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Envisioning a Better Tomorrow for Ophthalmic Therapies 2024 CORPORATE ANNUAL REPORT Outlook Therapeutics is a biopharmaceutical company working to achieve FDA approval for the launch of ONS-5010/ LYTENAVA (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. NASDAQ: OTLK outlooktherapeutics.com
February 2024 To our valued shareholders, In 2023, Outlook Therapeutics encountered some unexpected challenges. At the end of 2023, the Company was faced with the challenge to chart a path with the FDA to resolve the ONS-5010 / LYTENAVA (bevacizumab-vikg) Complete Response Letter (CRL) we received in August 2023, while securing the necessary capital to support that path forward. In the short time since the start of 2024, I am pleased that we have made significant progress in addressing both challenges and setting the stage for what we believe will be an exciting future for Outlook Therapeutics. Most critically, we reached agreement with FDA on the clinical development path forward for ONS-5010 under a Special Protocol Assessment (SPA). We were able to reach agreement with the FDA on the design and size of NORSE EIGHT, which is our 90 day non-inferiority clinical trial. Additionally, the SPA confirms that if the NORSE EIGHT trial is successful, it would satisfy the FDA s requirement for a second adequate and well-controlled clinical trial to fully address the clinical deficiency identified in the CRL. As we march forward, we remain confident in the potential of ONS-5010 to meet the needs of retina surgeons, patients and payers in the estimated $9.5 billion ophthalmic anti-VEGF market in the United States. With the SPA in place, we are now focused on the execution of NORSE EIGHT, which began dosing subjects in January 2024. We believe that successful completion of NORSE EIGHT, combined with our ongoing work to resolve the Chemistry, Manufacturing and Controls (CMC) comments in the CRL, should allow us to potentially resubmit the ONS-5010 Biologics License Application (BLA) by the end of calendar year 2024. Just as important, we recently announced that we have entered into definitive securities purchase agreements with certain institutional and accredited investors to provide up to $172 million in gross proceeds, before deducting placement agent fees and offering expenses. This financing will add new, fundamental, dedicated healthcare investors into Outlook Therapeutics, alongside additional investment from long-term shareholders, to support the advancement of ONS-5010. Subject to the satisfaction of closing conditions and achievement of milestones, this funding is expected to be sufficient to take ONS-5010 through potential FDA approval and support commercial launch. In light of the progress we have made over the last several months, we are planning for a potential wet AMD FDA approval for our investigational therapy, ONS-5010 as early as 2025. Beyond our regulatory efforts in the United States, our MAA is under review by the European Medicines Agency s (EMA) Committee for Medicinal Products for Human Use (CHMP) in the EU and we expect a decision in early 2024. We wholeheartedly believe that ONS-5010 has the potential to be a significant contribution to the retina community globally and we are excited for the opportunity to provide a bevacizumab treatment option that meets strict ophthalmic standards. On behalf of the entire Outlook Therapeutics team, I thank you for your continued support. We look forward to an exciting year ahead and taking another step closer to our goal to change the treatment landscape for wet AMD. Sincerely, Russell Trenary President & CEO Outlook Therapeutics
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OTLK Shareholder/Stockholder Letter Transcript:

Envisioning a Better Tomorrow for Ophthalmic Therapies
2024
CORPORATE
ANNUAL
REPORT
Outlook Therapeutics is a biopharmaceutical company working to achieve FDA
approval for the launch of ONS-5010/ LYTENAVA    (bevacizumab-vikg) as the
first FDA-approved ophthalmic formulation of bevacizumab for use in retinal
indications, including wet AMD, DME and BRVO.
NASDAQ: OTLK
outlooktherapeutics.com


February 2024
To our valued shareholders,
In 2023, Outlook Therapeutics encountered some unexpected challenges. At the end of 2023, the
Company was faced with the challenge to chart a path with the FDA to resolve the ONS-5010 / LYTENAVA   
(bevacizumab-vikg) Complete Response Letter (CRL) we received in August 2023, while securing the
necessary capital to support that path forward. In the short time since the start of 2024, I am pleased that
we have made significant progress in addressing both challenges and setting the stage for what we believe will
be an exciting future for Outlook Therapeutics.
Most critically, we reached agreement with FDA on the clinical development path forward for ONS-5010
under a Special Protocol Assessment (SPA). We were able to reach agreement with the FDA on the design
and size of NORSE EIGHT, which is our 90 day non-inferiority clinical trial. Additionally, the SPA confirms
that if the NORSE EIGHT trial is successful, it would satisfy the FDA   s requirement for a second adequate
and well-controlled clinical trial to fully address the clinical deficiency identified in the CRL. As we
march forward, we remain confident in the potential of ONS-5010 to meet the needs of retina surgeons,
patients and payers in the estimated $9.5 billion ophthalmic anti-VEGF market in the United States. With
the SPA in place, we are now focused on the execution of NORSE EIGHT, which began dosing subjects in
January 2024. We believe that successful completion of NORSE EIGHT, combined with our ongoing
work to resolve the Chemistry, Manufacturing and Controls (CMC) comments in the CRL, should allow us
to potentially resubmit the ONS-5010 Biologics License Application (BLA) by the end of calendar
year 2024.
Just as important, we recently announced that we have entered into definitive securities purchase
agreements with certain institutional and accredited investors to provide up to $172 million in gross
proceeds, before deducting placement agent fees and offering expenses. This financing will add new,
fundamental, dedicated healthcare investors into Outlook Therapeutics, alongside additional investment
from long-term shareholders, to support the advancement of ONS-5010. Subject to the satisfaction of closing
conditions and achievement of milestones, this funding is expected to be sufficient to take ONS-5010
through potential FDA approval and support commercial launch.
In light of the progress we have made over the last several months, we are planning for a potential wet
AMD FDA approval for our investigational therapy, ONS-5010 as early as 2025.
Beyond our regulatory efforts in the United States, our MAA is under review by the European
Medicines Agency   s (EMA) Committee for Medicinal Products for Human Use (CHMP) in the EU and we
expect a decision in early 2024. We wholeheartedly believe that ONS-5010 has the potential to be a
significant contribution to the retina community globally and we are excited for the opportunity to provide
a bevacizumab treatment option that meets strict ophthalmic standards.
On behalf of the entire Outlook Therapeutics team, I thank you for your continued support. We look
forward to an exciting year ahead and taking another step closer to our goal to change the treatment
landscape for wet AMD.
Sincerely,
Russell Trenary
President & CEO
Outlook Therapeutics

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