TriSalus Life Sciences, Inc. (NASDAQ:TLSI) is an oncology company dedicated to transforming the treatment of solid tumors by integrating its novel Pressure-Enabled Drug Delivery (PEDD) technology with standard-of-care therapies and an investigational immunotherapy, nelitolimod. Through its pioneering approach, TriSalus aims to address the significant unmet needs of patients battling challenging cancers, particularly in the liver and pancreatic cancer spaces.

Business Overview and History

TriSalus was founded in 2009 with the goal of developing innovative solutions to improve outcomes for patients with solid tumors. The company's initial focus was on the research and development of its Pressure-Enabled Drug Delivery (PEDD) platform, a novel technology designed to enhance the delivery of therapeutic agents to solid tumors. In 2020, TriSalus launched its first commercial product, the TriNav Infusion System, which utilizes the PEDD approach to optimize the delivery of therapies to liver tumors. This launch marked an important milestone for the company, as it transitioned from a research-stage organization to a commercial entity.

Over the next few years, TriSalus faced several challenges as it worked to drive broader adoption of the TriNav system. The company had to navigate a complex regulatory environment and educate the medical community on the benefits of its PEDD technology. Additionally, TriSalus encountered supply chain disruptions and other operational hurdles that impacted its ability to meet customer demand.

Despite these obstacles, TriSalus continued to make progress, expanding its commercial footprint and refining its manufacturing processes. The company's efforts to build out its sales and marketing infrastructure enabled it to achieve significant revenue growth in 2023 and 2024.

In parallel with its commercial activities, TriSalus has also been advancing the development of its drug candidate, nelitolimod, an investigational immunotherapy that the company believes has the potential to enhance the efficacy of standard-of-care cancer treatments when delivered using the PEDD platform. The company has initiated several early-stage clinical trials to evaluate nelitolimod in various solid tumor indications, including liver and pancreatic cancers.

Financial Overview

TriSalus has primarily funded its operations through the issuance of preferred stock, convertible debt, and the completion of the Business Combination with MedTech Acquisition Corporation in 2023. As of September 30, 2024, the company had cash, cash equivalents, and restricted cash of $11.64 million.

For the nine months ended September 30, 2024, TriSalus reported total revenue of $21.17 million, reflecting a 65.5% increase compared to the same period in 2023. Gross profit for the nine-month period was $18.28 million, with a gross margin of 86.4%. The company's net loss for the nine months ended September 30, 2024, was $19.94 million.

In the most recent fiscal year (2023), TriSalus reported revenue of $18.51 million, with a net loss of $59.04 million. Operating cash flow was negative $50.05 million, and free cash flow was negative $51.17 million.

For the most recent quarter (Q3 2024), TriSalus reported revenue of $7.35 million, representing a 41.5% year-over-year increase. The net loss for the quarter was $2.40 million. The increase in Q3 2024 revenue was primarily driven by a $2.2 million increase in sales of the TriNav device compared to Q3 2023. Gross margin decreased slightly to 86.3% in Q3 2024 from 88.7% in Q3 2023 due to lower manufacturing efficiencies.

TriSalus has provided guidance for 2025, expecting revenue growth of over 50% and a 20% reduction in operating expenses, with the goal of achieving positive full-year EBITDA and positive cash flow in the second half of 2025. The company's 2024 sales are projected to grow by more than 50%, reaching $28 million to $30 million.

Liquidity

As of September 30, 2024, TriSalus had cash, cash equivalents, and restricted cash of $11.64 million. The company's ability to fund its operations and meet its financial obligations will depend on its ability to generate revenue, raise additional capital, and manage expenses effectively.

TriSalus' debt-to-equity ratio as of September 30, 2024, was -1.15. The company had $11.29 million in cash and cash equivalents. TriSalus has a $50 million credit agreement with OrbiMed, of which $25 million was drawn initially. An additional $10 million can be drawn upon meeting certain revenue targets, and $15 million more is available subject to additional conditions. The company's current ratio is 2.40, and its quick ratio is 2.00.

Key Developments and Milestones

In 2024, TriSalus launched the TriNav LV Infusion System and TriGuide Guiding Catheter, expanding its portfolio of PEDD devices and increasing the number of patients eligible for its technology. This launch marked an important step in the company's strategy to provide a comprehensive solution for interventional radiologists treating complex liver and pancreatic tumors.

