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, 2020.
“Iterum has made excellent progress in the last
few months and we look forward to continuing that momentum
throughout 2021. In the fourth quarter of 2020, we submitted a New
Drug Application (NDA) for oral sulopenem for the treatment of
uncomplicated urinary tract infections (uUTI) in patients with a
quinolone non-susceptible organism, which is currently under review
by the U.S. Food and Drug Administration (FDA) with a July 25, 2021
Prescription Drug User Fee Act (PDUFA) goal date. We estimate that
the market for this indication is approximately 6.5 million uUTIs
caused by a quinolone non-susceptible organism annually in the
U.S.,” said Corey Fishman, Chief Executive Officer. “Our priorities
for the rest of this year are: (1) holding a positive Advisory
Committee meeting in June, (2) completion of FDA review of our NDA
by the end of July, (3) initiating the commercial launch in the
fourth quarter, if approved, and (4) working with the FDA to
understand the requirements for potential expansion of our label in
uUTI to include all patients, if approved, and to potentially add
the complicated urinary tract infection (cUTI) indication. In
anticipation of these key milestones, we have raised sufficient
capital to support the execution of our strategy as currently
planned.”
Highlights and Recent Events
- NDA accepted for priority review by FDA with PDUFA goal
date of July 25, 2021: In January 2021, the FDA accepted
for review our NDA for uUTI in patients with a quinolone
non-susceptible organism. The FDA has designated our application as
a priority review and consequently assigned a PDUFA goal date for
completion of the review of oral sulopenem of July 25, 2021. The
FDA currently plans to hold an advisory committee meeting to
discuss the NDA on June 2, 2021.
- Extended cash runway into first half
of 2023: In February 2021, we received
total net proceeds of $74.3 million from an underwritten public
offering and a registered direct offering which, along with
proceeds received from the exercise of certain warrants and
existing cash and cash equivalents, has extended our cash runway
into the first half of 2023, based on our current operating plan.
As of February 28, 2021, we had approximately 176.5 million
ordinary shares outstanding.
- Announced collaboration with a third-party provider of
commercialization services: In February 2021, we engaged
EVERSANA™, a leading provider of commercial services to the life
science industry, to initiate certain pre-launch activities. We are
in the process of finalizing an agreement with EVERSANA™ to provide
commercialization services to launch oral sulopenem, if
approved.
Fourth Quarter and Full Year 2020
Financial Results
As of December 31, 2020, Iterum had cash and cash
equivalents of $14.5 million. In February 2021, Iterum received
total net proceeds of $74.3 million from an underwritten public
offering and a registered direct offering. Iterum expects that its
current cash and cash equivalents, including the proceeds from
these recent financings and proceeds received from the exercise of
certain warrants, will be sufficient to fund its operations into
the first half of 2023.
Research and development (R&D) expenses for
the fourth quarter and full year 2020 were $2.4 million and $21.1
million, respectively, compared to $20.9 million and $90.8 million
for the same periods in 2019. The decreases for both the
three-month and twelve-month periods were primarily due to the
substantial completion of our three Phase 3 clinical trials in
2019.
General and administrative (G&A) expenses for
the fourth quarter and full year 2020 were $2.3 million and $11.1
million, respectively, compared to $2.3 million and $11.3 million
for the same periods in 2019. The slight decrease for the full
year was primarily due to lower consulting spend on
pre-commercialization activities and lower headcount, partially
offset by higher share-based compensation expense.
Interest expense, net for the fourth quarter and
full year 2020 was $4.2 million and $15.1 million, respectively,
compared to $0.4 million and $0.9 million for the same periods 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 fourth quarter and full year 2020, Iterum
reported a net loss of $11.2 million and $52.0 million,
respectively, compared to a net loss of $23.6 million and $103.1
million for the same periods in 2019.
Upcoming Investor
Presentations
- Corporate presentation at the Needham & Company 20th Annual
Healthcare Virtual Conference from April 12-15, 2021
- Corporate presentation at the RBC Capital Markets Global
Healthcare Virtual Conference from May 18-19, 2021
Conference Call and Webcast
Details
- Iterum will host a conference call and webcast
today, Friday, March 12, 2021 at 8:30 a.m. Eastern Time. To
register for this conference call, please use this link:
https://www.incommglobalevents.com/registration/client/6960/iterum-therapeutics-4th-quarter-and-full-year-2020/.
To access the webcast, click on this link:
https://event.on24.com/wcc/r/3046063/2E404D4F9FF92585C41DAAAF17569C27.
A recording will be available until Friday, March 19, 2021. To
access the replay, please click on the following link and enter the
access code 939536
https://www.incommglobalevents.com/replay/5511/iterum-therapeutics-4th-quarter-and-full-year-2020/
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. We believe that sulopenem and oral sulopenem have the
potential to be important new treatment alternatives to address the
growing concerns related to antibacterial resistance without the
known toxicities of some of the most widely used antibiotics,
specifically fluoroquinolones. Oral sulopenem is currently under
FDA review for uncomplicated urinary tract infections in patients
with a quinolone non-susceptible pathogen and has a PDUFA goal date
of July 25, 2021.
