Abivax to Present Three Abstracts for Obefazimod in Ulcerative Colitis at the UEG Week 2024

• Professor Bruce E. Sands, MD to present oral presentation of Phase 2b, open-label, maintenance efficacy and safety data at weeks 48 and 96 among week 8 induction non-responders in obefazimod-treated patients with moderately to severely active ulcerative colitis (UC)
• Two moderated poster presentations highlighting corticosteroid-free efficacy and safety data of obefazimod at weeks 48 and 96 of an open-label maintenance trial, as well as the impact of obefazimod induction therapy on combined histologic and endoscopic outcomes at week 8 in patients with UC

PARIS, France, September 26, 2024 – 08:30 a.m. CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX; NASDAQ: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced that three scientific abstracts on its lead drug candidate, obefazimod, will be presented during the United European Gastroenterology (UEG) Week meeting, Oct. 12-15, 2024, in Vienna, Austria.

“We look forward to returning to UEGW to share new analysis of our Phase 2b trial data on obefazimod in patients with moderately to severely active ulcerative colitis,” said Abivax Chief Medical Officer Fabio Cataldi, MD. “With this presentation, we have observed additional evidence that obefazimod has the potential to advance the treatment paradigm, designed to be a once-daily oral therapy, for people living with ulcerative colitis.”

For more information on the Abivax clinical program and company updates, please see the conference program at the UEG website.

Obefazimod data to be presented:

*****

About Obefazimod

Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with UC have generated positive data, resulting in the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. Initiation of a Phase 2b clinical trial in Crohn’s disease is expected in Q3 2024, and exploration of potential combination therapy opportunities in UC is ongoing.

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and X, formerly Twitter, @ABIVAX.

Contact:

Patrick Malloy
SVP, Investor Relations Abivax SA
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “expect,” “forward”,” will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax’s drug candidates, as well as the timing of initiation of a Phase 2b clinical trial of obefazimod in Crohn’s disease. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

Hamburg, Germany, 26 September 2024:
Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) announced today that Evotec has entered a technology development partnership with Novo Nordisk in cell therapy.

Both Evotec and Novo Nordisk have significant expertise and a strategic focus to support stem cell-based therapies. In order to provide next-generation off-the-shelf cell therapy products for clinical development and possible commercialisation thereafter, the companies will collaborate on development of advanced technologies in support thereof.

Under the collaboration agreement, Novo Nordisk will provide funding for technology development activities at Evotec’s R&D site in Göttingen, Germany and at Evotec’s certified cell therapy manufacturing facility in Modena, Italy. Novo Nordisk has an option to obtain exclusive rights to utilise the results of the collaboration for a pre-defined therapeutic area. Evotec receives R&D funding, an undisclosed upfront and possible milestone and royalty payments.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, said: “Cell therapies have already proven to be highly effective and have the potential to become functional cures in many disease areas. Stem cell-based cell therapy is a promising approach to modulate and scale cell therapies to ultimately provide tailor-made, off-the-shelf cell therapies at reasonable costs. Together with Novo Nordisk, we are confident to be able to generate novel and robust technologies that will help deliver on the promise of stem cell-based therapies.”

Dr Joachim Fruebis, Corporate Vice President, Cell Therapy R&D, at Novo Nordisk, added: “We are excited to join forces with Evotec on our cell therapy initiatives. We hope that this collaboration will enable us to bring cutting-edge, stem cell-based therapies to patients more efficiently. By integrating our strengths, we are setting the stage for significant breakthroughs to more efficiently advance our cell therapies. This partnership holds great promise, and I am confident it will lead to significant advancements in realising our full potential “

About Cell Therapy at Evotec
Cell therapy, one of the most promising regenerative medicine approaches, replaces a patient’s missing or broken cells with functioning cells from a range of different sources, either from a donor, from the patient’s own material, or from stem cells. Stem cell research has opened up an almost unlimited source of consistent-quality material for such cell therapies. At the same time, differentiating cell therapies from a single validated source circumvents critical risks of contamination associated with administering both donor and patient cell material.

Building on Evotec’s industrialised induced pluripotent stem cell (“iPSC”) platform, Evotec has built up a proprietary cell therapy with broad and deep capacity and capabilities. Evotec’s initiatives include proprietary and partnered cell types currently in pre-clinical development for a broad range of indications including diabetes, oncology, cardiology, and ophthalmology.

About Evotec SE
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec provides high value pipeline co-creating partnerships and solutions to all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s sites in Europe and the USA offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For further information, please contact:

Media

Gabriele Hansen
SVP Head of Global Corporate Communications
Gabriele.Hansen@evotec.com

Hinnerk Rohwedder
Director of Global Corporate Communications
Hinnerk.Rohwedder@evotec.com

Investor Relations

Volker Braun
EVP Head of Global Investor Relations & ESG
Volker.Braun@evotec.com

Abivax Provides Update on Ulcerative Colitis (UC) Combination Therapy Program Strategy and Announces Early Preclinical Combination Data of Obefazimod and Etrasimod in Inflammatory Bowel Disease (IBD) Mouse Model

• Abivax is actively conducting preclinical studies with multiple oral and injectable therapies and will report additional data in Q4 2024.
• Pre-clinical evaluation of obefazimod combined with etrasimod improved body weight protection and Disease Activity Index with a synergistic and statistically significant reduction of several cytokines (TNF-alpha, IL-17, IL-6, IFN-gamma) in the blood compared to each treatment alone.

PARIS, France, September 25, 2024, 10:00 p.m. CEST – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, announced today results of initial preclinical combination data of obefazimod combined with etrasimod in a mouse model of IBD. 

“Despite progress and development of multiple new advanced targeted therapies in IBD, efficacy rates appear to have reached a ceiling. Fewer than half of patients achieve clinical remission, and many of those lose response over time. It is imperative for our field to explore rational and scientifically driven combination therapies to break through the efficacy ceiling, which in turn will lead to improved long-term outcomes for patients,” said David Rubin, MD Professor of Medicine and Chief, Gastroenterology, Hepatology and Nutrition at The University of Chicago. 

“Our goal for this program is to develop a fixed-dose combination therapy for UC patients that delivers best-in-disease state induction and maintenance efficacy, a safety profile on par with obefazimod, and an IP runway into the late 2040’s”, said Marc de Garidel, CEO of Abivax. He went on to say, “We believe that obefazimod’s emerging safety and efficacy profile, with potentially best-in-disease maintenance efficacy, could provide a meaningful benefit to patients when taken as a monotherapy. Additionally, since obefazimod is an oral therapy that has thus far demonstrated a favorable safety profile, it is an attractive candidate to be combined with other mechanisms of action to attempt to break through the efficacy ceiling observed with advanced therapies.”

