Iterum Therapeutics(ITRM)

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Iterum Therapeutics (ITRM) Investor Presentation - Slideshow
2021-03-03 21:39
ITherapeutics ERUM Company Overview February 2021 Oral and IV treatment for serious bacterial infections ERUM 1 ITherapeutics Forward-looking Statements & Disclaimer This presentation contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem, the sufficiency of cash resources, the granting or issuing of patents, the expected timing of NDA and EMA filings and our plans, strategies and ...
Iterum Therapeutics(ITRM) - 2020 Q3 - Quarterly Report
2020-11-16 12:15
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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-38503 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Ireland 98- ...
Iterum Therapeutics(ITRM) - 2020 Q2 - Quarterly Report
2020-08-06 11:15
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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (+353) 1 903-8920 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 jurisdictio ...
Iterum Therapeutics(ITRM) - 2020 Q1 - Quarterly Report
2020-05-14 11:17
Financial Position - The company has an accumulated deficit of $251.0 million as of March 31, 2020, indicating significant operating losses since inception [142]. - The company has cash, cash equivalents, and restricted cash of $23.3 million as of March 31, 2020, raising concerns about its ability to continue operations without additional funding [145]. - The company has expressed substantial doubt about its ability to continue as a going concern without adequate financing [174]. - As of March 31, 2020, the company had cash, cash equivalents, and restricted cash totaling $23.3 million [173]. - As of March 31, 2020, the company had cash and cash equivalents of $23.3 million, consisting solely of cash [199]. - Contractual obligations as of March 31, 2020, total $69.7 million, including $64.0 million in principal debt repayments [191]. - The company may face increased capital costs and limited access to funding due to the COVID-19 pandemic's impact on capital markets [190]. Revenue and Funding - The company has not generated any revenue from product sales to date, relying primarily on government awards for funding [149]. - The company anticipates financing operations through a combination of equity offerings, debt financings, and collaboration agreements until it can generate significant revenue [143]. - The company reported no revenue for the three months ended March 31, 2020, compared to $37,000 for the same period in 2019, reflecting a decrease of $37,000 [163]. - Net cash provided by financing activities was $45.9 million for the three months ended March 31, 2020, primarily from a private placement [187]. - The company completed an IPO on May 30, 2018, raising net proceeds of $74.2 million from the sale of 6,350,000 ordinary shares at a price of $13.00 per share [136]. - The company has raised approximately $51.6 million from the issuance of 6.500% Exchangeable Notes and $0.1 million from RLNs as part of a private placement [172]. Expenses - Total operating expenses decreased to $12.9 million for the three months ended March 31, 2020, from $20.5 million in the same period in 2019, a reduction of $7.6 million [163]. - Research and development expenses were $9.7 million for the three months ended March 31, 2020, down from $17.4 million in 2019, primarily due to reduced costs associated with Phase 3 clinical trials [164]. - General and administrative expenses slightly increased to $3.2 million in Q1 2020 from $3.1 million in Q1 2019, with personnel-related costs rising due to increased headcount [165]. - The company anticipates an increase in general and administrative expenses in the future as it prepares for potential commercialization of its products [155]. - Interest expense, net rose significantly to $2.6 million for the three months ended March 31, 2020, compared to $0.1 million in the prior year, largely due to interest on exchangeable notes and amortization of debt costs [170]. - The company incurred private placement transaction costs of $2.1 million for the three months ended March 31, 2020, with no such costs in the same period in 2019 [167]. Clinical Trials and Commercialization - The company initiated three Phase 3 clinical trials for sulopenem in 2018, with topline data expected in the second quarter of 2020 [135]. - The company expects to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution if it obtains marketing approval for sulopenem [142]. - The company is evaluating its commercialization strategy in the United States and other territories as it advances its sulopenem program [142]. - The company expects to incur significant expenses for ongoing clinical trials and development of its sulopenem program, impacting future funding requirements [188]. Debt and Financing Arrangements - The company entered into a secured credit facility with SVB for up to $30 million, with an initial draw of $15 million funded [175]. - Monthly amortization payments for the initial $15 million draw began on November 1, 2019, with total principal repayments of $1,552 made during the three months ended March 31, 2020 [176]. - The company issued approximately $51.6 million in Exchangeable Notes with a 6.500% interest rate, repayable on January 31, 2025 [181]. - The interest rate on the secured credit facility is sensitive to changes in interest rates, with a minimum rate of 8.31% [201]. Royalty and Payment Obligations - The company anticipates royalty payments to Pfizer ranging from single-digit to mid-teens percentages based on net sales of licensed products [193]. - Payments on Royalty-Linked Notes will be based on a percentage of net revenues from U.S. sales of specified sulopenem products, capped at $160.00 per note [181][194]. - The payment rate for royalty payments on specified sulopenem products can be up to 20% based on FDA approvals [195]. - The maximum return on RLNs is $160.00, or 4,000 times the principal amount of such RLN [195]. Currency and Accounting - Substantially all of the company's liabilities were denominated in U.S. dollars as of March 31, 2020 [200]. - Realized net foreign currency gains and losses did not materially affect the company's results of operations for the three months ended March 31, 2020 [200]. - The company contracts with CROs and CMOs globally, which may expose it to fluctuations in foreign currency rates [200]. - The company has irrevocably elected to opt out of the extended transition period for new accounting standards applicable to public companies [196]. - The Wall Street Journal prime rate decreased from 5.50% to 3.25% between August 1, 2019, and March 16, 2020 [201].
Iterum Therapeutics (ITRM) Investor Presentation - Slideshow
2020-04-15 19:58
ITherapeutics ERUM Company Overview April, 2020 Oral and IV treatment for serious bacterial infections ERUM 1 ITherapeutics Forward-looking Statements & Disclaimer This presentation contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem, the sufficiency of cash resources, the granting or issuing of patents, the timing, progress and results of clinical trials, and the expected timin ...
Iterum Therapeutics(ITRM) - 2019 Q4 - Annual Report
2020-03-12 11:16
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, 2019 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) - 2019 Q3 - Quarterly Report
2019-11-12 22:01
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, 2019 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) Investor Presentation - Slideshow
2019-10-03 14:07
ITherapeutics ERUM Company Overview October 2019 Oral and IV treatment for serious bacterial infections ERUM 1 CONFIDENTIAL ITherapeutics Forward-looking Statements & Disclaimer This presentation contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem, the sufficiency of cash resources, the granting or issuing of patents, the timing, progress and results of clinical trials, and the ...
Iterum Therapeutics(ITRM) - 2019 Q2 - Quarterly Report
2019-08-14 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, 2019 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) Investor Presentation - Slideshow
2019-08-09 18:35
ITherapeutics ERUM Company Overview August 2019 Oral and IV treatment for serious bacterial infections ERUM 1 CONFIDENTIAL ITherapeutics Forward-looking Statements & Disclaimer This presentation contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem, the sufficiency of cash resources, the granting or issuing of patents, the timing, progress and results of clinical trials, and the e ...