Full Press Release Details
TriSalus Reports Q2 2024 Financial Results and Business Update
DENVER - August 15, 2024 - TriSalus Life Sciences Inc., (Nasdaq:
TLSI), an oncology company integrating novel delivery technology with immunotherapy to transform treatment for patients with liver and
pancreatic tumors, today announced its financial results for the second quarter ended June 30, 2024, and provided a business update.
Mary Szela, President and Chief Executive Officer of TriSalus Life
Sciences, stated, "We concluded the second quarter with robust revenue growth and effective execution across our operations. Our
sustained revenue growth underscores the critical demand for our Pressure Enabled Drug Delivery technology (PEDD ). We
are excited to launch the DELIVER program, which will showcase the advantages of our TriNav system in treating a diverse array of complex
"Additionally, we have successfully advanced development of
nelitolimod, having treated 100 patients in four indications and three clinical trials using our PEDD technology. Our progress to date
indicates that nelitolimod can be delivered to the liver and pancreas with minimal systemic exposure and shows early promise of benefit
in heavily pretreated patients with advanced disease," added Ms. Szela. "We anticipate further growth of our PEDD technology
and TriNav system and look forward to presenting our final Phase 1 data for uveal melanoma liver metastases and locally advanced pancreatic
cancer in the fourth quarter."
Second Quarter Business Update
Nelitolimod Clinical Studies in Uveal Melanoma Liver Metastases,
Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, and Locally Advanced Pancreatic Cancer via the Pressure-Enabled Regional Immuno-Oncology
(PERIO) Clinical Program
Closed up to $50 million of Debt Financing with OrbiMed to support
TriNav Growth Initiatives
In April, TriSalus announced the closing of a debt financing facility
with OrbiMed, a healthcare investment firm. Under the terms of the credit agreement with OrbiMed, the Company borrowed $25 million at
closing. In addition, an aggregate of up to an additional $25 million is available in two tranches at the Company's option, subject
to the Company's achievement of certain revenue thresholds.
Cash and cash equivalents on hand totaled $16.5 million at June 30,
2024. Including the Company's Standby Equity Purchase Agreement (SEPA) and other existing sources of liquidity and assuming it
achieves the revenue targets and borrow the remaining $25 million of the debt financing, the Company expects to have sufficient cash
runway to fund operations through the end of 2025.
Completion of Warrant Exchange Offer
Financial Results for Q2 2024
Revenue, all of which is from the sale of the TriNav system, was $7.4
million and $13.8 million, respectively, for the three and six months ended June 30, 2024, up 60% and 82%, respectively, compared to
the same periods in 2023. Revenue growth was driven primarily by increased selling resources and continued market share increases.
Gross margins were 88% and 86% for the three and six months ended
June 30, 2024, respectively, compared to 83% and 81%, respectively, for the same periods in 2023. The improvement in the quarter and
year-to-date is due to increased factory volumes and improved operational efficiency.
Operating losses were $8.2 million and $19.9 million, respectively,
for the three and six months ended June 30, 2024, respectively, compared to losses of $11.4 million and $21.6 million, respectively,
for the same periods in 2023. Current year reductions in operating losses are due to increased sales, improved gross margins, and reduced
research and development spending associated with the timing of clinical trial spending.
Net losses available to common stockholders were $4.3 million and
$17.6 million, respectively, for the three and six months ended June 30, 2024, compared to losses of $14.0 million and $22.2 million,
respectively, for the same periods in 2023. Net losses in 2024 include non-cash related losses on change in fair value of the Company's
SEPA, warrant and revenue base redemption liabilities of $9.0 million and $6.5 million, respectively for the three and six months ended
June 30, 2024, compared to gains of $1.1 million and $3.5 million, respectively, for the same periods in 2023. Net losses in 2023 also
include the impact of non-cash related losses on equity issuance of $4.2 million in the three and six months ended June 30, 2023. These
amounts are partially offset in 2024 by the impact of non-cash related gains on the change in fair value of contingent earnout liabilities
of $13.7 million and $9.7 million, respectively, for the three and six months ended June 30, 2024.
The basic and diluted loss per share for the three and six months
ended June 30, 2024, were $0.21 and $0.81, respectively, compared to $35.84 and $59.79 for the three and six months ended June 30, 2023,
will host a webcast to discuss its second quarter 2024 financial results and business highlights on August 15, 2024 at 9:00
a.m. EDT. The webcast can be accessed 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 and 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. The PEDD technology 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. Nelitolimod,
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 nelitolimod delivered via
the PEDD technology may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed
across cancer types and the mechanical barriers addressed by the PEDD technology are commonly present as well. Nelitolimod delivered
by the PEDD technology 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, TriNav system and nelitolimod investigational
immunotherapy, the expected timing for reporting results from the Company's clinical trials for nelitolimod, the Company's
expectation that the development of nelitolimod for the indications covered by PERIO-02 will continue through investigator led trials,
the Company's ability to achieve the revenue milestones under the credit facility, the Company's expectations about its cash
runway, the Company's expectations about its revenue growth for 2024, the expected benefits from the Company's DELIVER program,
the Company's expected timing to launch PROTECT study and any future studies, 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 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 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