TriSalus Reports Q3 2024 Financial Results and Provides Business Update
TriSalus Life Sciences reported strong Q3 2024 results with revenues of $7.3 million, up 42% year-over-year, and nine-month revenues of $21.2 million, up 66%. The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter for larger vessels, expanding into the $375 million embolization market. For 2025, TriSalus projects over 50% sales growth, 20%+ reduction in operating expenses, and expects positive EBITDA and cash flow in H2 2025. The company presented positive Phase 1 data from the PERIO-01 trial in uveal melanoma patients and is seeking strategic partnerships for further development.
TriSalus Life Sciences ha riportato risultati solidi nel terzo trimestre del 2024, con ricavi di $7,3 milioni, in aumento del 42% rispetto all'anno precedente, e ricavi di nove mesi pari a $21,2 milioni, con un incremento del 66%. L'azienda ha lanciato il TriNav LV Infusion System e il TriGuide Guiding Catheter per vasi di maggiori dimensioni, espandendosi nel mercato dell'embolizzazione del valore di $375 milioni. Per il 2025, TriSalus prevede una crescita delle vendite superiore al 50%, una riduzione delle spese operative superiore al 20% e un EBITDA e un flusso di cassa positivi nella seconda metà del 2025. L'azienda ha presentato dati positivi dalla fase 1 dello studio PERIO-01 su pazienti affetti da melanoma uveale e sta cercando partnership strategiche per ulteriori sviluppi.
TriSalus Life Sciences informó resultados sólidos para el tercer trimestre de 2024, con ingresos de $7.3 millones, un aumento del 42% interanual, y ingresos de nueve meses de $21.2 millones, un incremento del 66%. La compañía lanzó el TriNav LV Infusion System y el TriGuide Guiding Catheter para vasos más grandes, expandiéndose al mercado de embolización de $375 millones. Para 2025, TriSalus proyecta un crecimiento de ventas superior al 50%, una reducción de más del 20% en los gastos operativos y espera un EBITDA y flujo de caja positivos en la segunda mitad de 2025. La empresa presentó datos positivos de la fase 1 del ensayo PERIO-01 en pacientes con melanoma uveal y busca asociaciones estratégicas para un desarrollo adicional.
TriSalus Life Sciences가 2024년 3분기 실적을 발표했으며, 수익이 730만 달러로 지난해 대비 42% 증가했으며, 9개월 실적은 2,120만 달러로 66% 증가했습니다. 이 회사는 더 큰 혈관을 위한 TriNav LV Infusion System과 TriGuide Guiding Catheter를 출시하여 3억 7500만 달러 규모의 색전시장으로 진출하였습니다. TriSalus는 2025년 50% 이상의 매출 성장과 20% 이상의 운영비 절감을 예상하며, 2025년 하반기에는 긍정적인 EBITDA와 현금 흐름을 기대하고 있습니다. 이 회사는 유혈관 멜라노마 환자에 대한 PERIO-01 시험의 긍정적인 1상 데이터를 발표했으며, 추가 발전을 위해 전략적 파트너십을 찾고 있습니다.
TriSalus Life Sciences a annoncé de solides résultats pour le troisième trimestre 2024, avec des revenus de 7,3 millions de dollars, en hausse de 42 % par rapport à l'année précédente, et des revenus de neuf mois de 21,2 millions de dollars, soit une augmentation de 66 %. L'entreprise a lancé le TriNav LV Infusion System et le TriGuide Guiding Catheter pour des vaisseaux plus grands, s'ouvrant ainsi au marché de l'embolisation d'une valeur de 375 millions de dollars. Pour 2025, TriSalus prévoit une croissance des ventes de plus de 50%, une réduction des frais d'exploitation de plus de 20% et s'attend à un EBITDA et un flux de trésorerie positifs au second semestre 2025. L'entreprise a présenté des données positives de la phase 1 de l'essai PERIO-01 chez des patients atteints de mélanome uvéal et recherche des partenariats stratégiques pour un développement ultérieur.
TriSalus Life Sciences hat starke Ergebnisse für das dritte Quartal 2024 gemeldet, mit Einnahmen von 7,3 Millionen Dollar, was einem Anstieg von 42% im Vergleich zum Vorjahr entspricht, und Neunmonatseinnahmen von 21,2 Millionen Dollar, was einem Anstieg von 66% entspricht. Das Unternehmen hat das TriNav LV Infusion System und den TriGuide Guiding Catheter für größere Gefäße eingeführt und sich somit auf den 375-Millionen-Dollar-Markt für Embolisation ausgeweitet. Für 2025 prognostiziert TriSalus ein Verkaufswachstum von über 50%, eine Reduzierung der Betriebskosten um über 20% und erwartet einen positiven EBITDA und Cashflow in der zweiten Hälfte von 2025. Das Unternehmen präsentierte positive Phase-1-Daten aus der PERIO-01-Studie bei Patienten mit uvealem Melanom und sucht strategische Partnerschaften für die Weiterentwicklung.
