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 ...

Financial Performance - Oncternal Therapeutics reported a net loss of $8.4 million for the three months ended March 31, 2024, with an accumulated deficit of $206.2 million[97]. - The company has incurred net losses since inception, and profitability will depend on the successful development and commercialization of its product candidates[97]. - Net loss improved to $8.4 million in Q1 2024 from $11.5 million in Q1 2023, reflecting a reduction of 26.5%[111]. - Cash used in operating activities decreased to $7.4 million in Q1 2024 from $11.0 million in Q1 2023, a decline of 32.5%[123]. - Interest income decreased to $0.4 million in Q1 2024 from $0.7 million in Q1 2023, a decline of 42.9%[119]. Funding and Financial Position - The company has raised a total of $136.3 million from common stock issuance and $49.0 million from convertible preferred stock since its inception[96]. - As of March 31, 2024, Oncternal had cash, cash equivalents, and short-term investments totaling $27.0 million and no debt[96]. - The company anticipates that existing cash may not be sufficient to fund operations for at least the next twelve months without additional funding or collaborations[127]. - Oncternal anticipates needing substantial additional funding to support ongoing operations and business strategy[100]. Research and Development - The NIH has awarded Oncternal up to $4.0 million in research and development grants to support preclinical activities for ONCT-534 and ONCT-216[104]. - Zilovertamab demonstrated 100% progression-free survival at 42 months in CLL patients with a p53 mutation/del(17p)[96]. - The Phase 1 portion of the ONCT-534 study has completed the safety period for the 160 mg dosing cohort without dose-limiting toxicity[95]. - The company expects significant increases in research and development expenses as it advances its product candidates through clinical trials[106]. - Direct expenses for ONCT-534 increased by $0.6 million due to heightened clinical and manufacturing activities[114]. - The company estimates accrued research and development expenses based on services received and efforts expended, which may lead to uneven payment flows[137]. - Payments to vendors may exceed the level of services provided, resulting in prepayments of research and development expenses[138]. - The company periodically confirms the accuracy of its expense estimates with service providers and adjusts as necessary[137]. Operating Expenses - General and administrative expenses are expected to rise significantly due to costs associated with being a public company and hiring additional personnel[109]. - Total operating expenses decreased to $9.3 million in Q1 2024 from $12.3 million in Q1 2023, a reduction of 24.3%[111]. - Research and development expenses fell to $6.1 million in Q1 2024, down from $9.0 million in Q1 2023, a decrease of 32.9%[113]. - Grant revenue increased to $0.6 million for the three months ended March 31, 2024, compared to $0.2 million in the same period of 2023, representing a 200% increase[112]. Stock Activity - The company sold no shares of common stock in Q1 2024, compared to 55,274 shares sold for net proceeds of $1.2 million in Q1 2023[121].

Financial Performance - Grant revenue for Q1 2024 was $0.569 million, an increase from $0.203 million in Q1 2023, representing a growth of 180.8%[14] - Total operating expenses for Q1 2024 were $9.348 million, down from $12.346 million in Q1 2023, a decrease of 24.3%[14] - Research and development expenses for Q1 2024 totaled $6.059 million, compared to $9.031 million in Q1 2023, reflecting a reduction of 32.8%[14] - Net loss for Q1 2024 was $8.388 million, or a net loss of $2.83 per share, compared to a net loss of $11.487 million, or $3.93 per share in Q1 2023, indicating an improvement of 26.5% in loss per share[14] Cash Position - As of March 31, 2024, cash, cash equivalents, and short-term investments totaled $27.027 million, down from $34.255 million as of December 31, 2023[12] - The company has a projected cash runway into Q1 2025, with no debt reported[5] Clinical Trials - The Phase 1/2 study of ONCT-534 for advanced prostate cancer is fully enrolled in the fourth dosing cohort at 300 mg per day, with initial data readout expected in Q2 2024[6] - The ROR1 CAR T Phase 1/2 study (ONCT-808) is open and enrolling patients, with clinical data update anticipated in mid-2024[6] Accumulated Deficit and Equity - The accumulated deficit as of March 31, 2024, was $206.167 million, an increase from $197.779 million as of December 31, 2023[12] - Total stockholders' equity decreased to $22.926 million as of March 31, 2024, from $30.052 million as of December 31, 2023[12]

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 ...

