RAPT Therapeutics(RAPT) - 2021 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Financial Statements H1 2021 financial position strengthened, total assets doubled to $231.1 million from public offering, despite widening net losses and negative operating cash flow Condensed Consolidated Balance Sheets Balance sheet shows significant increase in cash and marketable securities, doubling total assets and stockholders' equity by June 30, 2021 Balance Sheet Highlights (in thousands) | Account | June 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $86,220 | $24,918 | | Marketable securities | $137,084 | $86,592 | | Total Assets | $231,081 | $118,969 | | Total Liabilities | $13,502 | $14,790 | | Total Stockholders' Equity | $217,579 | $104,179 | - Total assets more than doubled from $119.0 million at year-end 2020 to $231.1 million as of June 30, 2021, driven by increased cash and marketable securities from recent equity financings[11] Condensed Consolidated Statements of Operations Net losses widened in Q2 and H1 2021, driven by increased R&D and G&A expenses, despite a slight revenue decline Quarterly Operating Results (in thousands, except per share data) | Metric | Q2 2021 | Q2 2020 | | :--- | :--- | :--- | | Revenue | $869 | $1,277 | | Research and development | $13,190 | $10,986 | | General and administrative | $3,760 | $2,802 | | Net Loss | ($16,110) | ($12,387) | | Net Loss Per Share | ($0.63) | ($0.51) | Six-Month Operating Results (in thousands, except per share data) | Metric | H1 2021 | H1 2020 | | :--- | :--- | :--- | | Revenue | $2,091 | $2,212 | | Research and development | $26,961 | $21,669 | | General and administrative | $7,772 | $6,091 | | Net Loss | ($32,624) | ($25,526) | | Net Loss Per Share | ($1.29) | ($1.08) | - Net loss for Q2 2021 increased to $16.1 million from $12.4 million in Q2 2020, driven by a 20% increase in R&D expenses and a 34% increase in G&A expenses[12][78] Condensed Consolidated Statements of Cash Flows Operating cash flow remained negative, but significant financing activities, primarily from a public offering, led to a substantial net cash increase in H1 2021 Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($27,826) | ($15,172) | | Net cash used in investing activities | ($51,281) | ($103,990) | | Net cash provided by financing activities | $140,409 | $70,736 | | Net increase (decrease) in cash | $61,302 | ($48,426) | - Financing activities provided $140.4 million in cash during H1 2021, primarily from a public offering ($134.6 million net) and 'at the market' offerings ($4.7 million net), compared to $70.7 million in H1 2020[17][99] Notes to Financial Statements Notes detail significant H1 2021 equity financings, including a public offering and 'at the market' sales, along with collaboration revenue and stock-based compensation expenses - In June 2021, the company completed a public offering of 4,356,060 shares of common stock, raising approximately $134.6 million in net proceeds[23] - During H1 2021, the company sold 214,971 shares through 'at the market' offerings, generating $4.7 million in net proceeds[22] - Revenue from the Hanmi Pharmaceutical collaboration was $0.9 million for Q2 and $2.1 million for H1 2021, with deferred revenue of $3.3 million as of June 30, 2021[52] - Stock-based compensation expense increased to $5.6 million for H1 2021, up from $4.1 million in the prior-year period[56] Management's Discussion and Analysis (MD&A) MD&A discusses clinical-stage focus, positive RPT193 trial results, history of losses, $247.5 million accumulated deficit, future funding needs despite $223.3 million cash from public offering, and rising R&D expenses Business Overview Clinical-stage biopharmaceutical firm developing oral small molecule therapies for oncology and inflammatory diseases, with positive Phase 1b results for RPT193 in atopic dermatitis - RAPT is a clinical-stage biopharmaceutical company developing oral small molecule therapies for oncology and inflammatory diseases, with lead candidates FLX475 and RPT193 targeting CCR4[61] - In June 2021, the company announced positive topline results from its Phase 1b trial of RPT193 in patients with moderate-to-severe atopic dermatitis, showing continued improvement at the six-week time point post-treatment[62] Results of Operations Operating results show widening net losses for Q2 and H1 2021, driven by increased R&D and G&A expenses, particularly for FLX475 clinical trials Comparison of Three Months Ended June 30, 2021 and 2020 (in thousands) | Item | Q2 2021 | Q2 2020 | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | $869 | $1,277 | (32)% | | R&D Expenses | $13,190 | $10,986 | 20% | | G&A Expenses | $3,760 | $2,802 | 34% | | Net Loss | ($16,110) | ($12,387) | 30% | Comparison of Six Months Ended June 30, 2021 and 2020 (in thousands) | Item | H1 2021 | H1 2020 | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | $2,091 | $2,212 | (5)% | | R&D Expenses | $26,961 | $21,669 | 24% | | G&A Expenses | $7,772 | $6,091 | 28% | | Net Loss | ($32,624) | ($25,526) | 28% | - The increase in R&D expenses for both Q2 and H1 was primarily due to higher clinical trial costs related to FLX475, which