TLSI on Nasdaq

TriSalus Life Sciences, Inc.

American surgical and medical instruments and apparatus company1

In its 2026 annual report the company says: “We are a growing, oncology focused medical technology business seeking to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies, and with our investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. Our ultimate goal is to transform the treatment paradigm for patients battling solid tumors.”3 It is headquartered in Westminster, Colorado.1 Its shares trade on Nasdaq under the symbol TLSI.1

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Last updated Oct 21, 2026.

Overview

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  • TickerTLSI on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersWestminster, Colorado1
  • Incorporated inDE2
  • Business address6272 West 91St Avenue, Westminster, Co 800312
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

We are a growing, oncology focused medical technology business seeking to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies, and with our investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 ("TRL9") agonist, for a range of different therapeutic and technology applications. Our ultimate goal is to transform the treatment paradigm for patients battling solid tumors. We have developed an innovative technology designed to overcome two of the most significant challenges that prevent optimal delivery and performance of therapeutics in these difficult-to-treat diseases: (i) high intratumoral pressure caused by tumor growth and collapsed vasculature restricting the delivery of oncology therapeutics and (ii) off target delivery. Nelitolimod, specifically, combined with our technology aims …3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

84.6%Gross margin4
-59.7%Operating margin4
-86.9%Net margin4
53.4%Revenue growth, 20254
-$18.9MFree cash flow4

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue15¢$7.0M
  • Research and development33¢$15.0M
  • Other costs51¢$23.2M
  • Income tax0¢$7.0K

Out of $45.2M in revenue.4 The company lost money this year.

Financial statements

Revenue564$45.2M in 2025+264% since 2022
0$20.0M$40.0M$60.0M2022: $12.4M$12.4M20222023: $18.5M$18.5M2023+49%2024: $29.4M$29.4M2024+59%2025: $45.2M$45.2M2025+53%
Gross profit564$38.2M in 2025+277% since 2022
0$10.0M$20.0M$30.0M$40.0M2022: $10.1M$10.1M20222023: $15.9M$15.9M2023+57%2024: $25.3M$25.3M2024+59%2025: $38.2M$38.2M2025+51%
Operating income7564-$26.9M in 2025+786% since 2021
-$60.0M-$40.0M-$20.0M02021: -$3.0M-$3.0M20212022: -$36.4M-$36.4M2022+1098%2023: -$54.5M-$54.5M2023+49%2024: -$36.2M-$36.2M2024−34%2025: -$26.9M-$26.9M2025−25%
Net income7564-$39.2M in 2025
-$60.0M-$40.0M-$20.0M0$20.0M2021: $4.8M$4.8M20212022: -$47.2M-$47.2M20222023: -$59.4M-$59.4M2023+26%2024: -$30.0M-$30.0M2024−49%2025: -$39.2M-$39.2M2025+31%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Revenue$45.2M$29.4M
Cost of goods sold$7.0M$4.1M
Gross profit$38.2M$25.3M
Research and development$15.0M$17.7M
Sales and marketing$28.7M$25.8M
General and administrative$21.5M$18.0M
Loss from operations-$26.9M-$36.2M
Interest income$555.0K$404.0K
Interest expense-$5.5M-$3.1M
Change in fair value of SEPA, warrant and revenue base redemption liabilities-$4.1M-$2.1M
Change in fair value of contingent earnout liability-$2.7M$11.2M
Other expense, net-$456.0K-$312.0K
Loss before income taxes-$39.2M-$30.0M
Income tax expense-$7.0K-$6.0K
Net loss-$39.2M-$30.0M
Series A Preferred Stock conversion inducement-$18.5M$0
Deemed dividend related to Series B-2 preferred stock down round provision-$11.9M$0
Undeclared dividends on Series A Preferred Stock$0-$3.2M
Net loss attributable to common stockholders-$69.7M-$33.2M
Net loss per share, basic (in dollars per share)-$1.84-$1.31
Net loss per share, diluted (in dollars per share)-$1.84-$1.31
Weighted average common shares outstanding, diluted (in shares)37.9M shares25.3M shares
Weighted average common shares outstanding, diluted (in shares)37.9M shares25.3M shares

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Corporate structure

TriSalus Life Sciences, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of TriSalus Life Sciences, Inc.

