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Iterum Names Christine Coyne as Chief Commercial Officer to Lead ORLYNVAH™ Launch and Commercial Growth
Globenewswire· 2025-06-30 11:00
Company Overview - Iterum Therapeutics plc is focused on delivering next-generation oral and IV antibiotics to combat infections caused by multi-drug resistant pathogens [1][4] - The company is advancing the development of its first compound, sulopenem, which has shown potent in vitro activity against various resistant bacteria [4] Leadership Appointment - Christine Coyne has been appointed as the Chief Commercial Officer, a newly created position, to lead all commercial efforts for Iterum [1][2] - Coyne brings over 30 years of experience in the pharmaceutical industry, with a strong background in anti-infectives [2][3] Product Launch - The upcoming launch of ORLYNVAH™, an oral formulation of sulopenem, is a significant opportunity for the company to address unmet medical needs in treating uncomplicated urinary tract infections (uUTIs) [1][3][5] - ORLYNVAH™ has received FDA approval for the treatment of uUTIs caused by specific microorganisms in adult women with limited or no alternative oral antibacterial treatment options [4][5] Market Positioning - The company aims to accelerate launch readiness for ORLYNVAH™ and scale its capabilities for long-term growth [2][3] - ORLYNVAH™ is designed to be effective against Enterobacterales species that are resistant to third-generation cephalosporins [5]
Iterum Therapeutics Announces Publication of REASSURE Trial in NEJM Evidence
Globenewswire· 2025-06-25 11:00
Core Insights - Iterum Therapeutics has reported the publication of results from its Phase 3 REASSURE trial, demonstrating the efficacy of oral sulopenem compared to Augmentin for treating uncomplicated urinary tract infections (uUTIs) in women [1][2] - The trial showed that oral sulopenem was statistically superior to Augmentin, with an overall success rate of 61.7% compared to 55.0% for Augmentin [4] - The FDA has approved ORLYNVAH™, Iterum's new drug for treating uUTIs caused by specific resistant pathogens, based on robust data from the REASSURE trial and another pivotal study [5][6] Company Overview - Iterum Therapeutics focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens in both community and hospital settings [1][9] - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications [9] Clinical Trial Details - The REASSURE trial was a non-inferiority study designed to compare oral sulopenem with Augmentin in a population of adult women with uncomplicated uUTIs [2][4] - The trial enrolled 2,222 patients and was conducted under a Special Protocol Assessment (SPA) agreement with the FDA [2] Market Context - UTIs are among the most common bacterial infections, with approximately 15 million emergency room visits and over 40 million prescriptions for uUTIs annually in the U.S. [7] - The increasing rates of multi-drug resistance have made the treatment of uUTIs more challenging, with about 30% of uUTIs caused by quinolone non-susceptible pathogens [7]
Iterum Therapeutics (ITRM) Update / Briefing Transcript
2025-06-11 21:30
Summary of Iterum Therapeutics Conference Call Company Overview - **Company**: Iterum Therapeutics - **Product**: Orlynda (oral solopenem) - **Partnership**: Eversana for commercialization Key Points Industry Context - The uncomplicated urinary tract infection (UTI) market in the U.S. generates approximately **40 million prescriptions annually** [10] - **Two-thirds** of these prescriptions (about **26 million**) are for at-risk patients, including elderly women and those with comorbidities [10] - There have been **no new oral treatments** for uncomplicated UTIs in over **25 years**, with the market leader, nitrofurantoin, approved in **1953** [11] - Rising rates of **antibiotic resistance** are diminishing the effectiveness of existing treatments [12] Product Development and Commercialization - Orlynda received **FDA approval** in **October 2024** and is the only FDA-approved oral penum in the U.S. for uncomplicated UTIs [9] - Iterum has signed a **commercialization agreement** with Eversana to expedite the launch of Orlynda [8] - The expected launch date for Orlynda is by the **fourth quarter of 2025** [3][9] Financial Updates - Pfizer extended the due date for a **$20 million regulatory milestone** payment related to Orlynda from **October 2026** to **October 2029**, alleviating financial pressure [7] - Pricing strategy for Orlynda is not finalized, but expected to be between **$1,400 and $4,700** per treatment course [18] Market Dynamics and Research Insights - Physicians report a **high unmet need** for new antibiotics in the uncomplicated UTI space, with low confidence in existing treatments for at-risk patients [13] - Orlynda is viewed favorably by payers for its efficacy and safety, particularly against multidrug-resistant pathogens [13] Commercialization Strategy - A team of **national account managers** has been trained to ensure optimal market access for Orlynda [14] - The launch will occur in **phases**, with initial focus on territories with high prescription rates [15][16] - Each high-value physician in target territories writes an average of **over 500 prescriptions** for uncomplicated UTIs annually [17] Intellectual Property and Manufacturing - Orlynda has **10 years of marketing exclusivity** in the U.S. from the FDA, expiring in **October 2034** [21] - The company holds multiple patents related to Orlynda, with expiration dates ranging from **2039 to 2041** [24] - Current inventory is projected to last through **mid to late 2026**, with a shelf life of **six years** from manufacture [25] Conclusion - Iterum Therapeutics is making significant progress towards the commercialization of Orlynda, addressing a critical need in the UTI market, and anticipates a successful launch by the end of 2025 [26]
Iterum Therapeutics Announces Partnership for Commercialization Services
Globenewswire· 2025-06-11 11:00
Core Viewpoint - Iterum Therapeutics has entered into a Product Commercialization Agreement with EVERSANA to bring its oral antibiotic ORLYNVAH to the U.S. market by Q4 2025, targeting uncomplicated urinary tract infections (uUTIs) caused by multi-drug resistant pathogens [1][2]. Company Overview - Iterum Therapeutics focuses on developing next-generation oral and IV antibiotics to combat infections from multi-drug resistant pathogens in both community and hospital settings [1][5]. - The company has received FDA approval for ORLYNVAH (oral sulopenem) for treating uUTIs in adult women with limited or no alternative oral antibacterial treatment options [5][7]. Product Details - ORLYNVAH is a novel oral penem antibiotic effective against Enterobacterales species, including those resistant to third-generation cephalosporins [7]. - The treatment addresses a significant market need, as approximately 30% of uUTIs in the U.S. are caused by quinolone non-susceptible pathogens, and about 1% are resistant to all commonly available oral antibiotics [4]. Market Context - UTIs are among the most common bacterial infections, with around 15 million emergency room visits and over 40 million total prescriptions for uUTIs annually in the U.S. [4]. - Approximately two-thirds of uUTI prescriptions are for patients at elevated risk for treatment failure, highlighting the need for effective new treatments [4]. Partnership with EVERSANA - The partnership with EVERSANA aims to leverage their extensive commercial capabilities to ensure a swift market entry for ORLYNVAH [2][8]. - EVERSANA will provide a range of services including sales, marketing, logistics, and regulatory support for the commercialization of ORLYNVAH in the U.S. [1][2].
Iterum Therapeutics Announces Extension of Term of Promissory Note
Globenewswire· 2025-05-19 11:00
Iterum is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti- infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive an ...