- Revenue growth of 42% YoY in Q3 to $7.3M and 66% YoY for nine months to $21.2M
- Strong gross margins of 86% for both Q3 and nine-month period
- Operating losses decreased from $18.6M to $8.7M in Q3 2024
- Market expansion potential with TriNav LV system into $375M liver embolization market
- Additional $400M market opportunity in thyroid embolization
- Positive Phase 1 results from PERIO-01 trial
- Net loss of $2.4M in Q3 and $19.9M for nine months
- Cash position of $11.3M as of September 30, 2024
- Dependent on OrbiMed debt facility for cash runway
Insights
The Q3 results and 2025 guidance present a compelling growth trajectory. Revenue grew 42% YoY to
The clinical developments show strategic diversification. The PROTECT registry trial targeting multinodular goiters represents a smart expansion into thyroid embolization, addressing a significant market opportunity with
– Reported Q3 and nine-month revenues of
– Provided 2025 guidance with expectations of over
– Launched TriNav® LV Infusion System and TriGuide™ Guiding Catheter for larger vessels and complex cases, expanding the TriNav system’s full access to the
– Initiated the PROTECT registry trial using the TriNav system to treat multinodular goiters, expanding the TriNav system’s reach into the
– Presented positive Phase 1 data from PERIO-01 trial in patients with uveal melanoma with liver metastases (UM-LM) at the Society for Immunotherapy of Cancer (SITC) meeting and announced the strategic decision to seek a partner to drive further development of this indication
– Hosting earnings call on November 14, 2024 at 9:00 a.m. EST
“We enter the final quarter of 2024 with great momentum, both commercially and clinically, and we are positioned well for an even greater 2025,” stated Mary Szela, President and Chief Executive Officer of TriSalus Life Sciences. “Commercially, we enjoyed a strong third quarter highlighted by
“With the successful completion of our Phase 1 dose escalation study enrollment in UM-LM, we are actively pursuing a strategic partnership for nelitolimod,” continued Ms. Szela. “This follows the successful presentation of positive Phase 1 results from our PERIO-01 dose escalation study in UM-LM at SITC. Additionally, by mid-2025, we anticipate data from our Phase 1 study in locally advanced pancreatic cancer, which will guide our next steps.”
“Our clinical development efforts for the TriNav system have expanded with the launch of the DELIVER program, starting with the PROTECT registry trial for patients with multinodular goiter. There is significant potential to broaden our addressable market by
“Finally, we are initiating 2025 guidance that calls for greater than
Third Quarter Business Update
TriNav System Large Vessel Launch
TriSalus recently expanded its portfolio of Pressure-Enabled Drug Delivery™ (PEDD™) devices with the launch of the TriNav LV Infusion System and TriGuide Guiding Catheter to optimize therapeutic delivery for patients with larger vessels. The TriNav LV system is suitable for patients with vessels sized between 3.5 and 5.0 mm and is expected to allow the Company to meaningfully expand its addressable liver embolization market. The TriGuide Guiding Catheter has a larger inner diameter, lubricious inner lining, and reverse curve design to support femoral access for the TriNav LV system, which the Company believes will enhance procedural efficiency. These new products are eligible for the same HCPCS reimbursement codes as existing TriNav products, enabling seamless integration into current billing structures.
DELIVER and PROTECT Updates
During the quarter, TriSalus advanced the DELIVER clinical program, a series of clinical trials designed to demonstrate enhanced safety and efficacy across a broad spectrum of complex, difficult-to-treat patients through investigator-initiated studies, further underscoring the impact of PEDD technology. A key focus of the DELIVER program is to investigate the potential of combining use of the TriNav system with these therapies to enhance effectiveness and address resistance mechanisms in challenging cancers.
The first of these is a registry study called PROTECT (Pressure Enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease), which has been initiated, and TriSalus intends to enroll 100 patients across five leading academic sites. It is estimated that approximately
The Company anticipates opening additional DELIVER studies in the first half of 2025 and will provide more details as those studies commence.
PERIO Trial Update
TriSalus presented Phase 1 results from the PERIO-01 clinical trial at the recent SITC meeting. This dose escalation trial investigated the use of the PEDD method of nelitolimod in patients with UM-LM. The results suggested that PEDD-administered nelitolimod, combined with immune checkpoint inhibitors, provides promising clinical benefits and durable survival in heavily pretreated patients with UM-LM and a favorable safety profile. The Company is actively exploring strategic partnerships to advance this indication further.
