Veteran ophthalmology leader with 35+ years of market expertise selected as exclusive Switzerland partnerMediconsult to seek Marketing Authorization and lead commercialization activities for LYTENAVA™ (bevacizumab gamma) in SwitzerlandPartnership advances European commercial expansion strategy, with LYTENAVA™ (bevacizumab gamma) expected to launch in Switzerland in 2027 ISELIN, N.J., Feb. 19, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing ...

Product Launch and Market Overview - The company launched LYTENAVA (bevacizumab gamma) in Germany and the UK in June 2025, with plans for further expansion into other EU countries and potential U.S. approval [105]. - The total anti-VEGF retina market in Europe is estimated at approximately $3.6 billion, with around 1.52 million treated patients and 8.3 million total anti-VEGF units [106]. - The U.S. anti-VEGF retina market is estimated at $8.5 billion, with 55% of physicians preferring off-label repackaged bevacizumab as the first-line product [107]. - The global market for anti-VEGF retina is estimated to be approximately $16 billion [108]. - The company recognizes revenue from sales of LYTENAVA, which became available for commercial sale in the UK and Germany in June 2025 [121]. Financial Performance - The company reported a net loss of $23.1 million for the three months ended December 31, 2025, compared to a net income of $17.4 million for the same period in 2024 [115]. - For the three months ended December 31, 2025, the company reported net revenue of negative $1.2 million, primarily due to a $1.1 million increase in the returns reserve related to estimated product returns from the UK distributor [144]. - The company incurred a loss from operations of $13.5 million for the three months ended December 31, 2025, an improvement of $8.1 million compared to the loss of $21.6 million in the same period of 2024 [143]. - The company has not generated significant revenue from product sales and continues to incur net losses and negative cash flows from operations [152]. - As of December 31, 2025, the company reported a net cash used in operating activities of $14.9 million, primarily due to a net loss of $23.1 million [168]. Expenses and Cost Management - Research and development expenses for the three months ended December 31, 2025 totaled $3.6 million, a decrease of $6.0 million compared to the same period in 2024, mainly due to reduced expenses for the ONS-5010/LYTENAVA development [146][147]. - Selling, general and administrative expenses for the three months ended December 31, 2025 were $8.6 million, down $3.3 million from the prior year, attributed to decreased compensation and professional fees, partially offset by increased launch expenses for LYTENAVA in Europe [148]. - The total research and development expenses for the three months ended December 31, 2025 included $2.6 million specifically for ONS-5010/LYTENAVA development [146]. Going Concern and Financial Obligations - There is substantial doubt about the company's ability to continue as a going concern, as existing cash and cash equivalents are insufficient to fund operations for the next year [120]. - As of December 31, 2025, the company did not meet the required $3.0 million Quarterly Debt Reduction Obligation, resulting in a Major Trigger Event [116]. - A Major Trigger Event occurred due to the failure to meet a $3.0 million Quarterly Debt Reduction Obligation, resulting in a 10% increase to the outstanding balance of the March 2025 Note [160]. - The company plans to finance future operations through a combination of licensing arrangements, debt issuance, and equity sales, but faces potential dilution of ownership for existing shareholders [166]. Future Outlook and Strategic Plans - The company anticipates ongoing increases in general and administrative expenses as it expands its commercial presence and prepares for potential launches in additional territories [130]. - The company anticipates incurring additional losses until significant sales of ONS-5010/LYTENAVA or any other product candidates are generated, necessitating additional financing for future operations [153]. - The company plans to work with the FDA to discern a regulatory pathway for ONS-5010 and prepare for its potential launch, while expecting to incur net losses and negative cash flow from operations for the foreseeable future [163]. Stock and Financing Activities - The company sold 5,000,000 shares of common stock under the ATM Agreement, generating $2.4 million in net proceeds [118]. - The company generated approximately $14.9 million in net proceeds from the sale of 10,227,166 shares of common stock under the ATM Offering during the three months ended December 31, 2025 [156]. - The March 2025 Note issued for $33.1 million is convertible into common stock and bears interest at the prime rate plus 3%, with a minimum interest rate of 9.5% [173]. - The Conversion Price for the March 2025 Note is set at $2.26 per share prior to a Major Trigger Event, with adjustments for stock splits and combinations [179]. - Following the Major Trigger Event, the outstanding balance of the March 2025 Note automatically increased by 10% effective January 1, 2026 [181]. - The adjusted Conversion Price after the Major Trigger Event is the lesser of $2.26 or 90% of the lowest closing bid price over the three trading days preceding the conversion notice, with a floor price of $0.404 [181]. Accounting and Reporting - The Critical Accounting Policies and Significant Judgments and Estimates have not materially changed from the previous fiscal year ended September 30, 2025 [182]. - As a "Smaller Reporting Company," the company is not required to disclose certain market risk information [183].

