TriSalus Reports Q4 and Full Year 2023 Financial Results and Business Update
-
Reported revenues of
$5.7 million in 4Q23, up 77% over prior year -
Full year revenues of
$18.5 million , up 49% over prior year - Gross Margin of 90% in 4Q23 and 86% for full year
- CMS reimbursement granted for the TriNav® Infusion System via assignment of an HCPCS code
- Real-world data published on TriNav system demonstrating significant improvement in the delivery of therapeutics to liver tumors for patients with higher disease burden
- Received 510k clearance of TriNav Large and TriGuide systems
- Completed enrollment in phase 1 clinical trials (100 patients) in several liver indications; data will be analyzed in the second half of 2024
- Initiated first-in-man clinical trial of its novel pancreatic infusion technology (510k cleared), plus nelitolimod, to demonstrate safety and efficacy
“2023 was a critical year for TriSalus, underscored by significant growth in TriNav revenue, a landmark achievement of permanent reimbursement, and disciplined progress within our technology and clinical pipelines,” said
“The release of compelling real-world evidence demonstrating the impactful benefits of the TriNav method for complex patients, along with the exploration of nelitolimod in conjunction with the TriNav system through selected phase 1 clinical studies, reinforces our commitment to improving care options for oncology patients. As an example, the phase 1 clinical trial for locally advanced pancreatic patients utilizes our novel pancreatic infusion device in combination with nelitolimod with a goal to demonstrate improved outcomes for pancreatic patients.
Furthermore, receiving 510k clearance of a larger vessel size of the TriNav system, and successfully accessing the public markets underscore our dedication to advancing our company for sustained growth and success. As we reflect on the achievement of the past year, we recognize not only the milestones achieved but also acknowledge the solid foundation for continued future progress across the business, and we remain fully focused and committed to delivering benefit to patients.”
Fourth Quarter 2023 and Subsequent Highlights
CMS Reimbursement for the TriNav Infusion System via Assignment of a New Technology Healthcare Common Procedure Coding System (HCPCS) Code
In December, TriSalus announced that the
Real-World Data Demonstrates Ability of TriNav to Successfully Treat Patients with Higher Disease Burden and to Improve Delivery of Therapeutics to Liver Tumors
In February, the Company announced the publication in
The study data demonstrates that the TriNav method is preferentially selected to treat patients with a higher burden of disease than patients treated with standard catheters, yet these patients show similar results post-treatment compared to patients with a lower disease burden. TriNav patients showed impressive trends toward better outcomes in matched cohort comparisons, including an increased rate of liver transplants.
Completed Enrollment in Multiple Phase 1 Clinical Trials (100 Patients) in Uveal Melanoma Liver Metastases, Hepatocellular Cancer, and Intrahepatic Cholangiocarcinoma in Leading Academic Oncology Centers Across the
TriSalus presented phase 1 data for the PERIO-01 program, nelitolimod administered via the PEDD method for uveal melanoma liver metastases, at a late-breaking oral session by our lead investigator from
Data presented included the following:
- Safety data on 56 uveal melanoma patients with liver metastases, of whom 65% had failed prior therapy.
- Grade 3 or greater treatment related serious adverse event rate was 11% across all doses and cohorts.
- Pharmacokinetic data from the PERIO-01 trial indicate the TriNav system is able to achieve high drug levels in the liver, and systemic exposure is limited with drug undetectable by four hours in more than 95% of patients.
- Amongst patients with available data ctDNA clearance was 59%, with 86% showing reduction in ctDNA.
- Disease control rate (DCR) was 58% across all dose levels, and at the presumed optimal biologic dose (2mg, N=7), there was a DCR of 81%, median progression free survival (PFS) of 11.7 months and 1-year overall survival rate (OS) of 86%.
- The optimal biologic dose assessment was made based on PFS, OS, and immune signals, including MDSC elimination from liver metastases. There was also evidence of systemic immune activation, as measured by serum cytokines and peripheral immune cell activation.
Initiated Phase 1 Study with Nelitolimod via our Novel Pancreatic Infusion Device
The Pancreatic Infusion System with SmartValve® technology is an FDA-cleared device for delivery of therapeutics to the peripheral vasculature. This device is being studied for the delivery of nelitolimod into unresectable pancreatic tumors.
