财务数据和关键指标变化 - 2023年第一季度现金、现金等价物和有价证券为2970万美元,较2022年12月31日的3210万美元有所下降 [33] - 2023年第一季度一般及行政费用为320万美元,较2022年同期的260万美元有所增加,主要由于投资者关系活动增加,部分被股份支付费用降低所抵消 [34] - 2023年第一季度研发费用为350万美元,较2022年同期的370万美元有所下降,主要由于BRACELET-1研究成本和股份支付费用降低,部分被制造费用增加和人员相关费用增加所抵消 [34] - 2023年第一季度净亏损640万美元,较2022年同期的680万美元有所下降 [35] 各条业务线数据和关键指标变化 - 公司的两大核心业务为HR阳性/HER2阴性乳腺癌和胰腺癌项目,这两个项目都获得了FDA快速通道认定,代表了重大的注册机会 [13] - HR阳性/HER2阴性乳腺癌项目基于IND-213和AWARE-1研究的积极结果,为公司的价值主张提供了坚实的基础 [15][16][17] - BRACELET-1研究旨在验证IND-213的积极结果,并为后续注册研究的设计提供信息 [18][19][20] 各个市场数据和关键指标变化 - 到2028年,HR阳性/HER2阴性乳腺癌和一线胰腺癌的可治疗患者群体预计将分别达到30万和13.5万例,覆盖美国、主要欧洲国家和日本 [25] 公司战略和发展方向及行业竞争 - 公司将继续专注于乳腺癌和胰腺癌两大核心项目,这两个项目都有积极的临床数据支持,并获得了FDA快速通道认定 [13][39] - 公司计划与领先的行业和学术界合作伙伴合作,进一步拓展pelareorep在其他高价值适应症如肛门癌和结直肠癌的应用,以及在CAR-T疗法中的潜力 [22][30][31] - 公司正在与多方进行商业合作洽谈,希望能够达成一项涵盖乳腺癌和胰腺癌两大项目的单一许可交易 [26][29] 管理层对经营环境和未来前景的评论 - 管理层对BRACELET-1研究的结果以及后续注册研究的设计表示乐观,认为这些里程碑将进一步降低项目风险,加快进入注册环境 [39] - 管理层认为公司目前处于一个非常激动人心的时期,未来12个月内将实现多个重要里程碑,包括BRACELET-1结果公布、胰腺癌项目的进展以及对两大核心项目的注册路径的进一步指引 [37][38][39] 问答环节重要的提问和回答 问题1 **John Newman 提问** 询问pelareorep在乳腺癌潜在注册研究的设计,是否会包括checkpoint抑制剂 [44] **Matt Coffey 回答** - 考虑到avelumab已经从Pfizer手中转回到Merck KGaA,在注册研究设计中加入checkpoint抑制剂需要权衡其带来的成本效益 [45][46][57] - 根据与欧洲支付方的沟通,如果pelareorep加paclitaxel能够带来3.5-4个月的总生存期改善,可能就足以获得他们的支付兴趣 [55][56] - 公司可能会考虑在生命周期管理中单独评估checkpoint抑制剂的作用,而不是在注册研究中直接纳入 [58] 问题2 **Louise Chen 提问** 1) BRACELET-1研究是否没有统计学显著性的设计?期望看到什么样的结果才算成功? 2) 公司如何看待CAR-T的商业机会? 3) 公司的现金储备能支持到什么时候? [66] **Thomas Heineman 回答** 1) BRACELET-1研究设计并未针对统计学显著性进行powering,而是期望看到pelareorep组与对照组在客观缓解率和无进展生存期等主要指标上的数值差异 [71][72][73] **Andrew de Guttadauro 回答** 2) 公司看好pelareorep与CAR-T疗法联合用药在实体瘤治疗中的潜力,计划通过技术转移和收取双位数的特许权使用费的方式获得收益,而不是自主开发CAR-T业务 [76][77][78] **Kirk Look 回答** 3) 公司目前的现金储备可支持至少12个月,覆盖ASCO会议、GOBLET研究的更新等重要里程碑 [80]

Condensed Interim Consolidated Financial Statements (unaudited) Oncolytics Biotech® Inc. For the three and six months ended June 30, 2023 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) (in thousands of Canadian dollars, except share amounts) June 30, December 31, As at 2023 2022 Assets Current assets Cash and cash equivalents (note 4) $ 17,520 $ 11,666 Marketable securities 6,831 20,472 Other receivables (note 4) 559 521 Prepaid expenses (note 4) 6,085 3, ...

