Newron Notes Publication Highlighting Clinically Meaningful Benefits of Evenamide as an Adjunctive Treatment in Schizophrenia

Publication presents clinical findings highlighting evenamide’s glutamatergic modulation as a therapeutic strategy for patients with inadequate response or treatment-resistant schizophrenia (TRS)

By targeting the hippocampus region of the brain, evenamide addresses schizophrenia at the source of dysfunction

Milan, Italy, and Morristown, NJ, USA, February 3, 2026 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on developing novel therapies for patients with diseases of the central and peripheral nervous system, today announced the publication of peer-reviewed data in Therapeutic Advances in Psychopharmacology, co-authored by Newron’s Chief Medical Officer, Ravi Anand, MD, and colleagues¹. The publication presents clinical findings showing that evenamide, a novel glutamate modulator, is associated with clinically meaningful and sustained benefits when added to first- or second-generation antipsychotics in patients with schizophrenia who have an inadequate response to existing treatments, including those with TRS.

The publication synthesizes results from multiple randomized clinical trials and provides a scientific mechanistic rationale for the use of evenamide as a unique approach that targets disease mechanisms not addressed by existing antipsychotics. Drawing on data and analyses from randomized clinical studies, the publication highlights how modulation of aberrant glutamatergic signaling may deliver clinically meaningful benefits for patients with TRS and for those who continue to struggle despite standard antipsychotic treatment.

“This publication captures more than a decade of scientific and clinical work addressing one of psychiatry’s most difficult challenges,” said Ravi Anand, MD, Chief Medical Officer at Newron Pharmaceuticals. “The analyses highlight not only symptom improvement but also real-world functional gains that matter to people living with schizophrenia, particularly those who have exhausted available options.”

A Distinct Mechanism Targeting the Site of Dysfunction

Unlike currently marketed antipsychotics that act primarily by blocking dopamine receptors in the basal ganglia, evenamide’s primary site of action is the hippocampus, that controls hyperdopaminergic firing in the basal ganglia (a brain region intimately involved in the causation of the core symptoms of schizophrenia). By reducing excessive glutamate activity in the hippocampus, evenamide indirectly rebalances dopamine signaling while preserving normal neuronal function. The hippocampal site of action of evenamide may explain why evenamide has demonstrated improvements not only in positive symptoms but also in negative symptoms, social functioning, and life engagement – domains that together with cognition are controlled by the various nuclei in the hippocampus and remain largely unaddressed by existing therapies. Taken together, the findings support evenamide as a potential first-in-class adjunctive therapy capable of redefining expectations for patients with TRS.

Across clinical studies reported to date, evenamide has maintained a favorable safety and tolerability profile, being well-tolerated, with low rates of treatment discontinuation and no consistent pattern of serious safety concerns.

“Evenamide represents a fundamentally different treatment approach,” said Anand. “By targeting the hippocampus – the source of the deficit rather than its downstream effects – we believe evenamide has the potential to shift the treatment paradigm, particularly for patients with TRS who urgently need new options.”

Clinically Meaningful and Durable Benefits

The publication reports analyses from two key clinical programs. In a one-year study of patients with treatment-resistant schizophrenia, more than half of those patients treated with evenamide improved to such an extent that they no longer met the severity criteria for TRS after long-term adjunctive treatment. Approximately one-quarter achieved remission, based on the most stringent criteria for remission.

In a separate randomized, double-blind, placebo-controlled trial among patients with inadequate response to antipsychotics, evenamide showed statistically significant improvements over standard of care, regardless of the number of prior failed treatments. Importantly, benefits were observed not only in core symptoms but also in measures of social functioning and life engagement, domains often poorly addressed by existing therapies.

“These results are notable because they go beyond symptom reduction,” continued Anand. “With evenamide, we are seeing improvements that translate into patients’ daily lives, including their ability to function, engage socially, and potentially move closer to remission. That is a meaningful outcome for patients, families, and clinicians.”

Newron is advancing evenamide through ENIGMA-TRS, an international Phase III clinical program for patients with documented TRS. If successful, these studies could support the use of evenamide as a first-in-class adjunctive therapy, addressing a long-standing gap in the treatment landscape.
 

About ENIGMA-TRS
The ENIGMA-TRS pivotal Phase III program consists of ENIGMA-TRS 1 and ENIGMA-TRS 2. ENIGMA-TRS 1, initiated in August 2025, is an international, one-year, double-blind, placebo-controlled study in at least 600 patients to evaluate the efficacy, tolerability, and safety of evenamide 15 mg and 30 mg twice daily as an add-on therapy to current antipsychotics, including clozapine, compared to placebo. ENIGMA-TRS 2, initiated in December 2025, is a Phase III, international, 12-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of evenamide 15 mg twice daily as an add-on therapy to current antipsychotics, including clozapine, compared to placebo, in patients suffering from TRS. ENIGMA-TRS 2 will enroll at least 400 patients.

