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Oncternal Therapeutics, Inc.
8/8/2024
of the Private Securities Litigation Reform Act. We will be making forward-looking statements during this call about future events such as our business and product development strategies, the timing of our clinical studies, planned interim data updates, regulatory filings, and our cash runway. Our actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with our business. These forward-looking statements should be considered in conjunction with and are qualified by the cautionary statements contained in today's press release and our SEC filings, including our Form 10-Q filed today and our previously filed Form 10-K for the full year ended December 31, 2023. This call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 8, 2024. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances occurring after the date of this call. With that, it is my pleasure to hand the call over to our CEO, Dr. Jim Breitmaier.
Thank you, Rich, and good afternoon, everyone. At OCTURNAL, we are advancing two first-in-class clinical programs targeting cancers for patients with significant unmet medical needs. Oncd534, our novel dual-action androgen receptor inhibitor, or DARI, continues to advance through the dose escalation portion of the Phase I-II study, and we continue to see strong demand from investigators. As a reminder, preclinical studies showed that Oncd534 inhibited prostate cancer cells through both the ligand binding domain and the N-terminal domain of the androgen receptor, and it also induced degradation of the ender receptor. Thanks to this novel mechanism, we believe OCT534 may address key prostate cancer escape mechanisms from currently approved AR pathway inhibitors, such as enzalutamide and abiraterone, which include multiple LBD mutations, as well as splice variants, such as ARV7. The clinical trial is proceeding well. We have not observed any dose-limiting toxicities or other concerning side effects. And we recently announced that the sixth dosing cohort of the study is now fully enrolled. Patients in this cohort are receiving 1,200 milligrams of OX34 administered orally once per day. The decision to move to this dose level was made by the study's safety review committee after reviewing data from the patients treated to date, including the third dose level of 600 milligrams 534 daily. We plan to share an initial clinical data update for ONC534 later in the third quarter. Now switching gears to ONC808, our autologous ROAR-1 targeting CAR-T product. Our Phase 1-2 study in patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR-T treatment, is enrolling and treating patients. There have been no dose-limiting toxicities observed in the current dosing cohort. We expect to report updated clinical results, including data from patients treated with the new dosing schedule in the fourth quarter of 2024. With this, I now turn the call back to our CFO, Rich Vinson. Rich? Thank you, Jim.
Our revenue is currently derived from research and development grants received from the NIH. Our grant revenue was 0.8 million for the second quarter ended June 30, 2024. Our total operating expenses for the second quarter ended June 30, 2024 were 9.7 million. including 1.4 million in non-cash stock-based compensation expense. Research and development expenses totaled 6.6 million, and general and administrative expenses totaled 3.1 million. Net loss for the second quarter was 8.6 million for a net loss of $2.89 per share, basic and diluted. As of June 30, 2024, we had approximately 3 million shares of common stock outstanding, $21.4 million in cash, cash equivalents, and short-term investments, and no debt. We believe these funds will be sufficient to support our operations into the first quarter of 2025. With respect to upcoming milestones, we are looking forward to the following updates. For ONC 534, our lead DARI product candidate, we expect to present initial clinical data in the third quarter of 2024 with additional data readouts in the fourth quarter of 2024. Bronx 808 or Roar 1 Autologous RT, we expect to report a clinical data update in the fourth quarter of 2024. With that, I will turn things back over to the operator for the Q&A portion of this afternoon's call. Diego?
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