UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the Fiscal Year Ended December 31, 2020 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from _____ to _____ Commission File No. 001-34079 Ocuphire Pharma, Inc. (Exact name of registrant as specified in its charter) Delaware 11-3516358 (State or other jurisdiction of i ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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, 2020 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 No.:001-34079 Rexahn Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 11-3516358 (State or other j ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 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 No.:001-34079 Rexahn Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 11-3516358 (State or other jurisd ...

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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the transition period from to Commission File No.:001-34079 Rexahn Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 11-3516358 (State or other juris ...

PART I [Item 1. Description of Business](index=5&type=section&id=Item%201.%20Description%20of%20Business) Rexahn Pharmaceuticals is a clinical-stage biopharmaceutical company developing innovative cancer therapies, exploring strategic alternatives and reducing headcount - **Rexahn Pharmaceuticals** is a clinical-stage biopharmaceutical company developing innovative therapies for difficult-to-treat cancers[15](index=15&type=chunk) - The company's pipeline includes **two clinical-stage oncology product candidates (RX-3117, RX-5902)** and additional compounds in preclinical development (RX-0301)[15](index=15&type=chunk) - The company commenced a process in September 2019 to explore strategic alternatives to enhance shareholder value, including potential acquisition, merger, or asset sales, and has reduced its headcount to **five employees**[17](index=17&type=chunk)[230](index=230&type=chunk) [Overview](index=5&type=section&id=Overview) Rexahn Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapies for difficult-to-treat cancers, aiming to maximize efficacy and minimize toxicity - **Rexahn Pharmaceuticals** is a clinical stage biopharmaceutical company focused on developing innovative therapies to improve patient outcomes in difficult-to-treat cancers[15](index=15&type=chunk) - The company's mission is to maximize efficacy and minimize toxicity/side effects of cancer treatments[15](index=15&type=chunk) - The pipeline includes **two clinical-stage oncology product candidates** and additional compounds in preclinical development[15](index=15&type=chunk) [Pipeline Product Candidates](index=5&type=section&id=Pipeline%20Product%20Candidates) The company's pipeline features RX-3117 for pancreatic cancer, RX-5902 for TNBC, and preclinical RX-0301, with ongoing development and strategic collaborations - **RX-3117**, an oral small molecule nucleoside compound, is in a Phase 2a clinical trial for metastatic pancreatic cancer, showing an overall response rate of **23% in 40 patients** as of July 2019, and has received orphan drug designation[16](index=16&type=chunk)[26](index=26&type=chunk) - **RX-5902**, a potential first-in-class small molecule modulator of the Wnt/beta-catenin pathway, is being evaluated in a proposed combination trial with KEYTRUDA for metastatic TNBC, with monotherapy enrollment ceased in December 2018[16](index=16&type=chunk)[31](index=31&type=chunk) - **RX-0301**, a potential best-in-class Akt-1 inhibitor, is in preclinical development by HaiChang, which received an exclusive worldwide license for RX-0201 and RX-0301 in February 2020[17](index=17&type=chunk)[33](index=33&type=chunk) [Industry and Disease Markets](index=6&type=section&id=Industry%20and%20Disease%20Markets) Traditional cancer treatments face limitations, creating unmet needs for effective metastatic cancer therapies and favorable market opportunities for innovative new drugs - Traditional cancer treatments have limitations, including limited efficacy for metastatic disease, multi-drug resistance, and debilitating side effects[18](index=18&type=chunk) - Unmet needs include effective treatments for metastatic cancer, long-term management, overcoming multi-drug resistance, and reducing chemotherapy toxicity[20](index=20&type=chunk) - Favorable market opportunities exist for new cancer drugs, especially those that are **first-in-class or market leaders**, due to expedited regulatory pathways, favorable reimbursement, and lower marketing costs[20](index=20&type=chunk) [Research and Development Process](index=10&type=section&id=Research%20and%20Development%20Process) The company relies on third-party CROs and collaborators for R&D, which introduces risks of delays and increased expenses due to lack of direct control - The company relies on third-party **Contract Research Organizations (CROs)** and other collaborators for preclinical studies, toxicology studies, and clinical trials[34](index=34&type=chunk) - Reliance on third parties means that the completion of trials and studies is not within direct control and may lead to delays and additional expenses[34](index=34&type=chunk) [Competition](index=10&type=section&id=Competition) The biotechnology and pharmaceutical industries are intensely competitive, with the company's product candidates facing competition from larger companies and existing/developing drugs - The biotechnology and pharmaceutical industries are intensely competitive, with many larger companies having greater resources and experience[35](index=35&type=chunk)[38](index=38&type=chunk) - **RX-3117** could compete with other anti-metabolite compounds like NUC-1031, capecitabine, and gemcitabine[39](index=39&type=chunk) - **RX-5902**, if approved, could compete with drugs like LYNPARZA, sacituzumab govitecan, and various PD-1 inhibitors for TNBC[39](index=39&type=chunk) - **RX-0301** could compete with other Akt-1 inhibitors under development by major pharmaceutical companies[39](index=39&type=chunk) [Government Regulation](index=11&type=section&id=Government%20Regulation) Product development, manufacturing, and marketing are subject to rigorous U.S. and foreign governmental regulations, including lengthy FDA approval processes and post-approval compliance - Product development, manufacturing, and marketing are subject to rigorous U.S. and foreign governmental regulations, including preclinical, clinical, and post-approval testing[40](index=40&type=chunk) - The **FDA approval process** is lengthy, complex, and expensive, involving preclinical testing, IND application, three phases of clinical trials, and NDA submission and review[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk)[50](index=50&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk)[54](index=54&type=chunk) - Regulatory exclusivities like **Hatch-Waxman (5-year NCE, 3-year new clinical data)** and **Orphan Drug Act (7-year exclusivity)** provide market protection[61](index=61&type=chunk)[64](index=64&type=chunk) - Post-approval regulations include **Good Manufacturing Practices (cGMP)**, strict sales and marketing rules, and compliance with fraud and abuse laws such as the Anti-Kickback Law and False Claims Act[71](index=71&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk)[80](index=80&type=chunk) - The company is also subject to federal, state, and foreign data privacy laws, including **HIPAA and CCPA**, governing the collection, use, disclosure, and protection of health-related and personal information[81](index=81&type=chunk) [Coverage and Reimbursement](index=19&type=section&id=Coverage%20and%20Reimbursement) Uncertainty surrounds coverage and reimbursement for new product candidates, with commercialization success dependent on timely and adequate payments from government and private payors amid cost containment trends - Significant uncertainty exists regarding coverage and reimbursement for new product candidates, which varies widely by country and can involve additional costs and delays[82](index=82&type=chunk) - Commercialization success depends on timely and adequate reimbursement from government (Medicare, Medicaid) and private third-party payors, who often limit coverage to specific formularies and challenge drug prices[83](index=83&type=chunk)[85](index=85&type=chunk) - **Cost containment** is a primary trend in healthcare, leading to increased scrutiny of prices, medical necessity, and cost-effectiveness, potentially impacting demand and pricing for approved products[85](index=85&type=chunk) [United States Healthcare Reform](index=20&type=section&id=United%20States%20Healthcare%20Reform) The Affordable Care Act (ACA) and other legislative changes create uncertainty for the pharmaceutical industry, potentially impacting product commercialization, coverage, payment, and profitability - The **Affordable Care Act (ACA)** has significantly changed healthcare financing, aiming to broaden access, constrain spending, and impose new taxes/fees on manufacturers[90](index=90&type=chunk) - The ACA has faced judicial challenges and efforts to repeal or replace it, creating uncertainty about its future impact on the pharmaceutical industry and the company's ability to commercialize products[90](index=90&type=chunk) - Other legislative changes, such as **Medicare payment reductions (sequestration)**, could further pressure coverage, payment, and prices for approved products, potentially harming future revenues and profitability[91](index=91&type=chunk)[92](index=92&type=chunk) [Sales and Marketing](index=22&type=section&id=Sales%20and%20Marketing) The company lacks internal sales and marketing infrastructure and plans to seek strategic alliances and partnerships for product commercialization - The company currently lacks the internal sales and marketing infrastructure necessary to sell and market products[94](index=94&type=chunk) - Rexahn anticipates seeking strategic alliances and partnerships with third parties