About evenamide
Evenamide is a novel, orally available new chemical entity with a unique mechanism of action distinct from all currently marketed antipsychotics. It acts by selectively blocking voltage-gated sodium channels (VGSCs) and exhibits no biological activity at more than 130 other central nervous system (CNS) targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of subtherapeutic doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide meaningful benefits for patients who do not adequately respond to current APs, including those on clozapine. Importantly, the benefits seemed to persist for a substantial time after evenamide had been degraded, explaining the long-term effects seen in clinical studies. Through its novel glutamatergic modulation, evenamide represents a first-in-class approach aimed at addressing the unmet needs of patients with schizophrenia who are resistant to existing treatments.

About treatment-resistant schizophrenia (TRS)
A significant proportion of patients with schizophrenia show virtually little to no beneficial response to currently available antipsychotic (AP) treatments, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no or inadequate symptom relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. It is estimated that approximately 15% of patients develop TRS from the onset of illness, and about one-third to 50% of patients with schizophrenia overall. Emerging scientific evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of clinical benefit of most typical and atypical antipsychotics, which act primarily on dopamine receptors. These insights underline the need for novel therapeutic approaches that target the underlying glutamatergic dysfunction in schizophrenia, offering hope for patients who currently have limited or no effective treatment options.

About Newron Pharmaceuticals
Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase III development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: www.newron.com

References:

[1] Ravi Anand¹, Alessio Turolla https://orcid.org/0009-0005-2167-6143², Giovanni Chinellato https://orcid.org/0009-0001-7091-8672³, Francesca Sansi https://orcid.org/0009-0002-4495-5821⁴, Arjun Roy⁵, and Richard Hartman https://orcid.org/0000-0002-5980-0200⁶

For more information, please contact:

Newron
Stefan Weber – CEO; +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com  

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience; +1 617 865 0041, psagan@lavoiehealthscience.com
 

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

Frauenfeld, 2 February 2026

Press release

Early redemption of the 6.875% Convertible Bonds due 2026

• DocMorris Finance B.V. notifies the bondholders of its Convertible Bond due in 2026 that it has exercised the early redemption option
• Bonds not converted will be redeemed at nominal value plus accrued interest for 80 days

DocMorris Finance B.V. announces the exercise of its option to redeem the 6.875% Convertible Bonds due 15 September 2026 (the “Bonds”) on 5 March 2026 at nominal value plus accrued interest.

The early redemption occurs in accordance with condition 5.b) of the Bond terms whereby the Bonds may be redeemed if less than fifteen (15) per cent of the aggregate nominal value of the Bonds issued pursuant to the Bond terms is outstanding at the time of the notice. Following the settlement of the purchase of Convertible Bonds with an aggregate nominal value of approximately CHF 14.4 million, which was announced on 26 January 2026, approximately CHF 8 million remains outstanding, which is significantly less than 15% of the original aggregate nominal value of CHF 94.972 million.

The outstanding Bonds will be redeemed at nominal value plus accrued interest for 80 days. The last trading day for the Bonds on the SIX Swiss Exchange is 3 March 2026.

Note on conversion rights
According to the Bond terms, each Bond with a nominal value of CHF 1,000 can be converted into 41.23711 registered shares of DocMorris AG with a nominal value of CHF 0.01 each. This corresponds to a conversion price of CHF 24.25 per registered share, which is significantly above the closing price of DocMorris shares on 2 February 2026. Fractions of shares will be paid out in cash. The registered shares delivered upon conversion are fungible with the outstanding registered shares.

Notices to convert the Bonds may be deposited with the paying and conversion agent until 19 February 2026, 4 p.m. CET, whereby deposit banks or brokers may set an earlier deadline for bondholders to instruct the conversion. Bondholders are requested to contact their bank or broker directly in this regard.

Investors and analyst contact
Lisa Lüthi, Senior Investor Relations Manager
Email: ir@docmorris.com

Media contact
Torben Bonnke, Director Communications
Email: media@docmorris.com, phone: +49 171 864 888 1

Agenda

DocMorris
The Swiss-based DocMorris AG is a leading company in the fields of online pharmacy, telemedicine and marketplace with strong brands in Germany and other European countries. Deliveries are mainly from the highly automated logistics centre in Heerlen, the Netherlands. TeleClinic is Germany’s largest telemedicine platform, connecting patients with more than 6,000 physicians. DocMorris operates leading marketplaces for health and personal care products in Southern Europe. With its broad range of products and services, DocMorris is pursuing its vision of becoming the leading digital health companion for everyone to manage their health in one click. Around 1,600 employees in Germany, the Netherlands, Spain, France, Portugal and Switzerland generated an external revenue of CHF 1,186 million serving 11 million active customers in 2025. The shares of DocMorris AG are listed on the SIX Swiss Exchange (securities number 4261528, ISIN CH0042615283, ticker DOCM). For further information, please visit corporate.docmorris.com.

