PRESS RELEASE

Biotest and SteinCares partner to improve access to plasma-derived products in Latin America

• Financial and strategic reliability is key driver of partnership to start to penetrate Latin American markets with plasma-derived Factor VIII products
• Agreement will be the first step to its expand our commercial footprint in the area

Dreieich, Germany, October 29, 2024. Biotest announced today, that it has signed a new distribution agreement with SteinCares, a leading specialty healthcare company in Latin America, for the commercialization and distribution of Haemoctin^® in selected Latin American countries (Chile, Colombia, Costa Rica, Ecuador, Mexico and Peru).

The plasma-derived factor VIII product Haemoctin^®, indicated for the treatment and prophylaxis of bleeding in patients with hemophilia A, offers an accessible alternative compared to other available treatments. As a plasma-derived product, it ensures fast and reliable efficacy, high purity and a favorable safety profile and thus reduces the risk of long-term complications of hemophilia.

Hemophilia therapies are essential for the management of this disease, which affects approximately 56,000 people in Latin America. However, according to the World Federation of Hemophilia, only 57% of these patients are diagnosed and approximately 40% have access to prophylactic treatment. With the introduction of Haemoctin^®, Biotest reaffirms its commitment to improving patient access to high-quality, cost-effective specialty care treatments.

“We are pleased to partner with SteinCares, whose financial and strategic reliability is a key driver for us to begin penetrating the Latin American markets with our products, where economic and political challenges have historically presented opportunities for resilient and innovative growth,” indicates Enrico D’Aiuto, Senior Vice President Commercial Operations at Biotest AG. “With this first agreement we are making our Factor VIII product available to hemophilia patients in Latin America. SteinCares’ deep-rooted presence and established operations throughout the region, gives us confidence that this agreement will be a success and will be the first step in expanding our commercial footprint in the LATAM region” highlights Carolin Shah, Vice President responsible for the Business Unit Distribution Partners at Biotest.

“The addition of the Factor VIII to our portfolio underscores our commitment to making a meaningful impact on the well-being of hemophilia patients in Latin America. By offering a high-quality treatment alternative, we not only improve the economics of healthcare systems through budget balancing and cost-effectiveness, but also expand access to safe and effective therapies for patients with rare diseases,” said Sebastian Katz, Chief Strategy Officer at SteinCares.

About Haemoctin^®

Haemoctin^® is a von Willebrand factor containing coagulation factor VIII preparation obtained from blood plasma from qualified voluntary donors. It is manufactured from a pool of up to 20,000 plasma donations using state-of-the-art concentration and purification techniques. The injection solution consisting of powder and solvent has been successfully used for more than 25 years for the treatment and prophylaxis of bleeding in patients with congenital factor VIII deficiency (Haemophilia A) and is appreciated for its good tolerability and low immunogenicity. Haemoctin^® is storable for two years at room temperature and available in three different strengths. Dosage and duration of treatment with Haemoctin^® depend on the indication and the severity of the disease.

About Hemophilia

As a lifelong inherited bleeding disorder, hemophilia affects about 1 in 10,000 people worldwide. Hemophilia is one of a number of such disorders that prevent blood from clotting properly. People with hemophilia experience prolonged internal bleeding that can result from a seemingly minor injury. Bleeding into joints and muscles causes severe pain and disability while bleeding into major organs, such as the brain, can cause death. Treating the bleeding episodes involves the prompt and proper use of clotting factor concentrates. Hemophilia A is caused by a deficiency of clotting factor VIII. Therefore, intravenously administered therapeutic factor VIII is often recognized as a foreign protein (antigen) by the patient’s immune system. As a consequence up to 30% of patients with severe hemophilia develop antibodies against the therapeutic factor VIII. These antibodies are called inhibitors because they reduce or eliminate the therapeutic effect of factor VIII. Most inhibitors develop during early childhood and compromise the ability to effectively prevent or manage hemorrhages, resulting in a greater rate of disability, morbidity, complications and costs of therapy. The formation of inhibitors is the most serious complication of today’s hemophilia treatment. Avoiding the risk of inhibitor development would be the most effective prerequisite for a continuous therapy enabling hemophilia patients to live an almost normal life without irreversible joint damage. For more information on hemophilia and FVIII, please visit the World Federation of Hemophilia website at https://www.wfh.org/en/home.

