Announcement • Dec 04
Oncternal Therapeutics, Inc.(NasdaqCM:ONCT) dropped from NASDAQ Composite Index Oncternal Therapeutics, Inc. has been dropped from the NASDAQ Composite Index (^COMP) Announcement • Nov 25
Nasdaq Provides Notice on Oncternal's Common Stock Suspension on December 3, 2024 On November 22, 2024, Oncternal Therapeutics, Inc. received a notice from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (Nasdaq") indicating that, based on Oncternal's announcement on November 14, 2024 of a workforce reduction of all of its remaining employees and exploration of strategic alternatives, Nasdaq believes Oncternal is a public shell" and will apply more stringent criteria to maintain Oncternal's listing with Nasdaq. Nasdaq provided notice that trading of Oncternal's common stock will be suspended at the opening of business on December 3, 2024, and Nasdaq will file a Form 25 Notification of Delisting with the Securities and Exchange Commission, which will remove Oncternal's securities from listing and registration on Nasdaq. Oncternal does not plan to appeal the determination. New Risk • Aug 12
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$25m free cash flow). Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$40m net loss next year). Share price has been volatile over the past 3 months (11% average weekly change). Revenue is less than US$5m (US$1.8m revenue). Market cap is less than US$100m (US$15.5m market cap). Reported Earnings • Aug 11
Second quarter 2024 earnings: EPS and revenues exceed analyst expectations Second quarter 2024 results: US$2.89 loss per share (improved from US$3.05 loss in 2Q 2023). Revenue: US$801.0k (up US$695.0k from 2Q 2023). Net loss: US$8.56m (loss narrowed 4.5% from 2Q 2023). Revenue exceeded analyst estimates. Earnings per share (EPS) also surpassed analyst estimates by 4.7%. Revenue is expected to decline by 59% p.a. on average during the next 2 years, while revenues in the Biotechs industry in the US are expected to grow by 23%. Over the last 3 years on average, earnings per share has fallen by 2% per year but the company’s share price has fallen by 59% per year, which means it is performing significantly worse than earnings. Announcement • Aug 02
Oncternal Therapeutics, Inc. to Report Q2, 2024 Results on Aug 08, 2024 Oncternal Therapeutics, Inc. announced that they will report Q2, 2024 results After-Market on Aug 08, 2024 Announcement • Jul 15
Oncternal Therapeutics, Inc. Announces Enrollment Completed and Dosing Initiated for Sixth Dose Cohort of Phase 1/2 Study of Onct-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer Oncternal Therapeutics, Inc. announced that enrollment has been completed and dosing initiated for the sixth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the sixth cohort are receiving ONCT-534, the company’s dual-action androgen receptor inhibitor (DAARI), at a dose of 1200 mg taken orally once each day. The decision to proceed to this higher dose level was made by the study’s Safety Review Committee (SRC) after reviewing data from the fifth dose level of 600 mg ONCT-534 daily. An initial update on ONCT-534 safety and efficacy based on prostate–specific antigen (PSA) levels from this study is expected in the third quarter of 2024 and will include data from this 1200 mg dose cohort. Price Target Changed • Jun 02
Price target decreased by 9.8% to US$27.67 Down from US$30.67, the current price target is an average from 3 analysts. New target price is 200% above last closing price of US$9.21. Stock is up 50% over the past year. The company is forecast to post a net loss per share of US$10.78 next year compared to a net loss per share of US$13.43 last year. Major Estimate Revision • May 31
Consensus estimates of losses per share improve by 10% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$880.0k to US$940.0k. EPS estimate increased from -US$11.97 per share to -US$10.72 per share. Biotechs industry in the US expected to see average net income decline 10% next year. Consensus price target of US$27.67 unchanged from last update. Share price was steady at US$9.21 over the past week. Announcement • May 31
Oncternal Announces Enrollment Completed and Dosing Initiated for Fifth Dose Cohort of Phase 1/2 Study of Onct-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer Oncternal Therapeutics, Inc. announced that enrollment has been completed and dosing initiated for the fifth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the fifth cohort are receiving ONCT-534, the company’s dual-action androgen receptor inhibitor (DAARI), at a dose of 600 mg taken orally once each day. The decision to proceed to this higher dose level was made by the study’s Safety Review Committee (SRC) after reviewing data from the fourth dose level of 300 mg ONCT-534 daily. An initial update on ONCT-534 safety and efficacy based on prostate-specific antigen (PSA) levels from this study is expected in the third quarter of 2024 and will include data from this 600 mg dose cohort. Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in patients with mCRPC who have relapsed or are refractory to approved ARPIs including enzalutamide, abiraterone, apalutamide, and darolutamide. After the safety and tolerability and preliminary antitumor activity of ONCT-534 have been assessed in Phase 1, Phase 2 will commence to further evaluate the safety and antitumor activity of ONCT-534 to support selecting an optimal dose. Major Estimate Revision • May 12
