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 first quarter ended March 31,
2020.
"During this challenging time, it is more important than ever to
avoid hospitalization. We believe sulopenem, as potentially the
first and only oral and IV penem antibiotic, will provide
physicians the confidence and flexibility to treat their patients
in a community setting. Should hospitalization be required,
sulopenem can also be used as a step-down therapy allowing patients
to leave the hospital sooner thereby reducing the risk of
hospital-acquired infections, which is a benefit for patients,
their families, and the over-stressed healthcare system,”
said Corey Fishman, Chief Executive Officer of Iterum
Therapeutics. “We expect to share topline results from our
complicated urinary tract infection (cUTI) trial this month and
topline results from our uncomplicated urinary tract infection
(uUTI) trial shortly thereafter within the second quarter.”
Q1 2020 Highlights and Upcoming Events
- Strengthened the balance sheet: Iterum raised
approximately $51.6 million ($46.7 million net of fees and
expenses) in January 2020 through a private placement of units
comprised of approximately (i) $51.6 million aggregate principal
amount of its 6.500% exchangeable senior subordinated notes due
2025 and (ii) $0.1 million aggregate principal amount of its
limited recourse royalty-linked senior subordinated
notes.
- Phase 3 topline results from cUTI and uUTI studies are
expected in the second quarter: Iterum is in the final
stages of data processing and analysis of the clinical study
data.
Upcoming Investor Presentation
- Virtual corporate presentation at the RBC Capital Markets
Global Healthcare Conference on Wednesday, May 20, 2020 at
10:20-10:45am ET.
First Quarter 2020 Financial Results
As of March 31, 2020, Iterum had cash and cash equivalents of
$23.3 million and approximately 14.9 million shares outstanding.
Iterum expects that its current cash and cash equivalents will be
sufficient to fund its operations into the second half of 2020.
Research and development (R&D) expenses for the first
quarter of 2020 were $9.7 million compared to $17.4 million for the
same period in 2019. The decrease was primarily due to reduced
clinical trial expenses associated with the near completion of our
Phase 3 clinical trials in the first quarter of 2020.
General and administrative (G&A) expenses for the first
quarter of 2020 were $3.2 million compared to $3.1 million for the
same period in 2019.
Other expenses for the first quarter of 2020 were $3.1 million
compared to $0.0 million for the same period in 2019. The increase
was primarily due to interest and other costs associated with the
January 2020 private placement.
For the first quarter of 2020, Iterum reported a net loss of
$16.1 million compared to a net loss of $20.6 million for the same
period in 2019.
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 avoidance of hospitalization or 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
pivotal Phase 3 clinical trials of uncomplicated urinary tract
infections, complicated urinary tract infections and complicated
intra-abdominal infections.
The U.S. Food and Drug Administration (FDA) has granted Special
Protocol Agreements (SPA) and Qualified Infectious Disease Product
(QIDP) designations for oral and IV sulopenem in accordance with
the Generating Antibiotics Incentives Now (GAIN) Act, which will
provide five years of additional regulatory exclusivity and
expedited Fast Track FDA review.
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 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 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, 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,
the sufficiency of our cash resources and our ability to continue
as a going concern, the impact of COVID-19 and related responsive
measures thereto 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 May 14, 2020, 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 March 31, |
|
|
|
2020 |
|
2019 |
|
Revenue |
|
$ |
— |
$ |
37 |
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
|
(9,743 |
) |
|
|
(17,387 |
) |
|
General and
administrative |
|
|
(3,151 |
) |
|
|
(3,116 |
) |
|
Total
operating expenses |
|
|
(12,894 |
) |
|
|
(20,503 |
) |
|
Operating
loss |
|
|
(12,894 |
) |
|
|
(20,466 |
) |
|
Interest
expense, net |
|
|
(2,596 |
) |
|
|
(104 |
) |
|
Private
placement transaction costs |
|
|
(2,130 |
) |
|
|
— |
|
|
Adjustments
to fair value of derivatives |
|
|
1,679 |
|
|
|
— |
|
|
Other
(expense) / income, net |
|
|
(38 |
) |
|
|
124 |
|
|
Total other
(expense) / income |
|
|
(3,085 |
) |
|
|
20 |
|
|
Income tax
expense |
|
|
(121 |
) |
|
|
(134 |
) |
|
Net loss
attributable to ordinary shareholders |
|
$ |
(16,100 |
) |
|
$ |
(20,560 |
) |
|
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(1.08 |
) |
|
$ |
(1.44 |
) |
|
Weighted
average ordinary shares outstanding – basic and diluted |
|
|
14,868,973 |
|
|
|
14,290,437 |
|
|
|
|
|
|
|
|
Net loss -
GAAP |
|
|
(16,100 |
) |
|
|
(20,560 |
) |
|
Interest
expense - accrued interest and amortization on Exchangeable Notes
and Royalty-Linked Notes |
|
|
2,267 |
|
|
|
- |
|
|
Private
placement transaction costs - not capitalized |
|
|
2,130 |
|
|
|
- |
|
|
Adjustments
to fair value of derivatives |
|
|
(1,679 |
) |
|
|
- |
|
|
Non-GAAP
adjusted loss |
|
$ |
(13,382 |
) |
|
$ |
(20,560 |
) |
|
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(1.08 |
) |
|
$ |
(1.44 |
) |
|
Non-GAAP net
loss per share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.90 |
) |
|
$ |
(1.44 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
|
Condensed
Consolidated Balance Sheet Data |
|
(In
thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
As
of |
|
As
of |
|
|
|
March
31, |
|
December
31, |
|
|
|
2020 |
|
2019 |
|
Cash and
cash equivalents |
|
$ |
23,257 |
|
|
$ |
4,801 |
|
|
Other
assets |
|
|
19,055 |
|
|
|
20,950 |
|
|
Total assets |
|
$ |
42,312 |
|
|
$ |
25,751 |
|
|
Long-term
debt, less current portion |
|
$ |
18,847 |
|
|
$ |
7,625 |
|
|
Royalty-linked notes, less current portion |
|
|
10,965 |
|
|
|
— |
|
|
Derivative
liability |
|
|
25,359 |
|
|
|
— |
|
|
Other
liabilities |
|
|
28,882 |
|
|
|
44,364 |
|
|
Total
liabilities |
|
|
84,053 |
|
|
|
51,989 |
|
|
Total
shareholders' deficit |
|
|
(41,741 |
) |
|
|
(26,238 |
) |
|
Total liabilities and shareholders' deficit |
|
$ |
42,312 |
|
|
$ |
25,751 |
|
|
|
|
|
|
|
|
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