Financial Performance - Oncternal Therapeutics reported a net loss of $13.6 million for the six months ended June 30, 2021, with an accumulated deficit of $96.4 million[100]. - As of June 30, 2021, Oncternal had cash and cash equivalents of $103.7 million, which is expected to fund operations for at least the next twelve months[104]. - Net cash used in operating activities for the six months ended June 30, 2021, was $13.6 million, resulting from a net loss of $13.6 million[127]. - Grant revenue for the three months ended June 30, 2021, was $0.9 million, an increase of $0.3 million from $0.6 million in 2020, primarily due to higher research and development subaward costs[115]. - Total operating expenses for the three months ended June 30, 2021, were $8.6 million, an increase of $2.4 million from $6.2 million in 2020[114]. - Research and development expenses for the six months ended June 30, 2021, were $9.1 million, an increase of $2.6 million from $6.5 million in 2020, driven by a $1.6 million increase in direct product candidate costs[121]. - General and administrative expenses for the six months ended June 30, 2021, were $6.2 million, an increase of $1.2 million from $5.0 million in 2020, primarily due to higher personnel and professional costs[124]. Funding and Capital Requirements - The company has raised approximately $125.0 million from common stock issuance and $49.0 million from convertible preferred stock issuance as of June 30, 2021[99]. - The company anticipates needing substantial additional funding to support ongoing operations and business strategy[102]. - The company anticipates needing to raise substantial additional capital in the future to fund ongoing operations and development activities[111]. - Future capital requirements will depend on various factors, including the costs and timing of clinical trials and regulatory reviews[130]. - There is no assurance that the company will be able to obtain financing on acceptable terms, which could impact product development and commercialization efforts[131]. - The company may face dilution of stockholder ownership if additional capital is raised through debt or equity securities[131]. Clinical Development and Trials - Cirmtuzumab is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of B-cell lymphoid malignancies, with a target enrollment of at least 20 patients for the MCL cohort[96][97]. - The FDA has granted orphan drug designations for cirmtuzumab for MCL and CLL, and for TK216 for Ewing sarcoma[95]. - Cirmtuzumab's Phase 1/2 trial results were presented at the American Society of Clinical Oncology 2021 Annual Meeting, indicating encouraging interim results[96]. - The ongoing COVID-19 pandemic has impacted clinical trial timelines, with delays expected for the ROR1 CAR-T therapy's first-in-human dosing to the first half of 2022[105]. - Direct expenses for cirmtuzumab increased by $0.3 million for the six months ended June 30, 2021, primarily due to increased clinical trial costs[122]. Accounting and Financial Reporting - The company considers its critical accounting policies related to research and development expenses and revenue recognition, with no material changes during the six months ended June 30, 2021[136]. - The financial statements are prepared in accordance with generally accepted accounting principles, requiring estimates and judgments that affect reported amounts[134]. - Actual results may differ from estimates based on various assumptions or conditions[135]. - The company has not engaged in any off-balance sheet arrangements during the periods presented[137]. Regulatory and Compliance - As of June 30, 2021, the company was unable to estimate the timing or likelihood of achieving specified development, regulatory, and commercial milestones related to its license agreements[132]. - The company has payment obligations under license agreements that are contingent upon future events, including royalty payments for product sales developed under those agreements[132]. - The company enters into contracts with clinical trial sites and supply manufacturers, which generally allow for termination after a notice period[133]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[139].
Oncternal Therapeutics(ONCT) - 2021 Q2 - Quarterly Report