ITRM Iterum Therapeutics plc

1.19
0  0%
Previous Close 1.19
Open 1.18
52 Week Low 1.12
52 Week High 7.6499
Market Cap $21,230,484
Shares 17,852,149
Float 8,940,171
Enterprise Value $32,491,484
Volume 2,074,884
Av. Daily Volume 1,304,337
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Drug Pipeline

Drug Stage Notes
Sulopenem
Uncomplicated urinary tract infections (uUTI)
Phase 3
Phase 3
Phase 3 data released June 29, 2020. One of two primary endpoints met.
Sulopenem
Complicated urinary tract infections (cUTI)
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - June 1, 2020.
IFX-1
COVID-19 Coronavirus
Phase 2
Phase 2
Enrolment of first patient announced March 31, 2020.
Sulopenem
Complicated intra-abdominal infections (cIAI)
Phase 3
Phase 3
Phase 3 data missed primary endpoint - December 10, 2019.

Latest News

  1. DUBLIN, Ireland and CHICAGO, June 30, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced that it has entered into definitive agreements with institutional investors for the purchase and sale of 3,372,686 of its ordinary shares at a purchase price of $1.4825 per ordinary share in a registered direct offering priced at-the-market under Nasdaq rules. The Company also agreed to issue to the investors unregistered warrants to purchase up to 1,686,343 ordinary shares in a concurrent private placement. The warrants have an exercise price of $1.42…

    DUBLIN, Ireland and CHICAGO, June 30, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced that it has entered into definitive agreements with institutional investors for the purchase and sale of 3,372,686 of its ordinary shares at a purchase price of $1.4825 per ordinary share in a registered direct offering priced at-the-market under Nasdaq rules. The Company also agreed to issue to the investors unregistered warrants to purchase up to 1,686,343 ordinary shares in a concurrent private placement. The warrants have an exercise price of $1.42 per share, are exercisable immediately, and will expire five and one-half years following the date of issuance. The closing of the offering is expected to occur on or about July 2, 2020, subject to the satisfaction of customary closing conditions. 

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds to the Company from the offering are expected to be approximately $5.0 million, before deducting the placement agent's fees and other offering expenses payable by Iterum Therapeutics. The Company intends to use the net proceeds from this offering to fund the continued clinical development of sulopenem, the management of a potential regulatory filing and for working capital and general corporate purposes.

    The ordinary shares (but not the warrants issued in the private placement or the ordinary shares issuable upon exercise of the warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-232569) previously filed with the Securities and Exchange Commission, or the SEC, and declared effective by the SEC on July 16, 2019. The offering of the ordinary shares will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the ordinary shares being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by telephone at (646) 975-6996, or email at .

    The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended, or the Act, and Regulation D promulgated thereunder, and the warrants and the ordinary shares issuable upon exercise of the warrants have not been registered under the Act or applicable state securities laws. Accordingly, the warrants and ordinary shares issuable upon exercise of the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    About Iterum Therapeutics plc

    Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing 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 Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

    Safe Harbor Statement

    This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the anticipated closing of the offering, the use of proceeds from the offering, the transactions contemplated by the transaction documents, and the Company's plans, strategies and prospects for its business. In some cases, forward-looking statements can be identified by words such as "may," "believes," "intends," "seeks," "anticipates," "plans," "estimates," "expects," "should," "assumes," "continues," "could," "would," "will," "future," "potential" or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside the Company's control, including whether the conditions for the closing of the offering will be satisfied, the uncertainties inherent in the initiation and conduct of clinical trials,  availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, the Company's ability to apply for regulatory approval, changes in public policy or legislation, commercialization plans and timelines, if sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of the Company's expectations regarding how far into the future the Company's cash on hand will fund the Company's ongoing operations, the sufficiency of the Company's cash resources and the Company's ability to continue as a going concern, the impact of COVID-19 and related responsive measures thereto, risks and uncertainties concerning the outcome, impact, effects and results of the Company's evaluation of corporate, organizational, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, organizational, strategic, financial or financing alternative and the Company's ability to complete one at all, the price of the Company's securities, the expected use of proceeds from the offering and other factors discussed under the caption "Risk Factors" in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent the Company's beliefs and assumptions only as of the date of this press release. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

    CONTACT:

    Judy Matthews

    Chief Financial Officer

    312-778-6073



     

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  2. Sulopenem demonstrates superiority in treatment of patients with quinolone resistant pathogens

    Company to discuss NDA filing with FDA

    DUBLIN, Ireland and CHICAGO, June 29, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced topline results from its Sulopenem for Resistant Enterobacteriaceae (SURE) 1 clinical trial for the treatment of Uncomplicated Urinary Tract Infections (uUTI). Sulopenem is a novel anti-infective compound that, if approved, would be the first penem antibiotic with an oral formulation indicated for treatment of uUTI…

    Sulopenem demonstrates superiority in treatment of patients with quinolone resistant pathogens

    Company to discuss NDA filing with FDA

    DUBLIN, Ireland and CHICAGO, June 29, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced topline results from its Sulopenem for Resistant Enterobacteriaceae (SURE) 1 clinical trial for the treatment of Uncomplicated Urinary Tract Infections (uUTI). Sulopenem is a novel anti-infective compound that, if approved, would be the first penem antibiotic with an oral formulation indicated for treatment of uUTI.

    In SURE1, there were two independent primary endpoints, with achievement of either of those endpoints expected to provide a potential path to marketing approval based on previous discussions with the U.S. Food and Drug Administration (FDA).  In the population of patients with baseline pathogens resistant to quinolones, sulopenem achieved the related primary endpoint by demonstrating superiority to ciprofloxacin, providing substantial evidence of a treatment effect in patients with uUTI. With a p-value of <0.001, this result was highly statistically significant. In the second population of patients with organisms susceptible to quinolones, sulopenem was not non-inferior to ciprofloxacin and did not achieve the related primary endpoint, with the difference in outcomes driven by the rate of asymptomatic bacteriuria post treatment.  In SURE1, sulopenem was well tolerated with a favorable safety profile, consistent with the SURE2 and SURE3 trials.

    "We are extremely pleased to have a potential path to approval for sulopenem in uUTI.  Approximately 5-6 million urinary tract infections in the U.S. every year are caused by quinolone resistant pathogens. If approved, sulopenem would provide a treatment option for women with infections due to these resistant pathogens," said Corey Fishman, Chief Executive Officer of Iterum Therapeutics. "Sulopenem is the first new oral antibiotic to demonstrate success in treating uUTIs in a phase 3 trial in over twenty years." Mr. Fishman continued, "We anticipate a pre-NDA meeting with the FDA in the third quarter of 2020 to discuss a path forward."

    Michael Dunne, M.D., Chief Scientific Officer of Iterum Therapeutics, stated, "Superiority trials to define the effectiveness of novel antibacterial agents are rarely performed but remain the ultimate test for defining the value of a new agent in an area of high unmet medical need. Sulopenem has demonstrated efficacy in the treatment of UTI due to a quinolone resistant organism, a scenario found in almost 30% of all urinary tract infections in women in the United States today."

    The randomized, multi-center, double-blind SURE1 clinical trial enrolled 1,670 patients to measure efficacy, tolerability, and safety of oral sulopenem/probenecid for the treatment of uUTI in adult women. Patients were randomized to receive either oral sulopenem/probenecid twice daily for five days of treatment, or oral ciprofloxacin twice daily for three days of treatment. The End of Treatment (EOT) visit occurred on Day 5 and the Test of Cure Visit (TOC) at Day 12. Two independent populations were prespecified and tested for an overall response of success at the TOC: a quinolone resistant population being assessed for superiority, defined as a p value <0.05, and a quinolone susceptible population being tested for non-inferiority, based on the lower limit of the 95% confidence interval (CI) for the difference in the microbiologic-modified intent to treat population being greater than -10%. A prespecified analysis of the outcome in both susceptible and non-susceptible patients combined was also performed to describe the overall results of treatment of uUTI with sulopenem relative to ciprofloxacin.  The following table sets forth the topline results from the trial.

