Iterum Therapeutics Provides Business Update
March 06 2024 - 8:00AM
Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), 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 provided a general business
update.
Iterum announced that it now expects to resubmit its new drug
application (NDA) for oral sulopenem to the U.S. Food and Drug
Administration (FDA) in the first half of the second quarter
of 2024, earlier than originally planned. Provided that the
resubmitted NDA addresses all of the deficiencies identified in the
complete response letter (CRL) Iterum received from the FDA in July
2021, Iterum expects that the FDA will complete its review and take
action six months from the date the FDA receives the resubmitted
NDA (or during the first half of the fourth quarter of 2024).
Based on Iterum’s current operating plan, Iterum believes that
its existing cash and cash equivalents and short-term investments
as of December 31, 2023, together with the net proceeds from the
sale of ordinary shares under its “at-the-market” offering
agreement through February 29, 2024, are expected to enable it to
fund its operating expenses into 2025, including through the
expected Prescription Drug User Fee Act date in the first half of
the fourth quarter of 2024.
In January 2024, Iterum announced positive top-line results from
the REASSURE trial and that it would be focusing on a strategic
process to sell, license, or otherwise dispose of its rights to
sulopenem with the goal of maximizing value for its stakeholders.
Iterum plans to engage a financial advisor in the near-term to
assist management and the Board in evaluating Iterum’s strategic
alternatives.
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 is
currently advancing its first compound – sulopenem – a novel penem
anti-infective compound, in Phase 3 clinical development with an
oral formulation. Sulopenem also has an 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 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 www.iterumtx.com.
Forward-looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. These forward-looking statements include, without limitation,
statements regarding the development, therapeutic and market
potential of sulopenem, our ability to address the deficiencies set
out in the CRL received in July 2021, the expected timing of
resubmission of the NDA, the expected timing of review by the FDA,
the sufficiency of Iterum’s cash resources to enable it to fund its
operating expenses into 2025, and Iterum’s strategic process to
sell, license, or otherwise dispose of its rights to sulopenem,
including its expectation to engage a financial advisor in the
near-term. 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’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 Iterum’s control, including
uncertainties inherent in the conduct of clinical and non-clinical
development, changes in regulatory requirements or decisions of
regulatory authorities, the timing or likelihood of regulatory
filings and approvals, including the potential resubmission of the
NDA for oral sulopenem, 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
Iterum’s expectations regarding how far into the future Iterum’s
cash on hand will fund Iterum’s ongoing operations, Iterum’s
ability to maintain its listing on the Nasdaq Capital Market, risks
and uncertainties concerning the outcome, impact, effects and
results of Iterum’s pursuit of strategic alternatives, including
the terms, timing, structure, value, benefits and costs of any
strategic process and Iterum’s ability to complete one at all and
other factors discussed under the caption “Risk Factors” in its
Quarterly Report on Form 10-Q filed with the SEC on November 14,
2023, and other documents filed with the SEC from time to time.
Forward-looking statements represent Iterum’s beliefs and
assumptions only as of the date of this press release. Except as
required by law, Iterum 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 MatthewsChief Financial
Officer312-778-6073IR@iterumtx.com
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