About SteinCares

SteinCares is a leader in commercializing and distributing specialty healthcare products in Latin America, including innovative pharmaceuticals, biosimilars and complex generics. With over 40 years of progressive healthcare experience and operations in over 30 countries in Latin America and the Caribbean, SteinCares serves as a bridge between global pharmaceutical companies and the region’s healthcare providers. The company is deeply committed to creating healthcare opportunities that positively impact the lives of patients and their families in Latin America, with a vision of increasing access to innovative and cost-effective healthcare for patients in the region.

For more information, visit http://www.steincares.com/ or follow the company on LinkedIn.

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com).

IR contact

Dr Monika Baumann (Buttkereit)
Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

Dräger with good demand, robust net sales development and higher earnings in the first nine months of 2024

• Order intake exceeds high prior-year level
• Net sales almost reach the strong prior-year figure
• EBIT up around four percent
• Annual forecast confirmed

Lübeck – Drägerwerk AG & Co. KGaA increased its order intake in the first nine months of 2024 thanks to good overall demand. At around EUR 2,421 million, order intake was around EUR 17 million above the high prior-year figure. Net sales decreased by 0.4 percent (net of currency effects) to EUR 2,295.1 million (9 months 2023: EUR 2,320.9 million) after Dräger had benefited from strong catch-up effects in the prior-year period as a result of the noticeable improvement in delivery capacity and a surge in demand for ventilators in China. Earnings before interest and taxes (EBIT) rose by 4.2 percent to EUR 80.1 million (9 months 2023: EUR 76.9 million). The EBIT margin increased to 3.5 percent (9 months 2023: 3.3 percent). In addition to the operating business performance, several one-off effects with an impact on earnings contributed around EUR 32 million to EBIT.

“Our order intake increased in the first nine months of 2024 thanks to good demand for our ‘Technology for Life’ – and was thus able to exceed the high level of the prior year,” says Stefan Dräger, Chairman of the Executive Board of Drägerwerk Verwaltungs AG. “Net sales saw robust development and almost reached the high prior-year level despite the challenging comparative figures. Our earnings increased. This was due not only to the operating business but also to measures to improve profitability which included the sale of a non-core local business activity in the Netherlands.”

Rising demand for safety technology
In the first nine months of 2024, the Group’s order intake increased by 1.4 percent (net of currency effects) to EUR 2,420.5 million (9 months 2023: EUR 2,403.3 million). This was due in particular to growth in Germany and the positive development in the regions Europe, Middle East, and Africa and the Americas.

In the safety division, order intake rose by 6.5 percent (net of currency effects) to EUR 1,052.1 million (9 months 2023: EUR 992.7 million). Almost all product areas recorded higher demand. Growth was driven in particular by our occupational health and safety equipment as well as respiratory and personal protection products.

In the medical division, order intake fell by 2.1 percent (net of currency effects) to EUR 1,368.5 million (9 months 2023: EUR 1,410.7 million). This is due in particular to the significantly lower demand for ventilators, which had been supported by an extraordinary surge in demand from China in the same period of the prior year. The significant increase in order volumes in thermoregulation in particular had a positive effect.

Safety division continues to grow – base effects weigh on medical division
The safety division recorded an increase in net sales of 5.5 percent (net of currency effects) to EUR 1,009.7 million in the first nine months of 2024 (9 months 2023: EUR 961.7 million), due in particular to the good order situation.

In the medical division, net sales fell by 4.6 percent (net of currency effects) to EUR 1,285.3 million (9 months 2023: EUR 1,359.2 million). This was due in particular to the significant decline in net sales in the Asia-Pacific region, which, as expected, is primarily attributable to the China effect described above. In the same period of the prior year, the segment also benefited from catch-up effects as a result of the noticeable improvement in delivery capacity.