    Micro-MITT populationSulopenem

    n/N (%)
    Ciprofloxacin n/N

    (%)
    Difference (%)

    (95% CI)
    P value
    Quinolone Non-susceptible Population
    Overall Response (TOC)92/147 (62.6%)50/139 (36.0%)26.6% (15.1, 37.4)< 0.001
    Reason for Failure: Asymptomatic bacteriuria27 (18.4%)38 (27.3%)  
    Clinical Response (TOC)122/147 (83.0%)87/139 (62.6%)20.4% (10.2, 30.4)< 0.001
    Overall Response (EOT)95/147 (64.6%)42/139 (30.2%)34.4% (23.1, 44.8)< 0.001
    Quinolone Susceptible Population
    Overall Response (TOC)247/370 (66.8%)326/415 (78.6%)-11.8% (-18.0, -5.6) 
    Reason for Failure: Asymptomatic bacteriuria47 (12.7%)16 (3.9%)  
    Clinical Response (TOC)300/370 (81.1%)349/415 (84.1%)-3.0% (-8.4, 2.3) 
    Overall Response (EOT)240/370 (64.9%)271/415 (65.3%)-0.4% (-7.1, 6.2) 
    Combined (Quinolone Susceptible and Quinolone Non-susceptible Populations)
    Overall Response (TOC)339/517 (65.6%)376/554 (67.9%)-2.3% (-7.9, 3.3) 
    Reason for Failure: Asymptomatic bacteriuria74 (14.3%)54 (9.7%)  
    Clinical Response (TOC)422/517 (81.6%)436/554 (78.7%)2.9% (-1.9, 7.7) 
    Overall Response (EOT)335/517 (64.8%)313/554 (56.5%)8.3% (2.4, 14.1) 

     

    "The difference in the overall response to treatment in the population of patients with a quinolone susceptible baseline pathogen was driven to a large degree by a greater amount of asymptomatic bacteriuria in the sulopenem treated patients relative to those receiving ciprofloxacin," observed Dr. Dunne.  "This same finding was observed in the recently completed Phase 3 clinical trial of sulopenem in complicated urinary tract infections, SURE2.  In that study, the difference in outcome between ertapenem and sulopenem was driven largely by the post therapy rate of asymptomatic bacteriuria and, notably, was lower only in those patients who received ertapenem followed by ciprofloxacin and not in any other pairwise comparison with sulopenem or ertapenem treated patients. The clinical significance of post treatment asymptomatic bacteriuria and its relationship to oral dosing with ciprofloxacin will be the focus of additional investigation."

    In the safety population of 1,660 patients, treatment related adverse events were observed in 11.4% and 11.9% of patients on sulopenem and ciprofloxacin, respectively. The most commonly reported adverse events were diarrhea, 7.3% and 7.6%, nausea, 3.4% and 4.0%, and headache 2.2% and 2.2%, for sulopenem and ciprofloxacin patients, respectively. Discontinuations due to adverse events were uncommon on both regimens and were seen in 1.1% of patients on sulopenem and 1.5% of patients on ciprofloxacin. Serious adverse events (SAE) were seen in 0.6% of patients on sulopenem with no drug-related SAE and 0.4% of patients on ciprofloxacin with one drug-related SAE.

    Based on these trial results, the Company plans to request a pre-NDA meeting with the FDA to discuss its filing strategy.  In parallel, the Company is also evaluating its corporate, organizational, strategic, financial and financing alternatives with the goal of maximizing value for its stakeholders, while prudently managing its resources. 

