Outlook Therapeutics, Inc. develops and commercializes ONS-5010/LYTENAVA, an ophthalmic formulation of bevacizumab for retina diseases, including wet age-related macular degeneration. Company news commonly covers the product’s European Commission and MHRA marketing authorizations, commercial launch activity in Germany, Austria and the UK, and U.S. regulatory communications involving the biologics license application pathway for neovascular AMD.
Updates also include capital-structure actions used to fund operations, such as public offerings, registered direct offerings, warrants, convertible-note amendments and note financing. Governance and shareholder-approval matters appear in connection with securities issuance and authorized-share requirements.
Outlook Therapeutics (OTLK) named Greg DiPasquale Chief Commercial Officer to lead its commercial functions as it prepares for LYTENAVA’s U.S. launch. The company plans to make LYTENAVA (bevacizumab-vikg), an FDA-approved ophthalmic formulation of bevacizumab for wet age-related macular degeneration, available to eligible U.S. patients before the end of 2026.
DiPasquale joined Outlook in December 2025 as Head of Commercial for LYTENAVA. His responsibilities include market access, commercial operations, marketing, sales and reimbursement. He brings more than 30 years of commercial leadership experience, including nearly two decades in eye care. LYTENAVA will be his fifth retina launch, following BEOVU at Novartis, the EYLEA prefilled syringe and EYLEA HD at Regeneron, and the TRIESENCE relaunch at Harrow.
Outlook Therapeutics (Nasdaq: OTLK) participated in a Virtual Investor discussion featuring recently appointed Chief Financial Officer Kevin Lundquist on the company’s direction.
Lundquist discussed his decision to join following FDA approval of LYTENAVA for wet age-related macular degeneration, a retinal disease. He outlined the company’s plans to support a U.S. commercial launch. The recorded segment is available to watch online.
Outlook Therapeutics (OTLK) submitted an application to CMS for a permanent, product-specific J-code for LYTENAVA to support U.S. reimbursement. LYTENAVA (bevacizumab-vikg) is FDA-approved for wet age-related macular degeneration, a retinal disease. The company remains on track for a U.S. commercial launch before year-end 2026, with preparations focused on market access, reimbursement, practice readiness and supply.
A J-code is a standardized billing identifier used by government and commercial payers for physician-administered treatments. Outlook Therapeutics expects a permanent code would simplify billing, reduce administrative work and support practice adoption and patient access. The application does not guarantee code assignment. Assignment is separate from coverage and payment decisions and does not guarantee reimbursement by Medicare or other payers.
Outlook Therapeutics (OTLK) announced that its pre-recorded fireside chat from the H.C. Wainwright 28th Annual Global Investment Conference is now available for on-demand viewing starting September 11, 2026, at 7:00 a.m. ET.
The discussion features Chief Executive Officer Bob Jahr and H.C. Wainwright Managing Director and Senior Biotechnology Equity Research Analyst Douglas Tsao covering the company’s recent developments. The webcast can be accessed via the News & Events page in the Investors section of outlooktherapeutics.com. Management will also attend the New York conference on September 14-16, 2026, for one-on-one meetings with qualified, registered investors.
Outlook Therapeutics (OTLK) highlighted FDA approval and the commercial opportunity for its retinal therapy LYTENAVA™ in a Virtual Investor CEO Connect segment featuring CEO Bob Jahr.
The company said LYTENAVA is the only FDA-approved ophthalmic formulation of bevacizumab for treating neovascular (wet) age-related macular degeneration (nAMD) in the United States and described plans for a U.S. launch before the end of 2026. Management discussed the potential to convert current off-label bevacizumab use to LYTENAVA and cited an opportunity to achieve more than $500 million in annual U.S. sales by 2030. The segment also reviewed commercial readiness across manufacturing, distribution, market access, reimbursement, and physician education, as well as lessons from LYTENAVA’s commercialization in Europe, where it holds centralized EU and UK marketing authorizations and has launched in Germany, Austria, and the UK.
