Outlook Therapeutics (OTLK) AI Stock Analysis

• Market Cap: $34.62M
• Dividend Yield: N/A
• Average Volume (3M): 9.69M
• Price to Earnings (P/E): ―
• Beta (1Y): 0.89
• Revenue Growth: N/A
• EPS Growth: 86.28%
• Country: US
• Employees: 23
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -0.06
• Shares Outstanding: 64,114,400
• 10 Day Avg. Volume: 22,013,086
• 30 Day Avg. Volume: 9,688,613
• PEG Ratio: <0.01
• Price to Book (P/B): >-0.01
• Price to Sales (P/S): 0.00003
• P/FCF Ratio: >-0.01
• Enterprise Value/Market Cap: 2.45
• Enterprise Value/Revenue: 50.69
• Enterprise Value/Gross Profit: 77.73
• Enterprise Value/Ebitda: -1.76
• 1Y Price Target: $3.83
• Price Target Upside: 609.26% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 3
• EPS Forecast (FY): -0.67
• Revenue Forecast (FY): $25.31M

• Rating: 42 Neutral
• Price Target: $0.57 ▲(4.81% Upside)

The score is held down primarily by weak financial performance (large ongoing losses, negative equity, and persistent cash burn) and bearish technicals (price far below key moving averages with negative MACD). Valuation provides limited support due to negative earnings, and a recent FDA Complete Response Letter adds meaningful near-term regulatory risk.

Positive Factors

European commercial foothold

European authorization gives Outlook an immediate commercial presence outside the U.S., creating early revenue, payer relationships and real-world usage that can validate the product and fund operations. This diversification lowers sole dependence on U.S. approval and supports partnership leverage.

Experienced business-development hire

Hiring a seasoned BD and strategy executive with 20+ years strengthens management's ability to secure licensing, strategic partnerships and commercial alliances. This increases likelihood of non-dilutive deals and distribution arrangements that can materially extend runway and commercialization reach.

Recent revenue pickup

A sharp rise in reported revenue signals initial commercial traction post-authorization and begins to build a revenue base. If sustained, revenue growth can improve operating leverage, help cover fixed costs, and reduce reliance on external capital over the medium term.

Negative Factors

Weakened balance sheet (negative equity)

Negative shareholder equity combined with meaningful debt indicates an impaired balance sheet and limited financial cushion. This increases refinancing and covenant risk, constrains investment in R&D/commercial expansion, and raises the likelihood of dilutive financings over the medium term.

Persistent cash burn and weak cash generation

Sustained negative operating and free cash flow, with recent deterioration, reflects structural cash burn reliant on external funding. This undermines the company's ability to self-fund pivotal trials and commercialization, elevating financing risk and potential dilution in the coming months.

U.S. regulatory setback (FDA CRL)

The FDA Complete Response Letter requiring additional confirmatory efficacy evidence delays U.S. approval and likely forces extra studies or alternative regulatory strategies. This materially lengthens time to scale in the largest market and shifts strategic emphasis toward Europe and partnership-driven commercialization.

Outlook Therapeutics Business Overview & Revenue Model

Company Description

Outlook Therapeutics, Inc., a late clinical-stage biopharmaceutical company, focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications. Its lead product candidate is ONS-5010, an ophthalmic formulation of bevacizumab product candidate that is in Phase-III clinical trial for the treatment of wet age-related macular degeneration and other retina diseases. Outlook Therapeutics, Inc. has collaboration and license agreements with IPCA Laboratories Limited; Laboratorios Liomont, S.A. de C.V.; BioLexis Pte. Ltd.; and Zhejiang Huahai Pharmaceutical Co., Ltd. The company was formerly known as Oncobiologics, Inc. and changed its name to Outlook Therapeutics, Inc. in November 2018. Outlook Therapeutics, Inc. was incorporated in 2010 and is based in Iselin, New Jersey.

How the Company Makes Money

Outlook Therapeutics makes money through the development and commercialization of its ophthalmic products. The company's revenue model is primarily centered around the successful approval and market launch of its lead product, ONS-5010, which is anticipated to generate sales revenue from its use in treating retinal diseases. The company may also engage in strategic partnerships and collaborations with other pharmaceutical companies to enhance its product development capabilities and expand its market reach. Revenue streams are largely dependent on achieving regulatory approval and subsequent sales of its lead therapeutic, as well as potential licensing agreements or partnerships that can provide additional funding or revenue sharing opportunities.

Outlook Therapeutics Financial Statement Overview

Summary

Outlook Therapeutics faces significant financial challenges with no revenue and consistent historical losses. The balance sheet is highly leveraged with negative equity, and cash flow relies heavily on external financing, indicating financial instability.

Income Statement

The company has consistently reported zero revenue over the analyzed periods, indicating a lack of sales activity. The net income for TTM showed a significant positive figure due to a reversal or adjustment, but historical data shows substantial losses. EBIT and EBITDA are negative, suggesting ongoing operational challenges.