Consensus EPS estimates fall by 12% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -US$10.67 to -US$11.97 per share. Revenue forecast of US$569.0k unchanged since last update. Biotechs industry in the US expected to see average net income decline 9.1% next year. Consensus price target of US$30.67 unchanged from last update. Share price fell 6.5% to US$8.18 over the past week. Announcement • May 03
Oncternal Therapeutics, Inc. to Report Q1, 2024 Results on May 09, 2024 Oncternal Therapeutics, Inc. announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 09, 2024 Announcement • Apr 28
Oncternal Therapeutics, Inc., Annual General Meeting, Jun 20, 2024 Oncternal Therapeutics, Inc., Annual General Meeting, Jun 20, 2024, at 07:30 Pacific Standard Time. Agenda: To elect two directors for a three-year term to expire at the 2027 annual meeting of stockholders to consider and vote upon the ratification of the selection of BDO USA, P.C. as our independent registered public accounting firm for the year ending December 31, 2024; to approve, on an advisory basis, the compensation of our named executive officers as disclosed in this proxy statement pursuant to the compensation disclosure rules of the Securities and Exchange Commission;and to transact such other business as may be properly brought before the meeting or any adjournment or postponement thereof. Announcement • Apr 19
Oncternal Announces First Patient Dosed in Fourth Cohort of Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer Oncternal Therapeutics, Inc. announced that the first patient has been dosed in the fourth cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the fourth dosing cohort will receive ONCT-534, the company’s dual-action androgen receptor inhibitor (DAARI), at a dose of 300 mg taken orally each day. The decision to proceed to this higher dose level was made by the study’s Safety Review Committee (SRC) after reviewing data from the patients treated to date, including the third dose level of 160 mg ONCT-534 daily. Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in patients with mCRPC who have relapsed or are refractory to approved ARPIs including enzalutamide, abiraterone, apalutamide, and darolutamide. After the safety and tolerability and preliminary antitumor activity of ONCT-534 have been assessed in Phase 1, Phase 2 will commence to further evaluate the safety and preliminary antitumor activity of ONCT-534 to support selecting an optimal dose. Major Estimate Revision • Apr 16
Consensus revenue estimates fall by 25% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$400.0k to US$300.0k. Forecast losses increased from -US$11.28 to -US$11.97 per share. Biotechs industry in the US expected to see average net income decline 9.2% next year. Consensus price target down from US$31.33 to US$30.67. Share price was steady at US$8.69 over the past week. Recent Insider Transactions • Apr 02
Non-Independent Director recently bought US$59k worth of stock On the 28th of March, Robert Wills bought around 7k shares on-market at roughly US$8.48 per share. This trade did not impact their existing holding. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$136k more in shares than they have sold in the last 12 months. Reported Earnings • Mar 10
Full year 2023 earnings: EPS in line with analyst expectations despite revenue beat Full year 2023 results: US$13.43 loss per share (improved from US$16.80 loss in FY 2022). Net loss: US$39.5m (loss narrowed 11% from FY 2022). Revenue exceeded analyst estimates by 25%. Earnings per share (EPS) were mostly in line with analyst estimates. Revenue is forecast to grow 2.6% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has fallen by 60% per year, which means it is performing significantly worse than earnings. Announcement • Mar 01
Oncternal Therapeutics, Inc. to Report Q4, 2023 Results on Mar 07, 2024 Oncternal Therapeutics, Inc. announced that they will report Q4, 2023 results After-Market on Mar 07, 2024 Announcement • Feb 01
Oncternal Therapeutics, Inc. Appoints Damien Bresson as Senior Director, Preclinical and Translation Science Oncternal Therapeutics, Inc. announced that Damien Bresson as Senior Director, Preclinical and Translation Science. Price Target Changed • Jan 29
Price target decreased by 8.5% to US$39.67 Down from US$43.33, the current price target is an average from 3 analysts. New target price is 297% above last closing price of US$9.98. Stock is down 57% over the past year. The company is forecast to post a net loss per share of US$13.40 next year compared to a net loss per share of US$16.80 last year. Announcement • Jan 09
