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TRISALUS LIFE SCIENCES, INC.
Condensed Consolidated Balance Sheets
(unaudited, in thousands except share and per
| June 30, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 3,904 | $ | 9,414 | ||||
| Accounts receivable | 2,094 | 1,557 | ||||||
| Inventory, net | 1,522 | 1,471 | ||||||
| Prepaid expenses | 4,859 | 4,772 | ||||||
| Total current assets | 12,379 | 17,214 | ||||||
| Property and equipment, net | 1,885 | 2,231 | ||||||
| Right-of-use assets | 1,322 | 1,381 | ||||||
| Intangible assets, net | 858 | 802 | ||||||
| Other assets | 367 | 367 | ||||||
| Total assets | $ | 16,811 | $ | 21,995 | ||||
| Liabilities, Convertible Preferred Stock and Stockholders' Deficit | ||||||||
| Current liabilities: | ||||||||
| Trade payables | $ | 4,297 | $ | 4,947 | ||||
| Accrued liabilities | 9,106 | 6,377 | ||||||
| Series B-2 tranche liabilities | 959 | 4,702 | ||||||
| Series B-3 warrant liabilities | 17,190 | 15,819 | ||||||
| Short-term lease liabilities | 384 | 370 | ||||||
| Other current liabilities | 253 | 141 | ||||||
| Total current liabilities | 32,189 | 32,356 | ||||||
| Long-term lease liabilities | 1,410 | 1,593 | ||||||
| Warrant liabilities | 262 | 369 | ||||||
| Total liabilities | 33,861 | 34,318 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock | 181,313 | 164,006 | ||||||
| Stockholders' deficit: | ||||||||
| Common stock, $0.001 par value per share. Authorized 1,250,000,000 shares at June 30, 2023, and December 31, 2022, respectively; issued and outstanding, 18,138,685 and 14,075,524 shares at June 30, 2023, and December 31, 2022, respectively | 18 | 14 | ||||||
| Additional paid-in capital | 13,200 | 10,015 | ||||||
| Accumulated deficit | (211,581 | ) | (186,358 | ) | ||||
| Total stockholders' deficit | (198,363 | ) | (176,329 | ) | ||||
| Total liabilities, convertible preferred stock and stockholders' deficit | $ | 16,811 | $ | 21,995 |
See accompanying notes to condensed consolidated
financial statements.
TRISALUS LIFE SCIENCES, INC.
Condensed Consolidated Statements of Operations
(unaudited, in thousands except share and per
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue | $ | 4,612 | $ | 2,878 | $ | 7,596 | $ | 5,248 | ||||||||
| Cost of goods sold | 772 | 364 | 1,434 | 741 | ||||||||||||
| Gross profit | 3,840 | 2,514 | 6,162 | 4,507 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 6,862 | 5,516 | 12,504 | 10,283 | ||||||||||||
| Sales and marketing | 3,492 | 3,146 | 6,741 | 5,851 | ||||||||||||
| General and administrative | 4,920 | 2,517 | 8,472 | 4,929 | ||||||||||||
| Loss from operations | (11,434 | ) | (8,665 | ) | (21,555 | ) | (16,556 | ) | ||||||||
| Interest income | 36 | 25 | 71 | 26 | ||||||||||||
| Interest expense | (4 | ) | - | (9 | ) | - | ||||||||||
| Loss on equity issuance | (3,604 | ) | - | (4,189 | ) | - | ||||||||||
| Change in fair value of tranche and warrant liabilities | 1,070 | - | 3,491 | - | ||||||||||||
| Other income and expense, net | (25 | ) | (36 | ) | (43 | ) | (19 | ) | ||||||||
| Loss before income taxes | (13,961 | ) | (8,676 | ) | (22,234 | ) | (16,549 | ) | ||||||||
| Income tax benefit | (13 | ) | (3 | ) | (8 | ) | (3 | ) | ||||||||
| Net loss available to common stockholders | $ | (13,974 | ) | $ | (8,679 | ) | $ | (22,242 | ) | $ | (16,552 | ) | ||||
| Deemed dividend related to Series B-2 preferred stock down round provision | $ | (2,022 | ) | $ | - | $ | (2,981 | ) | $ | - | ||||||
| Net loss attributable to common stockholders | $ | (15,996 | ) | $ | (8,679 | ) | $ | (25,223 | ) | $ | (16,552 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.89 | ) | $ | (0.75 | ) | $ | (1.48 | ) | $ | (1.39 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 18,056,822 | 12,272,254 | 17,068,505 | 11,890,802 |
See accompanying notes to condensed consolidated
financial statements.
