Financial Performance - For the three months ended September 30, 2023, the company reported a net loss of $9.9 million, with an accumulated deficit of $188.6 million[93]. - Grant revenue decreased to $0.2 million for the three months ended September 30, 2023, down from $0.4 million in the same period of 2022, a decline of 50%[111]. - Total research and development expenses for the three months ended September 30, 2023, were $7.5 million, a decrease of $1.0 million or 11.5% compared to $8.4 million in 2022[112]. - General and administrative expenses for the three months ended September 30, 2023, were $3.1 million, down from $3.3 million in 2022, a decrease of 6.1%[118]. - Interest income increased to $0.5 million for the three months ended September 30, 2023, compared to $0.2 million in 2022, an increase of 150%[119]. - For the nine months ended September 30, 2023, grant revenue was $0.5 million, down from $1.3 million in 2022, a decrease of 61.5%[120]. - Total research and development expenses for the nine months ended September 30, 2023, were $23.1 million, a decrease of $1.1 million or 4.5% compared to $24.2 million in 2022[121]. - General and administrative expenses for the nine months ended September 30, 2023, were $9.5 million, down from $10.2 million in 2022, a decrease of 6.9%[127]. - Interest income for the nine months ended September 30, 2023, was $1.8 million, an increase of $1.5 million or 500% compared to $0.3 million in 2022[128]. Cash and Funding - The company had cash, cash equivalents, and short-term investments of $40.3 million as of September 30, 2023, with no debt[92]. - The company anticipates needing substantial additional funding to support ongoing operations and business strategy[96]. - The company expects existing cash resources to fund operations into 2025, but may need to raise additional capital thereafter[98]. - Net cash provided by financing activities decreased to $1.1 million in 2023 from $7.6 million in 2022, mainly due to proceeds from the sale of common stock under the "at-the-market" program[135]. - Existing cash, cash equivalents, and short-term investments are expected to fund operations into 2025, but actual results may vary due to regulatory requirements and other uncertainties[137]. - Additional capital will be required for research and development, with potential financing through equity or debt securities, government funding, or collaborations[138]. - The company has a Sales Agreement allowing for the sale of common stock up to $50.0 million, but there is no obligation to sell any shares[143]. Research and Development - The ongoing Phase 1/2 trial of ONCT-808 aims to enroll approximately 54 patients, with initial clinical data expected in late 2023[90]. - The Phase 1/2 study of ONCT-534 is expected to enroll approximately 59 patients, with initial clinical data anticipated in the first half of 2024[91]. - Research and development expenses are expected to decrease year over year through Q4 2023 due to the closure of certain studies, but are projected to increase starting Q1 2024[104]. - The company anticipates that research and development expenses will increase starting in Q1 2024 due to ongoing clinical trials[129]. - The company may face significant dilution if additional funds are raised through equity securities, and any debt financing may involve restrictive covenants[138]. - The company received $14.5 million in development milestone payments from UC San Diego under a grant agreement[92]. - The FDA granted fast track designation for ONCT-534 for the treatment of relapsed or refractory metastatic castrate-resistant prostate cancer[91]. - The company anticipates continued losses as it progresses with research and development and seeks regulatory approvals for its product candidates[136]. Future Outlook - Future funding requirements will depend on various factors, including the progress and costs of clinical trials and regulatory approvals[140]. - The company is party to license agreements with contingent payment obligations based on future milestones, but the timing and likelihood of achieving these milestones are uncertain[144]. - Critical accounting policies include research and development expenses and revenue recognition, with no material changes reported for the three months ended September 30, 2023[148].
Oncternal Therapeutics(ONCT) - 2023 Q3 - Quarterly Report