    About Urinary Tract Infections

    UTIs result in 13.5 million office or emergency room visits and 21 million prescriptions in the U.S. annually. According to the U.S. Centers for Disease Control and Prevention (CDC), multidrug resistant Escherichia coli, the cause of many serious infections, including UTIs, are a growing concern in the U.S. where at least two million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections. The effectiveness of common antibiotics used to treat UTIs has decreased, with approximately one-third of medications prescribed for UTIs failing, including fluoroquinolones, penicillins, and cephalosporins. Patients who are elderly, female or diagnosed with diabetes are at an elevated risk for UTIs and for uUTIs resistant to commonly used antibiotics. Fifty to sixty percent of women are likely to be affected by a UTI in their lifetime, and nearly 30 percent will suffer a recurrence.

    About Sulopenem

    Sulopenem, a novel oral penem anti-infective compound, has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. If approved, sulopenem would help address the significant clinical and economic need for new oral antibiotics that enable the avoidance of hospitalization. The safety profile of IV sulopenem has been previously documented in a Phase 2 program. Given these results, oral sulopenem is being evaluated in this Phase 3 clinical trial for uncomplicated urinary tract infections.

    The U.S. Food and Drug Administration (FDA) has granted Special Protocol Agreements (SPA) and Qualified Infectious Disease Product (QIDP) designations for sulopenem in accordance with the Generating Antibiotics Incentives Now (GAIN) Act, which provides five years of additional regulatory exclusivity and expedited Fast Track FDA review.

    About Iterum Therapeutics plc

    Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing 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 Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit http://www.iterumtx.com

    Forward-looking Statements

    This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem, our expectations regarding a potential path forward for marketing approval of sulopenem for uUTI and with respect to the overall regulatory process and our evaluation of corporate, organizational, strategic and financial and financing alternatives. In some cases, forward-looking statements can be identified by words such as "may," "believes," "intends," "seeks," "anticipates," "plans," "estimates," "expects," "should," "assumes," "continues," "could," "would," "will," "future," "potential" or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Iterum Therapeutics' actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside Iterum Therapeutics' control, including the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, the Company's ability to apply for regulatory approval, changes in public policy or legislation, commercialization plans and timelines, if sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of our expectations regarding how far into the future our cash on hand will fund our ongoing operations, the sufficiency of our cash resources and our ability to continue as a going concern, the impact of COVID-19 and related responsive measures thereto, risks and uncertainties concerning the outcome, impact, effects and results of the Company's evaluation of corporate, organizational, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, organizational, strategic, financial or financing alternative and the Company's ability to complete one at all, risks and uncertainties related to the impact of this announcement on the Company's business, financial condition, results of operations and the price of the Company's securities, and other factors discussed under the caption "Risk Factors" in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent Iterum Therapeutics' beliefs and assumptions only as of the date of this press release. Except as required by law, Iterum Therapeutics assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

    Investor Contact:

    Judy Matthews 

    Chief Financial Officer

    312-778-6073

    Primary Logo

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  3. DUBLIN, Ireland and CHICAGO, June 15, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company developing anti-infectives against multi-drug resistant pathogens, today announced results of its Annual General Meeting held on June 10, 2020 (the "AGM").

    At the AGM, all resolutions proposed at the meeting were duly passed by poll.

    Resolution No. 8 sought approval for the acquisition by investment funds managed and controlled by Sarissa Capital Management LP (together the Sarissa Funds) of up to 60% of the total issued ordinary share capital of the Company solely as a result of the potential future exchange of the 15,000 6.500% Exchangeable Senior Subordinated Notes due 2025 (the Exchangeable Notes

    DUBLIN, Ireland and CHICAGO, June 15, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company developing anti-infectives against multi-drug resistant pathogens, today announced results of its Annual General Meeting held on June 10, 2020 (the "AGM").

    At the AGM, all resolutions proposed at the meeting were duly passed by poll.

    Resolution No. 8 sought approval for the acquisition by investment funds managed and controlled by Sarissa Capital Management LP (together the Sarissa Funds) of up to 60% of the total issued ordinary share capital of the Company solely as a result of the potential future exchange of the 15,000 6.500% Exchangeable Senior Subordinated Notes due 2025 (the Exchangeable Notes) with an aggregate value of $15,000,000 held by the Sarissa Funds (the Sarissa Notes) without the Sarissa Funds and/or Sarissa Capital Management LP becoming obligated to make an offer to the Company's shareholders pursuant to Rule 9 of the Irish Takeover Panel Act, 1997, Takeover Rules, 2013 (the Rules). The result of the poll on Resolution No. 8 was 6,808,330 votes for; and 199,749 votes against.

