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 fourth quarter and year ended
December 31, 2019.
“2019 was a year of incredible progress for Iterum. We completed
enrollment in all three Phase 3 clinical trials of sulopenem and
reported topline results from our complicated intra-abdominal
infections (cIAI) trial,” said Corey Fishman, Chief Executive
Officer of Iterum Therapeutics plc. “2020 is a pivotal year
for the company. We started the year by raising additional
capital to fund the company through topline results of the
remaining two Phase 3 studies, complicated urinary tract infections
(cUTI) and uncomplicated urinary tract infections (uUTI), planned
submission of two new drug applications (NDAs) to the U.S. Food and
Drug Administration (FDA) and preparations for a potential
commercial launch in 2021.”
2019 Highlights and Recent Events
- Completed enrollment in all Phase 3 pivotal clinical
trials: In the fourth quarter of 2019, Iterum
completed patient enrollment in its two remaining clinical trials,
Sulopenem for Resistant
Enterobacteriaceae (SURE) 1 in uUTI and SURE 2 in
cUTI. Overall, more than 3,700 patients were enrolled in our
Phase 3 clinical trials of sulopenem since initiation in the third
quarter of 2018.
- Announced topline results in first Phase 3
trial: In December 2019, Iterum announced that it
narrowly missed the primary endpoint of its SURE 3 clinical trial
cIAI. While the trial narrowly missed the primary endpoint,
we believe the secondary supporting analysis and safety data
support the potential for sulopenem in the treatment of multi-drug
resistant infections.
- 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.
- Filed two non-provisional patent applications with
United States Patent and Trademark Office: One patent
application addressed the effect of probenecid on the plasma
concentrations of sulopenem after multi-day dosing and the second
patent application related to a method of preparing a bilayer
tablet composed of sulopenem etzadroxil and probenecid which
resulted in an increase in the amount of sulopenem in the blood
relative to dosing each agent in a separate formulation. If either
patent is granted, it would provide 20 years of intellectual
property protection for oral sulopenem from the date the
non-provisional patent application was filed (to 2039). The current
U.S. composition of matter patent on sulopenem etzadroxil expires
in 2029 with potential extension to 2034 under the Hatch-Waxman
Act.
Fourth Quarter and Full Year 2019 Financial
Results
As of December 31, 2019, Iterum had cash and cash equivalents of
$4.8 million and approximately 14.5 million shares outstanding. In
January 2020, Iterum received net proceeds of $46.7 million from
the private placement with accredited investors of 6.500%
exchangeable senior subordinated notes due 2025 and limited
recourse royalty-linked senior subordinated notes. Iterum expects
that its current cash and cash equivalents, including the proceeds
from this recent financing, will be sufficient to fund its
operations into the second half of 2020.
Research and development (R&D) expenses for the fourth
quarter and full year 2019 were $20.9 million and $90.8 million,
respectively, compared to $21.5 million and $68.6 million for
the same periods in 2018. The increases for both the
three-month and twelve-month periods were primarily due to higher
clinical trial expenses associated with the three Phase 3 clinical
trials initiated in the third quarter of 2018, partially offset by
milestone payments made to Pfizer Inc. of $7.5 million in the
fourth quarter of 2018 and $15.0 million in the 2018 twelve-month
period.
General and administrative (G&A) expenses for the fourth
quarter and full year 2019 were $2.3 million and $11.3 million,
respectively, compared to $2.7 million and $8.8 million for
the same periods in 2018. The increase for the full year
was primarily due to increased costs associated with operating as a
public company and additional headcount to support business
activities.
For the fourth quarter and full year 2019, Iterum reported a net
loss of $23.6 million and $103.1 million, respectively, compared to
a net loss of $24.3 million and $77.1 million for the same periods
in 2018.