One-off effects drive earnings growth
In the second quarter of 2024, we sold our fire alarm systems business in the Netherlands. In the 2023 fiscal year, net sales in this business area amounted to around EUR 20 million. However, there were only a few synergies with the core business of Dräger. We have therefore exited this business. In addition, we sold an unneeded plot of land in the USA in the second quarter. Together, these two one-off effects contributed around EUR 20 million to EBIT. In the third quarter, a further EUR 10 million was recognized in earnings from the sale of an unneeded building in Spain. Overall, these one-off effects contributed around EUR 30 million to EBIT of EUR 80.1 million (9 months 2023: EUR 76.9 million).

The gross margin rose to 44.4 percent (9 months 2023: 44.0 percent) as a result of the increased share of net sales and the improved gross margin of the safety division. Our functional costs increased by 0.4 percent (net of currency effects). Earnings after taxes amounted to EUR 49.4 million (9 months 2023: EUR 47.1 million).

Business development in the third quarter
In the third quarter, order intake increased by 2.6 percent (net of currency effects) to EUR 816.2 million (Q3 2023: EUR 806.7 million). In the safety division, it increased significantly by 11.9 percent (net of currency effects) to EUR 347.8 million (Q3 2023: EUR 313.5 million). In the medical division, it decreased by 3.4 percent (net of currency effects) to EUR 468.4 million (Q3 2023: EUR 493.1 million).

Dräger’s net sales in the third quarter decreased by 0.7 percent (net of currency effects) to EUR 774.6 million (Q3 2023: EUR 788.5 million). The gross margin fell to 43.5 percent (Q3 2023: 44.0 percent). EBIT amounted to EUR 24.4 million (Q3 2023: EUR 29.2 million). The EBIT margin came to 3.1 percent (Q3 2023: 3.7 percent).

Annual forecast confirmed
Dräger confirms its outlook for the current fiscal year and expects net sales growth of 1.0 to 5.0 percent (net of currency effects) and an EBIT margin of 2.5 to 5.5 percent. We continue to expect net sales growth in the lower half and an EBIT margin in the upper half of the forecast range.

Further information is available in the financial report at www.draeger.com.

Disclaimer
This press release contains statements on the future development of Dräger Group. These forward-looking statements are based on the current expectations, presumptions, and forecasts of the Executive Board as well as the information available to date. They were compiled to the best of the company’s knowledge. Dräger does not provide any warranty nor assume any responsibility for the future developments and results described above. These are dependent on a number of factors. They entail various risks and contingencies outside of the company’s influence and are based on assumptions which could prove to be incorrect. Dräger does not assume any responsibility for updating the forward-looking statements contained in this report. This does not infringe any legal stipulations on the adjustment of forecasts. Information on the financial indicators used (incl. alternative performance measures) can be found on our corporate website www.draeger.com in our Investor Relations section.

PRESS RELEASE | AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR
 

Evolva publishes half-year report 2024 and IFRS annual report 2023

Reinach, Switzerland, 29 October 2024 — Evolva Holding SA (SIX: EVE) today published the consolidated IFRS annual financial statements 2023 and the half-year report 2024 in accordance with applicable stock exchange regulations.

As a consequence of the resolutions taken at the Annual General Meeting (“AGM”) on 12 April 2024 (inter alia revoking the liquidation and delisting of the company), Evolva Holding SA was required to retrospectively publish the 2023 annual report based on IFRS. Evolva announced on 12 July 2024 that the Regulatory Board of SIX and SIX Exchange Regulation (“SER”) granted Evolva an extended deadline for publishing and submitting IFRS financial statements for 2023 as well as the half-year 2024 report until 31 October 2024. Reference is also made to the (audited) interim liquidation financial statements and the interim liquidation report 2023 approved by the AGM (link under ‘documentation’ below).

