Iterum Therapeutics Reports Second Quarter 2025 Financial Results
Iterum Therapeutics (Nasdaq: ITRM) reported Q2 2025 financial results and announced the upcoming launch of ORLYNVAH™, the first branded antibiotic for uncomplicated urinary tract infections (uUTIs) in over 25 years. The company reported a net loss of $6.5 million for Q2 2025, compared to $5.0 million in Q2 2024.
Key developments include a partnership with EVERSANA for U.S. commercialization, a manufacturing agreement with ACS Dobfar S.p.A, and the appointment of Christine Coyne as Chief Commercial Officer. The company's cash position of $13.0 million, plus $2.2 million raised through ATM offering, is expected to fund operations into 2026.
ORLYNVAH™, the only FDA-approved oral penem antibiotic in the U.S., targets resistant Gram-negative bacteria, including ESBL-producing Enterobacterales. The company also secured patent protection in Canada until 2039 and had its REASSURE Phase 3 trial results published in NEJM Evidence.
Iterum Therapeutics (Nasdaq: ITRM) ha comunicato i risultati finanziari del secondo trimestre 2025 e ha annunciato il prossimo lancio di ORLYNVAH™, il primo antibiotico di marca per le infezioni urinarie non complicate (uUTI) in oltre 25 anni. L'azienda ha registrato una perdita netta di 6,5 milioni di dollari nel Q2 2025, rispetto ai 5,0 milioni di dollari del Q2 2024.
Tra gli sviluppi principali vi sono una partnership con EVERSANA per la commercializzazione negli Stati Uniti, un accordo di produzione con ACS Dobfar S.p.A e la nomina di Christine Coyne a Chief Commercial Officer. La liquidità dell'azienda, pari a 13,0 milioni di dollari, più 2,2 milioni di dollari raccolti tramite offerta ATM, dovrebbe garantire le operazioni fino al 2026.
ORLYNVAH™, l'unico antibiotico orale penem approvato dalla FDA negli Stati Uniti, è efficace contro batteri Gram-negativi resistenti, inclusi gli Enterobacterales produttori di ESBL. L'azienda ha inoltre ottenuto la protezione brevettuale in Canada fino al 2039 e i risultati dello studio REASSURE di Fase 3 sono stati pubblicati su NEJM Evidence.
Iterum Therapeutics (Nasdaq: ITRM) informó los resultados financieros del segundo trimestre de 2025 y anunció el próximo lanzamiento de ORLYNVAH™, el primer antibiótico de marca para infecciones urinarias no complicadas (uUTIs) en más de 25 años. La compañía reportó una pérdida neta de 6,5 millones de dólares en el Q2 2025, frente a 5,0 millones en el Q2 2024.
Entre los avances clave se encuentran una asociación con EVERSANA para la comercialización en EE. UU., un acuerdo de fabricación con ACS Dobfar S.p.A y el nombramiento de Christine Coyne como Directora Comercial. La posición de efectivo de la empresa, de 13,0 millones de dólares, más 2,2 millones recaudados mediante oferta ATM, se espera que financie las operaciones hasta 2026.
ORLYNVAH™, el único antibiótico oral penem aprobado por la FDA en EE. UU., está dirigido a bacterias Gram-negativas resistentes, incluyendo Enterobacterales productores de ESBL. La empresa también aseguró protección de patente en Canadá hasta 2039 y los resultados del ensayo REASSURE de Fase 3 fueron publicados en NEJM Evidence.
Iterum Therapeutics (나스닥: ITRM)은 2025년 2분기 재무 실적을 발표하고, 25년 만에 처음으로 복잡하지 않은 요로감염(uUTIs)을 위한 브랜드 항생제 ORLYNVAH™의 출시를 예고했습니다. 회사는 2025년 2분기 순손실이 650만 달러로, 2024년 2분기의 500만 달러에 비해 증가했다고 보고했습니다.
주요 발전 사항으로는 미국 내 상업화를 위한 EVERSANA와의 파트너십, ACS Dobfar S.p.A와의 제조 계약, 그리고 크리스틴 코인(Christine Coyne)의 최고상업책임자(COO) 임명이 포함됩니다. 회사의 현금 보유액은 1300만 달러이며, ATM 공모를 통해 추가로 220만 달러를 조달해 2026년까지 운영 자금을 확보할 것으로 예상됩니다.
ORLYNVAH™는 미국에서 FDA 승인을 받은 유일한 경구용 페넴 항생제로, ESBL 생성 엔테로박테리아를 포함한 내성 그람음성균을 표적으로 합니다. 또한 캐나다에서 2039년까지 특허 보호를 확보했으며, REASSURE 3상 임상시험 결과가 NEJM Evidence에 게재되었습니다.
