OTLK

Outlook Therapeutics, Inc. OTLK used its fiscal third-quarter 2026 call to shift attention from approval to commercialization, detailing LYTENAVA's U.S. launch plan after FDA approval for wet AMD. President and chief executive officer (CEO) Robert Jahr said management expects a U.S. launch before year-end 2026, centering on reimbursement, pricing, supply and retina-practice engagement. The call also introduced first-year revenue guidance and clarified the 2030 sales objective. Robert Jahr said the U.S. anti-VEGF retina market is about $8.5 billion, with 3.6 million off-label repackaged bevacizumab injections in 2025, including 2.2 million for wet AMD. Jahr positioned LYTENAVA as an FDA-approved ophthalmic bevacizumab option alongside branded drugs, biosimilars and repackaged bevacizumab. He said management's base-case objective is more than $500 million in annual U.S. sales by 2030. The CEO added that OTLK has sufficient supply for launch later in 2026 and is prioritizing high-volume practices with significant bevacizumab use. Adjusted net loss was $0.09 per share, in line with the Zacks Consensus Estimate. Revenues of $9,000 missed the consensus estimate by 99.25%. Outlook Therapeutics, Inc. price-consensus-eps-surprise-chart | Outlook Therapeutics, Inc. Quote Executive vice president and chief financial officer Lawrence Kenyon guided $50 million to $75 million of net revenues in the first 12 months after the U.S. launch, with Europe contributing approximately 10% to 15%. Approximately 10% is expected in the first three months and approximately 50% in the fourth quarter. Kenyon tied the acceleration to an anticipated permanent J-code in April 2027. He expects quarterly SG&A to approximately double by year-end 2026, followed by an approximately 10% increase during 2027, while R&D remains relatively steady over the next 12 months. Jahr said LYTENAVA's wholesale acquisition cost is expected to be below $500 per vial, with pricing designed around patient affordability, payer access and buy-and-bill economics. OTLK plans approximately 30 customer-facing commercial hires and approximately 20 field reimbursement personnel. Jahr said practices need workable product access, coding and reimbursement alongside physician awareness. The company plans to apply for a permanent HCPCS code by Oct. 1, 2026. Jahr said launch pace will also reflect payer engagement, supply readiness and customer feedback. A BTIG analyst asked about upside if compounded bevacizumab availability is disrupted. Jahr said that scenario could add just under $300 million to the 2030 opportunity, while displaced volume could also move to biosimilars. Jahr also said just under 800 retina physicians, one-third of the target universe, represent slightly less than half of the $500 million 2030 opportunity and are potential early adopters once reimbursement is established. A Brookline Capital Markets analyst asked about biosimilar competition. Jahr said the model assumes compounded bevacizumab remains available, biosimilars arrive on time with continued pricing pressure, and other modalities enter as expected. He characterized the assumptions as conservative. Kenyon said OTLK had $11.2 million in cash at June 30. A subsequent public offering was expected to generate approximately $51.1 million in net proceeds for the U.S. launch and working capital. Kenyon said European unit sales rose 46% from the fiscal second quarter. Jahr said Outlook has reset European costs and will expand selectively amid pricing pressure, tenders and market-specific barriers. The Netherlands is targeted for early 2027, while partner Mediconsult is preparing a 2027 Switzerland launch. Jahr said Europe could be less than one-quarter of the U.S. opportunity by 2030, with the U.S. at 90% or more of the total commercial opportunity in net revenue terms. Jahr closed with priorities around payer access, field-force buildout, supply, medical affairs and account engagement. Kenyon's spending outlook points to a higher commercialization cost base ahead of the revenue ramp. Management's plan centers on launching in late 2026 and broadening adoption as reimbursement infrastructure matures. OTLK carries a Zacks Rank #3 (Hold). Its Growth Score and Momentum Score are A, while the Value Score is F and the VGM Score is C, reflecting a mixed Style Score profile. The Style Score framework favors stronger grades, especially with Zacks Rank #1 (Strong Buy) or 2 (Buy) stocks. OTLK's A grades in growth and momentum are favorable, but its F Value Score and C VGM Score temper the overall signal. The Zacks Rank can change as analyst estimates are revised after the reported results. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Outlook Therapeutics, Inc. (OTLK) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Secured FDA approval for LYTENAVA as the first and only ophthalmic formulation of bevacizumab, transforming the company from a clinical-stage to a commercial-stage entity. Strategic focus is on converting the existing 3.6 million annual off-label bevacizumab injections into LYTENAVA use by offering an FDA-approved alternative with standardized manufacturing. Management identifies a $500 million peak annual sales opportunity by 2030, assuming approximately 30% to 35% share of the current wet AMD bevacizumab market. The commercial model is intentionally lean and focused, targeting a concentrated group of approximately 800 high-volume retina specialists who account for nearly half of the potential market. Competitive differentiation relies on providing a familiar molecule with the added benefits of product consistency, regulatory oversight, and a dedicated J-code for reimbursement. Performance in Europe is being rightsized to ensure revenue leads expenses, with a strategic shift toward high-value markets like the Netherlands and Switzerland. Anticipates total net revenue between $50 million and $75 million in the first 12 months post-launch, with a significant ramp-up expected in the second half of 2027. Expects to receive a permanent J-code in April 2027, which management views as the primary catalyst for broader commercial adoption and reimbursement clarity. Planned organizational build-out includes hiring 30 customer-facing and 20 field reimbursement personnel to support the buy-and-bill operational model. SG&A expenses are projected to double by the end of calendar 2026 to support launch activities, while R&D will remain steady to focus on the prefilled syringe development. Pricing strategy targets a WAC price below $500 per vial to remain competitive with biosimilars while maintaining broad payer access. Management acknowledged that the path to approval was 'not a straight line,' involving significant regulatory hurdles and organizational persistence through periods of uncertainty. Identified a potential $300 million upside to peak sales guidance if the FDA intervenes in large-scale compounding pharmacy operations, though this is not in the base case. Recent $55 million public offering (approximately $51.1 million net) provides the necessary capital to fund the U.S. launch and general working capital. European operations faced headwinds due to regulatory requirements in Germany that mandate compounding even for approved vials, leading to a strategic reset of the cost structure. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management estimated a $300 million upside if the compounded market is disrupted, though they noted volume might be split with other biosimilars. Identified early adopters as the one-third of retina physicians currently using compounded bevacizumab due to payer-mandated step edits. The $500 million peak sales guide is described as conservative, factoring in the timely entry of all biosimilars (ranibizumab and aflibercept) and ongoing pricing pressure. The forecast assumes no disruption to the repackaged market and accounts for potential competition from future gene therapies and TKIs. Management argued that the 20% Medicare out-of-pocket math is not universal, as many patients have supplemental Medigap or commercial insurance. Stated that the buy-and-bill model for LYTENAVA offers practices reimbursement advantages (J-code) that compounded products do not provide. Outlook is evaluating partnerships for Asia and MENA regions following FDA approval, which serves as a key regulatory benchmark for those markets. Broader European expansion will likely be timed with the launch of the prefilled syringe to maximize market impact and pricing stability.

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., Aug. 14, 2026 (GLOBE NEWSWIRE) -- 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-approved bevacizumab specifically for ophthalmic use gives physicians an important new option, supported by the clinical data and quality standards of the FDA approval process. We are encouraged by this new treatment option for physicians and patients in the treatment of wet AMD,” stated Miguel A. Busquets, MD, FACS, FASRS, Vice Chairman, EyeCare Partners. Financial Results for the Third Quarter Fiscal Year 2026 ended June 30, 2026 For the third fiscal quarter ended June 30, 2026, Outlook Therapeutics reported net loss attributable to common stockholders of $20.3 million, or $0.15 per basic and diluted share. This compares with net loss attributable to common stockholders of $20.2 million, or $0.55 per basic and diluted share for the same period last year. For the fiscal quarter ended June 30, 2026, Outlook Therapeutics reported an adjusted net loss attributable to common stockholders of $10.9 million, or $0.09 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $15.8 million, or $0.44 per basic and diluted share for the third fiscal quarter of 2025. Adjusted net loss attributable to common stockholders for the fiscal quarter ended June 30, 2026, excludes $1.1 million of loss from change in fair value of promissory notes, $1.3 million of loss on extinguishment of debt, and $7.0 million of loss from change in fair value of warrant liability. Adjusted net loss attributable to common stockholders for the fiscal quarter ended June 30, 2025, excludes $2.0 million of loss from change in fair value of warrant liability, and $2.3 million of loss from change in fair value of promissory notes. Subsequent to the quarter end, in August 2026, the Company announced a public offering of 55,555,556 shares of common stock and accompanying warrants to purchase 55,555,556 shares of common stock, at a combined public offering price of $0.99 per share and accompanying warrant, for approximately $51.1 million of net proceeds, after deducting underwriting discounts and commissions and other estimated offering expenses. As of June 30, 2026, Outlook Therapeutics had cash and cash equivalents of $11.2 million, which does not include the proceeds from the public offering. Conference Call and Webcast As previously announced, Outlook Therapeutics will host a conference call and webcast to discuss the Company’s third quarter fiscal year 2026 operational and financial results today, August 14, 2026, at 8:30 AM ET. The call will be hosted by members of Outlook Therapeutics’ leadership team, Bob Jahr, Chief Executive Officer and Lawrence A. Kenyon, Executive Vice President and Chief Financial Officer. Interested participants and investors may access the conference call by dialing 877-407-8291 (domestic) or +1 201-689-8345 (international) and referencing the Outlook Therapeutics conference call. The webcast will be accessible here and will be archived following the live event. About LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. In the United States, ONS-5010/LYTENAVA (bevacizumab-vikg) is the only ophthalmic formulation approved by the FDA. LYTENAVA™ (bevacizumab gamma) is also the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In certain European Union Member States, LYTENAVA™ must receive pricing and reimbursement approval before it can be sold. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized IgG1 monoclonal antibody specific tofor human vascular endothelial growth factor (VEGF). Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. LYTENAVA binds to all isoforms of VEGF-A, thereby preventing interaction with receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A, LYTENAVA suppresses endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of such activity targets a pathophysiologic process that contributes to vision loss. Important Safety Information and Indication LYTENAVA (bevacizumab-vikg) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD). ContraindicationsLYTENAVA is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with a known hypersensitivity to bevacizumab products or any of the ingredients in LYTENAVA. Hypersensitivity reactions may manifest as severe intraocular inflammation. Warnings and Precautions Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering LYTENAVA. In addition, patients should be monitored following the injection to permit early treatment should an infection occur. Increases in intraocular pressure have been noted post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure prior to and following intravitreal injection with LYTENAVA and manage appropriately. Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). Adverse Reactions The most common adverse reaction (≥1%) reported in patients receiving LYTENAVA was conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters (2%). These are not all the possible side effects of LYTENAVA. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Outlook Therapeutics at 1-833-999-OTLK (6855). Please see the full U.S. Prescribing Information for LYTENAVA here. About Outlook Therapeutics, Inc. Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of LYTENAVA (bevacizumab-vikg (U.S.), bevacizumab gamma (E.U.)). LYTENAVA is the only ophthalmic formulation of bevacizumab to receive U.S. FDA approval and European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany, Austria, and the UK as a treatment for wet AMD. Non-GAAP Financial Measures Outlook Therapeutics prepares its consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant to accounting requirements of the Securities and Exchange Commission (SEC). In an effort to provide investors with additional information regarding the results and to provide a meaningful period-over-period comparison of Outlook Therapeutics’ financial performance, Outlook Therapeutics sometimes uses non-U.S. GAAP financial measures (NGFM) as defined by the SEC. In this press release, Outlook Therapeutics uses “adjusted net loss attributable to common stockholders,” which is defined as net loss attributable to common stockholders excluding loss on extinguishment of debt and changes in fair value of warrants and convertible promissory notes, as well as “adjusted net loss attributable to common stockholders per share of common stock – basic and diluted,” which is defined as net loss attributable to common stockholders per share of common stock – basic and diluted, excluding loss on extinguishment of debt and changes in fair value of warrants and convertible promissory notes. Management uses these NGFMs because they adjust for certain non-cash items that impact financial results but not cash flows, and that management believes are not related to its core business. Management uses these NGFMs to evaluate Outlook Therapeutics’ financial performance against internal budgets and targets. Management believes that these NGFMs are useful for evaluating Outlook Therapeutics’ core operating results and facilitating comparison across reporting periods. Outlook Therapeutics believes these NGFMs should be considered in addition to, and not in lieu of, GAAP financial measures. Outlook Therapeutics’ NGFMs may be different from the same NGFMs used by other companies. Reconciliations to the closest U.S. GAAP financial measures are provided in the tables below. Forward-Looking Statements This press release contains statements that may or are considered “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,” “can,” “could,” “continue,” “expect,” “may,” “on track,” “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, express or implied discussions regarding the Company’s planned launch of LYTENAVA in the United States and other jurisdictions and the timing thereof; expectations concerning potential revenue generation from sales of LYTENAVA; expectations surrounding market adoption of LYTENAVA; potential additional marketing approvals; expectations regarding the potential impact of LYTENAVA in the retina community; new indications or labeling for LYTENAVA; Outlook Therapeutics development or future revenue plans for LYTENAVA generally; 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 and commercializing pharmaceutical product candidates, risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC), including the Current Report on Form 8-K filed with the SEC on August 12, 2026, and future 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 conflicts, tariffs, and trade tensions, fluctuations in interest rates and 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: Jenene Thomas Chief Executive Officer JTC Team, LLC T: 908.824.0775

Interested in Oncobiologics, Inc.? Here are five stocks we like better. FDA approval clears the way for LYTENAVA’s U.S. launch later this year as the only FDA-approved ophthalmic bevacizumab formulation for wet AMD. Management is building commercial, reimbursement, supply and medical-affairs capabilities, including plans to hire roughly 50 field personnel. Outlook Therapeutics estimates an approximately $8.5 billion U.S. anti-VEGF retina market and is targeting more than $500 million in peak annual LYTENAVA sales by 2030. First-year post-launch revenue is projected at $50 million to $75 million, with pricing expected to remain below $500 per vial. The company reported a reduced adjusted quarterly net loss of $10.9 million but had only $11.2 million in cash as of June 30. A subsequent $55 million stock-and-warrant offering is expected to provide about $51.1 million in net proceeds to fund the launch and working capital. 3 Beaten Down Pharmaceuticals With Catalysts for Higher Prices Oncobiologics (NASDAQ:OTLK) said it is preparing for the U.S. commercial launch of LYTENAVA after the Food and Drug Administration approved the product as the only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration, or wet AMD, in the United States. President and Chief Executive Officer Bob Jahr called the approval a “transformational achievement” for the company and said the focus has shifted from regulatory work to establishing commercial, reimbursement, supply and medical-affairs capabilities needed to support a launch later this year. → Lumentum Just Delivered the AI Growth Investors Wanted MarketBeat Week in Review – 6/17 - 6/21 LYTENAVA is intended to address the established use of repackaged, off-label bevacizumab in retinal care. Jahr said retina specialists are already familiar with the bevacizumab molecule, which has been used for more than two decades, but previously lacked an FDA-approved formulation developed specifically for administration in the eye. The company estimates the U.S. anti-VEGF retina market totals about $8.5 billion annually. It cited an estimated 3.6 million injections of off-label repackaged bevacizumab across retinal indications in 2025, including roughly 2.2 million injections for wet AMD. → Ryman Checks Into a $1.38B Hospitality Upgrade Outlook Therapeutics: Analysts Forecast Over 500% Stock Upside Jahr said the company’s base-case objective is for LYTENAVA to generate more than $500 million in peak annual U.S. sales by 2030. That forecast assumes repackaged bevacizumab remains available in the market and does not assume