Greifswald, Germany, February 2, 2026

CHEPLAPHARM Arzneimittel GmbH (“CHEPLAPHARM”), a leading international pharmaceutical platform for established branded medicines, announces the successful placement of €950m of senior secured notes at an interest rate of 6.750%. The proceeds from the new notes will be used for the early redemption in full of two outstanding tranches of a bond maturing in 2028 totaling around €750m and for the partial repayment of a Term Loan B maturing in 2029. The transaction increases CHEPLAPHARM’s financial flexibility and enables it to extend its maturity profile at attractive conditions.

The new bond met with high investor demand and was multiple times oversubscribed, enabling CHEPLAPHARM to increase the volume from originally planned €750m to €950m, while simultaneously reducing the coupon to 6.750%.

“In 2025, we made significant progress with our transformation program and noticeably stabilized our business development, thereby laying the foundation for this successful refinancing”, says Sebastian Braun, Co-CEO of CHEPLAPHARM. “The high demand for our new bond demonstrates the great confidence investors have in the path we have chosen. Now we must continue to consistently implement our transformation program and prepare CHEPLAPHARM for the next phase of growth.”

“I am very pleased about this successful capital market transaction, which allows us to redeem several outstanding tranches of a bond early and to extend our maturity profile on attractive terms”, says Dr. Kia Parssanedjad, CFO of CHEPLAPHARM.

“Our new bond was multiple times oversubscribed, which enabled us to increase the volume by €200m, while simultaneously achieving a coupon of 6.750%. On behalf of the entire Management Board, I would like to once again express my sincere thanks to our existing and new investors for their support and trust.”

The new senior secured EUR notes mature in 2032. The Notes shall be issued on February 9, 2026, subject to customary closing conditions.

Citigroup and Deutsche Bank acted as Joint Global Coordinators and Bookrunners in the transaction. Joint Bookrunners were Barclays, BofA Securities, Commerzbank, Goldman Sachs, J.P. Morgan, ING, UBS Investment Bank, and UniCredit. On the legal side, CHEPLAPHARM was advised by Latham & Watkins, while Freshfields LLP was mandated as legal advisor to the banks.

About CHEPLAPHARM

CHEPLAPHARM is a family-owned company with headquarters in Greifswald. For over 20 years, the company has been very successful in taking over well-known and well-established medicines from the research-based pharmaceutical industry and transferring them to an existing global network of partners for production and distribution. In this way, CHEPLAPHARM ensures the continuous supply of these medicines to patients worldwide. In addition to its headquarters in Greifswald, CHEPLAPHARM operates further sites in France, Japan, Russia and Switzerland. The company employs around 800 people worldwide.

Please refer to www.cheplapharm.com for additional information.

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Germany

CHEPLAPHARM Investor Relations:

Email: investor-relations@cheplapharm.com

CHEPLAPHARM Press Office:

Email: presse@cheplapharm.com

DISCLAIMER

This announcement does not constitute an offer to sell or the solicitation of an offer to buy the Notes or any other security and shall not constitute an offer, solicitation or sale in the United States or in any jurisdiction in which, or to any persons to whom, such offering, solicitation or sale would be unlawful.

The Notes and the related guarantees have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), or the securities laws of any state or other jurisdiction of the United States, and may not be offered or sold within the United States, or to, or for the account or benefit of, U.S. persons, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state or local securities laws. Accordingly, the Notes and the related guarantees have been offered and sold (i) in the United States only to qualified institutional buyers in accordance with Rule 144A under the Securities Act and (ii) in “offshore transactions” to non-U.S. persons outside the United States in accordance with Regulation S under the Securities Act. There is no assurance that the issuance of the Notes will be completed or, if completed, as to the terms on which they will be completed.

The offer and sale of the Notes has been made pursuant to an exception under the Regulation (EU) 2017/1129 (the “Prospectus Regulation”) from the requirement to produce a prospectus for offers of securities. This press release does not constitute a prospectus within the meaning of the Prospectus Regulation or an offer to the public.

The distribution of this press release into certain jurisdictions may be restricted by law. Persons into whose possession this announcement comes should inform themselves about and observe any such restrictions. Any failure to comply with these restrictions may constitute a violation of the laws of any such jurisdiction.

