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,
2020.
“Based on data generated in our Phase 3 clinical program, we
continue to believe that sulopenem can play a vital role in the
treatment of infections caused by multi-drug resistant pathogens
that have become prevalent in our community,” said Corey Fishman,
Chief Executive Officer of Iterum Therapeutics. “We have been
granted a meeting with the FDA at the end of the third quarter and
plan to share the results of that meeting shortly thereafter.”
Q2 2020 Highlights and Recent Events
- Announced topline results in cUTI and uUTI Phase 3
trials and planning for a meeting with the FDA: In
June 2020, the Company announced that it achieved one of its two
independent primary endpoints in the uncomplicated urinary tract
infection (uUTI) trial by demonstrating superiority to
ciprofloxacin in the treatment of patients with quinolone resistant
pathogens. The Company also announced that sulopenem failed to
achieve the primary endpoint in its complicated urinary tract
infection (cUTI) trial. Based on these trial results and previous
discussions with the U.S. Food and Drug Administration (FDA), the
Company plans to discuss its potential regulatory filing options
with the FDA in a meeting scheduled for the end of the third
quarter.
- Strengthened the balance sheet: Raised
$10.0 million gross proceeds ($8.7 million net of estimated fees
and expenses) in two registered direct offerings to certain
institutional investors of ordinary shares and concurrent private
placements of warrants to purchase ordinary shares in June 2020 and
July 2020.
- Set record date for rights offering: As
previously disclosed, the Company established 5:00 p.m. on August
5, 2020, as the record date for its planned rights offering. The
Company had agreed to undertake a rights offering of subscription
rights to purchase additional units in connection with the
Company’s January 2020 private placement of units consisting of
6.500% Exchangeable Senior Subordinated Notes due 2025 and Limited
Recourse Royalty-Linked Subordinated Notes.
Second Quarter 2020 Financial Results
As of June 30, 2020, the Company had cash and cash equivalents
of $12.3 million and approximately 17.9 million shares outstanding.
In July 2020, the Company received net proceeds of approximately
$4.4 million from a registered direct offering of ordinary shares
and concurrent private placement of warrants to purchase ordinary
shares. The Company expects that its current cash and cash
equivalents, including the proceeds from the July 2020 financing,
will be sufficient to fund its operations into the fourth quarter
of 2020. The Company is continuing to evaluate its corporate,
organizational, strategic, financial and financing alternatives
with the goal of maximizing value for its stakeholders, while
prudently managing its resources.
Research and development (R&D) expenses for the second
quarter of 2020 were $5.0 million compared to $24.4 million for the
same period in 2019. The decrease was primarily due to reduced
clinical trial expenses associated with the completion of the
Company’s Phase 3 clinical trials initiated in the third quarter of
2018.
General and administrative (G&A) expenses for the second
quarter of 2020 were $3.2 million compared to $2.9 million in the
same period in 2019. The increase was primarily due to an increase
in share-based compensation for employees in our general and
administrative and commercial functions partially offset by a
decrease in headcount and related costs.
Interest expense, net in the second quarter of 2020 was $4.1
million compared to $0.1 million in the same period in 2019,
primarily due to non-cash interest expense and amortization of debt
discounts and deferred financing costs relating to the January 2020
private placement.
For the second quarter of 2020, the Company reported a net loss
of $12.5 million compared to a net loss of $27.6 million for the
same period in 2019.
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
an oral and IV formulation. 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.
