- 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
TriSalus Life Sciences Inc., (Nasdaq: TLSI), today announced its
financial results for the fourth quarter and full year ended
December 31, 2023, and provided a business update.
“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 Mary Szela, Chief
Executive Officer and President of TriSalus.
“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 Centers for Medicare
& Medicaid Services (CMS) had created a New Technology
Healthcare Common Procedure Coding System (HCPCS) code for
procedures involving the TriNav Infusion System. This new code,
HCPCS 9797, has been assigned to the Ambulatory Payment
Classification (APC) 5194 – Level 4 Endovascular Procedures. The
new code became effective on January 1, 2024, and may be reported
by hospital outpatient departments (HOPDs) and ambulatory surgical
centers (ASCs).
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
Current Medical Research and Opinion
of a manuscript detailing a real-world study of the use of the
Pressure-Enabled Drug Delivery™ (PEDD™) method with the TriNav
device for trans-arterial chemoembolization (TACE) and
trans-arterial radioembolization (TARE) in patients with
hepatocellular carcinoma (HCC) and liver metastases. The data
presented in the study captured real-world safety and clinical
outcomes data for the TriNav system utilizing a large, 300 million
patient dataset covering 98% of U.S. payers.
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 U.S. to Determine Which Indication to
Progress; Full Data Set Will be Analyzed in the Second Half of 2024
to Facilitate the Final Decision
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 The University of Texas MD Anderson Cancer Center
at the Society for Immunotherapy for Cancer meeting in November
2023.
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 SEC related to the Company’s Annual Report on Form
10-K for fiscal year 2023. The Company’s need to request a 15-day
extension is primarily due to errors identified in determining the
Company’s stock-based compensation expense for 2023 due in part to
the Company’s transition to a new service provider in 2023 and the
use of incorrect assumptions. The Company is working diligently to
evaluate the materiality of the errors to determine whether any
corrections for the third quarter financial results are required
and to complete the Company’s year-end 2023 financial statements.
As a result, the results below and elsewhere in this press release
are unaudited and subject to change pending the completion of the
Company’s financial statements as of and for the year ended
December 31, 2023.
Revenue and Gross Margin
Revenue, all of which is from the sale of the TriNav system, was
$5.7 million and $18.5 million, respectively, in the three months
and full year ended December 31, 2023. These amounts represent
growth vs. prior year of 77% in the fourth quarter and 49% for the
full year, primarily due to increased selling resources and
continued market share increases.
Gross margins were 90% in the fourth quarter and 86% for the
full year ended December 31, 2023, versus 75% and 82%,
respectively, in the fourth quarter and full year in 2022. The
improvement is due to increased factory volumes and improved
operations efficiency.
Operating Results
Operating losses were $14.1 million and $54.2 million,
respectively, for the fourth quarter and full year ended December
31, 2023. These amounts include non-recurring professional service
fee costs of $7.9 million year to date, primarily related to the
completion of the deSPAC process in August 2023. These amounts
compare to prior year losses of $11.8 million and $36.4 million,
respectively. The Company increased investments in 2023 in R&D
to support clinical program progress and in sales and marketing,
primarily to expand its sales force to continue to increase market
penetration.
Net Results and Earnings per Share
Net losses available to common stockholders were $35.5 million
and $59.0 million, respectively, for the fourth quarter and full
year ended December 31, 2023. These amounts compare to prior year
losses of $22.5 million and $47.2 million, respectively. Net losses
include the impact of non-cash related gains/(losses) on
revaluation of contingent earnout liabilities of ($9.6) million in
the fourth quarter and $10.3 million for the full year period of
2023. In addition, 2023 net losses include the impact of non-cash
related losses associated with revaluation of tranche and warrant
liabilities of $11.5 million and $10.9 million, respectively, for
the fourth quarter and full year ended December 31, 2023. These
amounts compare to prior year losses of $2.2 million in the fourth
quarter and full year. The fourth quarter and full year ended
December 31, 2023, also includes a non-cash related loss on equity
issuance of $0.2 million and $4.4 million, respectively. These
amounts compare to prior year losses of $8.3 million in the fourth
quarter and full year.
Basic and diluted loss per share for the fourth quarter and full
year ended December 31, 2023, was $1.56 and $6.73 respectively,
compared to a basic and diluted loss per share of $75.01 and
$161.55 for the fourth quarter and full year ended December 31,
2022, respectively.
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 SEC today. 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 success cost and timing of all
development activities and clinical trials, unexpected safety and
efficacy data observed during clinical studies, changes in expected
or existing competition or market conditions, changes in the
regulatory environment, unexpected litigation or other disputes,
the Company’s ability to timely file its Annual Report on Form
10-K, the risk that the unaudited financials reported in this press
release will differ from those in the Company’s Annual Report on
Form 10-K once filed, the risk the Company will need to make
corrections to its previously filed quarterly financial results,
and other risks described in the Company’s filings with the
Securities and Exchange Commission under the heading "Risk
Factors." All forward‐looking statements contained in this press
release speak only as of the date on which they were made and are
based on management’s assumptions and estimates as of such date.
The Company undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made except as required by law.
TRISALUS LIFE SCIENCES,
INC.
Consolidated Statement of Operations (unaudited, in
thousands) Three Months Ended Twelve Months
Ended December 31, December 31,
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)
December 31,
December 31,
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 $0.0001 par value per share, $10
liquidation value per share. Authorized 10,000,000 and 0 shares at
December 31, 2023 and 2022, respectively; issued and outstanding,
4,015,002 and 0 shares at December 31, 2023 and 2022, respectively
Common stock, $0.0001 par value per share.
Authorized 400,000,000 and 30,898,162 shares at December 31, 2023
and 2022, respectively; issued and outstanding 26,413,324 shares
and 347,926 shares at December 31, 2023 and 2022, respectively
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: Stephanie Jacobson Argot Partners
610.420.3049 TriSalus@argotpartners.com
For Investor Inquiries: James Young SVP-Investor
Relations/Treasurer 847.337.0655
james.young@trisaluslifesci.com
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