Financial Data and Key Metrics Changes - Revenue for the second quarter ended June 30, 2024, was $0.8 million, derived from research and development grants from the NIH [7] - Total operating expenses for the same period were $9.7 million, including $1.4 million in non-cash stock-based compensation [7] - Research and development expenses totaled $6.6 million, while general and administrative expenses were $3.1 million [7] - The net loss for the second quarter was $8.6 million, equating to a net loss of $2.89 per share, both basic and diluted [7] - As of June 30, 2024, the company had approximately 3 million shares of common stock outstanding and $21.4 million in cash, cash equivalents, and short-term investments, with no debt [7] Business Line Data and Key Metrics Changes - The company is advancing two first-in-class clinical programs: ONCT-534, a dual-action androgen receptor inhibitor, and ONCT-808, an autologous ROR1 targeting CAR-T product [4] - ONCT-534 is currently in the dose escalation portion of the Phase I/II study, with the sixth dosing cohort fully enrolled, receiving 1,200 milligrams daily [5][6] - The Phase I/II study for ONCT-808 is ongoing, with no dose-limiting toxicities observed in the current dosing cohort [6] Market Data and Key Metrics Changes - The company is targeting significant unmet medical needs in cancer treatment, particularly prostate cancer and aggressive B-cell lymphoma [4] - The clinical trials are showing strong demand from investigators, indicating a positive market reception for the company's products [4] Company Strategy and Development Direction - The company aims to address key escape mechanisms in prostate cancer treatment with ONCT-534, which may outperform currently approved AR pathway inhibitors [4] - The strategy includes presenting initial clinical data for ONCT-534 in the third quarter of 2024 and additional data for ONCT-808 in the fourth quarter of 2024 [8] Management's Comments on Operating Environment and Future Outlook - Management remains encouraged by the Phase I results from clinical programs and anticipates providing updates in the coming months [20] - The company believes its current cash position will support operations into the first quarter of 2025, indicating a stable financial outlook for the near term [7] Other Important Information - The company has not observed any dose-limiting toxicities in its clinical trials, which is a positive indicator for the safety profile of its products [5][6] - The management is collecting extensive data on patients, including pharmacokinetic data and novel biomarker work, to inform future dosing decisions [16] Q&A Session Summary Question: What to expect from the clinical data update for ONCT-534 in the third quarter? - Management expects to present safety data and some PSA parameters, likely from earlier cohorts due to the follow-up period [9][11] Question: What will the additional clinical data in the fourth quarter consist of? - The additional data will likely include longer follow-up results and data from more cohorts [12] Question: How many patients have been enrolled in the ONCT-808 study? - The company has not disclosed specific enrollment numbers but noted that they have revised the dosing regimen and are not seeing any dose-limiting toxicity [13][14] Question: Is there a possibility of moving to higher dosing cohorts after data from the sixth cohort? - Decisions regarding higher dosing cohorts will be made based on comprehensive data collected, including safety and efficacy [16] Question: Are there practical limits regarding administration if higher doses are considered? - The current tablet formulation allows for the feasibility of administering more than six tablets a day if data supports higher dosing [17]
Oncternal Therapeutics(ONCT) - 2024 Q2 - Earnings Call Transcript