On March 3, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported recent operational highlights and financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Oncolytics Biotech, MAR 3, 2023, View Source [SID1234628115]). All dollar amounts are expressed in Canadian currency unless otherwise noted.
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"This is a truly exciting time for Oncolytics, as our progress last year provides pelareorep with clear and substantially de-risked paths to registrational studies in both breast and pancreatic cancer," said Dr. Matt Coffey, President and Chief Executive Officer. "Our partner Adlai Nortye recently confirmed pelareorep’s ability to combine with paclitaxel and generate sustained clinical responses in HR+/HER2- metastatic breast cancer, which we believe bodes well for BRACELET-1’s anticipated readout next quarter. With this readout, we aim to showcase a randomized dataset that shows one or both of the trial’s pelareorep-based treatment regimens numerically outperforming the paclitaxel monotherapy arm on key metrics such as overall response rate and progression-free survival. We believe this result would represent a key inflection point, as it would confirm our breast cancer program’s prior statistically significant results, accelerate its advancement into a registrational trial, and bolster our business development prospects."
Dr. Coffey continued, "In pancreatic cancer, interim results from pelareorep’s GOBLET trial showed an objective response rate that was nearly three times greater than those recorded in historical control trials. These data supported a subsequent Fast Track designation from the FDA, which will be incredibly valuable as we work with the agency and other key stakeholders to identify the optimal path to registration. GOBLET’s data also transformed our pancreatic cancer program into our pipeline’s second core pillar, thereby adding an important value driver that strengthens our foundation for sustained growth."
Fourth Quarter Highlights
Pancreatic Cancer Program
Reported a 69% ORR and confirmed complete response in phase 1/2 GOBLET trial’s pancreatic cancer cohort
A poster presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting featured data from the phase 1/2 GOBLET trial’s cohort in first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) (link to PR, link to poster). Thirteen patients were evaluable for efficacy as of the poster’s cut-off date (October 12, 2022), with one achieving a confirmed complete response and eight achieving a partial response (PR) following treatment with the combination of pelareorep, Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel. The 69% objective response rate (ORR) reported in the SITC (Free SITC Whitepaper) poster is nearly triple the average ORR of ~25% achieved in historical control trials of gemcitabine plus nab-paclitaxel1-4, suggesting that pelareorep can synergize with checkpoint inhibition and chemotherapy to improve the standard-of-care in PDAC. Based upon these results and favorable safety data from GOBLET’s pancreatic cancer cohort,
Oncolytics will continue to engage with regulators to determine the optimal and most expeditious registration-enabling pathway.
Received FDA Fast Track designation for the treatment of advanced/metastatic PDAC
Following the announcement of interim data from GOBLET’s pancreatic cancer cohort, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel for the treatment of advanced/metastatic PDAC (link to PR). With this designation, Oncolytics’ pancreatic cancer program may be eligible for more frequent meetings and communications with the FDA to review development plans and discuss the data needed to support approval. Furthermore, programs that receive Fast Track designation may be eligible for Accelerated Approval and Priority Review in certain situations.
Breast Cancer Program
Interim results from Adlai Nortye’s bridging trial further demonstrate the anti-cancer activity of pelareorep plus paclitaxel in HR+/HER2- metastatic breast cancer
Oncolytics’ Chinese development partner, Adlai Nortye, presented interim results from its single-arm bridging trial of pelareorep-paclitaxel combination therapy in HR+/HER2- metastatic breast cancer at the San Antonio Breast Cancer Symposium (link to PR, link to poster). Fourteen patients were evaluable for efficacy as of the trial’s data cutoff date (September 26, 2022), with thirteen achieving disease control (PR or stable disease), twelve achieving tumor shrinkage from baseline, and seven achieving a PR. One patient achieved a PR at week 8, maintained the PR, and remained on study at week 48, providing evidence of the durable clinical benefit from pelareorep-paclitaxel combination therapy. Safety data showed that the studied combination was well tolerated, with no dose-limiting toxicities or serious adverse events reported. These results are expected to accelerate pelareorep’s development in China by allowing Adlai Nortye’s future regulatory submissions to include data from Oncolytics’ North American metastatic breast cancer trials, IND-213 and BRACELET-1.