Fabio Cataldi, MD Chief Medical Officer of Abivax provided key elements of the combination therapy program. “This program involves multiple stages.  First, we will perform additional pre-clinical experiments evaluating the efficacy of obefazimod in combination with several other mechanisms of action. Based on our findings, we plan to select a candidate in 2025 and work towards developing a fixed dose combination to move into clinical development.”

“We are setting a high bar for success and are excited about the promising data we are generating with this preclinical combination program,” Mr. de Garidel said. “We are planning to present this data at an upcoming scientific conference and are actively conducting additional combination studies that address various disease pathways. We look forward to providing an update on our progress by year end.”

Pre-Clinical Program and Initial Findings

Preclinical evaluation of obefazimod combined with etrasimod, was conducted in the T-cell adoptive transfer mouse model. In this study, CD4+CD45high or CD4+CD45low cells were intraperitoneally injected to 6-week-old male C57BL/6NRj-Rag2^tm1Ciphe/Rj mice (10 mice per group). The mice were then orally treated for 55 days with obefazimod or etrasimod alone or with the combination of both compounds. The results showed that treatment with the combination improved the response on body weight protection and Disease Activity Index with a synergistic and statistically significant reduction of several cytokines (TNF-alpha, IL-17, IL-6, IFN-gamma) in the blood compared to each drug alone.

About Obefazimod

Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with UC have generated positive data, resulting in the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. Initiation of a Phase 2b clinical trial in Crohn’s disease is expected in Q3 2024, and exploration of potential combination therapy opportunities in UC is ongoing.

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @Abivax.

Contact:

Patrick Malloy
SVP, Investor Relations, Abivax
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “expect,” “plan,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax’s drug candidates, the availability and timing of preclinical data to support decision-making on therapy candidates for use in combination with obefazimod in UC, as well as the availability and timing of disclosure of preclinical data of any such combination therapy, the timing of initiation of clinical trials, obefazimod’s potential, as monotherapy or in combination with other therapies, to provide meaningful benefit to patients suffering from UC, Crohn’s disease, IBD or other indications, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. Current results are not necessarily indicative of future results. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

Press Release – Ad-hoc announcement pursuant to Art. 53 LR                          

Medacta Group SA reports revenue growth of 14.3% at constant currency and adjusted EBITDA¹ margin 26.9%, or 28.1% at constant currency in 1H 2024.

First Capital Markets Day on 25 September 2024 to showcase the business strategy and mid-term outlook.

• 1H 2024 revenue increased to EUR 288.6 million, or 14.3% at constant currency¹ (13.1% reported) from 1H 2023;
• Adjusted EBITDA grew to EUR 77.5 million, corresponding to 28.1% margin in constant currency, or 26.9% reported;
• 1H 2024 profit increased to EUR 38.0 million (13.2% of revenue), representing a growth of 30.4% compared to 1H 2023;
• Outlook FY 2024: guidance confirmed – revenue growth at constant currency in the range of 13% to 15%, and Adjusted EBITDA margin at constant currency improving around 50 bps from 2023 reported, subject to unforeseen events;
• Mid-term Outlook: revenue Compound Annual Growth Rate (CAGR) at constant currency is expected to be in the low double-digits region, and Adjusted EBITDA targeted to be around the 2024 result, before any currency effects.

CASTEL SAN PIETRO, 25 September 2024 – Medacta Group SA (“Medacta”, SIX:MOVE) today reported financial results for the Half-Year ending 30 June, 2024 and hosts the first edition of the Capital Markets Day.

Francesco Siccardi, CEO of Medacta, commented: “The first half of 2024 delivered strong revenue growth, driven by our balanced geographical footprint and an effective marketing strategy to seize new opportunities. We are particularly pleased with this outstanding performance, which, in the year of our 25th anniversary celebration, further confirms the strength of our strategy and values, as well as the company’s ability to significantly outpace the market growth. Thanks to our continued focus on cost control, we were also able to defend our profitability despite higher sales and marketing expenses in the early part of the year.”

Our Achievements 

In 2024, Medacta is celebrating its 25^th anniversary with a World Tour that features a series of global scientific events, starting in April with the 10^th M.O.R.E. International Symposium held in Switzerland, followed by events in Australia, the U.S., and Japan. These events underscore our commitment to medical education by fostering the exchange of experience and knowledge among distinguished surgeons worldwide, focusing on how to improve patient outcomes through the sustainability of personalized medicine and technology in orthopedics and spine surgery.

• On the Knee side, after the 2023 launch, in the first semester of 2024, we continued introducing SpheriKA in Europe. Preliminary studies have successfully confirmed the initial positive results in terms of patient outcomes of the GMK SpheriKA^2,3, the first knee implant specifically designed for Kinematic Alignment procedures. It adds further value to Medacta’s MyKA platform, the most comprehensive solution for accurately and reproducibly performing Kinematic Alignment in Total Knee Replacement. Moreover, a new version of NextAR Knee was released, featuring significant enhancements to the user experience with a simplified workflow and improved intraoperative planning and soft tissue assessment interface, facilitating tailoring the surgeons decision-making process to the actual soft-tissue behavior of each patient, driving further market adoption.

• For the Hip, we focused on optimizing different tissue-sparing surgical approaches. This has led to the creation of the Medacta MIS Platform in hip replacement. This formula follows the same successful pathway used with AMIS, supporting each surgical technique across the platform with a complete set of advanced instruments, appropriate implants, and hi-tech enabling tools underpinned by effective and continuous medical education. In addition, the market positively received new options for Medacta’s revision platform, designed to address even the most complex cases.

• NextAR Shoulder Augmented Reality application was enhanced with new features, including the intraoperative guidance in anatomic cases and an improved registration path, potentially leading to a reduced O.R. time. These updated functionalities are currently available in the United States and Australia, with plans to expand further worldwide.

• In Spine surgery, we launched the NextAR Rod Optimizer, which is unique on the market and a disruptive technology that is quickly redefining rod management. This sustainable and personalized real-time system provides surgeons with a selection of around thousand combinations⁴ of pre-bent rods for a tailored fit to each patient’s unique anatomy, avoiding manual rod bending or custom-made rods which require production and long wait times with significant advantages for surgeons and patients. The NextAR Rod Optimizer has been awarded the 2024 Spine Technology Award from Orthopedics This Week, the third Medacta product to receive this prestigious honor after NextAR Spine and MySpine.

• In the nascent Sports Medicine business line, Medacta introduced a simplified approach to M-ARS ACL at the AGA Congress 2024 in Zürich, Switzerland. This optimized technique streamlines the natural anatomy reconstruction of ACL, enhancing knee biomechanics to help restore the patient’s natural joint motion.

