Outlook Therapeutics, Inc. Q2 FY2024 earnings call

• Mission: Enhance standard of care in retina anti-VEGF space with ONS-5010. • EU progress: Positive CHMP opinion in March, expect EU approval Q2 2024, plan to launch in EU and UK Q1 2025, working with Cencora. • US progress: Reached SPA with FDA, launched NORSE EIGHT study, expect top-line data and BLA resubmission by end of 2024, meeting FDA on CMC questions. • Financing: Closed private placement with gross proceeds up to $172M, accessible capital to fund through milestones. • Financials: Fiscal Q2 R&D expenses increased as clinical trial sites recruited for NORSE EIGHT, G&A expenses in line with Q1, expect R&D and G&A to continue at current levels.

No detailed product segment financial performance provided as it's the inaugural earnings call and focus is on the ONS-5010 product candidate.

• Expect EU approval in Q2 2024 and launch in EU and UK Q1 2025. • Target to resubmit BLA in US by end of 2024. • Accessible capital from financing to fund through potential EU approval, NORSE EIGHT, and potential US approval and launch. • Anticipate CMC items related to FDA CRL resolved in Q2 and Q3 2024.

• Forward-looking statements involve risks and uncertainties; actual results may differ. • Factors in Outlook Therapeutics Annual Report on Form 10-K could cause material differences. • CMC comments from FDA CRL last year pose potential risks, but current supply of ONS-5010 not impacted.

Q: Any preceding data sets derisking NORSE EIGHT and comparison of Europe vs US market size for ONS-5010 and partnership plans?

A: Russell Trenary noted NORSE TWO trial had dosing similar to NORSE EIGHT, Europe has ~3 million off-label bevacizumab injections annually, planning to work with Cencora in Europe.

Q: Number of sites enrolling patients in NORSE EIGHT and pricing discussions?

A: Russell Trenary said ~60 sites enrolling, 30% of patients enrolled as of recent, pricing shaping up with two-segment market in anti-VEGF space.

Q: Enrollment progress in NORSE EIGHT, thinking on DME and BRVO indications, and FDA division changes?

A: Russell Trenary said enrollment on track, planning studies for DME and BRVO, in discussions with FDA on requirements for approvals.

Q: Manufacturing and supply for Europe launch, remediation needed before FDA Type A meeting?

A: Russell Trenary said have inventory, conducting Type C and D meetings on CMC, relationship with FDA healthy.

Q: Commercialization in Europe, EU vs US health plan positioning?

A: Russell Trenary said focused on executing own commercialization, EU has similar injection numbers to US with price compression, practice of starting on off-label in Europe similar to US.

Q: Manufacturing and supply for Europe, timing of Type C and D meetings, pre-filled syringes?

A: Russell Trenary said no immediate need to move production to Europe, Type C and D meetings in Q2-Q3 2024, pre-filled syringe work ongoing but wait for final FDA approval.