Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), 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,
2023.
“We recently achieved 50% patient enrollment and expect to
complete the planned enrollment of 1,966 patients in our REASSURE
trial in the first quarter of next year. We have over 140 clinical
trial sites currently open to enrollment in the U.S.,” said Corey
Fishman, Iterum’s Chief Executive Officer. “Top-line data is
expected in the second quarter of 2024, with a potential
resubmission of our new drug application (NDA) to the U.S. Food and
Drug Administration (FDA) in the second 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 quarter of 2024. Iterum will conduct an
interim analysis for sample size re-estimation as specified in its
special protocol assessment (SPA) agreement with the FDA following
achievement of 50% patient enrollment. 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 for the treatment of uUTI.
- New Japanese Patent Issued: The Japanese
Patent Office has issued a Certificate of Patent for Japanese
Patent Registration No. 7295964 entitled “Combinations of
Beta-Lactam Compounds and Probenecid and Uses Thereof” directed to
the composition of the bilayer tablet of sulopenem etzadroxil and
probenecid (oral sulopenem) and its preparation. This patent is
scheduled to expire no earlier than 2039. In addition to
in-licensed patents, Iterum also owns two U.S. patents for oral
sulopenem, one directed to the composition of the bilayer tablet
and its related uses, and the other directed to the method of use
of oral sulopenem in treating multiple diseases, including
uncomplicated urinary tract infections as well as a number of
pending patent applications in the U.S. and other jurisdictions
including Europe and China.
Second Quarter 2023 Financial
Results
Cash, cash equivalents and short-term
investments were $44.7 million as of June 30, 2023. Based on its
current operating plan, Iterum expects that its current cash, cash
equivalents and short-term investments will be sufficient to fund
its operations into the third quarter of 2024. As of July 31, 2023,
Iterum had approximately 13.0 million ordinary shares
outstanding.
Research and development (R&D) expenses for the second
quarter 2023 were $9.0 million, compared to $4.0 million for the
same period in 2022. The increase for the three-month period was
primarily due to an increase in costs incurred supporting Iterum’s
REASSURE trial, which began enrollment in October 2022, partially
offset by a reduction in share-based compensation expense.
General and administrative (G&A) expenses for the second
quarter 2023 were $1.9 million, compared to $4.1 million for the
same period in 2022. The decrease for the three-month period was
primarily due to a reduction in share-based compensation expense,
as well as a decrease in legal fees associated with the lawsuit
filed in August 2021 and dismissed with prejudice in January
2023.
Net loss for the second quarter 2023 was $12.2 million, compared
to a net loss of $6.7 million for the same period in 2022.
Non-GAAP1 net loss for the second quarter 2023 was $10.0 million,
compared to a non-GAAP1 net loss of $5.7 million for the same
period in 2022.
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 $0.9 million);
share-based compensation expense ($0.1 million and $0.5 million);
the interest expense associated with accrued interest on the 6.500%
Exchangeable Senior Subordinated Notes due 2025 (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 $0.4 million); the non-cash
amortization of the Exchangeable Notes ($0.6 million and $1.2
million); and the non-cash adjustments to the fair value of
derivatives and the Limited Recourse Royalty-Linked Subordinated
Notes (Royalty-Linked Notes) ($1.0 million and $1.8 million) for
the three and six months ended June 30, 2023, respectively, and
intangible asset amortization ($0.4 million and $0.9 million);
share-based compensation expense ($2.0 million and $3.9 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 $0.4 million); the non-cash amortization
of the Exchangeable Notes ($0.6 million and $1.2 million); and the