TRISALUS LIFE SCIENCES, INC.
Condensed Consolidated Statements of Stockholders'
(unaudited, in thousands except share data)
| Six months ended June 30, 2022 | ||||||||||||||||||||
| Common stock | Additional | Accumulated | ||||||||||||||||||
| Shares | Amount | paid-in capital | deficit | Total | ||||||||||||||||
| At December 31, 2021 | 10,719,806 | $ | 11 | $ | 6,727 | $ | (136,342 | ) | $ | (129,604 | ) | |||||||||
| Exercise of options | 1,401,250 | 1 | 60 | - | 61 | |||||||||||||||
| Stock-based compensation | 0 | - | 62 | - | 62 | |||||||||||||||
| Net loss | 0 | - | - | (7,873 | ) | (7,873 | ) | |||||||||||||
| At March 31, 2022 | 12,121,056 | $ | 12 | $ | 6,849 | $ | (144,215 | ) | $ | (137,354 | ) | |||||||||
| Exercise of options | 379,989 | - | 4 | - | 4 | |||||||||||||||
| Stock-based compensation | - | - | 70 | - | 70 | |||||||||||||||
| Net loss | - | - | - | (8,679 | ) | (8,679 | ) | |||||||||||||
| At June 30, 2022 | 12,501,045 | $ | 12 | $ | 6,923 | $ | (152,894 | ) | $ | (145,959 | ) |
| Six months ended June 30, 2023 | ||||||||||||||||||||
| Common stock | Additional | Accumulated | ||||||||||||||||||
| Shares | Amount | paid-in capital | deficit | Total | ||||||||||||||||
| At December 31, 2022 | 14,075,524 | $ | 14 | $ | 10,015 | $ | (186,358 | ) | $ | (176,329 | ) | |||||||||
| Exercise of options | 3,877,352 | 4 | 46 | - | 50 | |||||||||||||||
| Stock-based compensation | - | - | 73 | - | 73 | |||||||||||||||
| Deemed dividend | - | - | 959 | (959 | ) | - | ||||||||||||||
| Net loss | - | - | - | (8,268 | ) | (8,268 | ) | |||||||||||||
| At March 31, 2023 | 17,952,876 | 18 | 11,093 | (195,585 | ) | (184,474 | ) | |||||||||||||
| Exercise of options | 185,809 | - | 16 | - | 16 | |||||||||||||||
| Stock-based compensation | - | - | 69 | - | 69 | |||||||||||||||
| Deemed dividend | - | - | 2,022 | (2,022 | ) | - | ||||||||||||||
| Net loss | - | - | - | (13,974 | ) | (13,974 | ) | |||||||||||||
| At June 30, 2023 | 18,138,685 | $ | 18 | $ | 13,200 | $ | (211,581 | ) | $ | (198,363 | ) |
See accompanying notes to condensed consolidated
financial statements.
TRISALUS LIFE SCIENCES, INC.
