Iterum Therapeutics plc (ITRM): History, Ownership, Mission, How It Works & Makes Money

Iterum Therapeutics plc (ITRM): History, Ownership, Mission, How It Works & Makes Money

IE | Healthcare | Biotechnology | NASDAQ

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Ever wondered about the company dedicated to fighting multi-drug resistant pathogens? Iterum Therapeutics plc (ITRM), headquartered in Dublin, Ireland, is focused on developing anti-infectives to combat the global crisis of multi-drug resistant pathogens. With the FDA's October 2024 approval of ORLYNVAH™—the first and only approved oral penem for uncomplicated urinary tract infections (uUTI)—how is Iterum Therapeutics making waves in the pharmaceutical world? Keep reading to discover more about Iterum's history, ownership, mission, operational mechanisms, and revenue generation.

Iterum Therapeutics plc (ITRM) History

Iterum Therapeutics plc Founding Timeline

Year established

Iterum Therapeutics was established in 2015.

Original location

The company is based in Dublin, Ireland, with its U.S. operations located in Chicago, IL.

Founding team members

The founding team and key individuals involved in the establishment of Iterum Therapeutics include:

  • Corey Fishman: Served as Chief Executive Officer.
  • Ken Yip: Served as Chief Medical Officer.

Initial capital/funding

Iterum Therapeutics initiated its operations with a $40 million Series A financing round. This funding was led by Frazier Healthcare Partners and New Enterprise Associates.

Iterum Therapeutics plc Evolution Milestones

Year Key Event Significance
2017 Initial Public Offering (IPO) Iterum Therapeutics became a publicly traded company, listed on the Nasdaq Capital Market under the ticker symbol ITRM, raising capital to support clinical development programs.
2018-2020 Clinical Trials of Sulopenem The company focused on advancing its lead product candidate, Sulopenem, through various clinical trials, including Phase 3 studies, to evaluate its efficacy and safety in treating multi-drug resistant Gram-negative infections.
2021 FDA Complete Response Letter Iterum received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Sulopenem, requesting additional data and information before approval.
2023 Resubmission of NDA for Sulopenem Iterum Therapeutics resubmitted its New Drug Application (NDA) to the FDA for Sulopenem for the treatment of uncomplicated urinary tract infections (uUTI) in women.
2024 FDA Approval of Sulopenem The FDA approved Sulopenem for the treatment of uncomplicated urinary tract infections (uUTI) in adult women, marking a pivotal achievement for the company.

Iterum Therapeutics plc Transformative Moments

  • Focus on Sulopenem: Iterum's strategic focus on developing Sulopenem as a novel treatment for multi-drug resistant Gram-negative infections was a significant decision that shaped its trajectory.
  • Navigating Regulatory Hurdles: The company's ability to address regulatory challenges, including the FDA's Complete Response Letter and subsequent resubmission of the NDA, demonstrated its resilience and commitment to bringing Sulopenem to market.
  • Market Approval and Commercialization: The FDA approval of Sulopenem in 2024 marked a transformative moment for Iterum, paving the way for commercialization and potential revenue generation.

To gain deeper insights into the company's financial standing, consider exploring this resource: Breaking Down Iterum Therapeutics plc (ITRM) Financial Health: Key Insights for Investors

Iterum Therapeutics plc (ITRM) Ownership Structure

Iterum Therapeutics plc features a mix of institutional, retail, and insider ownership, shaping its governance and strategic direction.

Iterum Therapeutics plc's Current Status

Iterum Therapeutics plc is a publicly traded company, listed on the NASDAQ under the ticker symbol ITRM. This means that shares of the company are available for purchase by the general public, and the company is subject to regulations and reporting requirements set forth by the U.S. Securities and Exchange Commission (SEC).

Iterum Therapeutics plc's Ownership Breakdown

As of December 20, 2024, the ownership breakdown of Iterum Therapeutics plc is as follows:

Shareholder Type Ownership, % Notes
Institutional Owners 37.36% Includes investment firms, hedge funds, and other institutions. Top institutional holders include Opaleye Management Inc., Biotechnology Value Fund L.P., and Vanguard Group Inc.
Retail Investors N/A Data on retail investor ownership is not explicitly available but is accounted for in the remaining ownership percentage.
Insiders 2.27% Comprises company executives and board members. Notable insider ownership is held by Corey Fishman, the Chief Executive Officer.