for commercialization, as building internal infrastructure is expensive, complicated, and time-consuming[94](index=94&type=chunk) [Manufacturing and Distribution](index=22&type=section&id=Manufacturing%20and%20Distribution) The company relies entirely on third-party contractors for all manufacturing, supply, storage, and distribution of its product candidates, with no plans for internal capacity - The company has no experience or internal capacity in drug formulation or manufacturing, relying entirely on third-party contractors for manufacturing, supply, storage, and distribution of product candidates[95](index=95&type=chunk) - There are no current plans to build internal manufacturing capacity or long-term supply arrangements[95](index=95&type=chunk) [Intellectual Property](index=22&type=section&id=Intellectual%20Property) The company seeks proprietary patent and IP protection for its product candidates, processes, and know-how, with patent portfolios for RX-3117 and RX-5902 expiring from 2025 to 2036 - The company seeks proprietary patent and intellectual property (IP) protection for its product candidates, processes, and know-how, relying on patents, trade secrets, and licensing[96](index=96&type=chunk) - The patent portfolio for **RX-3117** consists of three families with patents expiring from **2025 to 2036**, covering composition of matter, use, and process claims[98](index=98&type=chunk) - The patent portfolio for **RX-5902** also consists of three families with patents expiring from **2025 to 2036**, covering composition of matter, use, formulation, and process claims[99](index=99&type=chunk) [Collaboration and License Arrangements](index=23&type=section&id=Collaboration%20and%20License%20Arrangements) The company has several key collaboration and license agreements, including with BioSense Global for RX-3117, HaiChang for RX-0201/RX-0301, and Merck for RX-5902 with KEYTRUDA - **BioSense Global LLC** was granted an exclusive license to develop and commercialize **RX-3117** in specific Asian territories, with Rexahn eligible for up to **$126 million** in development/regulatory milestones and up to **$100 million** in sales milestones[101](index=101&type=chunk) - **Zhejiang HaiChang Biotechnology Co., Ltd.** entered an exclusive worldwide license agreement for **RX-0201, RX-0301, and RX-0047**, including a **$250,000 upfront payment** and up to **$96 million** in development milestones[104](index=104&type=chunk)[105](index=105&type=chunk) - **Merck Sharp & Dohme B.V.** entered a clinical trial collaboration and supply agreement in August 2018 to evaluate **RX-5902 with KEYTRUDA** in metastatic TNBC, with Rexahn sponsoring the trial and Merck supplying KEYTRUDA[107](index=107&type=chunk) - **Next BT** had its exclusive license to **RX-0201** in Asia reinstated in June 2018, while Rexahn retained rights to RX-0301 in Asia and elsewhere[109](index=109&type=chunk) - **Korea Research Institute of Chemical Technology (KRICT)** licensed IP related to quinoxaline-piperazine derivatives, including RX-5902, with a **one-time $1,000,000 milestone payment** due upon FDA marketing approval[111](index=111&type=chunk) [Employees](index=25&type=section&id=Employees) As of February 21, 2020, the company employed five full-time individuals - As of February 21, 2020, the company employed **five full-time individuals**[112](index=112&type=chunk) [Corporate Information](index=25&type=section&id=Corporate%20Information) Rexahn Pharmaceuticals, Inc. is a Delaware corporation with principal executive offices located in Rockville, Maryland - **Rexahn Pharmaceuticals, Inc.** is a Delaware corporation with principal executive offices in Rockville, Maryland[113](index=113&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks, including uncertainties in strategic alternatives, capital needs, clinical trial failures, reliance on third parties, intense competition, regulatory complexities, and intellectual property challenges - The evaluation of strategic alternatives may not result in a definitive transaction, could distract management, and may adversely affect operating results and business[116](index=116&type=chunk) - The company has no product revenues, incurred negative cash flows since inception, and will need to raise additional capital, which may not be available on favorable terms or at all, potentially leading to reduced or discontinued R&D activities[117](index=117&type=chunk)[120](index=120&type=chunk) - Clinical trials for product candidates are expensive, time-consuming, and difficult, with no guarantee of success or regulatory approval, and may be delayed or terminated[127](index=127&type=chunk)[128](index=128&type=chunk)[131](index=131&type=chunk) - Undesirable side effects from product candidates could delay or prevent regulatory approval, limit commercial viability, or lead to significant negative consequences post-approval[140](index=140&type=chunk)[141](index=141&type=chunk) - The company relies heavily on third-party CROs and manufacturers, exposing it to risks of delays, substandard performance, and higher costs if these third parties fail to meet obligations or comply with regulations[191](index=191&type=chunk)[196](index=196&type=chunk)[197](index=197&type=chunk) - The biotechnology and pharmaceutical industries are intensely competitive, with larger competitors possessing greater resources, potentially rendering the company's products obsolete or non-competitive[176](index=176&type=chunk)[177](index=177&type=chunk)[180](index=180&type=chunk) - Protecting intellectual property rights globally is challenging due to varying patent laws and enforcement, and the company faces risks of infringement claims from third parties[210](index=210&type=chunk)[212](index=212&type=chunk) [Item 1B. Unresolved Staff Comments](index=50&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reported no unresolved staff comments from the SEC - There are no unresolved staff comments[219](index=219&type=chunk) [Item 2. Description of Property](index=50&type=section&id=Item%202.%20Description%20of%20Property) The company's corporate headquarters in Rockville, Maryland, consists of 5,466 square feet of leased office space under a lease expiring in June 2024 - Corporate headquarters are in Rockville, Maryland, occupying **5,466 square feet** of leased office space[220](index=220&type=chunk) - The current lease for the office space expires in **June 2024**[220](index=220&type=chunk) - Management considers the current facilities adequate for present needs[220](index=220&type=chunk) [Item 3. Legal Proceedings](index=50&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any litigation or legal proceedings that management believes would have a material adverse effect on its business - The company is not currently party to any litigation or legal proceedings that are likely to have a material adverse effect on its business[221](index=221&type=chunk) [Item 4. Mine Safety Disclosures](index=50&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable to Rexahn Pharmaceuticals, Inc[222](index=222&type=chunk) PART II [Item 5. Market for Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=51&type=section&id=Item%205.%20Market%20for%20Common%20Equity%2C%20Related%20Stockholder%20Matters%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the Nasdaq Capital Market under 'REXN', with approximately 22 stockholders of record as of February 21, 2020 - Common stock is traded on **Nasdaq Capital Market** under the ticker symbol "**REXN**"[225](index=225&type=chunk) - As of February 21, 2020, there were approximately **22 stockholders of record**[225](index=225&type=chunk) [Item 6. Selected Financial Data](index=51&type=section&id=Item%206.%20Selected%20Financial%20Data) The company is not required to provide selected financial data for this report - Selected Financial Data is not required for this report[226](index=226&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=52&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Rexahn Pharmaceuticals, a clinical-stage biopharmaceutical company, reported a net loss of **$8.6 million** in 2019, an improvement from **$14.4 million** in 2018, with **$12.2 million** in cash and equivalents for future operations - **Rexahn Pharmaceuticals** is a clinical stage biopharmaceutical company with no product sales to date, relying on financings and licensing for working capital[229](index=229&type=chunk)[230](index=230&type=chunk) - The company is exploring strategic alternatives to enhance shareholder value and has reduced its headcount to **five employees**[230](index=230&type=chunk) - Key Financial Results (2019 vs. 2018) | Metric | 2019 (in thousands) | 2018 (in thousands) | Change (YoY) | Change (%) | | :-------------------------------- | :------------------ | :------------------ | :----------- | :--------- | | Total Revenues | $0 | $0 | $0 | 0% | | General and Administrative Expenses | $5,738 | $7,429 | $(1,691) | -22.8% | | Research and Development Expenses | $5,477 | $13,109 | $(7,632) | -58.2% | | Interest Income | $314 | $254 | $59 | 23.3% | | Other Income | $0 | $369 | $(369) | -100% | | Unrealized Gain on Fair Value of Warrants | $2,266 | $5,546 | $(3,280) | -59.1% | | Net Loss | $(8,635) | $(14,369) | $5,733 | -39.9% | | Net Loss per Share (basic and diluted) | $(2.18) | $(5.25) | $3.07 | -58.5% | | Weighted Average Shares Outstanding | 3,960,163 | 2,738,506 | 1,221,657 | 44.6% | - Cash, cash equivalents, and marketable securities totaled approximately **$12.2 million** as of December 31, 2019, believed sufficient for at least the next **12 months**[254](index=254&type=chunk)[306](index=306&type=chunk) - Cash Flow Summary (2019 vs. 2018) | Cash Flow Activity | 2019 (in thousands) | 2018 (in thousands) | | :-------------------------------- | :------------------ | :------------------ | | Net Cash Used in Operating Activities | $(10,277) | $(18,839) | | Net Cash Provided By Investing Activities | $3,099 | $11,911 | | Net