universal adoption, he said. During the question-and-answer session, Jahr said a disruption in the compounded or repackaged bevacizumab market could create “just under a $300 million” sales upside, although he noted that any displaced use could also shift to competing biosimilars. → Joby’s Defense Pivot Accelerates With $500M Resonant Sciences Deal The company is pursuing a focused commercial model because it views the retina market as concentrated among a relatively defined group of specialists and high-volume practices. It plans to hire approximately 30 customer-facing commercial employees and about 20 field reimbursement personnel. The reimbursement team will help practices navigate coverage, acquisition, coding, inventory and patient-access considerations in the physician-administered buy-and-bill market. Jahr said the company expects to submit an application for a permanent HCPCS code by the end of the third quarter and anticipates receiving a permanent J-code in April 2027. The company said it has sufficient supply for its planned launch and is scaling its commercial supply processes. Outlook Therapeutics expects LYTENAVA’s wholesale acquisition cost to be below $500 per vial. Jahr said pricing is intended to be competitive with biosimilars and other anti-VEGF treatments while reflecting the product’s differentiated profile. He said the company has considered patient affordability, payer access and the operational needs of retina practices in developing its approach. The approved label is based on the NORSE TWO registrational study. According to Jahr, 41.7% of patients treated with LYTENAVA gained at least 15 letters in visual acuity at month 11, compared with 23.1% of patients treated with ranibizumab. Management said its market segmentation work identified just under 800 retina physicians—about one-third of the physician target base—that represent slightly less than half of the company’s $500 million U.S. sales target. These practices tend to use compounded or repackaged bevacizumab because of payer step-edit requirements, Jahr said. The company’s forecast assumes the entry of ranibizumab and aflibercept biosimilars, continued price pressure for biosimilars, and potential approvals of other therapies, including TKIs, IL-6 therapies and gene therapy. It also incorporates continued pressure related to reduced funding availability from the Good Days Foundation, Jahr said. Executive Vice President and Chief Financial Officer Lawrence Kenyon reported an adjusted net loss attributable to common stockholders of $10.9 million, or $0.09 per basic and diluted share, for the third quarter of fiscal 2026. That compared with an adjusted net loss of $15.8 million, or $0.44 per share, in the prior-year quarter. As of June 30, the company had $11.2 million in cash and cash equivalents. After the quarter ended, the company announced a $55 million public offering of common stock and accompanying warrants, expected to generate approximately $51.1 million in net proceeds after underwriting discounts and offering expenses. The proceeds are intended to support the U.S. launch of LYTENAVA, working capital and general corporate purposes. Kenyon said the company expects total net revenue during the first 12 months after the U.S. launch to range from $50 million to $75 million, with Europe accounting for approximately 10% to 15% of the total. About 10% of first-year revenue is expected in the first three months after launch, increasing to roughly 50% in the fourth quarter following launch. The company expects quarterly selling, general and administrative expenses to approximately double from current levels by the end of calendar 2026, followed by an additional increase of approximately 10% during 2027. Research and development expense is expected to remain relatively steady over the next 12 months as the company advances its prefilled syringe program. LYTENAVA is currently available in Germany, Austria and the United Kingdom. Kenyon said European unit sales rose 46% in the fiscal third quarter compared with the second quarter, while fourth-quarter unit sales were on track to match current levels despite the expected summer slowdown. The company expects to launch in the Netherlands in early 2027 following its national reimbursement submission. Commercial partner Mediconsult is preparing for a Swiss launch in 2027. Jahr said the company is also assessing potential expansion opportunities in Latin America, Asia, the Middle East and North Africa, while taking a selective approach to additional European markets because of pricing and reimbursement pressures. Oncobiologics, Inc is a clinical-stage biopharmaceutical company specializing in the development of biosimilar therapeutics for cancer and autoimmune diseases. Leveraging recombinant DNA technology and advanced formulation platforms, the company aims to create high-quality, cost-effective alternatives to originator biologic drugs. Oncobiologics' research focus includes monoclonal antibodies and growth factors that support oncology treatment and immunomodulation. Founded in 2005 and headquartered in Marlborough, Massachusetts, Oncobiologics maintains research facilities in the Greater Boston area and an integrated manufacturing site in Hyderabad, India, through its wholly owned subsidiary. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Oncobiologics Q3 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

iRhythm Holdings, Inc. (IRTC) came out with quarterly earnings of $0.58 per share, beating the Zacks Consensus Estimate of a loss of $0.01 per share. This compares to a loss of $0.32 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +5,900.00%. A quarter ago, it was expected that this company would post a loss of $0.56 per share when it actually produced a loss of $0.35, delivering a surprise of +37.5%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. IRHYTHM HLDGS, which belongs to the Zacks Medical Info Systems industry, posted revenues of $224.17 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 2.18%. This compares to year-ago revenues of $186.69 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. IRHYTHM HLDGS shares have lost about 29.8% since the beginning of the year versus the S&P 500's gain of 12.8%. While IRHYTHM HLDGS has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for IRHYTHM HLDGS was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.03 on $220.97 million in revenues for the coming quarter and $0.13 on $881.52 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical Info Systems is currently in the top 28% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the broader Zacks Medical sector, Outlook Therapeutics, Inc. (OTLK), has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.09 per share in its upcoming report, which represents a year-over-year change of +79.6%. The consensus EPS estimate for the quarter has been revised 12.5% higher over the last 30 days to the current level. Outlook Therapeutics, Inc.'s revenues are expected to be $1.2 million, down 20% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report iRhythm Holdings, Inc. (IRTC) : Free Stock Analysis Report Outlook Therapeutics, Inc. (OTLK) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

