having multiple posters selected for presentation at two of the most esteemed scientific forums ...

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, 2023 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 ...

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 ...