  • First Light Asset Management, LLC Filed SCHEDULE 13G/A on TriSalus Life Sciences, Inc., latest Jul 7, 2026 (2 filings since May 15, 2026)
  • James J. Pallotta Filed SCHEDULE 13G/A on TriSalus Life Sciences, Inc., latest May 20, 2026 (2 filings since Dec 4, 2024)
  • Utmost Group Plc Filed SCHEDULE 13G on TriSalus Life Sciences, Inc., latest May 12, 2026 (3 filings since Aug 18, 2025)
  • Nantahala Capital Management, LLC Filed SCHEDULE 13G/A on TriSalus Life Sciences, Inc., latest Nov 14, 2025 (2 filings since Aug 14, 2025)
  • Frankenius Equity AB Filed SCHEDULE 13D/A on TriSalus Life Sciences, Inc., latest Aug 4, 2025 (4 filings since Aug 21, 2023)
  • Mats Wahlstrom Filed SCHEDULE 13D/A on TriSalus Life Sciences, Inc., latest Aug 1, 2025 (3 filings since Aug 21, 2023)
  • Lombard International Assurance S.A. Filed SC 13G on TriSalus Life Sciences, Inc., latest Oct 21, 2024 (2 filings since Aug 23, 2023)
  • Unique Diamond Investments Ltd Filed SC 13G on TriSalus Life Sciences, Inc., latest Aug 29, 2023
  • Michael P. Stansky Filed SC 13G on TriSalus Life Sciences, Inc., latest Aug 22, 2023
  • Christopher C. Dewey Filed SC 13G on TriSalus Life Sciences, Inc., latest Aug 21, 2023
  • David J. Matlin Filed SC 13D on TriSalus Life Sciences, Inc., latest Aug 21, 2023
  • Gene R. McGrevin Filed SC 13G on TriSalus Life Sciences, Inc., latest Aug 21, 2023
  • TriSalus Life Sciences, Inc. Westminster, Colorado

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What TriSalus Life Sciences, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Finance-lease assets$79.0K4 Dec 31, 2025$128.0K4 Dec 31, 2024−38.3%
Operating-lease assets (leased space)$861.0K4 Dec 31, 2025$1.2M4 Dec 31, 2024−28.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$20.4M4 Dec 31, 2025$8.5M4 Dec 31, 2024+139.8%

Inventory

ItemLatestA year beforeChange
Inventory, total$3.1M4 Dec 31, 2025$4.0M4 Dec 31, 2024−24.0%
Raw materials$1.3M4 Dec 31, 2025$1.3M4 Dec 31, 2024−3.7%
Finished goods$1.9M4 Dec 31, 2025$2.7M4 Dec 31, 2024−30.3%

Properties, in its own words

Our principal office is located in Westminster, Colorado, where we lease approximately 21.0 thousand square feet of office, manufacturing, and warehouse space pursuant to a lease that expires on December 31, 2031. The initial lease included two extension options, each for five years. On July 17, 2024, we exercised one of the two options to extend the current lease for the Westminster facility for an additional period of five years commencing on January 1, 2027, and ending on December 31, 2031 ("Second Extended Lease Term"). We lease office facilities in Bannockburn, Illinois. We exited our laboratory space at Rhode Island Hospital in Providence, Rhode Island during the first half of 2025. We believe our facilities are adequate to meet our current needs, although we may seek to negotiate new leases or evaluate additional or alternate space for our operations. We believe appropriate alternative space will be readily available on commercially reasonable terms.