Oncobiologics, Inc. (OTLK) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to a loss of $0.89 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -26.95%. A quarter ago, it was expected that this company would post a loss of $0.23 per share when it actually produced a loss of $0.22, delivering a surprise of +4.35%.Over the last four quarters, the company has s ...

Financial Performance - For the fiscal first quarter ended December 31, 2025, Outlook Therapeutics reported a net loss of $23.1 million, or $0.38 per share, compared to a net income of $17.4 million, or $0.72 per share for the same period last year [3]. - The adjusted net loss for the same quarter was $13.5 million, or $0.22 per share, an improvement from an adjusted net loss of $21.6 million, or $0.89 per share in the first fiscal quarter of 2025 [4]. - Total assets as of December 31, 2025, were $18.2 million, while current liabilities stood at $49.1 million [22]. - The loss from change in fair value of promissory notes for the quarter was $6.7 million, and the loss from change in fair value of warrant liability was $2.8 million [5]. Revenue and Sales - Revenue for the fiscal quarter was negatively impacted by an increase in the returns reserve for estimated product returns, but unit sales of LYTENAVA in Europe more than doubled compared to the previous quarter [7]. Product Development and Regulatory Matters - A Type A meeting request has been submitted to the U.S. FDA to discuss the Complete Response Letter regarding the Biologics License Application for ONS-5010 [9]. - The company believes the FDA's determination regarding the effectiveness of ONS-5010 is inconsistent with the totality of evidence submitted in the BLA [10]. - Outlook Therapeutics is committed to advancing ONS-5010 in the U.S. and is in ongoing discussions with the FDA regarding the path forward [10]. Expansion Plans - The company is expanding LYTENAVA in Europe, with planned launches in Ireland and the Netherlands in 2026, followed by France, Italy, and Spain in 2027 [2]. Cash Position - 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 that date [8].

Core Insights - Outlook Therapeutics reported a significant net loss of $23.1 million for the first fiscal quarter of 2026, a stark contrast to a net income of $17.4 million in the same period last year, indicating a challenging financial environment for the company [3][20]. - The company is experiencing increasing adoption of its product LYTENAVA™ (bevacizumab gamma) in Europe, with plans for further market expansion in 2026 and 2027 [2][9]. - Outlook Therapeutics is actively engaging with the FDA regarding its investigational product ONS-5010, following a Complete Response Letter that requested additional confirmatory evidence [8][10]. Financial Performance - For the fiscal first quarter ended December 31, 2025, the adjusted net loss attributable to common stockholders was $13.5 million, an improvement from an adjusted net loss of $21.6 million in the same quarter of the previous year [4][24]. - Revenue was negatively impacted by an increase in returns reserve due to short-dated products shipped to support the launch of LYTENAVA in Europe, although unit sales more than doubled compared to the previous quarter [6][20]. - As of December 31, 2025, the company had cash and cash equivalents of $8.7 million, which does not include additional proceeds from its at-the-market offering program [7][23]. Product Development and Regulatory Updates - The company is planning to launch LYTENAVA in additional EU markets, including Ireland and the Netherlands in 2026, followed by France, Italy, and Spain in 2027 [2][9]. - A Type A meeting has been requested with the FDA to discuss the Complete Response Letter regarding ONS-5010, with the company expressing confidence in the evidence submitted for its Biologics License Application [8][10]. - ONS-5010/LYTENAVA™ is positioned as a potential first approved ophthalmic formulation of bevacizumab for retinal indications in the U.S. if regulatory approval is granted [15].