Oncology Development - Oncternal Therapeutics is focused on developing novel oncology therapies for cancers with significant unmet medical needs, particularly prostate cancer and hematological malignancies[17]. - The company aims to build a leading oncology company by targeting novel cancer pathways and focusing on therapeutic approaches with identifiable biomarkers[23]. - ONCT-534, a dual-action androgen receptor inhibitor, has shown preclinical activity against various forms of AR alterations in prostate cancer models[18]. - ONCT-534 is expected to advance through clinical development for patients with advanced prostate cancer, with a focus on those who are resistant to prior ARPI therapy[25]. - The ROR1 CAR T cell therapy program aims to treat hematological malignancies and solid tumors, leveraging ROR1's selective expression on tumor cells[48]. - The Phase 1/2 study of ONCT-808 commenced in 2023, targeting aggressive B cell lymphoma, with initial results showing two of three patients achieving complete metabolic response[58][59]. - ROR1 is expressed in over 90% of lymphomas and CLL, with high expression linked to aggressive disease and poorer prognosis[43]. - ROR1 is expressed in approximately 90% of prostate cancers, with its expression linked to poor OS in advanced cases[81]. Financial Concerns - The company has substantial doubt regarding its ability to continue as a going concern as of December 31, 2023, due to the need for additional financing[17]. - The company received an $18.3 million grant from CIRM, with $14.5 million in development milestones received from October 1, 2017, to March 31, 2022[95]. - The Regents License Agreement requires the company to pay development and regulatory milestones ranging from $20.1 million to $24.5 million per product, and sales milestones aggregating $75.0 million[92]. Clinical Trials and Results - Zilovertamab demonstrated 100% progression-free survival through 48 months in CLL patients with p53 mutations in a Phase 1/2 study[20]. - The Phase 1/2 study ONCT-534-101 commenced in 2023 to evaluate ONCT-534's safety, tolerability, and preliminary anti-tumor activity in patients with mCRPC, with dosing cohorts ranging from 40 mg to 600 mg per day[40]. - In January 2024, the first two cohorts treated one patient each at 40 mg and 80 mg ONCT-534 per day, with the third cohort confirmed at 160 mg per day[41]. - A serious adverse event occurred in the second dose level of ONCT-808, leading to modifications in eligibility criteria and testing of lower doses[60][61]. - The combination of zilovertamab and ibrutinib showed a landmark progression-free survival (PFS) of 95% at 24 months in relapsed/refractory chronic lymphocytic leukemia (CLL) patients[75]. - For relapsed or refractory mantle cell lymphoma (MCL), 89% of patients achieved an overall response rate (ORR) with the combination of zilovertamab and ibrutinib[78]. Patent and Licensing - The company has exclusive worldwide rights to DAARI technologies, with obligations to pay mid five-digit annual maintenance fees and low single-digit to low double-digit royalties on net sales[89]. - As of February 4, 2024, the company holds approximately 50 issued U.S. patents and 19 pending U.S. patent applications related to its proprietary technology[103]. - The DAARI program includes 14 issued U.S. patents and various international patents, with patent terms not expiring before April 2036[104]. - The company has an exclusive license for ROR1 antibodies and CAR T therapies, with know-how related to cancer treatment methods and compositions[108]. - The licensed patent portfolio includes patents related to zilovertamab, with patent terms not expiring before 2032 and 2033 for various patents[109]. - Approximately 30 licensed patent applications are pending related to methods of treating cancer using zilovertamab and small-molecule chemotherapeutics, with potential expiration dates ranging from 2037 to 2041[110]. Regulatory Environment - Regulatory processes for drug approval in the U.S. require substantial time and financial resources, including the submission of an IND and compliance with FDA regulations[120][121]. - The FDA aims to review standard applications within ten months and priority applications within six months after filing[135]. - The FDA may grant orphan designation for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S.[139]. - The FDA offers expedited programs like Fast Track and Breakthrough Therapy to facilitate the development of drugs addressing serious conditions[142][143]. - The FDA requires pediatric assessments for most new drugs unless a deferral or waiver is granted[133]. - The FDA established the RMAT designation in 2017 to expedite the development and review of regenerative medicine therapies for serious conditions[146]. Market Potential - The global multiple myeloma market is projected to reach $31 billion by 2026, indicating significant growth potential[63]. - The competitive landscape includes various therapies such as chemotherapies, targeted therapies, and immunotherapies, posing challenges for market entry[83]. Company Structure and Workforce - The company had 27 full-time employees and three part-time employees as of March 1, 2024, with a focus on research and development activities[213].