Item 2 of the 10-K filed Mar 5, 2026.3

Leadership

Who has led TriSalus Life Sciences, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (21)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerBrian F. Cox named May 8, 202535
  • Executive OfficerJames Young named May 8, 202535
  • Executive OfficerBryan F. Cox named Dec 30, 202436
  • Chief Administrative Officer and SecretaryRobert H. Weiss named Jun 22, 202337
  • DirectorAndrew F. von Eschenbach named Dec 30, 2024 to May 8, 202535
  • DirectorArjun F. Desai named Dec 30, 2024 to May 8, 202535
  • DirectorSean Murphy named Dec 30, 2024 to May 8, 202535
  • DirectorGeorge Kelly Martin named Dec 30, 202436

Former names

  • MedTech Acquisition CorpNov 30, 2020 to Aug 10, 20232
  • MedTech Acquisition CorporationOct 29, 2020 to Oct 29, 20202

Timeline

  1. Sep 22, 20268-K Other events38
  2. Aug 6, 20268-K Results of operations39
  3. May 14, 20268-K Shareholder vote40
  4. May 12, 20268-K Results of operations41
  5. Apr 29, 20268-K Executive or director change42
  6. Apr 7, 20268-K Executive or director change; Regulation FD disclosure43
  7. Mar 5, 20268-K Results of operations44
  8. Feb 20, 20268-K Entered a material agreement; Other events45
  9. Feb 9, 20268-K Executive or director change; Regulation FD disclosure46
  10. Jan 12, 20268-K Results of operations47
  11. Nov 13, 20258-K Results of operations48
  12. Oct 1, 20258-K Executive or director change49
  13. Aug 15, 2023New chief executive Mary T. Szela becomes CEO11
  14. Dec 28, 2020New chief executive Christopher C. Dewey becomes CEO12

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.96) a share, on Nov 13, 2025.50

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results39
  2. May 12, 2026Reported quarterly or annual results41
  3. Mar 5, 2026Reported quarterly or annual results44
  4. Jan 12, 2026Reported quarterly or annual results47
  5. Nov 13, 2025Reported quarterly or annual results48
  6. Aug 12, 2025Reported quarterly or annual results51
  7. May 15, 2025Reported quarterly or annual results52
  8. Apr 30, 2025Reported quarterly or annual results53

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

449 filings to the SEC since October 2021: 7 annual reports, 16 quarterly reports, 79 major events, 149 insider forms, 37 large holders, 3 private raises, 158 other. The latest 20:

  1. Oct 7, 20264 EDGAR
  2. Oct 7, 20264 EDGAR
  3. Oct 7, 20264 EDGAR
  4. Oct 7, 20264 EDGAR
  5. Sep 22, 20268-K EDGAR
  6. Aug 6, 202610-Q EDGAR
  7. Aug 6, 20268-K EDGAR
  8. Jul 7, 2026SCHEDULE 13G/A EDGAR
  9. Jul 6, 20264 EDGAR
  10. Jul 1, 20264 EDGAR
  11. Jul 1, 20265 EDGAR
  12. Jul 1, 20264 EDGAR
  13. Jul 1, 20265 EDGAR
  14. Jun 29, 20264 EDGAR
  15. Jun 29, 20263 EDGAR
  16. May 20, 2026SCHEDULE 13G/A EDGAR
  17. May 19, 20264 EDGAR
  18. May 18, 20264 EDGAR
  19. May 18, 20264 EDGAR
  20. May 18, 20264 EDGAR