Cash Provided by Financing Activities | $7,654 | $6,773 | | Net Increase (Decrease) in Cash and Cash Equivalents | $475 | $(155) | - Financing activities included an underwritten public offering in January 2019, generating gross proceeds of **$8.6 million**, and a registered direct public offering in October 2018, generating gross proceeds of **$7.5 million**[259](index=259&type=chunk)[260](index=260&type=chunk) [Overview](index=52&type=section&id=OVERVIEW) Rexahn Pharmaceuticals is a clinical-stage biopharmaceutical company developing innovative cancer therapies, with no product sales, funding operations through financings and licensing, and exploring strategic alternatives - **Rexahn Pharmaceuticals** is a clinical stage biopharmaceutical company developing innovative therapies for difficult-to-treat cancers, with a pipeline of clinical-stage and preclinical product candidates[229](index=229&type=chunk) - The company has no product sales and funds operations through financings and licensing agreements[230](index=230&type=chunk) - A process to explore strategic alternatives was initiated in September 2019, leading to a reduction in headcount to **five employees**[230](index=230&type=chunk) [Critical Accounting Policies](index=52&type=section&id=Critical%20Accounting%20Policies) Critical accounting policies involve significant management judgments and estimates, particularly for stock-based compensation, warrant liabilities, marketable securities, and R&D contract costs - Critical accounting policies involve significant management judgments and estimates, particularly for stock-based compensation, warrant liabilities, marketable securities, and research and development contract costs[231](index=231&type=chunk) - Research and development costs, including third-party service costs and costs to acquire product rights, are expensed as incurred[232](index=232&type=chunk)[233](index=233&type=chunk) - Warrants are classified as either equity or liabilities at fair value, with changes in liability-classified warrants recorded as unrealized gains or losses in the statement of operations[238](index=238&type=chunk) [Recently Issued Accounting Standards](index=54&type=section&id=Recently%20Issued%20Accounting%20Standards) The company adopted ASU 2016-02, Leases, on January 1, 2019, recognizing lease assets and liabilities for operating leases with no material financial impact - The company adopted **ASU 2016-02, Leases**, on **January 1, 2019**, requiring recognition of lease assets and liabilities for operating leases[324](index=324&type=chunk) - Adoption resulted in recognition of additional net right-of-use assets and lease liabilities, but had no material impact on financial statements or liquidity[325](index=325&type=chunk) [Results of Operations](index=54&type=section&id=Results%20of%20Operations) The company reported a net loss of **$8.6 million** in 2019, a **39.9%** improvement from 2018, primarily due to significant reductions in R&D and G&A expenses - Revenue and Expense Comparison (2019 vs. 2018) | Metric | 2019 (in thousands) | 2018 (in thousands) | Change (YoY) | Change (%) | | :-------------------------------- | :------------------ | :------------------ | :----------- | :--------- | | Total Revenues | $0 | $0 | $0 | 0% | | General and Administrative Expenses | $5,738 | $7,429 | $(1,691) | -22.8% | | Research and Development Expenses | $5,477 | $13,109 | $(7,632) | -58.2% | | Interest Income | $314 | $254 | $59 | 23.3% | | Other Income | $0 | $369 | $(369) | -100% | | Unrealized Gain on Fair Value of Warrants | $2,266 | $5,546 | $(3,280) | -59.1% | | Net Loss | $(8,635) | $(14,369) | $5,733 | -39.9% | - The decrease in General and Administrative expenses was primarily due to lower personnel and operating costs from streamlining operations[245](index=245&type=chunk) - The significant decrease in Research and Development expenses resulted from the completion of enrollment in **RX-3117 and RX-5902 clinical trials**, reduced drug manufacturing costs, elimination of certain preclinical activities, and headcount reductions[246](index=246&type=chunk) - Research and Development Project Expenses (2019 vs. 2018) | Project | 2019 (in thousands) | 2018 (in thousands) | | :-------------------------------- | :------------------ | :------------------ | | RX-3117 | $3,088.9 | $6,126.2 | | RX-5902 | $887.2 | $3,104.4 | | RX-0201 | $175.6 | $651.2 | | Preclinical, Personnel and Overhead | $1,325.1 | $3,227.3 | | **Total R&D Expenses** | **$5,476.8** | **$13,109.1** | - Unrealized gains on fair value of warrants decreased due to a significant decrease in the underlying common stock price[251](index=251&type=chunk) [Liquidity and Capital Resources](index=56&type=section&id=Liquidity%20and%20Capital%20Resources) The company has incurred negative operating cash flow since inception but projects its **$12.2 million** in cash and equivalents as of December 31, 2019, will cover requirements for at least the next 12 months - The company has incurred negative cash flow from operations since inception and expects this to continue while exploring strategic alternatives[254](index=254&type=chunk) - Cash, cash equivalents, and marketable securities of approximately **$12.2 million** as of December 31, 2019, are projected to cover cash flow requirements for at least the next **12 months**[254](index=254&type=chunk) - Cash Flow Activities (2019 vs. 2018) | Cash Flow Activity | 2019 (in thousands) | 2018 (in thousands) | | :-------------------------------- | :------------------ | :------------------ | | Net Cash Used in Operating Activities | $(10,277) | $(18,839) | | Net Cash Provided By Investing Activities | $3,099 | $11,911 | | Net Cash Provided by Financing Activities | $7,654 | $6,773 | | Net Increase (Decrease) in Cash and Cash Equivalents | $475 | $(155) | - Operating cash flow improved in 2019 due to a lower net loss and reduced unrealized gain on warrants[255](index=255&type=chunk) - Financing activities in 2019 included **$7.65 million** from an underwritten offering, and in 2018, **$6.77 million** from a registered direct public offering[258](index=258&type=chunk)[259](index=259&type=chunk)[260](index=260&type=chunk) - The company has no off-balance sheet arrangements or holdings in variable interest entities[261](index=261&type=chunk) [Item 7A. Qualitative and Quantitative Disclosures About Market Risk](index=58&type=section&id=Item%207A.%20Qualitative%20and%20Quantitative%20Disclosures%20About%20Market%20Risk) The company is not required to provide qualitative and quantitative disclosures about market risk - Qualitative and Quantitative Disclosures About Market Risk are not required[263](index=263&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=58&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The company's financial statements and the Report of the Independent Registered Public Accounting Firm are included in this Annual Report starting on page F-1 - Financial statements and the Report of the Independent Registered Public Accounting Firm are included in the Annual Report starting on page **F-1**[264](index=264&type=chunk) [Item 9. Changes In and Disagreements with Accountants on Accounting and Financial Disclosure](index=58&type=section&id=Item%209.%20Changes%20In%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reported no changes in or disagreements with accountants on accounting and financial disclosure - There were no changes in or disagreements with accountants on accounting and financial disclosure[265](index=265&type=chunk) [Item 9A. Controls and Procedures](index=59&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2019, with no material changes during the quarter - Disclosure controls and procedures were evaluated and deemed effective as of **December 31, 2019**[266](index=266&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended **December 31, 2019**[267](index=267&type=chunk) - Management concluded that internal control over financial reporting was effective as of **December 31, 2019**, based on the **COSO Internal Control-Integrated Framework (2013)**[271](index=271&type=chunk) [Item 9B. Other Information](index=60&type=section&id=Item%209B.%20Other%20Information) The company reported no other information required under this item - There is no other information to report under this item[273](index=273&type=chunk) PART III [Item 10. Directors, Executive Officers, and Corporate Governance](index=61&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance will be incorporated by reference from the company's 2020 Proxy Statement - Information for this item will be incorporated by reference from the **2020 Proxy Statement**[274](index=274&type=chunk) [Item 11. Executive Compensation](index=61&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation will be incorporated by reference from the company's 2020 Proxy Statement - Information for this item will be incorporated by reference from the **2020 Proxy Statement**[275](index=275&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=61&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of certain beneficial owners and management, and related stockholder matters, will be incorporated by reference from the company's 2020 Proxy Statement - Information for this item will be incorporated by reference from the **2020 Proxy Statement**[276](index=276&type=chunk) [Item 13. Certain Relationships and Related Transactions; and Director Independence](index=61&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%3B%20and%20Director%20Independence) Information regarding certain relationships and related transactions, and director independence, will be incorporated by reference from the company's 2020 Proxy Statement - Information for this item will be incorporated by reference from the **2020 Proxy Statement**[277](index=277&type=chunk) [Item 14. Principal Accounting Fees and Services](index=61&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services will be incorporated