Forward-looking Statements

This news release may include “forward-looking statements” within the meaning of the securities laws of certain applicable jurisdictions. These forward-looking statements include, but are not limited to, all statements other than statements of historical facts contained in this news release, including, without limitation, those regarding Cheplapharm’s intentions, beliefs or current expectations concerning, among other things: Cheplapharm’s future financial conditions and performance, results of operations and liquidity; Cheplapharm’s strategy, plans, objectives, prospects, growth, goals and targets; future developments in the markets in which Cheplapharm participates or is seeking to participate; and anticipated regulatory changes in the industry in which Cheplapharm operates. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate”, “believe”, “continue”, “ongoing”, “estimate”, “expect”, “intend”, “may”, “plan”, “potential”, “predict”, “project”, “target”, “seek” or, in each case, their negative, or other variations or comparable terminology. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors because they relate to events and depend on circumstances that may or may not occur in the future. Readers are cautioned that forward-looking statements are not guarantees of future performance and that Cheplapharm’s actual financial condition, results of operations and cash flows, and the development of the industry in which Cheplapharm operates, may differ materially from (and be more negative).

M1 Kliniken AG: Completion of the Sale of 100% Subsidiary HAEMATO Pharm GmbH to PHOENIX group

Berlin, February 02, 2026 – M1 Kliniken AG (ISIN: DE000A0STSQ8) announces that the sale of HAEMATO Pharm GmbH by its majority holding, HAEMATO AG (85%), to the PHOENIX group was successfully completed effective as of the end of January 31, 2026.

Following the fulfillment of all closing conditions, including the necessary antitrust approvals, the transaction has now been legally consummated. Consequently, HAEMATO Pharm GmbH will be deconsolidated from the scope of consolidation of both HAEMATO AG and M1 Kliniken AG.

With the successful closing of this transaction, M1 Kliniken AG continues to consistently pursue its strategic focus and strengthens its positioning as a leading global, vertically integrated pure-play provider of medical aesthetics.

About M1 Kliniken AG

M1 Kliniken AG is the leading fully integrated provider of medical aesthetic services in Europe and Australia. With a clear strategic focus, high standardization, and consistent scalability, the Group currently operates 58 clinics in ten countries under the M1 Med Beauty brand. All treatments are performed exclusively by qualified physicians and adhere to uniform, high medical standards, while being offered at market-leading prices. Since late 2018, M1 has systematically driven its international expansion, which forms the basis for scalable future growth and the further development of its global market position. With the M1 Schlossklinik in Berlin, the Group operates one of Europe’s largest and most modern clinics for plastic and aesthetic surgery, featuring four operating theaters and 35 beds.

Contact:
M1 Kliniken AG
Grünauer Straße 5
12557 Berlin
T: +49 (0)30 347 47 44 14
M: ir@m1-kliniken.de

• Continued organic growth despite challenging comparative basis
• APAC region strongest growth driver
• Diversification contributes to stability and scalability
• Human clinical trials successfully completed, scientific visibility will increase

aap Implantate AG (“aap”) reports preliminary sales growth of 2% year-on-year for the financial year, thus confirming stable business performance with positive momentum in the fourth quarter. The main growth drivers were once again the Asian markets.

The sales decline of around 3% in the first half of 2025 – due to one-off major orders in the first half of 2024 – was fully compensated for in the further course of the year. In the second half of the year, aap achieved an increase in sales of 8% compared to the same period of the previous year. Most of the sales regions contributed to this development with improved performance in the second half of the year.

In Germany, sales increased by 5% despite persistently challenging market conditions, underlining the company’s solid market position in its home market. In the United States, the shortfall of –9% in local currency recorded in the first half of the year was gradually made up, resulting in a slight increase of 1% for the year.

The APAC region developed particularly strongly, with aap achieving significant revenue growth of 98% for the full year with existing and new customers, consolidating Asia’s role as an increasingly important growth driver for the company.

Sales FY/2025

In addition, the company made decisive progress in product development in the past fiscal year: The clinical human study on the innovative, antibacterial treated implants was successfully completed with excellent results. The complete study report is currently at the participating study centers for final approval.

The results are planned to be published in an internationally renowned journal later this year. This would further underpin the scientific relevance of technology and significantly increase its visibility in the global professional environment.

At the same time, the company is working with high priority on the approval of the new implants – both for the European market under the Medical Device Regulation (MDR) and for the US market under the regulations of the Food and Drug Administration (FDA). With the completion of these procedures, the company is creating the future basis for the global market launch of its exclusive “Silver Trauma Line” and the basis for licenses in other implant areas such as hip implants and others.

This step represents an important milestone and paves the way for the strategic development of the company into a new, international growth scenario.

The Company will provide information on the outlook for the 2026 financial year and the management agenda in a separate announcement.

The sales figures contained in this press release are preliminary figures as of December 31, 2025, and are subject to change until the final publication. aap plans to announce the final, audited results for the 2025 financial year at the end of April 2026 as part of the 2025 consolidated annual financial report.

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aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German Stock Exchanges –

About aap Implantate AG

aap Implantate AG is a global medical technology company headquartered in Berlin, Germany. The company develops manufactures and markets products for traumatology. In addition to the innovative anatomical plate system LOQTEQ®, the IP-protected portfolio includes a wide range of perforated screws. In addition, aap Implantate AG has an innovative pipeline with promising development projects, such as antibacterial silver coating technology. This technology addresses critical and not yet adequately solved problems of Surgical Site Infections (SSI) in traumatology and applicable in other MedTech areas.  In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and affiliated clinics, while on an international level, it primarily uses a broad network of distributors in around 41 countries. In the USA, the company and its subsidiary aap Implants Inc. rely on a distribution agent and selective direct sales strategy. The shares of aap Implantate AG are listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit our website at www.aap.de.

There may be technical rounding differences in the figures presented in this press release, which do not affect the overall statement.

Forward-Looking Statements

This release may contain forward-looking statements based on the current expectations, assumptions and forecasts of the Management Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of future developments and results referred to therein. Various known and unknown risks, uncertainties and other factors could cause the actual results, financial condition, development or performance of the Company to differ materially from the estimates given herein. These factors also include those described by aap in published reports. Forward-looking statements therefore speak only as of the date on which they are made. We undertake no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo; Chairman of the Board of Directors/CEO; Lorenzweg 5; 12099 Berlin
Tel.: +49 (0)30 75019 – 141; Fax: +49 (0)30 75019 – 170; E-Mail: r.digirolamo@aap.de

Affluent Medical officially becomes CARVOLIX

Completion of the acquisitions of CARANX MEDICAL and ARTEDRONE

10m€ first tranche of financing completed

Aix-en-Provence, February 2, 2026 – 7:30 a.m. CET – Carvolix (formerly Affluent Medical) (ISIN: FR0013333077 – Ticker: AFME – “Carvolix” or the “Company”), a French commercial and clinical-stage medical technology company specializing in the international development and industrialization of breakthrough AI-driven mini-robots and biomimetic implants, to revolutionize interventional cardiology and the treatment of brain stroke is today announcing the completion of the acquisitions of Caranx Medical and Artedrone (the “Acquisitions”), for a closing price paid in Carvolix shares, to form a new, integrated MedTech company named Carvolix, as well as the definitive terms of the capital increases and the issuance of new shares (the “Financing” and, together with the Acquisitions, the “Transaction”) pursuant to the use of the delegations granted by the general meeting held on January 30, 2026 (the “General Meeting”).

A 10M€ first tranche of Financing has been made available by funds managed by Truffle Capital and by Edwards Lifesciences at a subscription price of €2.34 per share (which represents a 18.8% premium versus the last closing share price).

This strategic consolidation is designed to create a company for the 21^st century interventional cardiologist – leveraging world leading technology in AI driven autonomous mini-robots with a mission to democratize complex, life-saving procedures. The combined platforms position Carvolix to accelerate radical innovation, expand its addressable market, and drive long term value creation.

“We’re applying our proven business builder model — uniting the capabilities of Truffle-founded companies to de-risk development, accelerate innovation, generate synergies and unlock value for shareholders” said Philippe Pouletty, M.D., CEO of Truffle Capital, founder of several successful biotech and medtech companies (including Abivax, Vexim, Symetis and Affluent Medical).  He added: “We expect to make the cardiology catheterization lab as autonomous and efficient as an aircraft cockpit so that our radical innovations could potentially benefit to millions of patients worldwide.”

Carvolix will focus on revolutionizing cardiac valve replacement and brain stroke treatment, addressing major unmet medical needs in large markets with a total addressable value of €23 billion. Currently, only 17% of the 1.7 million patients annually eligible for Transcatheter Aortic Valve Implantation (TAVI) undergo the procedure, and only 5% of ischemic stroke patients (second cause of death, third cause of disability) receive mechanical thrombectomy. Similarly, just 4% of the four million patients with severe mitral valve regurgitation undergo surgery.

“We are bringing together three extremely innovative and synergistic MedTech companies into one – with the goal of augmenting the cardiac catheterization lab to treat far more patients suffering from valve dysfunction and brain stroke” said Sebastien Ladet, CEO of Carvolix. “In addition, we will boost synergies in R&D and commercialization between the three companies to enable the development and delivery of additional products, such as a robotically delivered mitral valve.”

The combination of these companies unites deep expertise and R&D synergies across micro-robotics, AI, image guidance and biomimetic  valve technologies — accelerating innovation and establishing a robust, sustained product development cadence.

The first product launch is occuring in early 2026, with the TAVIPILOT software ‘already cleared by the FDA, being introduced in the US.  The Company plans to keep direct commercialization rights in Europe and seek partners in the US, Middle East, and Asia.

