Iterum Therapeutics(ITRM) - 2025 Q2 - Quarterly Results

Executive Summary Iterum Therapeutics reported Q2 2025 results, focusing on the upcoming August 2025 launch of ORLYNVAH™ for uUTIs, a significant development in antibiotic treatment Q2 2025 Overview and Key Announcements Iterum Therapeutics reported Q2 2025 financial results, with a significant focus on the anticipated August 2025 launch of ORLYNVAH™ for uncomplicated urinary tract infections (uUTIs) - Iterum Therapeutics expects to launch ORLYNVAH™ for uUTIs in August 2025, marking the first branded antibiotic for uUTIs in over 25 years[2][3] - ORLYNVAH™ is the only FDA-approved oral penem antibiotic in the U.S., offering a much-needed option for patients with limited alternatives due to resistant Gram-negative bacteria, including ESBL-producing Enterobacterales[3] Recent Business Developments Iterum Therapeutics advanced ORLYNVAH™ commercialization through partnerships, expanded intellectual property, and secured a debt repayment extension Commercialization and Partnerships Iterum Therapeutics has advanced its commercialization strategy for ORLYNVAH™ through key partnerships and personnel appointments - Iterum expects to launch ORLYNVAH™ for uUTIs in the U.S. by the end of August 2025, focusing most resources on pre-commercialization activities[4] - A Product Commercialization Agreement was signed with EVERSANA Life Science Services, LLC in June 2025 for sales, commercial operations, marketing, logistics, and regulatory services for ORLYNVAH™ in the U.S[4] - A Commercial Manufacturing and Supply Agreement was entered into with ACS Dobfar S.p.A in July 2025 for the manufacture and supply of ORLYNVAH™ bilayer tablets[4] - Christine Coyne was appointed Chief Commercial Officer to lead all commercial efforts for Iterum, including the ORLYNVAH™ launch[9] Clinical and Intellectual Property Updates The company expanded its patent estate in Canada for sulopenem etzadroxil and probenecid combinations, extending protection until December 2039 - The Canadian Patent Office issued patent 3,129,337 covering the use of sulopenem etzadroxil and probenecid combinations, expiring in December 2039[9] - Results from Iterum's REASSURE Phase 3 clinical trial comparing oral sulopenem to oral Augmentin® in adult women with uUTIs were published in NEJM Evidence[9] Corporate Finance and Debt Iterum secured an extension for the repayment of its $20.0 million regulatory milestone payment to Pfizer Inc. until October 25, 2029 - Pfizer Inc. agreed to extend the deferral term for payment of the $20.0 million regulatory milestone payment until October 25, 2029[9] Second Quarter 2025 Financial Performance Iterum Therapeutics reported a cash position of $13.0 million, increased operating expenses due to pre-commercialization, and a higher net loss for Q2 2025 Cash Position and Outlook As of June 30, 2025, Iterum's cash and cash equivalents stood at $13.0 million, with a projected cash runway into 2026 Cash Position and Shares Outstanding | Metric | Value | | :----------------------------------- | :------------------- | | Cash and cash equivalents (June 30, 2025) | $13.0 million | | Net proceeds from ATM offering (July 1 - Aug 1, 2025) | $2.2 million | | Cash runway estimate | Into 2026 | | Ordinary shares outstanding (Aug 1, 2025) | 44.7 million | Operating Expenses Analysis Operating expenses for Q2 2025 totaled $5.5 million, an increase from $4.0 million in Q2 2024, driven by pre-commercialization activities Q2 2025 Operating Expenses (YoY Change, in thousands) | Expense Category | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :------------------------ | :--------------------- | :--------------------- | :----------- | | Cost of sales | $(345) | $0 | N/A | | Research and development | $(1,000) | $(2,075) | Decrease of $1.1M | | General and administrative | $(4,184) | $(1,901) | Increase of $2.3M | | Total operating expenses | $(5,529) | $(3,976) | Increase of $1.5M | - The decrease in R&D expenses was primarily due to a decrease in clinical trial costs associated with the REASSURE trial[7] - The increase in G&A expenses was primarily due to increased spend associated with pre-commercialization activities[8] Net Loss Iterum reported a GAAP net loss of $6.5 million for Q2 2025, an increase from $5.0 million in Q2 2024 Q2 2025 Net Loss (YoY Comparison, in thousands) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :------------------ | :--------------------- | :--------------------- | | GAAP Net Loss | $(6,509) | $(4,997) | | Non-GAAP Net Loss | $(5,074) | $(3,773) | Non-GAAP Financial Measures This section defines and reconciles non-GAAP net loss and non-GAAP net loss per share, excluding specific non-cash and non-recurring items Definition and Reconciliation Iterum presents non-GAAP net loss and non-GAAP net loss per share to provide supplementary information for investors and management - Non-GAAP net loss and non-GAAP net loss per share are presented to supplement GAAP results, providing additional analysis for investors and management[12][13] - Adjustments to GAAP net loss for non-GAAP calculation include intangible asset amortization, share-based compensation expense, accrued interest and amortization