Oncternal Therapeutics Provides Business Update and Announces Fourth Quarter and Full Year 2023 Financial Results
Oncternal Therapeutics, Inc. (ONCT) provides a business update and financial results for the fourth quarter of 2023. The company's Phase 1/2 study for ONCT-534, a dual-action androgen receptor inhibitor for advanced prostate cancer, is progressing well with encouraging initial response signals. ONCT-808, an autologous CAR T cell therapy for aggressive B-cell lymphoma, also shows promising results. The company has a cash runway projected into 2025, with $34.3 million in cash, cash equivalents, and short-term investments as of December 31, 2023.
Positive
Encouraging progress in clinical programs for ONCT-534 and ONCT-808
Cash, cash equivalents, and short-term investments of $34.3 million as of December 31, 2023
Positive response signals in initial dosing cohorts for both therapies
Protocol changes for patient safety in the ONCT-808 study
Successful reverse stock split to regain compliance with Nasdaq's minimum bid price requirement
Negative
Grade 5 serious adverse event in a patient treated with ONCT-808
Common adverse events reported in the initial dosing cohort for ONCT-808
Net loss of $9.2 million for the fourth quarter of 2023
Total operating expenses of $42.5 million for the full year 2023
High non-cash stock-based compensation expenses
The enrollment of the third dosing cohort for ONCT-534 and the initial positive response signal for ONCT-808 represent significant milestones in the development of novel treatments for advanced prostate cancer and aggressive B-cell lymphoma, respectively. The unique mechanism of ONCT-534 as a dual-action androgen receptor inhibitor (DAARI) offers a potential new therapeutic strategy for patients who have developed resistance to current androgen receptor pathway inhibitors. Furthermore, the CAR T cell therapy, ONCT-808, targeting ROR1, provides hope for patients with relapsed or refractory aggressive B-cell lymphoma, especially those who have not responded to prior CD19 CAR T treatments.
However, the reported Grade 5 serious adverse event raises safety concerns and underscores the importance of careful dose escalation and patient monitoring in early-phase clinical trials. The protocol changes mandated by the FDA are a prudent step to enhance patient safety. These developments in the clinical trials could have a substantial impact on the treatment landscape for these malignancies if the therapies prove to be safe and efficacious in later-stage trials.
The financial health of Oncternal Therapeutics, as indicated by the reported cash, cash equivalents and short-term investments of $34.3 million, appears stable with a projected cash runway into 2025. This financial runway is critical for the company to continue its research and development activities without the immediate need for additional capital raises, which could dilute current shareholders' value. The 1-for-20 reverse stock split to regain compliance with Nasdaq's minimum bid price requirement is a strategic move to maintain the company's listing and attract institutional investors.
However, the net loss reported for both the quarter and the full year of 2023, including non-cash stock-based compensation expenses, reflects the high costs associated with the development of novel therapeutics. Investors should consider the potential for future funding requirements and the impact of clinical trial results on the company's financial position and stock performance.
The progress in the Phase 1/2 studies of ONCT-534 and ONCT-808 is a critical step forward in the clinical development pipeline. The initial positive responses and the complete metabolic response (CMR) observed in some patients are promising indicators of the potential efficacy of these therapies. However, the adverse events reported, including the fatal Grade 5 event, highlight the risks inherent in early-phase trials and the need for stringent safety protocols.
It is essential to monitor the upcoming clinical data readouts scheduled for the second and fourth quarters of 2024, as these will provide more comprehensive insights into the safety and efficacy profiles of these therapies. The outcomes of these studies will have significant implications for the company's valuation and strategic direction. The modifications to the study protocols in response to safety concerns also demonstrate the company's adaptability and commitment to patient safety, which are crucial for regulatory approval and market acceptance.
03/07/2024 - 04:01 PM
Third dosing cohort fully enrolled for our Phase 1/2 study for ONCT-534, our dual-action androgen receptor inhibitor, for the treatment of patients with advanced prostate cancer who are resistant to approved androgen receptor pathway inhibitors; initial data readout expected in the second quarter of 2024 Encouraging response signal at initial dose level in our ongoing Phase 1/2 study for ONCT-808, our ROR1-targeting autologous CAR T cell therapy, for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, including patients that have failed prior CD19 CAR T treatment; clinical data update expected in mid-2024 Cash, cash equivalents and short-term investments totaled $34.3 million as of December 31, 2023; cash runway projected into 2025 Management to host webcast today at 5:00 pm ET SAN DIEGO, March 07, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today provided a business update and reported fourth quarter and full year 2023 financial results.
