Oncolytics Biotech Inc (ONCY) Q4 2024 Earnings Call Highlights: Promising Cancer Study Results ...

GuruFocus.com
08 Mar
  • Cash and Cash Equivalents: $15.9 million as of December 31, 2024.
  • Net Cash Used in Operating Activities: $27 million for 2024, compared to $28.4 million for 2023.
  • General and Administrative Expenses: $3.9 million for Q4 2024, down from $4.2 million in Q4 2023.
  • Research and Development Expenses: $4.6 million for Q4 2024, compared to $4.7 million in Q4 2023.
  • Net Loss: $8 million for Q4 2024, compared to $3.9 million for Q4 2023.
  • Loss Per Share: $0.10 for Q4 2024, compared to $0.05 for Q4 2023.
  • Full-Year Net Loss: $31.7 million for 2024, compared to $27.8 million in 2023.
  • Full-Year Loss Per Share: $0.41 for 2024.
  • Warning! GuruFocus has detected 2 Warning Signs with ONCY.

Release Date: March 07, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • Oncolytics Biotech Inc (NASDAQ:ONCY) reported outstanding final data in the BRACELET-1 breast cancer study, exceeding expectations.
  • The company has promising initial safety and efficacy data in pancreatic and anal cancers from the GOBLET study.
  • Pelareorep demonstrated a 33% objective response rate in relapsed anal cancer, including a complete response lasting over 15 months.
  • The company is planning a large Phase 2 study for HR-positive/HER2-negative breast cancer, aiming for accelerated approval.
  • Oncolytics Biotech Inc (NASDAQ:ONCY) has secured a $5 million grant from PanCAN for pancreatic cancer research, indicating strong external support.

Negative Points

  • The company is currently without a permanent CEO, which may impact strategic direction and leadership.
  • Net loss for the fourth quarter of 2024 was $8 million, a significant increase from the previous year's $3.9 million.
  • The company reported a decrease in cash and cash equivalents, with $15.9 million as of December 31, 2024.
  • There is uncertainty regarding the total cost and timing of the upcoming registration-enabling trial for metastatic breast cancer.
  • Oncolytics Biotech Inc (NASDAQ:ONCY) faces competition from other oncolytic virus developers, which could impact market positioning and partnerships.

Q & A Highlights

Q: As you get closer to launching the registration-enabling trial in metastatic breast cancer, what are your thoughts on the total cost of that trial, and can you provide more details on the timing of the launch and initial readout? A: Kirk Look, CFO, explained that they are finalizing the protocol and working with identified sites for enrollment. They aim to start enrollment in the latter half of the year, with an 18-month enrollment period and a six-month data maturity for PFS readout. A futility analysis is expected about 14 months from the first patient enrolled.

Q: Are you seeing increased interest from pharma in oncolytic viruses, given recent developments in the field? A: Christophe Degois, VP of Business Development, noted increased activity in the field, citing recent successful fundraises by companies like CG Oncology and Candel. He emphasized Oncolytics' advantage of IV injection over intratumoral delivery, which is more appealing to big pharma. Kirk Look added that there's growing interest from investors in the oncolytic virus space.

Q: Regarding the pancreatic cancer front and your alignment with GCAR, is there a way to accelerate the trial launch? A: Jon Patton, Director of Investor Relations and Communication, stated that they are actively working with GCAR to finalize the study protocol. The next step involves discussions with regulators like the FDA. While it's early to specify timing, they are moving forward at the greatest possible pace.

Q: What are your thoughts on the commercial positioning of pelareorep given the positive results of ADCs in the same patient population? A: Dr. Thomas Heineman, CMO, explained that they aim to target patients who progress on ADC therapy, which is a large population. While ADCs are successful, they are not cures, and pelareorep could provide an attractive alternative post-ADC therapy. Christophe Degois added that they anticipate a significant market opportunity, targeting 55,000 patients annually in the US.

Q: Is there potential for combination therapy with ADCs and other agents? A: Dr. Thomas Heineman mentioned that pelareorep has shown potential to potentiate the activity of other therapies, including chemotherapy and immunotherapies. While not an immediate path, combination therapy with ADCs is worth considering in the future.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.

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