by reference from the company's 2020 Proxy Statement - Information for this item will be incorporated by reference from the **2020 Proxy Statement**[278](index=278&type=chunk) Item 15. Exhibits, Financial Statement Schedules [Item 15. Exhibits, Financial Statement Schedules](index=62&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists documents filed as part of the Annual Report, including financial statements, corporate documents, and collaboration/license agreements, with all financial statement schedules omitted - The Annual Report includes financial statements, corporate documents, common stock purchase warrants, and collaboration/license agreements as exhibits[280](index=280&type=chunk)[285](index=285&type=chunk)[286](index=286&type=chunk)[287](index=287&type=chunk) - All financial statement schedules are omitted because they are not applicable, not required, or the information is included elsewhere[283](index=283&type=chunk) Item 16. Form 10-K Summary [Item 16. Form 10-K Summary](index=62&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company did not provide a Form 10-K Summary - No Form 10-K Summary is provided[281](index=281&type=chunk) SIGNATURES [SIGNATURES](index=67&type=section&id=SIGNATURES) The Annual Report on Form 10-K was duly signed by Douglas J. Swirsky, President, CEO, and Director, and other directors on February 21, 2020 - The report was signed by **Douglas J. Swirsky**, President, Chief Executive Officer, and Director, and other directors on **February 21, 2020**[291](index=291&type=chunk)[292](index=292&type=chunk) Financial Statements [REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM](index=68&type=section&id=REPORT%20OF%20INDEPENDENT%20REGISTERED%20PUBLIC%20ACCOUNTING%20FIRM) Baker Tilly Virchow Krause, LLP issued an unqualified opinion on Rexahn Pharmaceuticals, Inc.'s financial statements for 2019 and 2018, confirming fair presentation in conformity with U.S. GAAP - **Baker Tilly Virchow Krause, LLP** audited the financial statements for **December 31, 2019 and 2018**[294](index=294&type=chunk) - The auditors issued an **unqualified opinion**, confirming that the financial statements fairly present the company's financial position and results of operations in accordance with **U.S. GAAP**[294](index=294&type=chunk) - The audit was conducted in accordance with **PCAOB standards**, including assessing risks of material misstatement and evaluating accounting principles and estimates[296](index=296&type=chunk)[297](index=297&type=chunk) [Balance Sheet](index=69&type=section&id=Balance%20Sheet) Total assets decreased from **$16.04 million** to **$12.97 million** in 2019, while total liabilities significantly decreased from **$5.48 million** to **$3.01 million**, primarily due to reduced warrant liabilities - Balance Sheet Summary (December 31, 2019 vs. 2018) | Category | December 31, 2019 (in thousands) | December 31, 2018 (in thousands) | Change (YoY) | Change (%) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------- | :--------- | | **ASSETS** | | | | | | Cash and cash equivalents | $9,220 | $8,744 | $476 | 5.4% | | Marketable securities | $2,997 | $5,982 | $(2,985) | -49.9% | | Prepaid expenses and other current assets | $447 | $1,174 | $(727) | -61.9% | | Total Current Assets | $12,664 | $15,900 | $(3,236) | -20.4% | | Total Assets | $12,969 | $16,043 | $(3,074) | -19.2% | | **LIABILITIES** | | | | | | Accounts payable and accrued expenses | $1,266 | $3,153 | $(1,887) | -59.8% | | Deferred revenue | $1,500 | $0 | $1,500 | N/A | | Warrant Liabilities | $42 | $2,308 | $(2,266) | -98.2% | | Total Liabilities | $3,011 | $5,480 | $(2,469) | -45.1% | | **STOCKHOLDERS' EQUITY** | | | | | | Additional paid-in capital | $173,278 | $165,268 | $8,010 | 4.8% | | Accumulated deficit | $(163,323) | $(154,687) | $(8,636) | 5.6% | | Accumulated Other Comprehensive Income (Loss) | $2 | $(18) | $20 | -111.1% | | **Total Stockholders' Equity** | **$9,958** | **$10,563** | $(605) | -5.7% | - The significant decrease in total liabilities was primarily driven by a substantial reduction in **warrant liabilities** and accounts payable and accrued expenses[299](index=299&type=chunk) - The accumulated deficit increased to **$163.3 million** as of December 31, 2019, reflecting ongoing net losses[299](index=299&type=chunk) [Statement of Operations](index=70&type=section&id=Statement%20of%20Operations) Net loss significantly decreased by **39.9%** from **$14.37 million** in 2018 to **$8.64 million** in 2019, primarily due to substantial reductions in R&D and G&A expenses - Statement of Operations Summary (2019 vs. 2018) | Metric | 2019 (in thousands) | 2018 (in thousands) | Change (YoY) | Change (%) | | :-------------------------------- | :------------------ | :------------------ | :----------- | :--------- | | Revenues | $0 | $0 | $0 | 0% | | General and administrative | $5,738 | $7,429 | $(1,691) | -22.8% | | Research and development | $5,477 | $13,109 | $(7,632) | -58.2% | | Total Expenses | $11,215 | $20,538 | $(9,323) | -45.4% | | Loss from Operations | $(11,215) | $(20,538) | $9,323 | -45.4% | | Interest income | $314 | $254 | $59 | 23.3% | | Other income | $0 | $369 | $(369) | -100% | | Unrealized gain on fair value of warrants | $2,266 | $5,546 | $(3,280) | -59.1% | | Total Other Income | $2,580 | $6,169 | $(3,589) | -58.2% | | Net Loss | $(8,635) | $(14,369) | $5,733 | -39.9% | | Net loss per share, basic and diluted | $(2.18) | $(5.25) | $3.07 | -58.5% | - The decrease in net loss was primarily driven by a substantial reduction in research and development expenses (down **$7.6 million**) and general and administrative expenses (down **$1.7 million**)[245](index=245&type=chunk)[246](index=246&type=chunk)[300](index=300&type=chunk) - Interest income increased by **23.3%** due to higher interest rates on cash and marketable securities[249](index=249&type=chunk)[300](index=300&type=chunk) [Statement of Comprehensive Loss](index=71&type=section&id=Statement%20of%20Comprehensive%20Loss) Comprehensive loss decreased by **39.9%** to **$8.62 million** in 2019 from **$14.33 million** in 2018, primarily reflecting the reduced net loss - Statement of Comprehensive Loss (2019 vs. 2018) | Metric | 2019 (in thousands) | 2018 (in thousands) | | :-------------------------------- | :------------------ | :------------------ | | Net Loss | $(8,635) | $(14,369) | | Unrealized gain on available-for-sale securities | $20 | $39 | | **Comprehensive Loss** | **$(8,616)** | **$(14,329)** | - Comprehensive loss decreased by **39.9%** year-over-year, primarily reflecting the reduction in net loss[301](index=301&type=chunk) [Statement of Stockholders' Equity](index=72&type=section&id=Statement%20of%20Stockholders%27%20Equity) Total stockholders' equity slightly decreased from **$10.56 million** in 2018 to **$9.96 million** in 2019, influenced by common stock issuances and stock-based compensation, offset by accumulated net loss - Stockholders' Equity Summary (December 31, 2019 vs. 2018) | Metric | December 31, 2019 (in thousands) | December 31, 2018 (in thousands) | | :-------------------------------- | :------------------------------- | :------------------------------- | | Common Stock (shares) | 4,019,141 | 3,122,843 | | Common Stock (amount) | $0.402 | $0.312 | | Additional Paid-in Capital | $173,278 | $165,268 | | Accumulated Deficit | $(163,323) | $(154,687) | | Accumulated Other Comprehensive Income (Loss) | $2 | $(18) | | **Total Stockholders' Equity** | **$9,958** | **$10,563** | - Issuance of common stock and units, net of issuance costs, contributed **$7.55 million** to additional paid-in capital in 2019 and **$6.87 million** in 2018[302](index=302&type=chunk) - Stock-based compensation added **$0.46 million** in 2019 and **$1.23 million** in 2018 to additional paid-in capital[302](index=302&type=chunk) - The accumulated deficit increased by **$8.64 million** in 2019 and **$14.37 million** in 2018 due to net losses[302](index=302&type=chunk) [Statement of Cash Flows](index=73&type=section&id=Statement%20of%20Cash%20Flows) Net cash increased by **$0.48 million** in 2019, a reversal from a **$0.15 million** decrease in 2018, driven by reduced operating cash use and increased financing activities - Cash Flow Summary (2019 vs. 2018) | Cash Flow Activity | 2019 (in thousands) | 2018 (in thousands) | | :-------------------------------- | :------------------ | :------------------ | | Net Cash Used in Operating Activities | $(10,277) | $(18,839) | | Net Cash Provided By Investing Activities | $3,099 | $11,911 | | Net Cash Provided by Financing Activities | $7,654 | $6,773 | | **Net Increase (Decrease) in Cash and Cash Equivalents** | **$475** | **$(155)** | | Cash and Cash Equivalents – end of period | $9,220 | $8,744 | - Operating cash used decreased significantly in 2019, primarily due to a lower net loss and changes in working capital components, including a **$1.5 million** deferred revenue inflow[255](index=255&type=chunk)[303](index=303&type=chunk) - Investing activities provided less cash in 2019 (**$3.1 million**) compared to 2018 (**$11.9 million**), mainly due to higher purchases of marketable securities in 2019[256](index=256&type=chunk)[303](index=303&type=chunk) - Financing activities provided **$7.65 million** in 2019 from common stock and warrant issuances, an increase from **$6.77 million** in 2018[258](index=258&type=chunk)[303](index=303&type=chunk) [Notes to Financial Statements](index=74&type=section&id=Notes%20to%20Financial%20Statements) The Notes detail the company's accumulated deficit, reliance on external funding, fair value measurements, new accounting standards, collaboration agreements, stock-based compensation, and income tax provisions - The company had an accumulated deficit of **$163.3 million** as of December 31, 2019, and anticipates incurring losses, relying on **$12.2 million** in cash, cash equivalents, and marketable securities for at least the next **12 months**[305](index=305&type=chunk)[306](index=306&type=chunk) - Significant accounting policies include expensing research and development costs as incurred, classifying warrants as liabilities or equity, and establishing a full valuation allowance for deferred tax assets due to cumulative losses[314](index=314&type=chunk)[315](index=315&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk) - The company adopted **ASU 2016-02 (Leases)** on **January 1, 2019**, recognizing right-of-use assets and lease liabilities for operating leases, with no material financial impact[324](index=324&type=chunk)[325](index=325&type=chunk) - Collaboration agreements include **BioSense Global LLC** (exclusive license for **RX-3117** in Asia, up to **$226 million** in milestones), **Zhejiang HaiChang Biotechnology Co., Ltd.