Financial Data and Key Metrics Changes - Revenue for the first quarter was $0.2 million, derived from research and development grants from the NIH [15] - Total operating expenses for the first quarter were $12.3 million, including $1.9 million in non-cash stock-based compensation [15] - Net loss for the first quarter was $11.5 million, resulting in a loss of $0.20 per share [16] - As of March 31, 2023, the company had approximately $54.3 million in cash and investments and no debt [16] Business Line Data and Key Metrics Changes - The company has shifted focus to advancing its ROR1 targeting cell therapy ONCT-808 and the novel dual acting AR inhibitor ONCT-534 [11] - ONCT-808 is currently in a Phase 1/2 clinical trial targeting aggressive B-cell lymphoma patients [12] - ONCT-534 is expected to initiate a Phase 1/2 clinical trial in metastatic castration-resistant prostate cancer shortly after IND clearance [14] Market Data and Key Metrics Changes - The company aims to address unmet medical needs in hematologic malignancies and prostate cancer, particularly for patients who have failed previous treatments [29] - The median progression-free survival for patients who have failed CD19 treatment is only 3 months, with overall survival at 5 months [30] Company Strategy and Development Direction - The company has announced a strategic reprioritization to focus on its two main product candidates, ONCT-808 and ONCT-534, which are expected to have significant clinical catalysts within the next 12 to 18 months [11] - The manufacturing process for ONCT-808 is noted to be quick, taking only 8 days, which is expected to facilitate patient treatment [37] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the clinical potential of ONCT-808 and ONCT-534, emphasizing their commitment to addressing high unmet medical needs [35] - The company expects to extend its cash runway into 2025, allowing for continued operations and development of its product pipeline [29] Other Important Information - The company is currently evaluating the potential for Zilovertamab in combination with other BTK inhibitors following the withdrawal of ibrutinib's FDA approval [48] - Initial clinical data for ONCT-808 is expected by the end of 2023, with additional data readouts in 2024 [33] Q&A Session Summary Question: How does experience with Zilovertamab help with ONCT-808? - Management indicated that the binding domains of Zilovertamab are used in the CAR T therapy, providing a safe toxicity profile based on previous patient treatments [21] Question: What is the starting dosing level for ONCT-808? - The starting dose proposed to the FDA is 1 million CAR expressing cells per kilogram, which is expected to be effective based on other CAR T products [23] Question: What are the expectations for initial data readout? - Management anticipates having data on a few patients by the end of the year, with a conservative approach to patient treatment intervals [36] Question: What is the bar for success in the Phase 1 portion for ONCT-534? - The primary marker for anti-tumor activity will be PSA reduction, with additional surrogate markers being evaluated [45]
Oncternal Therapeutics(ONCT) - 2023 Q1 - Earnings Call Transcript