“We are building a fantastic management team and board of directors to carry out our mission: a commercial stage MedTech leader dedicated to helping interventional cardiologists treat more patients around the world” said Liane Teplitsky, Executive Chair of the Board of Directors of Carvolix.

Completion of the Acquisitions

On December 19, 2025, the Company announced the upcoming acquisition of Caranx Medical and Artedrone, becoming Carvolix, pioneering cardiovascular therapies with AI driven autonomous mini-robots and innovative implants. On January 30, 2026, the Acquisitions have been formally completed and the consolidation of Caranx Medical and Artedrone with the pre-existing Affluent Medical entities into Carvolix is now effective.

The terms and conditions of the Acquisitions are further detailed in the Company press release dated December 19, 2025. In particular, Carvolix made closing payments of respectively €16.6M and €11.4M, entirely in Carvolix shares, for the acquisition of Caranx Medical and Artedrone. Carvolix also acquired from Truffle BioMedTech CrossOver FPCI a current account against Artedrone for an amount of €1M plus accrued interests (at a rate of 8% per annum) (the “Current Account”).

Truffle funds, acting as sellers in the context of the Acquisitions, entirely rolled-over the closing purchase price and the purchase price of the Current Account at a subscription price of €2.34 per ordinary share (i.e., the same price as for the Financing), resulting in the issuance of a total of 12,384,470 new ordinary shares.

These 12,384,470 new ordinary shares were issued by the Board of Directors on January 30, 2026 pursuant to the delegations granted by the general meeting of the Company held on January 30, 2026, for a total subscription price of €28,979,659.80 offset with the closing purchase price and the purchase price of the Current Account.

Initial Tranches of Financing

On December 19, 2025, the Company further announced the launch of a concomitant Financing of up to €30M led by Truffle Capital and Edwards Lifesciences who undertook to make available to the Company a first tranche of €10M (the “First Tranche”).  The Company will secure up to €300,000 from several business angels (the “Additional Tranche”, and together with the First Tranche, the “Initial Tranches”).

Following the adoption by shareholders of the appropriate resolutions at the General Meeting, the Board of Directors decided on January 30, 2026 to use the delegations granted by the General Meeting to proceed with the implementation of the Initial Tranches, consisting of 4,401,708 new ordinary shares at a subscription price of €2.34 per Financing Share (which represents a 18.8% premium versus the last closing share price).

The purpose of the Initial Tranches of the Financing is to extend the horizon of the Company’s cash position from December 2025 to the end of May 2026.

The Initial Tranches of the Financing will allow the Company to pursue clinical and regulatory development for all its devices, and to position itself favorably as it embarks on the next steps of value creation. These steps include, but are not limited to, launching the commercialization in the US of TAVIPILOT Software, negotiating a strategic agreement with an industrial player to speed up the clinical trials and marketing of Artus, progress towards first in human for the robotic platform for stroke treatment and continue the development and clinical activities of Epygon.

The allocation of the proceeds of the Initial Tranches between the different programs should be approximately as follows: 28% to TAVIpilot, 27% to Artus, 23% to structural heart devices (Kalios and Epygon), 22% to ARTE-DRONE.

The financing required to pursue the combined Carvolix activities over the next 12 months, according to current development plans, is estimated at around €26M, of which €10.3M is secured through the Initial Tranches of the Financing.

The Company expects to secure the remainder (i.e., an additional amount of €15.7M) from several international investors, with whom discussions are currently ongoing. The Company also expects to be able to further extend its cash runway through, among other things, the proceeds that would be generated from a potential partnership deal with regards to Artus, an artificial urinary sphincter currently in Carvolix’s product portfolio.

Conversion of the June 2025 convertible bonds

On June 20, 2025, the Company issued €5.4M in convertible bonds to some of its main historical shareholders (the “Convertible Bonds”). In accordance with their terms, the Convertible Bonds are immediately and automatically payable in connection with the implementation of the Financing.

Each bondholder has irrevocably undertaken to subscribe, by way of debt offset, to a capital increase concomitant to the First Tranche of the Financing, such that no cash reimbursement will be made in connection with the redemption of the Convertible Bonds. The ordinary shares issued in connection with the redemption of the Convertible Bonds are subscribed by the bondholders at a price of €1.872 per ordinary share (corresponding to a 20% discount).

Following the adoption by shareholders of the appropriate resolutions at the General Meeting, the Board of Directors decided on January 30, 2026 to use the delegations granted by the General Meeting to proceed with the redemption of the Convertible Bonds and the issuance of 3,107,305 ordinary shares (including 2,605,384 ordinary shares to be issued to Truffle Medeor FPCI) at a subscription price of €1.872 per ordinary share (which represents a 5% discount versus the last closing share price).

Impact of the Transaction on the share capital

Taking into account the share issues resulting from (i) the Roll-Over, (ii) the Initial Tranches of the Financing, and (iii) the redemption of the Convertible Bonds, the shareholding structure of the Company will be as follows:

The 19,893,483 shares issued will result in a dilution of 33.57% (on a non-diluted basis). Following such issuance, the Company’s share capital will amount to €5,924,367.50 divided into 59,243,675 shares with a nominal value of €0.10. A shareholder holding 1.00% of the Company’s share capital before the Transaction would therefore hold 0.66% of the capital after the completion of the Transaction.

As part of the Transaction, it is reminded that up to an additional 14,283,985 shares could be issued in connection with the payment of earn-outs for the acquisition of Caranx Medical and Artedrone as well as with the subsequent tranches of the Financing (assuming up to 20M€ in additional financing subscribed at a price of €2.34 per share), representing an additional dilution of 14% (on a non-diluted basis).

In accordance with applicable provisions of the French Commercial Code, each subscriber of ordinary shares has abstained from voting on the resolution related to the removal of shareholders’ preferential rights for its benefit at the General Meeting and, as the case may be, the representatives of the subscribers at the Board of Directors have abstained from participating to the relevant decisions of the Board of Directors.

Impact of the Transaction on the shareholders’ equity

The share of equity, based on the Company’s consolidated financial statements at June 30, 2025, would be as follows:

Governance

As previously announced, the Board has decided to appoint Mrs. Liane Teplitsky as Executive Chair of the Board of Directors in replacement of Mr. Michel Therin, who will continue to contribute to the Board as director, effective as from the date of closing of the Transaction.

Advisors

Dechert LLP acted as legal advisor to the Company in connection with the Transaction.

Settlement and Delivery – Documentation

The ordinary shares issued in connection with (i) the Roll-Over, (ii) the Initial Tranches of the Financing, and (iii) the redemption of the Convertible Bonds, are expected to be admitted to trading on Euronext on February 4, 2026.

Such ordinary shares will be subject to an application for admission to trading on Euronext on the same trading line as the existing ordinary shares of the Company currently listed on Euronext, under the same ISIN code FR0013333077.

The Transaction is not subject to a prospectus requiring approval by the Financial Markets Authority (the “AMF”). However, in accordance with Article 1.5.b bis of Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017, as amended (the “Prospectus Regulation”), the Company will file with the AMF a document containing the information required in Annex IX of the Prospectus Regulation (the “Information Document”), with a view to the admission to trading on the regulated market of Euronext in Paris (“Euronext Paris”) of the Shares to be issued in connection with the Transaction. The Information Document is not subject to a review by the AMF.

Risk factors

Members of the public should take note of the risk factors relating to Carvolix and its business, as presented in Chapter 3 of the 2024 Universal Registration Document filed with the AMF on April 30, 2025 under number D.25-0356, which is available free of charge on Carvolix’s website (www.affluentmedical.com). The occurrence of all or some of these risks would be likely to have an adverse effect on the business activity, financial position, results, development, or outlook of Carvolix. Such events could have a material adverse effect on Carvolix’s share price. Members of the public should particularly take note of the following risks:

• Raising additional capital, including as a result of this Transaction or of further offerings to finance the development or the commercialization of Carvolix’s products, may cause dilution to the Company’s shareholders, restrict its operations or require it to relinquish rights to its products;
• Future sales of ordinary shares by existing shareholders or investors participating in the Transaction could depress the market price of the Company’s shares;
• The market price of the Company’s shares can be subject to significant fluctuations and may decrease below the issuance price retained in the context of the Transaction;
• Volatility and liquidity of the shares of the Company can be subject to significant fluctuations;
• The Company’s management will have broad discretion over the use of the proceeds from the Financing and may apply these proceeds in ways that may not result in an increase of the share price.

In particular, Carvolix has updated risk factor 3.4.1 “Liquidity risk” of the 2024 Universal Registration Document in order to take into account the Financing, as well as risk factor 3.4.3 “Dilution risk” of the 2024 Universal Registration Document (for more information about the dilution, please see the above capitalization table) to reflect that the exercise of all the dilutive instruments held by officers, directors and employees, the warrants issued to Kreos and the earn-outs granted in the context of the Acquisitions, would result in a dilution of 31% to existing shareholders on the basis of the Company’s current share capital.

This press release does not constitute a prospectus as referred to in Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017, as amended, or an offer to the public.

About Carvolix

Carvolix is a French medical technologies company, commercial and clinical stage, founded by Truffle Capital, that aims to become a global leader in the treatment of structural heart diseases and brain strokes, world’s leading causes of mortality and disability. Carvolix develops novel AI and imaging driven mini-robots that make complex procedures doble by interventional cardiologists, as well as biomimetics heart valves.

