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Jun 30, 2021
Outlook Therapeutics Q3 2021 Earnings Report
Outlook Therapeutics reported financial results for the third quarter of fiscal year 2021 and provided a corporate update.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $12.2 million, or $0.07 per basic and diluted share, and had cash and cash equivalents of $19.7 million as of June 30, 2021. The company plans to submit a BLA for ONS-5010 in the first calendar quarter of 2022.
All three registration clinical trials are now completed, including the NORSE TWO pivotal trial, with positive, statistically significant results.
Plans to submit a BLA for ONS-5010 in the first calendar quarter of 2022.
The retinal anti-VEGF market is estimated to be in excess of $13.1 billion worldwide and growing annually.
Commercial launch planning activities have begun in anticipation of potential FDA marketing approval in 2022 for ONS-5010.
Outlook Therapeutics
Outlook Therapeutics
Forward Guidance
Outlook Therapeutics plans to submit a BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in the first quarter of calendar 2022. If the BLA is approved, it is expected to result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD. Outlook Therapeutics expects ONS-5010, if approved, to be a safe and cost-effective choice for patients, payors and clinicians worldwide for retinal indications.
Positive Outlook
- Potential FDA approval for ONS-5010 in 2022.
- 12 years of marketing exclusivity expected if BLA is approved.
- ONS-5010 expected to be a safe and cost-effective choice.
- Developing registration documents for approvals in Europe.
- Exploring potential strategic commercialization partners.
Challenges Ahead
- Risks associated with developing pharmaceutical product candidates.
- Risks of conducting clinical trials.
- Risks in obtaining necessary regulatory approvals.
- Uncertainty of future impacts related to the ongoing COVID-19 pandemic.
- Reliance on forward-looking statements that are subject to change.