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Iterum Therapeutics Plc (ITRM)
NASDAQ:ITRM
US Market
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Iterum Therapeutics (ITRM) AI Stock Analysis

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ITRM

Iterum Therapeutics

(NASDAQ:ITRM)

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Underperform 35 (OpenAI - 4o)
Rating:35Underperform
Price Target:
Iterum Therapeutics faces significant financial challenges with ongoing net losses and cash flow issues, despite positive developments such as FDA approval of ORLYNVAH. The technical indicators suggest weak market momentum, and valuation metrics reflect poor investment attractiveness. The potential market for ORLYNVAH and improved financial performance are notable positives, but strategic uncertainties and financial obligations weigh heavily on the stock's outlook.
Positive Factors
FDA Approval of ORLYNVAH
FDA approval of ORLYNVAH positions Iterum as a leader in the uUTI market, providing a unique product with significant market potential and exclusivity.
Market Launch of ORLYNVAH
The commercial launch of ORLYNVAH marks a critical step in revenue generation, offering a new treatment option in a market with limited alternatives.
Market Potential and Exclusivity
Market exclusivity and patent protection provide a competitive advantage, ensuring sustained revenue opportunities and market presence.
Negative Factors
Cash Flow Concerns
Limited cash runway highlights liquidity risks, potentially requiring additional financing which could dilute shareholder value or increase debt.
Regulatory Milestone Payment Obligation
The milestone payment obligation to Pfizer adds financial strain, impacting cash flow and necessitating careful financial management.
Uncertain Strategic Alternatives
Uncertainty in strategic alternatives creates risk around future revenue streams and strategic direction, affecting long-term business stability.

Iterum Therapeutics (ITRM) vs. SPDR S&P 500 ETF (SPY)

Iterum Therapeutics Business Overview & Revenue Model

Company DescriptionIterum Therapeutics plc, a clinical-stage pharmaceutical company, engages in developing and commercializing anti-infectives in Ireland, Bermuda, and the United States. It is developing sulopenem, a novel anti-infective compound with oral and IV formulations that is in Phase III clinical trials for the treatment of uncomplicated urinary tract infections, complicated urinary tract infections, and complicated intra-abdominal infections. The company was incorporated in 2015 and is headquartered in Dublin, Ireland.
How the Company Makes MoneyIterum Therapeutics makes money through the development and potential commercialization of its primary product candidate, sulopenem. The company's revenue model is expected to include income from the sale of sulopenem upon receiving regulatory approval, which would allow the company to market the drug to healthcare providers and institutions. Additionally, Iterum may pursue licensing agreements, strategic partnerships, and collaborations with other pharmaceutical companies to enhance distribution and commercialization efforts. These partnerships could provide upfront payments, milestone payments, and royalties based on sales, contributing significantly to the company's earnings. As a clinical-stage company, Iterum may also rely on funding from investors, grants, and other financial instruments to support its research and development activities until its products reach the market.

Iterum Therapeutics Earnings Call Summary

Earnings Call Date:Nov 14, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 12, 2026
Earnings Call Sentiment Neutral
The earnings call highlighted the successful early stages of Orlynda's launch and positive market feedback, indicating potential for growth. However, financial challenges remain due to limited initial revenue, increased expenses, and the need for additional capital.
Q3-2025 Updates
Positive Updates
Successful Initial Launch of Orlynda
Orlynda was launched on August 20, 2025, and generated more than 280 prescriptions through 100 unique prescribers, with nearly half prescribing to more than one patient.
Positive Physician Feedback
Physicians have shown strong interest in Orlynda as a new treatment option for uncomplicated urinary tract infections, particularly where antibiotic resistance is a challenge.
Advancements in Managed Care and Market Access
Iterum has a signed rebate agreement with a top Medicare Part D pharmacy benefit manager, increasing coverage and access for Orlynda starting in 2026 or 2027.
Patent Expansion
New patents granted in China and Mexico, extending Iterum's intellectual property protection to 2041 and 2039, respectively.
Negative Updates
Limited Initial Revenue
Net product sales were $400,000 for the third quarter of 2025, with expectations of modest sales in the fourth quarter.
Increased Operating Expenses and Net Loss
Total operating expenses rose to $8.1 million from $4.9 million year-over-year, contributing to a net loss of $9 million for the third quarter of 2025.
Need for Additional Capital
Iterum will need to raise more capital to continue commercialization efforts throughout 2026, as existing cash and cash equivalents are only sufficient to fund operations into 2026.
Company Guidance
In the third quarter of 2025, Iterum Therapeutics reported net product sales of $400,000 with the launch of Orlynda in the U.S. in August 2025. The company successfully generated over 280 prescriptions through more than 100 unique prescribers, indicating growing physician and patient engagement. Approximately 40% of prescriptions have been filled through payer approval processes, aligning with expectations despite awaiting broader payer coverage. Iterum anticipates 2026 net product revenue to range between $5 million and $15 million, supported by expanding insurance coverage, particularly with a recent signed rebate agreement with a top Medicare Part D pharmacy benefit manager. Operating expenses for 2026 are projected between $25 million and $30 million, with current cash reserves expected to fund operations into 2026. The company aims to raise additional capital to sustain commercialization efforts, targeting high-value territories and potentially expanding further.