Iterum Therapeutics (Nasdaq : ITRM) a annoncé ses résultats financiers du deuxième trimestre 2025 ainsi que le lancement prochain de ORLYNVAH™, le premier antibiotique de marque pour les infections urinaires non compliquées (uUTIs) depuis plus de 25 ans. La société a enregistré une perte nette de 6,5 millions de dollars au deuxième trimestre 2025, contre 5,0 millions au deuxième trimestre 2024.
Les développements clés incluent un partenariat avec EVERSANA pour la commercialisation aux États-Unis, un accord de fabrication avec ACS Dobfar S.p.A, ainsi que la nomination de Christine Coyne en tant que Chief Commercial Officer. La trésorerie de la société, s’élevant à 13,0 millions de dollars, plus 2,2 millions levés via une offre ATM, devrait financer les opérations jusqu’en 2026.
ORLYNVAH™, le seul antibiotique oral penem approuvé par la FDA aux États-Unis, cible les bactéries Gram-négatives résistantes, y compris les Enterobacterales producteurs de BLSE. La société a également obtenu une protection par brevet au Canada jusqu’en 2039 et les résultats de l’essai de phase 3 REASSURE ont été publiés dans NEJM Evidence.
Iterum Therapeutics (Nasdaq: ITRM) meldete die Finanzergebnisse für das zweite Quartal 2025 und kündigte die bevorstehende Markteinführung von ORLYNVAH™ an, dem ersten markenrechtlich geschützten Antibiotikum für unkomplizierte Harnwegsinfektionen (uUTIs) seit über 25 Jahren. Das Unternehmen verzeichnete im zweiten Quartal 2025 einen Nettoverlust von 6,5 Millionen US-Dollar, verglichen mit 5,0 Millionen US-Dollar im zweiten Quartal 2024.
Zu den wichtigsten Entwicklungen zählen eine Partnerschaft mit EVERSANA für die Vermarktung in den USA, eine Herstellungsvereinbarung mit ACS Dobfar S.p.A sowie die Ernennung von Christine Coyne zur Chief Commercial Officer. Die Liquiditätsposition des Unternehmens von 13,0 Millionen US-Dollar plus 2,2 Millionen US-Dollar, die durch ein ATM-Angebot aufgebracht wurden, soll den Betrieb bis ins Jahr 2026 finanzieren.
ORLYNVAH™ ist das einzige von der FDA zugelassene orale Penem-Antibiotikum in den USA und richtet sich gegen resistente gramnegative Bakterien, einschließlich ESBL-produzierender Enterobacterales. Das Unternehmen sicherte sich zudem Patentschutz in Kanada bis 2039, und die Ergebnisse der REASSURE Phase-3-Studie wurden in NEJM Evidence veröffentlicht.
- First branded antibiotic for uUTIs in 25+ years launching August 2025
- Strategic partnership with EVERSANA for U.S. commercialization secured
- Manufacturing agreement with ACS Dobfar S.p.A established
- Canadian patent protection extended until 2039
- Pfizer debt repayment extended to October 2029
- Cash runway extended into 2026
- Net loss increased to $6.5M in Q2 2025 from $5.0M in Q2 2024
- General and administrative expenses more than doubled to $4.2M from $1.9M YoY
- Limited cash position of $13.0M requiring additional ATM offering
Insights
Iterum's upcoming ORLYNVAH launch represents first branded uUTI antibiotic in 25 years, though $13M cash position will require careful cash management.
Iterum Therapeutics is preparing for a significant milestone with the upcoming launch of ORLYNVAH™, the first FDA-approved oral penem antibiotic in the U.S. and first branded treatment for uncomplicated urinary tract infections (uUTIs) in over 25 years. This launch, expected in August 2025, addresses a critical medical need as antimicrobial resistance has rendered many generic treatments ineffective.
The company has established key commercial infrastructure through its partnership with EVERSANA for U.S. commercialization services and secured manufacturing through ACS Dobfar. These partnerships, along with hiring a Chief Commercial Officer, position Iterum for its commercial transition.
Financially, Iterum reported
The company has strengthened its intellectual property with a new Canadian patent extending protection for ORLYNVAH until 2039, and publication in NEJM Evidence enhances clinical credibility. Additionally, Pfizer's agreement to defer the
While the ORLYNVAH launch represents a transformative opportunity addressing antimicrobial resistance in uUTIs, the relatively modest cash position will require careful management as Iterum transitions from R&D to commercial operations.
-- Launch of ORLYNVAHTM Expected August 2025—
--Cash Runway into 2026--
--Company to host conference call today at 8:30amET--
DUBLIN and CHICAGO, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a company focused on delivering 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, 2025.