Oncolytics Biotech Inc. (NASDAQ:ONCY) Q4 2022 Earnings Conference Call March 3, 2023 8:30 AM ET Company Participants Jon Patton - Director, Investor Relations and Communications Matt Coffey - Chief Executive Officer Thomas Heineman - Chief Medical Officer Andrew de Guttadauro - Global Head, Business Development Kirk Look - Chief Financial Officer Conference Call Participants John Newman - Canaccord Genuity Patrick Trucchio - H.C. Wainwright Operator Welcome to Oncolytics Biotech’s Fourth Quarter and Full Ye ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For fiscal year ended December 31, 2022 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ OR o SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE ...

Oncolytics Biotech® Reports Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights Pancreatic cancer program advancing towards registration path supported by phase 1/2 GOBLET data showing a confirmed complete response and 69% objective response rate in advanced/metastatic patients Phase 2 BRACELET-1 trial in HR+/HER2- metastatic breast cancer on track for a randomized data readout in Q2 2023 that will inform the design of a pivotal trial Registration opportunities in breast and pancr ...

Oncolytics Biotech, Inc. (NASDAQ:ONCY) Q3 2022 Earnings Conference Call November 7, 2022 8:30 AM ET Company Participants Jon Patton - Director, IR & Communication Matt Coffey - CEO Tom Heineman - CMO Andrew de Guttadauro - Global Head, Business Development Kirk Look - CFO Conference Call Participants John Newman - Canaccord Operator Good morning, and welcome to Oncolytics Biotech's Third Quarter 2022 Conference Call. All participants are now in a listen-only mode. There will be a question-and-answer session ...

Oncolytics Biotech Inc. (NASDAQ:ONCY) Q2 2022 Results Conference Call August 11, 2022 8:30 AM ET Company Participants Jon Patton - Director of Investor Relations and Communications Matthew Coffey - President and Chief Executive Officer Kirk Look - Chief Financial Officer Thomas Heineman - Chief Medical Officer Andrew de Guttadauro - President Conference Call Participants Jason Kolber - HC Wainwright Operator Good afternoon, and welcome to Oncolytics BiotechÂ's Second Quarter 2022 Conference Call. All partic ...

Oncolytics Biotech, Inc. (NASDAQ:ONCY) Q1 2022 Earnings Conference Call May 5, 2022 5:00 PM ET Corporate Participants Jon Patton - Director, Investor Relations and Communications Matthew Coffey - President and Chief Executive Officer Thomas Heineman - Chief Medical Officer Andrew de Guttadauro - Global Head of Business Development, President, Oncolytics Biotech (U.S.) Inc. Kirk Look - Chief Financial Officer Conference Call Participants John Newman - Canaccord Jason Kolbert - HC Wainwright Operator Good aft ...

Oncolytics Biotech, Inc. (NASDAQ:ONCY) Q4 2021 Earnings Conference Call March 3, 2022 5:00 PM ET Company Participants Jon Patton - Director, IR & Communication Matthew Coffey - President, CEO & Director Thomas Heineman - Chief Medical Officer Kirk Look - CFO Andrew de Guttadauro - Global Head, Business Development & President, Oncolytics Biotech (U.S.) Inc Conference Call Participants Operator Good afternoon, and welcome to Oncolytics Biotech's Fourth Quarter 2021 Conference Call. [Operator Instructions] Pl ...

Oncolytics Biotech Inc. (NASDAQ:ONCY) Q3 2021 Earnings Conference Call November 5, 2021 8:00 AM ET Company Participants Jon Patton - Director of Investor Relations & Communications Matt Coffey - President, Chief Executive Officer & Director Tom Heineman - Global Head of Clinical Development & Operations Andrew de Guttadauro - Global Head of Business Development Kirk Look - Chief Financial Officer Conference Call Participants John Newman - Canaccord Genuity Patrick Trucchio - H.C. Wainwright Operator Good mo ...