The Company also completed enrollment of 13 patients in its PERIO-03 Phase 1 dose escalation study of nelitolimod in locally advanced pancreatic cancer. Evidence gathered thus far supports a strong safety profile and further exploration of nelitolimod combined with the TriNav pancreatic infusion technology. The Company will outline the next steps once the final data are available in mid-2025.
Financial Results for Q3 2024
Revenue, all from the sale of the TriNav system, was
Gross margins were
Operating losses were
Net losses available to common stockholders were
On September 30, 2024, cash and cash equivalents totaled
2025 Guidance
The Company is providing guidance for 2025 for the first time, including:
-
Sales are expected to grow by more than
50% in 2025, driven by further market share increases in the TriNav system, the commercial launch of the TriNav LV system, and the TriNav target market expansion driven by the DELIVER program. -
Operating expenses are expected to decline greater than
20% in 2025 due to reductions in R&D associated with completing the PERIO Phase 1 trials and reductions in G&A expenses due to the non-recurrence of certain costs related to becoming a public Company. - The Company expects to achieve positive full-year EBITDA and positive cash flow in the second half of the year.
Conference Call
TriSalus will host a webcast to discuss its third quarter 2024 financial results and business highlights on November 14, 2024, at 9:00 a.m. EST. 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. 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.
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 Company’s guidance for its financial performance in 2025, 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 goal of finding a strategic partner to advance nelitolimod in UM-LM, the ability of TriNav LV to expand the Company’s addressable market, the expected benefits from the Company’s DELIVER program including the incremental market opportunity expected from the PROTECT study, the Company’s expected timing to open additional DELIVER studies, statements regarding the Company’s cash runway, the Company’s expectation that TriNav LV will seamlessly integrate into the current billing structures 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 risk that the Company may not be successful in identifying a strategic partner to advance PERIO-01, the risk that the Company may not achieve its projected financial results for 2025, the size and growth of the market for the Company’s products and the rate and degree of market acceptance thereof, 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.
Financials
| TriSalus Life Sciences | ||||||||||||||||||||||
| Condensed Consolidated Statement of Operations (unaudited, in thousands) | ||||||||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||
| September 30, | September 30, | |||||||||||||||||||||
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|||||||||||
| Revenue | $ |
7,349 |
|
$ |
5,193 |
|
$ |
21,170 |
|
$ |
12,790 |
|
||||||||||
| Cost of goods sold |
|
1,004 |
|
|
589 |
|
|
2,887 |
|
|
2,023 |
|
||||||||||
| Gross Profit |
|
6,345 |
|
|
4,604 |
|
|
18,283 |
|
|
10,767 |
|
||||||||||
| Operating expenses: | ||||||||||||||||||||||
| Research and development |
|
4,219 |
|
|
9,506 |
|
|
14,729 |
|
|
22,066 |
|
||||||||||
| Sales and marketing |
|
6,138 |
|
|
4,689 |
|
|
18,829 |
|
|
11,430 |
|
||||||||||
| General and administrative |
|
4,727 |
|
|
9,025 |
|
|
13,310 |
|
|
17,498 |
|
||||||||||
| Loss from operations |
|
(8,739 |
) |
|
(18,616 |
) |
|
(28,585 |
) |
|
(40,227 |
) |
||||||||||
| Other income (expense): | ||||||||||||||||||||||
| Interest income |
|
158 |
|
|
116 |
|
|
347 |
|
|
187 |
|
||||||||||
| Interest expense |
|
(1,142 |
) |
|
(4 |
) |
|
(2,022 |
) |
|
(13 |
) |
||||||||||
| Loss on equity issuance |
|
(5,691 |
) |
|||||||||||||||||||
| Extinguishment of tranche liability |
|
19 |
|
|
1,520 |
|
||||||||||||||||
| Change in fair value of SEPA, warrant, and | ||||||||||||||||||||||
