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Opus Genetics (IRD)
NASDAQ:IRD

Opus Genetics (IRD) AI Stock Analysis

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IRD

Opus Genetics

(NASDAQ:IRD)

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Neutral 51 (OpenAI - 5.2)
Rating:51Neutral
Price Target:
$2.00
▲(0.00% Upside)
The score is held down primarily by weak financial performance (deep losses and significant cash burn), only partly offset by low leverage. Technicals are neutral with a modest longer-term uptrend but limited momentum. Recent corporate events are constructive (pipeline/regulatory progress and added funding/runway), while valuation remains challenged due to negative earnings and no dividend support.
Positive Factors
LCA5 pediatric efficacy signal
Durable clinical activity in pediatric LCA5, with multi-measure improvements and sustained benefit through 18 months, meaningfully de-risks the program. Positive, durable human data increases probability of successful pivotal design, supports regulatory dialogue and long-term commercial potential.
Regulatory designations & FDA engagement
RMAT, orphan and rare pediatric designations and constructive FDA Type B feedback materially lower regulatory and development risk. These designations can shorten timelines, enable adaptive designs and exclusivities, improving the structural odds of approval for rare retinal indications.
Extended cash runway
A post-offering cash position exceeding $50M and runway into H2 2027 provides durable funding to complete planned pivotal starts and near-term readouts. This reduces immediate financing risk and supports executing value-driving clinical milestones over the next 12–24 months.
Negative Factors
Heavy cash burn
Persistent negative operating and free cash flow (~-$32.9M TTM) creates structural dependence on external capital. Even with recent funding, ongoing burn increases probability of additional financings before commercialization, which can dilute shareholders and divert management focus from execution.
Deep operating losses & revenue decline
A revenue decline and extremely negative net margin (~-379%) reflect a business that is not self-sustaining. Structural losses limit reinvestment capacity, heighten reliance on capital markets, and raise the operational stakes for each clinical program’s success to restore longer-term financial viability.
Equity erosion & dilution risk
Marked equity erosion and highly negative ROE signal a diminished capital buffer to absorb further losses. Low debt does not offset capital depletion; the balance-sheet weakness increases the likelihood of future dilutive financings and constrains strategic flexibility over the medium term.

Opus Genetics (IRD) vs. SPDR S&P 500 ETF (SPY)

Opus Genetics Business Overview & Revenue Model

Company DescriptionOpus Genetics, Inc., a clinical-stage ophthalmic biopharmaceutical company, focuses on developing and commercializing therapies for the treatment of unmet needs of patients with refractive and retinal eye disorders. The company offers Phentolamine Ophthalmic Solution for reversal of mydriasis, as well as is in Phase III clinical trials for presbyopia and dim light or night vision disturbances. Its lead retinal product candidate is APX3330, a small-molecule inhibitor of reduction oxidation effector factor-1 protein that has completed Phase II clinical trial for the treatment of diabetic retinopathy. The company also develops APX2009 and APX2014 that are preclinical product candidates for retina indications. The company was formerly known as Ocuphire Pharma, Inc. Opus Genetics, Inc. was founded in 2018 and is headquartered in Farmington Hills, Michigan.
How the Company Makes MoneyOpus Genetics generates revenue primarily through the development and commercialization of its gene therapy products. The company monetizes its innovations by partnering with larger pharmaceutical companies for the co-development and licensing of its therapies. These partnerships often involve upfront payments, milestone payments, and royalties on sales. Additionally, Opus Genetics may receive funding from grants, research collaborations, and venture capital investments to support its research and development efforts.