Oncternal Therapeutics, Inc. Enrolls Patients into the Third Dosing Cohort of its Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer Oncternal Therapeutics, Inc. announced that the fourth patient has now been enrolled into its Phase 1/2 study of ONCT-534, its dual-action androgen receptor inhibitors, for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). The last two patients were enrolled into the third dosing cohort, to receive ONCT-534 at a dose of 160 mg taken orally each day. The study utilizes an adaptive Bayesian Optimal Interval (BOIN) design, under which the first two dosing cohorts treated one patient each at 40 mg ONCT-534 per day and 80 mg ONCT-534 Per day, respectively. The decision to proceed to dose level 3 was confirmed by the study's Safety Review Committee (SRC). Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in patients with mCRPC who have relapsed or are refractory to approved ARPIs including enzalutamide, abiraterone, apalutamide and darolutamide. After the safety and tolerability and preliminary antitumor activity of ONCT-534 have been assessed in the Phase 1 portion of this study, Phase 2 will commence to further evaluate the safety and preliminary antitumor activity of ONCT-534 to support selecting an optimal dose. Announcement • Jan 05
Oncternal Therapeutics Announces Reverse Stock Split to Bring the Company into Compliance with Nasdaq’s Minimum Bid Price Requirement Oncternal Therapeutics, Inc. announced that its board of directors (Board) has approved a 1-for-20 reverse stock split of the company's common stock. The reverse stock split will become effective at 12:01 a.m. Eastern time on January 8, 2024. The company's common stock is expected to begin trading on a split-adjusted basis on The Nasdaq Capital Market under the same symbol (ONCT) when the market opens on January 8, 2024 with the new CUSIP number 68236P206. The reverse stock split was approved by the company's stockholders at its 2023 annual meeting, held on June 28, 2023, to be effected at the Board’s discretion with a ratio within the range of not less than 1-for-5 and not more than 1-for-30. As a result of the reverse stock split, every 20 shares of the company's common stock issued and outstanding will be automatically converted into one share of common stock, with no change in the $0.001 par value per share or authorized number of shares of common stock. No fractional shares will be issued in connection with the reverse split and stockholders who would otherwise be entitled to a fractional share of common stock will instead be entitled to receive a proportional cash payment. The reverse stock split is primarily intended to bring the company into compliance with Nasdaq’s minimum bid price requirement. To regain compliance, the bid price of the company’s common stock must close at $1.00 per share or more for a minimum of ten consecutive business days. Announcement • Dec 26
Oncternal Therapeutics, Inc. Updates the Status of its Phase 1/2 Study of ONCT-808, a ROR1-Targeting Autologous CAR T, in Patients with Relapsed or Refractory Aggressive B-Cell Lymphoma Oncternal Therapeutics, Inc. updated the status of its dose escalation/dose expansion Phase 1/2 Study ONCT-808-101, evaluating the company's 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. At the initial dose of 1x106 CAR T cells per kg, two of the three patients achieved complete metabolic response (CMR) and the third achieved a partial response (PR) by FDG PET-CT. Common adverse events in this 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 perkg, 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. Oncternal has been in communication and is aligned with the Food and Drug Administration (FDA) on proposed protocol changes that include modified eligibility criteria and testing lower doses of ONCT-808 for future patients in the study. Major Estimate Revision • Dec 05
Consensus revenue estimates increase by 13% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$540.0k to US$620.0k. EPS estimate unchanged at -US$0.67. Biotechs industry in the US expected to see average net income growth of 8.2% next year. Consensus price target of US$2.17 unchanged from last update. Share price was steady at US$0.35 over the past week. Reported Earnings • Nov 11
Third quarter 2023 earnings: Revenues exceed analysts expectations while EPS lags behind Third quarter 2023 results: US$0.17 loss per share (improved from US$0.20 loss in 3Q 2022). Net loss: US$9.86m (loss narrowed 11% from 3Q 2022). Revenue exceeded analyst estimates by 35%. Earnings per share (EPS) missed analyst estimates by 11%. Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 2% per year but the company’s share price has fallen by 60% per year, which means it is significantly lagging earnings. Announcement • Nov 03
Oncternal Therapeutics, Inc. to Report Q3, 2023 Results on Nov 09, 2023 Oncternal Therapeutics, Inc. announced that they will report Q3, 2023 results After-Market on Nov 09, 2023 Announcement • Oct 27
