Hoth Therapeutics(HOTH) - 2020 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements This section presents the unaudited condensed consolidated financial statements and notes, detailing the company's financial position, performance, and cash flows Condensed Consolidated Balance Sheets The balance sheet as of June 30, 2020, shows a significant increase in total assets to $7.4 million from $2.8 million at year-end 2019, primarily driven by a substantial rise in cash and marketable securities, funded by equity issuances, which also led to a corresponding increase in stockholders' equity from $2.4 million to $6.8 million | Account | June 30, 2020 (Unaudited) ($) | December 31, 2019 ($) | | :--- | :--- | :--- | | Current Assets | | | | Cash | $4,947,417 | $1,690,866 | | Marketable securities, at fair value | $2,011,529 | $803,664 | | Total Assets | $7,426,116 | $2,836,129 | | Current Liabilities | | | | Total current liabilities | $355,093 | $440,121 | | Total Liabilities | $590,093 | $440,121 | | Total Stockholders' Equity | $6,836,023 | $2,396,008 | Condensed Consolidated Statements of Operations and Comprehensive Loss The company, being pre-revenue, reported increased net losses for both the three and six-month periods ended June 30, 2020, compared to the same periods in 2019, with the net loss for the second quarter of 2020 at approximately $2.5 million and for the first half of 2020 at $4.3 million, primarily due to a significant year-over-year increase in research and development expenses | Period | Metric | 2020 (Unaudited) ($) | 2019 (Unaudited) ($) | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | Research and development | $927,696 | $388,934 | | | Total operating expenses | $2,515,817 | $1,267,586 | | | Net loss | $(2,497,530) | $(1,267,586) | | | Net loss per share | $(0.20) | $(0.13) | | Six Months Ended June 30 | Research and development | $1,574,924 | $523,684 | | | Total operating expenses | $4,332,267 | $2,096,951 | | | Net loss | $(4,324,106) | $(2,096,951) | | | Net loss per share | $(0.38) | $(0.25) | Condensed Consolidated Statements of Changes in Stockholders' Equity Stockholders' equity increased from $2.4 million at the end of 2019 to $6.8 million at June 30, 2020, primarily driven by net proceeds of approximately $8.7 million from common stock issuances, partially offset by a net loss of $4.3 million for the six-month period - For the six months ended June 30, 2020, the company raised a total of $8,668,756 in net proceeds from two separate issuances of common stock and warrants, after deducting offering costs[24] - The accumulated deficit increased from $(12,215,642) at December 31, 2019, to $(16,539,748) at June 30, 2020, due to the net loss incurred during the period[24] Condensed Consolidated Statements of Cash Flows For the six months ended June 30, 2020, the company used approximately $4.0 million in cash for operating activities and $1.7 million for investing activities, offset by $8.7 million in net cash provided by financing activities, resulting in a net cash increase of $3.1 million | Cash Flow Activity (Six Months Ended June 30) | 2020 (Unaudited) ($) | 2019 (Unaudited) ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,980,293) | $(1,810,246) | | Net cash used in investing activities | $(1,687,500) | $(20,000) | | Net cash provided by financing activities | $8,725,006 | $5,840,331 | | Net increase in cash | $3,056,551 | $4,010,085 | Notes to the Condensed Consolidated Financial Statements The notes provide critical details on the company's operations, liquidity, strategic agreements, public offerings, and the operational risks posed by the COVID-19 pandemic - The company's primary asset is an exclusive license for the BioLexa Platform from the University of Cincinnati, initially focused on treating eczema[30] - Management believes current cash is sufficient to fund operations for at least the next 12 months, but additional funding will be necessary to execute its long-term business plan[33] - In March 2020, the company formed a joint venture, HaloVax, LLC, with Voltron Therapeutics to develop COVID-19 vaccine candidates, purchasing a 5% interest for $250,000[74] - The COVID-19 pandemic has caused delays in the company's clinical trials and R&D activities due to disruptions at partner institutions and travel restrictions[98] - Subsequent to the quarter's end, the company entered into a new sublicense agreement with Isoprene Pharmaceutics and a patent license agreement with George Washington University for a SARS-CoV-2 detection device[108][109] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's clinical-stage biopharmaceutical focus, increased operating expenses, liquidity position, and the operational impact of the COVID-19 pandemic - The company's primary focus is on developing new therapies for dermatological disorders, with its main asset being the BioLexa Platform, licensed from the University of Cincinnati for indications like eczema[111][112] | Expense Category (Three Months Ended June 30) | 2020 (Approx.) ($) | 2019 (Approx.) ($) | | :--- | :--- | :--- | | Research and Development | $1.3 million | $0.4 million | | General and Administrative | $1.2 million | $0.9 million | - As of June 30, 2020, the company had approximately $4.9 million in cash and $2.0 million in marketable securities, which management believes is sufficient to fund operations for at least the next 12 months[132][133] - Net cash from financing activities was approximately $8.7 million for the first six months of 2020, resulting from two underwritten public offerings of common stock[139][81][83] Item 3. Quantitative and Qualitative Disclosures About Market Risk The company states that it is exempt from providing disclosures on market risk because it qualifies as a "smaller reporting company" under SEC rules - As a "smaller reporting company," the company is not required to provide the information for this item[147] Item 4. Controls and Procedures Based on an evaluation by management, including the CEO and CFO, the company's disclosure controls and procedures were deemed effective as of June 30, 2020, with no material changes to internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2020[148] - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[149] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company reports that it is not currently involved in any material legal proceedings and is unaware of any pending or threatened litigation that would materially impact its business - The company is not currently a party to any material legal proceedings[153] Item 1A. Risk Factors This section updates the company's risk factors, emphasizing dependence on its BioLexa Platform and licensed technologies, reliance on third-party licensors for intellectual property, and the adverse impacts of the COVID-19 pandemic - The company's business depends entirely on the successful development, regulatory approval, and commercialization of its product candidates, which may never occur[156] - The company relies on licenses from various universities and companies (the "Licensors") and has limited control over how these licensors defend the underlying intellectual property[158] - The COVID-19 pandemic has caused delays in business operations and clinical trials, and it may disrupt the supply chain, hinder access to capital, and divert healthcare resources away from the company's trials[160][161][163] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reports the issuance of unregistered equity securities during the first half of 2020, including 4,716 shares granted to board members and 18,750 shares from warrant exercises, conducted under registration exemptions - During the six months ended June 30, 2020, the company issued 4,716 shares of common stock to Board members for services rendered[167] - The company issued a total of 18,750 shares of common stock from warrant exercises in May and June 2020, generating gross proceeds of $18,750[167][168] Item 3. Defaults Upon Senior Securities The company reports that there have been no defaults upon its senior securities - None[170] Item 4. Mine Safety Disclosures This item is not applicable to the company's business - Not applicable[170] Item 5. Other Information The company reports that there is no other information to disclose for this item - None[171] Item 6. Exhibits This section provides a list of all exhibits filed with the Form 10-Q, including key license agreements with various universities and officer certifications - Filed exhibits include key license agreements, such as the Exclusive License Agreement with Virginia Commonwealth University and the assigned License Agreement from the University of Cincinnati[172] - Certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sarbanes-Oxley Act Sections 302 and 906 are included as exhibits[172]