Core Viewpoint - Outlook Therapeutics has submitted a Type A meeting request to the FDA following a Complete Response Letter regarding its Biologics License Application for ONS-5010/LYTENAVA™ for wet AMD treatment, citing a deficiency in evidence of effectiveness [1][2] Group 1: Regulatory Developments - The Complete Response Letter identified a single deficiency related to the lack of substantial evidence of effectiveness and recommended additional confirmatory evidence [2] - Outlook Therapeutics believes the FDA's determination is inconsistent with the totality of evidence submitted, including data from a well-controlled study [2] - The company conducted informal meetings with the FDA prior to submitting the Type A meeting request to discuss the CRL [2] Group 2: Clinical Evidence - ONS-5010 is supported by data from the NORSE TWO Phase 3 trial, which showed statistically significant improvements in visual acuity at 12 months, meeting its primary endpoint [3] - NORSE EIGHT, another Phase 3 study, provided additional evidence of efficacy despite not meeting its primary endpoint at 8 weeks, showing consistent gains in visual acuity [4] - A comprehensive package of confirmatory evidence was submitted, including mechanistic and pharmacodynamic data demonstrating VEGF inhibition [5] Group 3: Safety and Manufacturing - ONS-5010 demonstrated a favorable safety profile, with ocular adverse reactions consistent with the control arm and no safety concerns raised by the FDA [6] - The product is supported by a fully domestic U.S. manufacturing supply chain, enhancing reliability and aligning with public health objectives [7] Group 4: Market Authorization - LYTENAVA™ has received Marketing Authorization in the EU and UK for wet AMD treatment and became commercially available in Germany and the UK in June 2025 [8] - It is the first authorized ophthalmic formulation of bevacizumab for treating wet AMD in the EU and UK [9] - Outlook Therapeutics is exploring collaborations for commercial and distribution partnerships in additional European countries and beyond [8]

Core Viewpoint - Outlook Therapeutics' shares have dropped 66.5% in a week following the FDA's third complete response letter (CRL) rejecting the biologics license application (BLA) resubmission for ONS-5010, an ophthalmic formulation aimed at treating wet age-related macular degeneration (wet AMD) [2][7]. Regulatory Challenges - The FDA first issued a CRL in 2023 due to concerns regarding chemistry, manufacturing, and controls, as well as a lack of substantial evidence, necessitating a second study, the NORSE EIGHT study [3]. - A subsequent CRL in August 2025 cited insufficient evidence of efficacy, as ONS-5010 did not meet the primary efficacy endpoint in the NORSE EIGHT study [4]. - In the latest CRL, the FDA stated that additional data submitted in the November 2025 resubmission did not change its previous assessment, reiterating the need for confirmatory evidence without specifying acceptable forms [5]. Market Performance - Over the past six months, Outlook Therapeutics' shares have plummeted 72%, contrasting with the industry's growth of 19.1% [6]. Product Launch and Approvals - Despite setbacks in the U.S., Outlook Therapeutics has secured EU and UK approval for Lytenava, launching the drug in Germany and the UK in June 2025 [10][11]. - Lytenava is the first authorized ophthalmic formulation of bevacizumab for treating wet AMD in adults within the EU and UK, providing a regulated alternative to off-label Avastin [11]. Future Strategies - Outlook Therapeutics is exploring all available pathways for potential approval of ONS-5010 in the U.S. and is committed to providing alternatives to compounded Avastin [9]. - The company is also evaluating strategic collaborations for expanding its commercial footprint in additional European markets [12].