"We are on track to launch ORLYNVAH™ this month for the treatment of uncomplicated urinary tract infections (uUTIs),” said Corey Fishman, Chief Executive Officer of Iterum Therapeutics. “We’re proud to introduce the first branded antibiotic for uUTIs in over 25 years—a critical milestone as rising antimicrobial resistance has rendered many commonly used generic treatments ineffective across large parts of the U.S. ORLYNVAHTM is the only Food and Drug Administration (FDA) approved oral penem antibiotic in the U.S., offering a much-needed option for patients with limited alternatives due to resistant Gram-negative bacteria, including extended spectrum ß-lactamases (ESBL)-producing Enterobacterales.”
Highlights and Recent Events
- Expected Launch of ORLYNVAHTM for uUTIs in August 2025: Iterum began pre-commercialization activities in the first quarter of 2025 and is now focusing the majority of its efforts and resources on preparing for the commercial launch of ORLYNVAH™ in the U.S. with its commercialization partner, EVERSANA Life Science Services, LLC (EVERSANA), which is expected to occur by the end of August 2025.
- Entered into Partnership with EVERSANA: In June 2025, Iterum entered into a Product Commercialization Agreement with EVERSANA for the commercialization of its approved product, ORLYNVAHTM. Pursuant to the agreement, EVERSANA will provide sales and commercial operations services to Iterum in the U.S., as well as the provision of marketing, logistics, channel management, regulatory, medical affairs and other services related to the commercialization of ORLYNVAHTM in the U.S.
- Entered into Manufacturing and Supply Agreement: In July 2025, Iterum entered into a Commercial Manufacturing and Supply Agreement with ACS Dobfar S.p.A for the manufacture and supply of Iterum’s approved product, being the ORLYNVAHTM bilayer tablets, for commercial supply purposes.
- Hired Chief Commercial Officer: Iterum appointed Christine Coyne to the newly created position of Chief Commercial Officer to lead all commercial efforts for Iterum, including the near-term launch of ORLYNVAH™ in the U.S.
- Expansion of Patent Estate: The Canadian Patent Office has issued Iterum Canadian patent 3,129,337 entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof” that covers the use of a combination of sulopenem etzadroxil and probenecid in treating multiple diseases, including uUTIs. The Canadian patent will expire in December 2039, absent any extensions, and assuming timely payments of all maintenance fees during the lifetime of the patent.
- Publication in NEJM Evidence: NEJM Evidence published results from Iterum’s REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) Phase 3 clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uUTIs. https://evidence.nejm.org/doi/full/10.1056/EVIDoa2400414
- Extended Repayment of Pfizer Debt to 2029: In May 2025, Pfizer Inc. (Pfizer) agreed to extend the deferral term for payment of the regulatory milestone payment of
$20.0 million until October 25, 2029.
Second Quarter 2025 Financial Results
Cash and cash equivalents were
Cost of sales expense for the second quarter 2025 was
Research and development expenses for the second quarter 2025 were
General and administrative expenses for the second quarter 2025 were
Adjustments to the fair value of derivatives for the second quarter 2025 was
Net loss for the second quarter 2025 was
Conference Call Details
- Iterum will host a conference call today, Tuesday, August 5, 2025 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: 740801
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 (
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; the non-cash amortization of the Exchangeable Notes; the interest expense associated with accrued interest on the promissory note issued to Pfizer Inc.; and the non-cash adjustments to the fair value of the Royalty-Linked Notes for the three and six months ended June 30, 2025 and June 30, 2024. 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.
1 Definition and reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release
About Iterum Therapeutics plc
Iterum Therapeutics plc is focused on delivering 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 advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and 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 approval of its New Drug Application (NDA) for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the FDA and 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 www.iterumtx.com.
About ORLYNVAH™
ORLYNVAH™ is a novel oral penem antibiotic for the treatment of uUTIs. ORLYNVAH™ possesses potent activity against species of Enterobacterales including those that encode ESBL or AmpC-type ß-lactamases that confer resistance to third generation cephalosporins.