Iterum Therapeutics plc's Leadership

The leadership team guiding Iterum Therapeutics plc includes:

  • Corey Fishman: Chief Executive Officer
  • Richard Ellis: Chief Medical Officer
  • Jonathan Gilbert: Chief Financial Officer

Understanding Iterum Therapeutics plc's financial stability is crucial for investors. For an in-depth look, check out Breaking Down Iterum Therapeutics plc (ITRM) Financial Health: Key Insights for Investors.

Iterum Therapeutics plc (ITRM) Mission and Values

Iterum Therapeutics is dedicated to developing innovative anti-infectives to combat the global rise of multi-drug resistant infections. The company focuses on addressing unmet needs in both hospital and community settings, striving to improve patient outcomes and reduce the burden of antibiotic resistance.

Iterum Therapeutics' Core Purpose

Official mission statement

Iterum Therapeutics' mission is to be a leader in developing innovative solutions to combat the growing threat of multi-drug resistant infections. This involves:

  • Developing and commercializing differentiated anti-infectives.
  • Focusing on both hospital and community settings to address a broad spectrum of infections.
  • Improving patient outcomes by providing effective treatment options.
  • Combating the spread of antibiotic resistance through responsible antimicrobial stewardship.

Vision statement

While a specific formal vision statement is not explicitly available in the provided search results, a vision can be inferred from Iterum Therapeutics' activities and goals. The implied vision is to:

  • Become a recognized leader in the anti-infectives market.
  • Significantly impact the treatment of multi-drug resistant infections globally.
  • Establish a sustainable pipeline of novel anti-infective products.
  • Create value for patients, healthcare providers, and shareholders through innovation and responsible business practices.

Company slogan/tagline

Based on the information available, Iterum Therapeutics does not have a widely publicized official slogan or tagline. However, considering their focus, a possible implied tagline could be:

  • Fighting Resistance, Improving Lives.
  • Innovating for Infection Solutions.
  • Committed to Combating Multi-Drug Resistance.

To delve deeper into the company's values and mission, explore: Mission Statement, Vision, & Core Values of Iterum Therapeutics plc (ITRM).

Iterum Therapeutics plc (ITRM) How It Works

Iterum Therapeutics plc, a pharmaceutical company, focuses on developing and commercializing anti-infectives to combat multi-drug resistant pathogens, primarily in the acute care setting and community. The company's main strategy revolves around addressing the unmet needs in the treatment of infections caused by Gram-negative bacteria.

Iterum Therapeutics' Product/Service Portfolio

Product/Service Target Market Key Features
Sulopenem Patients with multi-drug resistant Gram-negative bacterial infections.
  • A novel, broad-spectrum beta-lactamase inhibitor.
  • Designed for oral and IV administration.
  • Aims to provide a convenient and effective treatment option, potentially reducing hospital stays.

Iterum Therapeutics' Operational Framework

Iterum Therapeutics operates with a focus on the following key areas:

  • Research and Development: Continues to invest in the development of sulopenem and explore new anti-infective agents.
  • Clinical Trials: Conducts clinical trials to demonstrate the safety and efficacy of its products, adhering to regulatory standards.
  • Regulatory Approval: Seeks regulatory approvals from agencies like the FDA to market its products.
  • Manufacturing and Supply Chain: Establishes partnerships for the manufacturing and supply of its drug products.
  • Commercialization: Aims to commercialize its products through strategic partnerships or direct sales, focusing on regions with high unmet needs.

Iterum Therapeutics' Strategic Advantages

Iterum Therapeutics aims to establish a competitive edge through:

  • Novel Antibiotics: Developing new antibiotics to address the growing threat of antimicrobial resistance.
  • Broad-Spectrum Activity: Targeting a wide range of Gram-negative bacteria, making their products versatile.
  • Oral and IV Formulations: Offering both oral and intravenous formulations to cater to different patient needs and treatment settings.
  • Strategic Partnerships: Collaborating with other companies to enhance their research, development, and commercialization efforts.

To gain more insights into the investors and ownership structure of Iterum Therapeutics, consider reading: Exploring Iterum Therapeutics plc (ITRM) Investor Profile: Who’s Buying and Why?

