TriSalus Reports Q3 2024 Financial Results and Provides Business Update
– Reported Q3 and nine-month revenues of
– Provided 2025 guidance with expectations of over 50% annual sales growth, 20%+ reduction in operating expenses, positive full-year EBITDA, and positive cash flow in H2 2025
– Launched TriNav® LV Infusion System and TriGuide™ Guiding Catheter for larger vessels and complex cases, expanding the TriNav system’s full access to the
– Initiated the PROTECT registry trial using the TriNav system to treat multinodular goiters, expanding the TriNav system’s reach into the
– Presented positive Phase 1 data from PERIO-01 trial in patients with uveal melanoma with liver metastases (UM-LM) at the
– Hosting earnings call on
“We enter the final quarter of 2024 with great momentum, both commercially and clinically, and we are positioned well for an even greater 2025,” stated
“With the successful completion of our Phase 1 dose escalation study enrollment in UM-LM, we are actively pursuing a strategic partnership for nelitolimod,” continued
“Our clinical development efforts for the TriNav system have expanded with the launch of the DELIVER program, starting with the PROTECT registry trial for patients with multinodular goiter. There is significant potential to broaden our addressable market by
“Finally, we are initiating 2025 guidance that calls for greater than 50% revenue growth, a greater than 20% reduction in operating expenses, positive full-year EBITDA, and positive cash flow in the second half of the year,” concluded
Third Quarter Business Update
TriNav System Large Vessel Launch
TriSalus recently expanded its portfolio of Pressure-Enabled Drug Delivery™ (PEDD™) devices with the launch of the TriNav LV Infusion System and TriGuide Guiding Catheter to optimize therapeutic delivery for patients with larger vessels. The TriNav LV system is suitable for patients with vessels sized between 3.5 and 5.0 mm and is expected to allow the Company to meaningfully expand its addressable liver embolization market. The TriGuide Guiding Catheter has a larger inner diameter, lubricious inner lining, and reverse curve design to support femoral access for the TriNav LV system, which the Company believes will enhance procedural efficiency. These new products are eligible for the same HCPCS reimbursement codes as existing TriNav products, enabling seamless integration into current billing structures.
DELIVER and PROTECT Updates
During the quarter, TriSalus advanced the DELIVER clinical program, a series of clinical trials designed to demonstrate enhanced safety and efficacy across a broad spectrum of complex, difficult-to-treat patients through investigator-initiated studies, further underscoring the impact of PEDD technology. A key focus of the DELIVER program is to investigate the potential of combining use of the TriNav system with these therapies to enhance effectiveness and address resistance mechanisms in challenging cancers.
The first of these is a registry study called PROTECT (Pressure Enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease), which has been initiated, and TriSalus intends to enroll 100 patients across five leading academic sites. It is estimated that approximately 5% of adults have multinodular goiters, and the prevalence in adults over 50 is estimated to be up to 50%. The Company estimates that this could expand the addressable market by approximately 50,000 procedures, representing an incremental
The Company anticipates opening additional DELIVER studies in the first half of 2025 and will provide more details as those studies commence.
PERIO Trial Update
TriSalus presented Phase 1 results from the PERIO-01 clinical trial at the recent SITC meeting. This dose escalation trial investigated the use of the PEDD method of nelitolimod in patients with UM-LM. The results suggested that PEDD-administered nelitolimod, combined with immune checkpoint inhibitors, provides promising clinical benefits and durable survival in heavily pretreated patients with UM-LM and a favorable safety profile. The Company is actively exploring strategic partnerships to advance this indication further.
The Company also completed enrollment of 13 patients in its PERIO-03 Phase 1 dose escalation study of nelitolimod in locally advanced pancreatic cancer. Evidence gathered thus far supports a strong safety profile and further exploration of nelitolimod combined with the TriNav pancreatic infusion technology. The Company will outline the next steps once the final data are available in mid-2025.
Financial Results for Q3 2024
Revenue, all from the sale of the TriNav system, was
Gross margins were 86% and 86% for the three and nine months ended
Operating losses were
Net losses available to common stockholders were
On
2025 Guidance
The Company is providing guidance for 2025 for the first time, including:
- Sales are expected to grow by more than 50% in 2025, driven by further market share increases in the TriNav system, the commercial launch of the TriNav LV system, and the TriNav target market expansion driven by the DELIVER program.