The 449 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

47 open-market trades by officers, directors and large owners since October 2021: 25 buys and 22 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 15, 2026Marshak RichardChief Commercial OfficerSale543$2.67$1.4KForm 4
May 15, 2026Wahlstrom MatsDirectorBuy60,000$2.53$151.8KForm 4
May 15, 2026Stansky Michael PDirectorBuy610,000$2.50$1.5MForm 4
May 15, 2026Szela Mary TCEO and PresidentBuy39,682$2.59$102.8KForm 4
May 15, 2026Patience DavidChief Financial OfficerBuy7,100$2.43$17.3KForm 4
May 15, 2026Gordon Gary B.DirectorBuy10,000$2.46$24.6KForm 4
Mar 17, 2026Szela Mary TCEO and PresidentSale15,944$3.85$61.4KForm 4
Mar 16, 2026Devlin JodiChief of Clinical OperationsSale273$4.12$1.1KForm 4
Mar 16, 2026Cox Bryan F.Chief of ResearchSale579$4.12$2.4KForm 4
Mar 16, 2026Marshak RichardChief Commercial OfficerSale419$4.12$1.7KForm 4
Mar 16, 2026Stevens JenniferChief Regulatory OfficerSale774$4.12$3.2KForm 4
Mar 12, 2026Devlin JodiChief of Clinical OperationsSale1,772$4.09$7.2KForm 4
Mar 12, 2026Cox Bryan F.Chief of ResearchSale1,467$4.09$6.0KForm 4
Mar 12, 2026Marshak RichardChief Commercial OfficerSale1,589$4.09$6.5KForm 4
Mar 12, 2026Stevens JenniferChief Regulatory OfficerSale1,552$4.09$6.3KForm 4
Mar 11, 2026Devlin JodiChief of Clinical OperationsSale1,162$4.13$4.8KForm 4
Mar 11, 2026Cox Bryan F.Chief of ResearchSale1,138$4.13$4.7KForm 4
Mar 11, 2026Marshak RichardChief Commercial OfficerSale1,449$4.13$6.0KForm 4
Mar 11, 2026Stevens JenniferChief Regulatory OfficerSale1,204$4.13$5.0KForm 4
Mar 11, 2026Szela Mary TCEO and PresidentSale4,358$4.13$18.0KForm 4

All 47 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Mary SzelaCEO and President$600.9K$4.8M72
2025David PatienceChief Financial Officer(*)40$268.5K$3.4M72
2025Richard MarshakChief Commercial Officer$435.3K$1.6M72
2024Mary SzelaCEO and President$601.4K$4.1M72
2024Richard MarshakChief Commercial Officer$424.8K$1.4M72

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$40.9M 2023–2025
Money received by yearMoney received by year, 2023–2025: $40.9M in all. Private raises (Form D) $40.9M.$0$10M$20M$30M2023 · Private raises (Form D): $17.9M20232024 · Private raises (Form D): $1.0M20242025 · Private raises (Form D): $22.0M2025
Figures by year
YearPrivate raises (Form D)Total
2025$22.0M$22.0M
2024$1.0M$1.0M
2023$17.9M$17.9M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. May 2, 2025Raised $22 million in a private offering of equity35 Form D: 24 investors so far Form D
  2. Dec 17, 2024Raised $999,984 in a private offering of equity36 Form D: 6 investors so far Form D
  3. Jun 7, 2023Raised $17.9 million in a private offering of equity37 Form D: $50 million offered in all Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 79. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
First Light Asset Management, LLC6,552,491$29.8M1.8%+1,485,664
BlackRock, Inc.2,659,218$12.1M0.0%+1,159,671
Nantahala Capital Management, LLC2,000,000$9.1M0.3%−70,827
Vanguard Capital Management LLC1,729,385$7.9M0.0%+382,349
Cerity Partners LLC1,603,538$7.3M0.0%+816,266
Geode Capital Management, LLC1,190,067$5.4M0.0%+412,973
Gilder Gagnon Howe & Co LLC850,081$3.9M0.0%−38,434
State Street Corp610,963$2.8M0.0%+282,943
White Pine Capital LLC547,577$2.5M0.6%+183,922
Kennedy Capital Management LLC476,261$2.2M0.0%−8,981
Morgan Stanley401,814$1.8M0.0%+7,905
Northern Trust Corp379,572$1.7M0.0%+158,099
Vanguard Portfolio Management LLC329,464$1.5M0.0%+164,606
Vanguard Fiduciary Trust Co320,956$1.5M0.0%+102,604
Lionhunter Capital Management, LLC300,275$1.4M0.6%New
Perkins Capital Management Inc235,101$1.1M0.8%+5,000
UBS Group AG223,047$1.0M0.0%+143,495
Bank Of America Corp /de/205,342$934.3K0.0%+3,623
Royce & Associates LP200,060$910.3K0.0%No change
Corient Private Wealth LP147,152$669.5K0.0%+56,152
Aqr Capital Management LLC117,977$536.8K0.0%New
Bank of New York Mellon Corp111,534$507.5K0.0%+45,730
Charles Schwab Investment Management Inc107,945$491.1K0.0%+23,808
Goldman Sachs Group Inc82,398$374.9K0.0%+7,349
CWA Asset Management Group, LLC72,000$327.6K0.0%No change

