Oncternal Provides Business Update and Announces Third Quarter 2021 Financial Results
- Progressed the development of zilovertamab (formerly cirmtuzumab) for the treatment of patients with mantle cell lymphoma, including ongoing interactions with the
US FDA on potential registration pathways - Identified ONCT-808 as the lead candidate for our autologous CAR-T program targeting ROR1-expressing malignancies
- Established collaboration with Celularity Inc. to evaluate placental derived-cellular therapies targeting ROR1
- Joined NextGenNK, Karolinska Institutet’s
Competence Center for the development of next generation NK cell-based cancer immunotherapies - Formed a cell therapy scientific advisory board to support the advancement of our ROR1 cell therapies pipeline
- Designated ONCT-534 (formerly GTx-534) as the lead candidate in our preclinical dual-action androgen receptor inhibitor (DAARI) program, based on significant preclinical assessments. ONCT-534 is a potential next-generation treatment option for patients with resistant prostate cancer, addressing the emerging unmet medical need of androgen receptor splice variant (AR-SV)-expressing tumors
“We are excited about the progress of our pipeline during this quarter, especially as we continue to advance towards a registration study for our lead asset, zilovertamab, which we believe can play a key role in the treatment paradigm of patients with mantle cell lymphoma,” said
Recent Highlights
Zilovertamab (ROR1 antibody, formerly cirmtuzumab or UC-961):
- Interactions with FDA continue on potential registration pathways.
- An abstract titled Phase 1b/2 Study of Cirmtuzumab and Ibrutinib in Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL) (Abstract 3534) (NCT0308887) has been accepted for a poster presentation at the
American Society of Hematology (ASH) Annual Meeting inAtlanta onDecember 13, 2021 . Abstracts are available on the ASH website at www.hematology.org.- This abstract reflects early data from
June 2021 , shortly after our interim data was presented at theAmerican Society of Clinical Oncology (ASCO) 2021 Annual Meeting. The results remain encouraging and consistent with previous data releases and will be further updated with additional patients and follow-up at the ASH meeting.
- This abstract reflects early data from
- The investigator-sponsored study of zilovertamab and paclitaxel for metastatic or locally advanced, unresectable breast cancer at UC San Diego (NCT02776917) has completed enrollment and the results are expected to be presented at a scientific conference or in a publication.
- The investigator-sponsored study of zilovertamab for treatment of patients with detectable CLL on venetoclax at UC San Diego (NCT04501939) is actively enrolling patients.
ONCT-216 (ETS inhibitor, formerly TK216):
- Interim clinical data update for ONCT-216 in patients with relapsed or refractory Ewing sarcoma was accepted for oral presentation at the 2021
Connective Tissue Oncology Society (CTOS) Virtual Annual Meeting onNovember 13, 2021 . - The Phase 2 expansion cohort targeting up to 21 Ewing sarcoma patients is active and enrolling patients, designed to evaluate clinical responses to single agent ONCT-216 using an optimized dosing regimen, treating for 28 days per cycle, to intensify the amount of ONCT-216 administered over time.
ROR1 Cell-Therapy Program:
- Selected ONCT-808 as our lead autologous CAR-T targeting ROR1 candidate and made progress on key IND-enabling activities.
- Initiated a collaboration with Celularity Inc. to evaluate placental derived T and NK-cell therapies targeting ROR1.
- Formed a cell therapy scientific advisory board (SAB) with cross-disciplinary industry and academic experts to support the advancement of our ROR1 cell therapy pipeline.
- Joined Karolinska Institutet’s
NextGenNK Competence Center for the development of next generation NK cell-based cancer immunotherapies.
Dual-Action Androgen Inhibitor (DAARI) Program:
- Selected ONCT-534 (formerly GTx-534) as our lead DAARI preclinical product candidate, based on significant new preclinical data and assessments. We believe ONCT-534 will address unmet medical needs related to tumor resistance to currently approved products for patients with advanced prostate cancer.
