Oncolytics Biotech (ONCY)

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Oncolytics Biotech (ONCY) - 2020 Q4 - Annual Report
2021-03-05 20:03
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, 2020 | | | OR | | o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | | For the transition period from ____ to ____ | | | ...
Oncolytics Biotech (ONCY) - 2020 Q4 - Earnings Call Transcript
2021-03-05 17:13
Oncolytics Biotech Inc. (NASDAQ:ONCY) Q4 2020 Results Conference Call March 5, 2021 8:30 AM ET Company Participants Jon Patton - Director, IR and Communication Dr. Matt Coffey - President and CEO Andrew de Guttadauro - Global Head, Business Development Kirk Look - CFO Conference Call Participants Patrick Trucchio - H.C. Wainwright Wangzhi Li - Ladenburg Operator Good morning and welcome to Oncolytics Biotech’s Fourth Quarter and Full Year 2020 Conference Call. All participants are in a listen-only mode. The ...
Oncolytics Biotech (ONCY) - 2020 Q3 - Earnings Call Transcript
2020-11-12 03:17
Oncolytics Biotech Inc. (NASDAQ:ONCY) Q3 2020 Earnings Conference Call November 11, 2020 5:00 PM ET Company Participants Jon Patton - Director of Investor Relations and Communication Matt Coffey - President and Chief Executive Officer Andrew de Guttadauro - Global Head of Business Development Kirk Look - Chief Financial Officer Conference Call Participants John Newman - Canaccord Wangzhi Li - Ladenburg Operator Good afternoon and welcome to Oncolytics Biotech's Third Quarter 2020 Conference Call. All partic ...
Oncolytics Biotech (ONCY) - 2020 Q2 - Earnings Call Transcript
2020-08-05 03:29
Oncolytics Biotech Inc. (NASDAQ:ONCY) Q2 2020 Earnings Conference Call August 4, 2020 4:30 PM ET Company Participants Tom Galassi - Investor Relations Matt Coffey - President & Chief Executive Officer Andrew de Guttadauro - Global Head of Business Development Kirk Look – Chief Financial Officer Conference Call Participants Jonathan Aschoff - Roth Capital Partners John Newman - Canaccord Operator Good day, everyone and welcome to the Oncolytics Biotech Second Quarter 2020 Earnings Conference Call. Today's co ...
Oncolytics Biotech (ONCY) - 2019 Q4 - Earnings Call Presentation
2020-03-10 18:20
| --- | --- | --- | --- | |----------------------------------|----------|-------|-------| | | | | | | | | | | | | | | | | Investor Presentation March 2020 | | | | | oncolyticsbiotech.com | TSX ONC | | | Forward-Looking Statements This presentation contains certain forward-looking statements relating to the company's business prospects and the development and commercialization of pelareorep, a first-in-class systemically administered immuno-oncology agent for solid tumors and heme malignancies. These stateme ...
Oncolytics Biotech (ONCY) - 2019 Q4 - Annual Report
2020-03-06 20:38
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, 2019 | | | OR | | o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | | For the transition period from ____ to ____ | | | ...
