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, 2023.
“Since we announced positive topline data from our REASSURE
trial in January, we’ve made significant progress in completing the
new drug application (NDA) for the planned resubmission early in
the second quarter,” said Corey Fishman, Iterum’s Chief Executive
Officer. “We believe the strong results from this trial, which was
conducted under a Special Protocol Assessment (SPA) agreement with
the U.S. Food and Drug Administration (FDA), address the FDA’s
recommendations for additional data to support approval of oral
sulopenem for the treatment of adult women with uncomplicated
urinary tract infections (uUTIs). The potential approval of
sulopenem would mark the first oral penem approved in the U.S., and
the first antibiotic approved for the treatment of uUTIs in over 25
years.”
Highlights and Recent Events
- Preparation of NDA Underway: 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 uUTIs in adult women in October 2022 and completed
enrollment in October 2023 enrolling 2,222 patients. Iterum
reported positive top-line data in January 2024 and plans to
resubmit its NDA early in the second quarter of 2024. Provided that
the resubmitted NDA addresses all of the deficiencies identified in
the Complete Response Letter (CRL), Iterum expects that the FDA
will complete its review and take action six months from the date
the FDA receives the resubmitted NDA (or early in the fourth
quarter of 2024).
- Extended Cash Runway: Subsequent to December
31, 2023, through February 29, 2024, Iterum sold 2.9 million
ordinary shares under an at-the-market offering (ATM) agreement, at
an average price of $2.52 per share for net proceeds of $7.1
million, which has extended cash runway into 2025 based on its
current operating plan. As of February 29, 2024, Iterum had
approximately 16.4 million ordinary shares outstanding.
- Engaged Financial Advisor: As previously
disclosed, after receiving positive data from the REASSURE trial,
Iterum’s board of directors determined that Iterum should focus on
a strategic process to sell, license, or otherwise dispose of its
rights to sulopenem with the goal of maximizing shareholder value.
In connection with this strategic process, Iterum has engaged a
financial advisor to assist management and the board in evaluating
strategic alternatives. There can be no assurance that its
exploration will result in Iterum pursuing a transaction or that
any transaction, if pursued, will be completed on attractive terms,
if at all. Iterum’s board of directors has not set a timetable for
completion of this evaluation process and does not intend to
disclose further developments unless and until it is determined
that further disclosure is appropriate or necessary.
Fourth Quarter and Full Year 2023
Financial Results
Cash, cash equivalents and short-term
investments were $23.9 million at December 31, 2023. Based on the
current operating plan, Iterum expects that its current cash, cash
equivalents and short-term investments, including amounts raised
under an ATM offering subsequent to year-end through February 29,
2024, will be sufficient to fund its operations into 2025,
including through the expected Prescription Drug User Fee Act date
early in the fourth quarter of 2024.
Research and development (R&D) expenses for the fourth
quarter and full year 2023 were $9.7 million and $40.0 million,
respectively, compared to $5.8 million and $17.6 million for the
same periods in 2022. The increase for the three-month period was
primarily due to an increase in costs to support Iterum’s REASSURE
trial, partially offset by a decrease in CMC related expenses due
to the write-off of a valuation allowance held against a research
and development tax credit. The increase in R&D expenses for
the full year was primarily due to the REASSURE trial, partially
offset by a decrease in share-based compensation expense and the
previously mentioned write-off of a valuation allowance.
General and administrative (G&A) expenses for the fourth
quarter and full year 2023 were $1.7 million and $7.5 million,
respectively, compared to $2.1 million and $12.8 million for the
same periods in 2022. The decrease for the three-month period was
primarily due to a decrease in legal fees and insurance costs. The
decrease for the full year was primarily due to lower share-based
compensation expense for employees and directors, lower insurance
costs, lower rent expense and a decrease in legal fees associated
with the lawsuit filed in August 2021 which was dismissed with
prejudice in January 2023.
Adjustments to the fair value of derivatives for the fourth
quarter and full year 2023 were ($0.3 million) and $11.1 million,
compared to $3.0 million and $5.5 million for the same periods in
2022. The non-cash adjustment for the full year 2023 primarily
related to a decrease in the fair value of the Limited Recourse
Royalty-Linked Subordinated Notes (the “Royalty-Linked Notes”) due
to a reduction in management’s revenue forecast of U.S. sulopenem
sales. 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 Royalty-Linked Notes.
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 2023 was $12.4
million and $38.4 million, respectively, compared to a net loss of
$5.1 million and $44.4 million for the same periods in 2022.
Non-GAAP1 net loss for the fourth quarter and full year 2023 of
$10.7 million and $43.8 million, respectively, compared to a
non-GAAP1 net loss of $6.4 million and $22.9 million for the same
periods in 2022.
Conference Call Details
- Iterum will host a conference call today, Thursday, March 28,
2024 at 8:30 a.m. Eastern Time. The dial-in information for the
call is as follows: United States: 1 833 470 1428; International: 1
404 975 4839; Access code: 891047
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 ($0.1 million and $0.8 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 (($0.3 million) and
$11.1 million) for the three and twelve months ended December 31,
2023, respectively, and 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 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.
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 the non-cash adjustments to the fair
value of derivatives and Royalty-Linked Notes for the three and
twelve months ended December 31, 2023 and December 31, 2022.
