Oncolytics Biotech® Reports 2021 First Quarter Development Highlights and Financial Results

First Quarter and Subsequent Highlights

Breast Cancer Program

Achieved primary endpoint in AWARE-1 study

An electronic poster at the American Association for Cancer Research (AACR) Annual Meeting 2021 included data from the twenty HR+/HER2- early-stage breast cancer patients included in AWARE-1's first two cohorts (link to PR; link to poster). Results from these patients, treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 inhibitor atezolizumab (Tecentriq^®), showed pelareorep and letrozole treatment upregulated tumor PD-L1 expression, induced the generation and expansion of T cell clones, promoted tumor infiltration of CD8+ T cells, and increased CelTIL score, a measure of tumor cellularity and inflammation associated with favorable clinical outcomes. These desired outcomes were further enhanced by the addition of atezolizumab, demonstrating that pelareorep and atezolizumab synergistically combine to generate an anti-cancer immune response in the tumor and peripheral blood. Notably, the trial demonstrated dose-related activity of pelareorep led to the achievement of the primary endpoint, with six of ten patients achieving at least a 30% increase in CelTIL score following treatment in cohort 2. Together, these data support the results of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment in HR+/HER2- patients and the clinical rationale behind the phase 2 BRACELET-1 trial, which is evaluating the safety and efficacy of pelareorep and chemotherapy alone, and in combination with a PD-L1 inhibitor, in HR+/HER2- breast cancer patients.

Additional Immunotherapeutic Combinations and Opportunities

Demonstrated the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors

A preclinical study from the Mayo Clinic showed that loading chimeric antigen receptor (CAR) T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to prior preclinical studies that showed intratumoral infection with the VSV oncolytic virus weakened CAR T cells (link to PR; link to poster). The efficacy of pelareorep-loaded CAR T cell ("CAR/Pela") therapy was further enhanced by subsequently administering a single intravenous dose of pelareorep, which led to the generation of highly persistent CAR T cells, the inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were notably specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Collectively, these data demonstrate the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors, an area where CAR T cell efficacy is currently limited due to immunosuppressive tumor microenvironments that promote T cell exhaustion and exclusion. 

Announced preclinical data highlighting pelareorep's ability to synergize with multiple classes of anti-cancer agents

Data presented in two electronic poster presentations at the AACR Annual Meeting 2021 showed that pelareorep enhanced the anti-tumor efficacy of the poly(ADP)-ribose polymerase 1 (PARP-1) inhibitor talazoparib and the cyclin-dependent kinase (CDK) 4/6 inhibitor palbociclib, which are both FDA approved for the treatment of breast cancer. The observed synergistic effects between pelareorep and both talazoparib and palbociclib were notably mediated through immunologic mechanisms rather than through the molecular pathways typically associated with PARP-1 and CDK 4/6 inhibition (link to PR; link to CDK4/6 poster; link to PARP-1 poster). Together, these results suggest that pelareorep may enhance the therapeutic potential of PARP-1 and CDK 4/6 inhibitors by expanding the mechanisms by which they exert anti-tumor effects.

Initiation of a preclinical research collaboration with Leiden University Medical Center (LUMC) and Oncode Institute to evaluate pelareorep-bispecific antibody combination therapies

Collaborative preclinical studies with LUMC will evaluate the combination of pelareorep-CD3-bispecific antibody combinations in breast and pancreatic tumor models. Pelareorep's clinically demonstrated ability to recruit T cells to solid tumors provides a strong rationale for these studies, as CD3-bispecific antibodies are designed to facilitate cancer-killing by simultaneously engaging both T cells and tumor tissue. Prior preclinical studies in breast and pancreatic cancer models also support this collaboration, as they have shown that the addition of pelareorep to CD3-bispecific antibody therapy results in cancer regression and prolonged survival.