Retrograde venous delivery to the pancreas involves the placement of a PEDD device into the veins draining the pancreas to enable targeted delivery of therapeutics using standard interventional radiology procedures. Unlike the liver, small vessels and extensive collateralization in the pancreas make the arterial route challenging for targeted delivery. Retrograde pancreatic venous infusion provides a potentially more feasible and reliable strategy for targeted delivery of therapeutics through direct venous access.
In November of 2023, TriSalus released study data on three patients receiving nelitolimod via its novel pancreatic infusion device demonstrating immune signals consistent with previous reported data for liver metastases. The Company expects to complete enrollment and report the phase 1 data in the second half of 2024.
Received 510k Clearance for TriNav Large and TriGuide
This year, TriSalus received 510k clearance for a larger vessel size of the TriNav system, TriNav Large, and its dedicated guide catheter, TriGuide. Currently, the Company is in market evaluation for both devices and intends to launch in the second half of 2024. The launch of this TriNav system provides a significant market expansion since the larger vessel size can access an incremental 25% of the embolization market.
Unaudited Financial Results for Q4 and Full Year 2023
Notification of Late Filing
The Company will file a Form 12b-25, Notification of Late Filing, with the
Revenue and Gross Margin
Revenue, all of which is from the sale of the TriNav system, was
Gross margins were 90% in the fourth quarter and 86% for the full year ended
Operating Results
Operating losses were
Net Results and Earnings per Share
Net losses available to common stockholders were
Basic and diluted loss per share for the fourth quarter and full year ended
Conference Call
The event will be webcast live on the investor relations section of TriSalus’ website at https://investors.trisaluslifesci.com/news-events/events-presentations. Following the conclusion of the event, a webcast replay will be available on the website for approximately 90 days. Interested parties participating by phone will need to register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin.
About TriSalus Life Sciences
TriSalus Life Sciences® is an oncology company integrating novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. SD-101, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that SD-101 delivered via PEDD may have favorable immune effects within the liver and systemically. The target for SD-101, TLR9, is expressed across cancer types and the mechanical barriers addressed by PEDD are commonly present as well. SD-101 delivered by PEDD will be studied across several indications in an effort to address immune dysfunction and overcome drug delivery barriers in the liver and pancreas.
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 benefits and potential benefits of the Company’s PEDD drug delivery technology and SD-101 investigational immunotherapy, the Company’s business strategy and clinical development plans, the safety and efficacy of the Company’s product candidates, the Company’s plans and expected timing with respect to clinical trials, including the timing for generating and reviewing data from clinical trials, the market opportunity for TriNav Large, and the Company’s intention to file Form 12b-25, Notice of Late Filing, with the
|
TRISALUS LIFE SCIENCES, INC. |
|||||||||||||||
| Consolidated Statement of Operations (unaudited, in thousands) | |||||||||||||||
| Three Months Ended | Twelve Months Ended | ||||||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
| Revenue |
$ |
5,721 |
|
$ |
3,226 |
|
$ |
18,511 |
|
$ |
12,398 |
|
|||
| Cost of goods sold |
|