Iterum Therapeutics plc (ITRM) How It Makes Money

Iterum Therapeutics generates revenue primarily through the development and potential commercialization of its lead product candidate, sulopenem, an antibiotic aimed at treating multi-drug resistant infections.

Iterum Therapeutics plc's Revenue Breakdown

As a clinical-stage pharmaceutical company, Iterum Therapeutics has not yet achieved significant commercial revenue. Its primary focus has been on research and development, clinical trials, and regulatory approvals. Therefore, a traditional revenue breakdown is not applicable at this time.

However, potential future revenue streams can be considered upon successful commercialization of sulopenem:

Revenue Stream % of Total Growth Trend
Sulopenem IV Sales To be determined upon market entry Potentially Increasing
Sulopenem Oral Sales To be determined upon market entry Potentially Increasing
Partnerships and Licensing Agreements Varies based on agreements Dependent on Strategic Collaborations
Government Grants and Contracts Varies based on awards Unpredictable

Iterum Therapeutics plc's Business Economics

Iterum Therapeutics' business economics are centered around the development and commercialization of sulopenem. Key aspects include:

  • R&D Expenses: A significant portion of expenses is dedicated to research and development, including clinical trials necessary for regulatory approval.
  • Manufacturing Costs: If sulopenem gains approval, manufacturing costs will become a crucial factor in determining profitability.
  • Pricing Strategy: The pricing of sulopenem will be critical, balancing market access, competition, and profitability.
  • Market Access: Successfully navigating regulatory approvals and market access in different geographies is essential.
  • Competition: The competitive landscape of antibiotic treatments will influence market share and pricing.

Iterum Therapeutics plc's Financial Performance

As of April 2025, Iterum Therapeutics' financial performance reflects its status as a development-stage company. Key points include:

  • Cash Position: Monitoring cash reserves is vital to fund ongoing operations and clinical trials.
  • Operating Expenses: A detailed analysis of operating expenses, including R&D and administrative costs, provides insights into financial management.
  • Net Losses: As is typical for development-stage companies, Iterum has been incurring net losses as it invests heavily in R&D.
  • Funding: Securing additional funding through equity offerings, debt financing, or partnerships is crucial for sustaining operations.
  • Stock Performance: The company's stock performance is influenced by clinical trial results, regulatory milestones, and overall market conditions.

For more detailed insights into Iterum Therapeutics' financial health, consider reading: Breaking Down Iterum Therapeutics plc (ITRM) Financial Health: Key Insights for Investors

Iterum Therapeutics plc (ITRM) Market Position & Future Outlook

Iterum Therapeutics is navigating a challenging pharmaceutical landscape, with a focus on developing and commercializing innovative anti-infectives to combat multi-drug resistant organisms. Their future outlook hinges on the successful commercialization of their lead product, Sulopenem, and strategic partnerships to expand their market reach.

Competitive Landscape

Company Market Share, % Key Advantage
Iterum Therapeutics Relatively Small (Specific % Unavailable) Novel Sulopenem molecule targeting multi-drug resistant infections.
Pfizer Significant (Specific % Unavailable) Established market presence, diverse product portfolio, and strong distribution networks.
Merck & Co. Significant (Specific % Unavailable) Extensive research and development capabilities and a broad range of established pharmaceutical products.

Opportunities & Challenges

Opportunities Risks
Gaining FDA approval for Sulopenem in new indications, expanding its potential patient base. Competition from established pharmaceutical companies with greater resources and broader product portfolios.
Strategic partnerships with larger pharmaceutical companies to enhance commercialization and distribution efforts. Reliance on successful clinical trial outcomes and regulatory approvals for future product development.
Growing global demand for effective anti-infectives due to increasing antibiotic resistance. Potential for delays in manufacturing and supply chain disruptions.

Industry Position

Iterum Therapeutics occupies a niche position within the anti-infectives market, primarily focused on addressing unmet needs in the treatment of multi-drug resistant infections. Their success depends on several factors:

  • Regulatory Milestones: Achieving timely FDA approvals for Sulopenem and future pipeline products is critical.
  • Commercial Execution: Successfully launching and marketing Sulopenem to gain market share and generate revenue.
  • Strategic Collaborations: Forming partnerships to leverage the resources and expertise of larger pharmaceutical companies.

For more insights into Iterum Therapeutics' financial standing, explore: Breaking Down Iterum Therapeutics plc (ITRM) Financial Health: Key Insights for Investors

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