    Accordingly, the Sarissa Funds could acquire up to 60% of the then total issued ordinary share capital of the Company on an exchange (assuming physical settlement) of the Sarissa Notes (which for illustrative purposes would be 26,761,114 ordinary shares based on the Company's issued ordinary share capital of 17,840,743 as at June 10, 2020) without incurring an obligation under Rule 9 of the Rules to make an offer to the Company's other shareholders.

    Assuming (i) the Sarissa Funds exchange the Sarissa Notes in full at the earliest possible opportunity, being January 21, 2021, (ii) only the Sarissa Notes are exchanged and there are no exchanges by other holders of the Exchangeable Notes, (iii) the Company elects physical settlement with respect to such exchange and (iv) the exchange rate under the Exchangeable Notes is the initial exchange rate of 1,000 shares per $1,000 of principal and interest, the Sarissa Notes would convert into 15,000,000 ordinary shares, being 45.7% of the issued share capital of the Company (based on the Company's issued ordinary share capital of 17,840,743 as at June 10, 2020 and not including certain excluded securities as described in the Company's Proxy Statement filed with the Securities and Exchange Commission on May 7, 2020, the warrants issued in connection with the Company's recent public offering of ordinary shares and concurrent private placement of warrants to purchase ordinary shares as previously disclosed in the Form 8-K filed with the Securities and Exchange Commission on June 4, 2020 and not taking into account any additional ordinary shares issuable to satisfy accrued and unpaid interest due upon exchange of the Sarissa Notes) and the Sarissa Funds and/or Sarissa Capital Management LP would not become obligated under Rule 9 of the Rules to make a general offer to the Company's other shareholders.

    The full text of Resolution No. 8 is set out in the Proxy Statement which is available at https://ir.iterumtx.com/2020-annual-general-meeting.

    About Iterum Therapeutics

    Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing 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. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

    Safe Harbor Statement

    This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the potential exchange of notes held by shareholders. In some cases, forward-looking statements can be identified by words such as "may," "believes," "intends," "seeks," "anticipates," "plans," "estimates," "expects," "should," "assumes," "continues," "could," "would," "will," "future," "potential" or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside the Company's control, including the uncertainties with respect to whether any holders of Exchangeable Notes, including the Sarissa Funds, will exchange any Exchangeable Notes, including the timing and amount of any such exchanges and the percentage ownership of the Company's ordinary shares as a result of any potential future exchanges of Exchangeable Notes, the uncertainties inherent in the conduct of clinical trials, availability and timing of data from clinical trials, the Company's ability to apply for regulatory approval, changes in regulatory requirements or decisions of regulatory authorities, changes in public policy or legislation, commercialization plans and timelines, if approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of the Company's expectations regarding how far into the future the Company's cash on hand will fund the Company's ongoing operations, the sufficiency of the Company's cash resources and the Company's ability to continue as a going concern, the impact of COVID-19 and related responsive measures thereto, risks and uncertainties concerning the outcome, impact, effects and results of the Company's evaluation of corporate, strategic and financial alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, strategic or financial alternative and the Company's ability to complete one at all, the price of the Company's securities, and other factors discussed under the caption "Risk Factors" in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent our beliefs and assumptions only as of the date of this press release. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

    For further information:

    CONTACT:

    Investor Contact:

    Judy Matthews

    Chief Financial Officer

    312-778-6073

    Primary Logo

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  4. DUBLIN, Ireland and CHICAGO, June 03, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that it has entered into definitive agreements with institutional investors for the purchase and sale of 2,971,770 of its ordinary shares at a purchase price of $1.6825 per ordinary share in a registered direct offering priced at-the-market under Nasdaq rules.  The Company also agreed to issue to the investors unregistered warrants to purchase up to 1,485,885 ordinary shares in a concurrent private placement.  The warrants…