Outlook Therapeutics (Nasdaq: OTLK) appointed Kevin Lundquist as Chief Financial Officer, effective September 1, 2026, as it builds financial and operational infrastructure for the planned U.S. commercial launch of LYTENAVA™ following its FDA approval for wet age-related macular degeneration (wet AMD).
Lundquist brings more than 20 years of corporate finance and capital markets experience across pharmaceutical, biotechnology, medical technology, and manufacturing businesses, including IPO support, SEC reporting, capital raising, M&A, and commercial operations leadership. He previously held senior roles at CapsoVision, Abzena Biologics, Revance Therapeutics, Genentech/Roche, Caterpillar Japan, and Abbott Laboratories.
Lawrence Kenyon will step down as CFO on September 1, 2026 and remain as a non-executive employee through September 30, 2026. Outlook Therapeutics also approved an inducement stock option grant for Lundquist covering 500,000 shares, vesting over four years.
Outlook Therapeutics (Nasdaq: OTLK) announced that CEO Bob Jahr participated in the Virtual Investor “Why Now” on-demand conference. The segment focuses on the company’s transition after FDA approval of LYTENAVA™ (bevacizumab-vikg) for wet age-related macular degeneration (wet AMD) in the U.S. on July 24, 2026.
According to Outlook Therapeutics, Jahr discussed moving from a development-stage to a commercial-stage company, U.S. launch preparations, the company’s existing commercial presence in Europe, and the opportunity for an FDA-approved ophthalmic bevacizumab in a market where bevacizumab is widely used off label. The webcast is now available for on-demand viewing.
Outlook Therapeutics (Nasdaq: OTLK) reported third quarter fiscal 2026 results and highlighted FDA approval of LYTENAVA™ (bevacizumab-vikg), the only FDA‑approved ophthalmic bevacizumab for treating wet age‑related macular degeneration (wet AMD) in the U.S. The company is preparing a U.S. launch before the end of calendar 2026, including payer engagement, commercial supply scaling, and a planned HCPCS reimbursement code application by October 1, 2026.
For the quarter ended June 30, 2026, OTLK posted a net loss attributable to common stockholders of $20.3 million, or ($0.15) per share, versus a $20.2 million loss, or ($0.55) per share, a year earlier. Adjusted net loss improved to $10.9 million from $15.8 million. Revenue declined to $9,000 from $1.5 million, with negative gross profit. Cash and cash equivalents were $11.2 million at quarter‑end.
Subsequent to quarter close, Outlook Therapeutics completed a public offering of 55,555,556 shares and accompanying warrants, generating approximately $51.1 million in net proceeds. Commercialization of LYTENAVA is underway in Germany, Austria and the UK, with launches planned in the Netherlands in 2026 and Switzerland in 2027 via partner Mediconsult.
Outlook Therapeutics (Nasdaq: OTLK) priced an underwritten public offering of 55,555,556 shares of common stock and accompanying warrants to purchase up to 55,555,556 shares. The combined public offering price per share and warrant is $0.99, with warrants exercisable immediately at $1.10 and expiring five years after issuance.
Underwriters have a 30-day option to buy up to 8,333,333 additional shares and/or warrants. Gross proceeds are expected to be about $55.0 million before fees, with closing expected on August 14, 2026. According to Outlook Therapeutics, net proceeds will support the planned U.S. commercial launch of LYTENAVA and general corporate purposes.
Outlook Therapeutics (Nasdaq: OTLK) has commenced an underwritten public offering of common stock and accompanying warrants to purchase common shares. All securities in the proposed deal will be sold by the company, with Piper Sandler and BTIG acting as joint bookrunning managers.
Outlook Therapeutics expects to grant underwriters a 30-day option to buy up to 15% additional shares and/or warrants on the same terms. Net proceeds, together with existing cash, are intended to fund the planned U.S. commercial launch of LYTENAVA for retinal diseases, and for working capital and general corporate purposes.