Pipeline Highlights - ONCT-534, a Dual-Action Androgen Receptor Inhibitor (DAARI), is in Phase 1/2 clinical study for prostate cancer, with initial data expected in Q3 2024[8, 86] - ONCT-808, an autologous CAR T cell therapy targeting ROR1, is in Phase 1/2 clinical study for aggressive B-cell NHL, with a clinical data update expected in Q3 2024[8, 86] - Zilovertamab, a monoclonal antibody targeting ROR1, is seeking partnerships for further clinical trials in hematological malignancies and solid tumors[15, 81] ONCT-534 Key Points - The sixth cohort (1200 mg once daily) is fully enrolled in the Phase 1/2 dose escalation study in R/R mCRPC[8, 90] - ONCT-534 has shown activity in preclinical prostate cancer models of androgen receptor inhibitor resistance[8, 90] ONCT-808 Key Points - In the ONCT-808-101 study, 2 out of 3 patients achieved complete metabolic response (CMR) and 1 out of 3 patients achieved partial response (PR) in the 1x10^6 CAR T cells/kg cohort[72] - ONCT-808 CAR T cells expand and are persistent in all three patients from the 1 x 10^6 CAR T cells/kg dose cohort and the first patient from the 03 x 10^6 CAR T cells/kg dose cohort[75] Zilovertamab Key Points - In a pooled analysis with a median follow-up of 40 months, PFS for p53 mut/del(17p) was 100% for zilovertamab + ibrutinib[79, 80] Financial Highlights - As of March 31, 2024, Oncternal Therapeutics had $270 million in cash and short-term investments, providing a cash runway into Q1 2025[8, 87, 90] - The company anticipates $40 million in non-dilutive support through NIH grants[87]

Core Viewpoint - Oncternal Therapeutics, Inc. plans to file a Form 25 Notification of Delisting with the SEC on March 17, 2025, to remove its securities from Nasdaq listing and subsequently deregister with the SEC [1][2] Group 1: Delisting and Deregistration Process - Nasdaq suspended trading of Oncternal's common stock on December 3, 2024, and notified the company about the Form 25 filing [1] - Following the delisting, Oncternal will file a Form 15 to deregister with the SEC, which will suspend its obligation to file periodic reports immediately [2] - The company's duty to file any other reports required by the Exchange Act will terminate 90 days after the Form 15 filing [2] Group 2: Company Overview - Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel oncology therapies for cancers with critical unmet medical needs [3] - The company targets promising biological pathways involved in cancer generation or progression, with a focus on hematological malignancies and prostate cancer [3]