Financial Performance - For the three months ended September 30, 2023, the company reported a net loss of $9.9 million, with an accumulated deficit of $188.6 million[93]. - Grant revenue decreased to $0.2 million for the three months ended September 30, 2023, down from $0.4 million in the same period of 2022, a decline of 50%[111]. - Total research and development expenses for the three months ended September 30, 2023, were $7.5 million, a decrease of $1.0 million or 11.5% compared to $8.4 million in 2022[112]. - General and administrative expenses for the three months ended September 30, 2023, were $3.1 million, down from $3.3 million in 2022, a decrease of 6.1%[118]. - Interest income increased to $0.5 million for the three months ended September 30, 2023, compared to $0.2 million in 2022, an increase of 150%[119]. - For the nine months ended September 30, 2023, grant revenue was $0.5 million, down from $1.3 million in 2022, a decrease of 61.5%[120]. - Total research and development expenses for the nine months ended September 30, 2023, were $23.1 million, a decrease of $1.1 million or 4.5% compared to $24.2 million in 2022[121]. - General and administrative expenses for the nine months ended September 30, 2023, were $9.5 million, down from $10.2 million in 2022, a decrease of 6.9%[127]. - Interest income for the nine months ended September 30, 2023, was $1.8 million, an increase of $1.5 million or 500% compared to $0.3 million in 2022[128]. Cash and Funding - The company had cash, cash equivalents, and short-term investments of $40.3 million as of September 30, 2023, with no debt[92]. - The company anticipates needing substantial additional funding to support ongoing operations and business strategy[96]. - The company expects existing cash resources to fund operations into 2025, but may need to raise additional capital thereafter[98]. - Net cash provided by financing activities decreased to $1.1 million in 2023 from $7.6 million in 2022, mainly due to proceeds from the sale of common stock under the "at-the-market" program[135]. - Existing cash, cash equivalents, and short-term investments are expected to fund operations into 2025, but actual results may vary due to regulatory requirements and other uncertainties[137]. - Additional capital will be required for research and development, with potential financing through equity or debt securities, government funding, or collaborations[138]. - The company has a Sales Agreement allowing for the sale of common stock up to $50.0 million, but there is no obligation to sell any shares[143]. Research and Development - The ongoing Phase 1/2 trial of ONCT-808 aims to enroll approximately 54 patients, with initial clinical data expected in late 2023[90]. - The Phase 1/2 study of ONCT-534 is expected to enroll approximately 59 patients, with initial clinical data anticipated in the first half of 2024[91]. - Research and development expenses are expected to decrease year over year through Q4 2023 due to the closure of certain studies, but are projected to increase starting Q1 2024[104]. - The company anticipates that research and development expenses will increase starting in Q1 2024 due to ongoing clinical trials[129]. - The company may face significant dilution if additional funds are raised through equity securities, and any debt financing may involve restrictive covenants[138]. - The company received $14.5 million in development milestone payments from UC San Diego under a grant agreement[92]. - The FDA granted fast track designation for ONCT-534 for the treatment of relapsed or refractory metastatic castrate-resistant prostate cancer[91]. - The company anticipates continued losses as it progresses with research and development and seeks regulatory approvals for its product candidates[136]. Future Outlook - Future funding requirements will depend on various factors, including the progress and costs of clinical trials and regulatory approvals[140]. - The company is party to license agreements with contingent payment obligations based on future milestones, but the timing and likelihood of achieving these milestones are uncertain[144]. - Critical accounting policies include research and development expenses and revenue recognition, with no material changes reported for the three months ended September 30, 2023[148].

