2025 results: Core EBITDA margin improved despite sales headwinds, driven by strong cost discipline




2025 results: Core EBITDA margin improved despite sales headwinds, driven by strong cost discipline

Progress against FOCUS-27 in a deteriorating environment

Accelerated transformation to strengthen the operating model

Full-year 2025 results

€848.2 million net sales

• (7.0) % decline year-on-year – (5.9) % on a comparable basis

EBITDA at €9.9 million compared to €(43.6) million in 2024

Core EBITDA at €66.2 million compared to €50.4 million in 2024

• 7.8% Core EBITDA margin vs 5.5% in 2024

• €10M decrease in OPEX¹, driven by effective cost control measures

€ (130.6) million Operating Income compared to € (120.4) million in 2024

• €(77.8) million impairments of assets

€ (211.2) million Net Income compared to € (130.6) million in 2024

€ (77.0) million CAPEX – 55% dedicated to growth

€ 68.2 million Net Cash Position at the end of December 2025

2026 outlook²

Due to the impact of portfolio rationalization, and considering the challenging business environment, the company expects a decrease of around 10% in net sales³ in 2026. In this context, EUROAPI will accelerate its transformation to protect profitability and expects to maintain its FY 2026 Core EBITDA margin broadly in line with FY 2025.

FOCUS-27 plan update

Transformation remains on track in a challenging environment with group fundamentals reinforced through timely execution of the initial phase of the plan:

• APIs portfolio streamlined as scheduled
• Haverhill site successfully divested
  • Cost base sustainably reduced through enhanced operational efficiencies.

With 2026 and 2027 sales now expected to be below initial assumptions, incremental Core EBITDA target will not be achieved in 2027. Consequently, we are accelerating the plan and launching additional business initiatives to continue to strengthen the operating model.

“0ur 2025 financial results reflect improved cost discipline, and we are prepared to navigate 2026 with the same rigor and focus,” said David Seignolle, Chief Executive Officer of EUROAPI. “The fast-moving business environment we face requires us to accelerate and intensify our efforts. We will take the necessary actions to drive profitable growth, with a long-term strategy anchored in discipline and value creation, in the interests of all stakeholders.”

2025 consolidated key figures

2025 non-financial key figures

2025 Net Sales

EUROAPI 2025 Net Sales reached €848.2 million, -7.0% versus 2024. On a comparable basis (at CER and excluding the Haverhill perimeter impact⁶), net sales would have declined by 5.9%.

Net sales per type of activity⁷

API Solutions

API Solutions net sales decreased by 6.0%

• The decline in sales to Sanofi was mainly due to three factors: an unfavorable comparison base with the stock clearance of Buserelin in 2024 (€21 million), the decline of volume of Sevelamer in H1, and the divestment of Haverhill at the end of June 2025. Excluding Opella, API Solutions sales to Sanofi would have decreased by 25.7% year-on-year.
  • Sales to Other Clients increased as a result of the cross-selling strategy (contributing to approximately 5.1% of API Solutions sales to Other Clients in 2025) and the addition of 31 new clients. Excluding Opella, API Solutions sales to Other Clients would have increased by 4.5% year-on-year.

The discontinued APIs accounted for approximately €70 million in FY2025 sales, including around €20 million related to strategic stockpiling from customers.

CDMO

CDMO sales decreased by 9.6%

CDMO activity included 39 active projects in 2025, compared to 58 in 2024. Middle and large companies now account for 66% of the CDMO pipeline versus 62% the previous year. As we continued to derisk our portfolio, Phase III and Commercial phase projects represented 70% of the portfolio versus 60% in 2024.

• Commercial Phase (CMO) projects represented 89% of total CDMO sales, amounting to €200.3 million, down 9.7% compared to previous year. Growing demand for Poly-L-Lactic Acid (PLLA) produced in Vertolaye and used in skin care products was more than offset by the downsizing and discontinuation of pre-carve out contracts.
• Phase I, II and III CDMO projects represented 11% of total CDMO sales for a total value of €24.1 million, down 9.1% versus last year.

Net Sales per type of molecule

The decrease in Large molecules was driven by an unfavorable comparison base as 2024 included a €21 million one-off impact from Buserelin stock clearance. Despite growth in glaucoma and veterinary prostaglandin therapeutics areas, overall sales of Highly potent molecules declined due to the completion of two early stage CDMO contracts and the intensified market pressure from Asian competitors. Growth in Biochemistry molecules derived from fermentation was driven by stockpiling of discontinued products, and a favorable base due to the temporary closure of the Brindisi site in 2024. Sales of Vitamin B12 remained flat amid persisting competitive dynamics. Reduced sales in Complex chemical synthesis molecules were mainly due to the divestment of Haverhill site in June 2025.

Financial performance

Gross profit totaled €144.8 million, an increase from €142.4 million in 2024, with the Gross Profit margin up 150 basis points year-on-year to 17.1%. Core EBITDA amounted to €66.2 million, up 31.2% compared to €50.4 million in 2024. The core EBITDA margin was 7.8% compared to 5.5% in 2024.

The increase in Core EBITDA margin was driven by the decrease in OPEX from lower personnel costs and substantial savings in external expenditures, supported by strengthened financial discipline and effective cost control measures.

EBITDA was €9.9 million compared to €(43.6) million in 2024, including €58.8 million of exceptional items linked to FOCUS-27 plan⁸, of which

• €36.1 million of idle costs⁹ linked to the execution of FOCUS-27
• €6.6 million in internal and external costs related to the company’s transformation

• €13.7 million of employee-related expenses linked to the FOCUS-27 plan.

Operating Income was €(130.6) million compared to €(120.4) million in 2024. The €77.8 million impairment of assets was triggered by the discontinuation of Vitamin B12 project in Elbeuf due to lower-than-expected economic potential in an increasingly price competitive environment, combined with a revision of growth assumptions to align with the latest market dynamics.

Financial income was €(7.5) million, compared with €(19.1) million in 2024, which included the impact of the refinancing of the Revolving Credit Facility. Income before tax was €(138.2) million. The €(72.9) million income tax expense in 2025 primarily derives from impairment of deferred tax assets following the update of growth assumptions. Net income was €(211.2) million in 2025.

Net Debt Position and Cash Flow

The company ended 2025 with a €68.2 million Net Cash position, compared to €24.6 million Net Cash at the end of December 2024.   The improvement was driven by Working Capital, including further reduction of inventories. Months on Hand at the end of December 2025 was 7.0 compared to 6.9 at the end of 2024. The decrease in receivables was notably driven by the factoring program in March 2025 (€26.5 million were factored by end 2025). DSO was 36 compared to 39 in December 2024 driven by enhanced cash collection. Other current assets and liabilities include a €36 million paid by Sanofi to reserve a minimum available capacity for five selected products as part of the financing of FOCUS-27, €21 million up-front grant from the IPCEI program, and €6.5 million related to the monetization of 2022, 2023, and 2024 Research Tax Credit in France.

