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Mar 31, 2021
Outlook Therapeutics Q2 2021 Earnings Report
Reported financial results for the second quarter of fiscal year 2021.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $13.1 million, or $0.09 per basic and diluted share, compared to a net loss attributable to common stockholders of $17.5 million, or $0.36 per basic and diluted share for the same period last year. The company's cash and cash equivalents were $37.2 million as of March 31, 2021.
Advanced ONS-5010 towards a BLA filing for wet AMD.
Reported promising results from two of the three clinical trials for planned BLA.
Focused on the topline data readout next quarter from NORSE TWO, pivotal Phase 3 study.
Cash and cash equivalents on hand are sufficient to fund operations through November 2021.
Outlook Therapeutics
Outlook Therapeutics
Forward Guidance
Outlook Therapeutics expects to report pivotal safety and efficacy data in the third quarter of calendar 2021 and plans to submit a new biologics license application (BLA) filing under the PHSA 351(a) regulatory pathway in the first quarter of calendar 2022.
Positive Outlook
- Expects to report pivotal safety and efficacy data in the third quarter of calendar 2021.
- Plans to submit a new BLA filing in the first quarter of calendar 2022.
- If the BLA is approved, it will result in 12 years of marketing exclusivity for ONS-5010.
- Commercial launch planning for ONS-5010 has begun.
- Expects to initiate registration clinical trials for ONS-5010 for DME and BRVO later in calendar 2021 or in early calendar 2022.
Challenges Ahead
- Developing pharmaceutical product candidates
- Conducting clinical trials
- Obtaining necessary regulatory approvals
- Uncertainty of future impacts related to the ongoing COVID-19 pandemic
- May cause actual results to differ materially from those expressed or implied by forward-looking statements