About Truffle Capital

Founded in 2001, Truffle Capital is an independent European Venture Capital firm specializing in disruptive technologies in the Life Sciences (Medtech and Biotech) and IT sectors (Fintech and Insurtech). Truffle Capital’s mission is to support the creation and development of innovative companies capable of becoming the leaders of tomorrow, and it has notably founded Abivax.

Managed by Philippe Pouletty, M.D. and Bernard-Louis Roques, Co-founders and co-CEOs, Truffle Capital manages €500 million in assets. It has raised more than €1.2 billion since its creation and has supported more than 124 companies in the digital technology and life sciences sectors. Discover more at www.truffle.com and follow us on LinkedIn.

Contacts :

Disclaimer

This press release contains forward-looking statements about Carvolix and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Carvolix’s financial condition, business, strategies, plans and objectives for future operations are forward-looking statements. Carvolix believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements are subject to numerous risks and uncertainties, including those described in Chapter 3 of the 2024 Universal Registration Document filed with the AMF on April 30, 2025 under number D.25-0356, which is available on the Company’s website (www.affluentmedical.com), as well as the risks associated with changes in economic conditions, financial markets and the markets in which Carvolix operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Carvolix or that Carvolix does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Carvolix to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, or the solicitation of an order to buy or subscribe for, shares of Carvolix in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.

This press release does not constitute a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the “Prospectus Regulation“). With respect to the member states of the European Economic Area (each, a “Relevant Member State“), no offer of the securities mentioned herein is made or will be made to the public in that Relevant Member State, except (i) to any legal person who is a qualified investor as defined in the Prospectus Regulation, (ii) to fewer than 150 natural or legal persons per Relevant Member State, or (iii) in other circumstances falling within Article 1(4) of the Prospectus Regulation; provided that none of these offers shall require the publication by the Company of a prospectus pursuant to Article 3 of the Prospectus Regulation. For the purposes of the foregoing, the expression “offer to the public” in any Relevant Member State has the meaning given to it in Article 2(d) of the Prospectus Regulation.

Solely for the purposes of each manufacturer’s product approval process, the target market assessment in respect of the securities offered in the Financing has led to the conclusion that, in relation to the type of clients criteria, (i) the target market for the securities is eligible counterparties and professional clients, each as defined in Directive 2014/65/EU, as amended (“MiFID II“); and (ii) all channels for distribution of the securities offered in the Financing to eligible counterparties and professional clients are appropriate. Any person subsequently offering, selling or recommending the shares (a “distributor“) should take into consideration the manufacturers’ client type assessment; however, a distributor subject to MiFID II is responsible for undertaking its own target market assessment in respect of the shares offered in the Financing (by either adopting or refining the manufacturers’ target market assessment) and determining appropriate distribution channels.

This press release has been prepared in French, German, Arabic and English. In the event of any discrepancy between the four versions of the press release, the French version shall prevail.

PRESS RELEASE

Heidelberg Pharma Received Development Milestone Payment from Partner Takeda

Ladenburg, Germany, 29 January 2026 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced that it has received a milestone payment under the terms of its license agreement with partner Takeda based on the achievement of a clinical development milestone for Takeda’s investigational medicine that utilizes Amanitin-based Antibody Drug Conjugate (ATAC) technology licensed from Heidelberg Pharma. With the dosing of the first patient in a Phase I/II clinical trial in patients with solid tumors, a milestone payment to Heidelberg Pharma became due. Financial details were not disclosed.

Dr. Dongzhou Jeffery Liu, Chief Executive Officer of Heidelberg Pharma AG, commented: “We are very delighted that our partner Takeda is progressing the development of their investigational medicine that utilizes ATAC technology, and that we have received the according milestone payment. We congratulate the Takeda team and wish them every success in clinical development. With this, three candidates that leverage ATAC technology are now in clinical development, two that are proprietary to Heidelberg Pharma including HDP-101 (INN: pamlectabart tismanitin) and HDP-102, and one under the responsibility of our partner. For us, this is a further validation of the potential of our unique Amanitin-based ADC technology.”

Takeda exclusively licensed the worldwide development and commercialization rights from Heidelberg Pharma for the use of the ATAC technology with an antibody directed to a defined target and the resulting product candidate. Under the terms of the agreement, Takeda is responsible for the development, as well as commercialization, of the resulting product candidate.

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology.

The lead candidate HDP-101 (INN: pamlectabart tismanitin) is a BCMA ATAC in clinical development for multiple myeloma. The candidate has been granted Orphan Drug Designation and Fast Track Designation from the FDA. A second ATAC candidate, HDP-102 is in clinical development stage in Non-Hodgkin Lymphoma. HDP-103 against metastatic castration-resistant prostate cancer and HDP-104 targeting gastrointestinal tumors such as colorectal cancer have completed preclinical development. Heidelberg Pharma is open for partnering.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH. 

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”, “should”, “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.