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Oncternal Therapeutics, Inc. (ONCT)

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Previous Close6.13
Open6.20
Bid6.50 x 800
Ask6.52 x 1100
Day's Range6.15 - 6.55
52 Week Range1.49 - 10.56
Volume1,144,316
Avg. Volume1,670,801
Market Cap319.877M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)-0.58
Earnings DateMar 11, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est15.00
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  • Oncternal Therapeutics Announces Appointment of Chase Leavitt as General Counsel
    GlobeNewswire

    Oncternal Therapeutics Announces Appointment of Chase Leavitt as General Counsel

    SAN DIEGO, April 12, 2021 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the appointment of Chase Leavitt as General Counsel. Mr. Leavitt joins the Company with extensive experience providing strategic, transactional, financial, and operational advice to life sciences companies. “Chase is a highly seasoned and pragmatic General Counsel and business leader with a broad background spanning both biotech and technology companies that will help to position Oncternal for our next stage of growth,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “I am excited to join the Oncternal team at this critical juncture. The Company is advancing an attractive and differentiated pipeline of ROR1-targeting immunotherapies and oncology products in areas of high unmet need,” said Mr. Leavitt. “I look forward to collaborating with this highly focused team to develop new cancer treatments while positioning Oncternal to become a leading player in the oncology space.” Mr. Leavitt served as General Counsel and Corporate Secretary of Lineage Cell Therapeutics, Inc., a publicly traded biotechnology company, from May 2019 to April 2021 where he focused on public company compliance and governance, business development transactions, financing activities, litigation, and managed all other legal needs of the company. From June 2018 to May 2019, Mr. Leavitt served as Vice President of Legal Affairs of Tang Capital Management, LLC, a life sciences-focused investment company, and its affiliate Odonate Therapeutics, Inc., a publicly traded biotechnology company. From May 2017 to May 2018, Mr. Leavitt served as the Deputy General Counsel of Switch, Inc., a publicly traded technology company, and previously served as its Associate General Counsel from July 2014 to May 2017. From 2007 to 2014, Mr. Leavitt was a corporate attorney at Latham & Watkins LLP, where his practice focused on public company representation, mergers and acquisitions and capital markets transactions. Mr. Leavitt received a B.S. degree in business administration and a J.D. from the University of Southern California and is admitted to practice law by the State Bar of California. Equity Inducement GrantOncternal granted an inducement award on April 12, 2021 to Chase Leavitt under Oncternal’s 2021 Employment Inducement Incentive Award Plan, which provides for the granting of equity awards to new employees of Oncternal as an inducement to join the Company. The inducement award to Mr. Leavitt consists of options to purchase 235,000 shares of Oncternal common stock. The options have a 10-year term and an exercise price equal to $6.76 per share, the fair market value of Oncternal’s common stock on the date of grant. The options vest over a four-year period, with 25% of the options vesting on the first anniversary of Mr. Leavitt’s employment start date, and the rest vesting in equal monthly installments over three years thereafter. The award was approved by Oncternal’s compensation committee, comprised entirely of independent directors, as required by Nasdaq Rule 5635(c)(4), and was granted as an inducement material to Mr. Leavitt entering into employment with Oncternal in accordance with Nasdaq Rule 5635(c)(4). About Oncternal TherapeuticsOncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of cancers with critical unmet medical need. Oncternal focuses drug development on promising yet untapped biological pathways implicated in cancer generation or progression. The clinical pipeline includes cirmtuzumab, an investigational monoclonal antibody designed to inhibit the ROR1 pathway, a type I tyrosine kinase-like orphan receptor, that is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) and in investigator-sponsored, Phase 1b clinical trial in combination with paclitaxel for the treatment of women with HER2-negative metastatic or locally advanced, unresectable breast cancer, as well as a Phase 2 clinical trial of cirmtuzumab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. We are also developing a chimeric antigen receptor T cell (CAR-T) therapy that targets ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors. The clinical pipeline also includes TK216, an investigational targeted small-molecule inhibitor of the ETS family of oncoproteins, that is being evaluated in a Phase 1/2 clinical trial for patients with Ewing sarcoma alone and in combination with vincristine chemotherapy. More information is available at www.oncternal.com. 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 the company’s current beliefs and expectations. Forward-looking statements include statements regarding Oncternal’s beliefs, goals, intentions and expectations including, without limitation, Oncternal’s expectations regarding its growth and development plans. Forward-looking statements are subject to risks and uncertainties inherent in Oncternal’s business, which include, but are not limited to: the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing product candidates such as cirmtuzumab, TK216, ROR1 CAR-T and Oncternal’s other product candidates, which could adversely impact the company’s ability to complete clinical trials and obtain regulatory approval for such product candidates; Oncternal has encountered delays, and may encounter additional delays or difficulties, in completing preclinical studies and enrolling and retaining patients in its clinical trials as a result of the COVID-19 pandemic; the COVID-19 pandemic may disrupt Oncternal’s business operations, increasing its costs; uncertainties associated with the clinical development and process for obtaining regulatory approval of cirmtuzumab, TK216 and Oncternal’s other product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; Oncternal’s dependence on the success of cirmtuzumab, TK216, ROR1 CAR-T and its other product development programs; the risk that the approval of one of Oncternal’s product candidates may be blocked for seven years if a competitor obtains approval of the same drug or biologic, as defined by the U.S. Food and Drug Administration, or if its product candidate is determined to be contained within the competitor’s product for the same indication or disease; the risk that competitors may develop technologies or product candidates more rapidly than Oncternal, or that are more effective than Oncternal’s product candidates, which could significantly jeopardize Oncternal’s ability to develop and successfully commercialize its product candidates; Oncternal’s limited operating history and the fact that it has incurred significant losses, and expects to continue to incur significant losses for the foreseeable future; the risk that the company will have insufficient funds to finance its planned operations and may not be able to obtain sufficient additional financing when needed or at all as required to achieve its goals, which could force the company to delay, limit, reduce or terminate its product development programs or other operations; the risk that the benefits associated with orphan drug designation may not be realized, including that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained; the risk that, if an orphan designated product, including cirmtuzumab, receives marketing approval for an indication broader than what is designated, it may not be entitled to orphan exclusivity; the possibility that competitors may receive approval of different products for the indication for which an orphan product has exclusivity or obtain approval for the same product but for a different indication for which the orphan product has exclusivity; and other risks described in the company’s prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Oncternal undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Oncternal Contacts: Company ContactRichard Vincent 858-434-1113rvincent@oncternal.com Investor ContactCorey Davis, Ph.D.LifeSci Advisors212-915-2577cdavis@lifesciadvisors.com Source: Oncternal Therapeutics, Inc.

