IDEAYA Biosciences(IDYA) - 2019 Q3 - Quarterly Report

Financial Performance - Total current assets increased to $112,161,000 as of September 30, 2019, up from $90,667,000 as of December 31, 2018, representing a growth of 23.6%[15] - Net loss for the three months ended September 30, 2019, was $10,969,000, compared to a net loss of $13,052,000 for the same period in 2018, reflecting a reduction of 15.9%[18] - Comprehensive loss for the nine months ended September 30, 2019, was $31,085,000, compared to $25,800,000 for the same period in 2018, showing an increase of 20.1%[18] - For the nine months ended September 30, 2019, the net loss was $31.194 million, compared to a net loss of $25.784 million for the same period in 2018[27] - The company reported a net loss per share attributable to common stockholders of $0.54 for the three months ended September 30, 2019, compared to $13.06 for the same period in 2018[18] - The company reported net losses of $31.2 million and $25.8 million for the nine months ended September 30, 2019, and September 30, 2018, respectively, with an accumulated deficit of $81.7 million as of September 30, 2019[132] Assets and Liabilities - Total liabilities increased to $11,925,000 as of September 30, 2019, compared to $7,098,000 as of December 31, 2018, marking a rise of 67.5%[15] - The company's cash and cash equivalents rose to $38,848,000 as of September 30, 2019, compared to $20,505,000 as of December 31, 2018, indicating an increase of 89.5%[15] - The company had cash, cash equivalents, and short-term marketable securities totaling $109.4 million as of September 30, 2019, which is expected to fund operations for at least 12 months[32] - The company has an accumulated deficit of $81.7 million as of September 30, 2019[31] - The company reported accrued liabilities of $3.992 million as of September 30, 2019, an increase from $3.583 million as of December 31, 2018, primarily due to higher accrued research and development expenses[70] Research and Development - Research and development expenses for the three months ended September 30, 2019, were $8,923,000, a decrease of 29.1% compared to $12,538,000 for the same period in 2018[18] - Research and development expenses decreased by $3.6 million, or 29%, from $12.5 million in Q3 2018 to $8.9 million in Q3 2019, primarily due to a one-time license fee of $6.3 million in Q3 2018[146] - Research and development expenses increased by $1.6 million, or 7%, from $24.2 million in the nine months ended September 30, 2018, to $25.8 million in the same period of 2019[151] - The company has initiated a Phase 1/2 clinical trial for IDE196, targeting enrollment of 60 evaluable patients with metastatic uveal melanoma (MUM) and anticipates submitting a new drug application (NDA) in Q4 2021 or Q1 2022[113][114] - IDE196 has shown a confirmed complete response in one of four patients at the 200 mg BID dose level, with five of 28 evaluable patients continuing therapy for over two years[111] Funding and Capital - The company raised $50.321 million from the issuance of common stock in its initial public offering, net of issuance costs[30] - The company expects to incur substantial additional losses in the future as it continues to develop its product candidates and seek regulatory approvals[159] - Future funding requirements will depend on various factors, including the development of product candidates and operational needs, with potential dilution for existing shareholders if additional equity is issued[161] - The company has not generated any revenue since inception and has funded operations primarily through $140.1 million in gross cash proceeds prior to its IPO in May 2019[128] - Net cash provided by financing activities was $50.6 million for the nine months ended September 30, 2019, primarily from net proceeds of the IPO, compared to $105.5 million in the same period of 2018 from the issuance of redeemable convertible preferred stock[170] Operational Expenses - General and administrative expenses increased by $1.6 million, or 148%, from $1.1 million in Q3 2018 to $2.7 million in Q3 2019, driven by higher payroll and professional fees[147] - General and administrative expenses rose by $4.1 million, or 131%, from $3.1 million in the nine months ended September 30, 2018, to $7.2 million in 2019, mainly due to increased professional fees and payroll[152] - The company incurred stock-based compensation expenses of $1.449 million for the nine months ended September 30, 2019, up from $625,000 in 2018[27] - The total stock-based compensation expense for the three months ended September 30, 2019 was $518,000, compared to $287,000 for the same period in 2018, representing an increase of 80.1%[90] Regulatory and Compliance Risks - The company is dependent on key personnel and must comply with government regulations, which could affect its future financial position[38] - The company’s product candidates require FDA approval, and there is no assurance that they will be commercially viable[39] - The regulatory approval process for IDE196 and other product candidates is uncertain and may incur higher costs and longer timelines than anticipated[208] - The company has limited experience in preparing and submitting regulatory filings, which could impact the approval timeline for IDE196[203] - The success of any approved products will depend on insurance coverage and reimbursement from third-party payors, which may be influenced by healthcare reform measures[209] Market and Competitive Landscape - The Company operates in a highly competitive biotechnology industry, facing risks such as the need for significant additional capital for research and development[38] - The company faces risks related to the variability and unpredictability of its operating results, which could affect stock price and investor expectations[192] - The company has not completed any clinical trials for its product candidates, which may delay the development process[203] - Clinical trials for targeted therapeutics may fail due to various factors, including ineffective results or harmful side effects[210] Stock and Shareholder Information - The weighted average number of shares outstanding for the three months ended September 30, 2019, was 20,158,223, compared to 999,369 for the same period in 2018[18] - As of September 30, 2019, the company had authorized 300,000,000 shares of common stock, with no dividends declared to date[84] - The company’s redeemable convertible preferred stock was fully converted into common stock following the IPO, with no outstanding shares as of September 30, 2019[83] - The total unrecognized stock-based compensation expense for stock options as of September 30, 2019 was $6.2 million, expected to be recognized over a weighted-average period of 2.92 years[93]