Iterum Therapeutics(ITRM) - 2025 Q1 - Earnings Call Transcript
2025-05-13 13:32
Financial Data and Key Metrics Changes - Total operating expenses decreased to $3.7 million in Q1 2025 from $6.2 million in Q1 2024 [16] - Research and development (R&D) costs significantly dropped to approximately $600,000 in Q1 2025 from $4 million in the same period in 2024, primarily due to reduced costs associated with the ReAssure trial [17] - General and administrative (G&A) expenses increased to $2.8 million in Q1 2025 from $2.2 million in Q1 2024, driven by pre-commercialization activities [18] - Net loss on a U.S. GAAP basis was $4.9 million in Q1 2025 compared to a net loss of $7.1 million in Q1 2024 [18] - Non-GAAP net loss improved to $3.3 million in Q1 2025 from $5.8 million in Q1 2024, reflecting lower R&D expenses [19] Business Line Data and Key Metrics Changes - The company is preparing for the potential commercialization of Orlynda, targeting the U.S. market for uncomplicated urinary tract infections [6][10] - The addressable market for Orlynda is estimated at 26 million prescriptions annually for at-risk patients, with a potential net sales of over $250 million if a 1% market share is captured [10] Market Data and Key Metrics Changes - The U.S. market for uncomplicated urinary tract infections generates approximately 40 million prescriptions annually, with a significant portion written for at-risk patients [9] - New competition is emerging, with a product approved in April 2024 and another from GlaxoSmithKline expected to launch in the second half of 2025, increasing urgency for Orlynda's market entry [10] Company Strategy and Development Direction - The company aims to launch Orlynda by Q4 2025, emphasizing the urgency due to the lack of innovation in the therapy area over the past 25 years [6][8] - A phased launch strategy is planned, focusing on territories with high antibiotic resistance and a significant number of prescribing physicians [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercialization timeline, stating no significant hurdles are anticipated before the launch of Orlynda [27] - The company has extended its cash runway into 2026, which includes the potential launch of Orlynda [14] Other Important Information - The company repaid outstanding principal and interest on exchangeable notes in January 2025, reducing its debt burden [13] - As of March 2025, the company had cash and cash equivalents of $12.7 million, which, along with recent fundraising, is expected to fund operations into 2026 [19] Q&A Session Summary Question: Can you elaborate on the maturity of conversations with potential commercial partners? - Management indicated ongoing discussions but noted that many potential partners may not see the timing as right for a partnership [25] Question: Are there any outstanding rate-limiting steps ahead of Orlynda's launch later this year? - Management stated there are no significant hurdles remaining and confirmed that product manufacturing is already in place [27]
Iterum Therapeutics(ITRM) - 2025 Q1 - Earnings Call Transcript
2025-05-13 13:30
Financial Data and Key Metrics Changes - Total operating expenses decreased to $3.7 million in Q1 2025 from $6.2 million in Q1 2024 [16] - Research and development (R&D) costs significantly dropped to approximately $600,000 in Q1 2025 from $4 million in the same period in 2024, primarily due to reduced costs associated with the ReAssure trial [17] - General and administrative (G&A) expenses increased to $2.8 million in Q1 2025 from $2.2 million in Q1 2024, driven by pre-commercialization activities [18] - The net loss on a U.S. GAAP basis was $4.9 million in Q1 2025, compared to a net loss of $7.1 million in Q1 2024 [18] - On a non-GAAP basis, the net loss was $3.3 million in Q1 2025, down from $5.8 million in Q1 2024, reflecting lower R&D expenses [19] Business Line Data and Key Metrics Changes - The company is preparing for the potential commercialization of Orlynda, targeting the U.S. market for uncomplicated urinary tract infections [6][10] - The addressable market for Orlynda is estimated at 26 million prescriptions annually for at-risk patients, with a potential net sales of over $250 million if a 1% market share is captured [9] Market Data and Key Metrics Changes - The U.S. market for uncomplicated urinary tract infections generates approximately 40 million prescriptions annually, with a significant portion for at-risk patients [8] - New competition is emerging, with a product approved in April 2024 and another from GlaxoSmithKline expected to launch in the second half of 2025, increasing urgency for Orlynda's market entry [10] Company Strategy and Development Direction - The company aims to launch Orlynda by Q4 2025, emphasizing the urgency due to the lack of innovation in the therapy area over the past 25 years [7][14] - The commercialization strategy involves phased launches based on antibiotic resistance rates, physician prescription volumes, and managed care access [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the market dynamics for Orlynda, highlighting the significant need for new therapies for