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 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 and non-GAAP net loss per share to GAAP net
loss per share have been provided in the tables included in 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, Iterum’s ability to address the
deficiencies set out in the CRL received in July 2021, the expected
timing of resubmission of the NDA, the expected timing of review of
such NDA by the FDA, and the sufficiency of Iterum’s cash resources
to fund its operating expenses into 2025, and Iterum’s strategic
process to sell, license, or otherwise dispose of its rights to
sulopenem. 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, changes in regulatory
requirements or decisions of regulatory authorities, the timing or
likelihood of regulatory filings and approvals, including the
planned 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 pursuit of
strategic alternatives, including the terms, timing, structure,
value, benefits and costs of any strategic process and Iterum’s
ability to complete one whether on attractive terms 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 28, 2024,
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) |
|
|
|
|
|
|
|
|
|
Three months ended December 31, |
|
Year ended December 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
(9,744 |
) |
|
|
(5,840 |
) |
|
|
(39,992 |
) |
|
|
(17,617 |
) |
General and administrative |
|
(1,687 |
) |
|
|
(2,086 |
) |
|
|
(7,476 |
) |
|
|
(12,766 |
) |
Total operating expenses |
|
(11,431 |
) |
|
|
(7,926 |
) |
|
|
(47,468 |
) |
|
|
(30,383 |
) |
Operating loss |
|
(11,431 |
) |
|
|
(7,926 |
) |
|
|
(47,468 |
) |
|
|
(30,383 |
) |
Interest expense, net |
|
(405 |
) |
|
|
80 |
|
|
|
(1,428 |
) |
|
|
(2,361 |
) |
Adjustments to fair value of derivatives |
|
(305 |
) |
|
|
2,960 |
|
|
|
11,056 |
|
|
|
5,458 |
|
Cancellation of share options |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(17,350 |
) |
Other (expense) / income, net |
|
(79 |
) |
|
|
(103 |
) |
|
|
82 |
|
|
|
503 |
|
Income tax expense |
|
(142 |
) |
|
|
(101 |
) |
|
|
(613 |
) |
|
|
(301 |
) |
Net loss attributable to ordinary shareholders |
$ |
(12,362 |
) |
|
$ |
(5,090 |
) |
|
$ |
(38,371 |
) |
|
$ |
(44,434 |
) |
Net loss per share attributable to ordinary shareholders – basic
and diluted |
$ |
(0.94 |
) |
|
$ |
(0.41 |
) |
|
$ |
(2.96 |
) |
|
$ |
(3.63 |
) |
Weighted average ordinary shares outstanding – basic and
diluted |
|
13,180,447 |
|
|
|
12,294,865 |
|
|
|
12,962,362 |
|
|
|
12,236,607 |
|
|
|
|
|
|
|
|
|
Reconciliation of non-GAAP net loss to GAAP net loss |
|
|
|
|
|
|
|
Net loss - GAAP |
$ |
(12,362 |
) |
|
$ |
(5,090 |
) |
|
$ |
(38,371 |
) |
|
$ |
(44,434 |
) |
Intangible asset amortization |
|
432 |
|
|
|
429 |
|
|
|
1,719 |
|
|
|
1,716 |
|
Share based compensation |
|
139 |
|
|
|
457 |
|
|
|
784 |
|
|
|
4,758 |
|
Cancellation of share options |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
17,350 |
|
Interest expense - accrued interest and amortization on
Exchangeable Notes |
|
782 |
|
|
|
786 |
|
|
|
3,150 |
|
|
|
3,154 |
|
Adjustments to fair value of derivatives |
|
305 |
|
|
|
(2,960 |
) |
|
|
(11,056 |
) |
|
|
(5,458 |
) |
Non-GAAP net loss |
$ |
(10,704 |
) |
|
$ |
(6,378 |
) |
|
$ |
(43,774 |
) |
|
$ |
(22,914 |
) |
Net loss per share attributable to ordinary shareholders – basic
and diluted |
$ |
(0.94 |
) |
|
$ |
(0.41 |
) |
|
$ |
(2.96 |
) |
|
$ |
(3.63 |
) |
Non-GAAP net loss per share attributable to ordinary shareholders –
basic and diluted |
$ |
(0.81 |
) |
|
$ |
(0.52 |
) |
|
$ |
(3.38 |
) |
|
$ |
(1.87 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM THERAPEUTICS PLC |
|
|
|
|
Condensed Consolidated Balance Sheet Data |
|
|
|
|
(In thousands) |
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
|
2023 |
|
2022 |
|
|
|
|
Cash, cash equivalents, short-term investments and restricted
cash |
$ |
23,964 |
|
|
$ |
60,838 |
|
|
|
|
|
Other assets |
|
2,295 |
|
|
|
5,995 |
|
|
|
|
|
Total assets |
$ |
26,259 |
|
|
$ |
66,833 |
|
|
|
|
|
Long-term debt, less current portion |
$ |
11,453 |
|
|
$ |
10,094 |
|
|
|
|
|
Royalty-linked notes |
|
7,503 |
|
|
|
18,372 |
|
|
|
|
|
Derivative liabilities |
|
— |
|
|
|
196 |
|
|
|
|
|
Other liabilities |
|
13,706 |
|
|
|
10,172 |
|
|
|
|
|
Total liabilities |
|
32,662 |
|
|
|
38,834 |
|
|
|
|
|
Total shareholders' (deficit) / equity |
|
(6,403 |
) |
|
|
27,999 |
|
|
|
|
|
Total liabilities and shareholders' (deficit) /
equity |
$ |
26,259 |
|
|
$ |
66,833 |
|
|
|
|
|
|
|
|
|
|
|
|
|
_________________________________1 Definition and
reconciliations of applicable GAAP reported to non-GAAP adjusted
information are included at the end of this press release
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