During the semester, 96 new jobs were added to support operations and a continued salesforce expansion across all geographies and business lines.

Reported Performance Measures

* Adjusted in 2024 for provision on litigations for patent matter with Mighty Oak Medical (Euro 2.1 million), extraordinary legal expenses (Euro 0.4 million) and MDR transition costs (Euro 0.2 million). The reconciliation is provided in the “Alternative Performance Measures” section of 2024 Half-Year Report.

** Adjusted in 2024 for extraordinary legal expenses (Euro 0.4 million), for the settlement of legal claims (Euro 1.9 million), MDR transition costs (Euro 0.2 million), non-recurring investments for corporate land acquisition and plant expansion (Euro 5.5 million) and international advances and deposits for future logistic expansion (Euro 0.2 million). Please see the “Alternative Performance Measures” section of 2024 Half Year Report for the reconciliation of the “Adjusted Free Cash Flow”.

Growth in all regions and business lines

In the first semester 2024, revenue increased 14.3% at constant currency and 13.1% on reported currency over the prior period, at EUR 288.6 million. We delivered robust organic growth, progressing with the acquisition of new customers across all geographies and business lines. In every region, the increase was sustained by a continued expansion of our salesforce and customer base, together with some new product introductions, particularly in the Knee business line through GMK SpheriKA, the shoulder with NextAR Shoulder for anatomic cases, and the introduction of the NextAR Rod Optimizer for Spine. Currency development had a negative impact on our top line with a headwind of 1.2%, mainly due to the strengthening of the Euro against the Australian Dollar and the Japanese Yen, only partially compensated by the Euro weakening against the Swiss Franc.

Gross Profit margin

The Gross Profit was EUR 197.7 million compared to EUR 175.9 million in the previous period. The Gross Profit margin was equal to 68.5% compared to 68.9% in the first semester of 2023. This change is primarily due to negative currency developments. Part of the impact stems from the effect on our revenue, as previously mentioned, while the weakening of the Euro against the Swiss Franc negatively affected the translation of our cost of sales. However, this was partially offset by the natural hedging by purchases in Euro and improvements in the industrial efficiency, which helped mitigate the FX driven increase in standard costs.

Adjusted EBITDA margin

Adjusted EBITDA reached EUR 77.5 million, up from EUR 71.9 million in H1 2023, representing a margin of 26.9%, including 1.2% headwind from FX. Net from FX effect, the EBITDA was in line compared to 1H23 result (28.2%). Additionally, the increase in sales and marketing expenses was mainly explained by the unusual concentration of marketing events in the first semester, particularly those related to Medacta’s 25^th Anniversary celebrations. This increase was partially offset by greater efficiency in G&A expenses.

Adjusted EBIT margin

The Adjusted EBIT amounted to EUR 45.5 million, 15.8% on revenue, compared to EUR 43.8 million, 17.2% on revenue, in the first semester 2023. The change of margin was due to the decrease of EBITDA and a negative contribution in currency development for additional 30 basis points.

Profit for the period

The Profit for the period was EUR 38.0 million, or 13.2% on revenue, representing an increase of 30.4% vs prior period.

Solid Balance Sheet

Medacta’s balance sheet has further strengthened, with total assets increasing to EUR 731.9 million and an equity ratio of 47.0% at the end of the reporting period. In the first semester of 2024, we generated a cash flow from operating activities of EUR 41.8 million. This robust cash flow generation was invested to sustain the short-term growth, primarily new instruments for Euro 34.2 million, and long-term growth for EUR 19.8 million, primarily buildings and product developments. As a result, we reported a negative free cash flow of EUR 12.2 million, compared to a negative EUR 5.3 million in the first half of 2023.

2024 Outlook

We confirm the existing guidance: revenue growth at constant currency in the range of 13% to 15% and Adjusted EBITDA margin at constant currency improving around 50 bps from 2023 reported, subject to unforeseen events.

Capital Markets Day and Mid-term Outlook

Medacta today holds its first Capital Markets Day and welcomes the financial community to its cutting-edge innovation hubs in Rancate and Castel San Pietro. The event will be hosted by Francesco Siccardi, CEO of Medacta, together with the senior management team. The program features a company overview followed by an outline of its strategy implementation through responsible and sustainable innovation, together with world-class medical education, indispensable for transforming innovation into benefits for patients, surgeons and the healthcare system. The success of this strategy is closely linked to Medacta’s continuous growth, with a direct presence in the most attractive markets and full control over the supply chain.

In the mid-term, revenue Compound Annual Growth Rate (CAGR) at constant currency is expected to be in the low double-digits region, and Adjusted EBITDA targeted to be around the 2024 result, before any currency effects. 

Francesco Siccardi, CEO of Medacta, commented: “I’m delighted to host our first Capital Markets Day, meeting the financial community on-site. It will be a great opportunity to share our dedication to advancing orthopedic care for improved patient outcomes worldwide and describe the main components of our strategy and our expectations in the mid-term”.

Webcast Today at 2:00 pm (CEST)

The presentation, held in English, will start at 2:00 pm (CEST) and it will be divided in two parts, the first part related to the 1H Results presentation and the second to the Capital Markets Day. The slide presentation, as well as the live online webcast, are accessible from Medacta website: https://www.medacta.com/EN/home-investors-global. Those who are not interested in participating in the Capital Markets Day may log off Zoom immediately after the 1H results presentation.

Contact

Medacta Group SA

Corrado Farsetta, CFO

investor.relations@medacta.ch

About Medacta

Medacta is a key global player specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgery. Established in 1999 in Switzerland, Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Through close collaboration with expert surgeons globally, continuous investments in R&D, and the adoption of cutting-edge technologies, Medacta’s innovation prioritizes minimally invasive surgery and personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 60 countries. Follow us on Medacta TV, YouTube, LinkedIn and X.

Disclaimer

This press release has been prepared by Medacta Group SA (‘Medacta’ and together with its subsidiaries, ‘we’, ‘us’ or the ‘Group’). The information contained in the press release does not purport to be comprehensive and is not to be taken as containing any securities advice, recommendation, offer or invitation to subscribe for, purchase or redeem any securities regarding Medacta.