at-risk patients [14] - There are no major hurdles anticipated before the launch, with product manufacturing already in place [30] Other Important Information - The company repaid outstanding principal and interest on exchangeable notes in January 2025, reducing debt significantly [13] - Cash and cash equivalents were reported at $12.7 million as of March 2025, with expectations to fund operations into 2026 [19] Q&A Session Summary Question: Can you elaborate on the maturity of conversations with potential commercial partners? - Management indicated ongoing discussions but noted that many potential partners may not see the timing as right for a partnership [26][28] Question: Are there any outstanding rate-limiting steps ahead of Orlynda's launch later this year? - Management stated there are no significant hurdles remaining, with all necessary product available for launch [30]
Iterum Therapeutics(ITRM) - 2025 Q1 - Quarterly Report
2025-05-13 11:30
PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=9&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported a reduced net loss but faces a significant cash decrease and a going concern warning Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $12,652 | $24,125 | | Total current assets | $13,513 | $24,787 | | Total assets | $32,975 | $44,595 | | **Liabilities & Shareholders' Deficit** | | | | Total current liabilities | $3,628 | $17,605 | | Total liabilities | $35,529 | $48,676 | | Total shareholders' deficit | $(2,554) | $(4,081) | Condensed Consolidated Statements of Operations Highlights (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total operating expenses | $(3,710) | $(6,163) | | Operating loss | $(3,710) | $(6,163) | | Net loss | $(4,891) | $(7,101) | | Net loss per share – basic and diluted | $(0.14) | $(0.46) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,060) | $(13,083) | | Net cash (used in) / provided by investing activities | $(2) | $7,211 | | Net cash (used in) / provided by financing activities | $(8,388) | $7,217 | | Net (decrease) / increase in cash | $(11,473) | $1,318 | - The company has identified conditions that raise **substantial doubt about its ability to continue as a going concern** due to insufficient funds[17](index=17&type=chunk)[40](index=40&type=chunk)[42](index=42&type=chunk) - On January 31, 2025, the company repaid its matured Exchangeable Notes, totaling **$14.7 million** in principal and accrued interest[33](index=33&type=chunk)[63](index=63&type=chunk)[79](index=79&type=chunk) - Subsequent to the quarter end, the company raised approximately **$957,000** through its Sales Agreement and an additional **$4.2 million (net)** from a direct offering[132](index=132&type=chunk)[133](index=133&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=38&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its strategic focus on sulopenem rights and a significant going concern issue - Following the FDA approval of ORLYNVAH™, the company's primary focus is a **strategic process to sell or license its sulopenem rights**[138](index=138&type=chunk)[187](index=187&type=chunk)[216](index=216&type=chunk) - The company has **substantial doubt about its ability to continue as a going concern**, with $12.7 million in cash insufficient for the next 12 months[144](index=144&type=chunk)[188](index=188&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Cost of sales | $ (342) | $ — | $ (342) | | Research and development | $ (591) | $ (3,977) | $ 3,386 | | General and administrative | $ (2,777) | $ (2,186) | $ (591) | | **Total operating expenses** | **$ (3,710)** | **$ (6,163)** | **$ 2,453** | - Research and development expenses **decreased by $3.4 million** due to lower CRO costs after completing the REASSURE trial[160](index=160&type=chunk) - General and administrative expenses **increased by $0.9 million** in professional fees for pre-commercialization activities[161](index=161&type=chunk) - Net cash used in financing activities was **$8.4 million**, driven by a $14.7 million repayment of notes, offset by $6.4 million from share sales[185](index=185&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=54&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are foreign currency fluctuations and potential inflation impacts - The company is subject to **foreign currency risk** from international contracts but does not currently engage in hedging[202](index=202&type=chunk) - **Inflation** is a risk that could increase operational costs but has not had a material effect to date[203](index=203&type=chunk) [Controls and Procedures](index=54&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025 - Management, including the CEO and CFO, concluded that the company's **disclosure controls and procedures were effective** as of March 31, 2025[204](index=204&type=chunk) - **No material changes** to internal control over financial reporting occurred during the first quarter of 2025[205](index=205&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=55&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the filing date, the company is **not a party to any material legal proceedings**[208](index=208&type=chunk) [Risk