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, 2022.
“We made significant progress in 2022 to move the clinical
development of oral sulopenem forward leading to a potential
resubmission of our new drug application (“NDA”) next year,” said
Corey Fishman, Iterum’s Chief Executive Officer. “Enrollment in our
REASSURE trial, which is being conducted under a Special Protocol
Assessment (“SPA”) agreement with the U.S. Food and Drug
Administration (“FDA”), is expected to be completed in the first
half of 2024.”
Highlights and Recent Events
- Enrollment in REASSURE Clinical Trial Ongoing:
Iterum began enrollment in its pivotal Phase 3 clinical trial,
REASSURE (REnewed ASsessment of
Sulopenem in uUTI caused by
Resistant Enterobacterales), for
the treatment of uncomplicated urinary tract infections (“uUTI”) in
adult women in October 2022. Enrollment is ongoing and expected to
be completed in the first half of 2024. An interim analysis at 50%
patient enrollment is expected to occur in the second half of 2023.
This trial is being conducted under a SPA agreement with the FDA.
The SPA agreement provides that the design and planned analysis of
the trial, as set out in the protocol submitted to the FDA,
adequately addresses the objectives necessary to support the
potential resubmission of Iterum’s NDA for oral sulopenem.
- Two New U.S. Patents Issued: The United States
Patent and Trademark Office has issued Iterum two new patents: 1)
US Patent No. 11,478,428, directed to the composition of the
bilayer tablet of sulopenem etzadroxil and probenecid (“oral
sulopenem”) and its related uses, and 2) US Patent No. 11,554,112
directed to the method of use of oral sulopenem in treating
multiple diseases, including uncomplicated urinary tract
infections. These U.S. patents are scheduled to expire no earlier
than 2039, excluding any additional term for patent adjustments or
patent term extensions. Existing patent protection for sulopenem
etzadroxil is scheduled to expire in 2029, subject to potential
extension. Iterum’s patent portfolio also contains pending patent
applications outside the U.S., including Europe and China,
submitted following receipt of the Written Opinion of the
International Search Authority indicating that several claims
directed to the composition of the bilayer tablet of oral sulopenem
are novel and inventive.
- Shareholder Lawsuit Dismissed: On January 25,
2023, the putative class action lawsuit filed against Iterum, its
Chief Executive Officer and Chief Financial Officer in the United
States District Court for the Northern District of Illinois on
August 5, 2021, was dismissed and cannot be brought back to court
(dismissed with prejudice).
Fourth Quarter and Full Year 2022
Financial Results
Cash, cash equivalents and short-term
investments were $60.8 million at December 31, 2022. Based on the
current operating plan, Iterum expects that its current cash, cash
equivalents and short-term investments will be sufficient to fund
its operations until mid-2024. As of February 28, 2023, we had
approximately 12.6 million ordinary shares outstanding.
Research and development (R&D) expenses for the fourth
quarter and full year 2022 were $5.8 million and $17.6 million,
respectively, compared to $3.7 million and $10.7 million for the
same periods in 2021. The increase for the three-month period was
primarily due to an increase in costs to support our REASSURE
trial, which began enrollment in October 2022, partially offset by
lower non-cash amortization of an intangible asset. The increase in
R&D expenses for the full year was primarily due to the
REASSURE trial, including an increase in headcount to support trial
activities, partially offset by a decrease in consulting fees for
R&D activities in 2022. Consulting fees for the year ending
December 31, 2021 primarily related to consultants used during the
FDA review of our NDA for oral sulopenem.
General and administrative (G&A) expenses for the fourth
quarter and full year 2022 were $2.0 million and $12.8 million,
respectively, compared to $3.1 million and $13.8 million for the
same periods in 2021. The decrease for the three-month period was
primarily due to a decrease in share-based compensation expense.
The decrease for the full year period was primarily due to lower
consulting fees used to support pre-commercialization activities
versus the prior year, partially offset by an increase in
compensation and headcount and an increase in legal fees associated
with the lawsuit filed in August 2021 and dismissed with prejudice
in January2023.