Forward-looking information

This press release has been prepared by Medacta and includes forward-looking information and statements concerning the outlook for our business. These statements are based on current expectations, estimates and projections about the factors that may affect our future performance. These expectations, estimates and projections are generally identifiable by statements containing words such as “expects”, “believes”, “estimates”, “targets”, “plans”, “outlook” or similar expressions. There are numerous risks and uncertainties, many of which are beyond our control, that could cause our actual results to differ materially from the forward-looking information and statements made in this press release. Important factors that could cause such differences include: changes in the global economic conditions and the economic conditions of the regions and markets in which the Group operates; changes in healthcare regulations (in particular with regard to medical devices); the development of our customer base; the competitive environment in which the Group operates; manufacturing or logistics disruptions; the impact of fluctuations in foreign exchange rates; and such other factors as may be discussed from time to time. Although we believe that our expectations reflected in any such forward-looking statement are based upon reasonable assumptions, we can give no assurance that those expectations will be achieved.

¹ Alternative Performance Measures

This press release contains certain financial measures of historical performance that are not defined or specified by IFRS, such as “constant currency”, “EBITDA”, “Adjusted EBITDA” or “CORE EBITDA”, “Free Cash Flow”, “Adjusted Free Cash Flow”, “Net Debt” and “Leverage”. Reconciliation of these measures as well as “CORE” financial measures is provided in the “Alternative Performance Measures” of our 2024 First Half Report. These Alternative Performance Measures (APM) should be regarded as complementary information to, and not as a substitute for, the IFRS beginning performance measures. For definitions of APM, together with reconciliations to the most directly reconcilable IFRS line items, please refer section headed “Alternative Performance Measures” of the 2024 First Half Report. The 2024 First Half Report is available at https://www.medacta.com/EN/financial-reports .

² Sappey-Marinier E, Howell SM, Nedopil AJ, Hull ML. The Trochlear Groove of a Femoral Component Designed for Kinematic Alignment Is Lateral to the Quadriceps Line of Force and Better Laterally Covers the Anterior Femoral Resection Than a Mechanical Alignment Design. J Pers Med. 2022 Oct 16;12(10):1724. doi: 10.3390/jpm12101724. PMID: 36294863; PMCID: PMC9605321.

³https://10more.medacta.com/assets/pages/video/?w=6c865c55-a98a-442f-b22b-51b17d25cbb5.mp4

⁴ Data on file Medacta

 Related Trademarks

Medacta Group Related Trademarks are registered at least in Switzerland. The products and services listed below may not be all-inclusive, and other Medacta products and services not listed below may be covered by one or more trademarks. The below products and services may be covered by additional trademarks not listed below. Note that Swiss trademarks may have foreign counterparts.

MyShoulder®, NextAR™, NextAR™ Knee, NextAR™ Shoulder, NextAR™ Spine, GMK® Sphere, MyKA™, AMIS®, GMK® SpheriKA, AMIS®, MySpine®.

• BfArM and lead ethics committee approve early end of recruitment
• Last patient included on 6 August 2024;
• A total of 202 patients were included in the study;
• Start of the MDR registration phase

aap Implantate AG (“aap” or “Company”) informs that due to the ongoing good results the patient recruitment of the human clinical trial could be terminated early. After the incidence rate remained at a very low level and more than 200 patients were recruited for the study, an application to discontinue patient recruitment was submitted in July 2024. This application was approved by the Federal Office for Drugs and Medical Devices (BfArM) and the lead ethics committee. The study has a follow-up period of one year and will end in August 2025. aap would like to thank all participating clinics for their excellent performance in the context of patient recruitment and the very good cooperation to date. 

The decision represents a milestone for aap after the company has invested around EUR 15 million in development work and associated costs in the years since the start of the project. This makes aap the only company with a nearly completed human clinical study on an antibacterial trauma implant, which puts it in an excellent starting position in a market worth billions.

Rubino Di Girolamo (CEO) comments on this success: “We are very pleased about the approval granted by the BfArM and the leading ethics committee. This underlines a successful intermediate step, which was achieved after several obstacles through persistent adherence to the goal and brings aap‘s opportunity to make a significant contribution to the fight against antibiotic resistance closer.”

In the next step, aap is preparing the MDR registration of the technology with the aim of authorising an initial product group in the 2026 – 2027 timeframe, depending on the regulatory requirements, and subsequently generating initial sales. The company anticipates that the funds required for product approval in the period 2025 – 2027 will amount to between EUR 1 million and EUR 2 million. With additional, manageable funds, aap can also initiate its own small series production, which will enable an adequate level of sales. Doctors and clinics that took part in the study have already signalled great interest in the product.  Depending on funding commitments or licence agreements with strategic market participants, the scope of product approvals and production capacities can be expanded considerably.

——————————————————————————————————————————————-

aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German stock exchanges –

About aap Implantate AG

aap Implantate AG is a globally active medical technology company based in Berlin, Germany. The company develops, produces and markets products for traumatology. In addition to the innovative LOQTEQ® anatomical plate system, the IP-protected portfolio includes a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and group clinics, while internationally it primarily utilises a broad network of distributors in around 25 countries. In the USA, the company utilises a hybrid sales strategy through its subsidiary aap Implants Inc. Sales are conducted both via distribution agents and through partnerships with global orthopaedic companies. The aap Implantate AG share is listed in the General Standard segment of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at www.aap.de.

The figures presented in this press release may be subject to technical rounding differences that do not affect the overall picture.

Forward-looking statements

This release may contain forward-looking statements that are based on the current expectations, assumptions and forecasts of the Executive Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of the future developments and results mentioned therein. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual results, financial situation, development or performance of the company and the estimates given here. These factors include those that aap has described in published reports. Forward-looking statements therefore only apply on the date on which they are made. We assume no obligation to update the forward-looking statements made in this release or to adapt them to future events or developments.

Contact:

aap Implantate AG; Rubino Di Girolamo; Chairman of the Management Board/ CEO; Lorenzweg 5; 12099 Berlin
Phone: +49 (0)30 75019 – 170; Fax: +49 (0)30 75019 – 290; Email: r.digirolamo@aap.de

MEDIA RELEASE

Medacta NextAR Rod Optimizer, a Disruptive Technology Redefining Rod Management in Spine Surgery, wins the 2024 Spine Technology Award from Orthopedics This Week

CASTEL SAN PIETRO, September 24, 2024—Medacta Group SA (“Medacta,” SIX:MOVE) announced today its NextAR Rod Optimizer has been awarded the 2024 Spine Technology Award from Orthopedics This Week. This marks the third time a Medacta spine product has received this prestigious honor after the MySpine Platform, patient-matched technology, and the NextAR Spine, Augmented Reality Surgical Application.

The unique NextAR Rod Optimizer is a sustainable and personalized solution designed to enhance intraoperative planning and provide real-time selection starting from a dozen pre-bent rods that allow thousands of solutions¹ in both minimally invasive and open approaches. Spine surgeons can now benefit from an advanced solution that eliminates the need for manual rod-bending, significantly reducing the risk of breakage and subsequent revision surgeries. This innovative approach also provides a compelling alternative to systems that are based on custom-made rods, eliminating preoperative imaging, production and waiting time, with significant advantages for surgeons and patients.

