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Mar 31, 2020
Outlook Therapeutics Q2 2020 Earnings Report
Reported a net loss attributable to common stockholders and provided a corporate update.
Key Takeaways
Outlook Therapeutics reported its financial results for the second quarter of fiscal year 2020, with a net loss attributable to common stockholders of $17.5 million, or $0.36 per share. The company highlighted progress in its ONS-5010 development program and the upcoming data readout for the NORSE 1 clinical trial.
Ongoing NORSE 1 registration clinical trial for ONS-5010 remains on track for topline data readout in August.
Enrollment in NORSE 2 registration clinical trial has regained momentum and nearly returned to pre-COVID-19 enrollment rates.
Received U.S. Food and Drug Administration (FDA) tentative approval of the trade name for ONS-5010 as LYTENAVA™.
The company had cash and cash equivalents of $4.7 million as of March 31, 2020.
Outlook Therapeutics
Outlook Therapeutics
Forward Guidance
Outlook Therapeutics is focused on advancing its ONS-5010 development program and expects to complete enrollment in NORSE 2 in the third calendar quarter of this year. The company intends to submit a new BLA to the FDA for the treatment of wet AMD.
Positive Outlook
- NORSE 1 registration clinical trial remains on track for topline data readout in August.
- Enrollment in NORSE 2 registration clinical trial has regained momentum.
- Expect to complete enrollment in NORSE 2 in the third calendar quarter of this year.
- Intends to complete development of ONS-5010 for submission to the FDA.
- Plans to submit for regulatory approvals in France, United Kingdom, Italy, Germany, Spain and Japan, as well as other countries.
Challenges Ahead
- Uncertainties of the evolving COVID-19 pandemic.
- 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.