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 third quarter ended September
30, 2019 and provided an update on its clinical programs.
“We look forward to reporting topline data from the first of
three Phase 3 studies of sulopenem in the very near future. The
remaining studies will complete enrollment around the end of the
year and produce topline data in the first quarter of 2020,” said
Corey Fishman, Chief Executive Officer of Iterum Therapeutics plc.
“Assuming positive data, we anticipate submitting a New Drug
Application (NDA) for our oral and IV formulations to the FDA in
the first half of 2020.”
Clinical Update
All three Phase 3 clinical trials of sulopenem have undergone
pre-planned protocol specified analyses related to the potential
opportunity for sample size adjustments. These analyses, performed
by a Data Management Committee, were done to determine whether the
initial protocol specified sample size was providing adequate
statistical power. Based on the outcome of these analyses, the
Company decided to add 225 patients to the complicated UTI study
for a total of 1,381 patients and 400 patients to the uncomplicated
UTI study for a total of 1,764 patients. No patients were added to
the complicated intra-abdominal infections study.
Third Quarter 2019 Financial Results
As of September 30, 2019, Iterum had cash and cash equivalents
of $28.9 million and approximately 14.9 million shares outstanding.
Iterum expects that its cash and cash equivalents will be
sufficient to fund operations into 2020.
Research and development expenses for the third quarter of 2019
were $28.1 million compared to $22.6 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 the
$7.5 million milestone payment made to Pfizer in the third quarter
of 2018 upon first patient dosing in the SURE 1 clinical
trial.
General and administrative expenses for the third quarter of
2019 were $2.9 million compared to $2.7 million for the same period
in 2018. The increase was primarily due to increased costs
associated with operating as a public company, and additional
headcount to support business activities.
For the third quarter of 2019, Iterum reported a net loss of
$31.3 million compared to a net loss of $24.9 million for the same
period in 2018.
Upcoming Corporate Event
Iterum’s senior management will be presenting an overview of the
Company at the Stifel 2019 Healthcare Conference on November 20,
2019 in New York City, NY.
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 uUTI, cUTI,
and cIAI.
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.
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 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, 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, the accuracy
of our expectations regarding how far into the future our cash on
hand will fund our ongoing operations and other factors discussed
under the caption “Risk Factors” in our Quarterly Report on Form
10- Q filed with the Securities and Exchange Commission (the “SEC”)
on November 12, 2019, 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 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 September 30, |
|
Nine months
ended September 30, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
Revenue |
|
$ |
- |
|
|
$ |
254 |
|
|
$ |
37 |
|
|
$ |
630 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
(28,066 |
) |
|
|
(22,583 |
) |
|
|
(69,892 |
) |
|
|
(47,188 |
) |
|
General and
administrative |
|
|
(2,933 |
) |
|
|
(2,657 |
) |
|
|
(8,988 |
) |
|
|
(6,058 |
) |
|
Total
operating expenses |
|
|
(30,999 |
) |
|
|
(25,240 |
) |
|
|
(78,880 |
) |
|
|
(53,246 |
) |
|
Operating
loss |
|
|
(30,999 |
) |
|
|
(24,986 |
) |
|
|
(78,843 |
) |
|
|
(52,616 |
) |
|
Interest
expense, net |
|
|
(216 |
) |
|
|
(138 |
) |
|
|
(455 |
) |
|
|
(100 |
) |
|
Other
income, net |
|
|
48 |
|
|
|
328 |
|
|
|
204 |
|
|
|
183 |
|
|
Income tax
expense |
|
|
(104 |
) |
|
|
(109 |
) |
|
|
(395 |
) |
|
|
(266 |
) |
|
Net loss
attributable to ordinary shareholders |
|
$ |
(31,271 |
) |
|
$ |
(24,905 |
) |
|
$ |
(79,489 |
) |
|
$ |
(52,799 |
) |
|
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(2.15 |
) |
|
$ |
(1.77 |
) |
|
$ |
(5.52 |
) |
|
$ |
(7.42 |
) |
|
Weighted
average ordinary shares outstanding – basic and diluted |
|
|
14,571,278 |
|
|
|
14,034,631 |
|
|
|
14,412,755 |
|
|
|
7,115,655 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
|
Condensed
Consolidated Balance Sheet Data |
|
(In
thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
As
of |
|
As
of |
|
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
|
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments |
|
$ |
28,883 |
|
|
$ |
84,551 |
|
|
|
|
|
|
Other
assets |
|
|
22,059 |
|
|
|
13,320 |
|
|
|
|
|
|
Total assets |
|
$ |
50,942 |
|
|
$ |
97,871 |
|
|
|
|
|
|
Long-term
debt, less current portion |
|
|
9,343 |
|
|
|
13,079 |
|
|
|
|
|
|
Other
liabilities |
|
|
44,695 |
|
|
|
13,170 |
|
|
|
|
|
|
Total
liabilities |
|
|
54,038 |
|
|
|
26,249 |
|
|
|
|
|
|
Total
shareholders' equity (deficit) |
|
|
(3,096 |
) |
|
|
71,622 |
|
|
|
|
|
|
Total liabilities and shareholders' equity
(deficit) |
|
$ |
50,942 |
|
|
$ |
97,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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