** (exclusive worldwide license for **RX-0201, RX-0301, RX-0047**, up to **$96 million** in milestones), and **Merck Sharp & Dohme B.V.** (clinical trial collaboration for **RX-5902 with KEYTRUDA**)[333](index=333&type=chunk)[341](index=341&type=chunk)[345](index=345&type=chunk)[394](index=394&type=chunk)[395](index=395&type=chunk) - Stock-based compensation expense was **$0.46 million** in 2019 and **$1.23 million** in 2018, with **204,574 options** outstanding as of December 31, 2019[362](index=362&type=chunk)[360](index=360&type=chunk) - Warrant liabilities decreased significantly from **$2.31 million** in 2018 to **$0.04 million** in 2019, primarily due to a decrease in the underlying common stock price and the expiration of some warrants[374](index=374&type=chunk)[382](index=382&type=chunk)[383](index=383&type=chunk)

[PART I FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=4&type=section&id=Item%201%20Financial%20Statements%20(Unaudited)) The company reduced its nine-month net loss to $6.8 million and held $13.9 million in cash while exploring strategic alternatives [Condensed Balance Sheet](index=4&type=section&id=1)%20Condensed%20Balance%20Sheet) Total assets slightly decreased to $15.0 million while a reduction in warrant liabilities helped increase stockholders' equity to $11.8 million Condensed Balance Sheet Summary (in thousands) | Balance Sheet Item | Sep 30, 2019 | Dec 31, 2018 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $7,932 | $8,744 | ($812) | | Total Current Assets | $14,636 | $15,900 | ($1,264) | | **Total Assets** | **$14,981** | **$16,043** | **($1,062)** | | Total Current Liabilities | $3,001 | $3,153 | ($152) | | Warrant Liabilities | $124 | $2,308 | ($2,184) | | **Total Liabilities** | **$3,226** | **$5,480** | **($2,254)** | | **Total Stockholders' Equity** | **$11,755** | **$10,563** | **$1,192** | [Condensed Statement of Operations](index=5&type=section&id=2)%20Condensed%20Statement%20of%20Operations) The company reported no revenue and narrowed its nine-month net loss to $6.8 million due to reduced operating expenses and warrant gains Condensed Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2019 | Q3 2018 | 9 Months 2019 | 9 Months 2018 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0 | $0 | $0 | $0 | | General and administrative | $1,149 | $1,796 | $4,185 | $5,192 | | Research and development | $1,131 | $2,888 | $5,022 | $10,379 | | Loss from Operations | ($2,281) | ($4,684) | ($9,207) | ($15,571) | | Unrealized gain (loss) on warrants | $243 | ($710) | $2,184 | $3,752 | | **Net Loss** | **($1,959)** | **($5,339)** | **($6,767)** | **($11,252)** | | Net loss per share | ($0.49) | ($2.02) | ($1.72) | ($4.26) | [Condensed Statement of Stockholders' Equity](index=7&type=section&id=4)%20Condensed%20Statement%20of%20Stockholders'%20Equity) Stockholders' equity rose to $11.8 million, driven by $7.6 million in net proceeds from stock issuance that offset the period's net loss - In January 2019, the company issued 895,834 shares of common stock and units, raising net proceeds of **$7,553,828**[13](index=13&type=chunk) - The accumulated deficit grew to **$161.5 million** as of September 30, 2019, from $154.7 million at the beginning of the year, reflecting the ongoing net losses[13](index=13&type=chunk) [Condensed Statement of Cash Flows](index=9&type=section&id=5)%20Condensed%20Statement%20of%20Cash%20Flows) Net cash used in operations was $8.6 million, offset by $7.7 million from financing, resulting in a period-end cash balance of $7.9 million Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($8,565) | ($14,218) | | Net Cash Provided by Investing Activities | $99 | $9,911 | | Net Cash Provided by Financing Activities | $7,654 | $0 | | **Net Decrease in Cash** | **($812)** | **($4,307)** | | Cash and Cash Equivalents - end of period | $7,932 | $4,592 | [Notes to the Condensed Financial Statements](index=10&type=section&id=6)%20Notes%20to%20the%20Condensed%20Financial%20Statements) Notes detail the company's financial condition, strategic review, key agreements, and management's belief in its 12-month operational funding - The company is a biopharmaceutical firm developing treatments for cancer and had an accumulated deficit of **$161,453,752** as of September 30, 2019[15](index=15&type=chunk) - In September 2019, the company began exploring **strategic alternatives** to enhance shareholder value[15](index=15&type=chunk) - Management believes its cash, cash equivalents, and marketable securities of approximately **$13.9 million** as of September 30, 2019, are sufficient to fund operations for at least the next 12 months[16](index=16&type=chunk) - A collaboration agreement with BioSense Global LLC for RX-3117 includes a **$3.0 million upfront payment**, of which $1.5 million was received and recorded as deferred revenue as of September 30, 2019[30](index=30&type=chunk)[35](index=35&type=chunk) - On April 12, 2019, the company executed a **1-for-12 reverse stock split** of its common stock[47](index=47&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its strategic review, significant reductions in operating expenses, and its assessment of having sufficient cash for the next year - The company is a clinical-stage biopharmaceutical company with two product candidates, **RX-3117 and RX-5902**, in Phase 2 clinical development[77](index=77&type=chunk) - In September 2019, the company began exploring strategic alternatives (e.g., merger, acquisition, asset sales) and **reduced its headcount to five employees** to conserve resources[80](index=80&type=chunk) - The company believes its cash, cash equivalents, and marketable securities of approximately **$13.9 million** as of September 30, 2019, will be sufficient to cover cash flow requirements for at least the next 12 months[94](index=94&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | 9 Months 2019 | 9 Months 2018 | % Change | | :--- | :--- | :--- | :--- | | General and administrative | $4,185 | $5,192 | -19.4% | | Research and development | $5,022 | $10,379 | -51.6% | [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This disclosure is not required as the company qualifies as a smaller reporting company - The company has indicated that this disclosure is not required[101](index=101&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes to internal controls during the quarter - The company's principal executive and financial officers concluded that **disclosure controls and procedures were effective** as of the end of the period[102](index=102&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[103](index=103&type=chunk) [PART II OTHER INFORMATION](index=34&type=section&id=PART%20II%20OTHER%20INFORMATION) [Risk Factors](index=34&type=section&id=Item%201A%20Risk%20Factors) Key risks include the uncertainty of the strategic review process and the potential for delisting from the Nasdaq Capital Market - The process of evaluating strategic alternatives may not lead to a definitive transaction, could distract management, and may **adversely affect business operations** and investor perception[106](index=106&type=chunk) - Failure to complete a strategic transaction could cause a **decline in the stock price** and harm the company's ability to access financial markets[106](index=106&type=chunk) - There is a risk of being **delisted from the Nasdaq Capital Market** for non-compliance with listing standards, which would negatively affect the stock's value, liquidity, and the company's ability to raise capital[107](index=107&type=chunk) [Exhibits](index=35&type=section&id=Item%206%20Exhibits) This section lists filed exhibits, including a collaboration agreement amendment, CEO certifications, and XBRL data files - Filed exhibits include Amendment No. 1 to the Collaboration and License Agreement with BioSense Global LLC, CEO certifications pursuant to Sarbanes-Oxley, and XBRL financial data[110](index=110&type=chunk) [Signatures](index=36&type=section&id=SIGNATURES)

