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, 2020.
“Following the positive feedback we received from the FDA at our
pre-NDA meeting in September, we have been diligently preparing our
new drug application (NDA) for oral sulopenem for the treatment of
uncomplicated urinary tract infections (uUTIs) due to
quinolone-resistant pathogens for submission in the coming weeks,
and are making preparations for a potential commercial launch of
oral sulopenem in the U.S.,” said Corey Fishman, Chief Executive
Officer of Iterum Therapeutics. “With potential approval
anticipated within the next three quarters, we are pleased to be
the first oral penem to market in the U.S., and the first approved
product in uUTI in over 20 years, where quinolone-resistant
pathogens now cause as many as one third of the 22 million uUTIs
annually.”
Q3 2020 Highlights and Recent Events
- Positive meeting with the FDA resulting in continued
preparation for submission of the NDA filing in the
near-term: Based on discussions with the FDA at a
pre-NDA meeting in September 2020 and previous correspondence with
the FDA, the Company plans to proceed with an NDA submission for
oral sulopenem (sulopenem etzadroxil/probenecid) for the treatment
of uUTIs in patients with a quinolone non-susceptible pathogen in
the fourth quarter of 2020. In June 2020, as previously disclosed,
the Company announced topline data from the SURE-1 clinical trial
demonstrating that oral sulopenem was statistically superior to
ciprofloxacin in the treatment of patients with uUTI caused by a
quinolone non-susceptible pathogen.
- Extended cash runway: In October 2020, the
Company raised approximately $17.4 million gross proceeds
(approximately $15.3 million net proceeds) in a registered public
offering of ordinary shares, pre-funded warrants exercisable for
ordinary shares and warrants exercisable for ordinary shares, which
extended the Company’s expected cash runway into the third quarter
of 2021.
- Presented results from two
Phase 3 studies at the Infectious Disease Society of
America (IDSA) IDWeek™ 2020 (IDWeek): In October
2020, the Company presented results from two of its Phase 3
clinical trials at IDWeek. The two data presentations included a
poster presentation of the results of the SURE-2 clinical trial in
complicated urinary tract infections, and an oral abstract
presentation of the results from the SURE-1 clinical trial in
uUTIs.
Third Quarter 2020 Financial Results
As of September 30, 2020, the Company had cash and cash
equivalents of $8.6 million and approximately 21.2 million shares
outstanding. In October 2020, the Company issued and sold, in a
public offering, ordinary shares, pre-funded warrants exercisable
for ordinary shares and warrants exercisable for ordinary shares
for aggregate gross proceeds of approximately $17.4 million and net
proceeds of approximately $15.3 million after deducting fees
payable to the placement agent and other estimated offering
expenses. The Company expects that its current cash and cash
equivalents, including the proceeds from the October 2020
financing, will be sufficient to fund its operations into the third
quarter of 2021. 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 third
quarter of 2020 were $3.9 million compared to $28.1 million for the
same period in 2019. The decrease was primarily due to reduced
clinical trial expenses and headcount associated with the
completion of the Company’s Phase 3 clinical trials, which had been
initiated in the third quarter of 2018.
General and administrative (G&A) expenses for the third
quarter of 2020 were $2.4 million compared to $2.9 million in the
same period in 2019. The decrease was primarily due to a decrease
in headcount and related costs, lower spending on
pre-commercialization activities and reduced share-based
compensation to directors, partially offset by an increase in
share-based compensation for employees in our general and
administrative functions.
Interest expense, net in the third quarter of 2020 was $4.2
million compared to $0.2 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 Company’s
Exchangeable Notes and Royalty-Linked Notes issued in 2020.