Oncternal Therapeutics Announces FDA Granted Fast Track Designation for ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer Oncternal Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ONCT-534, its novel dual-acting androgen receptor inhibitor (DAARI), as a Fast Track development program for the investigation of the treatment of patients with relapsed or refractory metastatic castration-resistant prostate cancer (mCRPC) resistant to approved androgen receptor pathway inhibitors (ARPIs). ONCT-534 interacts with both the N-terminal domain and the ligand-binding domain (LBD) of the AR, inhibiting cell growth and inducing AR degradation. Preclinical studies have shown activity in prostate cancer models against bothmutated AR, and against multiple mutations, including AR amplification, mutations in the AR LBD, and splice variants with loss of the AR LBD. Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in patients with mCRPC who have relapsed or are refractory to approved ARPIs including enzalutamide, abiraterone, apalutamide and daralutamide. After the safety and tolerability and preliminary antitumor activity of Oncternal Therapeutics have been assessed in Phase 1, Phase 2 will commence to further evaluate the safety and preliminary antitumor activities of ONCT-534 to allow for selecting an optimal dose. Announcement • Oct 26
Oncternal Therapeutics, Inc. Adds Matthew Smith to its Prostate Cancer Scientific Advisory Board Oncternal Therapeutics, Inc. announced the addition of Matthew Smith, M.D., Ph.D. to its Prostate Cancer Scientific Advisory Board (SAB). Dr. Smith, along with the other Prostate Cancer SAB members, will help guide Oncternal’s next steps in the clinical development of its novel dual-acting androgen receptor inhibitor (DAARI), ONCT-534, which is currently under investigation in an ongoing Phase 1/2 clinical study, ONCT-534-101. Dr. Matthew R. Smith is Director of the Genitourinary Oncology Program at Massachusetts General Hospital Cancer Center and a Professor of Medicine at Harvard Medical School. He is an internationally recognized expert in prostate cancer. He has published extensively on the treatment and prevention of bone metastases, prostate cancer survivorship, and novel androgen receptor pathway inhibitors. He has authored more than 200 peer-reviewed articles including manuscripts in New England Journal of Medicine, The Lancet, Journal of Clinical Oncology, and Clinical Cancer Research. He graduated summa cum laude from Canisius College with a B.A. in biochemistry. He received his MD and PhD degrees from Duke University School of Medicine. He trained in Internal Medicine at Brigham and Women's Hospital. He completed a fellowship in Medical Oncology at Dana Farber Cancer Institute and a postdoctoral fellowship at Massachusetts Institute of Technology. New Risk • Oct 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$41m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$41m free cash flow). Earnings are forecast to decline by an average of 9.3% per year for the foreseeable future. Revenue is less than US$1m (US$862k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$53m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (6.2% increase in shares outstanding). Market cap is less than US$100m (US$17.4m market cap). Announcement • Oct 08
Nasdaq Grants Oncternal Therapeutics an Additional 180 Calendar Days, or to April 1, 2024, to Regain Compliance with the Minimum Bid Requirement As previously reported, on April 4, 2023, Oncternal Therapeutics, Inc. (“Oncternal”) received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that because the closing bid price for Oncternal’s common stock had closed below $1.00 per share for 30 consecutive business days, Oncternal no longer complied with the minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Requirement”). The Notification Letter stated that Oncternal had 180 days, or until October 2, 2023, to demonstrate its compliance with the Minimum Bid Requirement. On October 3, 2023, Nasdaq notified Oncternal that it has granted Oncternal an additional 180 calendar days, or to April 1, 2024, to regain compliance with the Minimum Bid Requirement, in accordance with Nasdaq Listing Rule 5810(c)(3)(A). Oncternal intends to continue to actively monitor the closing bid price of its common stock and will evaluate available options to regain compliance with the Minimum Bid Requirement. Specifically, Oncternal has confirmed to Nasdaq that, if necessary, it will implement a reverse stock split of its outstanding common stock, to attempt to regain compliance. At Oncternal’s annual meeting of stockholders held on June 28, 2023, Oncternal’s stockholders approved a proposal granting Oncternal’s board authority to effect a reverse split of Oncternal’s outstanding common stock by amending Oncternal’s Restated Certificate of Incorporation within one year and within a range of not less than one-for-five and not more than one-for-thirty. If Oncternal does not regain compliance within the additional compliance period, Nasdaq will provide notice that Oncternal’s common stock will be subject to delisting. Oncternal would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that Oncternal will regain compliance with the Minimum Bid Requirement during the 180-day additional compliance period or maintain compliance with the other Nasdaq listing requirements. Announcement • Oct 06