“NextAR Rod Optimizer provides the most accurate and easy to deploy point of care solution for selecting personalized rods for long fusion constructs, providing the optimal rod length and contour for percutaneous or open deformity constructs,” states Lionel Metz, MD, University of California San Francisco Department of Orthopedic Surgery.

The NextAR Rod Optimizer is part of NextAR Spine and may also be used as a stand-alone technology. This innovative tool complements Medacta’s comprehensive spine offering by enhancing surgical procedures with cutting-edge precision and efficiency. NextAR Rod Optimizer aims to improve patient outcomes and streamline the surgical workflow. This advanced technology exemplifies Medacta’s commitment to developing innovative and sustainable solutions that support both surgeons and patients.

“The possibility of having an intraoperative planning tool to select a pre-bent rod among multiple solutions has enhanced my workflow and reduced potential complications associated with traditional techniques that require manual bending,” says Dr. Itsuo Shiina, from the Department of Orthopaedic Surgery, Moriya Daiichi Hospital, Japan.

The NextAR Rod Optimizer further expands the capabilities of the award-winning NextAR Spine, an innovative technology proven to be accurate in screw placement, and to seamlessly integrate into the OR workflow, enabling the surgeon to enhance efficiency, accuracy, and versatility in spine surgery².

NextAR Spine is a sustainable solution within Medacta’s NextAR Augmented Reality Surgical Platform for both joint replacement and spine procedures. This hardware system offers the ability to host software for multiple applications (NextAR Knee, NextAR Shoulder, NextAR Spine). It is a vital component of the MySolutions Personalized Ecosystem, a network of advanced digital solutions designed to enhance patient care and surgical outcomes.

The entire spine portfolio is supported by the comprehensive, tailored educational offerings provided by the M.O.R.E. Institute. With an international network of expert surgeons, the M.O.R.E. Institute is at the forefront of education on spine procedures and products with personalized high-level educational pathways. With Medacta, the surgeon is never alone.

For more information about the NextAR Rod Optimizer, please visit https://nextar-rod-optimizer.medacta.com/.

Contact
Gianluca Olgiati
Group Vice President Marketing
+41 91 696 60 60
media@medacta.ch

Medacta is a key global player specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgery. Established in 1999 in Switzerland, Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Through close collaboration with expert surgeons globally, continuous investments in R&D, and the adoption of cutting-edge technologies, Medacta’s innovation prioritizes minimally invasive surgery and personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 60 countries. Follow us on Medacta TV, YouTube, LinkedIn and X.

RELATED TRADEMARKS
Medacta Group Related Trademarks are registered at least in Switzerland. The products and services listed below may not be all-inclusive, and other Medacta products and services not listed below may be covered by one or more trademarks. The below products and services may be covered by additional trademarks not listed below. Note that Swiss trademarks may have foreign counterparts. MySolutions™ Personalized Ecosystem, NextAR™, NextAR™ Spine, NextAR™ Rod Optimizer, M.U.S.T.^®.

REFERENCES
[1] Data on file Medacta

[2] Schwendner M, Ille S, Wostrack M, Meyer B. Evaluating a cutting-edge augmented reality-supported navigation system for spinal instrumentation. Eur Spine J. 2023 Nov 14. doi: 10.1007/s00586-023-08011-w. Epub ahead of print. PMID: 37962688.

Marinomed Biotech AG reports positive clinical results for unique Carragelose eye drops

• Marinomeds new Carragelose eye drops improve dry eye-related symptoms in patients with mild to moderate dry eye syndrome by remarkable 54%
• Product was well tolerated by patients and ocular surface disease index (OSDI) was significantly reduced
• Eye drops hold valid Medical Device Directive (MDD) certificate and are in transition phase for the new Medical Device Regulation (MDR) – launch preparations for 2024

Korneuburg, Austria, 24. September 2024 – Marinomed Biotech AG (VSE:MARI) reports positive clinical data for the new moisturizing Carragelose-containing eye drops. The eye drops are part of the recent Carragelose portfolio expansion from viral respiratory infections to targeting allergy and dry eyes. The clinical study conducted in Spain investigated for the first time the lubricating and hydrating effectiveness of Carragelose eye drops in patients affected by mild to moderate dry eye syndrome. 28 Patients were exposed to adverse environmental conditions (23°C, 10% relative humidity and airflow) to challenge dry eye symptoms. Treatment was started after the first challenge and lasted 28 days with a dose of one drop per eye, three times daily. After this treatment period, the patients were again exposed to adverse conditions and the effectiveness of the eye drops were assessed compared to the first challenge. The primary endpoint of the study was the improvement of dry eye-related symptoms such as foreign body sensation, burning or stinging, itching, pain, sticky feeling, sensitivity to light or blurred vision.

The results of the study show that treatment with Carragelose eye drops for four weeks significantly improves dry eye-related symptoms by 54%. Next to excellent tolerability, patients also reported a significant improvement in Ocular Surface Disease Index (OSDI). Strongest effects were seen on pain and blurred vision.

Eva Prieschl-Grassauer, CSO of Marinomed, says: “The clinical data further confirm our knowledge of Carragelose. It adds a moisturizing and protective layer to epithelial surfaces such as eyes, nose or throat. After demonstrating the effectiveness of Carragelose in blocking viruses and allergens with extensive clinical and in-vitro data, this new study is the first clinical validation of the lubricating properties of Carragelose. The obtained results are quite impressive and confirm that this compound is applicable to a wide range of indications. Together with an outstanding safety profile and other key benefits, Carragelose is an ideal compound for providing relief for dry eyes. Introducing the Carragelose eye drops to our product range is a logical addition and complements our recent portfolio expansion together with the new allergy product.”

The patent-protected medical device product is certified under MDD and is already in the transition phase for the new MDR coming into effect in 2028. A first partnership for Austria is in place with the launch envisaged still for 2024. Marinomed has started a business development process to identify further partners, expecting first revenues in the near to medium term.

About Carragelose®

Carragelose® is a sulfated polymer from red seaweed and a unique, broadly active virus- and allergen-blocking compound. It is known as a gentle, effective, and safe prevention and treatment of various viral respiratory infections. Several clinical and preclinical studies have shown that Carragelose® forms a protective layer on the mucosa that prevents viruses from infecting cells. Laboratory and clinical data have demonstrated that Carragelose® can also inhibit the spreading of SARS-CoV-2.^[1],[2] Marinomed is the holder of the IP rights and has licensed Carragelose® for marketing in Europe, North America, Australia, and parts of Asia and Latin America. Marinomed’s portfolio of Carragelose®-containing nasal sprays and oral products can be accessed at https://www.carragelose.com/en/portfolio/launched-products, scientific publications on Carragelose® at https://www.carragelose.com/en/publications.

