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,
2022.
“As reported earlier this week, we have reached
general alignment with the U.S. Food and Drug Administration
(“FDA”) on key aspects of the proposed design of an additional
clinical trial comparing oral sulopenem to Augmentin®
(amoxicillin/clavulanate) for the treatment of uncomplicated
urinary tract infection (“uUTI”) in adult women to support a
potential resubmission of our new drug application (“NDA”) for oral
sulopenem,” said Corey Fishman, Iterum’s Chief Executive Officer.
“We plan to request an agreement with the FDA regarding the
proposed protocol under the special protocol assessment (“SPA”)
process. Subject to finalizing the SPA agreement with the FDA, we
expect to initiate enrollment in the second half of 2022.”
Highlights and Recent Events
- Met with FDA: We reached general alignment
with the FDA at a meeting in early May 2022 on key aspects of the
design of an additional clinical trial required to support the
potential resubmission of the NDA for oral sulopenem for uUTI.
- Reduced outstanding debt: We completed the
repayment of our term loan with Silicon Valley Bank in March
2022.
First Quarter 2022 Financial
Results
Cash, cash equivalents and short-term investments
was $75.3 million at March 31, 2022. Based on the current operating
plan, which includes the planned conduct of the additional Phase 3
clinical trial, Iterum expects that its current cash, cash
equivalents and short-term investments will be sufficient to fund
its operations into 2024. As of April 30, 2022, Iterum had
approximately 183.4 million ordinary shares outstanding.
Research and development (R&D) expenses for
the first quarter of 2022 were $3.4 million compared to $2.5
million for the same period in 2021. The increase was primarily due
to the non-cash amortization of an intangible asset in 2022, trial
start-up costs associated with the registrational trial expected to
begin in the second half of 2022, higher personnel costs due to an
increase in headcount to support additional clinical trial efforts
and higher share-based compensation, partially offset by lower
consulting spend.
General and administrative (G&A) expenses for
the first quarter of 2022 were $3.9 million compared to $3.4
million for the same period in 2021. The increase was primarily due
to an increase in share-based compensation expense, partially
offset by lower consulting spend.
Adjustments to the fair value of derivatives for
the first quarter of 2022 were $5.2 million compared to ($90.1)
million for the same period in 2021. The non-cash adjustment in the
first quarter of 2022 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, as well as a reduction in the
liability associated with the Limited Recourse Royalty-Linked
Subordinated Notes (the “Royalty-Linked Notes”) due to a change to
the expected timing of payments. The non-cash adjustment in the
first quarter of 2021 related to an increase in the value of the
derivative components associated with the Exchangeable Notes and
the Royalty-Linked Notes primarily as a result of an increase in
the price of Iterum’s ordinary shares and an increase in Iterum’s
market capitalization during the period.
Net loss for the first quarter of 2022 was $3.5
million compared to a net loss of $98.9 million for the same period
in 2021. Non-GAAP1 net loss of $5.6 million in the first quarter of
2022 was relatively flat compared to the non-GAAP1 net loss of $5.8
million for the same period in 2021.
Upcoming Presentations
- Corporate presentation at the 2022 H.C. Wainwright Global
Investment Conference to be held on Wednesday, May 25, 2022 at
11:30am ET
- Presentation at the FDA’s Public Workshop for uUTI to be held
on June 3, 2022. The purpose of this virtual public workshop,
entitled “Development Considerations of Antimicrobial Drugs for the
Treatment of Uncomplicated Urinary Tract Infections (uUTI),” is to
discuss nonclinical and clinical considerations regarding
developing antimicrobial drugs for the treatment of uUTI.
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 ($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 January 31, 2025 (“the Maturity Date”), whichever
is earlier ($0.2 million); the non-cash amortization of the
Exchangeable Notes and Royalty-Linked Notes ($0.6 million); and the
non-cash adjustments to the fair value of derivatives ($5.2
million) for the three months ended March 31, 2022, and share-based
compensation expense ($0.3 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 ($0.4 million); the
non-cash amortization of the Exchangeable Notes and Royalty-Linked
Notes ($2.3 million); and the non-cash adjustments to the fair
value of derivatives ($90.1 million) for the three months ended
March 31, 2021.
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
Royalty-Linked Notes; and the non-cash adjustments to the fair
value of derivatives for the three months ended March 31, 2022 and
March 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
and non-GAAP net loss per share to GAAP net loss per share have
been provided in the tables included in this press release.
