AI Earnings Predictions for Outlook Therapeutics Inc. (OTLK)

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EXHIBIT 99.1

Exhibit 99.1

Outlook Therapeutics Reports Third Quarter Fiscal Year 2026 Financial Results

and Provides Business Update Highlighting FDA Approval of LYTENAVA™

The only FDA-approved ophthalmic bevacizumab, LYTENAVATM, addresses a significant need in the U.S. wet AMD market where bevacizumab is already widely used

Advancing the U.S. launch strategy for LYTENAVA, including broad market access, reimbursement, pricing, medical affairs, and supply capabilities

Potential to exceed $500 million in annual U.S. LYTENAVA sales by 2030

Company to host corporate update conference call today, August 14th, at

8:30 AM ET — registration details below

ISELIN,

N.J., August 14, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today reported financial results for the third quarter of fiscal year 2026, ended June 30, 2026, and provided a business update. The Company continues to advance preparations for the U.S. commercial launch of LYTENAVA, the only FDA-approved ophthalmic bevacizumab for the treatment of wet age-related macular degeneration (wet AMD).

“FDA approval of LYTENAVA marks a defining moment for Outlook Therapeutics and creates a significant opportunity for the Company in the United States,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “Our priorities are clear: build an exceptional commercial team with deep retina and launch experience, prepare for our planned U.S. launch by the end of calendar 2026, and execute a strategy that reflects today’s competitive and evolving wet AMD treatment landscape. We believe LYTENAVA is well positioned to become an important treatment option for retina physicians and their patients.”

Outlook Therapeutics is advancing preparations for the U.S. commercial launch of LYTENAVA, planned before the end of calendar 2026. The Company is expanding payer engagement, scaling commercial supply, and building a focused commercial organization informed by feedback from retina physicians, practices, and other key stakeholders. Based on current estimates, management believes LYTENAVA has the potential to exceed $500 million in annual U.S. sales by 2030.

The Company has established its customer segmentation and targeting strategy to prioritize retina practices with the greatest potential for early adoption and is building its commercial team with experienced leaders with deep expertise in retina, product launches, and the increasingly competitive and complex wet AMD and anti-VEGF market. The Company’s launch and go-to-market strategy is designed to reflect the evolving biosimilar landscape, affordability considerations, and the potential for additional market entrants, while supporting broad patient access and reimbursement. As part of these efforts, the Company plans to submit an application for a permanent Healthcare Common Procedure Coding System or HCPCS code by October 1, 2026, to support reimbursement following launch.

“Our launch strategy reflects a deep understanding of the retina market and the needs of patients, physicians, practices, and payers,” continued Mr. Jahr. “We are taking a targeted approach to customer engagement, pricing, and reimbursement, while building the commercial and supply capabilities needed to support the introduction of LYTENAVA in the United States. We believe this foundation will position us to drive broad access and successful adoption following launch.”

In Europe, Outlook Therapeutics continues to expand the commercialization of LYTENAVA in Germany, Austria and the United Kingdom. The Company is also preparing for a planned launch in the Netherlands later in 2026 following its Netherlands submission. In Switzerland, the Company’s partner, Mediconsult, is leading regulatory and commercial activities in support of an anticipated launch in 2027.

Wet AMD remains a leading cause of vision loss among older adults, and anti-VEGF therapies represent the current standard of care for millions of patients worldwide. At the center of the Company’s strategy is a commitment to ensuring broad patient access and reimbursement while removing barriers to adoption for both patients and practices.

“For retina practices, the approval of LYTENAVA represents more than a new treatment option. It addresses a longstanding need for an FDA-approved bevacizumab specifically for ophthalmic use. The patient services and support resources available alongside LYTENAVA can also help practices navigate access and support eligible patients with wet AMD throughout their treatment journey,” said Albert Shirakian, CEO, Retina Vitreous Associates Medical Group.

“We have been working closely with the Outlook Therapeutics team since LYTENAVA received FDA approval and appreciate their commitment to meeting a longstanding need in retina care. Having an FDA-approv

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EXHIBIT 99.1

Exhibit 99.1

Risk Factors

You should consider carefully the risks and uncertainties described below. If any of the following risks are realized, our business, financial condition, results of operations, and prospects could be adversely affected. The risks described below are not the only risks facing our company. Risks and uncertainties not currently known to us or that we currently deem to be immaterial also may adversely affect our business, financial condition, results of operations, and/or prospects.

Summary of Select Risks

Our business faces significant risks and uncertainties. If any of the following risks are realized, our business, financial condition, results of operations, and future growth prospects could be materially and adversely affected. Some of the more significant risks we face include the following:

·We have incurred significant losses and negative cash flows from operations since our inception and expect to continue to incur significant losses and negative cash flows from operations for the foreseeable future and may not achieve consistent future profitability for some time, if ever.

·There is substantial doubt about our ability to continue as a going concern. We will need to raise substantial additional capital to fund the commercialization of LYTENAVATM (bevacizumab vikg, bevacizumab gamma) and support our operations until we are able to generate sufficient revenue from the sales of LYTENAVA. This additional funding may not be available on acceptable terms or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our commercialization and product development efforts or other operations.

·Our near-term prospects are wholly dependent on LYTENAVA. If we are unable to successfully commercialize LYTENAVA for wet age-related macular degeneration, or wet AMD, or to expand its indication of use, our ability to generate meaningful revenue or achieve profitability will be materially and adversely affected.

·We have limited experience as a commercial company and our sales, marketing, and distribution of LYTENAVA may be unsuccessful or less successful than expected.

·We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced or more effective than ours. Other products may be successfully commercialized before ours, which may adversely affect our financial condition and our ability to successfully commercialize LYTENAVA or any future product candidates.