Capex reached €(77.0) million (9.1% of Net Sales), of which 55% was dedicated to growth projects.

Free Cash Flow before financing activities reached €51.5 million, compared to €15.0 million at the end of 2024.¹¹

FOCUS-27 UPDATE

The execution of the FOCUS-27 plan over 2024 and 2025 has reinforced EUROAPI’s operating base. Since its launch in 2024, the most critical actions planned for this initial phase have been delivered.

Portfolio streamlining

• The APIs portfolio has been streamlined toward higher added value products. In 2025, 66% of APIs catalog sales were generated by differentiated products. In parallel, the CDMO roadmap has been refocused towards de-risked, late-stage projects and 70% of year-end 2025 CDMO projects were in late stage.

Footprint rationalization and high-return CAPEX

• In line with FOCUS-27, the Haverhill site in the UK was sold to Particle Dynamics on 30 June 2025¹².
• The mothballing of one workshop at the Frankfurt site has been completed, and consolidation of the remaining three workshops into one is ongoing.
  • 54% of the €185 million CAPEX invested over the past two years was dedicated to growth and performance

Cost reductions and organizational transformation

• The cost savings initiatives implemented since the launch of the plan have reduced the company’s cost base, delivering close to €20 million OPEX savings¹³. These savings were primarily achieved through new procurement, commercial and IT operating models, a more agile R&D organization, and tight control of General Expenses.

• Industrial efficiency programs have structurally improved productivity across all manufacturing sites. 
• Headcount has been reduced across all functions. Approximately 380 positions¹⁴ have been removed out of the 550 initially targeted, ahead of schedule.

In parallel with the deployment of FOCUS-27, EUROAPI and the French Government signed in July 2025 an agreement granting of up to €140 million in public aid to support part of R&D costs and investments related to the IPCEI Med4Cure project.

However, a fast-evolving business environment combined with certain internal challenges put pressure on the pace of delivery, calling for accelerated execution, and additional business initiatives.

• Asian competition continues to intensify, increasing pricing pressure in mature APIs, reinforcing the need for European players to move further toward higher-barrier segments.

• While APIs’ customers are placing greater emphasis on resilient and reliable supply chains, the pharmaceutical industry has started to outsource more late-stage complex commercial projects, favoring integrated CMO and CDMO partners.
• Historically framed as a key driver for future growth, the early-stage CDMO roadmap is progressing at a slower pace than anticipated. In parallel, the Commercial-phase CMO business requires increased focus to improve capacity utilization and accelerate volume ramp-up.
• Despite the improvement in the overall manufacturing processes, the project aimed at increasing Vitamin B12 capacities and enhancing cost efficiency has been stopped due to a deteriorating competitive environment, including rising pressure from Asian low-cost imports.

To address these dynamics, EUROAPI is accelerating the execution of the key pillars of the plan and launching additional initiatives to strengthen the company’s operating model.

Accelerated execution

• Further acceleration in high-margin complex molecules, achieved through a more active management of the API portfolio, with a focus on Prostaglandins, Corticosteroids, Opiates, and selected complex small molecules. Commoditized products will be deprioritized if necessary.
• Enhanced Commercial CMO offer, grounded in a strengthened commercial strategy and supported by sovereign and reshoring tailwinds. This will secure volumes and drive higher capacity utilization.
• Operational Excellence Model driving standardized, and digitalized manufacturing processes.
• Deeper organizational transformation, aligning skills and capabilities with a fast-evolving environment.

Launch of additional initiatives

• Geographic expansion – The customer base will be widened to under leveraged territories, for example North America and Latin America.
• Refocused CDMO – The CDMO businesses will concentrate on strategic customers and complex molecules, notably high value Peptides and Oligonucleotides.
• Supply chain optimization – To further improve the competitiveness of its industrial model, the company will optimize its supply chain to reduce costs while securing end-to-end control.

With 2026 and 2027 sales now expected to be below initial assumptions, the €75 – 80 million incremental Core EBITDA target will not be achieved in 2027.

Restructuring costs are expected to remain in the €110 – €120 million range. The €350 to 400 million CAPEX envelope planned for 2024 and 2027 is maintained.

With a clear customer value-proposition, and a more cost-efficient operating model, EUROAPI aims to position itself as a reliable European sovereign supplier for complex APIs and a trusted partner for new drug development.

Environment – Social – Governance

In 2025, EUROAPI’s near-term science-based emission reduction targets have been approved by the Science Based Targets initiative (SBTi), confirming the company’s alignment with the Paris Agreement trajectory. 2025 emissions data confirm good progress against these targets, with half of the targeted reduction for 2030 already achieved on scope 1+2, and scope 3 reduction already exceeded.

Despite our continuous efforts to limit accidents, the rate of injuries remained stable in 2025, and above our 2025 LTI target of 1.5 and TRI target of 2.5. Majority of these accidents could be qualified as minor (with a significant number being slip -trip-fall) but still resulted in conditions where the employee was unable to return immediately to physical activity.

The accident prevention plan launched in 2025 will be further rolled out in 2026 and reinforced with enhanced root cause analysis.

Turn-over and re-organization led to coming short of our target of 30% women in ELT by the end of 2025, although 2023 and 2024 ratio showed an increase and exceeded our target.

FY 2026 Guidance operational and financial main drivers

EUROAPI full-year guidance was built on the following assumptions:

• Net Sales are expected to decrease around 10% on a comparable basis compared to 2025 due to the negative impact of portfolio rationalization (€(55) to (60) million negative impact expected in 2026¹⁵), reduced demand from Sanofi, and the discontinuation of commercial CDMO contracts.
• The Core EBITDA margin is expected broadly with 2025 level. Industrial efficiencies and additional OPEX savings expected should be offset by unfavorable fixed cost absorption due to lower volume. EBITDA should be impacted by restructuring costs.
• CAPEX to sales ratio is expected around 8% of sales.

Glossary and definition of non-GAAP indicators

Net Sales at Constant Exchange Rate (CER)

FY 2025 sales at FY 2024 Exchange rates

On a comparable basis

At constant perimeter and constant exchange rates

EBITDA and Core EBITDA

EBITDA corresponds to operating income (loss) restated for depreciation and amortization and net impairment of intangible assets and property, plant and equipment.
Core EBITDA thus corresponds to EBITDA restated for restructuring costs and similar items (excluding depreciation and write-downs), allocations net of reversals of unutilized provisions for environmental risks, and other items not representative of the Group’s current operating performance or related to the effects of acquisitions or disposals.

Cash Flow before Financing activities

Cash Flow before Financing activities corresponds to the sum of Cash Flow from Operating Activities and Cash Flow from Investing Activities as presented in the consolidated statement of Cash Flow.

Months on Hand (MOH)

Net Inventory value at the of the period divided by Net Sales

New clients

Clients representing at least €50,000 net sales on the year.

Cross Selling

Selling a different product to an existing client that is already buying one or several products from EUROAPI.

Early-stage and Late-stage projects

Early-stage: pre-clinical, phase 1, and phase 2
Late-stage: phase3, in validation, and commercial

Presentation of 2025 results

EUROAPI’s management will hold an audio webcast presentation (04 March 2026) at 8 :30 a.m. CET. (live and replay), and the presentations are available on the corporate website Full-Year 2025 Results

EUROAPI consolidated financial statements as of December 31, 2025, were approved by the Board of Directors on March 3^rd, 2026. A presentation related to this announcement is also available on EUROAPI’s website (www.euroapi.com). Audit procedures on the consolidated financial statements are being finalized, and the certification report on the consolidated financial statements will be issued once the management report has been approved by the Board of Directors and verified by the Statutory Auditors.

Financial agenda (all dates to be confirmed)

• 27 May 2026: Annual General Meeting
• 28 July 2026: H1 2026 results

About EUROAPI
EUROAPI is focused on reinventing active pharmaceutical ingredients to sustainably meet customers’ and patients’ needs around the world. We are a leading player with approximately 200 products in our portfolio, offering a large span of technologies while also developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.
With strong R&D capabilities and five manufacturing sites located in Europe, EUROAPI provides its clients with high-quality API solutions in more than 80 countries. Our 3000+ people are committed to building together the future of public health by advancing and securing access to essential active ingredients, at the core of the healthcare value chain. EUROAPI is listed on Euronext Paris: EAPI. Find out more at www.euroapi.com and follow us on LinkedIn.

Forward-Looking Statements
Certain information contained in this press release is forward looking and not historical data. These forward-looking statements are based on opinions, projections and current assumptions including, but not limited to, assumptions concerning the Group’s current and future strategy, financial and non-financial future results and the environment in which the Group operates, as well as events, operations, future services or product development and potential. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Forward looking statements and information do not constitute guarantees of future performances, and are subject to known or unknown risks, uncertainties and other factors, a large number of which are difficult to predict and generally outside the control of the Group, which could cause actual results, performances or achievements, or the results of the sector or other events, to differ materially from those described or suggested by these forward-looking statements. These risks and uncertainties include those that are indicated and detailed in Chapter 3 “Risk factors” of the Universal Registration Document filed with the French Financial Markets Authority (Autorité des marchés financiers, AMF) on April 1, 2025. These forward-looking statements are given only as of the date of this press release and the Group expressly declines any obligation or commitment to publish updates or corrections of the forward-looking statements included in this press release in order to reflect any change affecting the forecasts or events, conditions or circumstances on which these forward-looking statements are based.

Consolidated Income Statement

Consolidated Balance Sheet

Consolidated Statements of Cash Flow

Reconciliation of Consolidated Operating Income (EBIT) to restated Core EBITDA

1 Selling, Distribution, R&D, Administrative and General Expenses
2 See operational drivers of the outlook page 8
3 On a comparable basis vs 2025
4 Methodology update impacts total scope 1&2 and % share of renewable energy
5 Market based
6 See glossary page 9
7 This includes an adjustment in the allocation of sales between Sanofi and Other Clients following the change in Opella’s majority shareholders. Since 01 May 2025, sales to Opella have been reported under the Other Client Segment (€50m between May and December 2025).
8 See appendix page 14

9 Under-activity triggered by the implementation of FOCUS-27
10 Including accrued interests
11 See detailed in Consolidated Cash Flow Statement page 14
12 Haverhill contributed to €14 million in net sales and €3 million in Core EBITDA in FY 2025 consolidated results, compared to €35 million net sales and €(1) million Core EBITDA in 2024. The capital gain impacting FY 2025 EBITDA was €4.4 million euros.
13 Selling, Distribution, R&D, Administrative and General Expenses
14 Excluding Haverhill (disposed), and Brindisi (planned to be divested),
15 € 10 to 15 million revenues expected from discontinued APIS in 2026 compared to around €70 million in 2025

Attachment

• EUROAPI_Press release_20260303

Suzanne Nora Johnson Joins Wellcome Leap Board of Directors




Suzanne Nora Johnson Joins Wellcome Leap Board of Directors

SAN DIEGO, March 03, 2026 (GLOBE NEWSWIRE) — Wellcome Leap (Leap), a U.S. nonprofit founded by the Wellcome Trust to accelerate breakthroughs in human health, today announced that Suzanne Nora Johnson has joined its Board of Directors.

“Innovation in healthcare has too often moved at a snail’s pace,” said Suzanne Nora Johnson. “What inspires me about Wellcome Leap is its deliberate departure from that model – setting bold, time-bound goals, assembling global multidisciplinary teams, and holding programs accountable to measurable milestones. This combination of urgency, agility, and collaboration defines a new model of philanthropic investment – one built to accelerate breakthroughs in years, not decades. It is precisely the kind of approach healthcare innovation needs.”

Suzanne brings to Leap more than two decades of leadership at the intersection of global finance, healthcare, and institutional strategy. As former Vice Chairman of The Goldman Sachs Group, Inc., she helped guide the firm through periods of transformation, serving on its Management Committee and chairing the Global Investment Research Division. She also headed Goldman Sachs’ Global Healthcare Business and founded the firm’s Latin American business – roles that required navigating complex markets, scaling ideas globally, and identifying opportunities to drive impact.

As a current member of the Pfizer Inc. Board of Directors and former Chair of the Intuit Inc. Board of Directors, Suzanne has developed deep insight into how innovation moves from research to real-world application. Across the public and private sectors, her experience has involved aligning resources, talent, and institutional leadership to drive meaningful, measurable outcomes – expertise that will contribute to Leap’s focus on advancing bold, unconventional programs.

“Suzanne shares our belief that we can increase the number of breakthroughs in human health if we challenge ourselves to work with greater speed and across disciplines, organizations, and countries,” said Jay Flatley, Chairman of the Board. “She brings deep experience from both finance and healthcare, but just as importantly, she brings decades of demonstrated commitment to driving progress in human health.”

In addition to her corporate leadership, Suzanne serves on the boards of several nonprofit and academic institutions, including the Brookings Institution (Co-Chair), the Markle Foundation (Chair), and the University of Southern California (Chair). She is a member of the American Academy of Arts and Sciences, the Council on Foreign Relations, and the Foreign Policy Association, and has contributed to Global Agenda Councils of the World Economic Forum. She is also a Henry Crown Fellow of the Aspen Institute.

Suzanne received her J.D. from Harvard Law School and her B.A. from the University of Southern California.

About Wellcome Leap
Wellcome Leap is a billion-dollar breakthrough engine for human health – at global scale. Founded by the Wellcome Trust in 2020 as a U.S. nonprofit, Wellcome Leap builds and executes bold, unconventional programs with the urgency required to deliver breakthroughs in years, not decades. Operating at the intersection of life sciences and engineering, Leap programs require best-in-class, multi-disciplinary, global teams assembled from universities, companies, and nonprofits working together to solve problems that they cannot solve alone. For more information, read how Wellcome Leap is Changing the Business of Breakthroughs and visit www.wellcomeleap.org.

Contact:
press@wellcomeleap.org

Spryte Medical Announces First Participants Enrolled in the INSYTE Trial at Baptist Health Jacksonville




Spryte Medical Announces First Participants Enrolled in the INSYTE Trial at Baptist Health Jacksonville

FDA-approved IDE trial to evaluate the safety and effectiveness of the nOCT™ Imaging System to provide quality images for diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up

BEDFORD, Mass., March 03, 2026 (GLOBE NEWSWIRE) — Spryte Medical, a pioneer in intravascular neuro imaging, today announced the successful enrollment of the first participants in the INSYTE trial at Baptist Health Jacksonville, which marks a major milestone in the clinical development of its neuro-optical coherence tomography (nOCT) imaging system. The trial will assess the system’s ability to provide high-quality intravascular images to support diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up procedures.

The INSYTE Trial — Intravascular Neuro OCT Imaging System for AneurYsm Treatment Evaluation — is a U.S. Food and Drug Administration (FDA)–approved Investigational Device Exemption (IDE) trial designed to evaluate the safety and effectiveness of Spryte Medical’s nOCT Imaging System.

Initial enrollments were completed with the neurointerventional team at Baptist Health Jacksonville, led by Ricardo Hanel, MD, PhD, neurosurgeon, who serves as Co-Principal Investigator of the INSYTE Trial.

“Despite advances in endovascular therapy, our ability to visualize the vessel wall and device–tissue interaction during aneurysm treatment remains limited,” said Dr. Hanel. “INSYTE represents a landmark trial that will significantly increase our understanding of brain vessel wall pathologies. Intravascular neuro-OCT imaging will enhance real-time diagnostic insights during these complex procedures.”

The INSYTE trial is the first FDA-approved clinical trial of an intravascular optical imaging system designed specifically for the neurovasculature. Additional clinical sites are expected to initiate enrollment as the trial progresses.

“Initiating enrollment in the INSYTE Trial is a significant milestone for Spryte Medical and for the neurointerventional community,” said Demetrius Lopes, MD, Co-Principal Investigator of the INSYTE Trial and neurosurgeon, Advocate Health. “This technology has the potential to deliver unprecedented image resolution within the neurovasculature, and this trial will help thoroughly evaluate its safety, performance, and clinical utility.”

“Reaching first participant enrollment in INSYTE reflects years of close collaboration between our clinical partners, engineers, physicians, and regulators,” said David W. Kolstad, Chief Executive Officer, Spryte Medical. “Our goal with nOCT is to provide clinicians with a new level of intravascular insight that may ultimately improve decision-making, procedural precision, and patient outcomes in the treatment of intracranial aneurysms.”

The nOCT Imaging System is an investigational device and has not been approved or cleared by the U.S. Food and Drug Administration. Its safety and effectiveness have not yet been established.

About the INSYTE Trial

The INSYTE Trial is a prospective, single-arm, unblinded, multicenter trial evaluating the Spryte Medical nOCT Imaging System for use during endovascular treatment and follow-up of intracranial aneurysms. The trial emphasizes safety and imaging performance to support diagnostic assessment in the neurovasculature. Details of the trial are available on ClinicalTrials.gov.

About Spryte Medical

Spryte Medical is an intravascular imaging, AI, and data company headquartered in Bedford, MA. The company’s unique imaging and data platform is purpose-built to accelerate understanding of target diseases, facilitate the development of novel therapies, and provide information for optimal treatment delivery to benefit patients worldwide.

Media Contact
Tara DiMilia
908.947.0500 x700
Tara.DiMilia@tmstrat.com

Persevere Therapeutics Launches as a Clinical-Stage Oncology Company with a Novel Phase 1b/2a Agent and Announces First Close of Seed Financing




Persevere Therapeutics Launches as a Clinical-Stage Oncology Company with a Novel Phase 1b/2a Agent and Announces First Close of Seed Financing

Chesterbrook, PA, March 03, 2026 (GLOBE NEWSWIRE) — Persevere Therapeutics, Inc. (“Persevere”), a Delaware-incorporated, clinical-stage oncology biotechnology company, today announced its official launch following a period of stealth operations. The company is emerging with a Phase 1b/2a-ready clinical asset and the first close of its Seed financing.

As part of its launch, Persevere has acquired the clinical-stage program and related assets for misetionamide (GP-2250) from Geistlich Pharma AG. Misetionamide is a novel, first-in-class dual inhibitor of c-MYC and NFκB with clinical activity in a Phase 1 trial.

Persevere has closed on a first tranche of a Seed round and is actively engaging prospective investors for the remaining allocation. The company is prepared to share equity round terms with qualified investors.

The Seed financing proceeds will be used to complete a Phase 1b/2a proof-of-concept clinical trial evaluating misetionamide in patients with platinum-resistant ovarian cancer (PROC), an area of significant unmet medical need.

“We named the company Persevere as an enduring reminder that we must ‘Never Give Up’ on behalf of cancer patients, who persevere every day,” said Greg Bosch, Founder and CEO. “Persevere Therapeutics’ mission is the unwavering pursuit of improved clinical outcomes for cancer patients with our novel therapeutic, misetionamide.”

Persevere benefits from the solid foundation already established by the significant effort and investment to-date in the development of misetionamide. These advancements include a broad preclinical program and the completion of a successful Phase 1 clinical trial where 56 cancer patients were treated. Persevere’s investors have a unique opportunity to leverage this prior investment as the company now advances the program into its next stage of clinical development. In addition to the multi-center Phase 1 which demonstrated excellent safety and encouraging efficacy profile of misetionamide, significant milestones have already been achieved including all CMC, toxicology and regulatory hurdles with two open INDs as well as 16 scientific publications and an extensive patent estate.

“Platinum resistant ovarian cancer remains one of the most challenging and underserved areas in gynecologic oncology, leaving patients with limited effective options and a poor prognosis,” noted Dr. Robert Coleman, MD, gynecologic oncologist with Texas Oncology and Chief Medical Officer at Vaniam Group. “Persevere’s misetionamide offers a much-needed therapeutic innovation, not only as a differentiated alternative to the growing number of antibody drug conjugates [ADCs] in development, but also as a potential option for patients whose disease has been exposed to, and/or progressed on prior ADC therapy.”

About Persevere Therapeutics

Persevere Therapeutics is a clinical-stage oncology company dedicated to advancing a novel antineoplastic therapeutic for patients with difficult-to-treat cancers. The name Persevere reflects an enduring reminder that we must ‘never give up’ on behalf of cancer patients who persevere every day.

Our mission is the singular pursuit of improved clinical outcomes for cancer patients with our novel therapeutic, misetionamide (GP-2250). Our lead clinical focus is the treatment of platinum-resistant ovarian cancer.

Misetionamide is a broadly active small molecule with a novel mechanism of action that inhibits two oncogenic transcription factors, c-MYC and NFκB. Through modulation of c-MYC, misetionamide selectively disrupts cancer cell energy metabolism, leading to tumor cell death. In parallel, inhibition of NFκB reduces cancer cell proliferation and survival signaling. 

The company is a privately held Delaware C-corporation headquartered in Chesterbrook, Pennsylvania. For more information, please visit perseveretherapeutics.com and follow Persevere on LinkedIn and X.

Investor and Media Contact:
Ben Steinmetz, Persevere Therapeutics, Chief Commercial Officer
ben.steinmetz@perseveretherapeutics.com

Inteleos 2026 Leadership Elections Accelerate Vision for Global Healthcare




Inteleos 2026 Leadership Elections Accelerate Vision for Global Healthcare

New leadership across the Board and Councils align with the organization’s fifty-year legacy and strategic policy

ROCKVILLE, Md., March 03, 2026 (GLOBE NEWSWIRE) — Inteleos today announced its 2026 leadership elections that build on more than 50 years of visionary governance and credentialing excellence while advancing its strategic policy to bridge global healthcare ecosystems through trusted data, validation, and continuous learning. These role transitions across the Board of Directors, ARDMS Council, APCA Council, POCUS Certification Academy Council, and Inteleos Foundation reflect the strength and continuity of the Inteleos leadership bench.

With experienced leaders stepping into new positions to reinforce an established long-term vision, Inteleos accelerates into the next phase of elevating the standard of healthcare globally and ensuring equitable access to quality care worldwide.

Elevating Governance Standards Across Board of Directors and Councils

As part of a scheduled term rotation, Teresa Bieker, MBA, CRA, RDMS, RDCS, RVT, began her tenure as the Chair of the Inteleos Board of Directors, bringing over two decades of experience in radiology quality, ultrasound management, and long-standing volunteer leadership with ARDMS and Inteleos. Her election builds directly on the work of prior Board Chairs, continuing a legacy of thoughtful, forward-looking governance that has guided Inteleos’ global impact. Tricia Turner, RDMS, RVT, FSDMS, moves from her previous Inteleos Executive Committee role as the Vice Chair of the Board of Directors.

In a further sign of continuity, Marquita Williams, RDMS, transitions from her leadership role on the ARDMS Council to serve on the Inteleos Board of Directors, building on over 25 years as a healthcare leader and educator, a journey that began with her service as an ARDMS volunteer in 2010. Steffen Sammet, MD, PhD, DABR, DABMRS, FAMP, was elected to the Board of Directors from his position as Chair of the Point-of-Care Ultrasound (POCUS) Certification Academy.

American Registry for Diagnostic Medical Sonography^® (ARDMS^®) Council

Madeline Jankowski, RDCS, FASE, moves from her Vice-Chair position in the ARDMS Council membership and committee leadership to serve as ARDMS Council Chair. Stephen McGlade, RDMS, will serve as the new Vice Chair of the ARDMS Council, continuing the Council’s tradition of strong, practitioner-led oversight that empowers sonographers to provide exceptional patient care through rigorous assessments and continual learning.

Alliance for Physician Certification & Advancement (APCA) Council

Leadership continuity also builds in the APCA Council as Teresa L. Carman, MD, extends a history of Council leadership and moves into the APCA Council Chair role and Scott D. Jerome, DO, FACC, FASNC, FSCCT, becomes APCA Council Vice Chair.

Point-of-Care Ultrasound (POCUS) Certification Academy

R. Eugene Zierler, MD, RPVI, and Nena Mason, PhD, continue their POCUS Certification Council service as they move into Chair and Vice Chair roles, respectively. Dr. Zierler’s appointment reflects 35 years of dedicated volunteer service, including prior leadership on the ARDMS Council.

Inteleos Foundation

Christine McEntee serves as Board Chair of the Inteleos Foundation, with Rose Matricciani as Vice Chair. Inteleos is also expanding its global perspective with the addition of Oluranti Doherty, MSc, FCA, as an Inteleos Foundation Board member, further strengthening the Foundation’s ability to support innovative programs that advance global health and extend the organization’s long-standing mission.

Unifying the Community

Collectively, these new leadership roles reinforce the organization’s belief that expertise and peer representation should anchor the governance process. By integrating leaders from various councils into the central Board, Inteleos fosters an abundance mindset that accelerates knowledge transfer.

“The breadth of leadership from all parts of the Inteleos community bridges our historic strengths to our new strategic policy,” said Dale Cyr, Chief Executive Officer of Inteleos. “This diverse group of experts unites clinicians and innovators to fuel the realization of equitable access to quality healthcare worldwide.”

About Inteleos

Inteleos is a mission-driven nonprofit organization that mobilizes and equips a network of individuals and entities to create value in the areas of certification and learning, communities of practice, global infrastructure development, and data & technology which collectively fuel the realization of equitable access to quality healthcare worldwide. It oversees the American Registry for Diagnostic Medical Sonography^® (ARDMS^®), the Alliance for Physician Certification & Advancement™ (APCA™), and the Point-of-Care Ultrasound Certification Academy™ (PCA), collectively representing over 150,000 certified medical professionals worldwide. The Inteleos Foundation is the philanthropic supporting organization. For more information, visit www.inteleos.org

Media Contact
Lisa Jordan
lisa.jordan@inteleos.org
(240) 386-1579

Psyence BioMed Announces Export of GMP-Manufactured Natural Psilocybin (NPX-5) to Australia for Ongoing Phase IIb Clinical Trial




Psyence BioMed Announces Export of GMP-Manufactured Natural Psilocybin (NPX-5) to Australia for Ongoing Phase IIb Clinical Trial

NEW YORK, March 03, 2026 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced the successful export of fully GMP-compliant manufactured psilocybin product NPX-5 (1mg and 5mg capsules) to Australia. The product was manufactured at the Psyence Labs Ltd. (“PsyLabs”) GMP-controlled production facility, supporting pharmaceutical-grade psychedelic development.

The shipment represents an operational achievement for both Psyence BioMed and PsyLabs, reinforcing their shared commitment to establishing a regulated global supply chain for nature-derived psychedelic therapeutics.

The exported NPX-5 product will now be used in Psyence BioMed’s ongoing Phase IIb clinical trial in Australia – a double-blind, randomized, low-dose comparator-controlled, multi-center study evaluating natural psilocybin for the treatment of Adjustment Disorder in patients with cancer in a palliative care context.

The trial is enrolling 87 participants across multiple Australian sites, including Melbourne and Perth. Psyence BioMed is currently the only company conducting a Phase IIb clinical trial using natural psilocybin to study Adjustment Disorder in a palliative oncology population. Patient dosing is underway, with initial participants having been dosed in late 2025, and all newly enrolled patients will be dosed with NPX-5.

“This export demonstrates more than regulatory clearance – it validates the operational readiness of our vertically integrated model,” said Jody Aufrichtig, Chief Executive Officer of Psyence BioMed. “The successful manufacture and export of GMP-compliant natural psilocybin at this stage of clinical development demonstrates that we are not simply participating in this sector – we are helping define its standards. Operational discipline, supply control, and product excellence are foundational to our platform.”

Clinical Significance

The Phase IIb trial focuses on Adjustment Disorder, an excessive and sometimes debilitating psychological response to a significant life stressor – in this case, advanced cancer. The study aims to evaluate the efficacy, safety, and durability of a psycho-therapeutic approach utilizing nature-derived psilocybin to reduce anxiety and depressive symptoms in this vulnerable patient population.

As a regulated, nature-derived formulation rather than a synthetic analogue, Psyence BioMed’s approach represents a differentiated pathway within psychedelic therapeutics – integrating pharmaceutical-grade manufacturing with clinical rigor in palliative mental health care.

“Our team executed this export with efficiency and strict adherence to GMP standards because patient safety is paramount,” said Tony Budden, CEO of PsyLabs. “Every capsule supplied to this trial has been produced under rigorous quality controls to help ensure a safe, consistent, and reliable experience for patients participating in this important study.”

Manufacturing & Global Supply Chain Leadership

PsyLabs operates a GMP-compliant production and analytical facility capable of manufacturing pharmaceutical-grade natural psilocybin and ethically sourced ibogaine at scale. The successful export of NPX-5 capsules to Australia demonstrates:

• Full GMP compliance.
• International regulatory authorization for shipment.
• Operational global supply chain capability.
• Vertical integration across cultivation, extraction, manufacturing, and quality assurance.

This development further strengthens the strategic alignment between Psyence BioMed and PsyLabs as they build a scalable, compliant, and resilient global infrastructure for nature-derived psychedelic medicines. PsyLabs holds a 49.98% equity stake in the Company and Certain members of the Company’s management are affiliates of PsyLabs and have financial interests in PsyLabs.

“As the psychedelic sector matures, infrastructure and supply certainty will differentiate sustainable pharmaceutical platforms,” added Aufrichtig. “This shipment marks meaningful progress in advancing our strategy and demonstrates our ongoing efforts to operate in a disciplined and globally coordinated manner.”

Learn more at www.psyencebiomed.com and on LinkedIn.

Contact Information for Psyence Biomedical Ltd. 
Email: ir@psyencebiomed.com   
Media Inquiries: media@psyencebiomed.com  
General Information: info@psyencebiomed.com  

Investor Contact: 
Michael Kydd 
Investor Relations Advisor 
michael@psyencebiomed.com  

Forward Looking Statements 

This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding future financial and operating results; the progress, timing, enrollment, dosing, data readouts and regulatory status of the Company’s Phase IIb clinical trial; the manufacture, export and supply of NPX-5; the expansion of PsyLabs’ manufacturing capabilities; the development of a regulated global supply chain; the Company’s vertically integrated business model; anticipated regulatory authorizations; market opportunity and demand for psychedelic-assisted therapies; and the Company’s plans, objectives, expectations and intentions with respect to future operations, products and services. Forward-looking statements are generally identified by words such as “will,” “may,” “expects,” “anticipates,” “believes,” “intends,” “plans,” “estimates,” “projects,” “continues,” “could,” “would,” or similar expressions.

Forward-looking statements in this communication are based on current assumptions and expectations, including, among others, assumptions that the Company’s clinical trial will proceed as currently anticipated; that patient enrollment, dosing and site expansion will occur on expected timelines; that required regulatory approvals, import/export authorizations and institutional consents will be maintained; that manufacturing operations will remain compliant with applicable GMP requirements; that product supply will not be disrupted; and that demand for psychedelic-assisted therapy will continue to develop. These assumptions may prove to be incorrect.

There can be no assurance that the Company’s clinical trial will be completed on its current timeline or at all, that regulatory approvals will be obtained or maintained, that manufacturing scale-up or international shipment of product will continue without interruption, or that the Company’s vertically integrated strategy will result in commercial success. There can be no assurance as to when a share consolidation will be implemented, if at all.

Numerous risks and uncertainties could cause actual results or performance to differ materially from those expressed or implied by forward-looking statements. These risks and uncertainties include, among others: (i) the Company’s ability to maintain compliance with Nasdaq’s continued listing standards; (ii) volatility in the Company’s share price; (iii) changes in applicable laws, regulations or regulatory interpretations in the United States, Australia or other jurisdictions; (iv) risks associated with clinical development, including delays in enrollment, dosing, data collection, analysis or regulatory review; (v) risks related to the manufacture, quality control, scale-up and continued GMP compliance of the Company’s product candidates; (vi) risks associated with international shipment, import/export controls and cross-border regulatory requirements; (vii) dependence on third-party manufacturers, suppliers, clinical sites and collaborators; (viii) competitive developments, including other companies pursuing similar indications or alternative therapeutic approaches; (ix) the uncertainty of clinical trial outcomes and the possibility that clinical results may not support regulatory approval or commercialization; and (x) general economic, capital markets and industry conditions. The foregoing list is not exhaustive.

You should carefully consider these risks and the other risks and uncertainties described in the “Risk Factors” section of the Company’s final prospectus (File No. 333-298285) filed with the Securities and Exchange Commission (the “SEC”) on November 3, 2025, as amended, and in other documents filed by Psyence BioMed from time to time with the SEC.

Actual results and future events could differ materially from those anticipated in forward-looking statements. Nothing in this communication should be regarded as a representation that any forward-looking statement will be achieved. Forward-looking statements speak only as of the date they are made, and except as required by applicable law, Psyence BioMed undertakes no obligation to update or revise them.

The Company does not make any medical, treatment or health benefit claims regarding its investigational product candidates. The U.S. Food and Drug Administration, Health Canada and other regulatory authorities have not approved psilocybin, psilocybin analogues or other psychedelic compounds for the treatment of Adjustment Disorder or other indications described herein. Any references to quality, consistency, efficacy or safety relate to investigational products that are currently being evaluated in clinical trials. The safety and efficacy of such product candidates have not been established, and there can be no assurance that ongoing or future clinical trials will demonstrate sufficient safety or efficacy to obtain regulatory approval. If the Company is unable to obtain required regulatory approvals or successfully commercialize its product candidates, its business, financial condition and results of operations may be materially adversely affected.

VivoSim Appoints Arumugham (Ragoo) Raghunathan as Vice President of Global Sales




VivoSim Appoints Arumugham (Ragoo) Raghunathan as Vice President of Global Sales

Veteran business development leader with deep expertise in human-relevant NAM and spheroid-based in vitro services to spearhead commercial growth along the US East Coast, deepening VivoSim’s reach with biopharma innovators seeking human-relevant liver and GI toxicity solutions

SAN DIEGO, March 03, 2026 (GLOBE NEWSWIRE) — VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company” or “VivoSim”), a provider of next-generation New Approach Methodologies (NAMs) for preclinical safety, today announced the appointment of Dr. Arumugham (Ragoo) Raghunathan, PhD as Vice President of Global Sales. Based in the Greater Boston area, Dr. Raghunathan will lead commercial expansion and secure strategic partnerships with biopharma innovators, established pharmaceutical companies, CROs/CDMOs, and research institutions. His focus will be on delivering VivoSim’s liver and gastrointestinal (GI) toxicity solutions for earlier de-risking of drug candidates and clearer feasibility decisions throughout the development process.

A seasoned executive, Dr. Raghunathan brings extensive experience building trusted, consultative relationships across drug discovery and advanced in vitro biology. He is recognized for bridging scientific and commercial stakeholders, structuring collaborative programs, and guiding customers from pilot studies to scaled deployments—particularly in complex, high-stakes areas such as safety assessment and translational decision-making.

“Ragoo builds and strengthens relationships through scientific rigor and a relentless emphasis on outcomes,” said Tony Lialin, Chief Commercial Officer of VivoSim. “He is the kind of leader customers instantly trust and recognize as a true long-term partner. He understands how discovery, DMPK, and safety teams operate under real-world timelines and constraints. As we accelerate adoption of our liver and GI tox services, Ragoo will be instrumental in helping partners generate clearer, earlier signals—so they can move forward with the best programs with confidence, maximizing both cost and time efficiency.”

Expanding Customer Impact Across Liver and GI Toxicology

Under Dr. Raghunathan’s leadership, VivoSim will intensify engagement with customers who need stronger human relevance and sharper predictivity in preclinical development, including:

• Discovery and translational teams seeking earlier insight into toxicity liabilities while optimizing efficacy and chemical series
• Preclinical safety, toxicology, and DMPK groups looking to improve go/no-go decision quality, candidate selection, and risk management
• Biotech startups and emerging pharma aiming to conserve capital by reducing late-stage attrition
• Large pharma portfolios requiring scalable, reproducible screening approaches across multiple programs
• CROs/CDMOs and strategic partners integrating advanced in vitro safety services into broader development packages
• Academic medical centers and research institutes studying mechanism, disease biology, and human-relevant endpoints

VivoSim’s portfolio supports safety assessment programs focused on liver toxicity   including drug-induced liver injury (DILI) risk—and GI toxicity, enabling teams to interrogate potential liabilities with models and readouts designed to better reflect human biology. This is particularly valuable for programs where traditional approaches can obscure or miss risk signals entirely.

“VivoSim is building exactly what the market has been asking for: practical, human-relevant tools that give development teams a clearer view of tox-compatible candidates earlier in the process,” said Dr. Raghunathan. “In the Boston area and across the East Coast pharma clusters, there is enormous demand for better prediction of liver and GI liabilities—especially as drug modalities diversify and development timelines compress. I’m excited to help customers translate VivoSim’s science into concrete wins: smarter prioritization, fewer late-stage surprises, and faster progress to the clinic.”

In his role, Dr. Raghunathan will also support VivoSim’s broader business and strategic initiatives, including key account development, bespoke partnership plans, and customer success programs designed to move engagements from pilot studies to long-term collaborations.

About VivoSim Labs
VivoSim Labs, Inc. (“VivoSim” and the “Company”), is a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional (“3D”) human tissue models of liver and intestine. The Company offers partners liver and intestinal toxicology insights using its new approach methodologies (“NAM”) models. The Company anticipates accelerated adoption of human tissue models following the U.S. Food and Drug Administration (“FDA”) announcement on April 10, 2025 to refine animal testing requirements in favor of these non-animal NAM methods. VivoSim Labs operates from San Diego, CA. Visit www.vivosim.ai.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Forward-looking statements include statements regarding NAMKind™, including target turnaround time and its potential to help users de-risk their pipelines, avoid costly downstream failures, reduce rework, prioritize the right assets, move faster, save millions and reduce risk; VivoSim’s commercial presence across Asia-Pacific; the evaluation and acceptance of scientifically robust NAM-based evidence; the Company’s ability to capture growing demand in the in vitro toxicology testing market; demand for human-relevant toxicology; the market opportunity and market size of gastrointestinal in vitro models and toxicology services; and the Company’s scaling capacity to support expanding global demand and development needs. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on June 5, 2025, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 11, 2026. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events. 

Contact(s):
Investor Relations
info@vivosim.ai
VivoSim Labs, Inc.

T-knife Therapeutics Announces Authorization of Clinical Trial Application for TK-6302, A Multi-Armored, CRISPR based T cell Therapy for Solid Tumors




T-knife Therapeutics Announces Authorization of Clinical Trial Application for TK-6302, A Multi-Armored, CRISPR based T cell Therapy for Solid Tumors

– Phase 1 ATLAS trial to evaluate TK-6302 in patients with advanced PRAME-positive solid tumors authorized for initiation

SAN FRANCISCO and BERLIN, March 03, 2026 (GLOBE NEWSWIRE) — T-knife Therapeutics, Inc., a biopharmaceutical company developing next-generation T cell therapies to fight cancer, today announced the authorization of its Clinical Trial Application (CTA) to begin the Phase 1 ATLAS trial of TK-6302 in Europe. TK-6302 is a multi-armored PRAME-targeted T cell therapy specifically engineered to overcome the challenges associated with treating solid tumor cancers. The ATLAS trial, which is poised to begin this year, is an adaptive, first-in-human, open-label, Phase 1 trial of TK-6302 in patients with advanced PRAME-positive solid tumors.

