Core Insights - Oncternal Therapeutics has completed enrollment and initiated dosing for the fifth dose cohort of its Phase 1/2 study of ONCT-534, targeting metastatic castration-resistant prostate cancer (mCRPC) patients who are relapsed or refractory to approved androgen receptor pathway inhibitors [1][2] - The fifth cohort is receiving ONCT-534 at a dose of 600 mg daily, following a review by the Safety Review Committee which found the previous 300 mg dose to be well tolerated [1][2] - Initial safety and efficacy data based on prostate-specific antigen (PSA) levels from this study is expected in Q3 2024, including results from the 600 mg cohort [1][2] Study Details - Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study assessing the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in mCRPC patients who have relapsed or are refractory to approved ARPIs [3] - The study will transition to Phase 2 after evaluating safety and preliminary anti-tumor activity to support optimal dose selection [3] Company Overview - Oncternal Therapeutics is focused on developing novel oncology therapies for cancers with critical unmet medical needs, particularly in hematological malignancies and prostate cancer [4] - ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with preclinical activity against both unmutated and aberrant forms of the androgen receptor, addressing resistance in mCRPC patients [4] - The company is also developing ONCT-808, an investigational CAR T cell therapy targeting ROR1, which has shown activity in preclinical models against various cancers [4]

Oncternal Therapeutics (ONCT) came out with a quarterly loss of $2.83 per share versus the Zacks Consensus Estimate of a loss of $2.88. This compares to loss of $4 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 1.74%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $3.09 per share when it actually produced a loss of $3.11, delivering a surprise of -0.65%.Over the last four quarters, the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 000-50549 Oncternal Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 62-1715807 (State or other jurisdiction of incorporation or organization) ...

Exhibit 99.1 Oncternal Therapeutics Provides Business Update and Announces First Quarter 2024 Financial Results SAN DIEGO, May 9, 2024 -- 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 first quarter 2024 financial results. "We are encouraged by the fast pace of execution for our clinical programs, and we are looking forward to important clinical data readouts in the ...

Investors might want to bet on Oncternal Therapeutics (ONCT) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a changi ...

SAN DIEGO, May 01, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (NASDAQ:ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the approval of an inducement award to one new employee, Anne C. Hansen, who is joining Oncternal as Senior Director, Clinical Data Management. The award will be made on May 1, 2024 under Oncternal's 2021 Employment Inducement Incentive Award Plan, which provides for the granting of equity awards to new empl ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 000-50549 Oncternal Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) (State or other jurisdiction of incorporation or organization) 12230 El Camino Real, Suite ...

or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2023 Commission File Number 000-50549 Oncternal Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 62-1715 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 000-50549 12230 El Camino Real, Suite 230 San Diego, CA 92130 (858) 434-1113 (Address, including zip code, and telephone number, including area code, of registrant's principal ex ...

Financial Data and Key Metrics Changes - Revenue for the first quarter was $0.2 million, derived from research and development grants from the NIH [15] - Total operating expenses for the first quarter were $12.3 million, including $1.9 million in non-cash stock-based compensation [15] - Net loss for the first quarter was $11.5 million, resulting in a loss of $0.20 per share [16] - As of March 31, 2023, the company had approximately $54.3 million in cash and investments and no debt [16] Business Line Data and Key Metrics Changes - The company has shifted focus to advancing its ROR1 targeting cell therapy ONCT-808 and the novel dual acting AR inhibitor ONCT-534 [11] - ONCT-808 is currently in a Phase 1/2 clinical trial targeting aggressive B-cell lymphoma patients [12] - ONCT-534 is expected to initiate a Phase 1/2 clinical trial in metastatic castration-resistant prostate cancer shortly after IND clearance [14] Market Data and Key Metrics Changes - The company aims to address unmet medical needs in hematologic malignancies and prostate cancer, particularly for patients who have failed previous treatments [29] - The median progression-free survival for patients who have failed CD19 treatment is only 3 months, with overall survival at 5 months [30] Company Strategy and Development Direction - The company has announced a strategic reprioritization to focus on its two main product candidates, ONCT-808 and ONCT-534, which are expected to have significant clinical catalysts within the next 12 to 18 months [11] - The manufacturing process for ONCT-808 is noted to be quick, taking only 8 days, which is expected to facilitate patient treatment [37] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the clinical potential of ONCT-808 and ONCT-534, emphasizing their commitment to addressing high unmet medical needs [35] - The company expects to extend its cash runway into 2025, allowing for continued operations and development of its product pipeline [29] Other Important Information - The company is currently evaluating the potential for Zilovertamab in combination with other BTK inhibitors following the withdrawal of ibrutinib's FDA approval [48] - Initial clinical data for ONCT-808 is expected by the end of 2023, with additional data readouts in 2024 [33] Q&A Session Summary Question: How does experience with Zilovertamab help with ONCT-808? - Management indicated that the binding domains of Zilovertamab are used in the CAR T therapy, providing a safe toxicity profile based on previous patient treatments [21] Question: What is the starting dosing level for ONCT-808? - The starting dose proposed to the FDA is 1 million CAR expressing cells per kilogram, which is expected to be effective based on other CAR T products [23] Question: What are the expectations for initial data readout? - Management anticipates having data on a few patients by the end of the year, with a conservative approach to patient treatment intervals [36] Question: What is the bar for success in the Phase 1 portion for ONCT-534? - The primary marker for anti-tumor activity will be PSA reduction, with additional surrogate markers being evaluated [45]