TriSalus Q2 2024 Financial Results and Business Update

TriSalus Life Sciences Inc., (Nasdaq: TLSI), a company focused on integrating innovative delivery technology with immunotherapy for liver and pancreatic tumors, has revealed its financial performance for Q2 2024 and shared updates on its business operations. Mary Szela, the President and CEO, highlighted the significant revenue growth and effective operational execution during the quarter, driven by the increasing demand for their Pressure Enabled Drug Delivery™ technology (PEDD™). Szela emphasized the launch of the DELIVER program, which will demonstrate the benefits of the TriNav system for a variety of complex medical cases.

The DELIVER program aims to expand the application of the TriNav system, which is based on PEDD technology, across a broader range of patients. This initiative seeks to generate extensive data to support the effectiveness of the TriNav system, particularly for patients who cannot undergo traditional chemotherapy and radioembolization treatments. The program's first clinical study, named "PROTECT," will focus on the advantages of Pressure Enabled Retrograde Occlusive Therapy combined with embolization for managing thyroid disease.

TriSalus has made notable progress in developing nelitolimod, a treatment for liver and pancreatic tumors. They have treated 100 patients across four indications and three clinical trials using PEDD technology. Initial results indicate that nelitolimod can be delivered to the liver and pancreas with minimal systemic exposure, showing early signs of benefit in patients with advanced, heavily pretreated diseases. Szela mentioned anticipating further growth in PEDD technology and the TriNav system and looks forward to presenting final Phase 1 data for uveal melanoma liver metastases and locally advanced pancreatic cancer by the end of Q4 2024.

In November 2023, TriSalus showcased initial Phase 1 results for PERIO-01 and PERIO-03 studies at the Society of Immunotherapy for Cancer annual meeting. In June 2024, the company presented top-line results for PERIO-02 at the American Society of Clinical Oncology annual meeting. The PERIO-01 Phase 1 trial evaluates hepatic arterial delivery of nelitolimod via PEDD technology in patients with uveal melanoma liver metastases, with promising preliminary data. PERIO-02 focuses on hepatic arterial delivery for patients with hepatocellular carcinoma or intrahepatic cholangiocarcinoma, and recent findings demonstrate consistent safety and encouraging survival times in certain patients treated with a systemic checkpoint inhibitor doublet. PERIO-03 is a Phase 1 dose-escalation study of nelitolimod in locally advanced pancreatic cancer, with results expected by Q4 2024.

In April 2024, TriSalus secured up to $50 million in debt financing with OrbiMed to support the growth of TriNav initiatives. At closing, the company borrowed $25 million, with an additional $25 million available in two tranches upon meeting certain revenue milestones. As of June 30, 2024, TriSalus had $16.5 million in cash and cash equivalents, which, along with their Standby Equity Purchase Agreement and assuming they meet revenue targets, is expected to fund operations through the end of 2025.

On May 24, 2024, TriSalus launched a warrant exchange offer to simplify its capital structure and reduce potential dilutive impacts. By July 1, the company issued over 2.1 million shares of common stock in exchange for a substantial portion of its publicly traded and private warrants.

For Q2 2024, TriSalus reported revenue of $7.4 million, an increase of 60% from the same period in 2023, driven by increased selling resources and market share growth. Gross margins improved to 88%, up from 83% in Q2 2023, due to better factory volumes and operational efficiency. Operating losses for Q2 2024 were $8.2 million, an improvement from the $11.4 million loss in Q2 2023, as a result of increased sales and better margins. Net losses for Q2 2024 were $4.3 million, a significant reduction from the $14.0 million loss in Q2 2023, influenced by non-cash related gains on contingent earnout liabilities.

In summary, TriSalus Life Sciences is poised for continued growth and innovation with its novel PEDD technology and the TriNav system, supported by strong financial strategies and clinical advancements. The company remains dedicated to transforming treatment options for liver and pancreatic tumors, aiming to improve patient outcomes significantly.