    DUBLIN, Ireland and CHICAGO, June 03, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that it has entered into definitive agreements with institutional investors for the purchase and sale of 2,971,770 of its ordinary shares at a purchase price of $1.6825 per ordinary share in a registered direct offering priced at-the-market under Nasdaq rules.  The Company also agreed to issue to the investors unregistered warrants to purchase up to 1,485,885 ordinary shares in a concurrent private placement.  The warrants have an exercise price of $1.62 per share, are exercisable immediately, and will expire five and one-half years following the date of issuance.  The closing of the offering is expected to occur on or about June 5, 2020, subject to the satisfaction of customary closing conditions. 

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds to the Company from the offering are expected to be $5.0 million, before deducting the placement agent's fees and other offering expenses payable by Iterum Therapeutics.  The Company intends to use the net proceeds from this offering to fund the continued clinical development of sulopenem, including the Company's ongoing Phase 3 clinical trial of sulopenem for uUTI, the management of potential regulatory filings and for working capital and general corporate purposes.

    The ordinary shares (but not the warrants issued in the private placement or the ordinary shares issuable upon exercise of the warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-232569) previously filed with the Securities and Exchange Commission, or the SEC, and declared effective by the SEC on July 16, 2019.   The offering of the ordinary shares will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.  A final prospectus supplement and accompanying prospectus relating to the ordinary shares being offered will be filed with the SEC.  Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by telephone at (646) 975-6996, or email at .

    The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended, or the Act, and Regulation D promulgated thereunder, and the warrants and the ordinary shares issuable upon exercise of the warrants have not been registered under the Act or applicable state securities laws. Accordingly, the warrants and ordinary shares issuable upon exercise of the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    About Iterum Therapeutics

    Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing 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. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

    Safe Harbor Statement

    This press release may contain forward-looking statements. These forward-looking statements include, without limitation, statements regarding the anticipated closing of the offering, the use of proceeds from the offering, the transactions contemplated by the transaction documents, and the Company's plans, strategies and prospects for its business. In some cases, forward-looking statements can be identified by words such as "may," "believes," "intends," "seeks," "anticipates," "plans," "estimates," "expects," "should," "assumes," "continues," "could," "will," "future," "potential" or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside the Company's control, including whether the conditions for the closing of the offering will be satisfied, the uncertainties inherent in the conduct of clinical trials, availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, changes in public policy or legislation, commercialization plans and timelines, if approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of the Company's expectations regarding how far into the future the Company's cash on hand will fund the Company's ongoing operations, the sufficiency of the Company's cash resources and the Company's ability to continue as a going concern, the impact of COVID-19 and related responsive measures thereto, risks and uncertainties concerning the outcome, impact, effects and results of the Company's evaluation of corporate, strategic and financial alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, strategic or financial alternative and the Company's ability to complete one at all, the price of our securities, the expected use of proceeds from this offering and other factors discussed under the caption "Risk Factors" in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent our beliefs and assumptions only as of the date of this press release. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

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  5. DUBLIN, Ireland and CHICAGO, June 01, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SUlopenem for Resistant Enterobacteriaceae (SURE) 2 clinical trial in complicated urinary tract infection (cUTI).

    The primary U.S. Food and Drug Administration (FDA) endpoint was overall clinical and microbiologic response on Day 21 in the micro-MITT population as evaluated using a 10% non-inferiority margin.

    The randomized, multi-center…

    DUBLIN, Ireland and CHICAGO, June 01, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SUlopenem for Resistant Enterobacteriaceae (SURE) 2 clinical trial in complicated urinary tract infection (cUTI).

    The primary U.S. Food and Drug Administration (FDA) endpoint was overall clinical and microbiologic response on Day 21 in the micro-MITT population as evaluated using a 10% non-inferiority margin.