- Presented preclinical in-vitro and in-vivo data as a virtual poster presentation at the
AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics in October. The data presented showed that ONCT-534 binds to the AR-AF-1, or N-terminal domain of the androgen receptor (AR) and induces degradation of both AR full length proteins and AR-SV proteins, including the AR-V7 splice variant. ONCT-534 demonstrated potent anti-tumor activity in AR-V7 expressing tumor xenografts in an animal model.
Corporate:
- Appointed
Steven Hamburger , Ph.D. as Senior Vice President, Regulatory Affairs and Quality Assurance.
Expected Upcoming Milestones
- Zilovertamab (ROR1 antibody) program
- Clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in the ongoing Phase 1b/2 study to be presented at the
American Society for Hematology (ASH) 2021 Annual Meeting inAtlanta inDecember 2021 - Ongoing FDA interactions regarding potential registration pathways for zilovertamab in patients with MCL
- Clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in the ongoing Phase 1b/2 study to be presented at the
- ONCT-216 (ETS inhibitor) programs
- Clinical data update for patients with relapsed or refractory Ewing sarcoma to be shared in an oral presentation at the
Connective Tissue Oncology Society (CTOS) 2021 Virtual Annual Meeting inNovember 2021
- Clinical data update for patients with relapsed or refractory Ewing sarcoma to be shared in an oral presentation at the
- ROR1 CAR-T program
- IND submission in the first half of 2022
- The Company will host an R&D Day on
January 25, 2022 to provide a comprehensive update of its pipeline of product candidates and key development priorities, which will include key opinion leaders in the fields of MCL therapies, cellular immunotherapies, and androgen receptor resistance in prostate cancer
Third Quarter 2021 Financial Results
Our grant revenue was
Our total operating expenses for the third quarter ended
As of
Management Webcast
As previously announced, Oncternal will host a webcast today,
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 development programs, including the anticipated timing for announcing additional preclinical and clinical data; timing of reaching any milestones, including IND submissions; timing for regulatory communications; Oncternal’s evaluation of clinical development opportunities; and Oncternal’s expected cash runway. 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 results seen in a case study of one patient likely will not predict the results seen in other patients in the clinical trial; 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
Chief Financial Officer
858-434-1113
rvincent@oncternal.com
Media
212-915-2577
cdavis@lifesciadvisors.com
Condensed Consolidated Balance Sheets Data
(in thousands)
2021 |
2020 |
||||||
Cash and cash equivalents | $ | 97,380 | $ | 116,737 | |||
Total assets | 100,296 | 118,809 | |||||
Total liabilities | 5,820 | 5,858 | |||||
Accumulated deficit | (106,057 | ) | (82,797 | ) | |||
Total stockholders’ equity | 94,476 | 112,951 |
Condensed Consolidated Statements of Operations Data
(Unaudited; in thousands, except per share data)
Three Months Ended |
Nine Months Ended |
||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Grant revenue | $ | 2,128 | $ | 585 | $ | 3,759 | $ | 1,787 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 8,963 | 3,047 | 18,068 | 9,558 | |||||||||||
General and administrative | 2,802 | 1,933 | 8,977 | 6,910 | |||||||||||
Total operating expenses | 11,765 | 4,980 | 27,045 | 16,468 | |||||||||||
Loss from operations | (9,637 | ) | (4,395 | ) | (23,286 | ) | (14,681 | ) | |||||||
Interest income | 7 | — | 26 | 13 | |||||||||||
Net loss | $ | (9,630 | ) | $ | (4,395 | ) | $ | (23,260 | ) | $ | (14,668 | ) | |||
Net loss per share, basic and diluted | $ | (0.19 | ) | $ | (0.22 | ) | $ | (0.47 | ) | $ | (0.85 | ) | |||
Weighted-average shares outstanding, basic and diluted | 49,363 | 20,126 | 49,285 | 17,251 |
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Source: Oncternal Therapeutics