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 first quarter ended March 31,
2023.
“We remain on track to complete enrollment in our REASSURE trial
in the first half of next year with over 100 sites currently open
to enrollment and a plan to add another 40-70 clinical trial
sites,” said Corey Fishman, Iterum’s Chief Executive Officer.
“Top-line data is expected soon after enrollment is completed, 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 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 special protocol assessment
(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 for the treatment of uUTI.
- Presented DOOR analysis at
ECCMID: Iterum presented scientific posters at ECCMID 2023
highlighting the application of the desirability of outcome ranking
(DOOR) to two registration trials. The DOOR methodology, utilized
recently by the Antibacterial Resistance Leadership Group to
develop a method to evaluate data from completed pivotal
complicated urinary tract infection (cUTI) trials, when applied
retrospectively to Iterum’s two Phase 3 studies of sulopenem, one
each in cUTI and uUTI, respectively, demonstrated that oral
sulopenem was comparably more effective than ciprofloxacin in
patients with uUTI and provided comparable efficacy to ertapenem in
patients with cUTI. This novel method of analyzing data from
clinical trials taking into account both benefits and harms of
drugs being evaluated and providing an assessment of the patient
experience has not yet been accepted by regulatory authorities as a
primary endpoint for UTI studies.
First Quarter 2023 Financial
Results
Cash, cash equivalents and short-term
investments were $51.8 million as of March 31, 2023. 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 April 30, 2023, we had
approximately 12.9 million ordinary shares outstanding.
Research and development (R&D) expenses for the first
quarter 2023 were $6.4 million, compared to $3.4 million for the
same period in 2022. 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
a reduction in share-based compensation expense.
General and administrative (G&A) expenses for the first
quarter 2023 were $2.1 million, compared to $3.9 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 first quarter 2023 was $9.9 million, compared
to a net loss of $3.5 million for the same period in 2022.
Non-GAAP1 net loss for the first quarter 2023 of $7.4 million,
compared to a non-GAAP1 net loss of $5.6 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); share-based
compensation expense ($0.4 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); the non-cash amortization of the Exchangeable Notes
($0.6 million); and the non-cash adjustments to the fair value of
derivatives and Royalty-Linked Notes ($0.9 million) for the three
months ended March 31, 2023, and intangible asset amortization
($0.4 million); share-based compensation expense ($1.9 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); the non-cash amortization of the
Exchangeable Notes ($0.6 million); and the non-cash adjustments to
the fair value of derivatives and Royalty-Linked Notes ($5.2
million) for the three months ended March 31, 2022.
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 months ended March 31, 2023 and
March 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, the timing, conduct, progress and results
of Iterum’s ongoing REASSURE clinical trial, including the ability
to open additional clinical sites and complete enrollment within
the projected timeframe, the expected timing of resubmission of the
NDA, 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
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 March 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
Research and
development |
|
|
(6,432 |
) |
|
|
(3,440 |
) |
General and
administrative |
|
|
(2,098 |
) |
|
|
(3,933 |
) |
Total
operating expenses |
|
|
(8,530 |
) |
|
|
(7,373 |
) |
Operating
loss |
|
|
(8,530 |
) |
|
|
(7,373 |
) |
Interest
expense, net |
|
|
(399 |
) |
|
|
(1,039 |
) |
Adjustments
to fair value of derivatives |
|
|
(878 |
) |
|
|
5,177 |
|
Other
income, net |
|
|
41 |
|
|
|
162 |
|
Income tax
expense |
|
|
(123 |
) |
|
|
(427 |
) |
Net
loss |
|
$ |
(9,889 |
) |
|
$ |
(3,500 |
) |
Net loss per
share – basic and diluted |
|
$ |
(0.78 |
) |
|
$ |
(0.29 |
) |
Weighted
average ordinary shares outstanding – basic and diluted |
|
|
12,681,900 |
|
|
|
12,193,435 |
|
|
|
|
|
|
Reconciliation of non-GAAP net loss to GAAP net loss |
|
|
|
|
Net loss -
GAAP |
|
$ |
(9,889 |
) |
|
$ |
(3,500 |
) |
Intangible
asset amortization |
|
|
429 |
|
|
|
429 |
|
Share based
compensation |
|
|
393 |
|
|
|
1,895 |
|
Interest
expense - accrued interest and amortization on Exchangeable
Notes |
|
|
783 |
|
|
|
783 |
|
Adjustments
to fair value of derivatives |
|
|
878 |
|
|
|
(5,177 |
) |
Non-GAAP net
loss |
|
$ |
(7,406 |
) |
|
$ |
(5,570 |
) |
Net loss per
share - basic and diluted |
|
$ |
(0.78 |
) |
|
$ |
(0.29 |
) |
Non-GAAP net
loss per share - basic and diluted |
|
$ |
(0.58 |
) |
|
$ |
(0.46 |
) |
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
Condensed
Consolidated Balance Sheet Data |
(In
thousands) |
(Unaudited) |
|
|
|
|
|
|
|
As
of |
|
As
of |
|
|
March 31, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Cash, cash
equivalents and short-term investments |
|
$ |
51,823 |
|
|
$ |
60,804 |
|
Other
assets |
|
|
6,297 |
|
|
|
6,029 |
|
Total assets |
|
$ |
58,120 |
|
|
$ |
66,833 |
|
Long-term
debt, less current portion |
|
$ |
10,877 |
|
|
$ |
10,094 |
|
Royalty-linked notes |
|
|
19,258 |
|
|
|
18,372 |
|
Derivative
liabilities |
|
|
187 |
|
|
|
196 |
|
Other
liabilities |
|
|
8,841 |
|
|
|
10,172 |
|
Total
liabilities |
|
|
39,163 |
|
|
|
38,834 |
|
Total
shareholders' equity |
|
|
18,957 |
|
|
|
27,999 |
|
Total liabilities and shareholders' equity |
|
$ |
58,120 |
|
|
$ |
66,833 |
|
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