Oncternal Therapeutics Announces First Patient Dosed in Phase 1/2 Study of Dual-Action AR Inhibitor, ONCT-534, in Patients with Metastatic Castration-Resistant Prostate Cancer Oncternal Therapeutics, Inc. announced that the first patient has been dosed in the Phase 1/2 dose escalation/dose expansion study of ONCT-534, the company’s dual-action androgen receptor inhibitor. ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) that interacts with both the N-terminal domain and the ligand-binding domain (LBD) of the androgen receptor (AR), inhibiting cell growth and inducing AR degradation. Preclinical studies have shown activity in prostate cancer models against both unmutated AR, and against multiple mutations, including AR amplification, mutations in the AR LBD, and splice variants with loss of the AR LBD. Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and anti-tumor activity of ONCT-534 in patients with metastatic castration-resistant prostate cancer (mCRPC) who have relapsed or are refractory to approved androgen receptor signaling inhibitors (ARSIs) including enzalutamide, abiraterone, apalutamide and darolutamide. After the safety and tolerability of ONCT-534 have been assessed to select the recommended Phase 2 dose (RP2D) in Phase 1, Phase 2 will commence to further validate the dose and evaluate the safety and efficacy of ONCT-534. Major Estimate Revision • Aug 17
Consensus revenue estimates increase by 26%, EPS downgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$600.0k to US$750.0k. EPS estimate fell from -US$0.598 to -US$0.61 per share. Biotechs industry in the US expected to see average net income decline 6.6% next year. Consensus price target of US$1.90 unchanged from last update. Share price fell 12% to US$0.32 over the past week. Reported Earnings • Aug 13
Second quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2023 results: US$0.15 loss per share (improved from US$0.23 loss in 2Q 2022). Net loss: US$8.97m (loss narrowed 24% from 2Q 2022). Revenue missed analyst estimates by 38%. Earnings per share (EPS) exceeded analyst estimates by 10%. Revenue is forecast to grow 49% during the next year, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Announcement • Aug 04
Oncternal Therapeutics, Inc. to Report Q2, 2023 Results on Aug 10, 2023 Oncternal Therapeutics, Inc. announced that they will report Q2, 2023 results at 4:00 PM, US Eastern Standard Time on Aug 10, 2023 Announcement • Jun 07
Oncternal Therapeutics, Inc. Announces First Patient Dosed in Phase 1/2 Study of ROR1 Targeting Autologous CAR T, ONCT-808, in Patients with Relapsed or Refractory Aggressive B-Cell Lymphoma Oncternal Therapeutics, Inc. announced that the first patient has been dosed in the Phase 1/2 dose escalation/dose expansion study of ONCT-808, the company’s ROR1 targeting autologous CAR T cell therapy. ONCT-808 is a ROR1 targeting autologous CAR T cell therapy that is being tested in a Phase 1/2 clinical trial for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, including those who have failed previous CD19 CAR T therapy. Preclinical models show robust and specific activity against ROR1 expressing cells from multiple tumor types. Oncternal has developed a manufacturing process that is reproducible, scalable, and only 8 days in duration. The company expects to present initial clinical data in late 2023, with additional clinical data readouts in 2024. Study ONCT-808-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and anti-tumor activity of ONCT-808 in subjects with aggressive B cell lymphoma, including large B-cell lymphoma (LBCL) and mantle cell lymphoma (MCL). After the safety and tolerability of ONCT-808 have been assessed to select the recommended Phase 2 dose (RP2D) in Phase 1, Phase 2 will commence to further validate the dose and evaluate the safety and efficacy of ONCT-808. In Phase 2, subjects with LBCL or MCL will be enrolled into 2 separate dose expansion cohorts. Current leading clinical sites for ONCT-808-101 are the MD Anderson Cancer Center in Houston, TX, the Dana-Farber Cancer Institute in Boston, MA, the City of Hope Comprehensive Cancer Center in Duarte, CA and the Mass General Cancer Center in Boston, MA. Announcement • May 17
Oncternal Therapeutics, Inc., Annual General Meeting, Jun 28, 2023 Oncternal Therapeutics, Inc., Annual General Meeting, Jun 28, 2023, at 08:00 Pacific Standard Time. Agenda: To elect four directors for a three-year term to expire at the 2026 annual meeting of stockholders; to consider and vote upon the ratification of the selection of BDO USA, LLP as company's independent registered public accounting firm for the year ending December 31, 2023; to approve, on an advisory basis, the compensation of company's named executive officers as disclosed in proxy statement pursuant to the compensation disclosure rules of the Securities and Exchange Commission; to consider and vote upon, on an advisory basis, whether the stockholder vote to approve the compensation of the named executive officers as required by Section 14A(a)(2) of the Securities Exchange Act of 1934, as amended, should occur every one, two or three years; to consider and vote upon the approval of an amendment to company's Restated Certificate of Incorporation to reflect new Delaware law provisions to permit exculpation of certain officers; and to consider other matters. Major Estimate Revision • May 11
