Secured approximately $55 million gross proceeds from recent financings, expected to provide funding through the anticipated FDA approval of ONS-5010 in the third calendar quarter of 2023 ISELIN, N.J., Dec. 29, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced its financial results for its fiscal year ended September 30, 2022, and provided recent corporate highlights. Recent Corporate Highlights
Closed on approximately $50 million net proceeds from two new financings to support pre-launch activities through anticipated approval of ONS-5010 in third calendar quarter 2023. Approximately $25 million registered direct equity offering priced at-the-market under Nasdaq rules. Approximately $30 million net proceeds from issuance of an unsecured convertible promissory note with an initial conversion price of $2.00.
Entered into a strategic commercialization agreement with AmerisourceBergen, a global healthcare company and leader in specialty pharmaceutical distribution and services who will provide third-party logistics (3PL) services and distribution, as well as medical information and pharmacovigilance services in the United States. Strengthened Board of Directors with appointment of Julia Haller, MD, one of the country’s most accomplished professionals in ophthalmic education, research and clinical ophthalmic practice.
“Our fiscal year 2022 laid a solid foundation for what we believe will be a transformational 2023. We are driving our commercialization planning towards expected launch with the accepted FDA filing of our BLA for ONS-5010 and PDUFA date set for August 29, 2023, and review of our MAA in the EU underway with a decision date expected in early 2024. We believe that ONS-5010 has the potential to be a game-changer for patients and physicians in the retina community, and we now have the necessary capital to support these efforts. We remain steadfast in our mission to enhance the standard of care in the retinal anti-VEGF space,” commented C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics. “On behalf of the entire team, I would like to thank all stakeholders for their continued support and look forward to what we believe will be an exciting future for Outlook Therapeutics.” Upcoming Anticipated Milestones
Continued progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in 2023; PDUFA goal date of August 29, 2023; and
Estimated decision date from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on the Company’s submitted MAA in EU for ONS-5010 expected in early 2024. According to GlobalData, the use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMDAMD 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. Outlook Therapeutics is also developing registration documents on a parallel path for approvals in Europe and submitted them in December 2022. The formal review process of the MAA by the EMA’s CHMP is now set to begin with an estimated decision date expected in early 2024 and is also exploring a relationship with AmerisourceBergen to support the launch of ONS-5010 in international markets. AmerisourceBergen expanded its global distribution capabilities in 2021 with the acquisition of Alliance Healthcare, a leading wholesaler of healthcare products in Europe. Additionally, Outlook Therapeutics continues to explore potential strategic commercialization partners, such as the current partnership with Syntone Biopharma JV in China. 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; the enrollment of patients in the arm of the study receiving ONS-5010 in vials has already been completed. Financial Highlights for the 2022 Fiscal Year Ended September 30, 2022
For the fiscal year ended September 30, 2022, Outlook Therapeutics reported a net loss attributable to common stockholders of $66.1 million, or $0.31 per basic and diluted share, compared to a net loss attributable to common stockholders of $53.2 million, or $0.35 per basic and diluted share, for fiscal 2021. Subsequent to September 30, 2022, the Company closed a registered direct equity offering priced at-the-market under Nasdaq rules, resulting in aggregate gross proceeds of approximately $25.0 million. Additionally, the Company closed on an unsecured convertible promissory note (the “Note”) with a face amount of $31.8 million and net proceeds of approximately $30.0 million after original issue discount and after deducting the Lender’s transaction costs covered by the Company in connection with the issuance. The combined proceeds from the Note and the registered direct offering are expected to provide funding through the anticipated FDA approval of ONS-5010 in the third calendar quarter of 2023. ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMDAMD 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 oncologic IV bevacizumab from compounding pharmacies for the treatment of wet AMDAMD. 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. Outlook Therapeutics is a biopharmaceutical company working to develop and launch ONS-5010/ LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMDAMD, DME and BRVO. The FDA accepted Outlook Therapeutics’ BLA submission for ONS-5010 to treat wet AMDAMD with a PDUFA goal date of August 29, 2023. The submission is supported by Outlook Therapeutics’ wet AMDAMD clinical program, which consists of three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, and other markets. As part of the Company’s multi-year commercial planning process, and in anticipation of potential FDA approval in August 2023, Outlook Therapeutics and AmerisourceBergen have entered into a strategic commercialization agreement to expand the Company’s reach for connecting to retina specialists and their patients. AmerisourceBergen will provide third-party logistics (3PL) services and distribution, as well as pharmacovigilance services in the United States. For more information, please visit www.outlooktherapeutics.com. Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “may,” “might,” “intend,” “potential,” “predict,” “should,” or “will,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, statements about ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, including benefits therefrom to patients, payors and physicians, including expectations of market exclusivity, potential approval and commercial launch of ONS-5010 and the timing thereof, expectations about the sufficiency of our capital, upcoming anticipated milestones, expectations concerning decisions of regulatory bodies, including the FDA and the EMA, and the timing thereof, our estimated market, expectations concerning our relationship with AmerisourceBergen and the benefits thereof, plans for and the timing of potential future clinical trials, including the expected completion of NORSE SEVEN and the expected commencement of NORSE FOUR, NORSE FIVE and NORSE SIX, potential strategic partners, plans for regulatory submissions, approvals and commercialization of ONS-5010 in other markets and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the “SEC”), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2022 to be filed with the SEC and future quarterly reports we file with the SEC, which include the uncertainty of future impacts related to the ongoing COVID-19 pandemic and the impacts of the pandemic and other macroeconomic factors, including as a result of the ongoing conflict between Russia and Ukraine, on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law. aarmy@lavoiehealthscience.com
Outlook Therapeutics, Inc. Consolidated Statements of Operations (Amounts in thousands, except per share data) Year ended September 30, 2022 2021 Operating expenses: Research and development $42,331 $38,958 General and administrative 20,740 12,769 63,071 51,727 Loss from operations (63,071) (51,727) Loss on equity method investment 49 46 Interest expense, net 1,487 936 Loss on extinguishment of debt 1,025 - Change in fair value of unsecured convertible promissory note 883 - Change in fair value of warrant liability (466) 452 Loss before income taxes (66,049) (53,161) Income tax expense 3 2 Net loss attributable to common stockholders $(66,052) $(53,163) Per share information: Net loss per share of common stock, basic and diluted $(0.31) $(0.35) Weighted average shares outstanding, basic and diluted 212,079 152,676 Consolidated Balance Sheet Data (Amounts in thousands) September 30, 2022 2021 Cash and cash equivalents $ 17,397 $ 14,477 Total assets $ 28,528 $ 22,811 Current liabilities $ 19,730 $ 6,752 Total stockholders' equity $ 8,737 $ 4,607