Iterum Therapeutics(ITRM) - 2024 Q2 - Quarterly Results

Financial Performance - Iterum reported a net loss of $5.0 million for Q2 2024, a significant decrease from a net loss of $12.2 million in Q2 2023, reflecting improved financial performance [6]. - Non-GAAP net loss for Q2 2024 was $3.8 million, compared to a non-GAAP net loss of $10.0 million in Q2 2023, indicating improved operational efficiency [6]. - Net loss for Q2 2024 was $4,997,000, compared to a net loss of $12,243,000 in Q2 2023, indicating a 59.1% improvement [13]. - Net loss per share for Q2 2024 was $0.30, an improvement from $0.95 in Q2 2023 [13]. - Non-GAAP net loss for Q2 2024 was $3,773,000, compared to $9,955,000 in Q2 2023, a 62.1% improvement [13]. Expenses - Research and development (R&D) expenses for Q2 2024 were $2.1 million, down from $9.0 million in the same period last year, primarily due to reduced costs associated with the REASSURE trial [5]. - General and administrative (G&A) expenses remained stable at $1.9 million for Q2 2024, consistent with the same period in 2023 [5]. - Total operating expenses for Q2 2024 were $3,976,000, a decrease from $10,822,000 in Q2 2023, representing a 63.3% reduction [13]. - Interest expense, net, increased to $571,000 in Q2 2024 from $324,000 in Q2 2023, a rise of 76.5% [13]. Cash and Investments - Cash, cash equivalents, and short-term investments totaled $11.7 million as of June 30, 2024, expected to fund operations into 2025, including through the PDUFA action date of October 25, 2024 [5]. - Cash, cash equivalents, and short-term investments decreased to $11,717,000 as of June 30, 2024, down from $23,930,000 as of December 31, 2023, reflecting a 51.0% decline [14]. Assets and Liabilities - Total assets decreased to $14,174,000 as of June 30, 2024, from $26,259,000 as of December 31, 2023, a reduction of 46.1% [14]. - Total liabilities decreased to $25,087,000 as of June 30, 2024, from $32,662,000 as of December 31, 2023, a decrease of 23.2% [14]. - Total shareholders' deficit increased to $(10,913,000) as of June 30, 2024, compared to $(6,403,000) as of December 31, 2023 [14]. Shareholder Information - Weighted average ordinary shares outstanding increased to 16,552,214 in Q2 2024 from 12,942,969 in Q2 2023, a growth of 28.5% [13]. - Iterum completed a rights offering on August 9, 2024, raising gross proceeds of $7.4 million by issuing 6.1 million ordinary shares at $1.21 per share [3]. Clinical Trials and Regulatory Updates - Enrollment for the pivotal Phase 3 clinical trial REASSURE was completed in October 2023, with a total of 2,222 patients enrolled [2]. - The FDA has assigned a PDUFA action date of October 25, 2024, for Iterum's resubmitted NDA for oral sulopenem, which aims to be the first oral penem approved in the U.S. [2]. - The Advisory Committee meeting to discuss the NDA for oral sulopenem is scheduled for September 9, 2024, focusing on antimicrobial stewardship and target patient populations [3]. Intellectual Property - Iterum received Notices of Allowance for two U.S. patent applications related to sulopenem, with patent expirations set for April 1, 2039, and March 11, 2041, respectively [4].