Oncolytics Biotech (ONCY) - 2019 Q4 - Earnings Call Transcript
2020-03-06 03:50
Financial Data and Key Metrics Changes - As of December 31, 2019, the company reported cash and cash equivalents of C$14.1 million, which is expected to fund continued operations [45] - The reported net loss for 2019 was C$33 million, including a non-cash charge of C$12.6 million, resulting in a loss of C$1.50 per share compared to C$1.6 per share in 2018 [47] - Research and development expenses increased to C$11 million in 2019 from C$9.4 million in 2018, with fourth-quarter R&D expenses at C$2.8 million compared to C$2.5 million in 2018 [49] - Operating costs increased to C$9.6 million for the full year 2019 from C$7.2 million in 2018, with fourth-quarter operating costs at C$4.1 million compared to C$2.4 million in 2018 [50] Business Line Data and Key Metrics Changes - The company is advancing multiple clinical studies, including AWARE-1 and BRACELET-1, targeting breast cancer, pancreatic cancer, and multiple myeloma [30][31] - AWARE-1 is investigating pelareorep in combination with Roche's Tecentriq, while BRACELET-1 is focused on the combination with Pfizer's Bavencio for HR+/HER2- metastatic breast cancer [23][30] - The pancreatic adenocarcinoma study is progressing well, with interim data expected at ASCO in June 2020 [31] Market Data and Key Metrics Changes - The market opportunity for HR+/HER2- metastatic breast cancer is estimated at C$2 billion, with a potential additional market of C$500 million to C$1 billion for triple-negative breast cancer [9][20] - The checkpoint inhibition market is valued at C$56 billion, reflecting significant interest from large pharmaceutical companies [12] Company Strategy and Development Direction - The company aims to advance its breast cancer program into a Phase 3 registrational study while exploring additional opportunities in gastrointestinal indications [56] - The strategy includes leveraging partnerships with major pharmaceutical companies to enhance clinical development and market reach [54] - The focus remains on combining pelareorep with immunotherapy and targeting oncology treatments where there is an unmet need [57] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the value creation potential in the biotech market, citing recent acquisitions and increased valuations in the sector [43] - The company is positioned to capture value from upcoming catalysts, with a strong financial position extending its runway into mid-2021 [52][58] - Management highlighted the importance of ongoing collaborations with major pharmaceutical companies to validate clinical results and enhance market opportunities [54][56] Other Important Information - The company welcomed Leonard Kruimer to its Board of Directors, bringing over 30 years of experience in corporate finance and strategy [41] - The company has raised over C$16 million through the exercise of warrants and effective use of its ATM facility, enhancing its financial stability [51] Q&A Session Summary Question: When will the decision on Phase III be made based on AWARE-1 data? - Management indicated that AWARE-1 will help start discussions with the FDA regarding the biomarker, while BRACELET-1 is crucial for validating the biomarker in the intended patient population [60] Question: What can be expected from the interim biomarker data for AWARE-1? - The interim data will include correlations between T cell clonality and tumor inflammation, along with cytokine responses within the tumor mass [65] Question: What focus will be on the NCI-9603 study in multiple myeloma? - The focus will be on both biomarker and efficacy data, with expectations of rapid responses in patients who have failed previous treatments [68] Question: What percentage of patients are expected to show expanded T cell clonality? - It is anticipated that about 80% of patients will have adequate immunological reserve for eligibility, with 70% to 80% showing a strong vaccination effect [73] Question: What other companies are interested in collaborations? - There is interest from CAR-T companies and other oncology firms looking to explore combinations with pelareorep, particularly in enhancing T cell responses [78]
Oncolytics Biotech (ONCY) - 2019 Q3 - Earnings Call Transcript
2019-11-13 04:36
Financial Data and Key Metrics Changes - As of September 30, 2019, the company reported cash and cash equivalents of $12.3 million, which includes gross proceeds of $3.7 million from a public offering, strengthening its financial position [56] - The net loss for Q3 2019 was $3.5 million, compared to $3.3 million in Q3 2018, equating to a loss of $0.16 per share in 2019 versus a loss of $0.20 per share in 2018 [57] - Research and development expenses for Q3 2019 were $1.6 million, down from $1.9 million in Q3 2018, focusing on ongoing clinical studies [58] Business Line Data and Key Metrics Changes - The company is advancing its lead program, pelareorep, in metastatic breast cancer, conducting two key clinical studies, AWARE-1 and BRACELET-1, which are expected to provide data supporting the Phase 3 registration program [8][9] - AWARE-1 