PART I FINANCIAL INFORMATION This section presents Rexahn Pharmaceuticals' unaudited condensed financial statements, providing a snapshot of its financial position and performance [Financial Statements (Unaudited)](index=4&type=section&id=Item%201%20Financial%20Statements%20(Unaudited)) This section details Rexahn Pharmaceuticals' unaudited condensed financial statements, showing a net loss of $4.8 million for the first six months of 2019 [Condensed Balance Sheet](index=4&type=section&id=1)%20Condensed%20Balance%20Sheet%20as%20of%20June%2030,%202019%20and%20December%2031,%202018) This section presents the company's condensed balance sheet, detailing assets, liabilities, and stockholders' equity at specific reporting dates Condensed Balance Sheet Summary | Balance Sheet Items | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $7,310,049 | $8,744,301 | | Total Current Assets | $17,293,210 | $15,899,668 | | **Total Assets** | **$17,677,234** | **$16,042,926** | | Total Current Liabilities | $3,551,200 | $3,152,550 | | **Total Liabilities** | **$4,054,128** | **$5,480,036** | | **Total Stockholders' Equity** | **$13,623,106** | **$10,562,890** | [Condensed Statement of Operations](index=5&type=section&id=2)%20Condensed%20Statement%20of%20Operations%20for%20the%20three%20and%20six%20months%20ended%20June%2030,%202019%20and%202018) This section outlines the company's condensed statement of operations, reporting revenues, expenses, and net loss for the specified periods Statement of Operations Summary (Six Months Ended June 30) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Revenues | $0 | $0 | | General and administrative | $3,035,538 | $3,396,170 | | Research and development | $3,890,631 | $7,491,126 | | Loss from Operations | ($6,926,169) | ($10,887,296) | | **Net Loss** | **($4,807,280)** | **($5,913,141)** | | Net loss per share, basic and diluted | ($1.23) | ($2.24) | - The company reported **no revenue** for the three and six-month periods ended June 30, 2019 and 2018, with both General & Administrative and Research & Development expenses **decreasing** in 2019 compared to 2018, leading to a **smaller net loss**[8](index=8&type=chunk) [Condensed Statement of Comprehensive Loss](index=6&type=section&id=3)%20Condensed%20Statement%20of%20Comprehensive%20Loss%20for%20the%20three%20and%20six%20months%20ended%20June%2030,%202019%20and%202018) This section presents the condensed statement of comprehensive loss, including net loss and other comprehensive income/loss components Comprehensive Loss Summary (Six Months Ended June 30) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Net Loss | ($4,807,280) | ($5,913,141) | | Unrealized gain (loss) on available-for-sale securities | $25,015 | ($8,069) | | **Comprehensive Loss** | **($4,782,265)** | **($5,921,210)** | [Condensed Statement of Stockholders' Equity](index=7&type=section&id=4)%20Condensed%20Statement%20of%20Stockholders'%20Equity%20for%20the%20three%20and%20six%20months%20ended%20June%2030,%202019%20and%202018) This section details changes in stockholders' equity, reflecting net loss, stock issuances, and other equity transactions - Total stockholders' equity **increased from $10.6 million to $13.6 million** at June 30, 2019, primarily due to the issuance of common stock and units providing **net proceeds of approximately $7.6 million**, offsetting the net loss for the period[12](index=12&type=chunk) [Condensed Statement of Cash Flows](index=9&type=section&id=5)%20Condensed%20Statement%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030,%202019%20and%202018) This section provides the condensed statement of cash flows, categorizing cash movements from operating, investing, and financing activities Cash Flow Summary (Six Months Ended June 30) | Cash Flow Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($6,186,631) | ($10,051,386) | | Net Cash (Used In) Provided by Investing Activities | ($2,901,449) | $6,246,507 | | Net Cash Provided by Financing Activities | $7,653,828 | $0 | | **Net Decrease in Cash and Cash Equivalents** | **($1,434,252)** | **($3,804,879)** | | Cash and Cash Equivalents - end of period | $7,310,049 | $5,094,275 | [Notes to the Condensed Financial Statements](index=10&type=section&id=6)%20Notes%20to%20the%20Condensed%20Financial%20Statements) This section provides explanatory notes to the condensed financial statements, offering additional details on accounting policies and significant transactions - The company, a biopharmaceutical firm focused on cancer treatments, reported an **accumulated deficit of $159.5 million** as of June 30, 2019, and believes its current cash will be **sufficient for at least the next 12 months**[14](index=14&type=chunk) - In February 2019, a collaboration and license agreement with BioSense Global LLC for RX-3117 included a **$3.0 million upfront payment** and **potential milestones up to $226 million**, with **$1.5 million of the upfront payment received** as of June 30, 2019[28](index=28&type=chunk)[33](index=33&type=chunk) - The company executed a **1-for-12 reverse stock split** on April 12, 2019, and in January 2019, closed a public offering raising **gross proceeds of approximately $8.6 million**[44](index=44&type=chunk)[45](index=45&type=chunk) - The fair value of liability-classified warrants **decreased significantly from $2.3 million to $366,732**, resulting in an **unrealized gain of $1.9 million** for the six-month period[62](index=62&type=chunk)[72](index=72&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operational results, and clinical pipeline, highlighting reduced R&D expenses and future capital needs [Overview](index=28&type=section&id=Overview) This section provides an overview of Rexahn's business, focusing on its clinical-stage oncology pipeline and key product candidates - Rexahn is a **clinical-stage biopharmaceutical company** focused on next-generation cancer therapies, with two product candidates, RX-3117 and RX-5902, in **Phase 2 clinical development**[78](index=78&type=chunk) - RX-3117 is in a **Phase 2a trial** for metastatic pancreatic cancer, showing a **23% overall response rate** and a **median progression-free survival of approximately 5.4 months**[78](index=78&type=chunk) - RX-5902 was in a **Phase 2a trial** for triple-negative breast cancer, but **enrollment was ceased in December 2018** to explore a potential combination trial with Merck's KEYTRUDA[81](index=81&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) This section analyzes the company's operating results, comparing expenses and financial performance for the current and prior periods Comparison of Operating Expenses (Three Months Ended June 30) | Expense Category | 2019 | 2018 | Change (%) | | :--- | :--- | :--- | :--- | | General and Administrative | $1,340,000 | $1,569,000 | -14.6% | | Research and Development | $1,648,000 | $3,433,000 | -52.0% | Comparison of Operating Expenses (Six Months Ended June 30) | Expense Category | 2019 | 2018 | Change (%) | | :--- | :--- | :--- | :--- | | General and Administrative | $3,036,000 | $3,396,000 | -10.6% | | Research and Development | $3,891,000 | $7,491,000 | -48.1% | - The **decrease in R&D expenses** was primarily due to **lower drug manufacturing costs** and **reduced clinical trial costs** following study completion and trial cessation[87](index=87&type=chunk) - The company recorded **significant unrealized gains** of **$1.9 million** on the fair value of warrants for the first six months of 2019, mainly due to a decrease in its stock price[91](index=91&type=chunk) [Research and Development Projects](index=33&type=section&id=Research%20and%20Development%20Projects) This section details the allocation of research and development expenses across various clinical candidates and projects R&D Expenses by Project (Six Months Ended June 30) | Clinical Candidate | 2019 | 2018 | | :--- | :--- | :--- | | RX-3117 | $2,136,400 | $3,596,900 | | RX-5902 | $530,200 | $1,864,000 | | RX-0201 | $171,100 | $317,000 | | Preclinical, Personnel and Overhead | $1,052,931 | $1,713,226 | | **Total R&D Expenses** | **$3,890,631** | **$7,491,126** | [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding requirements, and strategies for securing future capital - The company has incurred **negative cash flow from operations** since inception and anticipates continued substantial spending on R&D and clinical trials[101](index=101&type=chunk) - Management believes existing cash, cash equivalents, and marketable securities are **sufficient to cover cash flow requirements for at least the next 12 months**[101](index=101&type=chunk) - **Additional capital will be needed** for drug candidate development, planned through equity, debt offerings, or strategic partnerships[101](index=101&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company, as a smaller reporting entity, is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Rexahn Pharmaceuticals, Inc. is **not required** to provide quantitative and qualitative disclosures about market risk[108](index=108&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2019[109](index=109&type=chunk) - There were **no changes** in the company's internal control over financial reporting during the quarter that materially affected these controls[110](index=110&type=chunk) PART II OTHER INFORMATION This section provides additional information not covered in the financial statements, including risk factors and a list of exhibits [Risk Factors](index=37&type=section&id=Item%201A%20Risk%20Factors) This section outlines significant risks, including potential delisting from the Nasdaq Capital Market, which could impact stock value and capital raising - A key risk is the potential **delisting of its common stock** from the Nasdaq Capital Market if the company fails to comply with continued listing standards[113](index=113&type=chunk) - Delisting could lead to **adverse effects on financing**, **reduced liquidity and value** of common stock, **loss of investor confidence**, and potential breaches of warrant holder commitments[113](index=113&type=chunk) [Exhibits](index=38&type=section&id=Item%206%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, agreements, and required certifications - Key exhibits filed with this report include: - Certificates of Amendment to the Certificate of Incorporation - The Collaboration and License Agreement with BioSense Global LLC, dated February 25, 2019 - CEO certifications pursuant to Sarbanes-Oxley Act rules - Financial statements formatted in XBRL[115](index=115&type=chunk) Signatures This section contains the required signatures, confirming the report's submission by authorized company officers - The report was signed on **August 7, 2019**, by **Douglas J. Swirsky**, serving as the **Chief Executive Officer and President** and also as the **principal executive, financial, and accounting officer**[117](index=117&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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, 2019 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 No.:001-34079 Rexahn Pharmaceuticals, Inc. Indicate by check mark whether the registrant is a large accelerated filer, an accelerate ...