Condensed Consolidated Statements of Cash Flows
(unaudited, in thousands)
| Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss available to common stockholders | $ | (22,242 | ) | $ | (16,552 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 334 | 281 | ||||||
| Gain on fair value adjustment of warrants | (3,491 | ) | (19 | ) | ||||
| Non-cash interest expense | - | 197 | ||||||
| Loss on equity issuance | 4,189 | - | ||||||
| Stock-based compensation expense | 142 | 132 | ||||||
| Gain (loss) on disposal of fixed assets | 60 | 49 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (537 | ) | (132 | ) | ||||
| Inventory | (51 | ) | (55 | ) | ||||
| Prepaid expenses | (266 | ) | (1,471 | ) | ||||
| ROU assets | 59 | - | ||||||
| Trade payables, accrued expenses and other liabilities | 2,064 | (1,116 | ) | |||||
| Net cash used in operating activities | (19,739 | ) | (18,686 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchases of property and equipment | (38 | ) | (400 | ) | ||||
| Cash paid for intellectual property and licenses | (66 | ) | (21 | ) | ||||
| Net cash used in investing activities | (104 | ) | (421 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from the issuance of preferred stock | 9,184 | 3,499 | ||||||
| Proceeds from exercise of preferred stock warrants | 5,126 | - | ||||||
| Payments on finance lease liabilities | (43 | ) | (3 | ) | ||||
| Cash proceeds from the exercise of stock options and warrants for common stock | 66 | 66 | ||||||
| Net cash provided by financing activities | 14,333 | 3,562 | ||||||
| Decrease in cash, cash equivalents and restricted cash | (5,510 | ) | (15,545 | ) | ||||
| Cash, cash equivalents and restricted cash, beginning of period | 9,664 | 30,301 | ||||||
| Cash, cash equivalents and restricted cash, end of period | $ | 4,154 | $ | 14,756 |
See accompanying notes to condensed consolidated
financial statements.
TriSalus Life Sciences, Inc.
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
TriSalus Life Sciences, Inc. (the "Company,"
"we," "us"), a Delaware corporation, was incorporated in 2009 as Surefire Medical, Inc. We began doing business
as TriSalus Life Sciences ("TriSalus") in 2018, and changed our name to TriSalus Life Sciences, Inc. in August 2021.
We are engaged in the research, development, and sales of innovative drug delivery technology and immune-oncology therapeutics to improve
outcomes in difficult to treat liver and pancreatic cancer. Our technology is utilized in the delivery of our therapeutics and administered
by interventional radiologists. We are developing and marketing two product lines - Pressure Enabled Drug Delivery
("PEDD ) infusion systems, in use today, and an investigational agent, SD-101, which shows potential to enhance immune system
response in the treatment of hepatocellular cancer, pancreatic cancer and other liver solid tumors. Our PEDD with SmartValve is
the only technology designed to work in synchrony with the cardiac cycle to open collapsed vessels in the tumor to enable deeper perfusion
and improve therapeutic drug delivery in tumors with high intratumoral pressure. PEDD with SmartValve has been shown in prospective and
retrospective clinical studies and in multiple pre-clinical models to improve therapy uptake and tumor response.
TriNav is the newest therapy delivery device
with SmartValve technology for the proprietary PEDD approach. Current sales consist of the TriNav Infusion System, introduced in 2020,
and a family of related guiding catheters. In 2020, we gained transitional pass-through payments ("TPT") approval from the
Centers for Medicare & Medicaid Services ("CMS"), which allows hospitals to cover the cost of using TriNav. The approval
is scheduled to expire at the end of 2023. On June 1, 2023, TriSalus applied for a new technology Ambulatory Payment Classifications
("APC") code with CMS and met with them on June 26, 2023, to review the application. If granted, the new technology APC
code would allow for continuing reimbursement for the TriNav device at similar reimbursement rates for the period beginning January 1,
2024, but there can be no assurance that such code will be granted or that continuing reimbursement will be available at similar reimbursement
We believe the full potential of our technology
can be realized through the combination of our drug delivery technology with immune-oncology drugs, so, in July 2020, we acquired
our first immune-oncology drug, SD-101, and began clinical development of SD-101 for treatment of liver and pancreatic cancers.