Consensus revenue estimates increase by 11% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$540.0k to US$600.0k. Forecast losses expected to reduce from -US$0.63 to -US$0.598 per share. Biotechs industry in the US expected to see average net income decline 50% next year. Consensus price target of US$1.90 unchanged from last update. Share price fell 6.1% to US$0.31 over the past week. Reported Earnings • May 06
First quarter 2023 earnings: EPS in line with analyst expectations despite revenue beat First quarter 2023 results: US$0.20 loss per share. Net loss: US$11.5m (loss widened 16% from 1Q 2022). Revenue exceeded analyst estimates by 42%. Earnings per share (EPS) were mostly in line with analyst estimates. Revenue is forecast to grow 72% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Major Estimate Revision • Apr 05
Consensus revenue estimates decrease by 26%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$730.0k to US$540.0k. EPS estimate increased from -US$0.925 to -US$0.63 per share. Biotechs industry in the US expected to see average net income decline 50% next year. Consensus price target down from US$7.07 to US$3.08. Share price fell 59% to US$0.30 over the past week. Major Estimate Revision • Mar 23
Consensus revenue estimates increase by 11% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$660.0k to US$730.0k. EPS estimate unchanged from -US$0.93 at last update. Biotechs industry in the US expected to see average net income decline 51% next year. Consensus price target down from US$7.79 to US$7.07. Share price rose 22% to US$0.88 over the past week. Major Estimate Revision • Mar 16
Consensus revenue estimates fall by 30% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$940.0k to US$660.0k. Forecast losses increased from -US$0.823 to -US$0.958 per share. Biotechs industry in the US expected to see average net income decline 49% next year. Consensus price target of US$7.79 unchanged from last update. Share price fell 18% to US$0.73 over the past week. Reported Earnings • Mar 11
Full year 2022 earnings: EPS in line with expectations, revenues disappoint Full year 2022 results: US$0.84 loss per share (further deteriorated from US$0.64 loss in FY 2021). Net loss: US$44.2m (loss widened 41% from FY 2021). Revenue missed analyst estimates by 6.9%. Earnings per share (EPS) were mostly in line with analyst estimates. Revenue is forecast to grow 58% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 105% per year but the company’s share price has fallen by 39% per year, which means it is significantly lagging earnings. Announcement • Jan 05
Oncternal Therapeutics, Inc. Appoints Jill DeSimone to the Board of Directors Oncternal Therapeutics, Inc. announced the appointment of Jill DeSimone to its board of directors. Ms. DeSimone was most recently President of U.S. Oncology at Merck & Co., Inc., where she built the company’s oncology division, growing it to over a $9 billion business in just eight years. She led three key product launches and more than 45 indication launches, including Keytruda®. Prior to joining Merck, she served as senior vice president of Global Women’s Health at Teva Pharmaceutical Industries Ltd. from 2012 to 2014. Prior to her time at Teva, Ms. DeSimone served in several roles of increasing responsibility at Bristol Myers Squibb from 1980 to 2012, including senior vice president of U.S. Oncology & Commercial from 2010 to 2012 and senior vice president of U.S. Virology/HIV from 2006 to 2010. Ms. DeSimone currently serves as a member of the board of directors of Praxis Precision Medicines, Inc. and Affini-T Therapeutics Inc. She also serves as a board member for the Florida Cancer Specialists Foundation, a nonprofit organization that delivers non-medical aid for individuals undergoing cancer treatment. Ms. DeSimone received a B.S. in pharmacy from Northeastern University and completed a fellowship with the Wharton School of the University of Pennsylvania. Price Target Changed • Nov 16
Price target decreased to US$9.42 Down from US$10.80, the current price target is an average from 6 analysts. New target price is 832% above last closing price of US$1.01. Stock is down 73% over the past year. The company is forecast to post a net loss per share of US$0.84 next year compared to a net loss per share of US$0.64 last year. Reported Earnings • Nov 04
Third quarter 2022 earnings released: US$0.20 loss per share (vs US$0.20 loss in 3Q 2021) Third quarter 2022 results: US$0.20 loss per share (further deteriorated from US$0.20 loss in 3Q 2021). Net loss: US$11.1m (loss widened 16% from 3Q 2021). Revenue is forecast to grow 91% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 93% per year but the company’s share price has fallen by 46% per year, which means it is significantly lagging earnings. Seeking Alpha • Sep 02
Oncternal Therapeutics: Selling For Under Cash Value Summary
Today, we are circling back on Oncternal Therapeutics, Inc. for the first time since last October.