Upcoming Scientific and Investor
Presentations
- Corporate presentation at the Needham & Company 19th Annual
Healthcare Conference from April 14-15, 2020 in New York City,
New York
- A scientific presentation at the 30th European Congress of
Clinical Microbiology and Infectious Diseases from April
18-21, 2020 in Paris, France
- Corporate presentation at the RBC Capital Markets Global
Healthcare Conference from May 19-20, 2020 in New York City, New
York
- Multiple scientific presentations at American Society of
Microbiology (ASM) Microbe 2020 from June 18-22,
2020 in Chicago, IL
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, and other factors discussed under the
caption “Risk Factors” in our Annual Report on Form 10- K filed
with the Securities and Exchange Commission (the “SEC”) on March
12, 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 December 31, |
|
Year ended December 31, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Revenue |
$ |
- |
|
|
$ |
239 |
|
|
$ |
37 |
|
|
$ |
869 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
(20,882 |
) |
|
|
(21,460 |
) |
|
|
(90,774 |
) |
|
|
(68,647 |
) |
General and administrative |
|
(2,296 |
) |
|
|
(2,723 |
) |
|
|
(11,284 |
) |
|
|
(8,781 |
) |
Total operating expenses |
|
(23,178 |
) |
|
|
(24,183 |
) |
|
|
(102,058 |
) |
|
|
(77,428 |
) |
Operating loss |
|
(23,178 |
) |
|
|
(23,944 |
) |
|
|
(102,021 |
) |
|
|
(76,559 |
) |
Interest (expense) / income,
net |
|
(406 |
) |
|
|
(297 |
) |
|
|
(861 |
) |
|
|
(426 |
) |
Other (expense) / income,
net |
|
(8 |
) |
|
|
189 |
|
|
|
196 |
|
|
|
401 |
|
Income tax expense |
|
(49 |
) |
|
|
(206 |
) |
|
|
(444 |
) |
|
|
(472 |
) |
Net loss attributable to ordinary
shareholders |
$ |
(23,641 |
) |
|
$ |
(24,258 |
) |
|
$ |
(103,130 |
) |
|
$ |
(77,056 |
) |
Net loss per share attributable
to ordinary shareholders – basic and diluted |
$ |
(1.59 |
) |
|
$ |
(1.72 |
) |
|
$ |
(7.10 |
) |
|
$ |
(8.82 |
) |
Weighted average ordinary shares
outstanding – basic and diluted |
|
14,866,838 |
|
|
|
14,108,604 |
|
|
|
14,518,036 |
|
|
|
8,734,109 |
|
|
|
|
|
|
|
|
|
Net loss - GAAP |
|
(23,641 |
) |
|
|
(24,258 |
) |
|
|
(103,130 |
) |
|
|
(77,056 |
) |
Milestone payments to Pfizer |
|
- |
|
|
|
7,500 |
|
|
|
- |
|
|
|
15,000 |
|
Non-GAAP adjusted loss |
$ |
(23,641 |
) |
|
$ |
(16,758 |
) |
|
$ |
(103,130 |
) |
|
$ |
(62,056 |
) |
Net loss per share attributable
to ordinary shareholders – basic and diluted |
$ |
(1.59 |
) |
|
$ |
(1.72 |
) |
|
$ |
(7.10 |
) |
|
$ |
(8.82 |
) |
Non-GAAP net loss per share
attributable to ordinary shareholders – basic and diluted |
$ |
(1.59 |
) |
|
$ |
(1.19 |
) |
|
$ |
(7.10 |
) |
|
$ |
(7.11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
Condensed
Consolidated Balance Sheet Data |
(In
thousands) |
(Unaudited) |
|
|
|
|
|
As of |
|
As of |
|
December 31, |
|
December 31, |
|
2019 |
|
2018 |
Cash, cash equivalents and short-term investments |
$ |
4,801 |
|
|
$ |
84,551 |
Other assets |
|
20,950 |
|
|
|
13,320 |
Total
assets |
$ |
25,751 |
|
|
$ |
97,871 |
Long-term debt, less current
portion |
|
7,625 |
|
|
|
13,079 |
Other liabilities |
|
44,364 |
|
|
|
13,170 |
Total liabilities |
|
51,989 |
|
|
|
26,249 |
Total shareholders' (deficit) /
equity |
|
(26,238 |
) |
|
|
71,622 |
Total liabilities and
shareholders' (deficit) / equity |
$ |
25,751 |
|
|
$ |
97,871 |
|
|
|
|
|
|
|
Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Sep 2023 to Sep 2024