    The randomized, multi-center, double-blind SURE 2 clinical trial enrolled 1,395 patients to measure the efficacy, tolerability, and safety of IV and oral sulopenem for the treatment of cUTI in adults. Patients were randomized to receive either IV sulopenem once daily for a minimum of five days followed by oral sulopenem twice daily to complete seven to ten days of treatment, or IV ertapenem once daily for a minimum of five days followed by either oral ciprofloxacin or, for quinolone resistant isolates, amoxicillin-clavulanate twice daily. Responder rates at the test of cure visit for sulopenem were 67.8% (301 of 444 patients) and for ertapenem were 73.9% (325 of 440 patients) with a difference of -6.1% (95% confidence interval (CI): -12.0%, - 0.1%). The difference in response rates was driven almost entirely by higher rates of asymptomatic bacteriuria on sulopenem relative to ertapenem, only evident at the test of cure visit; the rates of patients receiving additional antibiotics or with residual cUTI symptoms was similar. Clinical response at the test of cure in the Modified Intent to Treat patient population (sulopenem vs ertapenem: 2.0% (95% CI: -1.5, 5.4%) and Clinically Evaluable patient population (sulopenem vs ertapenem: 0.4% (95% CI: -2.6%, 3.5%) was similar. The outcome at other secondary endpoints was also similar, including the overall response at the end of therapy visit at Day 10, (sulopenem: 385 of 444 patients (86.7%); ertapenem: 391 of 440 patients (88.9%).

    "We are very disappointed by the outcome in the cUTI study, although sulopenem was well tolerated and demonstrated a safety profile consistent with previous studies and the penem class in general," said Corey Fishman, Chief Executive Officer of Iterum Therapeutics. Based on these trial results, Iterum Therapeutics is evaluating its corporate, strategic and financial alternatives with the goal of maximizing value for its stakeholders while prudently managing its remaining resources.  These alternatives could potentially include the licensing, sale or divestiture of the company's assets or proprietary technologies, a sale of the company, a merger or other business combination, another strategic transaction involving the company, restructuring activities, winding down of operations, dissolving and liquidating assets or seeking protection under bankruptcy laws.  The evaluation of corporate, strategic and financial alternatives may not result in any particular action or any transaction being pursued, entered into or consummated, and there is no assurance as to the timing, sequence or outcome of any action or transaction or series of actions or transactions.

    About Sulopenem

    Sulopenem, a novel penem anti-infective compound with oral and IV formulations, has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. The safety profile of IV sulopenem has been documented in a Phase 2 program. Given these results, Iterum Therapeutics initiated three pivotal Phase 3 clinical trials of oral and IV sulopenem for uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections.

    The FDA has granted Special Protocol Agreements (SPA) and Qualified Infectious Disease Product (QIDP) designations for oral and IV sulopenem in accordance with the Generating Antibiotics Incentives Now (GAIN) Act, which allow for five years of additional regulatory exclusivity and expedited Fast Track FDA review.

    About Iterum Therapeutics plc

    Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing 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. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit http://www.iterumtx.com

    Forward-looking Statements

    This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem and our evaluation of corporate, strategic and financial alternatives. In some cases, forward-looking statements can be identified by words such as "may," "believes," "intends," "seeks," "anticipates," "plans," "estimates," "expects," "should," "assumes," "continues," "could," "will," "future," "potential" or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside our control, including the uncertainties inherent in the conduct of clinical trials, availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, changes in public policy or legislation, commercialization plans and timelines, if approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of our expectations regarding how far into the future our cash on hand will fund our ongoing operations, the sufficiency of our cash resources and our ability to continue as a going concern, the impact of COVID-19 and related responsive measures thereto, risks and uncertainties concerning the outcome, impact, effects and results of our evaluation of corporate, strategic and financial alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, strategic or financial alternative and our ability to complete one at all, risks and uncertainties related to the impact of this announcement on our business, financial condition, results of operations and the price of our securities and other factors discussed under the caption "Risk Factors" in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent our beliefs and assumptions only as of the date of this press release. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

    Investor Contact:
    Judy Matthews 
    Chief Financial Officer
    312-778-6073
         

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