On May 13, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2022 (Press release, Outlook Therapeutics, MAY 13, 2022, View Source [SID1234616059]).
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!
Recent Corporate Highlights
Successfully submitted a BLA for ONS-5010, an investigational therapy which, if approved, will be branded as LYTENAVA (bevacizumab-vikg), for the treatment of wet age-related macular degeneration (wet AMD);
Expanded commercial team with the appointment of Joel Prieve as Senior Vice President, Commercial Operations, in February 2022; and
Further expanded commercial team with appointment of Alicia Tozier as Senior Vice President, Marketing and Market Access, in March 2022.
"This past quarter was marked by the achievement of the most important milestone to date for Outlook Therapeutics – the submission of our BLA for ONS-5010. In anticipation of potentially providing an on-label, FDA-approved alternative for wet AMD patients in the United States, we are ramping up our pre-commercial launch activities. To support these efforts, we have continued to add to the expertise of our commercial team to build momentum among partners, payors and the retina community. We are focused on positioning ourselves to unlock the full potential of ONS-5010," commented C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics.
ONS-5010 / LYTENAVA (bevacizumab-vikg) Development Updates
Outlook Therapeutics’ wet AMD clinical program for ONS-5010 consists of three completed clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE. With the successful completion of these clinical trials, Outlook Therapeutics submitted its BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in March 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.
As previously announced, if ONS-5010 receives FDA approval, Outlook Therapeutics plans to submit a supplementary application (sBLA) for approval to provide the product in a pre-filled, silicone oil-liquid free syringe that meets the FDA’s strict specifications for ophthalmic use. To support the anticipated submission of this sBLA, Outlook Therapeutics is conducting its NORSE SEVEN clinical trial to compare the safety of ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN is expected to enroll approximately 120 subjects with visual impairment due to retinal disorders. Patients will be treated for three months and the enrollment of patients in the arm of the study receiving ONS-5010 in vials has already been completed.
Pre-Launch Commercial Planning Underway
According to the National Eye Institute (NEI), use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for at least 50% of all wet AMD injections in the United States each year. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases.
In anticipation of potential FDA marketing approval in early 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Biopharma Services for finished drug product. The Company also is actively building out its distribution and commercial team structures.
To bring ONS-5010 to market in a way that benefits all stakeholders – patients, clinicians and payors – Outlook Therapeutics has been in collaborative discussions with payors and the retina community. Outlook Therapeutics is also developing registration documents on a parallel path for approvals in Europe and expects to submit them in the fourth quarter of calendar 2022. Outlook Therapeutics continues to explore potential strategic commercialization partners, such as the current partnership with Syntone Biopharma JV in China. Outlook Therapeutics expects ONS-5010, if approved, to be a safe and cost-effective choice for patients, clinicians, and payors worldwide for retinal indications.
In addition to the clinical development program evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO), NORSE FOUR, and two planned registration clinical trials evaluating the drug candidate for the treatment of diabetic macular edema (DME), NORSE FIVE and NORSE SIX.
Upcoming Anticipated Milestones
Receive PDUFA date from FDA;
Continued progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in early 2023; and
Completion in calendar 2022 of the NORSE SEVEN study evaluating Outlook Therapeutics’ vial delivery system versus a pre-filled syringe of ONS-5010.
Financial Highlights for the Fiscal Second Quarter Ended March 31, 2022
For the fiscal second quarter ended March 31, 2022, Outlook Therapeutics reported a net loss attributable to common stockholders of $19.7 million, or $0.09 per basic and diluted share, compared to a net loss attributable to common stockholders of $13.1 million, or $0.09 per basic and diluted share, for the same period last year.
At March 31, 2022, Outlook Therapeutics had cash and cash equivalents of $58.4 million, compared to $70.2 million at December 31, 2021. Outlook Therapeutics’ cash and cash equivalents on hand are expected to provide funding into the first calendar quarter of 2023.
"We believe Outlook Therapeutics is in a strong financial position," stated Lawrence A. Kenyon, Chief Financial Officer of Outlook Therapeutics. "We have successfully accessed capital via our ATM program and plan to continue using this financing option, subject to market conditions. Also, we have initiated discussions with the holders of our unsecured notes to extend the maturity of these notes until 2024 after we begin generating revenue from LYTENAVA, if approved. With these steps, we believe we have charted a path that would allow Outlook Therapeutics to launch LYTENAVA without the need to raise significant additional capital."
About ONS-5010 / LYTENAVA (bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace the need to use unapproved repackaged IV bevacizumab from compounding pharmacies for the treatment of wet AMD.
Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.