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Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem

By Iterum, Press Release, Publicly Listed
Press Release.


If approved, First Oral Penem in the U.S. and First New Oral Treatment for uUTIs in Over 20 Years

PDUFA goal date of July 25, 2021

DUBLIN, Ireland and CHICAGO, Jan. 25, 2021 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), 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 the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a quinolone non-susceptible pathogen. The FDA has designated this application as a priority review and consequently assigned a PDUFA (Prescription Drug User Fee Act) goal date for completion of the review of oral sulopenem of July 25, 2021. The agency currently plans to hold an advisory committee meeting to discuss the NDA.

“The FDA acceptance of our NDA for review is an important milestone for Iterum. If approved, oral sulopenem would be the first penem available orally in the U.S. with the ability to treat multi-drug resistant infections in the community,”

said Corey Fishman, Chief Executive Officer.

“Specifically, this important antibiotic is one step closer to relieving the growing problem of quinolone resistance found in over six million uncomplicated urinary tract infections in the U.S. each year.”

The NDA includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated. The SURE-1 clinical trial (uUTIs) demonstrated statistical superiority of oral sulopenem to the widely used comparator, ciprofloxacin, for the primary efficacy endpoint of clinical and microbiologic response at the test-of-cure visit for patients with a quinolone non-susceptible pathogen.

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 and IV 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.

Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding, among other things, timing of the review of regulatory filings and the market opportunity for, and potential market acceptance of, oral sulopenem for uUTIs, 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 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 timing of approval of any submission, changes in public policy or legislation, commercialization plans and timelines, if oral 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, the Company’s ability to maintain listing on the Nasdaq Capital Market, 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 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.

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

Source: Iterum Therapeutics plc

Iterum Therapeutics Announces Pricing of Initial Public Offering

By Iterum, Press Release, Publicly Listed
Press Release.


DUBLIN and CHICAGO, May 24, 2018 /PRNewswire/ — Iterum Therapeutics plc
(NASDAQ:ITRM), a clinical-stage pharmaceutical company developing anti-infectives
aimed at combatting the global crisis of multi-drug resistant pathogens, today announced
the pricing of its initial public offering of 6,150,000 ordinary shares at a price to the public
of $13.00 per share, for total gross proceeds of approximately $80 million. All of the
shares are being offered by Iterum Therapeutics. The shares are expected to begin
trading on the Nasdaq Global Market on May 25, 2018 under the symbol “ITRM” and the
offering is expected to close on May 30, 2018, subject to customary closing conditions. In
addition, Iterum Therapeutics has granted the underwriters a 30-day option to purchase up
to an additional 922,500 ordinary shares to cover over-allotments, if any.

Leerink Partners and RBC Capital Markets are acting as joint book-running managers for
the offering. Guggenheim Securities is acting as lead manager for the offering. Needham
& Company is acting as co-manager for the offering.
The offering is being made only by means of a prospectus. A copy of the final prospectus
related to the offering, when available, may be obtained from: Leerink Partners LLC,
Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or
by telephone at (800) 808-7525, ext. 6132, or by email at; or from
RBC Capital Markets, LLC, Attention: Equity Syndicate Department, 200 Vesey Street, 8th
Floor, New York, NY 10281, or by telephone at (877) 822-4089, or by email at

A registration statement relating to these securities has been filed with, and declared
effective by, the SEC. This press release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be any sale of these securities in any state or
jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or jurisdiction.

Jeff Schaffnit
Chief Commercial Officer

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SOURCE Iterum Therapeutics

Iterum Secures $65 Million in Series B Financing

By Iterum, Press Release, Publicly Listed
Press Release.