IND-213 was a randomized phase 2 trial that showed a statistically significant near doubling of median overall survival in HR+/HER2- breast cancer patients treated with pelareorep plus paclitaxel compared to those treated with paclitaxel alone. BRACELET-1 is a randomized phase 2 trial in HR+/HER2- metastatic breast cancer with cohorts evaluating: (1) paclitaxel alone; (2) paclitaxel plus pelareorep; and (3) paclitaxel plus pelareorep in combination with the checkpoint inhibitor avelumab. Oncolytics expects to announce overall response rate and progression-free survival data from BRACELET-1 at a major medical meeting in the second quarter of 2023.
Financial Highlights
•As of December 31, 2022, the Company reported $32.1 million in cash, cash equivalents and marketable securities.
•The net loss for the fourth quarter of 2022 was $8.6 million, compared to a net loss of $7.8 million in the fourth quarter of 2021. The basic and diluted loss per share was $0.14 in the fourth quarter of 2022, compared to a basic and diluted loss per share of $0.14 in the fourth quarter of 2021. The net loss for the full year 2022 was $24.8 million, compared to a net loss of $26.3 million for the full year 2021. The basic and diluted loss per share was $0.43 for the full year 2022, compared to a basic and diluted loss per share of $0.49 for the full year 2021.
•Net cash used in operating activities was $23.4 million for the full year 2022, compared to $22.4 million for the full year 2021.
•General and administrative expenses for the fourth quarter of 2022 were $3.7 million and $11.5 million for the full year 2022, compared to $3.8 million for the fourth quarter of 2021 and $13.3 million for the full year 2021. The quarter-over-quarter decrease was largely due to lower share-based compensation expense, partly offset by higher office expenses. The year-over-year decrease was primarily due to lower public company-related costs.
•Research and development expenses for the fourth quarter of 2022 were $4.8 million and $15.4 million for the full year 2022, compared to $3.7 million for the fourth quarter of 2021 and $12.9 million for the full year 2021. The increases were primarily due to higher clinical trial costs and personnel-related expenses associated with our clinical development program.
2023 Anticipated Milestones and Catalysts
•Overall response rate, progression-free survival, and evolving overall survival data from phase 2 BRACELET-1 metastatic breast cancer study: Q2 2023
•Preclinical data from the combination of pelareorep and CAR T therapy: Q2 2023
•Updated advanced/metastatic PDAC data from the GOBLET study: H2 2023
•Updates on the metastatic colorectal and advanced anal cohorts from the GOBLET study: H2 2023
•Guidance for the registration paths for HR+/HER2- metastatic breast cancer and advanced/metastatic PDAC: H2 2023
Webcast and Conference Call
Management will host a conference call for analysts and investors at 8:30 a.m. ET today, March 3, 2023. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 and, if needed, provide confirmation number 4947-4770. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 474-770
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(in thousands of Canadian dollars, except share amounts)
As at December 31, 2022 2021
Assets
Current assets
Cash and cash equivalents $ 11,666 $ 41,262
Marketable securities 20,472 —
Other receivables 521 866
Prepaid expenses 3,025 2,776
Total current assets 35,684 44,904
Property and equipment 356 392
Right-of-use assets 296 584
Prepaid expenses 998 —
Total assets $ 37,334 $ 45,880
Liabilities And Shareholders’ Equity
Current liabilities
Accounts payable and accrued liabilities $ 3,650 $ 1,988
Other liabilities — 352
Lease liabilities 216 294
Warrant derivative 79 56
Total current liabilities 3,945 2,690
Contract liability 6,730 6,730
Lease liabilities 157 361
Total liabilities 10,832 9,781
Commitments and contingencies
Shareholders’ equity
Share capital
Authorized: unlimited
Issued: December 31, 2022 – 61,327,914
December 31, 2021 – 55,043,789
404,040 391,348
Warrants — 3,618
Contributed surplus 40,051 34,161
Accumulated other comprehensive income 662 388
Accumulated deficit (418,251) (393,416)
Total shareholders’ equity 26,502 36,099
