Full Press Release Details
TriSalus Reports Third Quarter 2023 Financial
Results and Provides Business Update
Completed merger with MedTech Acquisition Corporation
(MTAC) and started public trading August 11th
Reported 3Q23 revenues of $5.2 million in 3Q23,
up 32% over prior year and nine-month year to date net revenues of $12.8 million, up 39% over prior year
Favorable Phase 1 uveal melanoma PERIO-01 data
demonstrating median progression free survival (PFS) of 11.7 months, with an 81% Disease Control Rate and 1 year overall survival (OS)
Favorable Phase 1 pancreatic adenocarcinoma
PERIO-03 data utilizing innovative FDA cleared pancreatic delivery device demonstrates initial safety, feasibility and immunologic response
Conference call November 14th
TriSalus Life Sciences Inc., (Nasdaq: TLSI), a publicly traded oncology
company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors,
today announced its financial results for the third quarter ended September 30, 2023, and provided a business update.
"Today marks an important milestone for TriSalus as we host
our first quarterly earnings call as a public company. I am proud of our team's considerable progress in the commercialization
of the TriNav Infusion System, our Pressure Enabled Drug Delivery (PEDD ) method, which achieved $5.2 million in revenues
in the quarter, up over 30% from the third quarter of 2022," said Mary Szela, Chief Executive Officer of TriSalus. "We remain
focused on integrating the TriNav system with immunotherapy to transform treatment for patients with liver and pancreatic tumors by solving
two main barriers to tumor treatment in the tumor microenvironment (TME): mechanical barriers that limit drug delivery and biological
barriers to driving immunosuppression."
from our three Phase 1/1b trials indicates that our innovative immunotherapy approach for liver and pancreas tumors has been well tolerated,
with evidence of SD-101 being delivered into difficult to reach tumors, potentially overcoming limitations posed by intravenous or direct
needle injection approaches. The mechanical and biologic TME barriers that TriSalus is targeting are commonly present in solid tumors,
creating a significant opportunity to impact a large patient population across cancer types," commented Steven Katz, MD,
FACS, Chief Medical Officer of TriSalus.
Third Quarter 2023 and Subsequent Highlights
PERIO-01 Phase 1 Data Selected for Late Breaking Podium Presentation
at the 2023 Society for Immunotherapy of Cancer (SITC) Annual Meeting
In November, TriSalus announced that SITC had selected the PERIO-01
Phase 1 data for a late breaking podium presentation and participation in the press conference of its 2023 annual meeting. The data demonstrated
that delivery of SD-101 by TriNav plus systemic immune checkpoint inhibitor (ICI) in uveal melanoma with liver metastases (UMLM) patients
results in clinical activity with median progression free survival (PFS) of 11.7 months, myeloid derived suppressor cell (MDSC) re-programming,
and evidence of peripheral and intra-tumoral immune activation.
PERIO-03 Phase 1 Initial Safety and Feasibility Data Selected for
Poster Presentation at SITC Annual Meeting
In November, the company presented data on its PERIO-03 Phase 1 clinical
trial on pressure enabled intra-pancreatic delivery of SD-101 with checkpoint blockade for locally advanced pancreatic adenocarcinoma.
The data demonstrated that TriNav pancreatic retrograde venous infusions (PRVI) of SD-101 were well tolerated in the initial three patients
and infusions were associated with potentially favorable immune changes in the periphery and tumors. These findings support continuing
with single-agent dose escalation and subsequent combination with systemic ICI.
The PERIO-03 Phase 1 study with
single-agent SD-101 is expected to be completed at the end of 2023 with subsequent initiation of the Phase 1b PERIO-03 dose expansion
beginning early 2024. In the expansion study, intravenous anti-PD-1 therapy will be added to SD-101 delivered by PEDD. The trial will
target patients with unresectable, locally advanced pancreatic adenocarcinoma who failed or progressed on at least one line of standard
Jodi Devlin appointed as
President, Commercial Operations
In September, TriSalus announced
that Jodi Devlin was appointed as President, Commercial Operations. Ms. Devlin joined TriSalus with more than two decades of experience
in building brands in a wide range of therapeutic areas, with expertise in developing and executing strategies across sales, marketing,
medical affairs, market access, and policy for biotech and pharmaceutical products.
Revenue, all of which is from the sale of TriNav, was $5.2 million
and $12.8 million, respectively, in the three and nine months ended September 30, 2023. These amounts represent growth vs. prior
year of 32% in the third quarter and 39% for nine months year to date, primarily due to continued market share increases.
Gross margins were 89% in the third quarter ended September 30,
2023, and 84% for nine months year to date versus 82% and 84%, respectively, in the third quarter and year to date in 2022. The seven
percent improvement in the third quarter of 2023 is due to increased factory volumes and improved operations efficiency.
Operating losses are $18.5 million and $40.0 million, respectively,
for the third quarter and nine months ended September 30, 2023. These amounts include non-recurring professional service fee costs
of $4.8 million in the quarter and $7.7 million year to date, primarily related to the completion of our deSPAC process in August 2023.
These amounts compare to prior year losses of $8.1 million and $24.7 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
Net losses attributable to common stockholders are $1.7 million and
$27.0 million, respectively, for the third quarter and nine months ended September 30, 2023. These amounts compare to prior year
losses of $8.1 million and $24.6 million, respectively. Net losses include the impact of a non-cash related gain on revaluation of contingent
earnout liabilities of $19.9 million in the third quarter and nine-month period of 2023. In addition, net losses include the impact of
non-cash related gains/(losses) associated with revaluation of tranche and warrant liabilities of ($2.8) million and $0.7 million, respectively,
for the third quarter and nine-month period ending September 30, 2023. The nine-month period ending September 30, 2023 also
includes a non-cash related loss on equity issuance of $4.2 million.
Basic and diluted loss per share for the three and nine months ended
September 30, 2023, was $0.13 and $5.68, respectively, compared to a basic and diluted loss per share of $25.95 and $82.17 for the
three and nine months ended September 30, 2022, respectively.
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
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.
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
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