Adjustments to the fair value of derivatives for the fourth
quarter and full year 2022 were $3.0 million and $5.5 million,
compared to $3.6 million and ($61.0) million for the same periods
in 2021. The non-cash adjustment in the fourth quarter and full
year 2022 primarily related to a decrease in the value of the
derivative components associated with Iterum’s 6.500% Exchangeable
Senior Subordinated Notes due 2025 (the “Exchangeable Notes”) as a
result of a decrease in the price of its ordinary shares and market
capitalization during the period. In addition, during the fourth
quarter of 2022, a change in the discount rate impacted the fair
value of the Limited Recourse Royalty-Linked Subordinated Notes
(the “Royalty-Linked Notes”). The non-cash adjustment in the fourth
quarter of 2021 primarily related to a decrease in the value of the
derivative components associated with the Exchangeable Notes as a
result of a decrease in the price of its ordinary shares and market
capitalization during the period. The non-cash adjustment for the
full year 2021 was largely due to the fair value adjustments
recorded at the time of conversion of $39.2 million of the
Exchangeable Notes in 2021.
Cancellation of share options for the full year 2022 was $17.4
million and related to the non-cash charge in connection with
employee share options that were surrendered and cancelled in July
2022.
Net loss for the fourth quarter and full year 2022 was $5.1
million and $44.4 million, respectively, compared to a net loss of
$4.2 million and $91.6 million for the same periods in 2021.
Non-GAAP1 net loss for the fourth quarter and full year 2022 of
$6.4 million and $22.9 million, respectively, compared to a
non-GAAP1 net loss of $3.3 million and $19.4 million for the same
periods in 2021.
Conference Call Details
- Iterum will host a conference call today, Thursday, March 16,
2023 at 8:30 a.m. Eastern Time. The dial-in information for the
call is as follows: United States: 1 844 200 6205; International: 1
929 526 1599; Access code: 846586
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 is
currently advancing its first compound, sulopenem, a novel penem
anti-infective compound, in Phase 3 clinical development with an
oral formulation. Sulopenem also has an 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 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.
Non-GAAP Financial Measures
To supplement Iterum’s financial results presented in accordance
with U.S. generally accepted accounting principles (“GAAP”), Iterum
presents non-GAAP net loss and non-GAAP net loss per share to
exclude from reported GAAP net loss and GAAP net loss per share,
intangible asset amortization ($0.4 million and $1.7 million);
share-based compensation expense ($0.5 million and $4.8 million);
the non-cash cancellation expense of share options ($0.0 million
and $17.4 million); the interest expense associated with accrued
interest on the Exchangeable Notes, payable in cash, shares or a
combination of both upon exchange, redemption or at January 31,
2025 (“the Maturity Date”), whichever is earlier ($0.2 million and
$0.8 million); the non-cash amortization of the Exchangeable Notes
($0.6 million and $2.4 million); and the non-cash adjustments to
the fair value of derivatives and Royalty-Linked Notes ($3.0
million and $5.5 million) for the three and twelve months ended
December 31, 2022, respectively, and intangible asset amortization
($1.7 million and $1.7 million); share-based compensation expense
($2.0 million and $4.3 million); the interest expense associated
with accrued interest on the Exchangeable Notes payable in cash,
shares or a combination of both upon exchange, redemption or at the
Maturity Date, whichever is earlier ($0.2 million and $1.1
million); the non-cash amortization of the Exchangeable Notes and
Royalty-Linked Notes ($0.6 million and $4.1 million); and the
non-cash adjustments to the fair value of derivatives and
Royalty-Linked Notes ($3.6 million and $61.0 million) for the three
and twelve months ended December 31, 2021, respectively.