For the third quarter of 2020, the Company reported a net loss
of $12.2 million compared to a net loss of $31.3 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 formulation 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 Company’s plans, strategies and prospects for its
business, including with respect to the Company’s planned filing
and FDA review of an NDA for oral sulopenem and the sufficiency of
the Company’s cash resources. 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 timing or likelihood of regulatory
filings and approvals, changes in public policy or legislation,
commercialization plans and timelines, if oral 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 Company’s ability to continue as a going concern, the impact of
COVID-19 and related responsive measures thereto, the Company’s
ability to maintain its listing on the Nasdaq Stock Market, 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 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 Securities
and Exchange Commission 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
endedSeptember 30, |
|
Nine months
endedSeptember 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
37 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
|
(3,937 |
) |
|
|
(28,066 |
) |
|
|
(18,723 |
) |
|
|
(69,892 |
) |
General and
administrative |
|
|
(2,398 |
) |
|
|
(2,933 |
) |
|
|
(8,759 |
) |
|
|
(8,988 |
) |
Total
operating expenses |
|
|
(6,335 |
) |
|
|
(30,999 |
) |
|
|
(27,482 |
) |
|
|
(78,880 |
) |
Operating
loss |
|
|
(6,335 |
) |
|
|
(30,999 |
) |
|
|
(27,482 |
) |
|
|
(78,843 |
) |
Interest
expense, net |
|
|
(4,183 |
) |
|
|
(216 |
) |
|
|
(10,854 |
) |
|
|
(455 |
) |
Financing
transaction costs |
|
|
(685 |
) |
|
|
— |
|
|
|
(2,815 |
) |
|
|
— |
|
Adjustments
to fair value of derivatives |
|
|
(644 |
) |
|
|
— |
|
|
|
1,023 |
|
|
|
— |
|
Other
income, net |
|
|
68 |
|
|
|
48 |
|
|
|
27 |
|
|
|
204 |
|
Income tax
expense |
|
|
(420 |
) |
|
|
(104 |
) |
|
|
(719 |
) |
|
|
(395 |
) |
Net loss
attributable to ordinary shareholders |
|
$ |
(12,199 |
) |
|
$ |
(31,271 |
) |
|
$ |
(40,820 |
) |
|
$ |
(79,489 |
) |
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.60 |
) |
|
$ |
(2.15 |
) |
|
$ |
(2.39 |
) |
|
$ |
(5.52 |
) |
Weighted
average ordinary shares outstanding – basic and diluted |
|
|
20,392,357 |
|
|
|
14,571,278 |
|
|
|
17,078,326 |
|
|
|
14,412,755 |
|
|
|
|
|
|
|
|
|
|
Net loss -
GAAP |
|
$ |
(12,199 |
) |
|
$ |
(31,271 |
) |
|
$ |
(40,820 |
) |
|
$ |
(79,489 |
) |
Interest
expense - accrued interest and amortization on Exchangeable Notes
and Royalty-Linked Notes |
|
|
3,859 |
|
|
|
— |
|
|
|
9,829 |
|
|
|
— |
|
Financing
transaction costs - not capitalized |
|
|
685 |
|
|
|
— |
|
|
|
2,815 |
|
|
|
— |
|
Adjustments
to fair value of derivatives |
|
|
644 |
|
|
|
— |
|
|
|
(1,023 |
) |
|
|
— |
|
Non-GAAP
adjusted loss |
|
$ |
(7,011 |
) |
|
$ |
(31,271 |
) |
|
$ |
(29,199 |
) |
|
$ |
(79,489 |
) |
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.60 |
) |
|
$ |
(2.15 |
) |
|
$ |
(2.39 |
) |
|
$ |
(5.52 |
) |
Non-GAAP net
loss per share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.34 |
) |
|
$ |
(2.15 |
) |
|
$ |
(1.71 |
) |
|
$ |
(5.52 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
|
|
|
|
Condensed
Consolidated Balance Sheet Data |
|
|
|
|
(In
thousands) |
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
of |
|
As
of |
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
|
|
|
|
2020 |
|
2019 |
|
|
|
|
Cash and
cash equivalents |
|
$ |
8,570 |
|
|
$ |
4,801 |
|
|
|
|
|
Other
assets |
|
|
17,700 |
|
|
|
20,950 |
|
|
|
|
|
Total assets |
|
$ |
26,270 |
|
|
$ |
25,751 |
|
|
|
|
|
Long-term
debt, less current portion |
|
$ |
21,653 |
|
|
$ |
7,625 |
|
|
|
|
|
Royalty-linked notes, less current portion |
|
|
12,492 |
|
|
|
— |
|
|
|
|
|
Derivative
liabilities |
|
|
26,097 |
|
|
|
— |
|
|
|
|
|
Other
liabilities |
|
|
21,931 |
|
|
|
44,364 |
|
|
|
|
|
Total
liabilities |
|
|
82,173 |
|
|
|
51,989 |
|
|
|
|
|
Total
shareholders' deficit |
|
|
(55,903 |
) |
|
|
(26,238 |
) |
|
|
|
|
Total liabilities and shareholders' deficit |
|
$ |
26,270 |
|
|
$ |
25,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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