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) of 86%
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 at 9:00AM EDT
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.”
“Data 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 therapy.
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.
Financial Results
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 market penetration.
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.
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. 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 PERIO 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, changes in the regulatory
environment, unexpected litigation or other disputes, 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.
Financials
TriSalus Life Sciences
Condensed Consolidated
Statement of Operations (unaudited, in thousands)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
Revenue
$
5,193
$
3,923
$
12,790
$
9,172
Cost of goods sold
589
701
2,023
1,442
Gross profit
4,604
3,222
10,767
7,730
Operating expenses:
Research and development
9,367
4,808
21,871
15,091
Sales and marketing
4,689
3,030
11,430
8,881
General and administrative
9,025
3,495
17,498
8,425
Loss from operations
(18,477
)
(8,111
)
(40,032
)
(24,667
)
Interest income
116
49
187
75
Interest expense
(4
)
—
(13
)
—
Loss on equity issuance
—
—
(4,171
)
—
Change in fair value of tranche and
warrant liabilities
(2,812
)
—
660
21
Change in fair value of contingent earnout
liability
19,904
—
19,904
—
Other expense, net
(13
)
(31
)
(56
)
(71
)
Loss before income taxes
(1,286
)
(8,093
)
(23,521
)
(24,642
)
Income tax expense
—
—
8
3
Net loss available to common
stockholders
$
(1,286
)
$
(8,093
)
$
(23,529
)
$
(24,645
)
Deemed dividend related to Series B-2
preferred stock down round provision
$
—
$
—
$
(2,981
)
$
—
Undeclared dividends on Series A preferred
stock
$
(458
)
$
—
$
(458
)
$
—
Net loss attributable to common
stockholders
$
(1,744
)
$
(8,093
)
$
(26,968
)
$
(24,645
)
Net loss per common share, basic and
diluted
$
(0.13
)
$
(25.95
)
$
(5.68
)
$
(82.17
)
Weighted average common shares
outstanding, basic and diluted
13,173,422
311,823
4,749,849
299,936
TriSalus Life Sciences
Condensed Consolidated Balance
Sheets (in thousands)
September 30,
2023
December 31,
2022
(unaudited)
Assets
Assets
Cash and cash equivalents
$
21,383
$
9,414
Accounts receivable
3,052
1,557
Inventory, net
1,629
1,471
Prepaid expenses
2,977
4,772
Total current assets
29,041
17,214
Property and equipment, net
1,897
2,231
Right-of-use assets
1,252
1,381
Intangible assets, net
997
802
Other assets
367
367
Total assets
$
33,554
$
21,995
Liabilities and Stockholders’
Equity (Deficit)
Current liabilities:
Trade payables
$
1,899
$
4,947
Accrued liabilities
6,600
6,377
Series B-2 tranche liabilities
—
4,702
Series B-3 warrant liabilities
—
15,819
Short-term lease liabilities
379
370
Other current liabilities
427
142
Total current liabilities
9,305
32,357
Long-term lease liabilities
1,318
1,593
Contingent earnout liability
9,023
—
Warrant liabilities
5,421
369
Total liabilities
25,067
34,319
Commitments and contingencies
Convertible preferred stock
164,006
Stockholders’ equity (deficit):
Preferred stock, Series A,
$0.0001 par value per share. $10 liquidation value per share.
Authorized 10,000,000 and 0 shares at September 30, 2023, and
December 31, 2022, respectively; issued and outstanding, 4,015,002
and 0 shares at September 30, 2023, and December 31, 2022,
respectively
1
—
Common stock, $0.0001 par value
per share. Authorized 400,000,000 and 30,898,162 shares at
September 30, 2023, and December 31, 2022, respectively; issued and
outstanding, 26,316,681 and 347,926 shares at September 30, 2023,
and December 31, 2022, respectively
2
---
Additional paid-in capital
221,351
10,028
Accumulated deficit
(212,867
)
(186,358
)
Total stockholders’ equity (deficit)
8,487
(176,330
)
Total liabilities and stockholders’ equity
(deficit)
$
33,554
$
21,995
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231114785052/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
TriSalus Life Sciences (NASDAQ:TLSI)
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