Opus Genetics Financial Statement Overview

Summary
Opus Genetics is facing significant financial headwinds with declining revenues, persistent losses, and negative cash flows. While the absence of debt is a strength, the company's operational inefficiencies and declining equity raise concerns about its long-term viability. Strategic improvements are necessary to stabilize and improve its financial health.
Income Statement
Opus Genetics shows a volatile revenue trend with significant declines in 2023 and 2024 after a peak in 2022. The company has consistently posted negative net income, indicating persistent unprofitability. The gross profit margin remains high due to the absence of cost of goods sold, but negative EBIT and EBITDA margins highlight ongoing operational challenges.
Balance Sheet
The balance sheet reveals a strong equity position in 2022, which sharply declined in 2023 and 2024 due to accumulated losses. The company has no debt, which is a positive, but the declining stockholders' equity and recent negative equity in 2020 raise concerns about financial stability.
Cash Flow
Operating cash flow has been negative for the past two years, reflecting operational inefficiencies. Free cash flow has worsened significantly in 2024, indicating cash burn issues. The operating cash flow to net income and free cash flow to net income ratios highlight the company's struggle to convert income into cash.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue14.63M10.99M19.05M39.85M589.00K0.00
Gross Profit820.00K10.99M19.05M39.85M589.00K0.00
EBITDA-43.10M-57.52M-9.97M18.22M-56.69M-17.77M
Net Income-68.20M-57.53M-9.99M17.89M-56.69M-24.62M
Balance Sheet
Total Assets36.12M36.86M53.95M48.99M26.08M17.68M
Cash, Cash Equivalents and Short-Term Investments30.82M30.32M50.52M42.68M24.75M16.40M
Total Debt1.07M0.000.000.00538.00K0.00
Total Liabilities30.16M30.14M4.04M2.75M3.85M31.15M
Stockholders Equity5.97M6.72M49.91M46.24M22.22M-13.47M
Cash Flow
Free Cash Flow-32.86M-25.58M-1.11M14.31M-19.37M-6.80M
Operating Cash Flow-32.86M-25.58M-1.11M14.31M-19.37M-6.80M
Investing Cash Flow1.21M1.21M0.000.00-100.00K539.00K
Financing Cash Flow25.83M4.19M8.98M3.79M27.61M21.12M

Opus Genetics Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price2.00
Price Trends
50DMA
2.06
Negative
100DMA
1.83
Positive
200DMA
1.41
Positive
Market Momentum
MACD
>-0.01
Positive
RSI
45.56
Neutral
STOCH
33.33
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For IRD, the sentiment is Neutral. The current price of 2 is below the 20-day moving average (MA) of 2.10, below the 50-day MA of 2.06, and above the 200-day MA of 1.41, indicating a neutral trend. The MACD of >-0.01 indicates Positive momentum. The RSI at 45.56 is Neutral, neither overbought nor oversold. The STOCH value of 33.33 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for IRD.

Opus Genetics Risk Analysis

Opus Genetics disclosed 56 risk factors in its most recent earnings report. Opus Genetics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Opus Genetics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
54
Neutral
$229.19M-2.93-131.71%-100.00%79.01%
53
Neutral
$303.74M-4.55-57.84%-84.46%33.32%
52
Neutral
$126.76M-3.38-60.06%946.61%-11.30%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
51
Neutral
$145.51M-1.16-338.75%74.60%-58.14%
50
Neutral
$171.17M-0.87-63.96%-28.50%
45
Neutral
$94.04M-0.56-209.00%40.22%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
IRD
Opus Genetics
2.00
0.58
40.85%
OVID
Ovid Therapeutics
1.73
0.91
110.98%
STTK
Shattuck Labs
4.64
3.45
289.92%
IKT
Inhibikase Therapeutics
1.67
-1.28
-43.39%
SRZN
Surrozen
19.06
7.91
70.94%
BMEA
Biomea Fusion
1.34
-2.64
-66.33%

Opus Genetics Corporate Events

Business Operations and StrategyFinancial DisclosuresPrivate Placements and FinancingProduct-Related AnnouncementsRegulatory Filings and Compliance
Opus Genetics Details 2025 Progress and 2026 Milestones
Positive
Jan 8, 2026

