BRACELET-1 data showing impressive overall survival benefit in HR+/HER2- metastatic breast cancer affirms pelareorep + paclitaxel combination should be evaluated in a registrational studyUpcoming GOBLET milestones include updated efficacy data from anal cancer cohort and safety run-in data from the modified FOLFIRINOX pancreatic cancer cohortCash position of $19.6 million as of September 30, 2024Management hosting conference call and webcast today at 8:30 a.m. ETSAN DIEGO and CALGARY, AB, Nov. 12, 2024 /PRN ...

Conference call and webcast to take place on Tuesday, November 12, 2024, at 8:30 a.m. ETSAN DIEGO and CALGARY, AB, Nov. 11, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it will host a conference call and webcast on Tuesday, November 12, 2024, at 8:30 a.m. ET to discuss a corporate update and financial results for the third quarter 2024.Conference Call & WebcastDate: Tuesday, November ...

Shares of Oncolytics Biotech (ONCY) rallied 18.2% on Friday after the company announced that it is seeking an accelerated pathway for the approval of its lead developmental candidate, pelareorep, for the metastatic breast cancer (mBC) indication. The stock is also gaining today. Pelareorep follows a unique mechanism of action, different from currently available therapeutics for this indication. It selectively targets cancer cells, triggering a cascade of inflammatory responses (which include PDL1 upregulati ...

Recent clinical efficacy results from the BRACELET-1 trial in HR+/HER2- breast cancer pave the way for a clinical study designed to support an accelerated approval Key milestones in gastrointestinal cancer clinical trials expected in 2025, with potential for new registrationenabling studies SAN DIEGO and CALGARY, AB, Oct. 4, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, is issuing a corporate update to pr ...

Overall survival (OS) results from BRACELET-1 corroborate results of previous randomized IND-213 breast cancer study Together, these two studies support the compelling potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer Oncolytics Biotech is moving forward to secure funding for a registration-enabling study of pelareorepbased therapy in advanced or metastatic breast cancer Over half of BRACELET-1 patients in the pelareorep + chemotherapy ...

SAN DIEGO and CALGARY, AB, Sept. 6, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Chief Financial Officer Kirk Look will participate in a fireside chat at the H.C. Wainwright 26th Annual Global Investment Conference, which is taking place September 9-11, 2024 at the Lotte New York Palace Hotel in New York, NY. Chief Medical Officer Tom Heineman, M.D., Ph.D., will participate in a fire ...

SAN DIEGO and CALGARY, AB, Aug. 2, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Chief Medical Officer Dr. Thomas Heineman will participate in a fireside chat at Canaccord Genuity's 44th Annual Growth Conference, which is taking place August 13-15, 2024 at the InterContinental Boston Hotel in Boston, MA. Additional details on the fireside chat can be found below. Date: Tuesday, August ...