Forward-Looking Statements
This press release contains forward-looking statements. These
forward-looking statements include, without limitation, statements
regarding the expected timing, terms and completion of the planned
rights offering and the Company’s plans, strategies and prospects
for its business, including with respect to the Company’s scheduled
meeting with the FDA. 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,” “would,” “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 the Company’s 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 the Company’s control,
including the uncertainties inherent in the initiation and conduct
of clinical trials, availability and timing of data from clinical
trials, changes in regulatory requirements or decisions of
regulatory authorities, the Company’s ability to apply for
regulatory approval, changes in public policy or legislation,
commercialization plans and timelines, if sulopenem is approved,
the actions of third-party clinical research organizations,
suppliers and manufacturers, the accuracy of the Company’s
expectations regarding how far into the future the Company’s cash
on hand will fund the Company’s ongoing operations, the sufficiency
of the Company’s cash resources and the Company’s ability to
continue as a going concern, the impact of COVID-19 and related
responsive measures thereto, risks and uncertainties concerning the
outcome, impact, effects and results of the Company’s evaluation of
corporate, organizational, strategic, financial and financing
alternatives, including the terms, timing, structure, value,
benefits and costs of any corporate, organizational, strategic,
financial or financing alternative and the Company’s ability to
complete one at all, the price of the Company’s securities, the
expected use of proceeds from the planned rights offering and other
factors discussed under the caption “Risk Factors” in its most
recently filed Quarterly Report on Form 10-Q, and other documents
filed with the SEC from time to time. Forward-looking statements
represent the Company’s beliefs and assumptions only as of the date
of this press release. Except as required by law, the Company
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
endedJune 30, |
|
Six months
endedJune 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
37 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
(5,043 |
) |
|
|
(24,439 |
) |
|
|
(14,786 |
) |
|
|
(41,826 |
) |
|
General and
administrative |
|
|
(3,210 |
) |
|
|
(2,939 |
) |
|
|
(6,361 |
) |
|
|
(6,055 |
) |
|
Total
operating expenses |
|
|
(8,253 |
) |
|
|
(27,378 |
) |
|
|
(21,147 |
) |
|
|
(47,881 |
) |
|
Operating
loss |
|
|
(8,253 |
) |
|
|
(27,378 |
) |
|
|
(21,147 |
) |
|
|
(47,844 |
) |
|
Interest
expense, net |
|
|
(4,075 |
) |
|
|
(135 |
) |
|
|
(6,671 |
) |
|
|
(239 |
) |
|
Private
placement transaction costs |
|
|
— |
|
|
|
— |
|
|
|
(2,130 |
) |
|
|
— |
|
|
Adjustments
to fair value of derivatives |
|
|
(12 |
) |
|
|
— |
|
|
|
1,667 |
|
|
|
— |
|
|
Other
(expense) / income, net |
|
|
(3 |
) |
|
|
32 |
|
|
|
(41 |
) |
|
|
156 |
|
|
Income tax
expense |
|
|
(178 |
) |
|
|
(157 |
) |
|
|
(299 |
) |
|
|
(291 |
) |
|
Net loss
attributable to ordinary shareholders |
|
$ |
(12,521 |
) |
|
$ |
(27,638 |
) |
|
$ |
(28,621 |
) |
|
$ |
(48,218 |
) |
|
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.80 |
) |
|
$ |
(1.93 |
) |
|
$ |
(1.87 |
) |
|
$ |
(3.37 |
) |
|
Weighted
average ordinary shares outstanding – basic and diluted |
|
|
15,614,767 |
|
|
|
14,340,231 |
|
|
|
15,295,141 |
|
|
|
14,316,497 |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss -
GAAP |
|
$ |
(12,521 |
) |
|
$ |
(27,638 |
) |
|
$ |
(28,621 |
) |
|
$ |
(48,218 |
) |
|
Interest
expense - accrued interest and amortization on Exchangeable Notes
and Royalty-Linked Notes |
|
|
3,704 |
|
|
|
|
|
5,970 |
|
|
|
|
Private
placement transaction costs - not capitalized |
|
|
- |
|
|
|
— |
|
|
|
2,130 |
|
|
|
— |
|
|
Adjustments
to fair value of derivatives |
|
|
12 |
|
|
|
— |
|
|
|
(1,667 |
) |
|
|
— |
|
|
Non-GAAP
adjusted loss |
|
$ |
(8,805 |
) |
|
$ |
(27,638 |
) |
|
$ |
(22,188 |
) |
|
$ |
(48,218 |
) |
|
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.80 |
) |
|
$ |
(1.93 |
) |
|
$ |
(1.87 |
) |
|
$ |
(3.37 |
) |
|
Non-GAAP net
loss per share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.56 |
) |
|
$ |
(1.93 |
) |
|
$ |
(1.45 |
) |
|
$ |
(3.37 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
|
|
|
|
|
Condensed
Consolidated Balance Sheet Data |
|
|
|
|
|
(In
thousands) |
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
As
of |
|
As
of |
|
|
|
|
|
|
|
June
30, |
|
December
31, |
|
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
12,250 |
|
|
$ |
4,801 |
|
|
|
|
|
|
Other
assets |
|
|
19,437 |
|
|
|
20,950 |
|
|
|
|
|
|
Total assets |
|
$ |
31,687 |
|
|
$ |
25,751 |
|
|
|
|
|
|
Long-term
debt, less current portion |
|
$ |
20,931 |
|
|
$ |
7,625 |
|
|
|
|
|
|
Royalty-linked notes, less current portion |
|
|
11,826 |
|
|
|
— |
|
|
|
|
|
|
Derivative
liability |
|
|
25,371 |
|
|
|
— |
|
|
|
|
|
|
Other
liabilities |
|
|
22,348 |
|
|
|
44,364 |
|
|
|
|
|
|
Total
liabilities |
|
|
80,476 |
|
|
|
51,989 |
|
|
|
|
|
|
Total
shareholders' deficit |
|
|
(48,789 |
) |
|
|
(26,238 |
) |
|
|
|
|
|
Total liabilities and shareholders' deficit |
|
$ |
31,687 |
|
|
$ |
25,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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