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How TriSalus Life Sciences, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARTriSalus Life Sciences, Inc.1
  • CIK0001826667
  • Employer ID (EIN)85-30098693
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address6272 West 91St Avenue, Westminster, CO 800311
  • Phone415 336 89171
  • Shares outstanding61,574,600 as of Aug 4, 20269
  • Public float$111.5M as of Jun 30, 20253
  • AuditorGrant Thornton LLP, Chicago, Illinois PCAOB ID 248; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceOct 29, 20201
  • Filings493 in all: 4 (126), 8-K (87), 3 (34), 425 (28), 424B3 (23), 10-Q (17), CORRESP (17), EFFECT (17)1
    All 47 form types

    UPLOAD (15), SC 13G (14), S-4/A (8), SC 13G/A (7), 10-K (6), DEF 14A (6), POS AM (6), S-3 (5), SC 13D (5), SCHEDULE 13D/A (5), SCHEDULE 13G (5), DEFA14A (4), S-1 (4), S-1/A (4), S-8 (4), SC 13D/A (4), 10-K/A (3), 424B5 (3), ARS (3), D (3), S-4 (3), SC TO-I/A (3), SCHEDULE 13G/A (3), 5 (2), NT 10-K (2), PRE 14A (2), SC TO-I (2), SEC STAFF LETTER (2), 10-Q/A (1), 144 (1), 25-NSE (1), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), DEFM14A (1), DRS (1), NT 10-Q (1), S-1MEF (1)

  • Latest filingsAnnual report (10-K) Mar 5, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Mar 31, 2026
    Latest 8-K (8-K) Sep 22, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.0001 par valueTLSINasdaq
Warrants, each whole warrant exercisable for one share of registrant's common stock at an exercise price of $11.50 per shareTLSIWNasdaq

From the cover page of the 10-K filed Mar 5, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks TriSalus Life Sciences, Inc. names in Item 1A of its 10-K filed Mar 5, 2026: 68 risks under these headings, as written.3

