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news.Citius Oncology has secured up to $36.5m in a combination of debt and equity financing to accelerate the commercialisation of Lymphir (denileukin diftitox-cxdl), a recombinant fusion protein immune therapy.
Proceeds will fund Lymphir’s commercialisation, market access, medical affairs, and manufacturing. Credit: Gorodenkoff / Shutterstock.com.
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The therapy is approved by the US Food and Drug Administration (FDA) for adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) following at least one prior systemic treatment.
The capital includes a senior secured term loan facility of up to $25m from Avenue Venture Opportunities Fund II, as well as a warrant exercise agreement expected to yield $11.5m.
HC Wainwright & Co is serving as the exclusive origination, structuring, and placement agent for these financings.
The term loan spans three and a half years, consisting of an initial $10m tranche at closing and two additional tranches totalling up to $15m, contingent on revenue and liquidity milestones.
Avenue will receive warrants to buy up to 11.1 million shares at an exercise price of $0.90 per share, with a five-year exercisability window, alongside conversion rights for up to $4m.
Citius Oncology’s definitive agreements with a healthcare-focused institutional investor involve immediate exercise of warrants for up to 12.7 million shares, generating approximately $11.5m, offset by the issue of new unregistered warrants.
Proceeds will fund Lymphir’s commercialisation, market access, medical affairs, and manufacturing, and provide working capital.
Denileukin diftitox holds approvals in Japan and the US and is licensed globally except in India, Japan, and parts of Asia.
Citius Oncology and Citius Pharmaceuticals chairman and CEO Leonard Mazur said: “This credit facility strengthens our ability to continue to execute on the Lymphir launch, aligning capital access with commercial performance, and underscoring the confidence that a global investment firm like Avenue Capital has in our commercial trajectory and the long-term potential of Lymphir.
“In parallel, the warrant exercise financing provides additional near-term capital to further support our commercial efforts. Collectively, this provides the company with meaningful financial flexibility as we continue to scale our commercial infrastructure, drive adoption of Lymphir among treating physicians, and expand patient access to this important therapy for relapsed or refractory cutaneous T-cell lymphoma.”
Earlier this year, Citius Oncology signed an exclusive distribution agreement with Uniphar to enable access to Lymphir in selected European countries.
