Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2024 and Provides Corporate Update
Outlook Therapeutics, Inc. (OTLK) announces progress in NORSE EIGHT trial with first subject dosed and financial results for Q1 FY2024. Anticipates resubmission of ONS-5010 BLA by end of CY2024 and EU regulatory decision in first half of CY2024. Secures financing for regulatory efforts.
Positive
Confirmation from FDA on NORSE EIGHT trial protocol under SPA approval.
Agreement to satisfy FDA's requirement for a second clinical trial if NORSE EIGHT is successful.
Resolution plans for CMC comments in CRL identified through Type A meeting and interactions.
Entered into purchase agreements for financing of up to $172 million to support regulatory efforts and launch preparations.
Upcoming milestones include closing of private placement financing, MAA decision in the EU, completion of NORSE EIGHT, and resubmission of ONS-5010 BLA.
NORSE EIGHT trial details: randomized, controlled study for wet AMD subjects with primary endpoint at week 8.
Financial highlights: net loss reduced to $11.2 million for Q1 FY2024, entered into private placements for up to $65 million in gross proceeds.
Cash and cash equivalents of $10.4 million as of December 31, 2023, with potential additional gross proceeds of up to $107 million from warrants.
Proceeds from private placements expected to support business operations, NORSE EIGHT execution, ONS-5010 BLA resubmission, and commercial launch if approved.
The initiation of the NORSE EIGHT trial and subsequent dosing of the first subject represent significant milestones for Outlook Therapeutics. The successful completion of this trial is critical, as it addresses the FDA's requirement for an additional well-controlled clinical study. From a financial perspective, the trial's success could potentially enhance the company's valuation due to the increased likelihood of regulatory approval for ONS-5010. The announcement of anticipated milestones, including the closing of private placement financing and the expected decision by the European regulators, provides investors with a clearer timeline of expected developments, which can influence investment decisions and stock performance.
Furthermore, the private placements expected to raise up to $65 million, with an additional $107 million upon full exercise of warrants, indicate strong funding prospects. However, the reliance on shareholder approval and other conditions adds an element of uncertainty. The cash and cash equivalents position of $10.4 million as of December 31, 2023, suggests a need for the financing to support ongoing trials and potential commercialization efforts. The financial health of the company and the execution of these funding strategies will likely be closely monitored by investors as indicators of the company's ability to sustain operations and bring ONS-5010 to market.
The commencement of the NORSE EIGHT study is a pivotal step for Outlook Therapeutics, as it directly impacts the company's prospects of receiving FDA approval for its ophthalmic formulation of bevacizumab. The trial's design, focusing on non-inferiority to ranibizumab, aims to demonstrate that ONS-5010 is at least as effective as the existing treatment, which could lead to a significant shift in the treatment of retinal diseases. The primary endpoint, mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 8, is a standard measure of efficacy in ophthalmology trials and positive results here could position ONS-5010 as a strong competitor in the market.
It's also notable that the trial protocol has been agreed upon under a Special Protocol Assessment (SPA), which means that the FDA has signed off on the trial design, endpoints and statistical analyses. This agreement could increase the likelihood of a positive outcome, as the SPA process often leads to a clearer regulatory pathway. However, the complexity of resolving Chemistry, Manufacturing and Controls (CMC) issues should not be underestimated, as these can be significant hurdles in the approval process. The company's ability to address these issues before completing NORSE EIGHT will be critical for maintaining their projected timeline.
The potential introduction of ONS-5010 into the market could disrupt the current treatment landscape for retinal diseases. If approved, it would be the first ophthalmic formulation of bevacizumab in the U.S. or EU, offering a new option for patients and healthcare providers. This could lead to a reevaluation of the competitive dynamics within the ophthalmic pharmaceutical sector, with possible implications for market share distribution among existing treatments.
Outlook Therapeutics' strategy to explore strategic partnerships and expanded relationships with entities like Cencora indicates a proactive approach to market entry and distribution. The success of these partnerships could be instrumental in the effective commercialization of ONS-5010, potentially leading to increased market penetration and revenue streams. Stakeholders and potential investors will likely analyze these developments to gauge the company's market readiness and the potential impact on its growth trajectory.