  • Risks Related to Our Financial Condition
  • We have a limited operating history, have incurred significant losses since our inception and anticipate incurring increasing expenses and continuing losses for the foreseeable future.
  • Until we are able to generate significant revenues or achieve profitability through product sales, we may require substantial additional capital to finance our operations and continue development of our product candidates. We cannot be certain that such additional financing will be available on terms favorable to us, or at all, which could limit our ability to grow and jeopardize our ability to continue our business operations.
  • We may not be able to generate sufficient cash to service our indebtedness or borrow additional funds pursuant to our Loan Facility.
  • Any acquisitions, strategic investments, entries into new businesses, joint ventures, divestitures, and other transactions could fail to achieve strategic objectives, disrupt our ongoing operations, result in operating difficulties, liabilities and expenses, harm our business, or negatively impact our results of operations.
  • The Dynavax Agreement, entered into by Legacy TriSalus in connection with its purchase of nelitolimod, requires us to make potentially significant payments to Dynavax before we will have regulatory approval of nelitolimod and be able to generate revenue from sales of nelitolimod.
  • Risks Related to TriNav
  • Our revenue is primarily generated from sales of our TriNav device and we are therefore highly dependent on it for our success. Failure to achieve continued market acceptance of TriNav for any reason will harm our business and future prospects.
  • Our business is dependent upon the continued adoption of TriNav by hospitals and physicians.
  • Any change to TriNav’s reimbursement status that reduces our level of reimbursement could cause TriNav sales to materially decline and impede market adoption.
  • Increases in costs, disruption of supply or shortage of materials could harm our business.
  • Risks Related to Nelitolimod and Product Development
The other 59 risks
  • We are early in our pharmaceutical development efforts for nelitolimod, and if we are unable to advance our product candidates, including nelitolimod in clinical development for any reason (including due to lack of funding), obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business, results of operations, financial condition and prospects may be materially adversely affected.
  • Clinical trials of our product candidates or potential product candidates may fail to produce results necessary to support regulatory clearance or authorization.
  • Interim, “topline” and preliminary data from clinical trials of our product candidates may change as more patient data becomes available and are subject to confirmation, audit, and verification procedures that could result in material changes in the final data.
  • Delays in clinical trials are common and have many causes, and any delay could result in increased costs to us and could jeopardize or delay our ability to obtain regulatory approval and commence future product sales. We may also find it difficult to enroll patients in our clinical trials, which could delay or prevent the development of our product candidates.
  • Use of toll-like receptor (TLR) agonist, including nelitolimod, may negatively impact the immune system. Serious adverse event data relating to TLR agonists may require us to reduce the scope of or discontinue certain of our pre-clinical or clinical activities.
  • Even if we obtain regulatory approval for our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community, which could materially adversely impact our business, results of operations and financial condition.
  • Risks Related to Our Business and Industry
  • Changes in existing third-party coverage or our inability to secure and maintain favorable reimbursement may impact our ability to sell our products, which would materially and adversely impact our business, results of operations, financial condition and prospects.
  • The business and industry in which we participate are highly competitive. If we are unable to compete effectively, we will not be able to establish our products in the marketplace or maintain or grow our products’ market share in the marketplace, and as a result, our business and results of operations will be adversely impacted.
  • We may, in the future, enter into material collaborations, in-licensing arrangements, joint ventures, or strategic alliances with third parties that may not result in the development of commercially viable products or the generation of significant or any future revenues. Alternatively, part of our strategy is to enter into such kinds of relationships with third parties involving our products and product candidates, and we may not be able to do so on acceptable terms or at all.
  • We generally do not have long-term contractual commitments from our customers, and our customers may choose not to enter into new agreements with us.
  • We depend on our senior management team and the loss of one or more key employees or an inability to attract and retain highly skilled employees could adversely affect our business.
  • If we fail to promote, protect, and maintain our brand in a cost-effective manner, we may lose market share and our ability to commercialize our products and revenues will suffer.
  • The manufacturing of our product candidates may require outsourced, custom manufacturing, and we may encounter difficulties in production, particularly with respect to formulation, process development or scaling up of our manufacturing capabilities. If our third-party manufacturers or suppliers encounter such difficulties, our ability to provide supply of product candidates for preclinical studies, clinical trials or products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
  • We currently rely on, and may in the future rely on, third-party contractors, including certain suppliers and manufacturers, to supply and manufacture preclinical, clinical and commercial drug supplies for nelitolimod and any future product candidates.
  • Our risk management processes and procedures may not be effective.
  • If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
  • Natural or man-made disasters and other similar events may significantly disrupt our business, and negatively impact our business, financial condition and results of operations.
  • Risks Related to Our Legal and Regulatory Environment
  • We are subject to numerous complex regulatory requirements, and failure to comply with these regulations, or the cost of compliance with these regulations, may harm our business.
  • The complexity of a combination product that includes a drug and a medical device presents additional, unique development and regulatory challenges, which may adversely impact our development plans and our ability to obtain regulatory approval or clearance of our product candidates.
  • We intend to use the FDA’s expedited drug development programs for nelitolimod but may not be able to achieve expedited development or approval for this product candidate.