Corporate Highlights

Hosted a key opinion leader webinar on AWARE-1 data, the immunotherapeutic effects of pelareorep in breast cancer, and its synergistic activity with CAR T cells in solid tumors

The webinar featured presentations by Key Opinion Leaders (KOLs) Aleix Prat, M.D., Ph.D. (Clínic Barcelona) and Richard Vile, Ph.D., (Mayo Clinic), as well as a corporate update by members of the Oncolytics management team. The formal presentations were followed by a question and answer session. A replay of the event can be accessed by clicking here.

Financial Highlights

• As of March 31, 2021, the Company reported $50.4 million in cash and cash equivalents. The Company raised gross proceeds of $25.8 million during the first quarter through issuing of common stock through its ATM facility.
• Operating expense for the first quarter of 2021 was $3.1 million, compared to $3.0 million in the first quarter of 2020.
• R&D expense for the first quarter of 2021 was $2.8 million, compared to $2.5 million in the first quarter of 2020.
• Net cash used in operating activities for the first quarter of 2021 was $5.6 million, compared to $4.0 million for the first quarter of 2020.
• The net loss for the first quarter of 2021 was $6.4 million, compared to a net income of $0.4 million in the first quarter of 2020, which reflected a $4.2 million non-cash gain in fair value of warrant derivative. The basic and diluted loss per share was $0.13 in the first quarter of 2021, compared to a basic earnings and diluted loss per share of $0.01 and $0.04, respectively, in the first quarter of 2020.

Anticipated Milestones and Catalysts

• Announcement of final data from phase 2 NU 18I01 second-line pancreatic cancer study: H1 2021
• Dosing of the first patient in GOBLET study in gastrointestinal cancer: mid-2021
• Final biomarker data for AWARE-1 breast cancer study in the intended target population for a registrational study: H2 2021
• Completion of enrollment in BRACELET-1 metastatic breast cancer study: Q4 2021
• Interim safety update from IRENE study in triple-negative breast cancer: Q4 2021
• Interim safety data from phase 1 WINSHIP 4398-18 multiple myeloma study: Q4 2021

Oncolytics expects to provide updates on the timing of the following milestones over the coming months:

• Interim safety update from Phase 2 BRACELET-1 metastatic breast cancer study
• Phase 2 BRACELET-1 metastatic breast cancer study: final data

Update on COVID-19

Oncolytics continues to collaborate with its investigators to ensure the safety of patients and employees, as well as the productivity of its clinical programs. We expect these measures will allow us to build on the positive momentum of 2020, despite any COVID-19-related challenges that may arise. Moving forward, we plan to remain in contact with relevant stakeholders and keep the market apprised of any new information that may materially impact clinical timelines.

Accessing the Annual Corporate Update Presentation 

The Annual Corporate Update, which will also discuss first quarter 2021 financial results, beginning immediately following the Annual General Meeting at approximately 12:10 p.m. Eastern Daylight Time, may be accessed via the AGM webcast link, https://web.lumiagm.com/158281614, as a guest or by dialing +1-888-231-8191 for callers in North America and +1-647-427-7450 for International callers. The live webcast of the corporate update section of the call will be accessible on the Investor Relations page of Oncolytics' website at https://ir.oncolyticsbiotech.com/events-presentations and will be archived for three months. 

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
(in Canadian dollars, except share amounts)
As at	March 31, 2021 $		December 31, 2020 $
Assets
Current assets
Cash and cash equivalents	50,362,162		31,219,574
Other receivables	111,665		89,661
Prepaid expenses	2,881,730		2,427,200
Total current assets	53,355,557		33,736,435
Non-current assets
Property and equipment	215,587		236,664
Right-of-use assets	609,297		372,468
Total non-current assets	824,884		609,132
Total assets	54,180,441		34,345,567
Liabilities And Shareholders' Equity
Current Liabilities
Accounts payable and accrued liabilities	1,918,638		1,805,015
Other liabilities	—		123,985
Lease liabilities	252,356		248,885
Warrant derivative	237,546		531,228
Total current liabilities	2,408,540		2,709,113
Non-current liabilities
Contract liability	6,730,287		6,730,287
Lease liabilities	371,974		153,174
Total non-current liabilities	7,102,261		6,883,461
Total liabilities	9,510,801		9,592,574
Commitments and contingencies
Shareholders' equity
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