Total liabilities and shareholders’ equity $ 37,334 $ 45,880
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(in thousands of Canadian dollars, except share amounts)
For the years ended December 31, 2022 2021 2020
Expenses
Research and development $ 15,432 $ 12,920 $ 12,945
General and administrative 11,492 13,315 12,514
Loss before the following (26,924) (26,235) (25,459)
Change in fair value of warrant derivative (20) 17 3,492
Foreign exchange gain (loss) 1,665 (136) (659)
Interest income, net 528 99 121
Loss before income taxes (24,751) (26,255) (22,505)
Income tax expense (84) (49) —
Net loss (24,835) (26,304) (22,505)
Other comprehensive income (loss) items that may be reclassified to net loss
Translation adjustment 274 (12) (64)
Net comprehensive loss $ (24,561) $ (26,316) $ (22,569)
Basic and diluted loss per common share $ (0.43) $ (0.49) $ (0.56)
Weighted average number of shares (basic and diluted) 58,029,745 53,513,225 40,338,789
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(in thousands of Canadian dollars)
Share Capital Warrants Contributed Surplus Accumulated Other Comprehensive Income Accumulated Deficit Total
As at December 31, 2019 $ 311,078 $ 3,618 $ 29,339 $ 464 $ (344,607) $ (108)
Net loss and other comprehensive loss — — — (64) (22,505) (22,569)
Issued pursuant to stock option plan 385 — (144) — — 241
Issued pursuant to incentive share award plan 732 — (732) — — —
Issued pursuant to "At the Market" Agreement 40,038 — — — — 40,038
Issued pursuant to warrant derivative exercised 6,333 — — — — 6,333
Share-based compensation expense — — 2,559 — — 2,559
Share issue costs (1,742) — — — — (1,742)
As at December 31, 2020 $ 356,824 $ 3,618 $ 31,022 $ 400 $ (367,112) $ 24,752
Net loss and other comprehensive loss — — — (12) (26,304) (26,316)
Issued pursuant to stock option plan 381 — (143) — — 238
Issued pursuant to incentive share award plan 544 — (544) — — —
Issued pursuant to "At the Market" Agreement 34,168 — — — — 34,168
Issued pursuant to warrant derivative exercised 687 — — — — 687
Share-based compensation expense — — 3,826 — — 3,826
Share issue costs (1,256) — — — — (1,256)
As at December 31, 2021 $ 391,348 $ 3,618 $ 34,161 $ 388 $ (393,416) $ 36,099
Net loss and other comprehensive income — — — 274 (24,835) (24,561)
Issued pursuant to stock option plan 20 — (8) — — 12
Issued pursuant to incentive share award plan 98 — (98) — — —
Expiry of equity warrant agreement — (3,618) 3,618 — — —
Issued pursuant to "At the Market" Agreement 13,338 — — — — 13,338
Share-based compensation expense — — 2,378 — — 2,378
Share issue costs (764) — — — — (764)
As at December 31, 2022 $ 404,040 $ — $ 40,051 $ 662 $ (418,251) $ 26,502
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands of Canadian dollars)
For the years ended December 31, 2022 2021 2020
Operating Activities
Net loss for the year $ (24,835) $ (26,304) $ (22,505)
Depreciation – property and equipment 93 130 89
Depreciation – right-of-use assets 299 322 357
Share-based compensation expense 2,378 3,826 2,559
Interest (income) expense, net (76) 92 69
Unrealized foreign exchange (gain) loss (1,625) 426 645
Change in fair value of warrant derivative 20 (17) (3,492)
Net change in non-cash working capital 391 (908) 210
Cash used in operating activities (23,355) (22,433) (22,068)
Investing Activities
Acquisition of marketable securities (20,348) — —
Acquisition of property and equipment (55) (286) (29)
Cash used in investing activities (20,403) (286) (29)
Financing Activities
Proceeds from exercise of stock options 12 238 241
Proceeds from exercise of warrants — 231 1,697
Proceeds from "At the Market" equity distribution agreement
12,574 32,912 38,296
Payment of lease liabilities (381) (366) (461)
Cash provided by financing activities 12,205 33,015 39,773
(Decrease) increase in cash and cash equivalents (31,553) 10,296 17,676
Cash and cash equivalents, beginning of year 41,262 31,220 14,148
Impact of foreign exchange on cash and cash equivalents 1,957 (254) (604)
Cash and cash equivalents, end of year $ 11,666 $ 41,262 $ 31,220
References
1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
2. O’Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005
3. Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684
4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070