- Operating expenses are expected to decline greater than 20% in 2025 due to reductions in R&D associated with completing the PERIO Phase 1 trials and reductions in G&A expenses due to the non-recurrence of certain costs related to becoming a public Company.
- The Company expects to achieve positive full-year EBITDA and positive cash flow in the second half of the year.
Conference Call
TriSalus will host a webcast to discuss its third quarter 2024 financial results and business highlights on
About
In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on Twitter and LinkedIn.
Forward Looking Statements
Statements made in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding the Company’s guidance for its financial performance in 2025, the benefits and potential benefits of the Company’s PEDD drug delivery technology, TriNav system and nelitolimod investigational immunotherapy, the expected timing for reporting results from the Company’s clinical trials for nelitolimod, the Company’s goal of finding a strategic partner to advance nelitolimod in UM-LM, the ability of TriNav LV to expand the Company’s addressable market, the expected benefits from the Company’s DELIVER program including the incremental market opportunity expected from the PROTECT study, the Company’s expected timing to open additional DELIVER studies, statements regarding the Company’s cash runway, the Company’s expectation that TriNav LV will seamlessly integrate into the current billing structures and the Company’s ability to execute on its strategy. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company’s clinical trials, the risk that the Company may not be successful in identifying a strategic partner to advance PERIO-01, the risk that the Company may not achieve its projected financial results for 2025, the size and growth of the market for the Company’s products and the rate and degree of market acceptance thereof, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, the risks associated with the credit facility, including the Company’s ability to remain in compliance with all its obligations thereunder to avoid an event of default, the risk that the Company will continue to raise capital through the issuance and sale of its equity securities to fund its operations, the risk that the Company will not be able to achieve the applicable revenue requirements to access additional financing under the credit facility, changes in expected or existing competition or market conditions, changes in the regulatory environment, unexpected litigation or other disputes, unexpected expensed costs, and other risks described in the Company’s filings with the
Financials
| Condensed Consolidated Statement of Operations (unaudited, in thousands) | ||||||||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|||||||||||
| Revenue |
$ |
7,349 |
|
$ |
5,193 |
|
$ |
21,170 |
|
$ |
12,790 |
|
||||||||||
| Cost of goods sold |
|
1,004 |
|
|
589 |
|
|
2,887 |
|
|
2,023 |
|
||||||||||
| Gross Profit |
|
6,345 |
|
|
4,604 |
|
|
18,283 |
|
|
10,767 |
|
||||||||||
| Operating expenses: | ||||||||||||||||||||||
| Research and development |
|
4,219 |
|
|
9,506 |
|
|
14,729 |
|
|
22,066 |
|
||||||||||
| Sales and marketing |
|
6,138 |
|
|
4,689 |
|
|
18,829 |
|
|
11,430 |
|
||||||||||
| General and administrative |
|
4,727 |
|
|
9,025 |
|
|
13,310 |
|
|
17,498 |
|
||||||||||
| Loss from operations |
|
(8,739 |
) |
|
(18,616 |
) |
|
(28,585 |
) |
|
(40,227 |
) |
||||||||||
| Other income (expense): | ||||||||||||||||||||||
| Interest income |
|
158 |
|
|
116 |
|
|
347 |
|
|
187 |
|
||||||||||
| Interest expense |
|
(1,142 |
) |
|
(4 |
) |
|
(2,022 |
) |
|
(13 |
) |
||||||||||
| Loss on equity issuance |
|
(5,691 |
) |
|||||||||||||||||||