  • Oncternal Therapeutics Announces Presentation of Three Posters at AACR 2021 Virtual Meeting
    GlobeNewswire

    Oncternal Therapeutics Announces Presentation of Three Posters at AACR 2021 Virtual Meeting

    Updated interim results of a Phase 1b trial of cirmtuzumab and paclitaxel in locally advanced/unresectable or metastatic HER2-negative breast cancer showed 57% of evaluable patients (8 of 14) had a partial response and 29% (4 of 14) had stable disease. In a preclinical study of cirmtuzumab added to high grade serious ovarian cancer and endometrial cancer cell lines, cirmtuzumab demonstrated both single agent activity and enhanced the anti-proliferative effect of commonly-used chemotherapies.Preclinical data demonstrated that treatment with Oncternal’s investigational selective androgen receptor degraders inhibited androgen receptor-dependent triple negative breast cancer cell and tumor growth. SAN DIEGO, April 12, 2021 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the presentation of three posters at the American Association for Cancer Research (AACR) 2021 Annual Meeting being held virtually from April 10-15, 2021. “These data highlight the significant potential of our advanced and differentiated ROR1 platform, where cirmtuzumab has demonstrated promising preclinical and clinical activity across a broad spectrum of cancer indications. The results from the current preclinical studies create additional optionality to pursue future indications, which we are actively evaluating while we advance our Phase 2 cirmtuzumab program in mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) and advance our earlier-stage CAR-T and CAR-NK cell programs that also target ROR1,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. Poster Presentations: Session Date and Time: April 10, 2021 8:30 AM – 11:59 PM ETSession Title: Stem Cell BiologyPoster Title: A Phase 1b Trial of Cirmtuzumab and Paclitaxel in Locally Advanced/Unresectable or Metastatic Her2 Negative Breast Cancer (Poster #LB255) -In this Phase 1b investigator-initiated clinical trial from the University of California San Diego (UC San Diego) School of Medicine, 15 patients were treated with cirmtuzumab and paclitaxel after receiving a median of six prior therapies for metastatic disease. Of 15 intent-to-treat patients as of April 10, 2021, eight patients (53%) had a best response of partial response (PR), one of which remained durable for 52 weeks, and four patients (27%) had stable disease (SD). Of the 14 patients who were evaluable for efficacy per protocol, eight patients (57%) had a PR and four patients (29%) had SD. All reported adverse events were related to paclitaxel except for one Grade 3 neutropenia that was categorized as possibly related to cirmtuzumab. No patient stopped cirmtuzumab due to toxicity, no dose reductions of cirmtuzumab were required and no dose limiting toxicities were observed. The authors concluded that as of the cutoff date, cirmtuzumab given with paclitaxel was well-tolerated and demonstrated no added toxicity over what was expected with paclitaxel alone in heavily pre-treated patients with metastatic breast cancer. As of the cutoff date, all pre-treatment breast cancer samples available for analysis expressed ROR1 as assessed by immunohistochemistry. The authors concluded that further clinical evaluation of cirmtuzumab was warranted in patients with breast cancer. Poster Title: Inhibition of ovarian and endometrial cancer cell proliferation by an anti-ROR1 monoclonal antibody (Poster #1062)Session Title: Combination TherapiesSession Date and Time: April 10, 2021 8:30 AM – 11:59 PM ET In this preclinical study from the University of New South Wales, high-grade serous ovarian cancer (HGSOC) and endometrial cancer cell lines were treated with cirmtuzumab alone or in combination with chemotherapeutic agents, cisplatin, paclitaxel, or the PARP inhibitor olaparib. The authors concluded that cirmtuzumab demonstrated single agent activity against these tumor types, and also enhanced the anti-proliferative effects of commonly-used chemotherapies in these cancers. Future studies will further evaluate cirmtuzumab in ovarian and endometrial cancers in vitro and in relevant in vivo models. Poster Title: Selective androgen receptor degraders for the treatment of androgen receptor-positive, triple-negative breast cancer (Poster # 1235)Session Title: Novel Antitumor AgentsSession Date and Time: April 10, 2021 8:30 AM – 11:59 PM ET In this preclinical study from the University of Tennessee, androgen receptor (AR)-positive triple negative breast cancer (TNBC) cell proliferation and tumor growth were inhibited using Oncternal’s investigational selective androgen receptor degraders (SARDs). Notably, the SARDs demonstrated anti-tumor activity in a TNBC patient-derived xenograft model expressing a splice variant of the AR. Oncternal believes that these results support further development