Funding to support the Phase 3 clinical development of oral penem antibiotic

DUBLIN, IRELAND, and CHICAGO –May 19, 2017 – Iterum Therapeutics Limited, an Irish clinical-stage pharmaceutical company focused on the development and commercialization of anti-infectives for patients with infectious diseases and other acute illnesses, today announced that it has closed an oversubscribed Series B investment round raising $65 million. The financing was led by new investor Arix Bioscience plc, and included Pivotal bioVenture Partners, Advent Life Sciences, Domain Associates and Bay City Capital. All of Iterum’s current investors (Frazier Healthcare Partners, Canaan Partners, Sofinnova Ventures and New Leaf Venture Partners) also participated in the round.

Iterum is developing sulopenem, a novel oral and intravenous antibiotic, for the treatment of Gram-negative multi-drug resistant infections. The proceeds of this financing will be used for production of clinical supplies and registration batches, expanding the chemistry, manufacturing and control and development organizations and execution of the uncomplicated urinary tract infections Phase 3 pivotal program. The estimated timeline for filing an New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) is year-end 2019, with Phase 3 pivotal trials expected to begin in the first half of 2018.

Sulopenem has demonstrated broad-spectrum in vitro activity against extended spectrum β-lactamase producing and quinolone-resistant Gram-negative pathogens that are increasingly prevalent in both the inpatient and outpatient settings. These resistant pathogens are common causative agents of the initial target indications for sulopenem, including uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections (uUTI, cUTI and cIAI).

“The closing of this round, which was highly competitive and substantially oversubscribed, is an important milestone for Iterum,”

said Corey Fishman, CEO of Iterum.

“This success reflects the significant achievements we have made to date in the development of sulopenem. We are excited to welcome such high quality Series B investors into the existing blue-chip syndicate. With more than 25 million infections annually in the U.S. in our initial indications, and effective treatment options becoming more and more limited due to increasing resistance, we believe that sulopenem has the potential to play an important role in treating these infections.”

As part of the financing, Mark Chin of Arix Bioscience, Tracy Saxton of Pivotal bioVenture Partners and Shahzad Malik of Advent Life Sciences will join Iterum’s Board of Directors.

“Arix is delighted to lead Iterum’s financing of its novel, oral penem that has the potential to significantly improve the treatment paradigm for patients with multidrug resistant Gram-negative infections,”

said Chin, investment manager at Arix Bioscience.

“Since Iterum was founded in late 2015, it has made tremendous progress in the development of sulopenem, and we are excited to provide capital to fund the Phase 3 development of this novel product.”

About Iterum Therapeutics Limited
Iterum Therapeutics Limited is an Irish 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 is advancing its first compound, sulopenem, a novel penem anti-infective compound with oral and IV formulations in an IV only class of antibiotics that has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received QIDP designations for its oral and IV formulations for the treatment of uUTI, cUTI and cIAI. Iterum is led by a highly experienced team and backed by a blue-chip venture capital syndicate.For more information, please visit

About Arix Bioscience plc
Arix Bioscience plc is a global healthcare and life science company supporting medical innovation. Headquartered in London and with an office in New York, Arix Bioscience sources, finances and builds world class healthcare and life science businesses addressing medical innovation at all stages of development. Operations are supported by privileged access to breakthrough academic science and strategic relationships with leading research accelerators and global pharmaceutical companies.

Arix Bioscience plc is listed on the Main Market of the London Stock Exchange.

For further information, please visit

About Pivotal bioVenture Partners
Pivotal bioVenture Partners is a newly launched, San Francisco-based venture capital firm. Pivotal’s investment strategy is centered on identifying companies developing differentiated science from discovery to early clinical development with the potential to deliver transformative therapies.
For more information, please visit

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France. For more information, please visit

About Domain Associates
Founded in 1985, Domain was one of the first venture capital firms to exclusively invest in the life sciences sector. Today, with more than $2.7 billion in capital raised, Domain has been a trusted partner in life sciences investing helping more than 260 companies develop novel medical products to advance human health.

About Bay City Capital
Founded in 1997, Bay City Capital LLC is a life sciences venture capital firm with a global diversified strategy ranging from seed stage to public companies, and including innovation, restructuring opportunities, and growth investing. For more information, please visit

Media Contact:

Theresa Maloney
Cogenta Communications