Oncternal Therapeutics Provides Business Update and Announces Second Quarter 2024 Financial Results
- No dose-limiting toxicities or concerning side effects in our Phase 1/2 study with ONCT-534, our dual-action androgen receptor inhibitor (DAARI), for patients with advanced prostate cancer who are resistant to approved androgen receptor pathway inhibitors; 1200 mg cohort for ONCT-534 given orally once daily enrolled and treated; initial data readout expected in the third quarter of 2024
- Phase 1/2 study for ONCT-808, our ROR1-targeting autologous CAR T cell therapy, for patients with relapsed or refractory aggressive B-cell lymphoma is open and enrolling patients; clinical data update expected in the fourth quarter of 2024
- Cash, cash equivalents and short-term investments totaled
$21.4 million as ofJune 30, 2024 ; cash runway projected into Q1 2025 - Management to host webcast today at
5:00 pm ET
“Our Phase 1/2 study of ONCT-534 in patients with R/R mCRPC continues to advance through dose escalation cohorts without dose-limiting toxicities or concerning side effects. We are encouraged by the high pace of enrollment in the study and look forward to sharing initial clinical and biomarker data later in the third quarter,” said
Recent Highlights
- In
July 2024 , we announced that enrollment was complete and three patients dosed in the sixth cohort of our Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the sixth dosing cohort are being given 1200 mg of ONCT-534 orally once per day. - Our dose escalation/dose expansion Phase 1/2 Study ONCT-808-101, evaluating our ROR1-targeting autologous CAR T cell therapy, ONCT-808, for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, including patients that have failed prior CD19 CAR T treatment, is open and enrolling patients. Protocol changes that include modified eligibility criteria, increased monitoring for early infection, and evaluating lower doses of ONCT-808 have now been implemented.
Expected Upcoming Milestones
- ONCT-534, our dual-action androgen receptor inhibitor
- Initial clinical data in the third quarter of 2024
- Additional clinical data readouts in the fourth quarter of 2024
- ONCT-808, our autologous ROR1-targeted CAR T cell therapy
- Clinical data update in the fourth quarter of 2024
- Clinical data update in the fourth quarter of 2024
Second Quarter 2024 Financial Results
Our grant revenue was
About
Forward-Looking Information
Oncternal cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on Oncternal’s current beliefs and expectations. Forward-looking statements include statements regarding Oncternal’s expected cash runway and statements regarding Oncternal’s development programs, including the anticipated timing for study enrollment and announcing clinical data. Forward-looking statements are subject to risks and uncertainties inherent in Oncternal’s business, including risks associated with the clinical development and process for obtaining regulatory approval of Oncternal’s product candidates, such as potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of a clinical trial do not predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues, and as more patient data become available; and other risks described in Oncternal’s filings with the
Contact Information:
Investors
858-434-1113
rvincent@oncternal.com
Media
212-915-2577
cdavis@lifesciadvisors.com
Condensed Consolidated Balance Sheets Data
(Unaudited; in thousands)
2024 |
2023 |
|||||||
Cash, cash equivalents and short-term investments | $ | 21,429 | $ | 34,255 | ||||
Total assets | 23,859 | 36,729 | ||||||
Total liabilities | 8,105 | 6,677 | ||||||
Accumulated deficit | (214,726 | ) | (197,779 | ) | ||||
Total stockholders' equity | 15,754 | 30,052 |
Condensed Consolidated Statements of Operations Data
(Unaudited; in thousands, except per share data)
Three Months Ended |
Six Months Ended |
|||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Grant revenue | $ | 801 | $ | 106 | $ | 1,370 | $ | 309 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 6,612 | 6,577 | 12,671 | 15,608 | ||||||||||||
General and administrative | 3,052 | 3,074 | 6,341 | 6,389 | ||||||||||||
Total operating expenses | 9,664 | 9,651 | 19,012 | 21,997 | ||||||||||||
Loss from operations | (8,863 | ) | (9,545 | ) | (17,642 | ) | (21,688 | ) | ||||||||
Interest income | 304 | 579 | 695 | 1,235 | ||||||||||||
Net loss | $ | (8,559 | ) | $ | (8,966 | ) | $ | (16,947 | ) | $ | (20,453 | ) | ||||
Net loss per share, basic and diluted | $ | (2.89 | ) | $ | (3.05 | ) | $ | (5.73 | ) | $ | (6.98 | ) | ||||
Weighted-average shares outstanding, basic and diluted | 2,960 | 2,936 | 2,960 | 2,931 |
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Source: Oncternal Therapeutics