Financial Performance - Oncternal Therapeutics reported a net loss of $9.0 million for the three months ended June 30, 2023, with an accumulated deficit of $178.8 million as of the same date [96]. - Grant revenue decreased to $0.1 million for the three months ended June 30, 2023, down from $0.2 million in 2022, primarily due to the timing of NIH grant activities [114]. - Total research and development expenses for the three months ended June 30, 2023, were $6.6 million, a decrease of $2.2 million compared to $8.8 million in 2022, mainly due to a $2.5 million decrease in direct product candidate expenses [115]. - Interest income increased to $0.6 million for the three months ended June 30, 2023, compared to $0.1 million in 2022, primarily due to interest from short-term investments [121]. - General and administrative expenses for the six months ended June 30, 2023, were $6.4 million, a decrease of $0.5 million from $6.9 million in 2022, mainly due to lower legal and corporate insurance expenses [128]. - The accumulated deficit as of June 30, 2023, was $178.8 million, with expectations of continued net losses for the foreseeable future [130]. Funding and Capital Requirements - The company has raised a total of $136.3 million from common stock issuance and $49.0 million from convertible preferred stock issuance, along with $14.5 million in grant payments from UC San Diego [95]. - Oncternal anticipates needing substantial additional funding to support ongoing operations and business strategy, with potential financing through equity or debt offerings [99]. - The company expects existing cash resources to fund operations into 2025, but additional capital will be required beyond that point [101]. - The company may require additional capital for research and development sooner than expected, potentially leading to significant dilution for stockholders if equity securities are issued [138]. - The forecast for the adequacy of financial resources is subject to significant risks and uncertainties, which may adversely affect capital resources and liquidity [139]. - Key factors influencing future funding requirements include the costs and timing of preclinical studies and clinical trials for product candidates, as well as regulatory approval processes [140]. - The company has the ability to offer and sell shares of common stock with an aggregate offering price of up to $50.0 million under a Sales Agreement [143]. Product Development and Clinical Trials - ONCT-808, the lead product candidate, is currently in a Phase 1/2 trial for relapsed or refractory aggressive B-cell lymphoma, aiming to enroll approximately 57 patients [93]. - ONCT-534, a dual-action androgen receptor inhibitor, is expected to initiate a Phase 1/2 clinical trial in Q3 2023, with initial data anticipated in the first half of 2024 [94]. - Zilovertamab is being evaluated in multiple studies, including a Phase 1b study in combination with docetaxel for metastatic castrate-resistant prostate cancer [94]. - The company expects research and development expenses to decrease in future quarters following the closure of certain studies and implementation of cost reductions [107]. - The company expects research and development expenses to decrease in future quarters after closing two clinical studies and implementing cost reductions [130]. - Direct expenses for Zilovertamab decreased by $2.6 million for the three months ended June 30, 2023, primarily due to lower clinical trial activity [116]. Cash Position - The cash, cash equivalents, and short-term investments stood at $45.5 million as of June 30, 2023, with no debt reported [95]. - As of June 30, 2023, the company had $45.5 million in cash, cash equivalents, and short-term investments, with no debt, and anticipates sufficient funds to support operations into 2025 [130]. - Net cash used in operating activities was $20.2 million for the six months ended June 30, 2023, compared to $15.7 million in 2022, primarily due to the timing of payments related to clinical and manufacturing activities [133].

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]