The market expects Outlook Therapeutics, Inc. (OTLK) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.09 per share in its upcoming report, which represents a year-over-year change of +79.6%. Revenues are expected to be $1.2 million, down 20% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 12.5% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Outlook Therapeutics, Inc., the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +42.31%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Outlook Therapeutics, Inc. will most likely beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Outlook Therapeutics, Inc. would post a loss of$0.12 per share when it actually produced a loss of -$0.16, delivering a surprise of -33.33%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Outlook Therapeutics, Inc. appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Ovid Therapeutics (OVID), another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report loss per share of $0.1 for the quarter ended June 2026. This estimate points to a year-over-year change of -66.7%. Revenues for the quarter are expected to be $0.15 million, down 97.6% from the year-ago quarter. The consensus EPS estimate for Ovid Therapeutics has remained unchanged over the last 30 days. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -6.94%. When combined with a Zacks Rank of #2 (Buy), this Earnings ESP makes it difficult to conclusively predict that Ovid Therapeutics will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Outlook Therapeutics, Inc. (OTLK) : Free Stock Analysis Report Ovid Therapeutics (OVID) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

We expect Outlook Therapeutics OTLK to beat expectations when it reports third-quarter fiscal 2026 results later this month. In the last reported quarter, the company delivered a negative earnings surprise of 33.33%. The Zacks Consensus Estimate for revenues is pegged at $1.20 million, while the same for earnings is pinned at a loss of 9 cents per share. Let us see how things might have shaped up for OTLK in the soon-to-be-reported quarter. Being a single-asset biotechnology company, Outlook Therapeutics’ growth is entirely centered on its sole product, Lytenava, approved for the treatment of patients with wet age-related macular degeneration (wet AMD). The drug has been commercialized across the European Union and the United Kingdom since 2024. The most significant milestone during the quarter was the U.S. approval of Lytenava in late July for the said indication, ahead of schedule. The approval followed the successful resubmission of the biologics license application in June after the company resolved issues raised in the FDA's complete response letter in December 2025. The company expects to launch the product in the United States by the end of this year. Over the past few quarters, Outlook Therapeutics has generated modest revenues from sales of the drug in ex-U.S. markets, with investors expecting stronger commercial momentum ahead of the planned U.S. launch. OTLK is likely to have continued incurring losses in the to-be-reported quarter as it invests in U.S. commercial infrastructure and launch activities. However, investors will be looking for sequential improvement in European product sales, with Lytenava already launched in selected markets, as management previously noted a recovery in unit sales following an initial slowdown. Beyond quarterly financial performance, the earnings call is expected to provide important updates on the timing of the U.S. commercial rollout, inventory availability, reimbursement progress and management's expectations for revenue generation during the remainder of fiscal 2026. Outlook Therapeutics, Inc. price-consensus-chart | Outlook Therapeutics, Inc. Quote Outlook Therapeutics has a dismal history of earnings surprises. The company’s earnings missed estimates in three of the trailing four quarters, while beating the same on the remaining occasion, delivering an average negative surprise of 15.79%. Year to date, shares of Outlook Therapeutics have lost 38.2% against the industry’s 2.7% growth. Image Source: Zacks Investment Research Our proven model predicts an earnings beat for OTLK this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is the case here, as you will see below. You can uncover the best stocks to buy or sell before they are reported with our Earnings ESP Filter. Earnings ESP: Outlook Therapeutics has an Earnings ESP of +42.31% as the Most Accurate Estimate currently stands at a loss of 5 cents and the Zacks Consensus Estimate of loss is pegged at 9 cents. Zacks Rank: Outlook Therapeutics currently carries a Zacks Rank #3. You can see the complete list of today’s Zacks #1 Rank stocks here. Here are a few other stocks worth considering from the healthcare space, as our model shows that these too have the right combination of elements to beat on earnings this reporting cycle. Harmony Biosciences HRMY has an Earnings ESP of +14.14% and a Zacks Rank #1 at present. Shares of HRMY have lost 5.6% over the past six months. The company’s earnings missed estimates in each of the trailing four quarters, delivering a negative average surprise of 25.16%. ACADIA Pharmaceuticals ACAD has an Earnings ESP of +25.00% and a Zacks Rank #2 at present. Shares of ACAD have risen 6.8% over the past six months. The company’s earnings beat estimates in three of the trailing four quarters but missed in the remaining quarter, delivering an average surprise of 20.83%. Arcutis Biotherapeutics ARQT has an Earnings ESP of +52.94% and a Zacks Rank #2 at present. Shares of ARQT have risen 3% over the past six months. The company’s earnings beat estimates in three of the trailing four quarters but missed in the remaining quarter, delivering an average surprise of 42.78%. ARQT is scheduled to report second-quarter results on Aug. 5. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Outlook Therapeutics, Inc. (OTLK) : Free Stock Analysis Report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report Arcutis Biotherapeutics, Inc. (ARQT) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