Despite advancing its pipeline and strong analyst support, the stock currently sells for less than the cash on the company's balance sheet.
An investment analysis follows in the paragraphs below.
It is better to die on your feet than to live on your knees.”― Emiliano Zapata
We last looked at Oncternal Therapeutics, Inc. (ONCT) in October of last year. We concluded that article with the following summary:
The company's pipeline is also early stage and the company is years away from any potential commercialization. Given this, I plan to keep on the name and will probably revisit it when Oncternal advances its pipeline to late stage development. Other than that, we have no investment recommendation on this name."
A Seeking Alpha follower sent me a note asking if I could circle back on this small cap biotech concern. An analysis follows in the paragraphs below.
Seeking Alpha
Company Overview:
Oncternal Therapeutics Inc is based in San Diego, and is a clinical-stage biopharmaceutical company. Oncternal continues to be focused on developing novel therapies aimed at a broad spectrum of cancers with large unmet medical needs. These drug candidates work by exploiting pathways absent or minimally expressed in normal cells or tissue in order to inhibit cancer cell growth while reducing potential harm to healthy cells. Currently, the stock sells for around a buck a share and sports an approximate market capitalization of $60 million.
June Company Presentation
The company has several compounds in its pipeline. For the purpose of this analysis we will concentrate on lead candidate Zilovertamab, as it is the only compound past the very early stages of development. In April of the year, the company decided to deprioritized further development of its small molecule inhibitor ONCT-216 for the treatment of Ewing sarcoma so it could focus more on the development of Zilovertamab.
As we stated in the previous article, Zilovertamab:
Is a first-in-class humanized monoclonal antibody that binds with high affinity to a biologically important epitope on ROR1. ROR1 is a type 1 transmembrane protein that is expressed on the plasma membrane. When expressed by hematologic malignancies, ROR1 acts as a receptor for the tumor growth factor Wnt5a. When Zilovertamab binds to ROR1, it inhibits Wnt5a from being activated, causes differentiation of the tumor cells, and stops tumor cell proliferation, migration, and survival."
June Company Presentation
Early this year, announced that it had come to an agreement with the FDA around a phase 3 registrational study design for Zilovertamab in the treatment of mantle cell lymphoma or MCL. That trial will be called ZILO-301 and will consist of approximately 250 subjects. These individuals will be used to evaluate the potential benefit for patients who achieve either a partial response or stable disease during a lead-in with ibrutinib only. This compound is better known by its brand name IMBRUVICA. These patients will receive just ibrutinib daily for four months. Patients with an inadequate response will be randomized on a one to one basis to receive Zilovertamab or placebo in addition to ibrutinib.
June Company Presentation
Interim data from a phase 1/2 trial showed an objective response rate of 85% and a complete response [CR] rate of 41% in 27 evaluable patients. These results compared favorably to the historical overall response rate of 66% and the CR rate of 20% for ibrutinib monotherapy. The median PFS of 35.9 months for MCL patients with a median follow-up of 15.1 months. This is also compares favorably to the historical PFS of 12.8 months for ibrutinib monotherapy.
June Company Presentation
In patients with p53 mutated chronic lymphocytic leukemia or CLL the PFS of the combination of Zilovertamab with ibrutinib was 100% at 24 months and 100% at 30 months, which compares favorably to the historical ibrutinib monotherapy PFS of around 68% and around 55% at 24 months and 13 months, respectively.
Company Presentation
The ZILO - 301 study may provide two paths to potential approval. First, an escalated approval based on overall response rate, ORR, plus duration of response, DOR. And second a regular FDA approval based on progression-free survival of PFS, which is the primary endpoint.
