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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 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 47-23899 ...

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 ...

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, 2021 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 other j ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ⌧ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2021 (Exact name of Registrant as specified in its charter) Delaware 47-2389984 (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) 200 Berkeley Street, Office 19th Floor (Address of principal executive offices) (Zip Code) Bost ...