Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage
pharmaceutical company developing anti-infectives against
multi-drug resistant pathogens, today reported financial results
for the first quarter ended March 31, 2019.
“The first quarter of 2019 was highlighted by the U.S. Food and
Drug Administration (FDA) granting us Qualified Infectious Disease
Product (QIDP) status in four new indications, as well as Fast
Track designation for all seven potential indications of oral and
IV sulopenem for which QIDP status has been received,” said Corey
Fishman, Chief Executive Officer of Iterum Therapeutics plc. “We
remain focused on completing enrollment of all three of our ongoing
Phase 3 clinical trials this year. A new effective oral therapy in
our studied indications has become critical due to the rise in
multi-drug resistant infections in the community, and we are
excited to be at the forefront of seeking to provide a near-term
solution.”
Q1 2019 Highlights and Recent Events
- FDA granted QIDP designation and Fast
Track: In the first quarter, oral sulopenem and
sulopenem IV received QIDP designation in four new indications:
community-acquired bacterial pneumonia, acute bacterial
prostatitis, gonococcal urethritis, and pelvic inflammatory
disease. These indications, as well as the three indications
currently in Phase 3 development, also received Fast Track
designation from the FDA.
- Based on current enrollment rates, all three Phase 3
clinical trials are on track to complete enrollment before
year-end; sample size adjustment review underway for uncomplicated
urinary tract infection (uUTI) study: Based on current
enrollment rates, all three Phase 3 clinical trials are on track to
complete enrollment before year-end. Enrollment in the uUTI
study has passed the 1/3 target level and this triggers the first
of two pre-planned analyses relating to potential sample size
adjustments. The results of this analysis are expected to be
available around the end of Q2.
- Presented data showing that mismatched empiric
antibiotic therapy leads to double the rate of hospitalization for
a uUTI: As presented at the 29th European Congress
of Clinical Microbiology and Infectious Diseases in April 2019,
culture data shows that age, gender, Diabetes mellitus and prior
resistance to antibiotics increased the likelihood of treatment
failure, and that hospitalization rates doubled to over 15% for
patients whose pathogens were not susceptible to the antibiotic
they received.
- Filed a non-provisional patent application with United
States Patent and Trademark Office: The extensive
pharmacokinetic work supporting the sulopenem program demonstrated
that plasma levels of sulopenem after multiple days of oral dosing
when combined with probenecid remained at or above the
concentrations on Day 1, relative to dosing with oral sulopenem
alone, enhancing its potential antimicrobial effect. If
granted, this method of use patent on the combination of sulopenem
and probenecid would provide 20 years of intellectual property
protection. The current U.S. composition of matter patent on
sulopenem etzadroxil expires in 2029 with potential extension to
2034 under the HatchWaxman Act.
Upcoming Scientific and Investor
Presentations
- Corporate presentation at the RBC Capital Markets Global
Healthcare Conference on Tuesday, May 21, 2019, in New York, New
York
- Multiple scientific presentations at American Society of
Microbiology (ASM) Microbe 2019 from June 20-24, 2019, in San
Francisco, California
First Quarter 2019 Financial Results
As of March 31, 2019, Iterum had cash, cash equivalents and
short-term investments of $69.6 million and approximately 14.4
million shares outstanding. Iterum expects that its cash, cash
equivalents and short-term investments, along with its available
borrowings, will be sufficient to fund operations into
2020.
Research and development (R&D) expenses for the first
quarter of 2019 were $17.4 million compared to $10.9 million for
the same period in 2018. The increase was primarily due to higher
clinical trial expenses associated with the three Phase 3 clinical
trials initiated in the third quarter of 2018.
General and administrative (G&A) expenses for the first
quarter of 2019 were $3.1 million compared to $1.5 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
and market research expenses.
For the first quarter of 2019, Iterum reported a net loss of
$20.6 million compared to a net loss of $12.1 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
granting or issuing of patents, the development, therapeutic and
market potential of sulopenem, and the timing, progress and results
of clinical trials. 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. Forwardlooking 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, 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 10Q filed with the Securities and Exchange
Commission (the “SEC”) on May 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 Matthews Chief Financial
Officer 312-778-6073 IR@iterumtx.com
|
ITERUM THERAPEUTICS PLC |
Condensed Consolidated Statement of
Operations |
(In thousands except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
Three months ended |
|
|
March 31, |
|
|
|
2019 |
|
|
|
2018 |
|
Revenue |
|
$ |
37 |
|
|
$ |
191 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
(17,387 |
) |
|
|
(10,879 |
) |
General and administrative |
|
|
(3,116 |
) |
|
|
(1,515 |
) |
Total operating expenses |
|
|
(20,503 |
) |
|
|
(12,394 |
) |
Operating loss |
|
|
(20,466 |
) |
|
|
(12,203 |
) |
Interest (expense) / income, net |
|
|
(104 |
) |
|
|
85 |
|
Other income, net |
|
|
124 |
|
|
|
61 |
|
Income tax expense |
|
|
(134 |
) |
|
|
(89 |
) |
Net loss attributable to ordinary shareholders |
|
$ |
(20,580 |
) |
|
$ |
(12,146 |
) |
Net loss per share attributable to ordinary shareholders – basic
and diluted |
|
$ |
(1.44 |
) |
|
$ |
(61.36 |
) |
Weighted average ordinary shares outstanding – basic and
diluted |
|
|
14,290,437 |
|
|
|
197,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM THERAPEUTICS PLC |
Condensed Consolidated Balance Sheet Data |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
2019 |
|
|
|
2018 |
|
Cash, cash equivalents and short-term investments |
|
$ |
69,600 |
|
|
$ |
84,551 |
|
Other assets |
|
|
19,534 |
|
|
|
13,320 |
|
Total assets |
|
$ |
89,134 |
|
|
$ |
97,871 |
|
Long-term debt, less current portion |
|
|
12,139 |
|
|
|
13,079 |
|
Other liabilities |
|
|
25,365 |
|
|
|
13,170 |
|
Total liabilities |
|
$ |
37,504 |
|
|
$ |
26,249 |
|
Total shareholders' equity |
|
|
51,630 |
|
|
|
71,622 |
|
Total liabilities and shareholders' equity |
|
$ |
89,134 |
|
|
$ |
97,871 |
|
|
|
|
|
|
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