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Iterum Therapeutics Plc (ITRM)
NASDAQ:ITRM
US Market

Iterum Therapeutics (ITRM) AI Stock Analysis

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ITRM

Iterum Therapeutics

(NASDAQ:ITRM)

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Neutral 43 (OpenAI - 5.2)
Rating:43Neutral
Price Target:
$0.31
▼(-8.53% Downside)
The score is held down primarily by weak financial fundamentals (minimal revenue, persistent losses, cash burn, and negative equity) and bearish technicals (price below major moving averages with negative MACD). The earnings call adds some support due to early launch traction and 2026 revenue guidance, but this is tempered by the need for additional capital, while the Nasdaq listing compliance issue adds further downside risk.
Positive Factors
Patent expansion (China & Mexico)
Extended patents in China and Mexico through 2039–2041 materially lengthen market exclusivity in key international jurisdictions. This strengthens long-term commercial upside, supports pricing power versus generics, and enhances licensing or partnering optionality across global markets.
Initial prescriber adoption of Orlynda
More than 280 prescriptions across 100 unique prescribers at launch indicates early clinical acceptance and real prescriber engagement. Durable prescriber adoption is critical for sustained uptake, repeat prescribing, and revenue scale as payer coverage and distribution expand.
Managed-care rebate agreement
A rebate deal with a top Medicare Part D PBM materially improves payer access and formulary placement prospects beginning 2026/2027. Structural gains in coverage can raise fill rates, reduce out-of-pocket barriers, and support steadier prescription growth over multiple years.
Negative Factors
Negative shareholders' equity and elevated leverage
Negative equity and debt that exceeds assets constrain financial flexibility and increase refinancing and dilution risk. This capital-structure weakness can limit investment in commercial scale-up or R&D and raises vulnerability to adverse funding conditions over the next several quarters.
Ongoing cash burn and capital needs
Sustained operating cash burn (~-$19.9M TTM) and management's plan to seek additional funding create execution risk. Reliance on new capital can dilute shareholders and, if market access tightens, could slow commercialization and delay achieving self-sustaining cash generation.
Nasdaq listing compliance / delisting risk
Active non-compliance notices on market value and minimum bid price create a persistent governance and liquidity risk. A delisting or prolonged compliance process would impair access to U.S. capital markets, raise financing costs, and hamper long-term commercialization and investor confidence.

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
Very limited TTM revenue ($0.39M) with continued large losses (net loss ~$27.0M) and ongoing cash burn (operating/free cash flow about -$19.9M TTM). While losses, cash burn, and debt have improved versus prior years, negative shareholders’ equity (about -$7.4M TTM) and debt exceeding assets keep financial risk high.
Income Statement
12
Very Negative
TTM (Trailing-Twelve-Months) results show minimal revenue ($0.39M) and deeply negative profitability (net loss of about $27.0M), with gross profit also negative. Losses have narrowed versus prior years (net loss ~$91.6M in 2021 to ~$24.8M in 2024 and ~$27.0M TTM), but the business is still far from operating break-even and margins remain structurally weak.
Balance Sheet
18
Very Negative
Leverage is elevated relative to the company’s asset base (TTM debt ~$33.7M vs. assets ~$32.5M), and shareholders’ equity is negative (TTM about -$7.4M; also negative in 2023–2024), which limits financial flexibility and raises refinancing/dilution risk. A positive is that total debt has come down from 2024 (~$45.5M) to TTM (~$33.7M), but the capital structure remains pressured given negative equity.
Cash Flow
22
Negative
Cash burn remains significant with operating cash flow around -$19.9M TTM and free cash flow around -$19.9M, indicating the business is still consuming cash to fund operations. The burn rate has improved versus 2023–2024 (operating cash flow -$39.3M in 2023 and -$26.8M in 2024), and TTM free cash flow shows strong improvement versus the prior period (growth ~35%), but cash generation is not yet self-sustaining.
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 Price0.34
Price Trends
50DMA
0.34
Negative
100DMA
0.47
Negative
200DMA
0.67
Negative
Market Momentum
MACD
-0.02
Positive
RSI
31.17
Neutral
STOCH
10.37
Positive
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 0.34 is above the 20-day moving average (MA) of 0.31, below the 50-day MA of 0.34, and below the 200-day MA of 0.67, indicating a bearish trend. The MACD of -0.02 indicates Positive momentum. The RSI at 31.17 is Neutral, neither overbought nor oversold. The STOCH value of 10.37 is Positive, 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
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
$40.91M-908.28%588.40%61.76%
49
Neutral
$210.64M-1.63-172.70%5.51%
47
Neutral
$55.08M-1.41-98.81%
45
Neutral
$49.70M-1.33-49.17%23.37%
43
Neutral
$13.54M-0.3262.61%
43
Neutral
$40.19M-1.01-176.32%48.68%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ITRM
Iterum Therapeutics
0.22
-1.27
-85.17%
CVM
Cel-Sci
4.84
-7.85
-61.86%
CLNN
Clene
4.73
0.22
4.88%
XLO
Xilio Therapeutics
0.57
-0.49
-46.23%
CAMP
CAMP4 Therapeutics Corporation
4.45
-0.38
-7.87%
RADX
Radiopharm Theranostics Limited Sponsored ADR
5.02
0.36
7.73%

Iterum Therapeutics Corporate Events

Delistings and Listing ChangesRegulatory Filings and Compliance
Iterum Therapeutics Faces Nasdaq Listing Compliance Challenge
Negative
Dec 12, 2025

On December 11, 2025, Iterum Therapeutics received a notification from Nasdaq indicating that it no longer meets the listing requirements due to its market value of listed securities falling below $35 million for 30 consecutive business days. The company has until June 9, 2026, to regain compliance, or it risks delisting. Additionally, Iterum was previously notified on August 25, 2025, about non-compliance with the minimum bid price rule, with a deadline of February 23, 2026, to address this issue. Failure to meet these requirements could lead to delisting, although the company may appeal any delisting decisions.

The most recent analyst rating on (ITRM) stock is a Buy with a $9.00 price target. To see the full list of analyst forecasts on Iterum Therapeutics stock, see the ITRM 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: Dec 30, 2025