RAPT Therapeutics(RAPT) - 2022 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements This section presents the unaudited condensed consolidated financial statements for the three and six months ended June 30, 2022, including the balance sheet, statement of operations, and notes detailing significant accounting policies, a May 2022 PIPE financing, and the Hanmi collaboration agreement Condensed Consolidated Financial Statements The financial statements show total assets grew to $222.0 million by June 30, 2022, with a net loss widening to $39.7 million for the first six months, and $30.8 million net cash used in operating activities Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $57,203 | $24,027 | | Marketable securities | $150,138 | $165,627 | | Total current assets | $209,929 | $192,973 | | Total assets | $221,996 | $198,636 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $13,146 | $9,595 | | Total liabilities | $19,863 | $12,256 | | Total stockholders' equity | $202,133 | $186,380 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | 2022 | 2021 | 2022 | 2021 | | Revenue | $886 | $869 | $1,527 | $2,091 | | Research and development | $14,359 | $13,190 | $31,029 | $26,961 | | General and administrative | $5,436 | $3,760 | $10,184 | $7,772 | | Net loss | $(19,184) | $(16,110) | $(39,652) | $(32,624) | | Net loss per share, basic and diluted | $(0.62) | $(0.63) | $(1.31) | $(1.29) | Condensed Consolidated Statements of Cash Flows (in thousands) | | Six Months Ended June 30, | | :--- | :--- | :--- | | | 2022 | 2021 | | Net cash used in operating activities | $(30,773) | $(27,826) | | Net cash provided by (used in) investing activities | $13,379 | $(51,281) | | Net cash provided by financing activities | $50,570 | $140,409 | | Net increase in cash and cash equivalents | $33,176 | $61,302 | Notes to Condensed Consolidated Financial Statements The notes detail the May 2022 PIPE financing, which generated $49.8 million in net proceeds, along with $1.5 million in Hanmi collaboration revenue and $5.4 million in stock-based compensation expense for the six months ended June 30, 2022 - RAPT Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing oral small molecule therapies for inflammatory diseases and oncology[19] - In May 2022, the company completed a private investment in public equity (PIPE) financing, selling pre-funded warrants to purchase 4,000,000 shares of common stock, resulting in net proceeds of approximately $49.8 million[21][60] - Revenue recognized from the Hanmi Agreement was $1.5 million for the six months ended June 30, 2022. As of this date, the performance obligation was substantially complete, and there was no remaining deferred revenue[58] Stock-based Compensation Expense (in thousands) | | For the Three Months Ended June 30, | For the Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | 2022 | 2021 | 2022 | 2021 | | Research and development | $1,269 | $1,627 | $2,448 | $3,101 | | General and administrative | $1,403 | $1,261 | $2,926 | $2,474 | | Total | $2,672 | $2,888 | $5,374 | $5,575 | Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses operational progress, including the RPT193 Phase 2b trial, and financial results showing a net loss of $39.7 million for the first six months of 2022, with $207.3 million in cash and marketable securities deemed sufficient for the next 12 months Overview RAPT, a clinical-stage biopharmaceutical company, initiated a Phase 2b trial for RPT193 in May 2022, and has an accumulated deficit of $323.7 million as of June 30, 2022, expecting substantial future expenditures - The company's two lead drug candidates, RPT193 (inflammatory diseases) and FLX475 (oncology), both target C-C motif chemokine receptor 4 (CCR4)[70] - In May 2022, the company initiated a 16-week randomized, double-blind, placebo-controlled Phase 2b clinical trial to evaluate RPT193 in patients with moderate-to-severe atopic dermatitis (AD)[72] - As of June 30, 2022, the company had an accumulated deficit of $323.7 million and believes its cash and marketable securities of $207.3 million will be sufficient to fund planned operations for at least 12 months[73][74] Results of Operations For the six months ended June 30, 2022, revenue decreased to $1.5 million, R&D expenses increased 15% to $31.0 million, G&A expenses grew 31% to $10.2 million, resulting in a net loss of $39.7 million Comparison of Results for the Six Months Ended June 30 (in thousands) | | 2022 | 2021 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $1,527 | $2,091 | $(564) | (27)% | | Research and development | $31,029 | $26,961 | $4,068 | 15% | | General and administrative | $10,184 | $7,772 | $2,412 | 31% | | Loss from operations | $(39,686) | $(32,642) | $(7,044) | 22% | | Net loss | $(39,652) | $(32,624) | $(7,028) | 22% | External R&D Expenses by Program (in thousands) | Program | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | RPT193 | $7,034 | $3,213 | | FLX475 | $6,457 | $7,200 | | Other Programs | $1,187 | $936 | - The 15% increase in R&D expenses for the first six months of 2022 was primarily driven by a $3.8 million increase in development costs for RPT193[97] Liquidity and Capital Resources As of June 30, 2022, the company held $207.3 million in cash and marketable securities, bolstered by $49.8 million from a May 2022 PIPE financing, while net cash used in operating activities was $30.8 million - The company completed a PIPE financing in May 2022, raising approximately $49.8 million in net proceeds[100] - As of June 30, 2022, the company had cash, cash equivalents, and marketable securities of $207.3 million and working capital of $196.8 million[100] Summary of Cash Flows (in thousands) | | Six Months Ended June 30, | | :--- | :--- | :--- | | | 2022 | 2021 | | Net cash used in operating activities | $(30,773) | $(27,826) | | Net cash provided by (used in) investing activities | $13,379 | $(51,281) | | Net cash provided by financing activities | $50,570 | $140,409 | Item 3. Quantitative and Qualitative Disclosures About Market Risk The company is not required to provide this information as it qualifies as a "smaller reporting company" under SEC regulations - As a "smaller reporting company," RAPT Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[112] Item 4. Controls and Procedures Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2022, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[113] - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[114] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company states that it is not currently involved in any legal proceedings that are expected to have a material adverse effect on its operations, financial condition, or cash flows - Management believes there are currently no pending legal claims or actions against the company that would have a material adverse effect on its results of operations, financial condition, or cash flows[116] Item 1A. Risk Factors This section outlines significant risks, including a history of financial losses, high clinical development failure rates for RPT193 and FLX475, the need for additional funding, reliance on third parties, intense competition, and impacts from global economic instability and the COVID-19 pandemic - The company is a clinical-stage biopharmaceutical firm with a history of losses, an accumulated deficit of $323.7 million as of June 30, 2022, and expects to incur significant losses for the foreseeable future[119] - The company's lead drug candidates, RPT193 and FLX475, are in clinical development, a lengthy, expensive process with an uncertain outcome. Failure to demonstrate safety and efficacy could compromise their commercial viability[118][121] - The company will need substantial additional funds to advance its drug candidates and cannot guarantee that sufficient capital will be available in the future[118][146] - The ongoing COVID-19 pandemic and unfavorable global economic conditions, including the conflict in Ukraine and inflation, could materially impact operations, clinical trials, and the ability to access capital markets[130][135] - The company relies on third parties for manufacturing and conducting clinical trials, creating risks related to supply chain interruptions, quality control, and potential delays in development programs[118][155][161] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities, no use of proceeds from registered offerings, and no issuer purchases of its equity securities during the reporting period - There were no unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities during the quarter[289] Item 6. Exhibits This section lists exhibits filed with the Form 10-Q, including the Securities Purchase Agreement, Registration Rights Agreement for the May 2022 financing, and officer certifications - The report includes an index of exhibits filed, which incorporates by reference key documents such as the Amended and Restated Certificate of Incorporation, agreements related to the May 2022 PIPE financing, and required officer certifications[294][295]