Factors](index=55&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including a going concern warning and dependence on its sulopenem program - The company has **substantial doubt about its ability to continue as a going concern** due to insufficient cash reserves[210](index=210&type=chunk)[211](index=211&type=chunk) - The strategic process to sell or license sulopenem rights may not be successful, potentially leading to **liquidation of the business**[248](index=248&type=chunk)[250](index=250&type=chunk)[251](index=251&type=chunk) - The company is **heavily dependent on the success of its sulopenem program** and lacks a commercial organization[224](index=224&type=chunk)[254](index=254&type=chunk)[289](index=289&type=chunk) - The company relies on an **exclusive license agreement with Pfizer** for critical patent rights for sulopenem[326](index=326&type=chunk)[329](index=329&type=chunk) - The company's **reliance on third-party contract manufacturers** creates risks related to supply, cost, quality, and regulatory compliance[343](index=343&type=chunk)[347](index=347&type=chunk) - The company faces **substantial competition** from larger pharmaceutical companies and its products may not achieve market acceptance[296](index=296&type=chunk)[301](index=301&type=chunk) - The company's **stock price has been highly volatile**, and its retail investor base may hinder corporate initiatives[516](index=516&type=chunk)[520](index=520&type=chunk) [Other Information](index=160&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the first quarter - **No director or officer adopted or terminated** a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during Q1 2025[564](index=564&type=chunk) [Exhibits](index=161&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including required officer certifications - The report includes required **certifications from the CEO and CFO** under the Sarbanes-Oxley Act[565](index=565&type=chunk) - Exhibits incorporate by reference the **Securities Purchase Agreement** and Form of Pre-Funded Warrant from the April 2025 financing[565](index=565&type=chunk)
Iterum Therapeutics(ITRM) - 2025 Q1 - Quarterly Results
2025-05-13 11:15
Financial Performance - The net loss for Q1 2025 was $4.9 million, an improvement from a net loss of $7.1 million in the same period of 2024[10]. - Non-GAAP net loss for Q1 2025 was $3.3 million, compared to a non-GAAP net loss of $5.8 million in Q1 2024[10]. - Research and development expenses for Q1 2025 were $0.6 million, a significant decrease from $4.0 million in Q1 2024, primarily due to reduced clinical trial costs[7]. - General and administrative expenses increased to $2.8 million in Q1 2025 from $2.2 million in Q1 2024, driven by pre-commercialization activities[8]. Cash and Funding - The company extended its cash runway into 2026, raising approximately $5 million from a registered direct offering and an additional $1 million from its at-the-market offering program[3][5]. - As of March 31, 2025, Iterum had cash and cash equivalents of $12.7 million, which, along with recent fundraising, is expected to fund operations into 2026[5]. - Cash, cash equivalents, and short-term investments dropped significantly to $12,652 million from $24,125 million, a decrease of about 47.5%[23]. Assets and Liabilities - As of March 31, 2025, total assets decreased to $32,975 million from $44,595 million as of December 31, 2024, representing a decline of approximately 26.3%[23]. - Total liabilities decreased to $35,529 million from $48,676 million, reflecting a reduction of approximately 26.9%[23]. - Total shareholders' deficit improved to $(2,554) million from $(4,081) million, indicating a positive change of approximately 37.5%[23]. - Inventory stood at $533 million as of March 31, 2025, with no prior inventory reported[23]. - Other assets decreased to $386 million from $724 million, a decline of about 46.6%[23]. - Other liabilities increased to $3,504 million from $3,142 million, reflecting an increase of approximately 11.5%[23]. Shareholder Information - Iterum has approximately 40.0 million ordinary shares outstanding as of May 12, 2025[5]. Strategic Focus - The company is focused on addressing the increasing rate of antimicrobial resistance and the lack of innovation in uUTI treatments over the past 25 years[2]. Debt Management - The company repaid its 6.500% Exchangeable Senior Subordinated Notes due 2025 in January 2025[4]. - The Pfizer Promissory Note increased to $20,705 million from $20,300 million, a rise of about 2.0%[23]. - Royalty-linked notes rose to $11,320 million from $10,771 million, an increase of approximately 5.1%[23]. - Exchangeable notes were not reported as of March 31, 2025, compared to $14,463 million as of December 31, 2024[23].
Iterum Therapeutics Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-13 11:00
--Preparing for Potential Launch of ORLYNVAH by Q4 2025-- --Extended Cash Runway into 2026-- --Company to host conference call today at 8:30amET-- DUBLIN, Ireland and CHICAGO, May 13, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the first quarter ended March 31, 2025. "Based on pr ...