rose by $1.3 million in Q2 and $2.7 million in H1 year-over-year[80][81][87] Liquidity and Capital Resources As of June 30, 2021, the company had $223.3 million in cash and equivalents, believes it has sufficient funds for the next 12 months, but acknowledges the need for substantial additional future capital - As of June 30, 2021, the company had cash, cash equivalents, and marketable securities of $223.3 million and an accumulated deficit of $247.5 million[91][64] - Management believes current cash is sufficient to fund operations for at least the next 12 months following the report's filing date[91][64] - The company will require substantial additional capital to develop its drug candidates and fund future operations, which it may seek through equity/debt financings or collaborations[92][66] Controls and Procedures Management concluded disclosure controls and procedures were effective as of June 30, 2021, with no material changes to internal control over financial reporting identified - The CEO and CFO concluded that as of June 30, 2021, the company's disclosure controls and procedures were effective at a reasonable assurance level[106] - No material changes in internal control over financial reporting were identified during the quarter[107] PART II. OTHER INFORMATION Risk Factors Extensive risks include history of losses, uncertain clinical development for FLX475 and RPT193, COVID-19 impacts, reliance on third parties, intense competition, funding needs, IP protection, and regulatory complexities Business and Financial Risks Key business and financial risks include a history of significant losses, the need for substantial additional funding, and the uncertain, lengthy, and expensive nature of clinical development for lead drug candidates - The company is a clinical-stage biopharmaceutical firm with a history of losses, an accumulated deficit of $247.5 million as of June 30, 2021, and expects significant future losses[112] - Substantial additional funding is required to advance drug candidates, and failure to raise capital on acceptable terms could delay or eliminate R&D programs[137][92] - Lead drug candidates FLX475 and RPT193 are in lengthy, expensive, and uncertain clinical development, where early positive results do not predict future success[114][117] Operational and Strategic Risks Operational risks include potential COVID-19 impacts on trials and supply chains, reliance on sole-source third-party manufacturers and CROs, and intense competition from larger pharmaceutical companies - The COVID-19 pandemic has affected and could continue to impact operations, including slowing clinical trial enrollment and disrupting the supply chain[122][125] - The company relies on third-party manufacturers, some of which are sole-source vendors, for clinical trial supplies, where interruptions could significantly delay development efforts[154] - The company faces intense competition from large, well-funded pharmaceutical and biotechnology companies with greater resources and experience[160][161][162] - The company relies on third-party CROs and clinical investigators to conduct trials, with limited control over their performance, potentially delaying development programs[148] Regulatory and Legal Risks Regulatory and legal risks include the lengthy, expensive, and uncertain approval process, ongoing compliance obligations, and potential adverse impacts from healthcare legislative reforms and drug pricing scrutiny - The clinical development and regulatory approval process is lengthy, expensive, and uncertain, potentially preventing U.S. or foreign regulatory approval for drug candidates[230][234] - Approved products face ongoing regulatory obligations, and non-compliance could result in significant penalties or market withdrawal[238] - Healthcare legislative reform, cost-containment measures, and government scrutiny over drug pricing could adversely affect business and profitability[240][243] Intellectual Property Risks Intellectual property risks involve the costly and uncertain process of obtaining and enforcing patent protection, potential infringement litigation from third parties, and the adequacy of trade secret protection - The company's success depends on obtaining, maintaining, and enforcing patent protection for its technology and drug candidates, an expensive and uncertain process[189][190] - The company may face costly litigation from third parties alleging intellectual property infringement, diverting resources[212] - The company relies on trade secrets and confidentiality agreements, which may be breached or may not provide adequate protection for proprietary information[223] Other Disclosures The company reports no material legal proceedings, no unregistered equity sales, and no material change in planned IPO proceeds, with no other significant disclosures under Items 3, 4, or 5 - The company is not currently involved in any legal proceedings that would have a material adverse effect on its financial condition or operations[109] - There has been no material change in the planned use of proceeds from the company's Initial Public Offering (IPO) as described in its final prospectus[277]