The company is also planning to conduct a study called ZILO-302. This will be an open label companion study of Zilovertamab plus ibrutinib for patients who have progression -- progressive disease during the ibrutinib monotherapy run in phase of the study of ZILO-301 and result of the study could potentially support an additional approval and indication expansion. Major Estimate Revision • Aug 16
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$2.24m to US$1.60m. EPS estimate increased from -US$0.94 to -US$0.92 per share. Biotechs industry in the US expected to see average net income decline 77% next year. Consensus price target down from US$10.80 to US$9.42. Share price rose 20% to US$1.33 over the past week. Price Target Changed • Aug 12
Price target decreased to US$9.42 Down from US$10.80, the current price target is an average from 6 analysts. New target price is 712% above last closing price of US$1.16. Stock is down 69% over the past year. The company is forecast to post a net loss per share of US$0.92 next year compared to a net loss per share of US$0.64 last year. Reported Earnings • Aug 11
Second quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2022 results: US$0.23 loss per share (down from US$0.16 loss in 2Q 2021). Net loss: US$11.7m (loss widened 53% from 2Q 2021). Revenue missed analyst estimates by 58%. Earnings per share (EPS) exceeded analyst estimates by 8.0%. Over the next year, revenue is expected to shrink by 64% compared to a 52% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has increased by 75% per year but the company’s share price has fallen by 35% per year, which means it is significantly lagging earnings. Board Change • Jul 31
High number of new directors Independent Director Jinzhu Chen was the last director to join the board, commencing their role in 2021. Major Estimate Revision • May 12
Consensus revenue estimates increase by 24% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$1.50m to US$1.87m. Forecast losses expected to reduce from -US$0.99 to -US$0.92 per share. Biotechs industry in the US expected to see average net income decline 44% next year. Consensus price target down from US$12.20 to US$9.58. Share price fell 32% to US$0.73 over the past week. Price Target Changed • May 09
Price target decreased to US$10.80 Down from US$12.20, the current price target is an average from 4 analysts. New target price is 990% above last closing price of US$0.99. Stock is down 81% over the past year. The company is forecast to post a net loss per share of US$0.93 next year compared to a net loss per share of US$0.64 last year. Reported Earnings • May 06
First quarter 2022 earnings: EPS and revenues exceed analyst expectations First quarter 2022 results: US$0.20 loss per share (down from US$0.12 loss in 1Q 2021). Net loss: US$9.90m (loss widened 67% from 1Q 2021). Revenue exceeded analyst estimates by 42%. Earnings per share (EPS) also surpassed analyst estimates by 17%. Over the next year, revenue is expected to shrink by 64% compared to a 41% growth forecast for the industry in the US. Price Target Changed • Apr 27
Price target decreased to US$12.20 Down from US$13.40, the current price target is an average from 5 analysts. New target price is 1,286% above last closing price of US$0.88. Stock is down 87% over the past year. The company is forecast to post a net loss per share of US$0.99 next year compared to a net loss per share of US$0.64 last year. Board Change • Apr 27
High number of new and inexperienced directors There are 9 new directors who have joined the board in the last 3 years. The company's board is composed of: 9 new directors. 2 experienced directors. 1 highly experienced director. Independent Director Mike Carter is the most experienced director on the board, commencing their role in 2006. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Reported Earnings • Mar 12
Full year 2021 earnings: EPS and revenues miss analyst expectations Full year 2021 results: US$0.64 loss per share (up from US$0.85 loss in FY 2020). Net loss: US$31.3m (loss widened 82% from FY 2020). Revenue missed analyst estimates by 10%. Earnings per share (EPS) also missed analyst estimates by 11%. Over the next year, revenue is expected to shrink by 56% compared to a 60% growth forecast for the pharmaceuticals industry in the US. Price Target Changed • Feb 26
Price target decreased to US$13.40 Down from US$15.00, the current price target is an average from 4 analysts. New target price is 624% above last closing price of US$1.85. Stock is down 72% over the past year. The company is forecast to post a net loss per share of US$0.72 next year compared to a net loss per share of US$0.85 last year. Reported Earnings • Nov 06
Third quarter 2021 earnings released: US$0.20 loss per share (vs US$0.22 loss in 3Q 2020) Third quarter 2021 results: Net loss: US$9.63m (loss widened 119% from 3Q 2020). Reported Earnings • Aug 08
Second quarter 2021 earnings released: US$0.16 loss per share (vs US$0.34 loss in 2Q 2020) Second quarter 2021 results: Net loss: US$7.68m (loss widened 39% from 2Q 2020). Executive Departure • Jun 05
Independent Director Man Cho has left the company On the 25th of May, Man Cho's tenure as Independent Director ended after 1.4 years in the role. We don't have any record of a personal shareholding under Man's name. A total of 2 executives have left over the last 12 months. The current median tenure of the management team is 1.08 years, which is considered inexperienced in the Simply Wall St Risk Model. Reported Earnings • May 09
First quarter 2021 earnings released: US$0.12 loss per share (vs US$0.31 loss in 1Q 2020) First quarter 2021 results: Net loss: US$5.95m (loss widened 26% from 1Q 2020). Is New 90 Day High Low • Mar 16
New 90-day high: US$8.62 The company is up 76% from a price of US$4.90 on 15 December 2020. Outperformed the American market which is up 9.0% over the last 90 days. Exceeded the Biotechs industry, which is up 1.0% over the same period. 