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 (GLOBE NEWSWIRE) -- 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 extinguishment of debt, and $6.8 million of gain from change in fair value of warrant liability. Adjusted net loss attributable to common stockholders for the fiscal quarter ended March 31, 2025, excludes $33.9 million of warrant inducement expenses, $2.1 million of gain from change in fair value of warrant liability, and $2.1 million of loss from change in fair value of promissory notes. Net revenue in the fiscal quarter ended March 31, 2026, was offset by recurring fixed distribution costs during the quarter. Overall, unit sales of LYTENAVA in Europe for the second fiscal quarter of 2026 were down approximately 10% compared to the quarter ended December 31, 2025, but have trended upward early in the current quarter. Outlook Therapeutics has taken steps to reduce costs in Europe in an effort to improve margins in future quarters. In March 2026, Outlook Therapeutics reported that it had restructured its outstanding convertible promissory note to extend the maturity until December 2026, as well as entered into a non-convertible promissory note that was used to reduce the outstanding balance of the convertible note. Additionally, the Company completed a public offering of common stock and accompanying warrants in March 2026, for approximately $4.0 million of net proceeds, after deducting placement agent fees and other offering expenses. In April 2026, the Company completed a registered direct offering of common stock and, in a concurrent private placement, accompanying warrants, for $4.2 million of net proceeds, after deducting placement agent fees and other offering expenses. As of March 31, 2026, Outlook Therapeutics had cash and cash equivalents of $7.7 million, which does not include the net proceeds of the April 2026 registered direct offering. About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and a Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In the United States, ONS-5010/LYTENAVA ™ (bevacizumab-vikg) is investigational. In certain European Union Member States, ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) 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 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 focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retinal diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD. In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. Non-GAAP Financial Measures Outlook Therapeutics prepares its consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant to accounting requirements of the Securities and Exchange Commission (SEC). In an effort to provide investors with additional information regarding the results and to provide a meaningful period-over-period comparison of Outlook Therapeutics’ financial performance, Outlook Therapeutics sometimes uses non-U.S. GAAP financial measures (NGFM) as defined by the SEC. In this press release, Outlook Therapeutics uses “adjusted net loss attributable to common stockholders,” which is defined as net loss attributable to common stockholders excluding warrant inducement expenses, gain on extinguishment of debt and changes in fair value of warrants and convertible promissory notes, as well as “adjusted net loss attributable to common stockholders per share of common stock – basic and diluted,” which is defined as net loss attributable to common stockholders per share of common stock – basic and diluted, excluding warrant inducement expenses, gain on extinguishment of debt and changes in fair value of warrants and convertible promissory notes. Management uses these NGFMs because they adjust for certain non-cash items that impact financial results but not cash flows, and that management believes are not related to its core business. Management uses these NGFMs to evaluate Outlook Therapeutics’ financial performance against internal budgets and targets. Management believes that these NGFMs are useful for evaluating Outlook Therapeutics’ core operating results and facilitating comparison across reporting periods. Outlook Therapeutics believes these NGFMs should be considered in addition to, and not in lieu of, GAAP financial measures. Outlook Therapeutics’ NGFMs may be different from the same NGFMs used by other companies. Reconciliations to the closest U.S. GAAP financial measures are provided in the tables below. Forward-Looking Statements This press release contains statements that are, or may be deemed to be “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,” “are,” “believe,” “can,” “continue,” “expect,” “may,” “on track,” “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, expectations concerning Outlook Therapeutics’ ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, expectations concerning decisions of regulatory bodies and the timing thereof, including market exclusivity, the potential to receive approval from the FDA and the timing thereof, statements about Outlook Therapeutics’ commercialization strategy, including plans for commercial launch of LYTENAVA™ in additional markets and the timing thereof and potential partnerships in those countries, expectations regarding receipt of Marketing Authorization for LYTENAVA™ in Switzerland, expectations concerning Outlook Therapeutics’ partnership with Mediconsult AG in Switzerland, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD, the market opportunity for LYTENAVA™ in Europe and the United States, expectations concerning Outlook’s financial performance and condition, 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 and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, 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, 2025, filed with the SEC on December 19, 2025, as supplemented by future 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 global geopolitical conflict, tariffs and trade tensions, fluctuations in interest rates and 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: Jenene Thomas Chief Executive Officer JTC Team, LLC T: 908.824.0775 [email protected]