财务数据和关键指标变化 - 公司于2024年6月30日拥有2,490万加元的现金和现金等价物,预计现金可持续到2025年 [52] - 截至2024年6月30日的6个月内,经营活动净现金流出1,430万加元,较2023年同期的1,630万加元有所下降 [53] - 2024年第二季度的一般及行政费用为340万加元,与2023年同期的350万加元基本持平 [54] - 2024年第二季度的研发费用为460万加元,较2023年同期的370万加元有所增加,主要是由于临床试验费用、数据分析以及与GCAR合作等方面的增加 [54][55] - 2024年第二季度的净亏损为730万加元,较2023年同期的740万加元有所下降 [56] 各条业务线数据和关键指标变化 - 公司正在推进pelareorep在乳腺癌和胰腺癌适应症的注册研究 [15][18][23] - 在乳腺癌方面,公司与FDA进行了富有成果的III型会议,确定了下一步的关键要素 [16][24][25] - 公司预计将在2024年下半年公布BRACELET-1试验的总生存期数据 [18][29][30] - 在胰腺癌方面,公司在GOBLET试验中启动了新的改良FOLFIRINOX队列,这可能带来第二个注册机会 [35][38] - 公司正与GCAR合作,设计一项适应性注册研究,评估pelareorep联合吉西他滨、白蛋白紫杉醇和阿替利珠单抗的疗效 [39][48][59] 各个市场数据和关键指标变化 - 公司尚未提供具体的商业机会规模,但表示乳腺癌市场正在发生变化,仍有显著的商业机会 [66][67] - 公司计划在北美开展乳腺癌注册研究,并评估在欧洲的参与可能性 [77] 公司战略和发展方向及行业竞争 - 公司致力于推进pelareorep向注册研究的发展,并计划在2024年下半年和2025年实现多个里程碑 [15][57][58][59][60] - 公司与GCAR的合作有助于加快pelareorep在胰腺癌适应症的开发进度,降低成本 [47][48][49] - 公司正在评估其他潜在的合作和战略机会,以最大化pelareorep的治疗和商业潜力 [50] 管理层对经营环境和未来前景的评论 - 公司对pelareorep在乳腺癌和胰腺癌适应症的发展前景感到鼓舞,认为有望为癌症患者带来改善 [42][57][58][60][61] - 公司相信pelareorep作为一种免疫治疗药物的作用机制和广泛的治疗潜力得到了临床和转化数据的支持 [61] 其他重要信息 - 公司CEO Matt Coffey暂时休养,董事会和管理团队有信心继续执行公司使命 [13] - 公司在ASCO会议上就pelareorep在多种癌症中诱导肿瘤浸润淋巴细胞扩增的数据进行了报告 [40][41] 问答环节重要的提问和回答 问题1 **Kirby 提问** 1) 公司在HR+/HER2-转移性乳腺癌适应症下pelareorep的商业机会规模是多少? 2) 公司计划的乳腺癌注册研究的设计是什么样的? [64] **Wayne Pisano 和 Tom Heineman 回答** 1) 公司正在更新商业机会的评估,下次会议时会提供更多细节。但仍有显著的商业机会,因为这些患者在接受其他治疗后会继续复发,需要后续治疗 [66][67] 2) 公司计划开展一项大规模II期注册研究,主要终点为无进展生存期,患者人群为既往接受过抗体偶联药物治疗或不适合接受的患者 [69] 问题2 **Soumit Roy 提问** 1) BRACELET-1试验是否披露了p值? 2) 乳腺癌II/III期注册研究是否会有更多既往接受过抗体偶联药物治疗的患者,与BRACELET-1有何其他差异? [79] **Tom Heineman 回答** 1) BRACELET-1试验中无进展生存期的p值为0.03,小于0.05的显著性水平 [80] 2) 注册研究将会纳入既往接受过抗体偶联药物治疗的患者,这是BRACELET-1中没有的。但其他患者特征基本相同 [80][81] 问题3 **Michael Okunewitch 提问** 公司是否期望从GOBLET试验的第5队列获得加速批准的数据,还是只是为后续注册研究提供依据? [83] **Tom Heineman 回答** GOBLET第5队列的数据只是探索性的,不足以支持加速批准。但如果结果良好,可能会被纳入如GCAR的平台试验或其他注册研究 [84][85]

Received productive feedback from Type C meeting with the FDA for the planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer On track to report overall survival results from randomized BRACELET-1 breast cancer study in H2 2024 Dosed first patient in new GOBLET study pancreatic cancer cohort; supported by funding from PanCAN Entered into collaboration with GCAR for inclusion of pelareorep in adaptive registration-enabling pancreatic cancer trial Cash position of $24.9 millio ...

Conference call and webcast to take place on Thursday, August 1, 2024, at 4:30 p.m. ET SAN DIEGO, Calif. and CALGARY, Alberta, July 24, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it will host a conference call and webcast on Thursday, August 1, 2024, at 4:30 p.m. ET to discuss a corporate update and financial results for the second quarter 2024. Conference Call & WebcastDate: Thurs ...