Oncternal Provides Business Update and Announces First Quarter 2021 Financial Results
- Interim results of a Phase 1b trial of cirmtuzumab and paclitaxel in locally advanced/unresectable or metastatic HER2-negative breast cancer compare favorably to historical single-agent paclitaxel data (57% ORR vs. ~30% ORR historical single-agent paclitaxel)
- In a preclinical study of cirmtuzumab added to high-grade serous ovarian cancer cell lines, cirmtuzumab demonstrated single agent activity and enhanced the anti-proliferative effect of commonly used chemotherapies
- Oncternal appointed
Chase Leavittas General Counsel
- Oncternal presenting clinical updates on cirmtuzumab in MCL/CLL and TK216 in Ewing sarcoma at the ASCO Annual Meeting in
- Management to host webcast today at
5:00 pm ET
“We are continuing to advance our ROR1-focused platform in both liquid and solid tumors, while laying the groundwork for developing new ROR1 targeting cell therapies. Based on encouraging data recently reported at the
April 2021, we presented two scientific posters at the AACR Annual Meeting, which showcased the promise of cirmtuzumab in treating solid tumors.
- In a Phase 1b investigator-initiated clinical trial in heavily pre-treated patients with metastatic HER2-negative breast cancer treated with a combination of cirmtuzumab and paclitaxel, eight of 14 evaluable patients had a partial response (PR), one of which remained durable for 52 weeks, for an objective response rate (ORR) of 57%. Four additional patients (29%) had stable disease (SD). These results were consistent with the previously reported interim results of the study, and compared favorably to historical results for single-agent paclitaxel, particularly for patients such as these who had received a median of six prior therapies for metastatic disease. Cirmtuzumab when given with paclitaxel was well-tolerated and demonstrated no added toxicity over what was expected with paclitaxel alone. The trial is expected to enroll a total of 15 evaluable patients.
- In a preclinical study of cirmtuzumab used to treat high-grade serous ovarian cancer (HGSOC) and endometrial cell lines in vitro alone or in combination with chemotherapeutic agents cisplatin and paclitaxel, cirmtuzumab demonstrated single agent activity and enhanced the anti-proliferative effects of chemotherapeutic agents in both ovarian and endometrial cancer cell models. Oncternal is currently evaluating next steps for cirmtuzumab in solid tumors including breast and ovarian cancer.
April 2021, we appointed Chase Leavittas General Counsel.
April 2021, we announced that updated interim clinical trial results from Oncternal’s study of TK216 in patients with Ewing sarcoma will be presented in an oral session, and updated interim clinical trial results from Oncternal and UCSD’s study of cirmtuzumab plus ibrutinib in patients with MCL or chronic lymphocytic leukemia (CLL) will be presented in a poster session at the ASCO Annual Meeting in June 2021.
Expected Upcoming Milestones
- Cirmtuzumab (ROR1 antibody) programs
- Clinical data update for patients with MCL and CLL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study will be presented at the ASCO Annual Meeting
- Preclinical data in additional ROR1-expressing tumors is expected to be available in the third quarter of 2021
- ROR1 CAR-T program
- First-in-human dosing is expected in the first half of 2022
- TK216 (ETS inhibitor) program
- Clinical data update for patients with Ewing sarcoma treated in the ongoing Phase 1/2 study will be presented at the ASCO Annual Meeting
- Preclinical data in additional ETS-driven tumors is expected to be available in the third quarter of 2021
First Quarter 2021 Financial Results
Our grant revenue was
Our total operating expenses for the first quarter ended
As previously announced, Oncternal will host a webcast today,
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 initiating ROR1 CAR-T studies; 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
Condensed Consolidated Balance Sheets Data
|Cash and cash equivalents||$||111,211||$||116,737|
|Total stockholders’ equity||108,303||112,951|
Condensed Consolidated Statements of Operations Data
(Unaudited; in thousands, except per share data)
|Three Months Ended
|Research and development||3,913||2,696|
|General and administrative||2,794||2,633|
|Total operating expenses||6,707||5,329|
|Loss from operations||(5,959||)||(4,751||)|
|Net loss per share, basic and diluted||$||(0.12||)||$||(0.31||)|
|Weighted-average shares outstanding, basic and diluted||49,094||15,355|
Source: Oncternal Therapeutics