Continued expansion of LYTENAVA™ (bevacizumab gamma) in Europe underway, including commercial launch in Austria in January 2026 Additional European launches expected in 2026 Type A meeting request submitted to the U.S. Food and Drug Administration for ONS-5010 ISELIN, N.J., Feb. 17, 2026 (GLOBE NEWSWIRE) -- 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 first quarter fiscal year 2026 and provided a corporate update. “LYTENAVA™ (bevacizumab gamma) is demonstrating increasing adoption in Europe following our initial launches, with growing demand and quarter-over-quarter unit sales growth,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “Building on this momentum, we are actively working towards launching into additional EU markets in the near term, following our January launch into Austria, as part of a broader regional expansion strategy.” In addition to the planned launches of LYTENAVA in Ireland and the Netherlands in 2026, followed by France, Italy and Spain in 2027, Outlook Therapeutics also continues with its efforts to potentially partner with established companies in other countries in Europe, Latin America and Asia. Financial Highlights for the Fiscal First Quarter Ended December 31, 2025 For the fiscal first quarter ended December 31, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $23.1 million, or $ 0.38 per basic and diluted share. This compares with net income attributable to common stockholders of $17.4 million, or $0.72 per basic and diluted share for the same period last year. For the fiscal first quarter ended December 31, 2025, Outlook Therapeutics reported an adjusted net loss attributable to common stockholders of $13.5 million, or $0.22 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $21.6 million, or $0.89 per basic and diluted share for the first fiscal quarter of 2025. Adjusted net loss attributable to common stockholders for the fiscal quarter ended December 31, 2025 excludes $6.7 million of loss from change in fair value of promissory notes and $2.8 million of loss from change in fair value of warrant liability. Adjusted net loss attributable to common stockholders for the fiscal quarter ended December 31, 2024 excludes $40.3 million of gain from change in fair value of warrant liability and $1.3 million of loss from change in fair value of promissory notes. Revenue in the fiscal quarter ended December 31, 2025 was negatively impacted by an increase in the returns reserve for estimated product returns from the UK distributor resulting from short dated product used for the initial shipments into the distribution channel in June 2025 to support the launch of LYTENAVA in Europe. No further adjustments for these batches are anticipated for the remainder of fiscal year 2026. Overall, unit sales of LYTENAVA in Europe more than doubled in the quarter ended December 31, 2025, as compared to the previous three months. As of December 31, 2025, Outlook Therapeutics had cash and cash equivalents of $8.7 million, which does not include $2.4 million of net proceeds from sales under its at-the-market offering program after December 31, 2025. ONS-5010 U.S. Regulatory Update Outlook Therapeutics has requested a Type A meeting with the U.S. Food and Drug Administration to discuss the Complete Response Letter (CRL) dated December 30, 2025, regarding the Company’s Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic bevacizumab formulation for the treatment of wet age-related macular degeneration (wet AMD). The Company submitted the Type A meeting request to work with the FDA on a path forward to resolving the FDA’s request for additional confirmatory evidence. The timing of the Type A meeting is subject to FDA scheduling, and further updates will be provided as appropriate. “Outlook Therapeutics remains fully committed to advancing ONS-5010 in the United States,” Mr. Jahr continued. “Our ongoing discussions with the FDA beginning in September 2025 have confirmed alignment on CMC, safety, and the positive results from NORSE TWO, and we look forward to constructive discussions with the FDA as we seek guidance on confirmatory evidence that will withstand current dynamics.” The CRL identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence. Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence of effectiveness. Prior to submitting the Type A meeting request, Outlook Therapeutics conducted informal meetings with the FDA to discuss the CRL. About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In the United States, ONS-5010/LYTENAVA ™ (bevacizumab-vikg) is investigational. In certain European Union Member States ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) 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 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 focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD. In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. Non-GAAP Financial Measures Outlook Therapeutics prepares its consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant to accounting requirements of the Securities and Exchange Commission (SEC). In an effort to provide investors with additional information regarding the results and to provide a meaningful period-over-period comparison of Outlook Therapeutics’ financial performance, Outlook Therapeutics sometimes uses non-U.S. GAAP financial measures (NGFM) as defined by the SEC. In this press release, Outlook Therapeutics uses “adjusted net loss attributable to common stockholders,” which is defined as net loss attributable to common stockholders excluding warrant inducement expenses and changes in fair value of warrants and convertible promissory notes, as well as “adjusted net loss attributable to common stockholders per share of common stock – basic and diluted,” which is defined as net loss attributable to common stockholders per share of common stock – basic and diluted, excluding changes in fair value of warrants and convertible promissory notes. Management uses these NGFMs because they adjust for certain non-cash items that impact financial results but not cash flows and that management believes are not related to its core business. Management uses these NGFMs to evaluate Outlook Therapeutics’ financial performance against internal budgets and targets. Management believes that these NGFMs are useful for evaluating Outlook Therapeutics’ core operating results and facilitating comparison across reporting periods. Outlook Therapeutics believes these NGFMs should be considered in addition to, and not in lieu of, GAAP financial measures. Outlook Therapeutics’ NGFMs may be different from the same NGFMs used by other companies. Reconciliations to the closest U.S. GAAP financial measures are provided in the tables below. Forward-Looking Statements This press release contains statements that are, or may be deemed to be “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,” “are,” “believe,” “can,” “continue,” “expect,” “may,” “on