Full Press Release Details
Iterum Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results
On Track to Complete its Three Phase 3 Clinical Trials in 2019
Received Qualified Infectious Disease Product Designation in Four Additional Indications
Fast Track Designation received from the FDA in seven potential indications
DUBLIN, Ireland and CHICAGO, March 25, 2019 Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company
developing anti-infectives against multi-drug resistant pathogens, today reported financial results for the fourth quarter and year ended December 31, 2018.
We made tremendous progress in 2018. We raised over $80 million in an IPO to fund three Phase 3 trials in three indications of our lead asset,
sulopenem, which were initiated in the third quarter, said Corey Fishman, Chief Executive Officer of Iterum Therapeutics plc. In 2019, we remain focused on completing all three trials, delivering
top-line results, and preparing our New Drug Applications for submission to the U.S. Food and Drug Administration (FDA).
2018 Highlights and Recent Events
Fourth Quarter and Full-Year 2018 Financial Results
As of December 31, 2018, Iterum had cash, cash equivalents and short-term investments of $84.6 million and approximately 14.4 million shares
outstanding. Iterum expects that its cash, cash equivalents and short-term investments, along with its available borrowings, will be sufficient to fund operations into the first quarter of 2020.
Research and development (R&D) expenses for the fourth quarter and full year 2018 were $21.5 million and $68.6 million, respectively, compared
to $8.2 million and $25.5 million for the same periods in 2017. The increases for both the three-month and twelve-month periods were primarily due to higher clinical trial expenses associated with the three Phase 3 clinical trials
initiated in the third quarter of 2018, as well as clinical milestone payments to Pfizer of $7.5 million and $15.0 million in the fourth quarter and full year, respectively.
General and administrative (G&A) expenses for the fourth quarter and full year 2018 were $2.7 million and $8.8 million, respectively, compared
to $1.3 million and $4.5 million for the same periods in 2017. The increase was primarily due to increased costs associated with operating as a public company, additional headcount to support business activities, and increased marketing
and market research expenses.
For the fourth quarter and full year 2018, Iterum reported a net loss of $24.3 million and $77.1 million,
respectively, compared to a net loss of $9.1 million and $29.4 million for the same periods in 2017.
Upcoming Scientific and Investor
Sulopenem, a novel penem anti-infective compound with oral and IV formulations, has demonstrated potent in vitro activity against a
wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. If approved, sulopenem will help address the significant clinical and economic need for new oral antibiotics that enable the effective treatment of
resistant pathogens in the community, make possible the avoidance of hospitalization, and facilitate early hospital discharge by providing continuity-of-care step-down
therapy. The safety profile of IV sulopenem has been documented in a Phase 2 program. Oral and IV sulopenem are being evaluated in three pivotal Phase 3 clinical trials for uncomplicated urinary tract infections, complicated urinary tract
infections, and complicated intra-abdominal infections.
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 Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound,
in Phase 3 clinical development with oral and IV formulations. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum
Therapeutics 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.
Forward Looking Statements
This press release contains
forward-looking statements. These forward-looking statements include, without limitation, statements regarding expectations regarding future revenue, expenses, cash flows and net income or loss, the sufficiency of cash resources, the development,
therapeutic and market potential of sulopenem, the timing, progress and results of clinical trials, and the expected timing of NDA filings. 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,
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 Therapeutics
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 Therapeutics control, including the uncertainties inherent in the initiation and conduct of clinical trials,
clinical trial patient enrollment, availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, commercialization plans and timelines, if approved, the actions of third-party
clinical research organizations, suppliers and manufacturers and other factors discussed under the caption Risk Factors in its Annual Report on Form 10-K filed with the Securities and Exchange
Commission (the SEC ) on March 25, 2019, and other documents filed with the SEC from time to time. Forward-looking statements represent Iterum Therapeutics beliefs and assumptions only as of the date of this press release.
Except as required by law, Iterum Therapeutics 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.
Chief Financial Officer
ITERUM THERAPEUTICS PLC
Condensed Consolidated Statement of Operations
(In thousands except share and per share data)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenue | $ | 239 | $ | 349 | $ | 869 | $ | 508 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | (21,460 | ) | (8,241 | ) | (68,647 | ) | (25,499 | ) | ||||||||
| General and administrative | (2,723 | ) | (1,312 | ) | (8,781 | ) | (4,464 | ) | ||||||||
| Total operating expenses | (24,183 | ) | (9,553 | ) | (77,428 | ) | (29,963 | ) | ||||||||
| Operating loss | (23,944 | ) | (9,204 | ) | (76,559 | ) | (29,455 | ) | ||||||||
| Interest (expense) / income, net | (297 | ) | 108 | (426 | ) | 277 | ||||||||||
| Other income, net | 189 | 29 | 401 | 216 | ||||||||||||
| Income tax expense | (206 | ) | (51 | ) | (472 | ) | (444 | ) | ||||||||
| Net loss attributable to ordinary shareholders | $ | (24,258 | ) | $ | (9,118 | ) | $ | (77,056 | ) | $ | (29,406 | ) | ||||
| Net loss per share attributable to ordinary shareholders basic and diluted | $ | (1.72 | ) | $ | (43.24 | ) | $ | (8.82 | ) | $ | (170.84 | ) | ||||
| Weighted average ordinary shares outstanding basic and diluted | 14,108,604 | 210,859 | 8,734,109 | 172,130 | ||||||||||||
| Net Loss GAAP | (24,258 | ) | (9,118 | ) | (77,056 | ) | (29,406 | ) | ||||||||
| Milestone Payments to Pfizer | 7,500 | 15,000 | ||||||||||||||
| Non-GAAP adjusted loss | (16,758 | ) | (9,118 | ) | (62,056 | ) | (29,406 | ) | ||||||||
| Net loss per share attributable to ordinary shareholders basic and diluted | $ | (1.72 | ) | $ | (43.24 | ) | $ | (8.82 | ) | $ | (170.84 | ) | ||||
| Non-GAAP net loss per share attributable to ordinary shareholders basic and diluted | $ | (1.19 | ) | $ | (43.24 | ) | $ | (7.11 | ) | $ | (170.84 | ) |
ITERUM THERAPEUTICS PLC
Condensed Consolidated Balance Sheet Data
| Year Ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| Cash, cash equivalents, restricted cash and short-term investments | $ | 84,671 | $ | 39,216 | ||||
| Other assets | 13,200 | 7,541 | ||||||
| Total assets | $ | 97,871 | $ | 46,757 | ||||
| Long-term debt, less current portion | 13,079 | |||||||
| Other liabilities | 13,170 | 7,206 | ||||||
| Total liabilities | $ | 26,249 | $ | 7,206 | ||||
| Total convertible preferred shares and shareholders equity | 71,622 | 39,551 | ||||||
| Total liabilities, convertible preferred shares and shareholders equity | $ | 97,871 | $ | 46,757 |