We have funded operations to date principally
with proceeds from the sale of preferred stock and from the issuance of debt and convertible debt. Since inception of the Company in 2009
through June 30, 2023, we have issued for cash $122,980 of preferred stock, which, along with $523 from common stock and $57,466
from convertible notes and warrants, has funded our accumulated deficit of $211,581. During the six months ended June 30, 2023,
we raised $9,183 in cash through the issuance of Series B-2 preferred stock, $5,127 in cash through the issuance of Series B-3
preferred stock, and $66 from the exercise of stock options.
As of June 30, 2023, we had cash and cash
equivalents of $3,904. The Company is still in its early stage, has yet to generate revenues sufficient to create positive cash flow and
has an accumulated deficit of $211,581 as of June 30, 2023. We are currently undergoing a strategic transformation from a company
focused solely on the sale of our infusion systems to a therapeutics company whereby our medical devices will be marketed alongside the
pharmaceutical drugs and other treatments that the devices deliver to patients. This transformation requires that we restructure our operating
infrastructure, resulting in an increase in operating expenses - including the development of a candidate pharmaceutical - that,
in the short term, will not be fully offset by increased revenues. We expect that, absent the plans described below, cash on hand will
last into the third quarter of 2023.
In accordance with ASC Topic 205-40, Presentation
of Financial Statements, Going Concern: Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern,
we are required to evaluate whether there is substantial doubt about our ability to continue as a going concern each reporting period.
In evaluating our ability to continue as a going concern, management projected our cash flow sources and needs and evaluated the conditions
and events have raised substantial doubt about our ability to continue as a going concern within one year after the date that these consolidated
financial statements were issued. Management's plans to address the conditions and events have considered our current projections
of future cash flows, current financial condition, sources of liquidity and debt obligations for at least one year from the date of issuance
of these consolidated financial statements in considering whether we have the ability to fund future operations and meet our obligations
as they become due in the normal course of business.
Our ability to fund future operations and to continue
the execution of our long-term business plan and strategy, including our transformation into a therapeutics company, will require that
we raise additional capital through the issuance of additional equity and/or long-term debt. There can be no assurance that we will be
able to raise such additional financing or, if available, that such financing can be obtained on satisfactory terms. If adequate capital
resources are not available on a timely basis, we intend to consider limiting our operations substantially. This limitation of operations
could include a hiring freeze, reductions in our workforce, reduction in cash compensation, deferring clinical trials and capital expenditures,
and reducing other operating costs.
Our current operating plan, which is in part determined
based on our most recent results and trends, along with the items noted above, causes substantial doubt to exist about our ability to
continue as a going concern and management's plans do not alleviate the existence of substantial doubt. Our financial statements
have been prepared assuming we will continue as a going concern, which contemplates the continuity of normal business activities and realization
of assets and settlement of liabilities in the normal course of business, and do not include any adjustments that might be necessary should
we be unable to continue as a going concern.
We are subject to various risks and uncertainties
frequently encountered by companies in the early stages of growth, particularly companies in the rapidly evolving market for medical technology-based
and pharmaceutical products and services. Such risks and uncertainties include, but are not limited to, a limited operating history, need
for additional capital, a volatile business and technological environment, the process to test and obtain approval to market the candidate
pharmaceutical, an evolving business model, and demand for our products. To address these risks, we must, among other things, gain access
to capital in amounts and on acceptable terms, maintain and increase our customer base, implement and successfully execute our business
strategy, develop the candidate pharmaceutical, continue to enhance our technology, provide superior customer service, and attract, retain,
and motivate qualified personnel. There can be no guarantee that we will be successful in addressing such risks.
On August 10, 2023, we completed the Business
Combination with MedTech Acquisition Corporation, in which we received $42,854, less expenses of the Business Combination of $6,050.
Basis of Presentation
The accompanying interim unaudited condensed consolidated
financial statements have been prepared in accordance with the rules and regulations of the United States Securities and Exchange
Commission ("SEC"). The interim unaudited condensed consolidated financial statements are comprised of the financial statements