“We are encouraged by the progress in our clinical programs and their potential to address significant unmet needs in advanced prostate cancer and aggressive B-cell malignancies. Our Phase 1 study of ONCT-534 in patients with R/R mCRPC is progressing through the initial dose escalation portion of the study according to plan and we look forward to an initial clinical readout in the second quarter of this year that will include response readouts from patients dosed at potentially therapeutic levels. We continue to believe that the novel mechanism of action of ONCT-534 and the wealth of preclinical data we generated underpins its potential to address the needs of prostate cancer patients who progress after treatment with approved AR pathway inhibitors,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “Our ROR1 CAR T program showed encouraging initial response results and we believe that the protocol amendments will further ensure patient safety as we investigate the optimal dose of ONCT-808 for patients with relapsed or refractory aggressive B cell lymphoma, including patients who have relapsed after CD19 CAR T treatment.”
Recent Highlights
In January 2024, we announced that two patients with metastatic castration-resistant prostate cancer (mCRPC) were enrolled into the third dosing cohort (160 mg daily) in the Phase 1/2 dose escalation/dose expansion study of ONCT-534, our novel dual-action androgen receptor inhibitor (DAARI). The third cohort is now fully enrolled. In December 2023, we updated the status of 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 who have failed previous CD19 CAR T treatment. Encouraging response signal at the initial dose of 1x106 CAR T cells per kg, with two of the three patients achieving complete metabolic response (CMR) and the third achieving a partial response (PR) by FDG PET-CT. Common adverse events in the initial dosing cohort included decreased blood counts, pneumonia and Grade 1-2 cytokine release syndrome (CRS) as of a 4 December 2023 data cutoff. The first patient treated at the second dose level of 3x106 CAR T cells per kg, an 80-year-old with bulky disease who had received four previous lines of therapy including CD19 CAR T, experienced a Grade 5 (fatal) serious adverse event consistent with CRS and immune effector cell-associated neurotoxicity syndrome (ICANS). No evidence of his lymphoma was found histologically, based on the patient’s initial autopsy report. In alignment with the U.S. Food and Drug Administration, the company decided to implement protocol changes that include modified eligibility criteria and testing lower doses for future patients in the study. In January 2024, we announced a 1-for-20 reverse stock split of our common stock and regained compliance with Nasdaq’s minimum bid price requirement. Expected Upcoming Milestones
ONCT-534, our dual-action androgen receptor inhibitor Initial clinical data update in the second 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 mid-2024 Additional clinical data readouts in the fourth quarter of 2024 Fourth Quarter and Full Year 2023 Financial Results $0.3 million for the fourth quarter ended December 31, 2023 and was $0.8 million for the full year 2023. Our total operating expenses for the fourth quarter ended December 31, 2023 were $9.9 million , including $2.2 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $6.7 million , and general and administrative expenses for the quarter totaled $3.3 million . Interest income for the quarter totaled $0.5 million . Net loss for the quarter was $9.2 million , or a loss of $3.11 per share, basic and diluted. For the full year 2023, total operating expenses were $42.5 million , including $7.5 million in non-cash stock-based compensation expense, and our net loss was $39.5 million , or a loss of $13.43 per share, basic and diluted. As of December 31, 2023, we had approximately 2.9 million shares of common stock outstanding, $34.3 million in cash, cash equivalents and short-term investments and no debt. We believe these funds will be sufficient to fund our operations into the first quarter of 2025.