Additionally, TriSalus initiated the PROTECT registry trial in 2024, evaluating the use of the TriNav system to treat multinodular goiters. This represented an expansion of the TriNav technology into a new indication, the $400 million thyroid embolization market.

On the clinical front, TriSalus presented positive Phase 1 data from the PERIO-01 trial in patients with uveal melanoma liver metastases at the 2024 SITC meeting. The results demonstrated the potential of nelitolimod, when delivered via PEDD, to enhance the efficacy of immune checkpoint inhibitors in this patient population.

TriSalus also continued to advance the PERIO-03 trial, a Phase 1 study evaluating the use of nelitolimod delivered via the company's innovative pancreatic infusion device in patients with locally advanced pancreatic cancer. This trial has completed enrollment of 13 patients, and the company is evaluating the safety and immune-modulating effects of this approach.

Product Segments

TriSalus operates in two primary product segments: Medical Devices and Pharmaceuticals.

The Medical Devices segment is TriSalus' primary revenue driver, accounting for primarily all of the company's revenue. This segment consists of the TriNav device, which is TriSalus' cutting-edge Pressure Enabled Drug Delivery (PEDD) infusion system. TriNav is designed to optimize therapeutic delivery for the treatment of hepatocellular carcinoma, pancreatic cancer, and other solid liver tumors. The TriNav device utilizes SmartValve technology to work in synchrony with the cardiac cycle, opening collapsed vessels in the tumor to enable deeper perfusion and improve drug delivery.

TriNav was introduced in 2020 and has since gained transitional pass-through payment (TPT) approval from the Centers for Medicare & Medicaid Services (CMS), allowing hospitals to cover the cost of using the device. This TPT approval expired at the end of 2023, but in December 2023, CMS granted a new permanent Healthcare Common Procedure Coding System (HCPCS) code for procedures involving TriNav, enabling continued reimbursement.

The Pharmaceuticals segment is focused on the development of nelitolimod, an investigational toll-like receptor 9 (TLR9) agonist. Nelitolimod is believed to bind to TLR9 receptors found on suppressive immune cells, including myeloid-derived suppressor cells and antigen-presenting immune cells, in an effort to prime the immune system and promote anti-tumor T-cells.

TriSalus acquired nelitolimod in July 2020 and has initiated Phase 1 and Phase 1b clinical trials evaluating the drug candidate for the treatment of uveal melanoma, intrahepatic cholangiocarcinoma and hepatocellular carcinoma (ICC and HCC), and pancreatic cancer. Based on a review of the preliminary data, TriSalus has decided not to proceed with Phase 2 trials for the ICC and HCC indications, but the PERIO-3 clinical trial in pancreatic cancer is ongoing, with data expected sometime in 2025.

Risks and Challenges

As a clinical-stage biopharmaceutical company, TriSalus faces several risks and challenges common to the industry. These include the inherent uncertainty of clinical development, the potential for delays or failures in obtaining regulatory approvals, the ability to effectively commercialize its products, and the need for continued capital to fund its operations.

Additionally, TriSalus operates in a highly competitive landscape, with both medical device and pharmaceutical companies vying for market share in the solid tumor treatment space. The company's ability to maintain its technological advantage and drive adoption of its PEDD technology and nelitolimod will be crucial to its long-term success.

Outlook and Conclusion

TriSalus has made significant strides in advancing its innovative delivery technology and pipeline of investigational immunotherapies. The company's focus on addressing the complex challenges of solid tumors, particularly in the liver and pancreatic cancer indications, positions it well to transform patient outcomes.

With the launch of new PEDD devices, the expansion into the thyroid embolization market, and the promising clinical data for nelitolimod, TriSalus is poised for continued growth and value creation. The company's guidance for 2025, including expectations of over 50% revenue growth and positive EBITDA, further underscores its momentum and the potential of its integrated approach to solid tumor treatment.

TriSalus primarily sells its TriNav device in the United States and has not disclosed any significant international sales at this time. The medical device and pharmaceutical industries that TriSalus operates in have experienced a compound annual growth rate of approximately 5-7% in recent years.

As TriSalus navigates the regulatory landscape, advances its clinical programs, and strengthens its commercial footprint, the company's ability to execute on its strategic initiatives will be crucial to its long-term success. Investors interested in the transformative potential of innovative cancer therapies should closely monitor TriSalus' progress in the coming years.