Iterum Therapeutics Financial Statement Overview

Summary
Iterum Therapeutics is struggling financially with consistent net losses, negative cash flows, and a weak balance sheet. The lack of revenue and profitability, coupled with financial instability, underlines significant challenges the company must address. Strategic realignment and operational improvements are essential to achieve a turnaround and create long-term value.
Income Statement
20
Very Negative
Iterum Therapeutics demonstrates significant financial challenges, evidenced by consistent net losses and negative EBIT over the past years. The absence of revenue and gross profit undermines the potential for profitability. The company faces difficulty in generating income, with no visible growth trajectory in revenue, indicating a need for strategic changes to reverse the negative trend.
Balance Sheet
15
Very Negative
The balance sheet reveals a precarious financial position with negative stockholders' equity and a high level of liabilities relative to assets. Although the company has managed to reduce net debt, the negative equity indicates financial instability and potential risk for stakeholders. This situation demands a comprehensive approach to improve financial health and sustain operations.
Cash Flow
25
Negative
Iterum Therapeutics exhibits negative operating and free cash flows, highlighting the challenge of maintaining liquidity without external financing. The reliance on financing activities for cash inflows suggests an unsustainable cash flow model. Improving cash generation from operations is crucial to stabilize cash flow and reduce dependency on external capital.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue390.00K0.000.000.000.000.00
Gross Profit-668.00K-254.00K-1.75M-1.80M-2.10M-161.00K
EBITDA-23.07M-21.73M-34.58M-39.97M-83.20M-36.01M
Net Income-26.96M-24.77M-38.37M-44.43M-91.56M-52.01M
Balance Sheet
Total Assets32.50M44.59M26.26M66.83M91.51M32.79M
Cash, Cash Equivalents and Short-Term Investments11.00M24.13M23.93M60.80M81.34M14.57M
Total Debt33.73M45.53M18.96M30.10M30.43M48.08M
Total Liabilities39.88M48.68M32.66M38.83M41.27M83.35M
Stockholders Equity-7.38M-4.08M-6.40M28.00M50.23M-50.56M
Cash Flow
Free Cash Flow-19.93M-26.77M-39.34M-18.54M-15.90M-54.54M
Operating Cash Flow-19.91M-26.77M-39.33M-18.47M-15.84M-54.53M
Investing Cash Flow1.09M18.21M23.34M13.96M-54.59M-11.00K
Financing Cash Flow16.27M26.69M1.03M-1.82M83.13M64.47M

Iterum Therapeutics Technical Analysis

Technical Analysis Sentiment
Negative
Last Price0.46
Price Trends
50DMA
0.63
Negative
100DMA
0.70
Negative
200DMA
0.93
Negative
Market Momentum
MACD
-0.06
Negative
RSI
40.17
Neutral
STOCH
54.55
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ITRM, the sentiment is Negative. The current price of 0.46 is below the 20-day moving average (MA) of 0.51, below the 50-day MA of 0.63, and below the 200-day MA of 0.93, indicating a bearish trend. The MACD of -0.06 indicates Negative momentum. The RSI at 40.17 is Neutral, neither overbought nor oversold. The STOCH value of 54.55 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for ITRM.

Iterum Therapeutics Risk Analysis

Iterum Therapeutics disclosed 88 risk factors in its most recent earnings report. Iterum Therapeutics reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Iterum Therapeutics 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
$39.77M-908.28%588.40%61.76%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
50
Neutral
$107.06M-49.17%23.37%
44
Neutral
$76.01M-1.47-172.70%
35
Underperform
$29.40M-0.7162.61%
27
Underperform
$56.43M-0.72-328.04%42.29%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ITRM
Iterum Therapeutics
0.46
-1.93
-80.75%
CVM
Cel-Sci
7.67
-11.44
-59.86%
CLNN
Clene
10.36
6.26
152.68%
XLO
Xilio Therapeutics
0.76
-0.28
-26.92%
CAMP
CAMP4 Therapeutics Corporation
3.80
-1.27
-25.05%
RADX
Radiopharm Theranostics Limited Sponsored ADR
4.56
0.95
26.32%

Iterum Therapeutics Corporate Events

Executive/Board Changes
Iterum Therapeutics Appoints New Board Members
Neutral
Mar 10, 2025

On March 7, 2025, Iterum Therapeutics plc announced the appointment of Joseph J. Whalen to its Board of Directors, effective March 10, 2025. Mr. Whalen, with over 30 years of experience in the bio-pharmaceutical industry, will serve as a Class III director and join both the audit and compensation committees. His appointment ensures the company’s compliance with Nasdaq’s audit committee requirements. Additionally, David Kelly was appointed as Chairman of the Board, following the resignation of Ronald M. Hunt.

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: Apr 30, 2025