PART I [Business Description](index=5&type=section&id=Item%201.%20Description%20of%20Business) Rexahn Pharmaceuticals is a clinical-stage biopharmaceutical company developing next-generation cancer therapies, relying on third parties for R&D and manufacturing [Overview and Pipeline](index=5&type=section&id=Overview%20and%20Pipeline) Rexahn is a clinical-stage biopharmaceutical company advancing RX-3117 for pancreatic/bladder cancer and RX-5902 for triple-negative breast cancer, with RX-0301 in preclinical development - The company's lead clinical-stage product candidates are RX-3117 (pancreatic/bladder cancer) and RX-5902 (triple-negative breast cancer)[13](index=13&type=chunk) - RX-3117 has received orphan drug designation for pancreatic cancer from both the U.S. FDA and the European Commission[13](index=13&type=chunk)[22](index=22&type=chunk) Key Product Candidate Status | Product Candidate | Indication | Development Stage | Key Recent Data/Event | | :--- | :--- | :--- | :--- | | **RX-3117** | Metastatic Pancreatic Cancer | Phase 2a (Combination w/ ABRAXANE®) | Preliminary data showed a **38% overall response rate** in 24 evaluable patients. Target enrollment of 40 patients reached in Feb 2019 | | **RX-3117** | Advanced Bladder Cancer | Phase 2a (Monotherapy) | Preliminary signs of efficacy observed, including a complete response. No additional trials currently planned | | **RX-5902** | Metastatic TNBC | Phase 2 (Combination w/ KEYTRUDA®) | Collaboration with Merck established. Monotherapy trial enrollment ceased in Dec 2018 to focus on the combination trial | | **RX-0301** | Hepatocellular Carcinoma (HCC) | Preclinical | Being developed in collaboration with Zhejiang Haichang Biotechnology Co., Ltd | [Competition](index=11&type=section&id=Competition) The company faces intense competition from larger pharmaceutical and biotech firms with superior resources, with specific competitors for each product candidate - The biotechnology and pharmaceutical industries are intensely competitive, with many competitors having substantially greater financial resources and experience than Rexahn[40](index=40&type=chunk)[42](index=42&type=chunk) Competitive Landscape by Product Candidate | Product Candidate | Competing Mechanisms/Products | Key Competitors | | :--- | :--- | :--- | | **RX-3117** | Anti-metabolite mechanism, nucleoside analogues | NuCana (NUC-1031), capecitabine, gemcitabine | | **RX-5902** | Other mechanisms for TNBC (e.g., PARP inhibitors, PD-1 inhibitors) | AstraZeneca (LYNPARZA®), Immunomedics, Genentech (TECENTRIQ®) | | **RX-0301** | Akt-1 inhibitors | Merck & Co., GlaxoSmithKline, AstraZeneca, Gilead Sciences, MEI Pharma, PIQUR Therapeutics | [Government Regulation](index=12&type=section&id=Government%20Regulation) Rexahn's operations are subject to extensive government regulation by the FDA and foreign authorities, covering product development, testing, approval, and post-market activities - The company's product candidates require rigorous preclinical and clinical testing and regulatory approval by the FDA and foreign authorities before commercialization[44](index=44&type=chunk)[47](index=47&type=chunk) - The clinical trial process typically involves three phases (Phase 1, 2, and 3) to assess safety, efficacy, and optimal dosage before an NDA can be submitted[52](index=52&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk)[56](index=56&type=chunk) - RX-3117 has received orphan drug designation for pancreatic cancer from the FDA (September 2014) and the European Commission (January 2018), which provides potential benefits like market exclusivity[69](index=69&type=chunk)[71](index=71&type=chunk) - Post-approval, the company is subject to ongoing regulations including cGMP for manufacturing, restrictions on sales and marketing, and compliance with fraud and abuse laws like the federal Anti-Kickback Law[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk)[81](index=81&type=chunk) [Intellectual Property](index=23&type=section&id=Intellectual%20Property) The company protects its product candidates through patents, trade secrets, and know-how, holding U.S. and foreign patents expiring between 2023 and 2036 Patent Portfolio Expiration Summary | Product Candidate | Patent Families | Key Expiration Dates | | :--- | :--- | :--- | | **RX-3117** | 3 | 2025, 2034, 2036 | | **RX-5902** | 3 | 2025, 2034, 2036 | | **RX-0301** | 1 | 2023 - 2025 | [Collaboration and License Arrangements](index=24&type=section&id=Collaboration%20and%20License%20Arrangements) Rexahn has collaborations with Zhejiang Haichang for RX-0301 in China, Merck for RX-5902 with KEYTRUDA®, and a license agreement with KRICT for RX-5902 - Collaboration with Zhejiang Haichang for RX-0301 development in China, with Haichang funding up to **$10 million** through a Phase 2a trial[107](index=107&type=chunk) - Clinical trial collaboration with Merck to evaluate RX-5902 in combination with KEYTRUDA® for metastatic TNBC[108](index=108&type=chunk) - License agreement with KRICT for RX-5902 intellectual property, requiring a **$1 million** milestone payment upon first marketing approval[112](index=112&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, operational, third-party reliance, and intellectual property risks, including a history of losses and the need for additional capital - **Financial Risks:** The company has no product revenues, a history of significant net losses (**$154.7 million** accumulated deficit as of Dec 31, 2018), and will need to raise additional capital to fund operations[120](index=120&type=chunk)[123](index=123&type=chunk) - **Clinical and Regulatory Risks:** Product candidates are in early stages, and clinical trials are expensive, time-consuming, and may not be successful, with FDA approval being a long and uncertain process[135](index=135&type=chunk)[136](index=136&type=chunk)[141](index=141&type=chunk) - **Third-Party Reliance Risks:** The company depends on third-party CROs to conduct clinical trials and on third-party manufacturers for drug supply, exposing it to risks of delays, substandard performance, and supply chain disruptions[192](index=192&type=chunk)[196](index=196&type=chunk) - **Competition Risk:** The biotechnology industry is intensely competitive, and competitors may develop more effective or safer products or obtain regulatory approval more rapidly[178](index=178&type=chunk) - **Intellectual Property Risks:** Success depends on the ability to obtain and maintain patent protection, which is uncertain and subject to legal challenges and changes in patent law[203](index=203&type=chunk)[206](index=206&type=chunk) [Unresolved Staff Comments](index=50&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments - None[219](index=219&type=chunk) [Properties](index=50&type=section&id=Item%202.%20Description%20of%20Property) The company leases approximately 7,193 square feet of office space in Rockville, Maryland, with the lease expiring in June 2019 - The company leases approximately **7,193 square feet** of office space in Rockville, Maryland, under a lease expiring in June 2019[220](index=220&type=chunk) [Legal Proceedings](index=50&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any litigation or legal proceedings expected to have a material adverse effect on its business - The company is not currently party to any material legal proceedings[221](index=221&type=chunk) [Mine Safety Disclosures](index=50&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[222](index=222&type=chunk) PART II [Market for Registrant's Common Equity and Related Matters](index=51&type=section&id=Item%205.%20Market%20for%20Common%20Equity%2C%20Related%20Stockholder%20Matters%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the NYSE American under "RNN", with no equity repurchases in 2018 - Common stock trades on NYSE American under the ticker "**RNN**"[225](index=225&type=chunk) - There were no repurchases of equity securities in 2018[226](index=226&type=chunk) [Selected Financial Data](index=52&type=section&id=Item%206.