On May 15, 2024 Outlook Therapeutics, Inc., a biopharmaceutical company working to achieve regulatory approval for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of retinal diseases, reported financial results for the second quarter of fiscal year 2024 and provided a corporate update (Press release, Outlook Therapeutics, MAY 15, 2024, View Source [SID1234643335]). As previously announced, the Company will host its inaugural quarterly conference call and live audio webcast, on Thursday, May 16, 2024, at 8:30 AM ET (details below).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are extremely pleased with our corporate, clinical, and regulatory progress. On the regulatory front, we continue to drive toward anticipated marketing authorization of ONS-5010 in the EU and have also submitted our marketing application for authorization in the UK. In the US, we are executing on our NORSE EIGHT clinical trial and advancing toward a topline data readout expected in the fourth quarter of calendar year 2024. On the financial front, assuming full exercise of the warrants issued in our recent private placement transactions, we believe we now have access to sufficient capital to take ONS-5010 through potential FDA approval and funding of the commercial launch," commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. "We remain steadfast in our mission to enhance the standard of care in the retinal anti-VEGF space. On behalf of the entire team, I would like to thank all our partners and stakeholders for their continued support and look forward to what we believe will be an exciting remainder of the year for Outlook Therapeutics."
Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics, added, "Our adjusted financial results for the quarter met our expectations as we initiated the NORSE EIGHT clinical trial and began enrolling patients. We believe we are well positioned financially to continue executing on NORSE EIGHT enrollment, resubmission of the ONS-5010 BLA by the end of calendar 2024, and launch of ONS 5010 in 2025, if approved."
Upcoming Anticipated Milestones
MAA decision in the European Union (EU) for ONS-5010 anticipated in Q2 CY2024;
Full enrollment of NORSE EIGHT clinical trial in the US expected in Q3 CY2024;
Topline readout of NORSE EIGHT clinical trial planned in Q4 CY2024;
Resubmission of the ONS-5010 BLA targeted for the end of CY2024;
Planning underway for potential commercial launches in the EU and UK to begin in first quarter of CY2025; and
Potential for US FDA approval of ONS-5010 in 2025.
ONS-5010 / LYTENAVA (bevacizumab-vikg) Regulatory Update
As previously announced, following Type A meetings with the FDA in Q4 CY2023, the FDA informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary efficacy endpoint at 2 months (NORSE EIGHT). In January 2024, Outlook Therapeutics announced that it received written agreement on the NORSE EIGHT trial protocol and statistical analysis plan from the FDA under a SPA for NORSE EIGHT. The SPA also confirms in writing that if the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to fully address the clinical deficiency identified in the Complete Response Letter (CRL). In addition, through a Type A meeting and additional interactions, Outlook Therapeutics has identified the approaches needed to resolve the Chemistry, Manufacturing and Controls (CMC) comments in the CRL. Outlook Therapeutics has scheduled a series of Type C and Type D meetings with the FDA to address the open CMC items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.
NORSE EIGHT is a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 newly diagnosed, wet age-related macular degeneration (wet AMD) subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and Week 8 visits. The primary endpoint is mean change in BCVA from baseline to week 8. Currently, over 30% of the required subjects have been enrolled in the study. Outlook Therapeutics continues to plan NORSE EIGHT enrollment completion in Q3 CY2024, with topline results expected to be reported, and the planned resubmission of the ONS-5010 BLA to occur, by the end of calendar year 2024.
In March 2024, the CHMP issued a positive opinion concerning the EU Marketing Authorization Application (MAA) of ONS-5010/LYTENAVA (bevacizumab gamma), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU. The CHMP positive opinion was based on results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials – NORSE ONE, NORSE TWO and NORSE THREE, as well as studies and peer reviewed literature substituting or supporting certain tests and studies.
This positive opinion supports the grant of marketing authorization by the European Commission for Outlook Therapeutics’ application for ONS-5010 in the EU. The European Commission is expected to make a decision on approval within approximately 67 days following the CHMP opinion. The decision will apply automatically in all 27 EU Member States, and, within 30 days, also to Iceland, Norway and Liechtenstein. If approved, an initial ten years of market exclusivity in the EU is expected for ONS-5010/LYTENAVA.
Additionally, the Company recently announced the submission of its MAA to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK seeking authorization of ONS-5010/LYTENAVA (bevacizumab gamma) for the treatment of wet AMD. The submission was completed under the new International Recognition Procedure (IRP), which allows the MHRA to rely on a positive opinion by the CHMP concerning an application for grant of marketing authorization for the same product in the EU. The IRP is available for new UK MAAs of a medicinal product (having the same qualitative and quantitative composition, and the same pharmaceutical form) that has previously been authorized by a Reference Regulator (RR). In this case this is the EMA.
If ONS-5010/LYTENAVA (bevacizumab-vikg or bevacizumab gamma) is approved, Outlook Therapeutics expects to commercialize it as the first and only European Commission, MHRA or FDA approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the EU, UK, and United States. Authorization may also be sought in other European markets, Japan, and elsewhere. If approved, Outlook Therapeutics plans to commercialize ONS-5010/LYTENAVA (bevacizumab-vikg) directly in the US and is assessing both direct commercialization and partnering for ONS-5010/LYTENAVA (bevacizumab gamma) in Europe and other regions outside of the US.
Financial Highlights for the Fiscal Second Quarter Ended March 31, 2024
For the fiscal second quarter ended March 31, 2024, Outlook Therapeutics reported a net loss attributable to common stockholders of $114.3 million, or $8.01 per basic and diluted share, compared to a net loss attributable to common stockholders of $6.7 million, or $0.52 per basic and diluted share, for the same period last year. For the fiscal second quarter ended March 31, 2024, Outlook Therapeutics also reported an adjusted net loss attributable to common stockholders1 of $22.1 million, or $1.55 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $6.7 million, or $0.52 per basic and diluted share, for fiscal second quarter 2023.
Adjusted net loss attributable to common stockholders for the fiscal second quarter ended March 31, 2024 includes $34.1 million of warrant related expenses, $49.6 million of increase in fair value of warrant liability and $8.5 million of increase in fair value of convertible promissory notes. Adjusted net loss attributable to common stockholders was not materially different than net loss attributable to common stockholders for the fiscal second quarter ended March 31, 2023.
In March and April 2024, the Company closed its previously announced private placements of common stock and accompanying warrants. In addition to the upfront gross proceeds of $65 million, the Company has the potential to receive additional gross proceeds of up to $107 million upon the full cash exercise of the warrants issued in the private placements, before deducting placement agent fees and offering expenses.
As of March 31, 2024, Outlook Therapeutics had cash and cash equivalents of $47.2 million.