582 |
|
|
816 |
|
|
2,605 |
|
|
2,258 |
|
|||
| Gross Profit |
|
5,139 |
|
|
2,410 |
|
|
15,906 |
|
|
10,140 |
|
|||
| Operating expenses: | |||||||||||||||
| Research and development |
|
7,639 |
|
|
6,267 |
|
|
29,510 |
|
|
21,358 |
|
|||
| Sales and marketing |
|
5,604 |
|
|
3,857 |
|
|
17,034 |
|
|
12,738 |
|
|||
| General and administrative |
|
6,014 |
|
|
4,058 |
|
|
23,512 |
|
|
12,483 |
|
|||
| Loss from operations |
|
(14,118 |
) |
|
(11,772 |
) |
|
(54,150 |
) |
|
(36,439 |
) |
|||
| Interest income |
|
244 |
|
|
105 |
|
|
431 |
|
|
180 |
|
|||
| Interest expense |
|
(3 |
) |
|
(1 |
) |
|
(16 |
) |
|
(1 |
) |
|||
| Loss on equity issuance |
|
(182 |
) |
|
(8,312 |
) |
|
(4,353 |
) |
|
(8,312 |
) |
|||
| Change in fair value of tranche and warrant liabilities |
|
(11,515 |
) |
|
(2,207 |
) |
|
(10,855 |
) |
|
(2,186 |
) |
|||
| Change in fair value of contingent earnout liability |
|
(9,611 |
) |
|
10,293 |
|
|||||||||
| Other expense, net |
|
(323 |
) |
|
(349 |
) |
|
(379 |
) |
|
(420 |
) |
|||
| Loss before income taxes |
|
(35,508 |
) |
|
(22,536 |
) |
|
(59,029 |
) |
|
(47,178 |
) |
|||
| Income tax expense |
|
(1 |
) |
|
(6 |
) |
|
(9 |
) |
|
(9 |
) |
|||
| Net loss available to common stockholders |
$ |
(35,509 |
) |
$ |
(22,542 |
) |
$ |
(59,038 |
) |
$ |
(47,187 |
) |
|||
| Deemed dividend related to Series B-2 preferred stock down round provision |
|
(2,829 |
) |
|
(2,981 |
) |
|
(2,829 |
) |
||||||
| Undeclared dividends on Series A preferred stock |
|
(800 |
) |
|
(1,258 |
) |
|||||||||
| Net loss attributable to common stockholders |
$ |
(36,309 |
) |
$ |
(25,371 |
) |
$ |
(63,277 |
) |
$ |
(50,016 |
) |
|||
| Net loss per common share, basic and diluted |
$ |
(1.56 |
) |
$ |
(75.01 |
) |
$ |
(6.73 |
) |
$ |
(161.55 |
) |
|||
| Weighted average common shares outstanding, basic and diluted |
|
23,231,975 |
|
|
338,221 |
|
|
9,395,748 |
|
|
309,609 |
|
|||
|
TRISALUS LIFE SCIENCES, INC. |
||||||
| Consolidated Balance Sheets (unaudited, in thousands) | ||||||
|
|
|
|||||
|
2023 |
2022 |
|||||
|
Assets |
|
|
|
|
|
|
| Assets | ||||||
| Cash and cash equivalents |
11,777 |
|
9,414 |
|
||
| Accounts receivable |
3,554 |
|
1,557 |
|
||
| Inventory, net |
2,545 |
|
1,471 |
|
||
| Prepaid expenses |
2,986 |
|
4,772 |
|
||
| Total current assets |
20,862 |
|
17,214 |
|
||
| Property and equipment, net |
2,091 |
|
2,231 |
|
||
| Right-of-use assets |
1,179 |
|
1,381 |
|
||
| Intangible assets, net |
1,127 |
|
802 |
|
||
| Other assets |
466 |
|
367 |
|
||
| Total assets |
25,725 |
|
21,995 |
|
||
|
Liabilities and Stockholders' Equity (Deficit) |
||||||
| Current liabilities: | ||||||
| Trade payables |
3,391 |
|
4,947 |
|
||
| Accrued liabilities |
10,556 |
|
6,377 |
|
||
| Series B-2 tranche liabilities |
4,702 |
|
||||
| Series B-3 warrant liabilities |
15,819 |
|
||||
| Short-term lease liabilities |
351 |
|
370 |
|
||
| Other current liabilities |
389 |
|
142 |
|
||
| Total current liabilities |
14,687 |
|
32,357 |
|
||
| Long-term lease liabilities |
1,244 |
|
1,593 |
|
||
| Contingent earnout liability |
18,632 |
|
||||
| Warrant liabilities |
17,100 |
|
369 |
|
||
| Total liabilities |
51,663 |
|
34,319 |
|
||
| Convertible preferred stock |
164,006 |
|
||||
| Stockholders' deficit: | ||||||
| Preferred Stock, Convertible preferred stock, Series A |
||||||
| Common stock, |
2 |
|
||||
| Additional paid-in capital |
222,437 |
|
10,028 |
|
||
| Accumulated deficit |
(248,377 |
) |
(186,358 |
) |
||
| Total stockholders' deficit |
(25,938 |
) |
(176,330 |
) |
||
| Total liabilities, convertible preferred stock and stockholders' deficit |
25,725 |
|
21,995 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240331588957/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: TriSalus Life Sciences