non-cash adjustments to the fair value of derivatives and
Royalty-Linked Notes ($2.2 million and $7.3 million) for the three
and six months ended June 30, 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 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, which
is the most directly comparable GAAP measure, adjusted to exclude
intangible asset amortization; share-based compensation expense;
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 six months ended June 30,
2023 and June 30, 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, the timing, conduct, progress and results
of Iterum’s ongoing REASSURE clinical trial, including the ability
to complete planned enrollment within the projected timeframe and
the timing of top-line results, the expected timing of resubmission
of the NDA, the term and coverage provided by Iterum’s patents, 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 Quarterly Report on Form
10-Q filed with the SEC on August 11, 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__________________________
1 Definition and reconciliations of applicable GAAP reported to
non-GAAP adjusted information are included at the end of this press
release
ITERUM THERAPEUTICS PLC |
Condensed Consolidated Statement of
Operations |
(In thousands except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
(8,964 |
) |
|
|
(3,984 |
) |
|
|
(15,396 |
) |
|
|
(7,424 |
) |
General and administrative |
|
|
(1,858 |
) |
|
|
(4,066 |
) |
|
|
(3,956 |
) |
|
|
(7,999 |
) |
Total operating expenses |
|
|
(10,822 |
) |
|
|
(8,050 |
) |
|
|
(19,352 |
) |
|
|
(15,423 |
) |
Operating loss |
|
|
(10,822 |
) |
|
|
(8,050 |
) |
|
|
(19,352 |
) |
|
|
(15,423 |
) |
Interest expense, net |
|
|
(324 |
) |
|
|
(766 |
) |
|
|
(723 |
) |
|
|
(1,805 |
) |
Adjustments to fair value of derivatives |
|
|
(960 |
) |
|
|
2,155 |
|
|
|
(1,838 |
) |
|
|
7,332 |
|
Other income, net |
|
|
50 |
|
|
|
269 |
|
|
|
91 |
|
|
|
431 |
|
Income tax expense |
|
|
(187 |
) |
|
|
(343 |
) |
|
|
(310 |
) |
|
|
(770 |
) |
Net loss |
|
$ |
(12,243 |
) |
|
$ |
(6,735 |
) |
|
$ |
(22,132 |
) |
|
$ |
(10,235 |
) |
Net loss per share – basic and diluted |
|
$ |
(0.95 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.73 |
) |
|
$ |
(0.84 |
) |
Weighted average ordinary shares outstanding – basic and
diluted |
|
|
12,942,969 |
|
|
|
12,224,324 |
|
|
|
12,812,398 |
|
|
|
12,208,961 |
|
|
|
|
|
|
|
|
|
|
Reconciliation of non-GAAP net loss to GAAP net loss |
|
|
|
|
|
|
|
|
Net loss - GAAP |
|
$ |
(12,243 |
) |
|
$ |
(6,735 |
) |
|
$ |
(22,132 |
) |
|
$ |
(10,235 |
) |
Intangible asset amortization |
|
|
429 |
|
|
|
429 |
|
|
|
858 |
|
|
|
858 |
|
Share based compensation |
|
|
110 |
|
|
|
1,984 |
|
|
|
503 |
|
|
|
3,879 |
|
Interest expense - accrued interest and amortization on
Exchangeable Notes |
|
|
789 |
|
|
|
789 |
|
|
|
1,572 |
|
|
|
1,572 |
|
Adjustments to fair value of derivatives |
|
|
960 |
|
|
|
(2,155 |
) |
|
|
1,838 |
|
|
|
(7,332 |
) |
Non-GAAP net loss |
|
$ |
(9,955 |
) |
|
$ |
(5,688 |
) |
|
$ |
(17,361 |
) |
|
$ |
(11,258 |
) |
Net loss per share - basic and diluted |
|
$ |
(0.95 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.73 |
) |
|
$ |
(0.84 |
) |
Non-GAAP net loss per share - basic and diluted |
|
$ |
(0.77 |
) |
|
$ |
(0.47 |
) |
|
$ |
(1.36 |
) |
|
$ |
(0.92 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM THERAPEUTICS PLC |
|
|
|
|
Condensed Consolidated Balance Sheet Data |
|
|
|
|
(In thousands) |
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
44,732 |
|
|
$ |
60,804 |
|
|
|
|
|
Other assets |
|
|
6,289 |
|
|
|
6,029 |
|
|
|
|
|
Total assets |
|
$ |
51,021 |
|
|
$ |
66,833 |
|
|
|
|
|
Long-term debt, less current portion |
|
$ |
11,666 |
|
|
$ |
10,094 |
|
|
|
|
|
Royalty-linked notes |
|
|
20,251 |
|
|
|
18,372 |
|
|
|
|
|
Derivative liabilities |
|
|
154 |
|
|
|
196 |
|
|
|
|
|
Other liabilities |
|
|
11,821 |
|
|
|
10,172 |
|
|
|
|
|
Total liabilities |
|
|
43,892 |
|
|
|
38,834 |
|
|
|
|
|
Total shareholders' equity |
|
|
7,129 |
|
|
|
27,999 |
|
|
|
|
|
Total liabilities and shareholders' equity |
|
$ |
51,021 |
|
|
$ |
66,833 |
|
|
|
|
|
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