Iterum Therapeutics plc (ITRM) has successfully closed a $5 million registered direct offering of ordinary shares, securing crucial funding for the commercialization of its recently FDA-approved antibiotic. The Dublin, Ireland and Chicago-based company announced on April 30, 2025, that it sold 5,555,556 ordinary shares at a purchase price of $0.90 per share to a single institutional investor.
H.C. Wainwright & Co. served as the exclusive placement agent for the transaction, which was conducted under a shelf registration statement previously filed with the Securities and Exchange Commission (SEC).
The company plans to use the proceeds to fund its ongoing strategic process and pre-commercialization activities for ORLYNVAH™ (oral sulopenem), which recently received FDA approval for treating uncomplicated urinary tract infections (uUTIs) in adult women with limited or no alternative oral antibacterial treatment options.
Strategic Funding Allocation
Judy Matthews, Chief Financial Officer at Iterum Therapeutics, indicated that the net proceeds will primarily support the company's strategic initiatives and preparation for market entry. If the strategic process does not result in a transaction, the funds will be directed toward commercialization activities including product manufacturing, sales, marketing, and distribution for ORLYNVAH™.
The financing comes at a critical juncture for Iterum as it transitions from a development-stage company to commercial operations. The company's focus remains on delivering differentiated anti-infectives to combat the global crisis of multi-drug resistant pathogens.
ORLYNVAH™: Addressing an Unmet Medical Need
ORLYNVAH™ represents a significant advancement in the treatment landscape for urinary tract infections. The oral formulation of sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics.
The FDA approval specifically covers uUTIs caused by designated microorganisms including Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women with limited treatment options. These pathogens are among the most common causative agents of UTIs and have shown increasing resistance to currently available antibiotics.
The U.S. Food and Drug Administration has recognized the importance of this novel antibiotic by granting Qualified Infectious Disease Product (QIDP) and Fast Track designations for both oral and IV formulations of sulopenem across seven indications.
Market Opportunity and Commercialization Challenges
Urinary tract infections represent one of the most common bacterial infections, affecting approximately 150 million people worldwide annually. The rising prevalence of antibiotic-resistant strains has created a significant unmet need for new treatment options.
Iterum faces the challenge of successfully launching ORLYNVAH™ in a competitive market while building the necessary commercial infrastructure. The company is considering various strategic options, including potential partnerships to maximize the drug's market penetration.
Ongoing Development Program
Beyond the approved indication, Iterum continues to advance the development of sulopenem in both oral and intravenous formulations. The company's pipeline includes additional potential indications where the QIDP and Fast Track designations have been secured.
The successful commercialization of ORLYNVAH™ could provide Iterum with the financial foundation to further develop its antibiotic portfolio and address the growing global threat of antimicrobial resistance.
Financial Outlook
Despite the recent funding, Iterum has acknowledged in its forward-looking statements that challenges remain regarding its ability to continue as a going concern. The company must successfully execute its commercialization strategy to generate sustainable revenue from ORLYNVAH™.
The $5 million raised, while significant, represents just one step in the company's journey toward financial stability. Iterum will need to carefully manage these resources while exploring additional funding options to support its long-term objectives.
As multi-drug resistant infections continue to pose a serious global health threat, Iterum's progress with ORLYNVAH™ represents an important advancement in the field of anti-infectives, potentially offering new hope to patients with limited treatment options.