of Oncternal’s SARDs as a potential treatment for women affected by the luminal androgen receptor (LAR) subtype of TNBC. About Cirmtuzumab Cirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of MCL or CLL, in a collaboration with the University of California San Diego (UC San Diego) School of Medicine and the California Institute for Regenerative Medicine (CIRM). In addition, Oncternal is supporting two investigator-sponsored studies being conducted at the UC San Diego School of Medicine: (i) a Phase 1b clinical trial of cirmtuzumab in combination with paclitaxel for the treatment of women with HER2-negative metastatic or locally advanced, unresectable breast cancer, and (ii) a Phase 2 clinical trial of cirmtuzumab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. ROR1 is a potentially attractive target for cancer therapy because it is an onco-embryonic antigen – not usually expressed on adult cells, and its expression confers a survival and fitness advantage when reactivated and expressed by tumor cells. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to specifically targeting ROR1 expressing tumors. This led to the development of cirmtuzumab, that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when cirmtuzumab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells. The FDA has granted Orphan Drug Designations to cirmtuzumab for the treatment of MCL and CLL/small lymphocytic lymphoma. Cirmtuzumab is in clinical development and has not been approved by the FDA for any indication. About SARDsOncternal’s preclinical Selective Androgen Receptor Degrader (SARD) program is based on inventions by Professors Duane Miller and Ramesh Narayanan from the University of Tennessee Health Science Center (UTHSC) in Memphis, TN. The androgen receptor (AR) is a validated target for the treatment of castration-resistant prostate cancer (CRPC) and there are currently several FDA-approved AR-targeting therapies. However, resistance development occurs, often through mutations or AR splice variants rendering most therapies ineffective. In preclinical studies, Oncternal’s investigational SARDs have demonstrated activity against prostate cancer tumors resistant to approved AR-targeting therapies. Oncternal is currently evaluating strategic development options for SARDs as potential therapies for castration-resistant prostate cancer (CRPC) and LAR-TNBC as well as AR-driven non-oncology indications. About Oncternal TherapeuticsOncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of cancers with critical unmet medical need. Oncternal focuses drug development on promising yet untapped biological pathways implicated in cancer generation or progression. The clinical pipeline includes cirmtuzumab, an investigational monoclonal antibody designed to inhibit the ROR1 pathway, a type I tyrosine kinase-like orphan receptor, that is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) and in investigator-sponsored, Phase 1b clinical trial in combination with paclitaxel for the treatment of women with HER2-negative metastatic or locally advanced, unresectable breast cancer, as well as a Phase 2 clinical trial of cirmtuzumab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. We are also developing a chimeric antigen receptor T cell (CAR-T) therapy that targets ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors. The clinical pipeline also includes TK216, an investigational targeted small-molecule inhibitor of the ETS family of oncoproteins, that is being evaluated in a Phase 1/2 clinical trial for patients with Ewing sarcoma alone and in combination with vincristine chemotherapy. More information is available at www.oncternal.com. 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 the Company’s current beliefs and expectations. Forward looking statements include statements regarding Oncternal’s development programs. Forward looking statements are subject to risks and uncertainties inherent in Oncternal’s business, which include, but are not limited to the risk that interim results of the ongoing clinical trials and/or preclinical studies of cirmtuzumab and SARDs do not necessarily 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, and as more patient data become available and other risks described in the Company’s prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Oncternal undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Oncternal Contacts: Company ContactRichard Vincent 858-434-1113rvincent@oncternal.com Investor ContactCorey Davis, Ph.D.LifeSci Advisors212-915-2577cdavis@lifesciadvisors.com Source: Oncternal Therapeutics, Inc.

  • Oncternal Therapeutics (ONCT) Soars 8.4%: Is Further Upside Left in the Stock?
    Zacks

    Oncternal Therapeutics (ONCT) Soars 8.4%: Is Further Upside Left in the Stock?

    Oncternal Therapeutics (ONCT) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might help the stock continue moving higher in the near term.