About Marinomed Biotech AG

Marinomed Biotech AG is an Austrian, science-based biotech company with a growing development pipeline and globally marketed therapeutics. The Company develops innovative patent-protected products in the therapeutic areas immunology and virology based on the platform Marinosolv® and the virus-blocking activity of Carragelose®. The Marinosolv® technology improves the solubility and bioavailability of hardly soluble compounds and is used to develop new therapeutics for autoreactive immune disorders. The virology segment includes Carragelose®-based over-the-counter (OTC) products to prevent and treat respiratory viral infections that are partnered in more than 40 countries. The Company is headquartered in Korneuburg, Austria, and is listed on the Vienna Stock Exchange (VSE:MARI). For further information, please visit: https://www.marinomed.com.

For further inquiries contact:

Disclaimer

This press release contains forward-looking statements, which are based on current views, expectations and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as “anticipate,” “believe”, “estimate”, “expect”, “intend”, “plan”, “project” and “target”. Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise. Marinomed, Marinosolv® and Carragelose® are registered trademarks of Marinomed Biotech AG. These trademarks may be owned or licensed in select locations only.

^[1]  https://www.dovepress.com/efficacy-of-a-nasal-spray-containing-iota-carrageenan-in-the-postexpos-peer-reviewed-fulltext-article-IJGM

^[2]  https://www.marinomed.com/en/news/marinomed-biotech-ag-shares-positive-clinical-trial-results-for-iota-carrageenan-nasal-spray-in-the-prevention-of-covid-19-1

PRESS RELEASE

Heidelberg Pharma Announces New Clinical Data on Lead ATAC Candidate HDP-101 to be Presented at International Myeloma Society Annual Meeting 2024

Ladenburg, Germany, 23 September 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage company developing innovative Antibody Drug Conjugates (ADCs), today announces that new data from its Phase I/IIa clinical study with lead Amanitin-based ADC candidate, HDP-101, will be presented at the 21^st International Myeloma Society (IMS) Annual Meeting, being held in Rio De Janeiro, Brazil on 25 to 28 September 2024.

HDP-101 is an Anti-BCMA antibody-Amanitin drug conjugate for the treatment of relapsed or refractory multiple myeloma, a bone marrow cancer with a high unmet medical need. Phase I of the trial is a dose escalation study to determine an optimal and safe dose level of HDP-101 in patients in preparation for Phase II clinical studies.

Professor Marc-Steffen Raab, Head of the Myeloma Center at the University Hospital Heidelberg and clinical investigator of the study will present new clinical findings from five patient cohorts of the ongoing open-label, multicenter Phase I/IIa trial evaluating HDP-101 in multiple myeloma.

Details of the presentation are as follow:

Presentation title: The Anti-BCMA Antibody-Drug Conjugate HDP-101 with a Novel Amanitin Payload Shows Promising Initial First in Human Results in Relapsed Multiple Myeloma (OA – 60)

Previous data from cohort five have demonstrated biological activity in three out of five patients, and an objective improvement in disease was detected (“partial remission”). The trial is currently treating patients in its sixth cohort with further data to be presented at upcoming scientific conferences.

Following the presentation at IMS, Heidelberg Pharma will host a R&D Webinar on 15 October 2024 at 17:00 pm CEST/ 11:00 am ET, for investors, analysts and media. Further registration information will be announced in due course.

About Heidelberg Pharma

Heidelberg Pharma develops novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the high affinity and specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with various toxins, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kills the diseased cells.

Heidelberg Pharma is the first company to use the mushroom toxin Amanitin in cancer therapies by exploiting the toxin’s biological mechanism of action with its innovative ATAC technology as a new therapeutic modality. It offers the opportunity to not only overcome resistance of cancer cells against therapeutic agents currently used, but also has the ability to eliminate dormant tumor cells. This could lead to significant advances in cancer therapy – even for patients who no longer respond to any other treatment. The most advanced product candidate HDP-101 is an BCMA-ATAC for the indication multiple myeloma, which is currently in clinical development.

In addition to Amanitin, other payloads are expanding the ADC platform technologies of Heidelberg Pharma to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors.

Heidelberg Pharma AG is a biopharmaceutical company 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, or 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.

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NOT FOR DISTRIBUTION OR ANNOUNCEMENT, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR ANNOUNCEMENT WOULD BE UNLAWFUL

Press Release

Pentixapharm Holding AG Sets Price Range for Planned IPO

• Offering of up to 3.9 million new shares at a price range of EUR 4.70 to EUR 6.00 per share
• IPO proceeds to secure financing for further development of promising product pipeline in the rapidly growing field of radioligand therapies
• Subscription period for institutional and retail investors begins on September 24, 2024, and is expected to end on October 1, 2024
• First trading day on the Prime Standard of the Frankfurt Stock Exchange anticipated on October 3, 2024
• High free float of over 60% expected post-IPO

Berlin and Würzburg, Germany, September 23, 2024 – Pentixapharm Holding AG (“Pentixapharm”), a biopharmaceutical company focused on developing innovative first-in-class radiopharmaceuticals for the diagnosis and therapy (“theranostics”) of blood cancer and other widespread indications not yet treated with radiopharmaceuticals, announces details of its planned initial public offering (“IPO”) on the Prime Standard of the Frankfurt Stock Exchange. The German Federal Financial Supervisory Authority (BaFin) has today approved the prospectus for the public offering in Germany and the listing of Pentixapharm shares.

The IPO price range has been set at EUR 4.70 to EUR 6.00 per share. The final offer price will be determined based on a bookbuilding process at the end of the offering period, which begins on September 24, 2024, and is expected to end on October 1, 2024, at 12:00 p.m. CEST for retail investors and at 2:00 p.m. CEST for institutional investors.

The public offering comprises up to 3,900,000 registered shares. There is no over-allotment option (“greenshoe”). In addition to the offered shares, 50,000 nominal shares and 20,845,477 spin-off shares will be admitted to trading on the regulated market of the Frankfurt Stock Exchange (Prime Standard). The spin-off shares result from a capital increase in kind resolved by the extraordinary general meeting on June 26, 2024, consisting of all shares held by Eckert & Ziegler SE in Pentixapharm AG following the spin-off of Pentixapharm AG approved by Eckert & Ziegler SE’s general meeting on the same day. In total, up to 24,795,477 registered shares of Pentixapharm Holding AG will be admitted to trading. All shares have a notional value of EUR 1.00 per share in the company’s share capital and carry full dividend rights from March 25, 2024.

Proceeds from the Offering to Fund Further Development of the Product Pipeline

Assuming full placement of the shares, the IPO would result in a market capitalization of EUR 132.7 million at the midpoint of the bookbuilding range. The expected gross proceeds for Pentixapharm from the placement of new shares amount to between EUR 18.3 million and EUR 23.4 million, based on the bookbuilding range and the maximum number of 3.9 million offer shares. With an additional convertible bond of up to EUR 18.5 million subscribed by the listed Eckert & Ziegler SE, Pentixapharm would have over EUR 39 million in additional financial resources at the midpoint of the bookbuilding range to implement the first phase of its growth strategy.

The proceeds from the IPO are primarily intended for the further development of the company’s product pipeline. The growth strategy in the coming years is focused on the clinical development and approval of main candidates, Ga68-PentixaFor and Y90-PentixaTher, as well as on strategic partnerships and potential acquisitions in the field of radiopharmaceuticals. The IPO is thus a milestone on the planned path toward commercialization of well-validated programs. Lead candidate PentixaFor is already in Phase III clinical development in Europe.

Dr. Hakim Bouterfa, CEO of Pentixapharm Holding AG, commented: “We are now in the home stretch with our IPO plans and are pleased with the positive feedback from investors. Our goal is to make the stock attractive to investors who join early and to minimize the dilution of Eckert & Ziegler SE shareholders who become Pentixapharm shareholders as a result of the spin-off. Therefore, only a limited number of shares are being offered in the IPO. We are convinced of a positive development of Pentixapharm and aim to achieve further milestones in the coming months.”

Dr. Andreas Eckert, Chairman of the Supervisory Board of Pentixapharm Holding AG, stated: “Pentixapharm has an attractive product pipeline and is gaining access to capital market investors through the IPO. As previously announced, as part of the spin-off of Pentixapharm from Eckert & Ziegler SE, Eckert Wagniskapital und Frühphasenfinanzierung GmbH is also participating in the IPO, underscoring its confidence in Pentixapharm. For future investments, several options are available, including further capital measures or other financing possibilities such as collaborations with established pharmaceutical companies. The current valuations of companies in the field of radiopharmaceuticals with programs in clinical trials in the US underscore the potential that investors see in this field.”

IPO Targeted at Both Institutional and Retail Investors Interested in Pentixapharm’s Innovative Growth Model

The shares will be offered as part of a public offering in Germany and an international private placement. The offering is aimed at both institutional and retail investors. Retail investors in Germany can place purchase orders in the public offering one day after the start of the offer period, i.e., from September 25, 2024, exclusively via the DirectPlace© subscription functionality of the Frankfurt Stock Exchange or through their custodian bank. Qualified investors can place purchase orders directly with BankM AG, acting as sole global coordinator and sole bookrunner, during the offer period. The free float after the IPO is expected to be over 60%. The main shareholder of Pentixapharm is Eckert Wagniskapital und Frühphasenfinanzierung GmbH, which will hold 31.57% of the share capital after the completion of the spin-off.

Admission to trading is expected on October 2, 2024. On October 3, 2024, the listing of the existing shares and the spin-off shares of Pentixapharm Holding AG under the ticker symbol “PTP” and the International Securities Identification Number (ISIN) DE000A40AEG0 is scheduled to take place on the regulated market (Prime Standard) of the Frankfurt Stock Exchange. The offer shares are expected to be traded from October 10, 2024, following the registration of the capital increase in the commercial register and the admission decision by the Deutsche Börse AG.

The securities prospectus regarding the public offering and the admission of the shares to trading on the regulated market (Prime Standard) was approved today by the German Federal Financial Supervisory Authority (BaFin) and is available in the Investor Relations section of the company’s website at www.pentixapharm.com.

About Pentixapharm Holding AG

Pentixapharm Holding AG was founded in 2024 to incorporate all shares held by Eckert & Ziegler SE in Pentixapharm AG, based in Würzburg, following the spin-off resolved by the Annual General Meetings of Eckert & Ziegler SE and Pentixapharm Holding AG on June 26, 2024. It is intended to list Pentixapharm Holding AG on the Prime Standard of the Frankfurt Stock Exchange.

Pentixapharm AG is a clinical-stage radiopharmaceutical development company founded in 2019 with its headquarters in Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a US-centric Phase III registration study with PentixaFor in PA that will start in 2025.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
phillip.eckert@pentixapharm.com
Tel. +49 30 94 10 84 227
www.pentixapharm.com

Media Contact:
MC Services AG
Anne Hennecke
Tel. +49 211 529252 22
anne.hennecke@mc-services.eu

Important Notice

This announcement is an advertisement for the purposes of the prospectus regulation EU 2017/1129, as amended (“Prospectus Regulation”): lt does not constitute an offer to purchase any shares in Pentixapharm Holding AG and does not replace the securities prospectus which will be available free of charge, together with the relevant translation of the summary, in the IR section of the Pentixapharm Group website at https://www.pentixapharm.com/. The approval of the securities prospectus by the German Federal Financial Supervisory Authority (“BaFin”) should not be understood as an endorsement of the investment in any shares in Pentixapharm Holding AG. Investors should purchase shares solely on the basis of the prospectus (including any supplements thereto, if any) relating to the shares and should read the prospectus which is yet to be published (including any supplements thereto, if any) before making an investment decision in order to fully understand the potential risks and rewards associated with the decision to invest in the shares. Investment in shares entails numerous risks, including a total loss of the initial investment.

This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States, Australia, Canada, South Africa, Japan or in any jurisdiction to whom or in which such offer or solicitation is unlawful.

Neither this announcement nor the publication in which it is contained is for publication or distribution, directly or indirectly, in whole or in part, in or into the United States of America, including its territories and possessions, any state of the United States and the District of Columbia (“United States”). The information in this announcement does not contain or constitute an offer to acquire, subscribe or otherwise trade in shares in Pentixapharm Holding AG in any jurisdiction. Any securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”), or the securities laws of any state or other jurisdiction of the United States, and may not be offered, subscribed, used, pledged, sold, resold, allotted, delivered or otherwise transferred, directly or indirectly, in or into the United States absent such registration, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements under the Securities Act, in each case in compliance with any applicable securities laws of any state or other jurisdiction of the United States. There will be no public offer of the securities in the United States.

Subject to certain exceptions under applicable law, the securities referred to in this announcement may not be offered or sold in Australia, Canada, South Africa or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada, South Africa or Japan. There will be no public offer of the securities in Australia, Canada, South Africa or Japan.

