Oncternal Therapeutics Updates Business and Announces Q1 2024 Financial Results

Oncternal Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in oncology therapies, has disclosed its business advancements and financial outcomes for the first quarter of 2024. The company is notably engaged in developing treatments addressing unmet medical needs in cancer patients, with a focus on hematological malignancies and prostate cancer.

Dr. James Breitmeyer, Oncternal's President and CEO, highlighted the progress in their clinical programs, expressing optimism regarding the potential effectiveness of ONCT-534 for patients with advanced prostate cancer resistant to current treatments. This optimism stems from preclinical data suggesting that the 300 mg dose may fall within the active range necessary for tumor activity.

Key progress includes the full enrollment of the fourth dosing cohort for the Phase 1/2 study of ONCT-534, targeting patients with relapsed or refractory metastatic castration-resistant prostate cancer (mCRPC). This cohort involves a daily oral intake of 300 mg of ONCT-534. The company anticipates an initial data readout later in the second quarter of 2024.

Additionally, the Phase 1/2 study for ONCT-808, an autologous CAR T cell therapy targeting ROR1, is currently enrolling patients with relapsed or refractory aggressive B-cell lymphoma, including those who have previously not responded to CD19 CAR T treatment. Protocol amendments have been introduced to modify eligibility criteria, enhance early infection monitoring, and evaluate lower doses. Clinical updates are expected in mid-2024, with further data readouts anticipated in the fourth quarter.

Financially, Oncternal reported grant revenue of $0.6 million for Q1 2024. Operating expenses for the quarter were $9.3 million, of which $6.0 million was attributed to research and development, and $3.3 million to general and administrative costs. The company experienced a net loss of $8.4 million, translating to a loss of $2.83 per share. As of March 31, 2024, Oncternal held $27.0 million in cash, cash equivalents, and short-term investments, with no outstanding debt, projecting sufficient funds to sustain operations into the first quarter of 2025.

Oncternal continues to focus on developing ONCT-534 and ONCT-808, alongside other promising oncology therapies. ONCT-534 is an investigational dual-action androgen receptor inhibitor showing preclinical activity against various forms of androgen receptor aberration in prostate cancer models. This drug targets patients with mCRPC who have developed resistance to androgen receptor pathway inhibitors, addressing significant unmet needs in this patient population.

ONCT-808, an investigational autologous CAR T cell therapy targeting ROR1, has demonstrated preclinical efficacy against multiple hematological malignancies and solid tumors. Oncternal is refining the manufacturing process to expedite the production of CAR T therapies, potentially reducing patient wait times compared to existing CAR T products. The ongoing study, ONCT-808-101, is enrolling patients with relapsed or refractory aggressive B-cell lymphoma, inclusive of those previously treated with CD19 CAR T therapies.

Overall, Oncternal Therapeutics remains committed to advancing its clinical programs and addressing critical gaps in cancer treatment through innovative oncology therapies. The company is on track to deliver significant clinical data updates throughout 2024, underpinning its strategic focus on addressing high unmet medical needs in cancer care.