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Outlook Therapeutics, Inc.

OTLK

Outlook Therapeutics, Inc. • NASDAQ
$1.79 ▲ 6.55% (+0.11)
Market Cap $79.51 M
52w High $3.39
52w Low $0.79
Dividend Yield 0%
P/E -2.13
Volume 1.42M
Outstanding Shares 44.42M

Income Statement

Period Revenue Operating Expense Net Income Net Profit Margin Earnings Per Share EBITDA
Q3-2025 $1.505M ▲ $16.814M ▲ $-20.153M ▲ -1.339K% ▼ $-0.55 ▲ $-20.074M ▼
Q2-2025 $0 $12.392M ▼ $-46.357M ▼ 0% $-1.5 ▼ $-12.362M ▲
Q1-2025 $0 ▼ $21.578M ▼ $17.378M ▲ 0% ▼ $0.72 ▲ $-21.578M ▼
Q4-2024 $170.124K ▲ $22.877M ▲ $5.691M ▼ 3.345K% ▲ $0.31 ▼ $5.72M ▼
Q3-2024 $0 $19.563M $44.409M 0% $1.91 $44.438M

Balance Statement

Period Cash & Short-term Total Assets Total Liabilities Total Equity
Q3-2025 $8.901M ▲ $22.392M ▲ $59.581M ▲ $-37.19M ▼
Q2-2025 $7.556M ▲ $19.075M ▲ $51.538M ▼ $-32.463M ▲
Q1-2025 $5.703M ▼ $17.006M ▼ $67.296M ▼ $-50.29M ▲
Q4-2024 $14.928M ▼ $28.823M ▼ $101.9M ▼ $-73.077M ▲
Q3-2024 $32.024M $47.092M $130.765M $-83.673M

Cash Flow Statement

Period Net Income Cash From Operations Cash From Investing Cash From Financing Net Change Free Cash Flow
Q3-2025 $-20.153M ▲ $-11.901M ▲ $0 $13.246M ▼ $1.345M ▼ $-11.901M ▲
Q2-2025 $-46.357M ▼ $-16.584M ▼ $0 $18.437M ▲ $1.854M ▲ $-16.584M ▼
Q1-2025 $17.378M ▲ $-10.967M ▲ $0 $1.742M ▲ $-9.225M ▲ $-10.967M ▲
Q4-2024 $5.691M ▼ $-16.982M ▲ $0 $-114.954K ▼ $-17.097M ▼ $-16.982M ▲
Q3-2024 $44.409M $-19.512M $0 $4.308M $-15.205M $-19.512M

Five-Year Company Overview

Income Statement

Income Statement Outlook Therapeutics is still a pre-commercial biotech, so it has not been generating product revenue over the past several years. Its income statement is driven almost entirely by research and operating expenses, leading to recurring losses each year. Those losses have been fairly steady rather than sharply worsening, and the loss per share has gradually narrowed as the company has adjusted its cost base and capital structure. Overall, this is a classic early-stage biotech profile: all cost, no sales yet, and financial performance is highly dependent on eventual product approval and commercialization rather than current operations.

Balance Sheet

Balance Sheet The balance sheet is small and relatively thin, with limited total assets and a modest cash cushion. Debt sits above the company’s equity value, and shareholder equity has recently turned negative, which signals that accumulated losses and obligations now outweigh the book value of its assets. This structure suggests a high dependence on continued access to external capital, whether through new equity raises, partnerships, or debt. There is little margin for error, so the balance sheet is a constraint rather than a strength at this stage.

Cash Flow

Cash Flow Cash flows are consistently negative because the company spends on research, development, and overhead but does not bring in operating cash from product sales. Operating and free cash flow are both in the red and move in a relatively narrow range, showing steady rather than explosive cash burn, but still clearly unsustainable without ongoing financing. Capital expenditures are minimal, which is typical for a lean biotech model, but the business remains reliant on raising money in the capital markets or through deals to fund its clinical and regulatory plans.

Competitive Edge

Competitive Edge Outlook Therapeutics’ competitive story centers on one main idea: being the first to offer a fully approved, on-label version of a drug (bevacizumab) that retina specialists already know and use off-label. If successful, this could create a meaningful quality, safety, and predictability advantage over compounded versions, and potentially a cost advantage versus premium branded eye drugs. The regulatory setbacks in the U.S. are a major overhang and delay this potential advantage. At the same time, the company is operating in a very competitive space dominated by large players with established brands and relationships, so gaining share will likely depend on pricing, payer support, and clear evidence that its product is at least as effective and reliably available.

Innovation and R&D

Innovation and R&D The company is a focused, single-asset R&D story built around ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for eye diseases. Its innovation is less about a brand-new molecule and more about tailoring a well-known drug into a purpose-built, standardized eye therapy with strong manufacturing controls and intellectual property around formulation and process. The R&D strategy is concentrated on proving this product in several retinal diseases and generating the extra data needed to satisfy regulators, particularly in the U.S. This concentration can be powerful if the program succeeds, but it also means scientific, regulatory, and commercial risk is not diversified across multiple products.

Summary

Outlook Therapeutics is an early-stage biotech with no current product revenue, ongoing operating losses, and a balance sheet that leaves little room for setbacks, making it highly dependent on external funding. The company’s value proposition is tightly linked to a single lead asset targeting a large, established market where physicians already use the underlying drug off-label. Its potential edge lies in converting that practice into an approved, standardized, and potentially more economical on-label therapy, supported by IP and manufacturing know-how. However, regulatory hurdles in the U.S., intense competition from entrenched eye-care brands, and a narrow pipeline create significant uncertainty. The story is binary: future outcomes depend heavily on regulatory progress and real-world uptake of its lead product rather than on current financial performance.

NEWS

November 24, 2025 · 9:05 AM UTC

Outlook Therapeutics to Present at the Piper Sandler 37th Annual Healthcare Conference

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November 13, 2025 · 8:30 AM UTC

Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD

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November 3, 2025 · 8:35 AM UTC

Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010

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September 29, 2025 · 8:45 AM UTC

Outlook Therapeutics Provides Update on Type A Meeting with FDA

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September 3, 2025 · 8:35 AM UTC

Outlook Therapeutics to Present at the 2025 EURETINA Innovation Spotlight (EIS)

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