Iterum Therapeutics (ITRM) Releases Positive Phase 3 Trial Results | ITRM Stock News

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Jun 25, 2025
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Iterum Therapeutics (ITRM, Financial) has announced the publication of promising data from its REASSURE Phase 3 clinical trial in the journal NEJM Evidence. This trial evaluated the efficacy of oral sulopenem compared to oral Augmentin in treating adult women with uncomplicated urinary tract infections (uUTI). The results underscore a critical demand for innovative antibiotics, such as Iterum's ORLYNVAH(TM), due to the rising issue of multidrug resistance to existing treatments.

The company's Chief Executive Officer, Corey Fishman, expressed satisfaction with the trial's findings being recognized in a leading medical journal. Iterum anticipates making ORLYNVAH(TM) available to patients struggling with drug-resistant infections as early as the upcoming quarter. This development marks a significant advancement in addressing the challenges posed by resistant strains in uUTIs, offering new hope for affected women.

Wall Street Analysts Forecast

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Based on the one-year price targets offered by 2 analysts, the average target price for Iterum Therapeutics PLC (ITRM, Financial) is $7.00 with a high estimate of $9.00 and a low estimate of $5.00. The average target implies an upside of 611.60% from the current price of $0.98. More detailed estimate data can be found on the Iterum Therapeutics PLC (ITRM) Forecast page.

Based on the consensus recommendation from 2 brokerage firms, Iterum Therapeutics PLC's (ITRM, Financial) average brokerage recommendation is currently 2.0, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

ITRM Key Business Developments

Release Date: May 13, 2025

  • Total Operating Expenses: $3.7 million in Q1 2025, down from $6.2 million in Q1 2024.
  • R&D Costs: $600,000 in Q1 2025, compared to $4 million in Q1 2024.
  • G&A Costs: $2.8 million in Q1 2025, up from $2.2 million in Q1 2024.
  • Net Loss (GAAP): $4.9 million in Q1 2025, compared to $7.1 million in Q1 2024.
  • Net Loss (Non-GAAP): $3.3 million in Q1 2025, compared to $5.8 million in Q1 2024.
  • Cash and Cash Equivalents: $12.7 million at the end of March 2025.
  • Outstanding Shares: Approximately 40 million as of May 12, 2025.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • Iterum Therapeutics PLC (ITRM, Financial) is preparing for the potential commercialization of ORLYNVAH, targeting a large U.S. market with approximately 40 million prescriptions annually for uncomplicated urinary tract infections.
  • The company has extended its cash runway into 2026, providing financial stability for upcoming operations and potential product launch.
  • Iterum Therapeutics PLC (ITRM) has significantly reduced its operating expenses, with a decrease from $6.2 million in Q1 2024 to $3.7 million in Q1 2025.
  • The company has repaid the outstanding principal and interest on its exchangeable notes, eliminating a large amount of debt.
  • Iterum Therapeutics PLC (ITRM) has partnered with Everson, an end-to-end commercialization firm, to prepare for the potential launch of ORLYNVAH, indicating a strategic approach to market entry.

Negative Points

  • Iterum Therapeutics PLC (ITRM) has not yet secured a business development transaction that the Board finds acceptable, indicating challenges in finding suitable partners.
  • The company faces competition from new products approved in the uncomplicated urinary tract infection space, increasing urgency for ORLYNVAH's market entry.
  • Iterum Therapeutics PLC (ITRM) reported a net loss of $4.9 million for Q1 2025, although reduced from the previous year, it still indicates financial challenges.
  • The increase in general and administrative expenses due to pre-commercialization activities suggests higher operational costs.
  • The company's ability to expand its commercialization efforts is contingent on successfully raising additional capital, indicating potential financial constraints.

Disclosures

I/We may personally own shares in some of the companies mentioned above. However, those positions are not material to either the company or to my/our portfolios.