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Oncternal Therapeutics (ONCT) Investor Presentation - Slideshow
2022-03-25 18:12
O O ONCTERNAL O therapeutics™ TARGETING CANCER New Science. New Cancer Therapies. New Hope. Company Overview – March 2022 ONCT Corporate Presentation March 2022 FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements (including within the meaning of §21E of the U.S. Securities Exchange Act of 1934, as amended, and § 27A of the U.S. Securities Act of 1933, as amended). Forward-looking statements, which generally include statements regarding goals, plans, intentions and expectations, ...
Oncternal Therapeutics(ONCT) - 2021 Q4 - Earnings Call Transcript
2022-03-11 03:28
Oncternal Therapeutics, Inc. (NASDAQ:ONCT) Q4 2021 Earnings Conference Call March 10, 2022 5:00 PM ET Company Participants Richard Vincent - Chief Financial Officer James Breitmeyer - President & Chief Executive Officer Salim Yazji - Chief Medical Officer Conference Call Participants Hartaj Singh - Oppenheimer Carl Byrnes - Northland Capital Markets Kaveri Pohlman - BTIG Robert Burns - H.C. Wainwright Shubhendu Sen Roy - Brookline Capital Markets Operator Greetings and welcome to Oncternal Therapeutics Inc ...
Oncternal Therapeutics(ONCT) - 2021 Q4 - Annual Report
2022-03-10 22:15
Clinical Efficacy and Safety - Zilovertamab demonstrated an objective response rate (ORR) of 81% and a complete response (CR) rate of 35% in patients with relapsed/refractory mantle cell lymphoma (MCL) when combined with ibrutinib, compared to historical ORR of 66% and CR rate of 20% for ibrutinib alone [22]. - The median progression-free survival (PFS) for patients treated with zilovertamab plus ibrutinib was reported at 35.9 months, significantly higher than the 12.8 months for those treated with ibrutinib alone [22]. - Zilovertamab demonstrated a favorable safety profile, with no dose-limiting toxicities or serious adverse events reported in the Phase 1 trial [56]. - The combination therapy of zilovertamab and ibrutinib showed lower rates of Grade 3 or higher neutrophil and platelet decreases compared to historical data for ibrutinib alone [64]. - In a Phase 1 clinical trial of zilovertamab in CLL, 22 patients were evaluable, with 17 achieving stable disease and an average delay of 262 days before further treatment was needed [57]. - The overall response rate (ORR) for patients with MCL in Study CIRM-0001 was 81%, with 35% achieving complete response (CR) and 46% achieving partial response (PR), resulting in a total clinical benefit rate of 92% [66]. - For high Ki-67 patients, the ORR was 85% with a median duration of response of 14 months, while patients with more than one prior systemic therapy had an ORR of 82% [66]. - In the CLL cohort, the ORR was 91%, with a CR rate of 6% and a total clinical benefit rate of 100% [72]. - The median PFS for CLL patients with more than two prior therapies was 36.1 months, while landmark PFS was 100% at 36 months for those with two or fewer prior lines of therapy [72]. Drug Development and Regulatory Status - The FDA granted orphan drug designations for zilovertamab for MCL and chronic lymphocytic leukemia (CLL) in 2020, indicating its potential for treating rare diseases [21]. - The company plans to conduct a Phase 3 clinical trial (ZILO-301) for zilovertamab in relapsed/refractory MCL, with a primary endpoint of PFS and an interim analysis for ORR [77]. - ZILO-301 will be conducted internationally in at least 50 centers, with an expected enrollment of up to 250 randomized patients [78]. - The company is also planning Study ZILO-302 to evaluate zilovertamab plus ibrutinib for patients with progressive disease during initial ibrutinib monotherapy [79]. - The company expects to continue relying on third parties for the production and testing of clinical and commercial quantities of all product candidates, maintaining flexibility in its manufacturing strategy [174]. - The company has established a quality control and assurance program to ensure compliance with current Good Manufacturing Practices (cGMPs) [175]. - The FDA requires substantial time and financial resources for obtaining regulatory approvals for drug candidates [197]. - The IND submission must include preclinical study results, clinical protocols, and CMC information before human trials can begin [198]. - The FDA reviews NDAs and BLAs within 60 days to determine if they are complete for substantive review [209]. - Standard applications are reviewed within ten months, while priority applications are reviewed within six months after filing [210]. - The FDA may issue a Complete Response Letter (CRL) if the NDA or BLA does not meet regulatory criteria, outlining specific deficiencies [213]. - Approval may be limited to specific disease subsets or dosages, potentially restricting commercial value [214]. - The Pediatric Research Equity Act requires pediatric clinical trials for most new drugs and biologics unless a deferral or waiver is granted [215]. - Clinical trials must adhere to Good Clinical Practices (GCP) and require independent review board approval [202]. - The manufacturing process must comply with current Good Manufacturing Practices (cGMP) to ensure product quality [211]. - The FDA may require post-marketing studies to further assess product safety and effectiveness after approval [214]. - The FDA grants orphan designation to drugs for rare diseases affecting fewer than 200,000 individuals in the U.S. or where development costs cannot be recovered from sales [216]. - Products with orphan designation that receive the first FDA approval are entitled to seven years of orphan product exclusivity [218]. Research and Collaborations - The company announced a research collaboration with Karolinska Institutet to advance ROR1-targeting cell therapies, focusing on CAR-T and CAR-NK cells [90]. - A collaboration with Celularity Inc. was established to evaluate placental-derived cellular therapies targeting ROR1, including preclinical studies on zilovertamab and CAR gene modification [90]. - The company is collaborating with SPH USA to develop ROR1-targeted CAR-T cell therapy candidates in Greater China, with initial clinical trials planned at experienced hospitals [92]. - The company has entered into a research agreement with the Regents of UC San Diego for further research on the ROR1 therapeutic development program, with a budget of $1.6 million over four years [161]. - The company has established a research collaboration with Celularity to evaluate placental-derived cellular therapies targeting ROR1, including the use of zilovertamab in combination with CYNK-101 [165]. Market Potential and Competitive Landscape - The global market for CLL therapies was estimated at $9.1 billion in 2021, driven by targeted therapies such as ibrutinib and venetoclax, indicating a significant commercial opportunity for zilovertamab [50]. - The company is developing multiple therapies targeting oncology indications, including zilovertamab and ONCT-534, amidst high competition in the market [157]. Patent and Intellectual Property - The company is actively seeking to protect its proprietary technology through patent applications and relies on trade secrets and know-how to maintain its competitive position in cancer therapeutics [176]. - As of February 4, 2022, the company owned approximately 42 issued U.S. patents and 42 pending U.S. patent applications related to proprietary technology, with an additional 57 issued patents and 66 pending applications in jurisdictions outside of the U.S. [179]. - The company has an exclusive, worldwide license for a portfolio of patents related to ROR1 antibodies and CAR-T therapies, which includes know-how and trade secrets for treating cancers [180]. - The zilovertamab clinical candidate is currently in Phase 1 and Phase 2 clinical trials, with two issued U.S. patents related to its composition not expiring before 2032 and 2033 [181]. - The company has approximately 29 licensed patent applications pending in the U.S. and abroad related to methods of treating cancer using zilovertamab and small-molecule chemotherapeutics, with one issued patent directed to the combination with a BTK inhibitor [182]. - The DAARI program includes ten issued U.S. patents and approximately three pending U.S. patent applications, with a patent term not due to expire before April 2036 [188]. - The ONCT-216 portfolio contains approximately eight U.S. issued patents and two pending applications, with a patent term not due to expire before October 2035 [193]. - The Georgetown Licensed Portfolio includes three U.S. patents directed to compounds for treating Ewing sarcoma or pancreatic cancer, with patent terms not expiring before November 2028, August 2028, and December 2027 [194]. - The company has a total of approximately 17 patents outside the U.S. related to the Georgetown Licensed Portfolio, with patent terms not expiring before April 2033 [195]. - The validity of one of the issued European patents is being challenged, but the company believes it has strong defenses against the opposition [181]. - The company holds a portfolio of patents and applications related to methods of screening for antibodies that specifically bind to ROR1, with two issued U.S. patents not expiring before January 2032 [186].
Oncternal Therapeutics(ONCT) - 2021 Q3 - Earnings Call Transcript
2021-11-05 03:36
Oncternal Therapeutics, Inc. (NASDAQ:ONCT) Q3 2021 Earnings Conference Call November 4, 2021 5:00 PM ET Company Participants Rich Vincent - Chief Financial Officer James Breitmeyer - President & Chief Executive Officer Salim Yazji - Chief Medical Officer Conference Call Participants Hartaj Singh - Oppenheimer and Company Carl Byrnes - Northland Capital Markets Shubhendu Sen Roy - Brookline Capital Management Operator Greetings. Welcome to the Oncternal Therapeutics, Inc. Q3 2021 Financial Results Call. At t ...
Oncternal Therapeutics(ONCT) - 2021 Q3 - Quarterly Report
2021-11-04 20:48
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, 2021 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 62-1715 ...
Oncternal Therapeutics (ONCT) Investor Presentation - Slideshow
2021-08-13 19:30
O O ONCTERNAL O therapeutics™ TARGETING CANCER New Science. New Cancer Therapies. New Hope. Company Overview – August 2021 ONCT Corporate Presentation August 2021 FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements (including within the meaning of §21E of the U.S. Securities Exchange Act of 1934, as amended, and § 27A of the U.S. Securities Act of 1933, as amended). Forward-looking statements, which generally include statements regarding goals, plans, intentions and expectations ...