Balance Sheet

The balance sheet reveals negative stockholders' equity, indicating a deficit that exceeds assets. The company is highly leveraged, with liabilities far surpassing assets. This financial structure suggests potential solvency issues and high financial risk.

Cash Flow

The company exhibits negative operating and free cash flows, indicating cash outflows from operations and lack of free cash for reinvestment. Financing cash flows are positive due to capital raising activities, which may not be sustainable long-term.

Breakdown	TTM	Dec 2025	Dec 2024	Dec 2023	Dec 2022	Dec 2021
Income Statement
Total Revenue	1.68M	1.41T	0.00	0.00	0.00	0.00
Gross Profit	1.09M	57.20B	-113.86K	-44.19K	-204.69K	-262.14K
EBITDA	-48.29M	-67.06T	-72.09M	-57.38M	-64.36M	-51.51M
Net Income	-43.44M	-62.42T	-75.37M	-58.98M	-66.05M	-53.16M
Balance Sheet
Total Assets	22.39M	18.58T	28.82M	32.30M	28.53M	22.81M
Cash, Cash Equivalents and Short-Term Investments	8.90M	8.08T	14.93M	23.39M	17.40M	14.48M
Total Debt	34.70M	247.70B	29.74M	35.56M	10.96M	11.90M
Total Liabilities	59.58M	50.77T	101.90M	46.74M	19.79M	18.20M
Stockholders Equity	-37.19M	-32.19T	-73.08M	-14.44M	8.74M	4.61M
Cash Flow
Free Cash Flow	-56.43M	-51.83T	-68.79M	-42.97M	-56.67M	-54.25M
Operating Cash Flow	-56.43M	-51.83T	-68.79M	-42.97M	-56.67M	-54.25M
Investing Cash Flow	-3.00	0.00	0.00	0.00	0.00	0.00
Financing Cash Flow	33.31M	44.98T	60.33M	48.97M	59.59M	56.19M

Outlook Therapeutics Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 0.54
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Positive
• STOCH: Positive

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For OTLK, the sentiment is Negative. The current price of 0.54 is below the 20-day moving average (MA) of 1.24, below the 50-day MA of 1.55, and below the 200-day MA of 1.59, indicating a bearish trend. The MACD of -0.36 indicates Positive momentum. The RSI at 24.38 is Positive, neither overbought nor oversold. The STOCH value of 11.23 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for OTLK.

Outlook Therapeutics Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
ORMP	62 Neutral	$144.88M	3.68	24.38%	―	―	814.20%
WHWK	56 Neutral	$136.67M	20.54	-13.82%	―	-42.62%	―
ADAG	52 Neutral	$84.84M	-2.98	-63.41%	―	-87.59%	11.53%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
ATRA	46 Neutral	$32.23M	2.11	―	―	51.27%	―
CELU	44 Neutral	$38.35M	-0.39	―	―	-15.81%	-113.06%
OTLK	42 Neutral	$34.62M	-0.48	―	―	―	86.28%

Outlook Therapeutics Corporate Events

FDA Issues New Setback for Outlook Therapeutics’ LYTENAVA

On December 31, 2025, Outlook Therapeutics reported that the U.S. Food and Drug Administration issued a Complete Response Letter to its resubmitted biologics license application for ONS-5010/LYTENAVA for the treatment of wet age-related macular degeneration, stating it could not approve the application in its current form and again calling for additional confirmatory evidence of efficacy without specifying what form that evidence should take. The setback delays potential U.S. approval despite the company’s reliance on data from its NORSE clinical trial program, including the successful NORSE TWO pivotal study and the NORSE EIGHT non-inferiority trial, and shifts strategic emphasis toward exploring alternative regulatory pathways in the U.S. while expanding commercialization and partnership efforts in Europe and other regions, where LYTENAVA is already authorized and beginning to establish a foothold as a differentiated, on-label bevacizumab option for wet AMD patients.

The most recent analyst rating on (OTLK) stock is a Hold with a $2.00 price target. To see the full list of analyst forecasts on Outlook Therapeutics stock, see the OTLK Stock Forecast page.

Outlook Therapeutics’ FDA Review for ONS-5010 Resubmission

On November 13, 2025, Outlook Therapeutics announced that the FDA acknowledged receipt of its resubmitted Biologics License Application for ONS-5010, a bevacizumab-vikg product. The FDA classified the application as a Class 1 review, setting a two-month review period and a PDUFA goal date of December 31, 2025, which could significantly impact the company’s market positioning and stakeholder interests.

The most recent analyst rating on (OTLK) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Outlook Therapeutics stock, see the OTLK Stock Forecast page.

Outlook Therapeutics Resubmits Biologics License Application

On November 3, 2025, Outlook Therapeutics announced the resubmission of its Biologics License Application for ONS-5010 to the U.S. FDA, following a productive meeting with the agency in September 2025. This step aims to address issues raised in a Complete Response Letter received in August 2025, potentially paving the way for U.S. approval and expanding its market presence in the treatment of wet age-related macular degeneration.

The most recent analyst rating on (OTLK) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Outlook Therapeutics stock, see the OTLK Stock Forecast page.