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, 2023 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) (State or other jurisdiction of incorporation or organization) Delaware 62-1715807 ...

Company Participants Greetings and welcome to the Oncternal Therapeutics, Inc. Fourth Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator instructions] And as a reminder, this conference is being recorded. Thank you, John. Good afternoon, everyone, and thank you for joining us today. Joining me on the call this afternoon are our President and CEO, Dr. James Breitmeyer, and ...

Financial Performance - The company incurred net losses of $44.2 million and $31.3 million for the years ended December 31, 2022, and 2021, respectively, with an accumulated deficit of $158.3 million as of December 31, 2022[272]. - The company expects to continue incurring significant operating losses for the foreseeable future as it develops and seeks regulatory approval for its product candidates[272]. - The company faces substantial doubt about its ability to continue as a going concern, based on expected operating losses and negative cash flows[282]. - The company may need to seek additional capital sooner than planned due to changing operating plans and demands on cash resources[277]. - The company’s future capital requirements will depend on various factors, including the progress and costs of clinical trials and regulatory reviews[278]. Clinical Development - The company is in clinical development for zilovertamab and ONCT-808, with zilovertamab being evaluated in a Phase 3 study for relapsed or refractory MCL and a Phase 1/2 study for CLL, MCL, and MZL[287]. - The company is developing ONCT-808 as a CAR T therapy candidate targeting ROR1 for hematologic cancers and solid tumors, alongside ONCT-534, an investigational dual-action androgen receptor inhibitor[287]. - The company is conducting two clinical trials of zilovertamab: a Phase 3 global registrational study for relapsed or refractory MCL and a Phase 1/2 trial for B-cell lymphoid malignancies[302]. - The ongoing COVID-19 pandemic continues to impact the timeline for clinical trials, including the global Phase 3 study of zilovertamab[298]. - The company has sufficient quantities of zilovertamab clinical trial materials to treat patients through at least the end of 2024[300]. Regulatory Environment - The company has not yet demonstrated the ability to successfully obtain marketing authorization approvals or commercialize its product candidates, which may affect future revenue generation[271]. - Regulatory changes in the EU regarding clinical trials may impact the company's development plans, with a new centralized process effective from January 31, 2022[294]. - The regulatory approval process for gene therapy products is lengthy, rigorous, and expensive, with significant oversight from the FDA and EMA[325]. - The FDA may require additional clinical trials or studies post-approval, which can delay commercialization and increase costs[334]. - The company may seek Breakthrough Therapy designation for product candidates, including zilovertamab, but this does not guarantee faster development or approval processes[350]. Risks and Challenges - The historical failure rate for product candidates in the pharmaceutical industry is high, and many candidates fail despite promising early results[290]. - The company faces risks from potential delays in clinical trials due to various factors, including regulatory disagreements and difficulties in patient recruitment[303]. - The company may encounter additional risks and delays if conducting clinical trials in foreign countries due to differing healthcare practices and regulatory schemes[305]. - The company may face delays in clinical trials due to difficulties in patient enrollment, particularly for rare diseases with limited patient pools[310]. - The company faces significant liability risks if found to have promoted off-label uses of its products, which are strictly regulated by the FDA[386]. Market and Commercialization - The commercial success of product candidates will depend on market acceptance by physicians, patients, and healthcare payors, which may not be guaranteed even with regulatory approval[379]. - Coverage and adequate reimbursement from third-party payors are essential for the successful commercialization of products, and failure to secure this could limit revenue generation[387]. - The potential market for product candidates may be limited to patients who have failed prior treatments, affecting overall market opportunity[381]. - International operations are subject to extensive price controls and regulations, which may pressure pricing and reimbursement levels compared to the U.S.[393]. - The company currently lacks marketing and sales capabilities and must invest significantly to develop these functions or collaborate with third parties[404]. Compliance and Legal Issues - The company is subject to various healthcare laws and regulations, which could significantly impact its operations and financial condition[417]. - Non-compliance with the federal Anti-Kickback Statute could lead to civil, criminal, and administrative penalties, including exclusion from government-funded healthcare programs[418]. - The company may face substantial costs to ensure compliance with healthcare laws, which could affect profitability and operational efficiency[420]. - Legislative changes, such as the Affordable Care Act, may impose additional fees and rebates, impacting the company's pricing strategies and reimbursement rates[422]. - Compliance with evolving data protection laws, such as HIPAA, is critical, as violations could lead to significant penalties and reputational damage[432]. Intellectual Property - The company's success relies on protecting intellectual property; failure to do so could harm its competitive position and financial results[456]. - The patent application process is uncertain, and there is no guarantee that patents will be issued or provide adequate protection against competitors[459]. - The company may need to obtain licenses from third parties to advance research or commercialization, and failure to do so could materially harm its business[464]. - Legal challenges could lead to reduced scope or invalidation of patent rights, allowing competitors to commercialize similar products[468]. - The breadth and strength of patent protection are critical for attracting collaboration and licensing opportunities[469]. Operational Risks - The company relies on CROs and clinical trial sites for timely conduct of clinical trials, but has limited influence over their performance[311]. - The company has no control over third-party manufacturers, which poses risks related to compliance with cGMP regulations and could impact the ability to develop or market product candidates[357]. - The company entered into Clinical Trial and Supply Agreements with Pharmacyclics, LLC for supplying ibrutinib at no upfront cost, but termination of these agreements could incur substantial additional costs[366]. - The company faces risks related to fluctuating operating results, which can be influenced by various external factors, making future predictions challenging[407]. - Cybersecurity threats are increasing, with potential disruptions to product development programs and significant costs associated with breaches[446].

Oncternal Therapeutics, Inc. (NASDAQ:ONCT) Q3 2022 Earnings Conference Call November 3, 2022 5:00 PM ET Company Participants Rich Vincent - Chief Financial Officer Dr. James Breitmeyer - President and CEO Dr. Salim Yazji - Chief Medical Officer Conference Call Participants Hartaj Singh - Oppenheimer Carl Byrnes - Northland Capital Markets Robert Burns - H.C. Wainwright Kenny Storch - BTIG Operator Ladies and chairman, greetings and welcome to the Oncternal Therapeutics, Inc. Q3 2022 Financial Results Call. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 62-1715807 (IRS Employer Identification No.) 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, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 0 ...

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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, 2022 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) (State or other jurisdiction of incorporation or organization) Delaware 62-1715807 ( ...

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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, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 San Diego, CA 92130 (858) 434-1113 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) Securities registered pursuant to Section 12(b) ...