is ongoing, with additional data expected before the end of the year, while BRACELET-1 is set to begin enrolling patients in Q1 2020 [10][21] Market Data and Key Metrics Changes - The company is seeing renewed interest from large pharmaceutical companies in oncolytic viruses, with recent deals executed by major players like Merck and BMS [41] - The systemic effect of pelareorep allows it to impact metastatic disease, a critical aspect that IV-administered oncolytic viruses have yet to prove [45] Company Strategy and Development Direction - The company aims to expand its pipeline to access additional markets with unmet needs and explore combination therapies with checkpoint inhibitors and other oncology drug classes [65] - The focus remains on demonstrating the potential synergies of pelareorep with various checkpoint inhibitors and CDK 4/6 inhibitors, which are among the fastest-growing drug classes in oncology [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unique position of pelareorep within the oncolytic virus space, highlighting its ability to demonstrate efficient viral replication following systemic delivery [63] - The company anticipates a rich period of data catalysts over the next 21 months, with multiple upcoming milestones expected to enhance shareholder value [66] Other Important Information - The company announced the addition of Leonard Kruimer to its Board of Directors, bringing over 30 years of experience in corporate finance and strategy [40] - The company has seen a significant increase in its share price, which has more than doubled in the last month, leading to the exercise of warrants and additional funding [60] Q&A Session Summary Question: Additional data for AWARE-1 by the end of the year - Management confirmed that additional data from the AWARE-1 study is expected in December, focusing on T cell characterization and inflammatory cell counts [75] Question: Clarification on SITC presentation regarding biopsy timing - Management clarified that biopsies were taken before the administration of Tecentriq, confirming the virus's ability to stimulate T cell expansion [77] Question: Impact of biomarker on patient enrollment - Management indicated that the biomarker will not critically limit patient enrollment, with an anticipated screen failure of no more than one in eight [88] Question: Potential path to market for multiple myeloma program - Management discussed ongoing studies combining pelareorep with proteasome inhibitors, noting impressive responses in early trials [90] Question: Resource use going forward - Management stated that partnerships with major pharmaceutical companies have allowed for a cost-effective strategy, maintaining steady operational costs [93]
Oncolytics Biotech (ONCY) Investor Presentation - Slideshow
2019-06-07 15:50
Pelareorep Clinical Development and Advantages - Pelareorep is a clinical-stage immuno-oncolytic virus delivered intravenously, promoting an inflamed tumor phenotype through immune responses[5, 8] - It is the first IV-delivered immuno-oncolytic virus to demonstrate an overall survival benefit in a randomized study[5, 14] - A predictive and prognostic biomarker derived from a simple blood draw was correlated with clinical response in a second-line pancreatic cancer study[9] - Pelareorep has competitive advantages including ease of intravenous delivery, standard dosing, and access to metastatic disease[16] - The company has identified a predictive and prognostic biomarker, making Pelareorep the only oncolytic virus with a biomarker[17] Breast Cancer Studies and Strategy - A Phase 2 metastatic breast cancer study (IND-213) showed a statistically significant increase in overall survival (OS)[10, 23] from 104 months to 174 months in the ITT population (HR = 065, p = 01)[23] - In HR+/HER2- breast cancer patients, the median OS improved from 108 months to 210 months (HR = 06, p = 01)[23] - In PgR+/HER2- breast cancer patients, the median OS improved from 108 months to 218 months (HR = 036, p = 0003)[23] - The company plans to initiate a Phase 3 registration study in metastatic breast cancer after a window of opportunity study[79] Partnerships and Financials - The company has an established partnership with Adlai Nortye to develop the Chinese market, with potential upfront and milestone payments of up to $866 million[11, 65] - The company reported CDN $142 million (USD $106 million) in cash and cash equivalents as of Q1 2019, with a financial runway of over 12 months[74]
Oncolytics Biotech's (ONCY) Co-Development Agreement with Pfizer and Merck KGaA Call (Transcript)
2019-06-05 20:10
Oncolytics Biotech, Inc. (NASDAQ:ONCY) Oncolytics Co-Development Agreement Call June 5, 2019 8:30 AM ET Company Participants Michael Moore – Vice President-Investor Relations and Corporate Communications Matt Coffey – President and Chief Executive Officer Andrew de Guttadauro – President-Oncolytics Biotech U.S. and Global Head of Business Development Kirk Look – Chief Financial Officer Conference Call Participants John Newman – Canaccord Genuity Wangzhi Li – Ladenburg Thalmann Tom Shrader – BTIG Chad Messer ...