| Extinguishment of tranche liability |
|
19 |
|
|
1,520 |
|
||||||||||||||||
| Change in fair value of SEPA, warrant, and | ||||||||||||||||||||||
| revenue base redemption liabilities |
|
4,974 |
|
|
(2,831 |
) |
|
(1,521 |
) |
|
660 |
|
||||||||||
| Change in fair value of contingent earnout liability |
|
2,360 |
|
|
19,904 |
|
|
12,061 |
|
|
19,904 |
|
||||||||||
| Other expense, net |
|
(13 |
) |
|
(13 |
) |
|
(210 |
) |
|
(56 |
) |
||||||||||
| Loss before income taxes |
|
(2,402 |
) |
|
(1,425 |
) |
|
(19,930 |
) |
|
(23,716 |
) |
||||||||||
| Income tax benefit (expense) |
|
3 |
|
|
(7 |
) |
|
(8 |
) |
|||||||||||||
| Net loss available to common stockholders |
$ |
(2,399 |
) |
$ |
(1,425 |
) |
$ |
(19,937 |
) |
$ |
(23,724 |
) |
||||||||||
| Deemed dividend related to Series B-2 preferred stock down | ||||||||||||||||||||||
| round provision |
|
(2,981 |
) |
|||||||||||||||||||
| Undeclared dividends on Series A preferred stock |
|
(803 |
) |
|
(458 |
) |
|
(2,405 |
) |
|
(458 |
) |
||||||||||
| Net loss attributable to common stockholders |
$ |
(3,202 |
) |
$ |
(1,883 |
) |
$ |
(22,342 |
) |
$ |
(27,163 |
) |
||||||||||
| Net loss per common share, basic and diluted |
$ |
(0.12 |
) |
$ |
(0.14 |
) |
$ |
(0.91 |
) |
$ |
(5.72 |
) |
||||||||||
| Weighted average common shares outstanding, basic and diluted |
|
26,501,597 |
|
|
13,173,422 |
|
|
24,588,500 |
|
|
4,749,849 |
|
||||||||||
| Condensed Consolidated Balance Sheets (unaudited, in thousands) | ||||||||||||||
|
2024 |
|
2023 |
|
|||||||||||
| Assets | (unaudited) | |||||||||||||
| Current assets: | ||||||||||||||
| Cash and cash equivalents |
11,288 |
|
11,777 |
|
||||||||||
| Accounts receivable |
4,912 |
|
3,554 |
|
||||||||||
| Inventory, net |
3,999 |
|
2,545 |
|
||||||||||
| Prepaid expenses |
3,609 |
|
2,986 |
|
||||||||||
| Total current assets |
23,808 |
|
20,862 |
|
||||||||||
| Property and equipment, net |
1,818 |
|
2,091 |
|
||||||||||
| Right-of-use assets |
1,427 |
|
1,179 |
|
||||||||||
| Other assets |
424 |
|
466 |
|
||||||||||
| Total assets |
27,477 |
|
24,598 |
|
||||||||||
| Liabilities and Stockholders' Deficit | ||||||||||||||
| Current liabilities: | ||||||||||||||
| Trade payables |
1,446 |
|
3,391 |
|
||||||||||
| Accrued liabilities |
7,877 |
|
10,556 |
|
||||||||||
| Short-term lease liabilities |
266 |
|
351 |
|
||||||||||
| Other current liabilities |
329 |
|
389 |
|
||||||||||
| Total current liabilities |
9,918 |
|
14,687 |
|
||||||||||
| Long-term debt, net of unamortized discount and debt issuance costs |
21,678 |
|
||||||||||||
| Revenue base redemption liability |
426 |
|
||||||||||||
| Long-term lease liabilities |
1,506 |
|
1,244 |
|
||||||||||
| Contingent earnout liability |
6,571 |
|
18,632 |
|
||||||||||
| Warrant and SEPA liabilities |
7,812 |
|
17,100 |
|
||||||||||
| Total liabilities |
47,911 |
|
51,663 |
|
||||||||||
| Stockholders' deficit: | ||||||||||||||
| Preferred Stock, Series A, |
||||||||||||||
| per share. Authorized 10,000,000 shares at |
||||||||||||||
| 4,015,002 shares at |
||||||||||||||
| Common stock, |
||||||||||||||
| at |
||||||||||||||
| 30,469,664 and 26,413,213 shares at |
||||||||||||||
| respectively |
3 |
|
2 |
|
||||||||||
| Additional paid-in capital |
249,004 |
|
222,437 |
|
||||||||||
| Accumulated deficit |
(269,441 |
) |
(249,504 |
) |
||||||||||
| Total stockholders' deficit |
(20,434 |
) |
(27,065 |
) |
||||||||||
| Total liabilities and stockholders' deficit |
27,477 |
|
24,598 |
|
||||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20241114379025/en/
For Media Inquiries:
610.420.3049
TriSalus@argotpartners.com
For Investor Inquiries:
SVP-Investor Relations/Treasurer
847.337.0655
james.young@trisaluslifesci.com
Source: