On March 28, 2025 Merck, a leading science and technology company, reported it has exercised its option with Abbisko Therapeutics Co. Ltd, Shanghai, China for commercialization of pimicotinib in the U.S. and rest of world and will pay Abbisko an option fee of $85 million (Press release, Merck KGaA, MAR 28, 2025, View Source [SID1234651542]). Under the agreement signed in 2023 for the commercialization rights in Mainland China, Hong Kong, Macau, and Taiwan, Merck now holds worldwide commercialization rights for pimicotinib. The companies recently reported positive topline results from the global Phase III MANEUVER study, demonstrating pimicotinib significantly improved the primary endpoint of objective response rate versus placebo (54.0% vs. 3.2% at week 25, p<0.0001) in the treatment of patients with tenosynovial giant cell tumor (TGCT). The companies also will explore pimicotinib in additional indications, such as chronic graft-versus-host disease (cGvHD).

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"Today marks a significant milestone in our partnership with Abbisko as we work together to deliver a potentially best-in-class therapy for patients with TGCT around the world," said Andrew Paterson, Chief Marketing Officer for the Healthcare business sector of Merck. "This collaboration underscores our commitment to advancing new treatment options in rare oncology for patients who need them. With this important step forward, we aim to transform the treatment landscape and offer hope to those living with TGCT, who today have very limited treatment options."

TGCT is a non-malignant and often recurring tumor of the joints that can cause high morbidity associated with swelling, pain, stiffness, and limited mobility of the affected joints, significantly impacting daily activities and quality of life in the primarily working-age population that it affects.

If left untreated or in recurrent cases, TGCT can result in irreversible damage to the bone, joint and surrounding tissues. This highlights the need for well-tolerated and effective systemic treatments that can impact tumor growth while relieving the symptoms of the disease.

About MANEUVER

The pivotal Phase III MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT, who are eligible for systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted in China (n=45), Europe (n=28), and the US and Canada (n=21).

In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint is objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review in the intent-to-treat (ITT) population. Secondary endpoints include tumor volume score, active range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS).

After the double-blind Part 1, eligible patients may continue to the open-label Part 2 for up to 24 weeks of dosing, results of which are expected in mid-2025. Patients who complete Part 2 may then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up.

About Pimicotinib (ABSK021)

Pimicotinib (ABSK021), which is being developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib has been granted breakthrough therapy designation (BTD) for the treatment of inoperable TGCT by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA).

On March 27, 2025 Havah Therapeutics, a clinical stage biopharmaceutical company developing innovative therapies for prevention and treatment of breast cancers, reported the filing of a new provisional patent application directed to the use of HAV-088 for treating Ductal Carcinoma In-Situ (Press release, HavaH Therapeutics, MAR 27, 2025, View Source [SID1234651553]).

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Backed by human in vivo data demonstrating on-target effect, the patent application covers the potential application of HAV-088, a novel androgen receptor (AR) agonist, in treating hormone receptor positive (HR+) disease.

"The filing of this provisional patent application marks an important step in our broader strategy to strengthen our intellectual property portfolio with additional disease-specific claims," said Matthew Brewer, CEO of Havah Therapeutics. "This week’s release of 20-year survival data from a Mayo Clinic trial showed that just one year of adjuvant therapy with an AR agonist in early breast cancer led to a statistically significant reduction in recurrence or death.

"Endocrine therapy has been the foundation of treatment for hormone receptor-positive cancers for over 40 years, yet few advances have focused on the androgen receptor pathway. HAV-088, through AR agonism, is designed to reduce estrogen-driven gene transcription, thereby lowering estrogen receptor expression and limiting the tumor’s ability to respond to estrogen. Over time, we believe this could offer meaningful benefits to patients whose disease is resistant to standard endocrine therapies."

"The data supporting this provisional patent may represent a significant advancement in the treatment of HR-positive DCIS and builds upon the foundational research conducted by Dr. Wayne Tilley and myself," said Stephen Birrell, MD, PhD, Founder and Chair of Havah’s Clinical Advisory Board.

On March 27, 2025 Havah Therapeutics, a clinical stage biopharmaceutical company developing innovative therapies for prevention and treatment of breast cancers, reported the filing of a new provisional patent application directed to the use of HAV-088 for treating Ductal Carcinoma In-Situ (Press release, HavaH Therapeutics, MAR 27, 2025, View Source [SID1234651553]).

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Backed by human in vivo data demonstrating on-target effect, the patent application covers the potential application of HAV-088, a novel androgen receptor (AR) agonist, in treating hormone receptor positive (HR+) disease.

"The filing of this provisional patent application marks an important step in our broader strategy to strengthen our intellectual property portfolio with additional disease-specific claims," said Matthew Brewer, CEO of Havah Therapeutics. "This week’s release of 20-year survival data from a Mayo Clinic trial showed that just one year of adjuvant therapy with an AR agonist in early breast cancer led to a statistically significant reduction in recurrence or death.

"Endocrine therapy has been the foundation of treatment for hormone receptor-positive cancers for over 40 years, yet few advances have focused on the androgen receptor pathway. HAV-088, through AR agonism, is designed to reduce estrogen-driven gene transcription, thereby lowering estrogen receptor expression and limiting the tumor’s ability to respond to estrogen. Over time, we believe this could offer meaningful benefits to patients whose disease is resistant to standard endocrine therapies."

"The data supporting this provisional patent may represent a significant advancement in the treatment of HR-positive DCIS and builds upon the foundational research conducted by Dr. Wayne Tilley and myself," said Stephen Birrell, MD, PhD, Founder and Chair of Havah’s Clinical Advisory Board.

On March 28, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the year ending December 31, 2024. The consolidated financial statements are attached to this press release (Press release, Innate Pharma, MAR 27, 2025, View Source [SID1234651552]).

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"Our strategy is clear: drive innovation through our ANKET NK-cell engager platform and accelerate our ADC programs. We are making strong clinical progress, with our lead proprietary ANKET, IPH6501 advancing in B-cell non-Hodgkin’s lymphoma and commencing the Phase 1 study for the Nectin-4 ADC IPH4502 in solid tumors. The FDA’s Breakthrough Therapy Designation for lacutamab highlights its potential to transform treatment for Sézary syndrome. With these achievements as well as disciplined financial management, we are pleased to extend our cash runway to mid 2026, reinforcing our commitment to delivering innovative new therapies for patients," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.

Webcast and conference call will be held today at 2:00pm CET (9:00am EDT)

Access to live webcast:

View Source

Participants may also join via telephone using the registration link below:

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This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com.

A replay of the webcast will be available on the Company website for 90 days following the event.

________________
1 Including short term investments (€14.4m) and non-current financial instruments (€10.3m).

Pipeline highlights:

ANKET (Antibody-based NK cell Engager Therapeutics):

ANKET is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. Innate’s pipeline includes five drug candidates that have emerged from the ANKET platform: SAR443579/IPH6101 (SAR’579; trifunctional anti-CD123 NKp46xCD16 NKCE), SAR445514/IPH6401 (SAR’514 trifunctional anti-BCMA NKp46xCD16 NKCE), IPH62 (anti-B7-H3), IPH67 (target undisclosed, solid tumors) and tetra-specific IPH6501 (anti-CD20 with IL-2v). Several other undisclosed proprietary preclinical targets are being explored.

IPH6501 (proprietary)

IPH6501 is Innate’s proprietary CD20-targeted IL-2v bearing second-generation ANKET. In March 2024 the first patient was dosed in the Phase 1/2 clinical trial evaluating IPH6501 in B cell Non-Hodgkin’s lymphoma (B-NHL). The study is planned to enroll up to 184 patients. Clinical sites are open in the US, Australia and France and the first safety and preliminary activity data are expected in late 2025.

Innate presented preclinical data of IPH6501 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) Annual congress in June 2024. Preclinical data showed that IPH6501 depletes autologous CD20+ B cells from healthy donors with greater efficacy and lower induction of pro-inflammatory cytokines than a CD20-T-cell engager. IPH6501 also effectively and preferentially stimulates NK cell proliferation from peripheral blood mononuclear cells of relapsed /refractory B-cell non-hodgkin’s lymphoma (R/R NHL) patients.
In November 2024, preclinical data demonstrating the potential of IPH6501 were published in Science Immunology.
Innate Pharma and the Institute for Follicular Lymphoma (IFLI) entered into an agreement to clinically study the potential of IPH6501 in follicular lymphoma (FL). To support the Phase 1/2 trial and inclusion of FL patients, IFLI will initially invest 3m USD into new shares of Innate, issued through a capital increase reserved to IFLI at a price of €1.56 per share and representing 2.26% of the share capital of Innate. IFLI may also invest up to an additional 4.9m USD into new shares of Innate, depending on the completion of certain milestones, at a price to be determined at the time of the said investments.
IPH67 (proprietary)

Following termination of its license by Sanofi during the third quarter 2024, Innate regained full rights on IPH67, a NK-cell engager program in solid tumors from Innate’s ANKET platform under development.

SAR’579/IPH6101, SAR’514/IPH6401, IPH62 (partnered with Sanofi)

SAR’579/IPH6101

The Phase 1/2 clinical trial by Sanofi is progressing well. Updated efficacy and safety results from the dose-escalation part of the Phase 1/2 study with SAR’579 / IPH6101, were shared in an oral presentation at the EHA (Free EHA Whitepaper) 2024 Congress. The data demonstrated that SAR’579 continues to show clinical benefit and durable responses along with a favorable safety profile in patients with relapsed or refractory acute myeloid leukemia (AML), with 5 complete responses (4 CR / 1 CRi) achieved at 1 mg/kg, with durable CR (>10 months) observed in 3 patients.
In April 2024, Sanofi advanced SAR’579 / IPH6101, to the Phase 2 preliminary dose expansion of the trial. Under the terms of the 2016 research collaboration with Sanofi, the progression to the dose expansion part of the trial has triggered a milestone payment from Sanofi to Innate of €4m.
SAR’514/IPH6401

The Sanofi-led Phase 1/2 study (clinical study identifier: NCT05839626) for the treatment of patients with relapsed or refractory multiple myeloma will be terminated early as SAR’514/IPH6401 will now be pursued in autoimmune indications.
IPH62 and other target

IPH62 is a NK-cell engager program targeting B7-H3 under development from Innate’s ANKET platform. Following a research collaboration period and upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.
Sanofi still retains the option of one additional ANKET target under the terms of the 2022 research collaboration and license agreement.
Antibody Drug Conjugates:

IPH4502 (Nectin-4 ADC):

IPH4502 is Innate’s novel and differentiated topoisomerase I inhibitor ADC targeting Nectin-4.

First preclinical data for IPH45 were presented in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024. In preclinical studies, IPH4502 showed anti-tumor efficacy in vivo, in Nectin-4 expressing tumors including in enfortumab vedotin refractory models.
In September, the U.S Food and Drug Administration cleared Innate’s investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502 in Nectin-4 expressing solid tumor indications.
The first patient was dosed in a Phase 1 study in January 2025. The Phase 1 includes a part 1 dose escalation and a part 2 dose optimization, and will assess the safety, tolerability, and preliminary efficacy of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients.
New preclinical data will be presented at the AACR (Free AACR Whitepaper) Annual Meeting 2025.
Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T Cell Lymphoma

TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides.

Favorable results from the Phase 2 TELLOMAK study with lacutamab in mycosis fungoides were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2024. The data demonstrate that treatment with lacutamab resulted in meaningful antitumor activity, regardless of the KIR3DL2 baseline expression, and an overall favorable safety profile. The global objective response rate was 16.8% (Olsen 2011) and 22.4% (Olsen 2022), including 2 complete responses and 16 partial responses.
Quality of life data and translational analysis from the TELLOMAK trial in patients with relapsed/refractory cutaneous T-cell lymphoma were presented at the ASH (Free ASH Whitepaper) Annual Meeting 2024.
Long Term Follow up for Sezary syndrome and mycosis fungoides will be presented at an upcoming medical congress.
During the financial quarter ending September 30, 2024, the FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, and the Company continues to align with the FDA around the confirmatory Phase 3 trial.
In February 2025, the FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary syndrome based on TELLOMAK Phase 2 results demonstrating efficacy and a favorable safety profile in patients with advanced Sézary syndrome, heavily pretreated, post-mogamulizumab. Breakthrough Therapy Designation is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition. Partnering discussions are underway.
Peripheral T Cell lymphoma (PTCL)

The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized controlled trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing and continues to recruit patients.

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing.
After the period, the Independent Data Monitoring Committee recommended the continuation of the Phase 3 PACIFIC-9 trial based on a pre-planned analysis.
Updated results from COAST, a Phase 2 study of durvalumab with oleclumab or monalizumab in patients with Stage III unresectable non-small-cell lung cancer were presented at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting, in June 2024 showing increased objective response rate, prolonged progression free survival, and trended toward improved overall survival compared to durvalumab alone.
AstraZeneca presented interim results from the randomized NeoCOAST-2 Phase 2 platform trial during the 2024 World Conference on Lung Cancer in September 2024. In this preliminary analysis on the first 60 of 72 patients randomized to Arm 2, monalizumab added to durvalumab plus platinum-based chemotherapy doublet induced a pathological complete response rate of 26.7% [95% CI; 16.1–39.7] and a major pathological response rate of 53.3% [95% CI; 40.0–66.3] which are numerically higher than the durvalumab plus platinum doublet approved regimen. Treatment in Arm 2 showed manageable safety profile and no impact on surgical rate. The NeoCOAST-2 platform study is intended to assess the safety and efficacy of neoadjuvant durvalumab alone or combined with novel immuno-oncology agents and chemotherapy in resectable, early-stage NSCLC, followed by adjuvant treatment with durvalumab with or without the novel agents.
IPH5201 (anti-CD39), partnered with AstraZeneca:

The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing and recruitment is on track. Following a pre-planned interim analysis, the MATISSE Phase 2 trial continues according to plans.
IPH5301 (anti-CD73):

The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.
Corporate Update:

As of December 31, 2024, the balance available under our April 2023 sales agreement under the At-The-Market program remains at $75 million.
Post period event

In February 2025, Arvind Sood, Executive Vice President, President of U.S. Operations left the Company and resigned from his position as member of the Executive Board.
Financial highlights for 2024:

The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2024 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €91.1 million (€m) as of December 31, 2024 (€102.3m as of December 31, 2023), including €10.3m in short-term investments (€9.8m as of December 31, 2023).
As of December 31, 2024, financial liabilities amount to €31.0m (€39.9m as of December 31, 2023). This change is mainly due to loan repayments.
Revenue and other income from continuing operations amounted to €20.1m in 2024 (2023: €61.6m, -67.4%). It mainly comprises revenue from collaboration and licensing agreements (€12.6m in 2024 vs €51.9m in 2023, -75.7%), and research tax credit (€7.5m in 2024 vs €9.7m in 2023, -23.3%):
Revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi. They are recognized when the entity’s performance obligation is met. Their accounting is made at a point in time or spread over time according to the percentage of completion of the work that the Company is committed to carry out under these agreements:
(i) Revenue from collaboration and licensing agreements for monalizumab decreased by €5.1m to €4.4m in 2024 ( €9.5m in 2023). This decrease is mainly due to the recognition of an increase in revenues in the first half of 2023. Indeed, at June 30, 2023, the Company had carried out an analysis of the cost base used to calculate the progress of Phase 1/2 trials, taking into account their progression. This analysis led to a reduction in the cost base through a re-estimation of projected expenditure. Consequently, this adjustment to the cost base had a positive impact on the percentage of completion and led to the recognition of additional revenue of 5.9 million euros for the first half of 2023, which did not recur in 2024;
(ii) Revenue related to the research collaboration and licensing agreement signed with Sanofi in 2022 amounted €2.1m as of December 31, 2024 (€34.7m as of December 31, 2023). On January 25, 2023, the Company announced the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 and the effectiveness of the licensing agreement as of January 24, 2023. Consequently, the Company received an upfront payment of €25.0m in March 2023, including €18.5m for the exclusive license, €1.5m for the research work and €5.0m for the two additional targets options, for which the Company will recognize the related revenues either at the reporting date or the latest five years after the effective date. The €18.5m upfront payment relating to the exclusive license has been fully recognized in revenue since June 30, 2023. On December 19, 2023, the Company announced that Sanofi had exercised one of the two license options for a new program based on the Company’s ANKET platform. This decision triggered a milestone payment of €15.0m, including €13.3m for the exclusive license, fully recognized in revenue as of December 31, 2023, and €1.7m for research work to be carried out by the Company as well as the recognition in revenue of an amount of €2.5m initially received in March 2023 in connection with this option. On October 9, 2024, the company received a letter terminating the license agreement for IPH67, a NKCE program, from ANKET platform, currently under development in solid tumors. Termination was effective at the end of a 90 days notice period, i.e. on January 7, 2025. As a result, Innate did recover full rights to IPH67;
(iii) Revenue related to the license and collaboration agreement signed with Sanofi in 2016 increased by €2.0m, to €4.0m for year ended December 31, 2024, as compared to €2.0m for year ended December 31, 2023. On April 15, 2024, the Company announced the treatment of the first patient in the phase 2 dose extension of the Sanofi-led study evaluating the NK Cell Engager SAR443579/IPH6101 in various blood cancers. Under the terms of the 2016 agreement, this trial progress triggered a milestone payment of 4.0 million euros, fully recognized in revenue during the first quarter of 2024 and collected by the Company on May 17, 2024. As a reminder, last year, the Company announced that, in June 2023, the first patient was dosed in a Sanofi-sponsored Phase 1/2 clinical trial evaluating SAR’514/IPH6401 in relapsed or refractory Multiple Myeloma. As provided by the licensing agreement signed in 2016, Sanofi made a milestone payment of €2.0 million, fully recognized in revenue since of June 30, 2023. This amount was received by the Company on July 21, 2023;
The research tax credit (CIR) of €7.5m of as December 31, 2024 (€9.7m for year ended December 31, 2023. The 24% decrease resulted from the eligible costs decrease.
Operating expenses from continuing operations amounted to €71.7m in 2024 (2023: €74.3m, -3.5%):
General and administrative (G&A) expenses from continuing activities amounted to €19.7m in 2024 (2023: €18.3m, 7.8%). These expenses represented 25% and 27% of net operating expenses for continuing operations for the years ended December 31, 2023 and 2024 respectively. G&A expenses mainly comprise personnel costs not allocated to research and development, as well as costs of services relating to the management of the Company. The increase in this item between 2023 and 2024 results cumulatively from (i) the increase in Other income and expenses, mainly related to the financing of the 2023 R&D tax credit for €0.8m; (ii) the increase in non-scientific fees, partially offset by (iii) the decrease in personnel expenses, and (iv) the decrease in depreciation and amortization.
Research and development (R&D) expenses from continuing activities amounted to €52.0m in 2024 (2023: €56.0m, -7.2%). This change was mainly due to a decrease in direct research and development expenses in line with the maturity of clinical development programs and a decrease in indirect research and development expenses mainly in the fields of personnel costs and depreciation, amortization and impairment.
A net financial income of €2.1m in 2024 (2023: €5.1m gain). The financial income has been reduced due to unfavorable fx impact.
A net loss of €49.5m in 2024 (2023: net loss of €7.6m).
The table below summarizes the IFRS consolidated financial statements as of and for the year ended December 31, 2024, including 2023 comparative information.

In thousands of euros, except for data per share

December 31, 2024

December 31, 2023

Revenue and other income

20,121

61,641

Research and development

(51,980)

(56,022)

Selling, general and administrative

(19,716)

(18,288)

Total operating expenses

(71,696)

(74,310)

Operating income (loss) before impairment

(51,575)

(12,669)

Impairment of intangible asset

—

—

Operating income (loss) after impairment

(51,575)

(12,669)

Net financial income (loss)

2,104

5,099

Income tax expense

—

—

Net income (loss) from continuing operations

(49,471)

(7,570)

Net income (loss) from discontinued operations

—

—

Net income (loss)

(49,471)

(7,570)

Weighted average number of shares outstanding (in thousands)

81,052

80,453

Basic income (loss) per share

(0.61)

(0.09)

Diluted income (loss) per share

(0.61)

(0.09)

Basic income (loss) per share from continuing operations

(0.61)

(0.09)

Diluted income (loss) per share from continuing operations

(0.61)

(0.09)

Basic income (loss) per share from discontinued operations

—

—

Diluted income (loss) per share from discontinued operations

—

—

December 31, 2024

December 31, 2021

Cash, cash equivalents and financial asset

91,051

102,252

Total assets

111,059

175,187

Shareholders’ equity

8,834

51,901

Total financial debt

30,995

39,893

On March 27, 2025 TriSalus Life Sciences Inc., (Nasdaq: TLSI), 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, reported its financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update (Press release, TriSalus Life Sciences, MAR 27, 2025, View Source [SID1234651551]).

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"We achieved commercial and clinical progress throughout 2024, and positioning TriSalus for greater success in 2025," said Mary Szela, President and Chief Executive Officer of TriSalus Life Sciences. "We achieved $29.4 million in total revenue, marking 59% growth year-over-year, and continue to expect to deliver greater than 50% revenue growth in 2025. Additionally, we anticipate reducing operating expenses by more than 20%, achieving positive EBITDA for the full year, and achieving positive cash flow in the second half of the year."

"We were also pleased to strengthen our Board of Directors with the additions of William Valle and Dr. Gary Gordon. Additionally, we want to sincerely thank Sean Murphy for his leadership in guiding the Company through the process of going public, a milestone that would not have been possible without his dedication and expertise. We are thrilled to welcome him back to the Board of Directors and look forward to his continued contributions to our success," concluded Ms. Szela.

Clinical and Commercial Advancements

Expanded Product Portfolio

In the second half of 2024, TriSalus expanded its portfolio of 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 is suitable for patients with vessels sized between 3.5 and 5.0mm. The TriGuide Guiding Catheter is equipped with a larger inner diameter, lubricious inner lining, and reverse curve design to support femoral access for the TriNav LV.

These new products are eligible for the same HCPCS reimbursement codes as existing TriNav products, which should enable seamless integration into current billing structures. The Company believes these expanded features will allow physicians to address more complex cases, enhance procedural efficiency, meaningfully expand its addressable market, and provide full access to the $375 million liver embolization market.

Expanding the DELIVER Clinical Program

The Company continues to advance its DELIVER clinical program, a series of Investigator Initiated Trials (IITs) designed to further underscore the impact of PEDD technology by demonstrating enhanced safety and efficacy of the TriNav system across a broad spectrum of complex, difficult-to-treat patients. A key focus of the DELIVER program is to investigate the potential of combining use of the TriNav system with other therapies to enhance effectiveness and address resistance mechanisms in challenging cancers.

The first IIT is a registry study called PROTECT (Pressure Enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease). The PROTECT study has been initiated and intends to enroll 100 patients across five leading academic sites. It is estimated that approximately 5% of adults have multinodular goiters, prevalence in adults over 50 is estimated to be up to 50%. The Company estimates that this may expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million market opportunity and putting the Company’s total addressable market at more than $1 billion.

Advancing Pancreatic Cancer Treatment – Enrollment was completed in the PERIO-03 Phase 1 trial investigating nelitolimod in locally advanced pancreatic cancer. Final data are expected mid-2025, with next steps to be determined based on results.

Clinical Progress in Immunotherapy – In November 2024, we presented positive Phase 1 results from our PERIO-01 trial at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), demonstrating promising clinical benefits and durable survival in heavily pretreated uveal melanoma liver metastases (UM-LM) patients. We are actively seeking strategic partnerships to advance this program.

Strengthened Board and Financial Position

New Board Members – Industry veterans William Valle and Dr. Gary Gordon joined the Board of Directors, bringing deep expertise in medical devices and oncology. Additionally, Sean Murphy retired from the management team and rejoined the Board.

Extended Cash Runway – TriSalus secured a $10 million drawdown under its existing $50 million credit facility with OrbiMed, ensuring financial flexibility through the end of 2025.

Unaudited Financial Results for Fourth Quarter and Full Year 2024

The Company will file a Form 12b-25, Notification of Late Filing, with the SEC related to the Company’s Annual Report on Form 10-K for fiscal year 2024. The Company’s need to request a 15-day extension is primarily due to errors identified in determining the Company’s stock-based compensation and clinical trial related research and development expense timing in 2024. The Company is working diligently to evaluate the materiality of the errors to determine whether any corrections for previously issued quarterly financial statements are required and to complete the Company’s year end 2024 financial statements. As a result, the results below and elsewhere in this press release are unaudited and subject to change pending the completion of the Company’s financial statement as of and for the year ended December 31, 2024.

Full year 2024 revenue was $29.4 million, representing growth of approximately 59% versus the full year 2023. Momentum in revenue growth is expected to continue in 2025 and, consistent with previously announced guidance, is expected to grow in excess of 50% in 2025.

Operating Cash Flow in the fourth quarter of 2024 was ($5.7) million, reflecting a notable improvement compared to the previous quarter amount of ($10.8) million. Consistent with previously announced guidance, the Company expects to achieve positive full year EBITDA in 2025 and positive cash flow during the second half of 2025.

Cash and Cash Equivalents were $8.5 million as of December 31st, 2024. The Company expects existing liquidity sources and the $15 million of available capacity on the OrbiMed debt facility to provide sufficient cash runway throughout 2025.

2025 Guidance

The company is reaffirming previously issued guidance for 2025, including:

Sales are expected to grow by more than 50% in 2025, driven by further market share increases in TriNav, the commercial launch of TriNav LV, and the TriNav target market expansion driven by the DELIVER program and the new HCPCS reimbursement code for TriNav simulation angiograms —commonly known as mapping procedures—conducted prior to transarterial radioembolization (TARE) from Centers for Medicare & Medicaid Services (CMS).
Gross margins are expected to exceed 87%.
Operating expenses are expected to decline greater than 20% in 2025 due to reductions in R&D associated with the completion of the PERIO phase 1b trials and reductions in G&A expenses due to the non-recurrence of certain costs related to becoming a public Company in 2024.
The company expects to be EBITDA positive for 2025 and achieve positive cash flow by the second half of 2025, extending total cash runway beyond 2025.
Conference Call

The company will host a conference call and webcast on March 27, 2025, at 8:00 a.m. ET to discuss financial results for the fourth quarter and full year ended December 31, 2024, and provide a business update. A press release detailing the fourth quarter and full year results will be issued prior to the call. To register for the webcast, click here.