Iterum believes that the presentation of non-GAAP net loss and
non-GAAP net loss per share, when viewed with its results under
GAAP and the accompanying reconciliation, provides useful
supplementary information to, and facilitates additional analysis
by, investors, analysts, and Iterum’s management in assessing
Iterum’s performance and results from period to period. These
non-GAAP financial measures closely align with the way management
measures and evaluates Iterum’s performance. These non-GAAP
financial measures should be considered in addition to, and not a
substitute for, or superior to, net (loss) / income or other
financial measures calculated in accordance with GAAP. Non-GAAP net
loss and non-GAAP net loss per share are not based on any
standardized methodology prescribed by GAAP and represents GAAP net
(loss) / income, which is the most directly comparable GAAP
measure, adjusted to exclude intangible asset amortization;
share-based compensation expense; the non-cash expense for the
cancellation of share options; the interest expense associated with
accrued interest on the Exchangeable Notes payable in cash, shares
or a combination of both upon exchange, redemption or at the
Maturity Date, whichever is earlier; the non-cash amortization of
the Exchangeable Notes and Royalty- Linked Notes; and the non-cash
adjustments to the fair value of derivatives and Royalty-Linked
Notes for the three and twelve months ended December 31, 2022 and
December 31, 2021. Because of the non-standardized definitions of
non-GAAP financial measures, non-GAAP net loss and non-GAAP net
loss per share used by Iterum Therapeutics in this press release
and accompanying tables has limits in its usefulness to investors
and may be calculated differently from, and therefore may not be
directly comparable to, similarly titled measures used by other
companies. A reconciliation of non-GAAP net loss to GAAP net (loss)
/ income and non-GAAP net loss per share to GAAP net (loss) /
income per share have been provided in the tables included in this
press release.
1 Definition and reconciliations of applicable GAAP reported to
non-GAAP adjusted information are included at the end of this press
release
Special Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. These forward-looking statements include, without limitation,
statements regarding Iterum’s plans, strategies and prospects for
its business, including the development, therapeutic and market
potential of sulopenem, the timing, conduct, progress and results
of Iterum’s ongoing REASSURE clinical trial, the expected timing of
resubmission of the NDA, the term and coverage provided by Iterum’s
patent and other intellectual property rights, and the sufficiency
of Iterum’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 Iterum’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 Iterum’s
control, including uncertainties inherent in the design, initiation
and conduct of clinical and non-clinical development, including the
REASSURE clinical trial, availability and timing of data from the
REASSURE clinical trial, changes in regulatory requirements or
decisions of regulatory authorities, the timing or likelihood of
regulatory filings and approvals, including the potential
resubmission of the NDA for oral sulopenem, 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 Iterum’s expectations regarding how far into the future Iterum’s
cash on hand will fund Iterum’s ongoing operations, , Iterum’s
ability to maintain its listing on the Nasdaq Capital Market, risks
and uncertainties concerning the outcome, impact, effects and
results of Iterum’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 Iterum’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 SEC on March 16, 2023,