| revenue base redemption liabilities |
|
4,974 |
|
|
(2,831 |
) |
|
(1,521 |
) |
|
660 |
|
||||||||||
| Change in fair value of contingent earnout liability |
|
2,360 |
|
|
19,904 |
|
|
12,061 |
|
|
19,904 |
|
||||||||||
| Other expense, net |
|
(13 |
) |
|
(13 |
) |
|
(210 |
) |
|
(56 |
) |
||||||||||
| Loss before income taxes |
|
(2,402 |
) |
|
(1,425 |
) |
|
(19,930 |
) |
|
(23,716 |
) |
||||||||||
| Income tax benefit (expense) |
|
3 |
|
|
(7 |
) |
|
(8 |
) |
|||||||||||||
| Net loss available to common stockholders | $ |
(2,399 |
) |
$ |
(1,425 |
) |
$ |
(19,937 |
) |
$ |
(23,724 |
) |
||||||||||
| Deemed dividend related to Series B-2 preferred stock down | ||||||||||||||||||||||
| round provision |
|
(2,981 |
) |
|||||||||||||||||||
| Undeclared dividends on Series A preferred stock |
|
(803 |
) |
|
(458 |
) |
|
(2,405 |
) |
|
(458 |
) |
||||||||||
| Net loss attributable to common stockholders | $ |
(3,202 |
) |
$ |
(1,883 |
) |
$ |
(22,342 |
) |
$ |
(27,163 |
) |
||||||||||
| Net loss per common share, basic and diluted | $ |
(0.12 |
) |
$ |
(0.14 |
) |
$ |
(0.91 |
) |
$ |
(5.72 |
) |
||||||||||
| Weighted average common shares outstanding, basic and diluted |
|
26,501,597 |
|
|
13,173,422 |
|
|
24,588,500 |
|
|
4,749,849 |
|
||||||||||
| TriSalus Life Sciences | ||||||||||||||
| Condensed Consolidated Balance Sheets (unaudited, in thousands) | ||||||||||||||
| September 30, | December 31, | |||||||||||||
2024 |
|
2023 |
|
|||||||||||
| Assets | (unaudited) | |||||||||||||
| Current assets: | ||||||||||||||
| Cash and cash equivalents | 11,288 |
|
11,777 |
|
||||||||||
| Accounts receivable | 4,912 |
|
3,554 |
|
||||||||||
| Inventory, net | 3,999 |
|
2,545 |
|
||||||||||
| Prepaid expenses | 3,609 |
|
2,986 |
|
||||||||||
| Total current assets | 23,808 |
|
20,862 |
|
||||||||||
| Property and equipment, net | 1,818 |
|
2,091 |
|
||||||||||
| Right-of-use assets | 1,427 |
|
1,179 |
|
||||||||||
| Other assets | 424 |
|
466 |
|
||||||||||
| Total assets | 27,477 |
|
24,598 |
|
||||||||||
| Liabilities and Stockholders' Deficit | ||||||||||||||
| Current liabilities: | ||||||||||||||
| Trade payables | 1,446 |
|
3,391 |
|
||||||||||
| Accrued liabilities | 7,877 |
|
10,556 |
|
||||||||||
| Short-term lease liabilities | 266 |
|
351 |
|
||||||||||
| Other current liabilities | 329 |
|
389 |
|
||||||||||
| Total current liabilities | 9,918 |
|
14,687 |
|
||||||||||
| Long-term debt, net of unamortized discount and debt issuance costs | 21,678 |
|
||||||||||||
| Revenue base redemption liability | 426 |
|
||||||||||||
| Long-term lease liabilities | 1,506 |
|
1,244 |
|
||||||||||
| Contingent earnout liability | 6,571 |
|
18,632 |
|
||||||||||
| Warrant and SEPA liabilities | 7,812 |
|
17,100 |
|
||||||||||
| Total liabilities | 47,911 |
|
51,663 |
|
||||||||||
| Stockholders' deficit: | ||||||||||||||
| Preferred Stock, Series A, |
||||||||||||||
| per share. Authorized 10,000,000 shares at September 30, 2024, and | ||||||||||||||
| December 31, 2023, respectively; issued and outstanding, 3,985,002 and | ||||||||||||||
| 4,015,002 shares at September 30, 2024 and December 31, 2023, respectively. | ||||||||||||||
| Common stock, |
||||||||||||||
| at September 30, 2024 and December 31, 2023, respectively; issued and outstanding, | ||||||||||||||
| 30,469,664 and 26,413,213 shares at September 30, 2024, and December 31, 2023, | ||||||||||||||
| respectively | 3 |
|
2 |
|
||||||||||
| Additional paid-in capital | 249,004 |
|
222,437 |
|
||||||||||
| Accumulated deficit | (269,441 |
) |
(249,504 |
) |
||||||||||
| Total stockholders' deficit | (20,434 |
) |
(27,065 |
) |
||||||||||
| Total liabilities and stockholders' deficit | 27,477 |
|
24,598 |
|
||||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20241114379025/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
Source: TriSalus Life Sciences
FAQ
What was TriSalus (TLSI) revenue growth in Q3 2024?
What is TriSalus (TLSI) guidance for 2025?
What new products did TriSalus (TLSI) launch in Q3 2024?
What were TriSalus (TLSI) gross margins in Q3 2024?