on Exchangeable Notes, interest on Pfizer promissory note (non-cash), and adjustments to fair value of Royalty-Linked Notes[12][13] Company and Product Information Iterum Therapeutics is a biopharmaceutical company focused on anti-infectives, with ORLYNVAH™ as its FDA-approved lead product for uUTIs About Iterum Therapeutics plc Iterum Therapeutics plc is a biopharmaceutical company focused on developing differentiated anti-infectives to combat multi-drug resistant pathogens - Iterum Therapeutics plc focuses on delivering differentiated anti-infectives to combat multi-drug resistant pathogens globally[15] - The company is advancing sulopenem, a novel penem anti-infective, with both oral (ORLYNVAH™) and IV formulations, demonstrating potent in vitro activity against various resistant bacteria[15] - ORLYNVAH™ (oral sulopenem) has received FDA approval for the treatment of uncomplicated urinary tract infections (uUTIs) caused by specific microorganisms in adult women with limited or no alternative oral antibacterial treatment options[15] - Sulopenem has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations in seven indications[15] About ORLYNVAH™ ORLYNVAH™ is a novel oral penem antibiotic specifically designed for the treatment of uUTIs - ORLYNVAH™ is a novel oral penem antibiotic for the treatment of uUTIs[16] - It shows potent activity against Enterobacterales, including those encoding ESBL or AmpC-type ß-lactamases, which cause resistance to third-generation cephalosporins[16] Additional Information This section provides conference call details, a cautionary note on forward-looking statements, and investor contact information Conference Call Details Iterum Therapeutics hosted a conference call on August 5, 2025, at 8:30 a.m. Eastern Time to discuss the financial results and recent developments - Iterum hosted a conference call on August 5, 2025, at 8:30 a.m. Eastern Time[11] Cautionary Note Regarding Forward-looking Statements This section provides a standard disclaimer regarding forward-looking statements, highlighting that actual results may differ materially due to various risks and uncertainties - The press release contains forward-looking statements regarding Iterum's plans, strategies, and prospects, including ORLYNVAH™'s potential and cash resources[17] - Actual future results may differ materially due to factors such as the ability to raise capital, successful commercialization of ORLYNVAH™, market acceptance, regulatory changes, and the company's ability to continue as a going concern[17][18] Investor Contact Contact information for investor inquiries is provided, with Judy Matthews, Chief Financial Officer, listed as the primary contact - Investor contact: Judy Matthews, Chief Financial Officer, 312-778-6073, IR@iterumtx.com[19] Condensed Consolidated Financial Statements This section presents the condensed consolidated statement of operations and balance sheet data for Q2 2025, detailing financial performance and position Condensed Consolidated Statement of Operations The condensed consolidated statement of operations shows a GAAP net loss of $6.5 million for Q2 2025, compared to $5.0 million in Q2 2024 Condensed Consolidated Statement of Operations (Q2 2025 vs Q2 2024, in thousands except share and per share data) | (In thousands except share and per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Costs and expenses: | | | | | | Cost of sales | $(345) | $— | $(687) | $— | | Research and development | $(1,000) | $(2,075) | $(1,591) | $(6,052) | | General and administrative | $(4,184) | $(1,901) | $(6,961) | $(4,087) | | Total operating expenses | $(5,529) | $(3,976) | $(9,239) | $(10,139) | | Operating loss | $(5,529) | $(3,976) | $(9,239) | $(10,139) | | Interest expense, net | $(316) | $(571) | $(850) | $(1,058) | | Adjustments to fair value of derivatives | $(585) | $(407) | $(1,134) | $(793) | | Other expense, net | $(20) | $(12) | $(58) | $(29) | | Income tax expense | $(59) | $(31) | $(119) | $(79) | | Net loss (GAAP) | $(6,509) | $(4,997) | $(11,400) | $(12,098) | | Net loss per share – basic and diluted (GAAP) | $(0.16) | $(0.30) | $(0.31) | $(0.76) | | Weighted average ordinary shares outstanding | 39,935,213 | 16,552,214 | 37,013,653 | 15,992,454 | | Non-GAAP Net Loss | $(5,074) | $(3,773) | $(8,327) | $(9,600) | | Non-GAAP net loss per share – basic and diluted | $(0.13) | $(0.23) | $(0.22) | $(0.60) | Condensed Consolidated Balance Sheet Data As of June 30, 2025, total assets were $34.0 million, down from $44.6 million at December 31, 2024, with a decrease in total liabilities Condensed Consolidated Balance Sheet Data (in thousands) | (In thousands) | As of June 30, 2025 | As of December 31, 2024 | | :---------------------------------- | :------------------ | :---------------------- | | Cash, cash equivalents and short-term investments | $13,026 | $24,125 | | Inventory | $948 | $— | | Intangible asset, net | $19,059 | $19,746 | | Other assets | $981 | $724 | | Total assets | $34,014 | $44,595 | | Pfizer Promissory Note | $20,653 | $20,300 | | Exchangeable notes | $— | $14,463 | | Royalty-linked notes | $11,905 | $10,771 | | Other liabilities | $5,343 | $3,142 | | Total liabilities | $37,901 | $48,676 |