Hoth Therapeutics(HOTH) - 2019 Q2 - Quarterly Report

Part I. Financial Information Financial Statements Hoth Therapeutics' unaudited financial statements as of June 2019 show significant asset and equity growth post-IPO, despite continued net losses from rising operating expenses Condensed Balance Sheets As of June 30, 2019, total assets rose to $4.4 million and stockholders' equity to $4.19 million due to IPO proceeds, while liabilities decreased Condensed Balance Sheet Highlights (Unaudited) | Account | June 30, 2019 ($) | December 31, 2018 ($) | | :--- | :--- | :--- | | Assets | | | | Cash | $4,092,706 | $282,621 | | Total current assets | $4,226,153 | $501,648 | | Total assets | $4,427,813 | $503,916 | | Liabilities & Equity | | | | Total current liabilities | $239,393 | $348,951 | | Total liabilities | $239,393 | $348,951 | | Accumulated deficit | $(6,607,957) | $(4,511,006) | | Total stockholders' equity | $4,188,420 | $154,965 | Condensed Statements of Operations For the three and six months ended June 30, 2019, net losses widened to $1.27 million and $2.10 million, driven by increased operating expenses Condensed Statements of Operations (Unaudited) | Metric | Three Months Ended June 30, 2019 ($) | Three Months Ended June 30, 2018 ($) | Six Months Ended June 30, 2019 ($) | Six Months Ended June 30, 2018 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $388,934 | $216,667 | $523,684 | $257,907 | | Professional fees | $544,849 | $229,899 | $838,364 | $422,159 | | Total operating expenses | $1,267,586 | $763,420 | $2,096,951 | $1,290,966 | | Net loss | $(1,267,586) | $(763,420) | $(2,096,951) | $(1,290,966) | | Net loss per share | $(0.13) | $(0.15) | $(0.25) | $(0.26) | Condensed Statements of Changes in Stockholders' Equity For the six months ended June 30, 2019, stockholders' equity increased to $4.19 million from $154,965, driven by $5.84 million net IPO proceeds and preferred stock conversion - Upon IPO completion, 3,102,480 shares of Series A Preferred Stock converted into common stock[25] - The company issued 1,250,000 shares of common stock in its IPO, raising $5.84 million in net proceeds after offering costs[25] Condensed Statements of Cash Flows For the six months ended June 30, 2019, net cash used in operations was $1.81 million, offset by $5.84 million from IPO financing, resulting in a $4.01 million net cash increase Cash Flow Summary (Six Months Ended June 30) | Cash Flow Activity | 2019 ($) | 2018 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,810,246) | $(949,937) | | Net cash used in investing activities | $(20,000) | $0 | | Net cash provided by financing activities | $5,840,331 | $1,186,321 | | Net increase in cash | $4,010,085 | $236,384 | | Cash and restricted cash, end of period | $4,292,706 | $1,466,824 | Notes to the Condensed Financial Statements Notes detail the company's BioLexa Platform for eczema, the February 2019 IPO raising $5.8 million, accounting policies, new license agreements, and changes in stockholders' equity - The company's primary asset is an exclusive sublicense agreement with Chelexa Biosciences for the BioLexa Platform, initially focused on treating eczema[33] - The company completed its IPO on February 15, 2019, issuing 1,250,000 shares of common stock and receiving $5.8 million in net proceeds[35] - New agreements include a sublicense and option agreement with the University of Maryland and Isoprene Pharmaceuticals, and a term sheet with Zylö Therapeutics[53][55] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's biopharmaceutical focus on eczema, detailing increased operating expenses and improved liquidity from the $5.8 million IPO, which funds operations for 12 months but requires more for long-term trials Overview Hoth Therapeutics develops eczema treatments using the BioLexa Platform, leveraging the FDA's 505(b)(2) pathway for accelerated development, targeting Phase 1/1b trials and a late 2021 NDA submission - The company's primary focus is on developing therapeutics for atopic dermatitis (eczema) using the sublicensed BioLexa Platform[71][72] - Hoth utilizes the FDA's 505(b)(2) regulatory pathway to potentially shorten development timelines and reduce costs by relying on existing drug data[75] - The company plans a Phase 1b trial in adolescent eczema patients and targets an NDA submission for mid to late 2021[77][78] Results of Operations Operating expenses increased for both three and six-month periods ended June 30, 2019, driven by higher R&D (to $0.5 million) and G&A (to $1.6 million) costs, primarily from payroll, stock-based compensation, and professional fees Comparison of Operating Expenses (Three Months Ended June 30) | Expense Category | 2019 ($ millions) | 2018 ($ millions) | | :--- | :--- | :--- | | Research and Development | ~$0.4 million | ~$0.2 million | | General and Administrative | ~$0.9 million | ~$0.5 million | Comparison of Operating Expenses (Six Months Ended June 30) | Expense Category | 2019 ($ millions) | 2018 ($ millions) | | :--- | :--- | :--- | | Research and Development | ~$0.5 million | ~$0.4 million | | General and Administrative | ~$1.6 million | ~$0.9 million | Liquidity and Capital Resources As of June 30, 2019, the company had $4.1 million cash and a $6.6 million accumulated deficit; $5.8 million IPO proceeds fund 12 months, but significant additional capital is needed for long-term plans and clinical trials - The company had approximately $4.1 million in cash as of June 30, 2019[89] - Net proceeds from the IPO were approximately $5.8 million, expected to fund operations for at least the next 12 months[91][97] - Significant additional capital will be needed to execute the longer-term business plan and fund clinical trials for BioLexa[90][91] Quantitative and Qualitative Disclosures About Market Risk The company is exempt from providing quantitative and qualitative market risk disclosures as it qualifies as a "smaller reporting company" - As a "smaller reporting company," Hoth Therapeutics is exempt from market risk disclosures under this item[102] Controls and Procedures Management concluded the company's disclosure controls and procedures were effective as of June 30, 2019, with no material changes to internal control over financial reporting during the quarter - Management concluded the company's disclosure controls and procedures were effective as of June 30, 2019[104] - No material changes occurred in internal control over financial reporting during the quarter[105] Part II. Other Information Legal Proceedings The company is not currently involved in any material legal proceedings and is unaware of any pending or threatened claims that could materially affect its business - As of the filing date, the company is not involved in any material legal proceedings[108] Risk Factors The company is exempt from providing risk factor disclosures in this quarterly report as it qualifies as a "smaller reporting company" - As a "smaller reporting company," Hoth Therapeutics is exempt from risk factor disclosures in its Form 10-Q[109] Unregistered Sales of Equity Securities and Use of Proceeds During Q2 2019, the company issued common stock through unregistered transactions, including 223,877 shares from cashless warrant exercises and 16,333 shares from a consultant warrant, exempt under Section 4(a)(2) - On April 16, 2019, the company issued 176,272 shares of common stock upon cashless warrant exercise[110] - On June 27, 2019, the company issued 16,333 shares of common stock upon a consultant warrant exercise[111] - On June 6, 2019, the company issued 47,605 shares of common stock upon cashless warrant exercise[112] Defaults Upon Senior Securities The company reports no defaults upon senior securities - None[114] Mine Safety Disclosures This item is not applicable to the company - Not applicable[115] Other Information The company reports no other information under this item - None[116] Exhibits This section lists exhibits filed with Form 10-Q, including CEO and CFO certifications required by Sarbanes-Oxley, and XBRL data files - Exhibits filed include CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[118]