Financial Performance - The company incurred a net loss of $25.4 million for the nine months ended September 30, 2024, with an accumulated deficit of $223.2 million [86]. - Net loss for Q3 2024 was $8.5 million, an improvement from a net loss of $9.9 million in Q3 2023, reflecting a reduction of 14.4% [100]. - Grant revenue for the nine months ended September 30, 2024, was $1.9 million, up from $0.5 million in the same period of 2023, a 180% increase [110]. - Total research and development expenses for the nine months ended September 30, 2024, were $19.1 million, down from $23.1 million in 2023, a decrease of 17.2% [111]. - Interest income for the nine months ended September 30, 2024, was $0.9 million, down from $1.8 million in 2023, a decrease of 50% [118]. - Total operating expenses for Q3 2024 were $9.2 million, down from $10.6 million in Q3 2023, a decrease of 13.2% [100]. - Research and development expenses for Q3 2024 were $6.4 million, a decrease of $1.0 million or 13.8% compared to $7.5 million in Q3 2023 [102]. Cash and Investments - As of September 30, 2024, Oncternal had cash, cash equivalents, and short-term investments totaling $14.6 million and no debt [85]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $20.2 million, a decrease from $25.7 million in 2023, reflecting a reduction of 21.5% [122]. - Net cash provided by investing activities for the nine months ended September 30, 2024, was $26.7 million, a significant increase from $2.5 million in the same period of 2023 [123]. - Net cash used in financing activities was $0.1 million for the nine months ended September 30, 2024, compared to net cash provided of $1.1 million in 2023 [124]. Strategic Decisions - Oncternal Therapeutics announced the discontinuation of clinical trials for ONCT-534 and ONCT-808, and is exploring strategic alternatives to maximize asset value for stockholders [81]. - The company is considering options such as asset sales, out-licensing, or mergers as part of its strategic alternatives evaluation [81]. - General and administrative expenses are expected to fluctuate based on the Board's decisions regarding strategic alternatives [98]. - There is substantial doubt about Oncternal’s ability to continue as a going concern for the next twelve months without additional funding or collaborations [90]. Research and Development - Research and development expenses are expected to significantly decrease as clinical activities are discontinued, although some expenses will continue for trial closing costs and ongoing nonclinical activities [87][95]. - The NIH has awarded Oncternal grants totaling up to $4.1 million to support preclinical activities for ONCT-534 and ONCT-216 programs [92]. - Grant revenue for Q3 2024 was $0.5 million, up from $0.2 million in Q3 2023, representing a 150% increase due to NIH grant activities [101]. Obligations and Estimates - The company has contractual obligations related to license agreements, with payment obligations contingent upon achieving specified development, regulatory, and commercial milestones [126]. - The company estimates accrued research and development expenses based on contracts and quotations, which may result in uneven payment flows due to varying financial terms [130]. - The company is subject to potential adjustments in reported expenses if the actual timing of services or level of effort varies from estimates [131]. Public Offering and Float - As of September 30, 2024, the company's public float was calculated to be less than $75.0 million, limiting future primary public offerings to one-third of the public float under SEC regulations [125].

Financial Data and Key Metrics Changes - Revenue for the second quarter ended June 30, 2024, was $0.8 million, derived from research and development grants from the NIH [7] - Total operating expenses for the same period were $9.7 million, including $1.4 million in non-cash stock-based compensation [7] - Research and development expenses totaled $6.6 million, while general and administrative expenses were $3.1 million [7] - The net loss for the second quarter was $8.6 million, equating to a net loss of $2.89 per share, both basic and diluted [7] - As of June 30, 2024, the company had approximately 3 million shares of common stock outstanding and $21.4 million in cash, cash equivalents, and short-term investments, with no debt [7] Business Line Data and Key Metrics Changes - The company is advancing two first-in-class clinical programs: ONCT-534, a dual-action androgen receptor inhibitor, and ONCT-808, an autologous ROR1 targeting CAR-T product [4] - ONCT-534 is currently in the dose escalation portion of the Phase I/II study, with the sixth dosing cohort fully enrolled, receiving 1,200 milligrams daily [5][6] - The Phase I/II study for ONCT-808 is ongoing, with no dose-limiting toxicities observed in the current dosing cohort [6] Market Data and Key Metrics Changes - The company is targeting significant unmet medical needs in cancer treatment, particularly prostate cancer and aggressive B-cell lymphoma [4] - The clinical trials are showing strong demand from investigators, indicating a positive market reception for the company's products [4] Company Strategy and Development Direction - The company aims to address key escape mechanisms in prostate cancer treatment with ONCT-534, which may outperform currently approved AR pathway inhibitors [4] - The strategy includes presenting initial clinical data for ONCT-534 in the third quarter of 2024 and additional data for ONCT-808 in the fourth quarter of 2024 [8] Management's Comments on Operating Environment and Future Outlook - Management remains encouraged by the Phase I results from clinical programs and anticipates providing updates in the coming months [20] - The company believes its current cash position will support operations into the first quarter of 2025, indicating a stable financial outlook for the near term [7] Other Important Information - The company has not observed any dose-limiting toxicities in its clinical trials, which is a positive indicator for the safety profile of its products [5][6] - The management is collecting extensive data on patients, including pharmacokinetic data and novel biomarker work, to inform future dosing decisions [16] Q&A Session Summary Question: What to expect from the clinical data update for ONCT-534 in the third quarter? - Management expects to present safety data and some PSA parameters, likely from earlier cohorts due to the follow-up period [9][11] Question: What will the additional clinical data in the fourth quarter consist of? - The additional data will likely include longer follow-up results and data from more cohorts [12] Question: How many patients have been enrolled in the ONCT-808 study? - The company has not disclosed specific enrollment numbers but noted that they have revised the dosing regimen and are not seeing any dose-limiting toxicity [13][14] Question: Is there a possibility of moving to higher dosing cohorts after data from the sixth cohort? - Decisions regarding higher dosing cohorts will be made based on comprehensive data collected, including safety and efficacy [16] Question: Are there practical limits regarding administration if higher doses are considered? - The current tablet formulation allows for the feasibility of administering more than six tablets a day if data supports higher dosing [17]

