Outlook Therapeutics Inc Stock Price, News & Analysis

Outlook Therapeutics (NASDAQ:OTLK), a biopharmaceutical company developing bevacizumab treatments for retina diseases, announced its participation in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference. Bob Jahr, the company's newly appointed CEO, shared his professional journey and vision for the company's future in a video presentation.

The presentation is now accessible to investors through the Virtual Investor website and Outlook Therapeutics' investor relations page.

Outlook Therapeutics (NASDAQ: OTLK) has appointed Bob Jahr as its new Chief Executive Officer and Board member. Jahr brings over 20 years of biopharmaceutical industry experience specializing in building and leading commercial teams across various therapeutic areas including rare disease, oncology, and neuroscience.

The appointment comes at a strategic time as Outlook Therapeutics is launching LYTENAVA™ (bevacizumab-vikg) in Europe and awaiting potential FDA approval in the United States. Lawrence A. Kenyon, who served as interim CEO, will continue as Chief Financial Officer and Board member.

As part of his employment agreement, Jahr will receive an inducement grant of options to purchase 800,000 shares of common stock, vesting over four years with 25% vesting in the first year and the remainder monthly over three years.

[ "Strategic timing of CEO appointment coincides with European launch of LYTENAVA™ and pending FDA approval", "New CEO brings extensive commercial leadership experience with multiple billion-dollar assets", "Continued stability with CFO Lawrence Kenyon remaining in his role" ]

Outlook Therapeutics (NASDAQ: OTLK) announced its participation in a Virtual Investor Lunch Break Event scheduled for June 25, 2025, at 12:00 PM ET. The company's leadership team, including Lawrence Kenyon (CFO and Interim CEO), Jeff Evanson (CCO), and Jedd Comiskey (SVP - Head of Europe), will discuss commercial strategy, upcoming milestones, and current activities. The event will feature a moderated discussion followed by a live Q&A session. Investors can access the live video webcast through the Events page on Outlook Therapeutics' website, with a replay available for 90 days after the event.

Outlook Therapeutics (NASDAQ: OTLK) has received Scottish Medicines Consortium (SMC) recommendation for LYTENAVA (bevacizumab gamma) to treat wet age-related macular degeneration (wet AMD) within NHS Scotland. LYTENAVA is the first licensed ophthalmic formulation of bevacizumab for wet AMD in the UK, with 10 years of market exclusivity. The recommendation follows successful clinical trials (NORSE ONE, TWO, and THREE) and the recent commercial launch in the UK. Outlook has partnered with Cencora for global distribution support, aiming to enhance market access in the EU, UK, and potentially the US pending approval.

Outlook Therapeutics (NASDAQ: OTLK) has launched LYTENAVA (bevacizumab gamma), the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment, in Germany and the UK. This marks a significant milestone as the drug addresses the current practice of using off-label repackaged bevacizumab, which accounts for approximately 2.8 million injections annually in Europe. The company has partnered with Cencora (formerly AmerisourceBergen) for global commercial distribution and plans additional European launches throughout 2025 and 2026. LYTENAVA aims to mitigate risks associated with current off-label bevacizumab use while maintaining the standard of care for retinal diseases.

Outlook Therapeutics (OTLK) has announced the pricing of a $13.0 million public offering of common stock and warrants. The offering consists of 9,285,714 shares of common stock priced at $1.40 per share, with each share accompanied by warrants to purchase two additional shares. The warrants have an exercise price of $1.40 per share, are immediately exercisable, and will expire in five years. The offering is expected to close on May 27, 2025. BTIG, LLC serves as the sole book-running manager. The company plans to use the proceeds for working capital and general corporate purposes.

Outlook Therapeutics (OTLK), a biopharmaceutical company specializing in bevacizumab treatments for retina diseases, has announced a proposed public offering of common stock and warrants. The offering will be managed by BTIG, LLC as the sole book-running manager. The company plans to use the proceeds for working capital and general corporate purposes.

The securities will be offered under a previously effective shelf registration statement (Form S-3, No. 333-278340). The final size, terms, and completion of the offering are subject to market conditions and cannot be guaranteed. A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC.

Outlook Therapeutics (OTLK) reported its Q2 FY2025 financial results and provided key updates. The company is preparing for the commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK in Q2 CY2025, following Marketing Authorization approvals in both regions. In the US, OTLK awaits FDA decision for ONS-5010 with a PDUFA date of August 27, 2025. The company reported a net loss of $46.4 million ($1.50 per share) and had cash reserves of $7.6 million as of March 31, 2025. LYTENAVA™ is positioned as the first authorized ophthalmic formulation of bevacizumab for wet AMD treatment, targeting a market where approximately 2.8 million off-label injections are administered annually in Europe and 2.7 million in the US. The company has partnered with Cencora for global commercial distribution.

Outlook Therapeutics (Nasdaq: OTLK) announced the FDA's acceptance of their resubmitted Biologics License Application (BLA) for ONS-5010, their ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD). The FDA designated it as a Class 2 review with a PDUFA goal date of August 27, 2025.

If approved, ONS-5010 will be marketed as LYTENAVA™ in the United States and is expected to receive 12 years of regulatory exclusivity. The resubmission includes efficacy and safety data from the NORSE EIGHT trial, along with additional chemistry, manufacturing, and controls information requested by the FDA.

The company has already secured regulatory approval for this treatment in the European Union and United Kingdom, marking it as the first authorized ophthalmic formulation of bevacizumab for wet AMD in these regions.