On January 8, 2026, Opus Genetics highlighted its 2025 operational progress and outlined key milestones expected in 2026, underscoring the maturation of its multi-asset ophthalmic pipeline and strengthening financial position. In 2025, the company advanced two lead gene therapies—OPGx-BEST1 for BEST1-related inherited retinal disease, which began dosing patients in a Phase 1/2 trial, and OPGx-LCA5 for Leber congenital amaurosis, which produced positive Phase 1/2 safety and efficacy data in adults and pediatric patients and is being advanced into an adaptive pivotal Phase 3 study. The pipeline benefited from multiple regulatory designations for OPGx-LCA5, including Rare Pediatric Disease, Orphan Drug and RMAT status, while OPGx-BEST1 is being positioned for similar regulatory pathways, and preclinical IRD programs targeting RHO, CNGB1, MERTK, RDH12-LCA and NMNAT1 moved toward first-in-human studies with support from patient advocacy partnerships and non-dilutive funding. Opus also submitted a supplemental new drug application for Phentolamine Ophthalmic Solution 0.75% for presbyopia and continued a pivotal Phase 3 trial (LYNX-3) in keratorefractive patients experiencing low-light visual disturbances. Financially, as of September 30, 2025, Opus held $30.8 million in cash and equivalents and subsequently raised about $23 million in a registered direct equity offering, bringing its cash balance to more than $50 million and extending its operational runway into the second half of 2027, a position that supports the planned clinical readouts and regulatory milestones that could influence its future revenue potential and competitive standing in retinal gene therapy.

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

Product-Related AnnouncementsRegulatory Filings and Compliance
Opus Genetics Partner Files Supplemental NDA for Presbyopia Drug
Positive
Dec 19, 2025

On December 17, 2025, Viatris Inc., the commercialization partner for Phentolamine Ophthalmic Solution 0.75% (Phentolamine), filed a supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval of Phentolamine as a treatment for presbyopia. The submission, backed by positive efficacy, safety, and durability data from the VEGA-3 Phase 3 trial that confirmed earlier VEGA-2 results, marks a key regulatory step that could expand Phentolamine’s commercial prospects in the presbyopia market, though there remains uncertainty over if and when the FDA will accept and review the application.

The most recent analyst rating on (IRD) stock is a Buy with a $9.00 price target. To see the full list of analyst forecasts on Opus Genetics stock, see the IRD Stock Forecast page.

Private Placements and Financing
Opus Genetics Announces $23M Direct Offering
Positive
Nov 6, 2025

On November 5, 2025, Opus Genetics, Inc. entered into a securities purchase agreement with affiliates of Perceptive Advisors LLC, Nantahala Capital Management, LLC, and Balyasny Asset Management L.P. for a registered direct offering. The company plans to issue and sell shares and pre-funded warrants, expecting to raise approximately $23 million to support its gene therapy clinical programs and general corporate purposes. The offering is set to close around November 7, 2025, and involves no placement agent or underwriter, minimizing costs for Opus Genetics.

The most recent analyst rating on (IRD) stock is a Buy with a $8.00 price target. To see the full list of analyst forecasts on Opus Genetics stock, see the IRD Stock Forecast page.

Business Operations and StrategyPrivate Placements and Financing
Opus Genetics Announces $23 Million Direct Offering
Positive
Nov 6, 2025

On November 6, 2025, Opus Genetics announced a $23 million registered direct offering to fund the development of its gene therapy programs, particularly for LCA5 and BEST-1. The company also reported the successful completion of a Type B RMAT meeting with the FDA for its OPGx-LCA5 gene therapy candidate, which showed promising results in Phase 1/2 trials. The FDA’s feedback will guide the Phase 3 study, expected to start dosing in the second half of 2026. The offering and FDA meeting position Opus Genetics to advance its mission of restoring vision in patients with inherited retinal diseases.

The most recent analyst rating on (IRD) stock is a Buy with a $8.00 price target. To see the full list of analyst forecasts on Opus Genetics stock, see the IRD Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Jan 08, 2026