分组1 - Oncternal Therapeutics reported a quarterly loss of $2.89 per share, which was better than the Zacks Consensus Estimate of a loss of $3.03, representing an earnings surprise of 4.62% [1] - The company posted revenues of $0.8 million for the quarter ended June 2024, exceeding the Zacks Consensus Estimate by 233.75%, compared to revenues of $0.11 million a year ago [2] - The stock has underperformed, losing about 46.5% since the beginning of the year, while the S&P 500 gained 9% [3] 分组2 - The current consensus EPS estimate for the coming quarter is -$3.04 on revenues of $0.24 million, and for the current fiscal year, it is -$11.63 on revenues of $1.28 million [7] - The Medical - Drugs industry is currently in the top 42% of Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Performance - Oncternal Therapeutics reported a net loss of $16.9 million for the six months ended June 30, 2024, with an accumulated deficit of $214.7 million[72]. - Net loss for the three months ended June 30, 2024, was $8.6 million, an improvement from a net loss of $9.0 million in the same period of 2023, reflecting a $0.4 million decrease[87]. - Cash used in operating activities for the six months ended June 30, 2024, was $13.3 million, a decrease from $20.2 million in 2023, primarily due to expense timing and program reprioritization[104]. - The company anticipates continuing to incur net losses for the foreseeable future, indicating substantial doubt about its ability to continue as a going concern for twelve months following the financial statement issuance date[101]. - The company has a substantial doubt about its ability to continue as a going concern for twelve months following the issuance date of its financial statements[77]. Capital and Funding - 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[71]. - Oncternal plans to raise substantial additional capital to support ongoing operations and product development efforts[75]. - The company filed a new shelf registration statement on March 8, 2024, which was declared effective on May 1, 2024, allowing it to raise capital under certain conditions[110]. - As of June 30, 2024, the company's public float was calculated to be less than $75.0 million, limiting the amount that can be raised through primary public offerings to one-third of the public float[110]. - Future sales of common stock will depend on key milestones, including the initiation and completion of clinical trials for DAARI and ROR1 CAR T product candidates[111]. Research and Development - ONCT-534, an investigational dual-action androgen receptor inhibitor, is currently in a Phase 1/2 study with six dosing cohorts ranging from 40 mg to 1200 mg[69]. - Zilovertamab has shown 100% progression-free survival at 42 months in CLL patients with a p53 mutation/del(17p) in a Phase 1/2 study[70]. - Total research and development expenses for the six months ended June 30, 2024, were $12.7 million, down from $15.6 million in 2023, a decrease of $2.9 million primarily due to reduced direct product candidate expenses[96]. - Direct expenses for ONCT-534 increased by $1.6 million for the six months ended June 30, 2024, compared to the same period in 2023, primarily due to increased clinical activities[97]. - Unallocated research and development expenses decreased by $1.3 million for the six months ended June 30, 2024, compared to the same period in 2023, due to lower consulting and personnel costs[98]. Revenue and Grants - The company received $1.5 million in award payments from NIH during the six months ended June 30, 2024, and recorded $1.4 million in grant revenue[78]. - Grant revenue increased to $0.8 million for the three months ended June 30, 2024, compared to $0.1 million in the same period of 2023, reflecting a $0.7 million increase due to NIH grant activities[88]. Operational Costs - General and administrative expenses are anticipated to increase significantly due to costs associated with being a public company and hiring additional personnel[85]. - The company is subject to risks and uncertainties regarding the adequacy of cash and short-term investments to support operations[109]. - The costs and timing of obtaining regulatory approvals for product candidates are significant factors affecting future funding requirements[109]. - The company may need to hire additional personnel and consultants as preclinical and clinical activities increase, impacting capital resources[109]. - The ability to achieve market acceptance and adequate reimbursement from third-party payors is crucial for any approved products[109]. Contracts and Obligations - The company has contractual obligations related to license agreements that include payment obligations contingent on achieving specified development and commercial milestones[112]. - The company has entered into contracts with clinical trial sites and manufacturers, which are generally cancelable after a notice period[112]. - Research and development expenses are estimated based on contracts and quotations, with adjustments made as necessary based on actual service levels[114].