·The commercial success of LYTENAVA or any future product candidate will depend upon the degree of market acceptance by physicians, patients, third-party payors and others in the medical community, which can be slow to adopt or unreceptive to new products.

·Although LYTENAVA is approved in the United States, or US, European Union, or EU, and the United Kingdom, or UK, off-label repackaging of Avastin at compounding pharmacies may continue, which could have a material adverse effect on our business and financial condition.

·We currently are building a marketing and sales organization. If we are unable to establish and maintain sales and marketing capabilities in jurisdictions for which we choose to retain commercialization rights, we may be unable to generate any revenue.

·The third-party coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for LYTENAVA or any other product candidates we may develop in the future could limit our ability to market those products and decrease our ability to generate revenue.

1

·The affected populations for LYTENAVA or any future product candidate may be smaller than we or third parties currently project, which may affect the addressable markets for our product candidates.

·If the commercial launch of LYTENAVA is delayed or unsuccessful, or if sales of LYTENAVA do not meet the levels currently expected, we may face costs related to excess inventory or unused capacity at our manufacturing facilities and at the facilities of third parties or our collaborators.

·We depend on third parties for the commercialization of LYTENAVA. Failure to commercialize in the relevant markets could harm our business and operating results.

·We rely on a select network of third party distributors, and other vendors to distribute LYTENAVA, and any failure by such distributors, and vendors could adversely affect our revenues, financial condition, or results of operations.

·If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be harmed. Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.

·Due to our limited resources and access to capital, we have, and will continue to need to, prioritize the development and commercialization o

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EXHIBIT 99.1

Exhibit 99.1

Outlook Therapeutics Reports Second Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update

·Completed Formal Dispute Resolution Meeting with FDA regarding Complete Response Letter (CRL) for ONS-5010; Decision Expected This Month

·Continued expansion of LYTENAVA™ (bevacizumab gamma) in Europe with Commercial Distribution Agreement with Mediconsult AG in Switzerland

·Launched Real-World Evidence Study in Germany to Further Strengthen the Overall Value Proposition of LYTENAVA™

ISELIN,

N.J., May 15, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced financial results for the second quarter of fiscal year 2026 ended March 31, 2026, and provided a corporate update.

“We remain committed to working collaboratively with the FDA to establish a clear path forward toward potential U.S. approval. Our objective is clear: to bring the first FDA-approved ophthalmic formulation of bevacizumab to patients in the United States,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “In addition, we are encouraged by the continued momentum of our European commercial launch of LYTENAVA, highlighted by our expansion into new markets, as well as our recently announced partnership in Switzerland and growing physician adoption in our initial launch countries.”

During the second quarter of fiscal year 2026, Outlook Therapeutics continued to advance the commercial rollout of LYTENAVA™ (bevacizumab gamma) in Europe. In anticipation of a potential launch in Switzerland, the Company entered into a Commercial Distribution Agreement with Mediconsult AG for the sale and distribution of LYTENAVA™ (bevacizumab gamma) in Switzerland. As part of the agreement, Mediconsult AG will be responsible for regulatory activities in Switzerland, including seeking and maintaining Marketing Authorization. The Company is targeting a 2027 launch of LYTENAVA™ in Switzerland in 2027, subject to receipt of Marketing Authorization in that country.

Building on the initial launch momentum, Outlook Therapeutics intends to expand into the Netherlands and Ireland later in 2026 and additional European markets and beyond in 2027. As Outlook Therapeutics continues to see increasing physician adoption and demand in the initial launch countries, the Company remains focused on executing its commercialization strategy to pursue additional launches and potential partnerships inside and outside of Europe and further establishing LYTENAVA as a new treatment option for wet AMD.

The Company also launched a real-world evidence study in Germany to further evaluate the performance of LYTENAVA™ in routine clinical practice following its approval in the European Union and the United Kingdom. These data are expected to support reimbursement and market access efforts in key European markets, inform potential regulatory interactions, and further strengthen the overall value proposition of LYTENAVA™ for physicians, patients, and stakeholders.

ONS-5010

U.S. Regulatory Update

Outlook Therapeutics continues to advance its regulatory efforts in the United States for ONS-5010/LYTENAVA™ (bevacizumab-vikg). The Company conducted its formal dispute resolution meeting with the U.S. Food and Drug Administration (FDA) in April 2026 and remains engaged in the process as it awaits the formal decision from the FDA. The Company has provided a comprehensive package of clinical, functional, pharmacodynamic, and safety data, including results from the NORSE TWO and NORSE EIGHT studies, which the Company believes support the efficacy and safety profile of ONS-5010/LYTENAVA™ for the treatment of wet AMD. Outlook Therapeutics remains committed to working collaboratively with the FDA to establish a clear path forward toward potential U.S. approval.

Outlook Therapeutics expects a formal decision from the FDA in May 2026.

Financial Highlights for the Second Fiscal Quarter Ended March 31, 2026

For the second fiscal quarter ended March 31, 2026, Outlook Therapeutics reported net loss attributable to common stockholders of $4.5 million, or $0.05 per basic and diluted share. This compares with net loss attributable to common stockholders of $46.4 million, or $1.50 per basic and diluted share for the same period last year.

For the fiscal quarter ended March 31, 2026, Outlook Therapeutics reported an adjusted net loss attributable to common stockholders of $14.1 million, or $0.16 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $12.4 million, or $0.40 per basic and diluted share for the second fiscal quarter of 2025.

Adjusted net loss attributable to common stockholders for the fiscal quarter ended March 31, 2026, excludes $2.5 million of gain from change in fair value of promissory notes, $0.3 million of gain on extinguish