02/14/2024 - 08:05 AM
NORSE EIGHT underway with first subject dosed and additional clinical sites beginning enrollment Continue to expect planned resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024 Anticipate review decision from European regulators in the first half of CY2024 ISELIN, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for first quarter fiscal year 2024 and provided a corporate update.
“We are proud of the recent progress our team has made. In January 2024, we received confirmation that the FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA they approved. We also reached agreement 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 address fully the clinical deficiency identified in the CRL. Importantly, the first subject was enrolled in NORSE EIGHT in January 2024,” commented Russell Trenary, President and Chief Executive Officer. “In addition, through a Type A meeting and additional interactions, we have identified the approaches needed to resolve the CMC comments in the CRL. We are working to address the open items and expect to resolve these comments prior to the expected completion of NORSE EIGHT. Finally, we have entered into purchase agreements for a financing of up to $172 million , subject to shareholder approval, to support our regulatory efforts and launch preparations.”
Upcoming Anticipated Milestones
Closing of private placement financing in March 2024, subject to receipt of stockholder approval and other closing conditions; MAA decision date in the EU for ONS-5010 targeted for first half of 2024; Completion of NORSE EIGHT in the United States anticipated in 2024; and Resubmission of the ONS-5010 BLA expected by the end of calendar year 2024. ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Regulatory Update
As previously announced, following a Type A meeting with the FDA in October 2023, 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 from the FDA under a SPA for NORSE EIGHT. The SPA confirms 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 is working 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 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 will be mean change in BCVA from baseline to week 8. Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
Additionally, the formal review process of the ONS-5010 MAA by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) is underway with an estimated decision date expected in the first half of 2024. In addition to pursuing potential strategic partnering opportunities in the EU and other regions, Outlook Therapeutics is also exploring potential expanded relationships with Cencora (formerly AmerisourceBergen) to support the launch of ONS-5010 in international markets.
If approved, ONS-5010 / LYTENAVA™ (bevacizumab-vikg) would be the first approved ophthalmic formulation of bevacizumab in the U.S. or EU.
Financial Highlights for the Fiscal First Quarter Ended December 31, 2023
For the fiscal first quarter ended December 31, 2023, Outlook Therapeutics reported a net loss attributable to common stockholders of $11.2 million , or $0.04 per basic and diluted share, compared to a net loss attributable to common stockholders of $18.7 million , or $0.08 per basic and diluted share, for the same period last year.
In January 2024, the Company announced that it has entered into definitive securities purchase agreements with certain institutional and accredited investors to purchase shares of common stock and accompanying warrants in private placements, the closing of which is conditioned upon stockholder approval of the transactions and certain other corporate actions, expected in the first quarter of 2024. The private placements are expected to provide up to $65 million in gross proceeds at closing, before deducting placement agent fees and offering expenses. In addition, Outlook Therapeutics will have the potential to receive additional gross proceeds of up to $107 million upon the full cash exercise of the warrants being issued in the private placements, before deducting placement agent fees and offering expenses. The warrants include a feature that allows Outlook Therapeutics to require cash exercise if certain stock price and milestone conditions are met.
At December 31, 2023, Outlook Therapeutics had cash and cash equivalents of $10.4 million . Assuming closing of the private placements as planned (subject to closing conditions) and full cash exercise of the related warrants, the proceeds from the private placements are expected to support business operations, complete the execution of NORSE EIGHT, resubmit the ONS-5010 BLA and, if approved, support the commercial launch of ONS-5010.
About ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no FDA-approved ophthalmic formulations of bevacizumab are available currently, 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 would provide an FDA-approved option for physicians that currently prescribe unapproved repackaged oncologic 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.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company working to achieve FDA and EMA approval for the launch of ONS-5010/ LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA and/or EMA 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 Outlook Therapeutics' multi-year commercial planning process, Outlook Therapeutics and Cencora entered into a strategic commercialization agreement to expand the Outlook Therapeutics’ reach for connecting to retina specialists and their patients. Cencora will provide third-party logistics (3PL) services and distribution, as well as pharmacovigilance services and other 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,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “target,” “will,” or “would” 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, expectations concerning Outlook Therapeutics’ ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, including with respect to an additional clinical trial and CMC issues, expectations concerning the NORSE EIGHT trial design, the timing for completion of NORSE EIGHT and resubmission of the BLA for ONS-5010, the private placement, including expected proceeds from the issuance of the shares of common stock and exercise of the warrants, satisfaction of closing conditions, including receipt of necessary stockholder approvals, and uses of proceeds, the sufficiency of Outlook Therapeutics’ resources, including funds from the financing, to fund its operations through various milestones, expectations concerning decisions of regulatory bodies, including the FDA and EMA, and the timing thereof, plans for potential commercial launch of ONS-5010, expectations concerning the relationship with Cencora and the benefits and potential expansion thereof, 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, the content and timing of decisions by the FDA, receipt of necessary stockholder approvals for the private placements, 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, 2023, filed with the SEC on December 22, 2023, and future quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflict, high interest rates, inflation and potential future bank failures 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.
Investor Inquiries: OTLK@jtcir.com
Outlook Therapeutics, Inc. Consolidated Statements of Operations (Amounts in thousands, except per share data) Three months ended December 31, 2023 2022 Operating expenses: Research and development $ 4,529 $ 9,862 General and administrative 5,794 5,826 10,323 15,688 Loss from operations (10,323 ) (15,688 ) Income on equity method investment (3 ) (22 ) Interest (income) expense, net (188 ) 2,449 Loss on extinguishment of debt - 578 Change in fair value of promissory notes 993 - Change in fair value of warrant liability 53 (30 ) Net loss attributable to common stockholders $ (11,178 ) $ (18,663 ) Per share information: Net loss per share of common stock, basic and diluted $ (0.04 ) $ (0.08 ) Weighted average shares outstanding, basic and diluted 260,258 227,411
Consolidated Balance Sheet Data (Amounts in thousands) December 31, 2023 September 30, 2023 Cash and cash equivalents $ 10,357 $ 23,392 Total assets $ 21,685 $ 32,301 Current liabilities $ 45,969 $ 46,732 Total stockholders' deficit $ (24,343 ) $ (14,438 )
What is the primary endpoint of the NORSE EIGHT trial for Outlook Therapeutics (OTLK)?
The primary endpoint of the NORSE EIGHT trial is the mean change in BCVA from baseline to week 8 for wet AMD subjects.
What are the upcoming milestones for Outlook Therapeutics (OTLK) mentioned in the press release?
The upcoming milestones include closing of private placement financing, MAA decision in the EU, completion of NORSE EIGHT, and resubmission of ONS-5010 BLA by the end of CY2024.
What were the financial highlights for the fiscal first quarter ended December 31, 2023, for Outlook Therapeutics (OTLK)?
Outlook Therapeutics reported a net loss of $11.2 million for the fiscal first quarter ended December 31, 2023, with cash and cash equivalents of $10.4 million.
What is the amount of financing secured by Outlook Therapeutics (OTLK) for regulatory efforts and launch preparations?
Outlook Therapeutics has entered into purchase agreements for financing of up to $172 million to support regulatory efforts and launch preparations.
What did the FDA confirm regarding the NORSE EIGHT trial protocol for Outlook Therapeutics (OTLK)?
The FDA confirmed the NORSE EIGHT trial protocol under SPA approval, agreeing that it would satisfy the requirement for a second clinical trial if successful.
What are the plans to address the CMC comments in the CRL for Outlook Therapeutics (OTLK)?
Outlook Therapeutics has identified the approaches needed to resolve the CMC comments in the CRL through Type A meeting and additional interactions.
What is the expected decision date for the ONS-5010 MAA by the European Medicines Agency (EMA) for Outlook Therapeutics (OTLK)?
The expected decision date for the ONS-5010 MAA by the EMA is in the first half of CY2024.
What is the purpose of the private placements entered into by Outlook Therapeutics (OTLK)?
The private placements are expected to provide up to $65 million in gross proceeds at closing, with potential additional gross proceeds of up to $107 million from warrants.