and other documents filed with the SEC from time to time.
Forward-looking statements represent Iterum’s beliefs and
assumptions only as of the date of this press release. Except as
required by law, Iterum 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
Officer 312-778-6073IR@iterumtx.com
|
ITERUM THERAPEUTICS PLC |
|
Condensed Consolidated Statement of
Operations |
|
(In thousands except share and per share
data) |
|
(Unaudited) |
|
|
|
For the three months ended |
|
|
|
Year ended |
|
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
| Operating expenses: |
|
|
|
|
|
|
| Research and development |
|
(5,840 |
) |
|
|
(3,702 |
) |
|
|
(17,617 |
) |
|
|
(10,712 |
) |
| General and
administrative |
|
(2,086 |
) |
|
|
(3,127 |
) |
|
|
(12,766 |
) |
|
|
(13,825 |
) |
| Total operating expenses |
|
(7,926 |
) |
|
|
(6,829 |
) |
|
|
(30,383 |
) |
|
|
(24,537 |
) |
| Operating loss |
|
(7,926 |
) |
|
|
(6,829 |
) |
|
|
(30,383 |
) |
|
|
(24,537 |
) |
| Interest income / (expense),
net |
|
80 |
|
|
|
(772 |
) |
|
|
(2,361 |
) |
|
|
(5,553 |
) |
| Adjustments to fair value of
derivatives |
|
2,960 |
|
|
|
3,562 |
|
|
|
5,458 |
|
|
|
(60,964 |
) |
| Cancellation of share
options |
|
- |
|
|
|
- |
|
|
|
(17,350 |
) |
|
|
- |
|
| Other (expense) income,
net |
|
(103 |
) |
|
|
28 |
|
|
|
503 |
|
|
|
195 |
|
| Income tax expense |
|
(101 |
) |
|
|
(171 |
) |
|
|
(301 |
) |
|
|
(705 |
) |
| Net loss attributable to
ordinary shareholders |
$ |
(5,090 |
) |
|
$ |
(4,182 |
) |
|
$ |
(44,434 |
) |
|
$ |
(91,564 |
) |
| Net loss per share
attributable to ordinary shareholders –basic and diluted |
$ |
(041 |
) |
|
$ |
(0.34 |
) |
|
$ |
(3.63 |
) |
|
$ |
(8.41 |
) |
| Weighted average ordinary
shares outstanding – basic and diluted |
|
12,294,865 |
|
|
|
12,185,019 |
|
|
|
12,236,607 |
|
|
|
10,891,178 |
|
| Reconciliation of non-GAAP net
loss to GAAP net loss |
|
|
|
|
|
|
| Net loss - GAAP |
$ |
(5,090 |
) |
|
$ |
(4,182 |
) |
|
$ |
(44,434 |
) |
|
$ |
(91,564 |
) |
| Intangible asset
amortization |
|
429 |
|
|
|
1,713 |
|
|
|
1,716 |
|
|
|
1,713 |
|
| Share based compensation |
|
457 |
|
|
|
1,967 |
|
|
|
4,758 |
|
|
|
4,319 |
|
| Cancellation of share
options |
|
- |
|
|
|
- |
|
|
|
17,350 |
|
|
|
- |
|
| Interest expense - accrued
interest and amortization on Exchangeable Notes and Royalty-Linked
Notes |
|
786 |
|
|
|
796 |
|
|
|
3,154 |
|
|
|
5,175 |
|
| Adjustments to fair value of
derivatives |
|
(2,960 |
) |
|
|
(3,562 |
) |
|
|
(5,458 |
) |
|
|
60,964 |
|
| Non-GAAP net loss |
$ |
(6,378 |
) |
|
$ |
(3268 |
) |
|
$ |
(22,914 |
) |
|
$ |
(19,393 |
) |
| Net loss per share
attributable to ordinary shareholders –basic and diluted |
$ |
(0.41 |
) |
|
$ |
(0.34 |
) |
|
$ |
(3.63 |
) |
|
$ |
(8.41 |
) |
| Non-GAAP net loss per share
attributable to ordinaryshareholders – basic and diluted |
$ |
(0.52 |
) |
|
$ |
(0.27 |
) |
|
$ |
(1.87 |
) |
|
$ |
(1.78) |
|
|
ITERUM THERAPEUTICS PLC |
|
Condensed Consolidated Balance Sheet Data (In
thousands) |
|
(Unaudited) |
|
|
As of |
As of |
| |
December 31, |
December 31, |
|
|
2022 |
|
2021 |
|
Cash, cash equivalents and short-term investments |
$ |
60,838 |
$ |
81,344 |
| Other
assets |
|
5,995 |
|
10,165 |
|
Total assets |
$ |
66,833 |
$ |
91,509 |
|
Long-term debt, less current portion |
$ |
10,094 |
$ |
6,930 |
|
Royalty-linked notes |
|
18,372 |
|
17,968 |
|
Derivative liabilities |
|
196 |
|
6,058 |
| Other
liabilities |
|
10,172 |
|
10,319 |
| Total
liabilities |
|
38,834 |
|
41,275 |
| Total
shareholders' equity |
|
27,999 |
|
50,234 |
|
Total liabilities and shareholders' equity |
$ |
66,833 |
$ |
91,509 |
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