As regards the half-year 2024 financial report,

(i) during 1H 2024,

• Operating expenses which incurred until the decision of the AGM in April 2024 to revoke the liquidation have been recorded against the liquidation cost accruals.
• The remaining accruals to liquidate the company of CHF 1.6 million were consequently released in April 2024 resulting in a credit on operating expenses and a positive net profit for the period.
• As previously announced, the purchase price was set at CHF 20 million (of which CHF 0.6 million is still held in an escrow account; see below), subject to upward or downward adjustments depending on certain post-signing / completion adjustments. The purchase price adjustment was completed by positive (upward) adjustments (i.e. increase in the purchase price) of CHF 1.929 million in March 2024 (recorded in 2023 accounts) and another CHF 188’000 which were recorded in April 2024.

(ii) on 30 June 2024,

• Evolva Holding SA has a cash balance of CHF 7.2 million and short-term receivables of CHF 0.8 million which comprise mainly CHF 0.6 million in an escrow account which will be released depending on the outcome of a legal case that transferred as part of the sale of Evolva AG to Danstar Ferment AG.
• Accrued and other current and non-current liabilities of CHF 0.9 million include a reserve taken for the above-mentioned legal case in the amount of CHF 0.6 million.
• Equity balance stands at CHF 7.1 million.

Since the AGM’s resolutions, as communicated before, the Board of Directors of Evolva Holding SA is pursuing market opportunities in the area of public mergers and acquisitions, in particular reverse takeovers, continuing acting in the best interest of and maximizing the value for our shareholders.
 

Documentation
The consolidated annual financial statements 2023 as well as the previously issued (audited) interim liquidation financial statements and the interim liquidation report 2023 approved by the AGM are available under this link. The half-year report 2024 is available here.
 

Contact Evolva
Doris Rudischhauser
Investor Relations and Corporate Communications
+41 79 410 81 88
investors@evolvaholding.com

Disclaimer
This announcement is not an offer of securities into the United States. The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered, pledged, sold, delivered or otherwise transferred, directly or indirectly, in the United States, except pursuant to an exemption from, or transaction not subject to, the registration requirements of the Securities Act. No public offering of securities is being made in the United States. Further, the securities referred to herein have not been and will not be registered under the applicable securities laws of Canada, Australia or Japan or under the applicable securities laws of any other jurisdiction where to do so might constitute a violation of such laws.             
This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.

Relief Therapeutics Announces Publication of Plain Language Summary on PKU GOLIKE

GENEVA (OCT. 29, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, announced the publication of a Plain Language Summary in Future Rare Diseases highlighting findings on PKU GOLIKE^® for phenylketonuria (PKU) management. Titled “The Benefits of a Prolonged-Release Protein Substitute with Similarities to Natural Proteins as a Treatment for Phenylketonuria,” the summary was co-authored by PKU specialists with insights from patient associations, translating complex clinical insights for a broad audience. The article is available here.

Summarizing findings previously published in Nutrients, this Plain Language Summary presents results from a clinical study comparing PKU GOLIKE^®, Relief’s prolonged-release amino acid mix, with a standard amino acid formulation. The results showed that while both mixtures provide the same total amino acid levels, PKU GOLIKE^® offers a more natural absorption pattern, closely resembling the release of proteins from whole foods. This sustained absorption benefits individuals with PKU who rely on stable amino acid intake for metabolic balance.

Plain Language Summaries play an important role in bridging the gap between scientific research and public understanding. By enhancing public comprehension of complex studies, these summaries raise awareness of a study’s impact and promote the active involvement of patients and caregivers. “Our core value as a rare disease pharma company is patient centricity, putting patients at the heart of drug development,” said Patrizia Marzorati, Head of Medical Affairs at Relief. “Creating accessible information and resources that meet patient needs is one of our strategies to foster inclusion. By helping patients and caregivers understand scientific information, we aim to support both compliance and acceptance of dietary management in PKU.”