“We are proud to achieve this important milestone, which enables the initiation of the Phase 1 ATLAS clinical trial and our transition to becoming a clinical-stage company,” stated Thomas M. Soloway, President and Chief Executive Officer of T-knife. “TK-6302 is a highly differentiated therapy, engineered for greater potency against PRAME, a clinically validated target with attractive commercial potential. PRAME is highly prevalent across multiple high unmet-need solid tumor indications, including squamous non-small cell lung, ovarian, endometrial, skin, and triple-negative breast cancers. Today’s announcement reflects the dedication, expertise, and urgency our team brings to transforming innovative science into life-changing therapies.”

Peggy Sotiropoulou, Ph.D., Chief Scientific Officer of T-knife, added, “The CTA was supported by a comprehensive and compelling preclinical data package demonstrating TK-6302’s best-in-class anti-tumor efficacy. By bolstering T-cell fitness and persistence while overcoming challenging tumor mediated immune barriers, TK-6302 has the potential to deliver meaningful clinical benefit, including deep, durable responses across a range of solid tumor cancers. Bringing a first-of-its-kind multi-armored, CRISPR gene-edited T cell therapy into the clinic underscores our commitment to pushing scientific boundaries in the service of delivering transformative therapies to patients.”

About TK-6302
TK-6302 is a PRAME-targeted T cell therapy that has been “supercharged” by the inclusion of multiple armoring innovations: a high affinity PRAME targeting receptor to enhance cytotoxicity; a costimulatory CD8 coreceptor to engage CD4 T cells and enhance T cell fitness and persistence; and a FAS-based checkpoint converter designed to boost engraftment and promote T cell survival in the hostile tumor micro-environment. Preclinical data with TK-6302 demonstrated sustained serial killing and cytokine secretion in a model mirroring the inhibitory ligand expression in PRAME-expressing tumors. In a complex 3-dimensional (3D) spheroid tumor model, TK-6302 eliminated multiple rounds of tumors and demonstrated superior anti-tumor activity compared to controls. TK-6302 is manufactured with a non-viral gene editing process for improved T cell receptor expression, and it has been successfully manufactured at-scale using the clinical process.

About T-knife Therapeutics
T-knife is a biopharmaceutical company dedicated to developing T cell therapies to deliver broad, deep and durable responses to solid tumor cancer patients. The company’s unique approach leverages its proprietary platforms and synthetic biology capabilities to design the next-generation of supercharged T cells with best-in-class potential.

T-knife was founded by leading T cell and immunology experts utilizing technology developed at the Max Delbrück Center for Molecular Medicine together with Charité – Universitätsmedizin Berlin, is led by an experienced management team, and is supported by a leading group of international investors, including Andera Partners, EQT Life Sciences, RA Capital Management and Versant Ventures. For additional information, please visit the company’s website at www.t-knife.com.

T-knife Therapeutics, Inc. 
Camille Landis  
Chief Business Officer / Chief Financial Officer 
media@t-knife.com 

T-knife Therapeutics Announces Authorization of Clinical Trial Application for TK-6302, A Multi-Armored, CRISPR based T cell Therapy for Solid Tumors




T-knife Therapeutics Announces Authorization of Clinical Trial Application for TK-6302, A Multi-Armored, CRISPR based T cell Therapy for Solid Tumors

– Phase 1 ATLAS trial to evaluate TK-6302 in patients with advanced PRAME-positive solid tumors authorized for initiation

SAN FRANCISCO and BERLIN, March 03, 2026 (GLOBE NEWSWIRE) — T-knife Therapeutics, Inc., a biopharmaceutical company developing next-generation T cell therapies to fight cancer, today announced the authorization of its Clinical Trial Application (CTA) to begin the Phase 1 ATLAS trial of TK-6302 in Europe. TK-6302 is a multi-armored PRAME-targeted T cell therapy specifically engineered to overcome the challenges associated with treating solid tumor cancers. The ATLAS trial, which is poised to begin this year, is an adaptive, first-in-human, open-label, Phase 1 trial of TK-6302 in patients with advanced PRAME-positive solid tumors.

“We are proud to achieve this important milestone, which enables the initiation of the Phase 1 ATLAS clinical trial and our transition to becoming a clinical-stage company,” stated Thomas M. Soloway, President and Chief Executive Officer of T-knife. “TK-6302 is a highly differentiated therapy, engineered for greater potency against PRAME, a clinically validated target with attractive commercial potential. PRAME is highly prevalent across multiple high unmet-need solid tumor indications, including squamous non-small cell lung, ovarian, endometrial, skin, and triple-negative breast cancers. Today’s announcement reflects the dedication, expertise, and urgency our team brings to transforming innovative science into life-changing therapies.”

Peggy Sotiropoulou, Ph.D., Chief Scientific Officer of T-knife, added, “The CTA was supported by a comprehensive and compelling preclinical data package demonstrating TK-6302’s best-in-class anti-tumor efficacy. By bolstering T-cell fitness and persistence while overcoming challenging tumor mediated immune barriers, TK-6302 has the potential to deliver meaningful clinical benefit, including deep, durable responses across a range of solid tumor cancers. Bringing a first-of-its-kind multi-armored, CRISPR gene-edited T cell therapy into the clinic underscores our commitment to pushing scientific boundaries in the service of delivering transformative therapies to patients.”

About TK-6302
TK-6302 is a PRAME-targeted T cell therapy that has been “supercharged” by the inclusion of multiple armoring innovations: a high affinity PRAME targeting receptor to enhance cytotoxicity; a costimulatory CD8 coreceptor to engage CD4 T cells and enhance T cell fitness and persistence; and a FAS-based checkpoint converter designed to boost engraftment and promote T cell survival in the hostile tumor micro-environment. Preclinical data with TK-6302 demonstrated sustained serial killing and cytokine secretion in a model mirroring the inhibitory ligand expression in PRAME-expressing tumors. In a complex 3-dimensional (3D) spheroid tumor model, TK-6302 eliminated multiple rounds of tumors and demonstrated superior anti-tumor activity compared to controls. TK-6302 is manufactured with a non-viral gene editing process for improved T cell receptor expression, and it has been successfully manufactured at-scale using the clinical process.

About T-knife Therapeutics
T-knife is a biopharmaceutical company dedicated to developing T cell therapies to deliver broad, deep and durable responses to solid tumor cancer patients. The company’s unique approach leverages its proprietary platforms and synthetic biology capabilities to design the next-generation of supercharged T cells with best-in-class potential.

T-knife was founded by leading T cell and immunology experts utilizing technology developed at the Max Delbrück Center for Molecular Medicine together with Charité – Universitätsmedizin Berlin, is led by an experienced management team, and is supported by a leading group of international investors, including Andera Partners, EQT Life Sciences, RA Capital Management and Versant Ventures. For additional information, please visit the company’s website at www.t-knife.com.

T-knife Therapeutics, Inc. 
Camille Landis  
Chief Business Officer / Chief Financial Officer 
media@t-knife.com