%20Selected%20Financial%20Data) The company reported no revenues for the past five years, with a **$14.4 million** net loss in 2018 and an accumulated deficit of **$154.7 million** Selected Financial Data (Years Ended December 31) | (in thousands, except per share data) | 2018 | 2017 | 2016 | 2015 | 2014 | | :--- | :--- | :--- | :--- | :--- | :--- | | **Statement of Operations Data** | | | | | | | Revenues | $0 | $0 | $0 | $0 | $0 | | Loss from operations | $(20,538) | $(17,355) | $(16,413) | $(18,263) | $(13,269) | | Net Loss | $(14,369) | $(25,295) | $(9,307) | $(14,385) | $(18,522) | | Net Loss per share, basic and diluted | $(0.44) | $(0.92) | $(0.43) | $(0.79) | $(1.05) | | **Balance Sheet Data** | | | | | | | Cash, Cash Equivalents, and Marketable Securities | $14,726 | $26,831 | $20,316 | $23,440 | $32,698 | | Total Assets | $16,043 | $28,288 | $21,044 | $24,805 | $33,533 | | Accumulated Deficit | $(154,687) | $(140,319) | $(115,024) | $(105,717) | $(91,332) | | Total Stockholders' Equity | $10,563 | $16,769 | $17,058 | $18,776 | $26,580 | [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=53&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2018, Rexahn's net loss decreased to **$14.4 million** due to warrant valuation gains, despite increased R&D and G&A expenses, with management projecting sufficient liquidity for 12 months [Results of Operations (2018 vs. 2017)](index=55&type=section&id=Results%20of%20Operations) The 2018 net loss of **$14.4 million** improved from 2017's **$25.3 million**, primarily due to a **$5.5 million** gain on warrant liabilities, despite increased operating expenses Comparison of Operations (Years Ended December 31) | (in thousands) | 2018 | 2017 | Change (%) | | :--- | :--- | :--- | :--- | | General and administrative expenses | $7,429 | $6,639 | **11.9%** | | Research and development expenses | $13,109 | $10,715 | **22.3%** | | **Loss from Operations** | **$(20,538)** | **$(17,355)** | **18.3%** | | Unrealized gain (loss) on warrants | $5,546 | $(7,594) | N/A | | **Net Loss** | **$(14,369)** | **$(25,295)** | **(43.2%)** | | Net Loss per share | $(0.44) | $(0.92) | **(52.2%)** | Research and Development Expenses by Project | (in thousands) | 2018 | 2017 | | :--- | :--- | :--- | | RX-3117 | $6,126 | $4,559 | | RX-5902 | $3,104 | $2,020 | | RX-0201 | $651 | $536 | | Preclinical, Personnel and Overhead | $3,227 | $3,601 | | **Total R&D Expenses** | **$13,109** | **$10,715** | [Liquidity and Capital Resources](index=58&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity relies on capital raises, with **$18.8 million** cash used in operations in 2018, and management believes current cash is sufficient for the next 12 months Summary of Cash Flows (Years Ended December 31) | (in thousands) | 2018 | 2017 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(18,839) | $(15,420) | | Net Cash Provided By (Used In) Investing Activities | $11,911 | $(9,373) | | Net Cash Provided by Financing Activities | $6,773 | $22,114 | | **Net Decrease in Cash and Cash Equivalents** | **$(155)** | **$(2,679)** | - The company raised gross proceeds of **$7.5 million** in a registered direct offering in October 2018 and **$8.6 million** in an underwritten public offering in January 2019[271](index=271&type=chunk)[272](index=272&type=chunk) - Management believes current cash resources, including the January 2019 financing, are sufficient to cover cash flow requirements for at least the next **12 months**[273](index=273&type=chunk) [Controls and Procedures](index=61&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2018, with no material changes in Q4 2018 - Management concluded that disclosure controls and procedures were effective as of December 31, 2018[279](index=279&type=chunk) - There were no material changes to internal control over financial reporting in the fourth quarter of 2018[280](index=280&type=chunk) - Management assessed internal control over financial reporting using the COSO framework (2013) and concluded it was effective as of December 31, 2018[284](index=284&type=chunk) PART III [Directors, Executive Officers, Compensation, and Other Matters](index=64&type=section&id=Items%2010-14) Information for Items 10 through 14 is incorporated by reference from the company's Definitive Proxy Statement for its 2019 Annual Meeting of Shareholders - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the company's 2019 Proxy Statement[287](index=287&type=chunk)[288](index=288&type=chunk)[289](index=289&type=chunk) [Exhibits and Financial Statement Schedules](index=65&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) [Financial Statements](index=71&type=section&id=Financial%20Statements) Audited financial statements for 2018 and 2017 show a **$14.4 million** net loss in 2018, **$18.8 million** cash used in operations, and **$16.0 million** total assets as of December 31, 2018 [Balance Sheet](index=72&type=section&id=Balance%20Sheet) As of December 31, 2018, total assets decreased to **$16.0 million** from **$28.3 million**, primarily due to reduced cash and marketable securities, while total liabilities also decreased Balance Sheet Summary (as of December 31) | (in thousands) | 2018 | 2017 | | :--- | :--- | :--- | | Cash and cash equivalents | $8,744 | $8,899 | | Marketable securities | $5,982 | $17,932 | | **Total Assets** | **$16,043** | **$28,288** | | Warrant Liabilities | $2,308 | $7,854 | | **Total Liabilities** | **$5,480** | **$11,519** | | Accumulated Deficit | $(154,687) | $(140,319) | | **Total Stockholders' Equity** | **$10,563** | **$16,769** | [Statement of Operations](index=73&type=section&id=Statement%20of%20Operations) The 2018 net loss was **$14.37 million** (or **$0.44** per share), an improvement from 2017's **$25.29 million** loss, mainly due to a **$5.55 million** unrealized gain on warrants Statement of Operations Summary (Years Ended December 31) | (in thousands, except per share data) | 2018 | 2017 | | :--- | :--- | :--- | | Total Expenses | $20,538 | $17,355 | | Loss from Operations | $(20,538) | $(17,355) | | Unrealized gain (loss) on fair value of warrants | $5,546 | $(7,594) | | **Net Loss** | **$(14,369)** | **$(25,295)** | | Net loss per share, basic and diluted | $(0.44) | $(0.92) | [Statement of Cash Flows](index=76&type=section&id=Statement%20of%20Cash%20Flows) In 2018, net cash used in operating activities was **$18.8 million**, with **$11.9 million** provided by investing activities and **$6.8 million** from financing, resulting in a **$0.15 million** net decrease Statement of Cash Flows Summary (Years Ended December 31) | (in thousands) | 2018 | 2017 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(18,839) | $(15,420) | | Net Cash Provided by (Used In) Investing Activities | $11,911 | $(9,373) | | Net Cash Provided by Financing Activities | $6,773 | $22,114 | | **Net Decrease in Cash and Cash Equivalents** | **$(155)** | **$(2,679)** | [Notes to Financial Statements](index=77&type=section&id=Notes%20to%20Financial%20Statements) Notes highlight the company's going concern dependency on capital, warrant liability re-measurement, **$147.1 million** NOL carryforwards, and a significant **$8.6 million** January 2019 financing - The company believes its cash, including proceeds from the January 2019 offering, is sufficient to fund operations for at least the next **12 months** from the financial statement issuance date[318](index=318&type=chunk) - In October 2018, the company raised gross proceeds of approximately **$7.5 million** through a registered direct offering of common stock and warrants[362](index=362&type=chunk) - Certain outstanding warrants are classified as liabilities and re-measured to fair value each period, resulting in a **$5.5 million** unrealized gain in 2018[387](index=387&type=chunk)[394](index=394&type=chunk) - As of December 31, 2018, the company had net operating loss carry-forwards of approximately **$147.1 million**, which are fully offset by a valuation allowance[395](index=395&type=chunk) - Subsequent to year-end, in January 2019, the company closed an underwritten public offering for gross proceeds of approximately **$8.6 million**[415](index=415&type=chunk)