Cautionary 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 ORLYNVAH™, the sufficiency of Iterum’s cash resources to fund its operating expenses into 2026, and Iterum’s ability to complete pre-commercialization activities for ORLYNVAH™ and prepare for and implement the commercial launch of ORLYNVAH™ in the United States in August 2025. 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 risks and uncertainties concerning Iterum’s ability to raise sufficient capital and successfully prepare and implement commercialization plans for ORLYNVAH™ with its commercial partner, EVERSANA, including Iterum’s ability to build and maintain a sales force and prepare for commercial launch of ORLYNVAH™, the ability of shareholders and other stakeholders to realize any value or recovery as part of a wind down process if Iterum is unsuccessful at preparing and implementing its commercialization plans for ORLYNVAH™, the market opportunity for and the potential market acceptance of ORLYNVAH™ for uUTIs caused by certain designated microorganisms in adult women who have limited or no alternative oral antibacterial treatment options, Iterum’s ability to continue as a going concern, uncertainties inherent in the 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, changes in public policy or legislation, commercialization plans and timelines, 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 and other factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q filed with the SEC on August 5, 2025, 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of sales | (345 | ) | — | (687 | ) | — | ||||||||||
| Research and development | (1,000 | ) | (2,075 | ) | (1,591 | ) | (6,052 | ) | ||||||||
| General and administrative | (4,184 | ) | (1,901 | ) | (6,961 | ) | (4,087 | ) | ||||||||
| Total operating expenses | (5,529 | ) | (3,976 | ) | (9,239 | ) | (10,139 | ) | ||||||||
| Operating loss | (5,529 | ) | (3,976 | ) | (9,239 | ) | (10,139 | ) | ||||||||
| Interest expense, net | (316 | ) | (571 | ) | (850 | ) | (1,058 | ) | ||||||||
| Adjustments to fair value of derivatives | (585 | ) | (407 | ) | (1,134 | ) | (793 | ) | ||||||||
| Other expense, net | (20 | ) | (12 | ) | (58 | ) | (29 | ) | ||||||||
| Income tax expense | (59 | ) | (31 | ) | (119 | ) | (79 | ) | ||||||||
| Net loss | $ | (6,509 | ) | $ | (4,997 | ) | $ | (11,400 | ) | $ | (12,098 | ) | ||||
| Net loss per share – basic and diluted | $ | (0.16 | ) | $ | (0.30 | ) | $ | (0.31 | ) | $ | (0.76 | ) | ||||
| Weighted average ordinary shares outstanding – basic and diluted | 39,935,213 | 16,552,214 | 37,013,653 | 15,992,454 | ||||||||||||
| Reconciliation of non-GAAP net loss to GAAP net loss | ||||||||||||||||
| Net loss - GAAP | $ | (6,509 | ) | $ | (4,997 | ) | $ | (11,400 | ) | $ | (12,098 | ) | ||||
| Intangible asset amortization | 345 | — | 687 | — | ||||||||||||
| Share based compensation | 56 | 68 | 117 | 206 | ||||||||||||
| Interest expense - accrued interest and amortization on Exchangeable Notes | — | 749 | 282 | 1,499 | ||||||||||||
| Interest on promissory note - non-cash | 449 | — | 853 | — | ||||||||||||
| Adjustments to fair value of derivatives | 585 | 407 | 1,134 | 793 | ||||||||||||
| Non-GAAP net loss | $ | (5,074 | ) | $ | (3,773 | ) | $ | (8,327 | ) | $ | (9,600 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.16 | ) | $ | (0.30 | ) | $ | (0.31 | ) | $ | (0.76 | ) | ||||
| Non-GAAP net loss per share - basic and diluted | $ | (0.13 | ) | $ | (0.23 | ) | $ | (0.22 | ) | $ | (0.60 | ) | ||||
| ITERUM THERAPEUTICS PLC | ||||||||||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||||||||||
| (In thousands) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| As of | As of | |||||||||||||||
| June 30, | December 31, | |||||||||||||||
| 2025 | 2024 | |||||||||||||||
| Cash, cash equivalents and short-term investments | $ | 13,026 | $ | 24,125 | ||||||||||||
| Inventory | 948 | - | ||||||||||||||
| Intangible asset, net | 19,059 | 19,746 | ||||||||||||||
| Other assets | 981 | 724 | ||||||||||||||
| Total assets | $ | 34,014 | $ | 44,595 | ||||||||||||
| Pfizer Promissory Note | $ | 20,653 | $ | 20,300 | ||||||||||||
| Exchangeable notes | — | 14,463 | ||||||||||||||
| Royalty-linked notes | 11,905 | 10,771 | ||||||||||||||
| Other liabilities | 5,343 | 3,142 | ||||||||||||||
| Total liabilities | 37,901 | 48,676 | ||||||||||||||
| Total shareholders' deficit | (3,887 | ) | (4,081 | ) | ||||||||||||
| Total liabilities and shareholders' deficit | $ | 34,014 | $ | 44,595 | ||||||||||||
FAQ
When will Iterum Therapeutics (ITRM) launch ORLYNVAH for uUTI treatment?
What was Iterum Therapeutics (ITRM) net loss in Q2 2025?
How long will Iterum's (ITRM) current cash position last?
What makes ORLYNVAH unique in the antibiotic market?
Who will commercialize ORLYNVAH for Iterum Therapeutics?
