Financial Performance - Oncternal Therapeutics reported a net loss of $16.9 million for the six months ended June 30, 2024, with an accumulated deficit of $214.7 million[72]. - Net loss for the three months ended June 30, 2024, was $8.6 million, an improvement from a net loss of $9.0 million in the same period of 2023, reflecting a $0.4 million decrease[87]. - Cash used in operating activities for the six months ended June 30, 2024, was $13.3 million, a decrease from $20.2 million in 2023, primarily due to expense timing and program reprioritization[104]. - The company anticipates continuing to incur net losses for the foreseeable future, indicating substantial doubt about its ability to continue as a going concern for twelve months following the financial statement issuance date[101]. - The company has a substantial doubt about its ability to continue as a going concern for twelve months following the issuance date of its financial statements[77]. Capital and Funding - The company has raised a total of $136.3 million from common stock issuance and $49.0 million from convertible preferred stock since its inception[71]. - Oncternal plans to raise substantial additional capital to support ongoing operations and product development efforts[75]. - The company filed a new shelf registration statement on March 8, 2024, which was declared effective on May 1, 2024, allowing it to raise capital under certain conditions[110]. - As of June 30, 2024, the company's public float was calculated to be less than $75.0 million, limiting the amount that can be raised through primary public offerings to one-third of the public float[110]. - Future sales of common stock will depend on key milestones, including the initiation and completion of clinical trials for DAARI and ROR1 CAR T product candidates[111]. Research and Development - ONCT-534, an investigational dual-action androgen receptor inhibitor, is currently in a Phase 1/2 study with six dosing cohorts ranging from 40 mg to 1200 mg[69]. - Zilovertamab has shown 100% progression-free survival at 42 months in CLL patients with a p53 mutation/del(17p) in a Phase 1/2 study[70]. - Total research and development expenses for the six months ended June 30, 2024, were $12.7 million, down from $15.6 million in 2023, a decrease of $2.9 million primarily due to reduced direct product candidate expenses[96]. - Direct expenses for ONCT-534 increased by $1.6 million for the six months ended June 30, 2024, compared to the same period in 2023, primarily due to increased clinical activities[97]. - Unallocated research and development expenses decreased by $1.3 million for the six months ended June 30, 2024, compared to the same period in 2023, due to lower consulting and personnel costs[98]. Revenue and Grants - The company received $1.5 million in award payments from NIH during the six months ended June 30, 2024, and recorded $1.4 million in grant revenue[78]. - Grant revenue increased to $0.8 million for the three months ended June 30, 2024, compared to $0.1 million in the same period of 2023, reflecting a $0.7 million increase due to NIH grant activities[88]. Operational Costs - General and administrative expenses are anticipated to increase significantly due to costs associated with being a public company and hiring additional personnel[85]. - The company is subject to risks and uncertainties regarding the adequacy of cash and short-term investments to support operations[109]. - The costs and timing of obtaining regulatory approvals for product candidates are significant factors affecting future funding requirements[109]. - The company may need to hire additional personnel and consultants as preclinical and clinical activities increase, impacting capital resources[109]. - The ability to achieve market acceptance and adequate reimbursement from third-party payors is crucial for any approved products[109]. Contracts and Obligations - The company has contractual obligations related to license agreements that include payment obligations contingent on achieving specified development and commercial milestones[112]. - The company has entered into contracts with clinical trial sites and manufacturers, which are generally cancelable after a notice period[112]. - Research and development expenses are estimated based on contracts and quotations, with adjustments made as necessary based on actual service levels[114].
Oncternal Therapeutics(ONCT) - 2024 Q2 - Quarterly Report