Iterum Therapeutics(ITRM)

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Iterum Therapeutics(ITRM) - 2023 Q2 - Quarterly Report
2023-08-11 11:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38503 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...
Iterum Therapeutics(ITRM) - 2023 Q1 - Quarterly Report
2023-05-12 11:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38503 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporatio ...
Iterum Therapeutics(ITRM) - 2022 Q4 - Earnings Call Transcript
2023-03-16 13:50
Financial Data and Key Metrics Changes - Total operating expenses for Q4 2022 were $7.9 million, up from $6.8 million in Q4 2021, and full-year expenses were $30.4 million compared to $24.5 million in 2021 [13] - R&D expenses increased to $5.8 million in Q4 2022 from $3.7 million in Q4 2021, and full-year R&D costs rose to $17.6 million from $10.7 million in 2021 [13] - The net loss on a U.S. GAAP basis was $5.1 million for Q4 2022 and $44.4 million for the full year, impacted by a non-cash charge of $17.4 million related to share option cancellations [14] Business Line Data and Key Metrics Changes - General and administrative (G&A) costs were $2.1 million for Q4 2022, down from $3.1 million in Q4 2021, and full-year G&A costs were $12.8 million, lower than $13.8 million in 2021 [35] Market Data and Key Metrics Changes - The market for uncomplicated urinary tract infections (uUTI) treatment is significant, with approximately 33 million prescriptions annually in the U.S., highlighting the need for new oral treatments due to safety and efficacy challenges of existing options [30] Company Strategy and Development Direction - The company is focused on the clinical development of oral sulopenem, with a new Phase 3 clinical trial (REASSURE) currently enrolling patients, expected to complete enrollment in the first half of 2024 [8][9] - The company has received two U.S. patents for oral sulopenem, providing protection until 2039, which supports its market strategy [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the value of oral sulopenem to address multi-drug resistant infections and emphasized the importance of completing ongoing clinical work [24] - The company anticipates resubmitting its NDA to the FDA in the second half of 2024 if the REASSURE trial is successful [15] Other Important Information - As of December 31, 2022, the company had cash, cash equivalents, and short-term investments of $60.8 million, expected to fund operations until mid-2024 [15][32] - The company has pending patent applications in various international markets, indicating a broader strategy for global market entry [31] Q&A Session Summary Question: How many patients have been enrolled in the REASSURE trial? - Management did not disclose specific enrollment numbers but indicated that the study is progressing well with a significant number of sites open [39] Question: What type of data can be expected from the interim analysis of the REASSURE trial? - The interim analysis will assess patient size and ensure the trial maintains its statistical power, but no specific efficacy data will be revealed at that stage [21] Question: Will the cash runway extend to include top-line data readout from REASSURE? - Yes, the company expects to fund operations through to the data readout, which is anticipated shortly after enrollment completion [22]
Iterum Therapeutics(ITRM) - 2022 Q4 - Annual Report
2023-03-16 11:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38503 Iterum Therapeutics plc (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorporation or ...
Iterum Therapeutics(ITRM) - 2022 Q3 - Earnings Call Presentation
2022-11-10 18:03
ITherapeutics ERUM Non-Confidential Information Presentation November 2022 Oral and IV treatment for serious bacterial infections ERUM 1 ITherapeutics Forward-looking Statements & Disclaimer This Confidential Overview (this "Overview") contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem, the granting or issuing of patents, the timing, progress and results of clinical trials, the ...
Iterum Therapeutics(ITRM) - 2022 Q3 - Earnings Call Transcript
2022-11-10 16:42
Iterum Therapeutics plc (NASDAQ:ITRM) Q3 2022 Earnings Conference Call November 10, 2022 8:30 AM ET Company Participants Louise Barrett – Senior Vice President-Legal Affairs Corey Fishman – Chief Executive Officer Judy Matthews – Chief Financial Officer Conference Call Participants Ed Acre – H.C. Wainwright Operator Ladies and gentlemen, welcome to the Iterum Therapeutics Third Quarter 2022 Financial Results Call. My name is Maxine, and I'll be coordinating the call today. [Operator Instructions] I will now ...
Iterum Therapeutics(ITRM) - 2022 Q3 - Quarterly Report
2022-11-10 12:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38503 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpor ...
Iterum Therapeutics(ITRM) - 2022 Q2 - Quarterly Report
2022-08-12 11:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38503 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...
Iterum Therapeutics(ITRM) - 2022 Q1 - Quarterly Report
2022-05-13 11:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) Ireland 98-1283148 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Fitzwilliam Court 1st Floor, Leeson Close, Dublin 2, Ireland (Address of principal executive offices) Not applicable (Zip Code) (+353 ...
Iterum Therapeutics(ITRM) - 2021 Q4 - Earnings Call Transcript
2022-03-28 14:53
Iterum Therapeutics plc (NASDAQ:ITRM) Q4 2021 Earnings Conference Call March 28, 2022 8:30 AM ET Company Participants Louise Barrett - Senior Vice President of Legal Affairs Corey Fishman - Chief Executive Officer Judy Matthews - Chief Financial Officer Conference Call Participants Thomas Yip - H.C. Wainwright Operator Hello, and welcome to the Iterum Therapeutics Fourth Quarter and Full Year 2021 Financial Results Call. My name is Alex, and I will be coordinating the call today. [Operator Instructions]. I ...