Oncternal Therapeutics(ONCT) - 2021 Q2 - Earnings Call Transcript
2021-08-09 07:59
Oncternal Therapeutics, Inc. (NASDAQ:ONCT) Q2 2021 Results Earnings Conference Call August 5, 2021 5:00 PM ET Company Participants Richard Vincent - Chief Financial Officer James Breitmeyer - President, Chief Executive Officer Salim Yazji - Chief Medical Officer Conference Call Participants Hartaj Singh - Oppenheimer Robert Burns - H.C. Wainwright Carl Byrnes - Northland Securities Kumar Raja - Brookline Capital Markets Operator Greetings and welcome to the Oncternal Therapeutics, Incorporated's second-quar ...
Oncternal Therapeutics(ONCT) - 2021 Q2 - Quarterly Report
2021-08-05 21:02
Financial Performance - Oncternal Therapeutics reported a net loss of $13.6 million for the six months ended June 30, 2021, with an accumulated deficit of $96.4 million[100]. - As of June 30, 2021, Oncternal had cash and cash equivalents of $103.7 million, which is expected to fund operations for at least the next twelve months[104]. - Net cash used in operating activities for the six months ended June 30, 2021, was $13.6 million, resulting from a net loss of $13.6 million[127]. - Grant revenue for the three months ended June 30, 2021, was $0.9 million, an increase of $0.3 million from $0.6 million in 2020, primarily due to higher research and development subaward costs[115]. - Total operating expenses for the three months ended June 30, 2021, were $8.6 million, an increase of $2.4 million from $6.2 million in 2020[114]. - Research and development expenses for the six months ended June 30, 2021, were $9.1 million, an increase of $2.6 million from $6.5 million in 2020, driven by a $1.6 million increase in direct product candidate costs[121]. - General and administrative expenses for the six months ended June 30, 2021, were $6.2 million, an increase of $1.2 million from $5.0 million in 2020, primarily due to higher personnel and professional costs[124]. Funding and Capital Requirements - The company has raised approximately $125.0 million from common stock issuance and $49.0 million from convertible preferred stock issuance as of June 30, 2021[99]. - The company anticipates needing substantial additional funding to support ongoing operations and business strategy[102]. - The company anticipates needing to raise substantial additional capital in the future to fund ongoing operations and development activities[111]. - Future capital requirements will depend on various factors, including the costs and timing of clinical trials and regulatory reviews[130]. - There is no assurance that the company will be able to obtain financing on acceptable terms, which could impact product development and commercialization efforts[131]. - The company may face dilution of stockholder ownership if additional capital is raised through debt or equity securities[131]. Clinical Development and Trials - Cirmtuzumab is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of B-cell lymphoid malignancies, with a target enrollment of at least 20 patients for the MCL cohort[96][97]. - The FDA has granted orphan drug designations for cirmtuzumab for MCL and CLL, and for TK216 for Ewing sarcoma[95]. - Cirmtuzumab's Phase 1/2 trial results were presented at the American Society of Clinical Oncology 2021 Annual Meeting, indicating encouraging interim results[96]. - The ongoing COVID-19 pandemic has impacted clinical trial timelines, with delays expected for the ROR1 CAR-T therapy's first-in-human dosing to the first half of 2022[105]. - Direct expenses for cirmtuzumab increased by $0.3 million for the six months ended June 30, 2021, primarily due to increased clinical trial costs[122]. Accounting and Financial Reporting - The company considers its critical accounting policies related to research and development expenses and revenue recognition, with no material changes during the six months ended June 30, 2021[136]. - The financial statements are prepared in accordance with generally accepted accounting principles, requiring estimates and judgments that affect reported amounts[134]. - Actual results may differ from estimates based on various assumptions or conditions[135]. - The company has not engaged in any off-balance sheet arrangements during the periods presented[137]. Regulatory and Compliance - As of June 30, 2021, the company was unable to estimate the timing or likelihood of achieving specified development, regulatory, and commercial milestones related to its license agreements[132]. - The company has payment obligations under license agreements that are contingent upon future events, including royalty payments for product sales developed under those agreements[132]. - The company enters into contracts with clinical trial sites and supply manufacturers, which generally allow for termination after a notice period[133]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[139].
Oncternal Therapeutics(ONCT) - 2021 Q1 - Earnings Call Transcript
2021-05-07 02:16
Oncternal Therapeutics, Inc. (NASDAQ:ONCT) Q1 2021 Earnings Conference Call May 6, 2021 5:00 PM ET Company Participants Richard Vincent - Chief Financial Officer Jim Breitmeyer - President & Chief Executive Officer Edwina Baskin-Bey - Acting Chief Medical Officer Conference Call Participants Carl Byrnes - Northland Capital Markets Robert Burns - H.C. Wainwright Kumar Raja - Brookline Capital Market Operator Good day ladies and gentlemen and welcome to Oncternal's Therapeutics Inc. First Quarter 2021 Financi ...
Oncternal Therapeutics(ONCT) - 2021 Q1 - Quarterly Report
2021-05-06 21:09
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, 2021 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) ...