Clinical Trials - ONCT-534 Phase 1/2 study for advanced prostate cancer shows no dose-limiting toxicities; 1200 mg cohort enrolled and treated, with initial data expected in Q3 2024[1] - ONCT-808 Phase 1/2 study for relapsed or refractory aggressive B-cell lymphoma is open for enrollment, with clinical data update anticipated in Q4 2024[2] - The company has implemented protocol changes in the ONCT-808 study to enhance patient monitoring and evaluate lower doses[2] - ONCT-534 and ONCT-808 are part of Oncternal's strategy to address critical unmet medical needs in oncology[4] Financial Performance - Cash, cash equivalents, and short-term investments totaled $21.4 million as of June 30, 2024, with a cash runway projected into Q1 2025[1] - Grant revenue for Q2 2024 was $0.8 million, while total operating expenses were $9.7 million, including $1.4 million in non-cash stock-based compensation[3] - Net loss for Q2 2024 was $8.6 million, or $2.89 per share, with approximately 3.0 million shares of common stock outstanding[3] - Research and development expenses for Q2 2024 totaled $6.6 million, while general and administrative expenses were $3.1 million[3] - Total assets as of June 30, 2024, were $23.9 million, down from $36.7 million as of December 31, 2023[7] - Accumulated deficit increased to $214.7 million as of June 30, 2024, compared to $197.8 million at the end of 2023[7]

Company Overview - Oncternal Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel oncology therapies for cancers with critical unmet medical needs [3] - The company targets promising biological pathways involved in cancer generation or progression, with a focus on hematological malignancies and prostate cancer [3] Key Products and Studies - ONCT-534 is an investigational dual-action androgen receptor inhibitor (DAARI) showing preclinical activity in prostate cancer models, particularly for patients with metastatic castration-resistant prostate cancer (mCRPC) who have resistance to current treatments [3] - Study ONCT-534-101 has completed enrollment and dosing in six cohorts for mCRPC treatment [3] - ONCT-808 is an investigational CAR T cell therapy targeting ROR1, demonstrating activity against multiple hematological malignancies and solid tumors [3] - Patients have been dosed under Study ONCT-808-101 with relapsed or refractory aggressive B-cell lymphoma, including those who failed previous CD19 CAR T treatment [3] - Zilovertamab, an investigational monoclonal antibody, has shown promising results in a Phase 1/2 study for patients with mantle cell lymphoma, chronic lymphocytic leukemia, and marginal zone lymphoma, achieving 100% progression-free survival at 42 months in a specific patient population [3] Upcoming Financial Results - Oncternal Therapeutics will report its second quarter 2024 financial results after U.S. market close on August 8, 2024, followed by a webcast for a business update [1][2]

Core Insights - Oncternal Therapeutics has completed enrollment and initiated dosing for the sixth 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 sixth cohort is receiving ONCT-534 at a dose of 1200 mg orally once daily, following a decision by the Safety Review Committee based on data from the previous 600 mg cohort [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 1200 mg dose cohort [1][2] Company Overview - Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel oncology therapies for cancers with critical unmet medical needs, particularly in hematological malignancies and prostate cancer [6] - ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with preclinical activity against both unmutated androgen receptors and various forms of androgen receptor aberrations, aimed at treating mCRPC patients resistant to existing therapies [6] - The company is also developing ONCT-808, an investigational CAR T cell therapy targeting ROR1, which has shown activity in preclinical models against multiple cancers [6]

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]