Core Viewpoint - Outlook Therapeutics, Inc. has appointed Laura Cantrell as Vice President of Corporate Strategy and Business Development to enhance its strategic initiatives and shareholder value during a critical phase of the company's evolution [3][4]. Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg) to improve the standard of care for retinal diseases [6]. - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and MHRA for treating wet AMD, with a commercial launch already commenced in Germany and the UK [6]. Leadership Appointment - Laura Cantrell brings over 20 years of experience in global corporate strategy, business development, and portfolio leadership within the biotechnology and pharmaceutical sectors [4][5]. - Cantrell has held senior roles at notable companies such as Medivation, BeiGene, Sobi, Axovant Sciences, and Genentech/Roche, and has been involved in significant licensing and acquisition initiatives, including Medivation's $14 billion acquisition by Pfizer [4][5]. Strategic Focus - In her new role, Cantrell will lead the business development strategy, focusing on strategic partnerships, licensing opportunities, and corporate development initiatives to support the company's growth [3][4]. - The company aims to advance its mission of delivering a differentiated ophthalmic formulation of bevacizumab while maximizing long-term shareholder value [3].

Market Sentiment - The CNN Money Fear and Greed index showed almost no change in overall market sentiment, remaining in the "Neutral" zone with a reading of 44.6, slightly down from 44.8 [5][6] - U.S. stocks settled mostly higher, with the Dow Jones index gaining over 300 points during the session [1] Stock Performance - The Dow Jones closed higher by approximately 319 points to 48,382.39, while the S&P 500 gained 0.19% to 6,858.47 [4] - Key chip stocks, including Nvidia and Micron Technology, experienced gains during the session [1] Sector Performance - Most sectors on the S&P 500 closed positively, with energy, industrials, and materials stocks recording the biggest gains [4] - Consumer discretionary and communication services stocks closed lower, bucking the overall market trend [4] Company-Specific News - Outlook Therapeutics, Inc. shares dropped over 58% after the FDA issued a complete response letter regarding its biologics license application for the treatment of wet age-related macular degeneration [3]

Company Overview - Intelligent Bio Solutions Inc. (NASDAQ:INBS) announced plans to raise $10 million through a private placement, leading to a significant drop in its share price [1] - Following the announcement, shares of Intelligent Bio fell 19.7% to $7.65 [1] Stock Movements - Lavoro Limited (NASDAQ:LVRO) saw a substantial increase of 181%, reaching $1.2900 [4] - Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) rose 57.7% to $5.32 after issuing FY26 guidance, expecting US net sales of Linzess to be between $1.125 billion and $1.175 billion [4] - Brand Engagement Network, Inc. (NASDAQ:BNAI) jumped 56% to $3.6290 after entering a Vendor Services Project Agreement with a global advertising agency [4] - ChowChow Cloud International Holdings Limited (NYSE:CHOW) increased by 39.7% to $0.8500 due to year-over-year revenue and net income growth in H1 2025 [4] - Sidus Space, Inc. (NASDAQ:SIDU) gained 29% to $4.0314, marking a 470% surge over the past month [4] - Baidu, Inc. (NASDAQ:BIDU) rose 12.1% to $146.57 after announcing a proposed spin-off and Hong Kong listing of its AI unit [4] Declines - Outlook Therapeutics, Inc. (NASDAQ:OTLK) experienced a significant decline of 58% to $0.6632 after receiving a complete response letter from the FDA regarding its biologics license application [4] - ESH Acquisition Corp. (NASDAQ:ESHA) fell 23.5% to $14.68 [4] - Nuvve Holding Corp. (NASDAQ:NVVE) declined 15.3% to $2.1500 after announcing the closing of a private placement [4]