Iterum Therapeutics Reports Second Quarter 2019 Financial Results
August 14 2019 - 7:00AM
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
reported financial results for the second quarter ended June 30,
2019.
“The second quarter was marked by continued progress in our
three pivotal Phase 3 clinical trials of sulopenem,” said Corey
Fishman, Chief Executive Officer of Iterum Therapeutics plc. “Based
on current enrollment rates, we anticipate topline data from the
complicated intra-abdominal (cIAI) and the complicated urinary
tract infection (cUTI) trials in the fourth quarter. This
would allow us the flexibility to file our new drug applications
(NDAs) in the first quarter of 2020. Our trial for
uncomplicated urinary tract infections (uUTI) just passed
two-thirds enrollment, which triggers a pre-planned review of the
blinded data for potential sample size adjustment. The outcome of
this analysis will determine the enrollment timeline, which will
guide our decision on the optimal filing strategy for the uUTI
data.”
Recent Highlights
- Presented research at ASM Microbe that supports the
need for new antibiotics to treat uUTIs: In June,
Iterum presented data that showed patients with uUTIs in the
community treated with the most commonly prescribed antibiotic for
that infection, ciprofloxacin, have a significantly greater rate of
treatment failure when the organism is quinolone resistant.
Based on our uUTI trial, Iterum estimates that resistance to
quinolones in the community is greater than 25% in many geographies
in the U.S., and greater than 30% outside of the U.S.
Second Quarter 2019 Financial Results
As of June 30, 2019, Iterum had cash and cash equivalents of
$51.2 million and approximately 14.4 million shares outstanding.
Iterum expects that its cash and cash equivalents will be
sufficient to fund operations into 2020.
Research and development (R&D) expenses for the second
quarter of 2019 were $24.4 million compared to $13.7 million for
the same period in 2018. The increase was primarily due to higher
clinical trial expenses associated with our three Phase 3 clinical
trials initiated in the third quarter of 2018, partially offset by
a reduction in chemistry, manufacturing and control-related
expenses as a result of the completion of manufacturing of clinical
trial materials for our Phase 3 clinical trials by our primary
suppliers.
General and administrative (G&A) expenses for the second
quarter of 2019 were $2.9 million compared to $1.9 million for the
same period in 2018. The increase was primarily due to increased
costs associated with operating as a public company, additional
headcount to support business activities, and increased marketing
expenses.
For the second quarter of 2019, Iterum reported a net loss of
$27.6 million compared to a net loss of $15.7 million for the same
period in 2018.
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. If approved, sulopenem will help address the
significant clinical and economic need for new oral antibiotics
that enable the effective treatment of resistant pathogens in the
community, make possible the avoidance of hospitalization, and
facilitate early hospital discharge by providing continuity-of-care
step-down therapy. The safety profile of IV sulopenem has been
documented in a Phase 2 program. Oral and IV sulopenem are being
evaluated in three pivotal Phase 3 clinical trials for
uncomplicated urinary tract infections, complicated urinary tract
infections, and complicated intra-abdominal infections.
Probenecid, which is being co-administered with sulopenem in a
bilayer tablet, is approved as an adjuvant to therapy for elevation
and prolongation of plasma levels of β-lactam compounds including
penicillin, ampicillin, methicillin, oxacillin, cloxacillin, and
nafcillin.
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
oral and IV formulations. 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 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 expectations about future revenue, expenses, cash flows
and net income or loss, the sufficiency of cash resources, the
development, therapeutic and market potential of sulopenem, and the
timing, progress and results of clinical trials and regulatory
submissions. 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 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, clinical trial patient enrollment, 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 and other factors discussed under the
caption “Risk Factors” in its Quarterly Report on Form 10- Q filed
with the Securities and Exchange Commission (the “SEC”) on August
14, 2019, 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 MatthewsChief Financial
Officer312-778-6073IR@iterumtx.com
ITERUM
THERAPEUTICS PLC |
Condensed
Consolidated Statement of Operations |
(In
thousands except share and per share data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenue |
|
$ |
- |
|
$ |
185 |
|
$ |
37 |
|
$ |
376 |
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
(24,439) |
|
(13,725) |
|
(41,826) |
|
(24,604) |
General and administrative |
|
(2,939) |
|
(1,886) |
|
(6,055) |
|
(3,401) |
Total operating expenses |
|
(27,378) |
|
(15,611) |
|
(47,881) |
|
(28,005) |
Operating loss |
|
(27,378) |
|
(15,426) |
|
(47,844) |
|
(27,629) |
Interest (expense) / income,
net |
|
(135) |
|
(76) |
|
(239) |
|
9 |
Other income / (expense),
net |
|
32 |
|
(177) |
|
156 |
|
(116) |
Income tax expense |
|
(157) |
|
(68) |
|
(291) |
|
(157) |
Net loss attributable to ordinary
shareholders |
|
$ |
(27,638) |
|
$ |
(15,747) |
|
$ |
(48,218) |
|
$ |
(27,893) |
Net loss per share attributable
to ordinary shareholders – basic and diluted |
|
$ |
(1.93) |
|
$ |
(2.22) |
|
$ |
(3.37) |
|
$ |
(6.72) |
Weighted average ordinary shares
outstanding – basic and diluted |
|
14,340,231 |
|
7,085,655 |
|
14,316,497 |
|
4,148,535 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
|
|
|
|
Condensed
Consolidated Balance Sheet Data |
|
|
|
|
(In
thousands) |
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
|
|
2019 |
|
2018 |
|
|
|
|
Cash, cash equivalents and
short-term investments |
|
$ |
51,241 |
|
$ |
84,551 |
|
|
|
|
Other assets |
|
20,052 |
|
13,320 |
|
|
|
|
Total
assets |
|
$ |
71,293 |
|
$ |
97,871 |
|
|
|
|
Long-term debt, less current
portion |
|
10,771 |
|
13,079 |
|
|
|
|
Other liabilities |
|
35,946 |
|
13,170 |
|
|
|
|
Total liabilities |
|
46,717 |
|
26,249 |
|
|
|
|
Total shareholders' equity |
|
24,576 |
|
71,622 |
|
|
|
|
Total liabilities and
shareholders' equity |
|
$ |
71,293 |
|
$ |
97,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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