In member states of the European Economic Area (other than Germany), this announcement is only addressed to and directed at persons who are “qualified investors” within the meaning of Article 2(e) of the Prospectus Regulation.

In the United Kingdom, this announcement is only addressed to and directed at persons who are “qualified investors” within the meaning of Article 2 of the Prospectus Regulation (Regulation (EU) 2017/1129 and amendments thereto) as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 and who (i) have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (“Order”) or (ii) are high net worth entities falling within article 49(2)(a) to (d) of the Order (all such persons being referred to as “Relevant Persons”). In the United Kingdom, this announcement is directed only at Relevant Persons. Any person who is not a Relevant Person should not act or rely on this announcement or any of its contents. Any investment or investment activity to which this announcement relates is available only to Relevant Persons and will be engaged in only with Relevant Persons and it should not be relied on by anyone other than a relevant person.

This announcement does not purport to contain all information required to evaluate the Pentixapharm Holding AG and its future combined subsidiaries (i.e. Pentixapharm AG, Würzburg , and the 100 % subsidiary of Pentixapharm AG, Myelo Therapeutics GmbH, Berlin) upon the completion of the spin-off by absorption (Abspaltung zur Aufnahme) in accordance with the German Transformation Act (Umwandlungsgesetz) of all of the shares held by Eckert & Ziegler SE, Berlin in Pentixapharm AG to Pentixapharm Holding AG (“Spin-off” and such combined subsidiaries together with Pentixapharm Holding AG “Pentixapharm Group”) and/or their financial position and, in particular, is subject to amendment, revision, verification, correction, completion and updating in its entirety. Neither (i) Pentixapharm Holding AG nor (ii) BankM AG (“Bank“, and together with Pentixapharm Holding AG “Persons“), or any of the respective directors, officers, personally liable partners, employees, agents, affiliates, shareholders or advisers of such Persons may notify you of changes nor is under an obligation to update or keep current the announcement or to provide the recipient thereof with access to any additional information that may arise in connection with it, save for the making of such disclosures as are required by mandatory provisions of law. This announcement does not constitute investment, legal, accounting, regulatory, taxation or other advice.

No person is authorized to give any information or to make any representation not contained in and not consistent with this announcement and, if given or made, such information or representation must not be relied upon as having been authorized by or on behalf of Pentixapharm Holding AG or any Person.

Certain market positioning data about Pentixapharm Holding AG and Pentixapharm Group included in this announcement is sourced from or based on third-party sources. Third-party industry publications, studies and surveys generally state that the data contained therein have been obtained from sources believed to be reliable, but that there is no guarantee of the fairness, quality, accuracy, relevance, completeness or sufficiency of such data. Such research, estimates and forecasts, and their underlying methodology and assumptions, have not been verified by any independent source for accuracy or completeness and are subject to change without notice. Accordingly, Pentixapharm Holding AG expressly disclaims any responsibility for, or liability in respect of, such information and undue reliance should not be placed on such data.

This announcement may contain forward-looking statements which reflect Pentixapharm Holding AG’s and Pentixapharm Group’s current view on future events and financial and operational development. Forward-looking statements are sometimes, but not always, identified by their use of a date in the future or such words as “will”, “anticipates”, “aims”, “could”, “may”, “should”, “expects”, “believes”, “intends”, “plans”, “prepares” or “targets” (including in their negative form or other variations). By their nature, forward-looking statements are inherently predictive, speculative and involve risk and uncertainty because they relate to events and depend on circumstances that may or may not occur in the future. There are a number of factors that could cause actual results, performance and developments to differ materially from those expressed or implied by these forward-looking statements. All subsequent written or oral forward-looking statements attributable to Pentixapharm Holding AG or its affiliates, or any persons acting on their behalf are expressly qualified in their entirety by the factors referred to above. No assurances can be given that the forward-looking statements in this announcement will be realized. Any forward-looking statements are made of the date of this announcement.

Subject to compliance with applicable law and regulations, neither Pentixapharm Holding AG, nor the Bank nor their respective affiliates intend to update, review, revise or conform any forward-looking statement contained in this announcement to actual events or developments whether as a result of new information, future developments or otherwise, and do not undertake any obligation to do so.

The information contained in this announcement does not purport to be comprehensive and has not been subject to any independent audit or review.

Certain figures, including financial and market data, contained in this announcement have been rounded and the relevant sums may not add up to 100% due to rounding.

The Bank is acting exclusively for Pentixapharm Holding AG and no-one else in connection with the planned offering of shares of Pentixapharm Holding AG (“Offering“). It will not regard any other person as their respective clients in relation to the Offering and will not be responsible to anyone other than Pentixapharm Holding AG for providing the protections afforded to their respective clients, nor for providing advice in relation to the Offering, the contents of this announcement or any transaction, arrangement or other matter referred to in this announcement.

In connection with the Offering, the Bank and any of its affiliates, acting as investors for their own accounts, may subscribe for or purchase securities of Pentixapharm Holding AG and in that capacity may retain, purchase, sell, offer to sell or otherwise deal for their own accounts in such securities and other securities of Pentixapharm Holding AG or related investments in connection with the Offering or otherwise. Accordingly, references in the prospectus, once published, to the securities being issued, offered, subscribed, acquired, placed or otherwise dealt in should be read as including any issue or offer to, or subscription, acquisition, placing or dealing by the Bank and any of its affiliates acting as investors for their own accounts.

In addition, the Bank or its affiliates may enter into financing arrangements and swaps with investors in connection with which the Bank (or its affiliates) may from time to time acquire, hold or dispose of Pentixapharm Holding AG’s shares. The Bank does not intend to disclose the extent of any such investment or transactions otherwise than in accordance with any legal or regulatory obligations to do so.

None of the Bank or any of its affiliates, directors, officers, personally liable partners, employees, advisers or agents accepts any responsibility or liability whatsoever for or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to Pentixapharm Holding AG, its combined subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith.

The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed by any person for any purpose on the information contained in this announcement or its accuracy, fairness or completeness.

The dates of the admission(s) to trading of shares of Pentixapharm Holding AG on the regulated market segment (regulierter Markt) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) with simultaneous admission to the sub-segment of the regulated market with additional post-admission obligations (Prime Standard) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) (together “Admission”) may be influenced by things such as market conditions. There is no guarantee that Admission will occur and no financial decision should be based on the intentions of Pentixapharm Holding AG in relation to Admission at this stage. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing all of the amount invested. Persons considering making such investments should consult an authorized person specializing in advising on such investments. This announcement does not constitute a recommendation concerning the Offering. The value of shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of the Offering for the person concerned.