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 the Company’s plans, strategies
and prospects for its business, including with respect to the
timing of review by the FDA of the NDA for oral sulopenem and the
Company’s expectations for potential approval on the PDUFA date,
the market potential for sulopenem, commercialization activities
including the ability to enter into a definitive agreement with
respect to commercialization services, the ability to expand any
approved label for sulopenem, the ability to add the cUTI
indication, and the sufficiency of the Company’s cash resources to
execute its strategy. 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 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, strategic,
financial and financing alternatives, including the terms, timing,
structure, value, benefits and costs of any corporate, strategic,
financial or financing alternative and the Company’s ability to
complete one at all and other factors discussed under the caption
“Risk Factors” in its Annual Report on Form 10- K filed with the
Securities and Exchange Commission (the “SEC”) on March 12, 2021,
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 Matthews
Chief Financial Officer 312-778-6073 IR@iterumtx.com
ITERUM
THERAPEUTICS PLC |
Consolidated
Statement of Operations |
(In
thousands except share and per share data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three months
ended December 31, |
|
Year ended
December 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Revenue |
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
37 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
|
(2,351 |
) |
|
|
(20,882 |
) |
|
|
(21,074 |
) |
|
|
(90,774 |
) |
General and
administrative |
|
(2,293 |
) |
|
|
(2,296 |
) |
|
|
(11,052 |
) |
|
|
(11,284 |
) |
Total
operating expenses |
|
(4,644 |
) |
|
|
(23,178 |
) |
|
|
(32,126 |
) |
|
|
(102,058 |
) |
Operating
loss |
|
(4,644 |
) |
|
|
(23,178 |
) |
|
|
(32,126 |
) |
|
|
(102,021 |
) |
Interest
expense, net |
|
(4,243 |
) |
|
|
(406 |
) |
|
|
(15,097 |
) |
|
|
(861 |
) |
Financing
transaction costs |
|
(33 |
) |
|
|
— |
|
|
|
(2,848 |
) |
|
|
Adjustments
to fair value of derivatives |
|
(2,768 |
) |
|
|
— |
|
|
|
(1,745 |
) |
|
|
— |
|
Extinguishment of debt |
|
340 |
|
|
|
— |
|
|
|
340 |
|
|
|
— |
|
Other
income, net |
|
186 |
|
|
|
(8 |
) |
|
|
213 |
|
|
|
196 |
|
Income tax
expense |
|
(24 |
) |
|
|
(49 |
) |
|
|
(743 |
) |
|
|
(444 |
) |
Net loss
attributable to ordinary shareholders |
$ |
(11,186 |
) |
|
$ |
(23,641 |
) |
|
$ |
(52,006 |
) |
|
$ |
(103,130 |
) |
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
$ |
(0.28 |
) |
|
$ |
(1.59 |
) |
|
$ |
(2.17 |
) |
|
$ |
(7.10 |
) |
Weighted
average ordinary shares outstanding – basic and diluted |
|
40,645,864 |
|
|
|
14,866,838 |
|
|
|
24,009,818 |
|
|
|
14,518,036 |
|
|
|
|
|
|
|
|
|
Net loss -
GAAP |
$ |
(11,186 |
) |
|
$ |
(23,641 |
) |
|
$ |
(52,006 |
) |
|
$ |
(103,130 |
) |
Interest
expense - accrued interest and amortization on Exchangeable Notes
and Royalty-Linked Notes |
|
3,877 |
|
|
|
— |
|
|
|
13,706 |
|
|
|
— |
|
Financing
transaction costs - not capitalized |
|
33 |
|
|
|
— |
|
|
|
2,848 |
|
|
|
— |
|
Adjustments
to fair value of derivatives |
|
2,768 |
|
|
|
— |
|
|
|
1,745 |
|
|
|
— |
|
Non-GAAP
adjusted loss |
$ |
(4,508 |
) |
|
$ |
(23,641 |
) |
|
$ |
(33,707 |
) |
|
$ |
(103,130 |
) |
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
$ |
(0.28 |
) |
|
$ |
(1.59 |
) |
|
$ |
(2.17 |
) |
|
$ |
(7.10 |
) |
Non-GAAP net
loss per share attributable to ordinary shareholders – basic and
diluted |
$ |
(0.11 |
) |
|
$ |
(1.59 |
) |
|
$ |
(1.40 |
) |
|
$ |
(7.10 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
|
|
|
|
Consolidated
Balance Sheet Data |
|
|
|
|
(In
thousands) |
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
As
of |
|
As
of |
|
|
|
|
|
December
31, |
|
December
31, |
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
Cash and
cash equivalents |
$ |
14,508 |
|
|
$ |
4,801 |
|
|
|
|
|
Other
assets |
|
18,284 |
|
|
|
20,950 |
|
|
|
|
|
Total assets |
$ |
32,792 |
|
|
$ |
25,751 |
|
|
|
|
|
Long-term
debt, less current portion |
$ |
22,462 |
|
|
$ |
7,625 |
|
|
|
|
|
Royalty-linked notes, less current portion |
|
13,389 |
|
|
|
— |
|
|
|
|
|
Derivative
liabilities |
|
28,865 |
|
|
|
— |
|
|
|
|
|
Other
liabilities |
|
18,635 |
|
|
|
44,364 |
|
|
|
|
|
Total
liabilities |
|
83,351 |
|
|
|
51,989 |
|
|
|
|
|
Total
shareholders' deficit |
|
(50,559 |
) |
|
|
(26,238 |
) |
|
|
|
|
Total liabilities and shareholders' deficit |
$ |
32,792 |
|
|
$ |
25,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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