Forward Looking Statements
This press release contains forward-looking
statements. These forward-looking statements include, without
limitation, statements regarding Iterum’s plans, strategies and
prospects for its business, including with respect to planned
interactions with the FDA and Iterum’s ability to finalize a SPA
agreement with the FDA, Iterum’s expectations with regard to its
ability to resolve the matters set forth in the complete response
letter (CRL) received by Iterum in July 2021 and obtain approval
for oral sulopenem, the design, timing and conduct of future
clinical and non-clinical development of sulopenem to support a
potential resubmission of the NDA for oral sulopenem, 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 any additional clinical trials and non-clinical
development that may be conducted in response to the CRL,
availability and timing of data from such potential clinical and
non-clinical development, changes in regulatory requirements or
decisions of regulatory authorities, the timing or likelihood of
regulatory filings and approvals, including any 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, the impact of
COVID-19 and related responsive measures thereto, Iterum’s ability
to maintain its listing on the Nasdaq Stock 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 Securities and
Exchange Commission (the “SEC”) on May 13, 2022, 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 Matthews
Chief Financial Officer 312-778-6073 IR@iterumtx.com
ITERUM
THERAPEUTICS PLC |
Condensed
Consolidated Statement of Operations |
(In
thousands except share and per share data) |
(Unaudited) |
|
|
|
|
|
Three months
ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
Operating
expenses: |
|
|
|
Research and
development |
|
(3,440 |
) |
|
|
(2,451 |
) |
General and
administrative |
|
(3,933 |
) |
|
|
(3,396 |
) |
Total
operating expenses |
|
(7,373 |
) |
|
|
(5,847 |
) |
Operating
loss |
|
(7,373 |
) |
|
|
(5,847 |
) |
Interest
expense, net |
|
(1,039 |
) |
|
|
(2,952 |
) |
Adjustments
to fair value of derivatives |
|
5,177 |
|
|
|
(90,103 |
) |
Other
income, net |
|
162 |
|
|
|
41 |
|
Income tax
expense |
|
(427 |
) |
|
|
(60 |
) |
Net loss
attributable to ordinary shareholders |
$ |
(3,500 |
) |
|
$ |
(98,921 |
) |
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
$ |
(0.02 |
) |
|
$ |
(0.81 |
) |
Weighted
average ordinary shares outstanding – basic and diluted |
|
182,901,530 |
|
|
|
121,549,083 |
|
|
|
|
|
Reconciliation of non-GAAP net income / (loss) to GAAP net
loss |
|
|
|
Net loss -
GAAP |
$ |
(3,500 |
) |
|
$ |
(98,921 |
) |
Intangible
asset amortization |
|
429 |
|
|
|
— |
|
Share based
compensation |
|
1,895 |
|
|
|
281 |
|
Interest
expense - accrued interest and amortization on Exchangeable Notes
and Royalty-Linked Notes |
|
783 |
|
|
|
2,748 |
|
Adjustments
to fair value of derivatives |
|
(5,177 |
) |
|
|
90,103 |
|
Non-GAAP net
loss |
$ |
(5,570 |
) |
|
$ |
(5,789 |
) |
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
$ |
(0.02 |
) |
|
$ |
(0.81 |
) |
Non-GAAP net
loss per share attributable to ordinary shareholders – basic and
diluted |
$ |
(0.03 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
Condensed
Consolidated Balance Sheet Data |
(In
thousands) |
(Unaudited) |
|
|
|
|
|
As
of |
|
As
of |
|
March 31, |
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
Cash, cash
equivalents, restricted cash and short-term investments |
$ |
75,334 |
|
|
$ |
81,408 |
|
Other
assets |
|
8,729 |
|
|
|
10,101 |
|
Total assets |
$ |
84,063 |
|
|
$ |
91,509 |
|
Long-term
debt, less current portion |
$ |
7,713 |
|
|
$ |
6,930 |
|
Royalty-linked notes |
|
14,397 |
|
|
|
17,968 |
|
Derivative
liabilities |
|
4,451 |
|
|
|
6,058 |
|
Other
liabilities |
|
8,867 |
|
|
|
10,319 |
|
Total
liabilities |
|
35,428 |
|
|
|
41,275 |
|
Total
shareholders' equity |
|
48,635 |
|
|
|
50,234 |
|
Total liabilities and shareholders' equity |
$ |
84,063 |
|
|
$ |
91,509 |
|
|
|
|
|
1 Reconciliations of applicable GAAP reported to non-GAAP
adjusted information are included at the end of this press
release
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