  • Disruptions at the FDA, SEC and other government agencies (e.g., CMS) caused by funding shortages or global health concerns could hinder our ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Even if we complete the necessary preclinical studies and clinical trials, the regulatory approval or clearance process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals or clearances for the commercialization of nelitolimod or any future product candidates. If we or any future collaborators are not able to obtain, or if there are delays in obtaining, required regulatory approvals or clearances, we or they will not be able to commercialize nelitolimod, and our ability to generate revenue will be materially impaired.
  • Even if we obtain regulatory approval or clearance for nelitolimod or any future product candidates, such product candidates will remain subject to ongoing regulatory oversight.
  • If any of our product candidates receives marketing approval or clearance and we or others later discover that the product is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the product could be compromised.
  • Healthcare reform and other governmental and private payor initiatives may have an adverse effect upon, and could prevent, the commercial success of our products or product candidates.
  • TriNav and the PRVI device must be manufactured in accordance with federal and foreign regulations, and we or any of our suppliers or third-party manufacturers could be forced to recall the products or terminate production if we fail to comply with these regulations.
  • If treatment guidelines for the cancer indications that we are targeting change or the standard of care evolves, we may need to redesign our preclinical or clinical trials of, or seek new marketing authorization from, the FDA for any approved products.
  • Our relationships with customers, hospitals, physicians, and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • We could be subject to litigation that could have an adverse effect on our business and operating results.
  • Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
  • We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, policies and other obligations related to data privacy and security. Our (or the third parties with whom we work) actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes is limited.
  • Risks Related to Our Intellectual Property
  • Failure to obtain, adequately protect, maintain or enforce our intellectual property rights could substantially harm our business and results of operations.
  • The expiration or loss of patent protection may adversely affect our future revenues.
  • If we do not obtain protection under the Hatch-Waxman Amendments by extending the patent term, our business may be harmed.
  • We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
  • We may be subject to claims that we or our employees, consultants, contractors or advisors have infringed, misappropriated or otherwise violated the intellectual property of a third party, or claiming ownership of what we regard as our own intellectual property.
  • Our business model may require reliance on third parties and the need to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed, and if we are unable to protect the confidentiality of our trade secrets, the value of our intellectual property could be materially adversely affected and our business would be harmed.
  • Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products and product candidates.
  • Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations to our licensors.
  • If we fail to comply with our obligations under any agreements, we may be required to pay damages and could lose intellectual property rights that are necessary or useful for developing and protecting our product candidates.
  • If we do not obtain protection under the Hatch-Waxman Amendments by obtaining data exclusivity, our business may be harmed.
  • If our trademarks are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Risks Related to the Ownership of Our Securities
  • We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management now devotes substantial time to new compliance initiatives and corporate governance practices. We may fail to comply with the rules that apply to public companies, including Section 404 of the Sarbanes-Oxley Act, which could result in sanctions or other penalties that would adversely impact our business.
  • Our management has identified material weaknesses in its internal control over financial reporting and we may identify additional material weaknesses in the future. If we fail to remediate the unremediated material weakness or if we otherwise fail to establish and maintain effective control over financial reporting, it may adversely affect our ability to accurately and timely report our financial results, and may adversely affect investor confidence and business operations.
  • If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired.
  • The price of our securities has been and may continue to be volatile.
  • We may be unable to maintain the listing of our securities on Nasdaq in the future.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.
  • If our operating and financial performance in any given period does not meet the guidance provided to the public or the expectations of investment analysts, the market price of Common Stock may decline.
  • We could be subject to securities class action litigation.
  • Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our securities.
  • Sales of our securities or the perception of such sales, by us or our equity holders, in the public market or otherwise, could cause the market price for our securities to decline.
  • We are a smaller reporting company within the meaning of the Securities Act and, if we take advantage of certain exemptions from disclosure requirements available to smaller reporting companies, our securities may be less attractive to investors and it may be more difficult to compare our performance with other public companies.
  • Anti-takeover provisions contained in our Certificate of Incorporation and Bylaws, as well as provisions of Delaware law, could limit the ability of stockholders to take certain actions and could delay or discourage takeover attempts that stockholders may consider favorable.
  • Our Certificate of Incorporation designates the Delaware Court of Chancery or Delaware state or U.S. federal district courts as the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit such stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, other employees or other stockholders.
  • Our Certificate of Incorporation, to the extent permitted by applicable law, contains provisions renouncing our interest and expectation to participate in certain corporate opportunities identified or presented to our non- employee directors or stockholders.

Legal proceedings

From time to time, we may be subject to legal proceedings. We are not currently a party to or aware of any pending or threatened legal proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.3

Sources

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