track,” “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, plans for commercial launch of LYTENAVA™ in additional markets, either directly or with a partner, and the timing thereof, expectations concerning Outlook Therapeutics’ plans to conduct a Type A meeting with the FDA and the ability to remediate or otherwise resolve deficiency identified in the CRL, expectations concerning decisions of regulatory bodies and the timing thereof, the potential to receive approval from the FDA, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD, the market opportunity for LYTENAVA™ in Europe and the United States, 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 and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, including the risk that Outlook Therapeutics is not able to provide sufficient evidence to support the approval by the FDA of the ONS-5010 BLA, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, 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, 2025, filed with the SEC on December 19, 2025, as supplemented by future 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 conflicts, tariffs and trade tensions, fluctuations in interest rates and 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: Jenene Thomas Chief Executive Officer JTC Team, LLC T: 908.824.0775 [email protected]

ISELIN, N.J., Dec. 19, 2025 (GLOBE NEWSWIRE) -- 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 fiscal year 2025. Financial Highlights for the Fiscal Year Ended September 30, 2025 For the fiscal year ended September 30, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $62.4 million, or $1.79 per basic and diluted share, and $1.4 million of revenue. This compares with net loss attributable to common stockholders of $75.4 million, or $4.06 per basic and diluted share, and no revenue for the prior year. Revenue in fiscal 2025 consisted of the initial sales in June 2025 into the sales channels in Germany and the UK for LYTENAVA™ (bevacizumab gamma) where title to the product has transferred to the distributor. Overall, there has been a sustained increase in both the number of accounts ordering LYTENAVA™ and the breadth of prescribing clinicians across both markets during the early stages of fiscal year 2026. In addition to optimal market access and pricing at the national and sub-national level in both the UK and Germany, recent developments that should contribute to continued improvements in unit sales include LYTENAVA™ acceptance into the tender framework in the UK in December 2025 and the initiation of a multi-center non-interventional study in Germany to gather real-world data. Gross profit for fiscal 2025 was impacted negatively due to increased reserves for short-dated inventory included in the original shipments to the UK in June 2025. Overall expenses in fiscal 2025 were $4.6 million lower than fiscal 2024 primarily due to a significant reduction in R&D expenses associated with the completion of the NORSE Eight clinical trial in fiscal 2024. The reduction in R&D expenses was partially offset by increased SG&A expenses primarily related to launching LYTENAVA™ in Europe in June 2025. As of September 30, 2025, Outlook Therapeutics had cash and cash equivalents of $8.1 million, which does not include $14.9 million of net proceeds from sales under its at-the-market offering program after September 30, 2025. “Over the course of fiscal year 2025, our team has worked diligently to position Outlook Therapeutics for success. We are preparing now for potential approval and progressing commercial launch activities in the U.S., as we await a decision from the FDA in just a few short weeks,” commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “In Europe, our initial shipments of inventory are being used to prime and prepare to grow the market. Commercial activities remain ongoing as we push ahead with our efforts to expand into the next wave of country launches, including Austria and the Netherlands. Outside the U.S., we continue to identify potential partners for additional expansion. As we close out the remainder of 2025, our commitment remains focused on providing patients and physicians with access to an approved ophthalmic formulation of bevacizumab.” Upcoming Near Term Milestone U.S. Food and Drug Administration (FDA) PDUFA goal date for ONS-5010 is December 31, 2025. About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. In certain European Union Member States, ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) 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 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 focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD. In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. Forward-Looking Statements This press release contains statements that are, or may be deemed to be “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 “aim,” “anticipate,” “believe,” “can,” “continue,” “expect,” “may,” “on track,” “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, expectations concerning future levels of sales for LYTENAVA™, plans for commercial launch of LYTENAVA™ in additional markets and the timing thereof, expectations concerning decisions of regulatory bodies and the timing thereof, including market exclusivity, the potential to receive approval from the FDA and the timing thereof, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD, the market opportunity for LYTENAVA™ in Europe and the United States, 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 and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, including the risk that the data from the NORSE EIGHT trial does not support the approval by the FDA of the ONS-5010 BLA, the content and timing of decisions by regulatory bodies, the acceptance of Outlook Therapeutics’ products by healthcare professionals and patients as safe, effective, and cost-effective, the impact of governmental and semi-governmental laws, regulations and guidelines, reliance on third-party service providers, suppliers, and manufacturers, the sufficiency of Outlook Therapeutics’ resources, 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, 2024, filed with the SEC on December 27, 2024, as supplemented by the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025 and future 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 conflicts, tariffs and trade tensions, fluctuations in interest rates and 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: Jenene Thomas Chief Executive Officer JTC Team, LLC T: 908.824.0775 [email protected]