About Oncternal Therapeutics ONCT-534 is an investigational dual-action androgen receptor inhibitor (DAARI) with demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR aberration. It is a potential treatment for patients with mCRPC with unmet medical need because of resistance to androgen receptor pathway inhibitors, including those with AR amplification, mutations in the AR ligand binding domain (LBD), or splice variants with loss of the AR LBD. Study ONCT-534-101 (NCT05917470 ) has dosed patients and continues to enroll patients for treatment with mCRPC. ONCT-808 is an investigational autologous chimeric antigen receptor T (CAR T) cell therapy that targets Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1) using the binding domain from zilovertamab. ONCT-808 has demonstrated activity in preclinical models against multiple hematological malignancies and solid tumors and has been shown to be specific for cancer cells expressing ROR1. Oncternal has developed a robust and reproducible manufacturing process that has the potential to reduce the time patients must wait for their individual CAR T therapy to be produced, compared with currently approved CAR T products. Oncternal has dosed patients under Study ONCT-808-101 (NCT05588440 ) with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment. Zilovertamab is an investigational monoclonal antibody designed to inhibit the function of ROR1. Zilovertamab has been evaluated in a Phase 1/2 Study CIRM-0001 (NCT03088878 ) in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL), which resulted in 100% progression free survival (PFS) at 42 months in CLL patients expressing a p53 mutation/del(17p), a population underserved by current treatment options. Zilovertamab is also being evaluated in an investigator-initiated Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (NCT05156905 ). More information on our company and programs is available at https://oncternal.com/ .
Forward-Looking Information
Contact Information:
Investors rvincent@oncternal.com
Media cdavis@lifesciadvisors.com
Oncternal Therapeutics, Inc. Consolidated Balance Sheets Data (in thousands) December 31, 2023 December 31, 2022 Cash, cash equivalents, and short-term investments $ 34,255 $ 63,724 Total assets 36,729 68,651 Total liabilities 6,677 7,682 Accumulated deficit (197,779 ) (158,300 ) Total stockholders' equity 30,052 60,969
Oncternal Therapeutics, Inc. Consolidated Statements of Operations Data (in thousands, except per share data) Three Months Ended December 31, Years Ended December 31, 2023 2022 2023 2022 Grant revenue $ 297 $ 171 $ 785 $ 1,490 Operating expenses: Research and development 6,670 8,798 29,753 32,980 General and administrative 3,263 3,288 12,746 13,457 Total operating expenses 9,933 12,086 42,499 46,437 Loss from operations (9,636 ) (11,915 ) (41,714 ) (44,947 ) Interest income 472 515 2,235 777 Net loss $ (9,164 ) $ (11,400 ) $ (39,479 ) $ (44,170 ) Net loss per share, basic and diluted $ (3.11 ) $ (4.03 ) $ (13.43 ) $ (16.80 ) Weighted-average shares outstanding, basic and diluted 2,948 2,829 2,940 2,630
What is the ticker symbol for Oncternal Therapeutics, Inc.?
The ticker symbol for Oncternal Therapeutics, Inc. is ONCT.
What is the focus of ONCT-534?
ONCT-534 is a dual-action androgen receptor inhibitor for the treatment of patients with advanced prostate cancer.
What is the expected timeline for the initial data readout for ONCT-534?
The initial data readout for ONCT-534 is expected in the second quarter of 2024.
What is the focus of ONCT-808?
ONCT-808 is an autologous CAR T cell therapy for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma.
What were the common adverse events reported in the initial dosing cohort of ONCT-808?
Common adverse events included decreased blood counts, pneumonia, and Grade 1-2 cytokine release syndrome (CRS).
What financial results were reported for the fourth quarter of 2023?
The net loss for the quarter was $9.2 million, with total operating expenses of $9.9 million, including $2.2 million in non-cash stock-based compensation expense.
What is the cash position of Oncternal Therapeutics as of December 31, 2023?
As of December 31, 2023, Oncternal Therapeutics had $34.3 million in cash, cash equivalents, and short-term investments.
What upcoming milestones are expected for ONCT-534?
Initial clinical data update in the second quarter of 2024 and additional clinical data readouts in the fourth quarter of 2024.
What protocol changes were implemented for the ONCT-808 study?
The company decided to implement modified eligibility criteria and testing lower doses for future patients in the study.
What was the purpose of the reverse stock split announced in January 2024?
The reverse stock split was implemented to regain compliance with Nasdaq's minimum bid price requirement.