ABOUT PKU GOLIKE^®
PKU GOLIKE products are Foods for Special Medical Purposes (FSMPs) for the dietary management of PKU in children and adults. Developed with Relief’s proprietary, patent-protected Physiomimic Technology™ drug delivery platform, PKU GOLIKE products are the first prolonged-release amino acid FSMPs, characterized by a special coating that ensures physiological absorption of the amino acids mirroring that of natural proteins, while also masking the unpleasant taste and odor typically associated with amino acids. PKU GOLIKE products are marketed in the U.S. by Eton Pharmaceuticals Inc. under an exclusive license and supply agreement with Relief, in key European markets by Relief, and in select countries worldwide through licensing and distribution partners.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief’s filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.

Berlin, Germany, October 28, 2024 – Prof. Dr. Ken Herrmann, a distinguished scientist and Head of the Department of Nuclear Medicine at Universitätsklinikum Essen, Germany, has as of today formally assumed his seat on the Supervisory Board of Pentixapharm Holding AG. While the appointment dates back to the shareholder meeting in June 2024 and has been effective with the registration of the split-off of Pentixapharm AG from Eckert & Ziegler SE in the commercial register, the assumption of his position was up until now hindered by delayed permits to take up secondary employment.

“We are thrilled to welcome Ken Herrmann to our Supervisory Board,” said Dr. Andreas Eckert, Executive Chairman of Pentixapharm Holding AG. “Ken Herrmann is one of the most influential clinicians in the field of radiopharmaceuticals. We look forward to benefiting from his expertise, particularly in advancing our oncology pipeline, which includes Y90-PentixaTher and Ga68-PentixaFor for the treatment and diagnosis of non-Hodgkin lymphomas (NHL).

Prof. Herrmann is an internationally recognized expert in nuclear medicine and theranostics. Apart from his position at the university clinic of Essen, he headed the Chair of the European Association of Nuclear Medicine (EANM) Oncology & Theranostics Committee. He serves as a section editor for The Journal of Nuclear Medicine (JNM) and has (co-)authored over 700 peer-reviewed articles.

After earning his medical degree from Charité Berlin and completing a habilitation in nuclear medicine at Technical University of Munich, Prof. Dr. Herrmann further advanced his education with an executive MBA from the University of Zürich. He frequently shares his expertise at major industry events, including the annual conferences of the EANM and the Society of Nuclear Medicine and Molecular Imaging (SNMMI). Notably, he participated in Pentixapharm’s CXCR4 Symposium at last year’s EANM and the 2nd Boston Radionuclide Theranostics Forum hosted by Eckert & Ziegler SE this year.

Prof. Dr. Herrmann joins an esteemed Supervisory Board chaired by Frank Perschmann. Apart from Harald Hasselmann, CEO of Eckert & Ziegler SE and Jens Giltsch, it includes Pentixapharm’s Founder Dr. Hakim Bouterfa and the endocrinologist Prof. Dr. med. Marcus Quinkler, who contributes his experience for the development of Ga68-PentixaFor in the indication of primary aldosteronism, one of the major causes of secondary hypertension.

About Pentixapharm

Pentixapharm is a clinical-stage radiopharmaceutical development company with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceuticals 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 Phase III registration study with PentixaFor in PA that will start in Europe and the United States in 2025.
 

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

 CureVac to Present at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting
 

TÜBINGEN, Germany/BOSTON, USA – October 28, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced poster presentations at the Society for Immunotherapy of Cancer (SITC) 39^th Annual Meeting, taking place November 8-10 in Houston, USA.

CureVac will present, among other data, extended preliminary immunogenicity results from Part A of the dose escalation phase of its ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma. The presentation will expand on safety, tolerability and immunogenicity results of the CVGBM trial presented last month at the European Society for Medical Oncology (ESMO) Congress, which demonstrated treatment with CVGBM monotherapy successfully induced cancer antigen-specific T-cell responses in 77% of evaluable patients, 84% of which were de novo.

Details on all poster presentations are below:

Abstract:  697
Title: Preliminary immunogenicity results from the dose escalation phase of a first-in-human study of the mRNA-based cancer vaccine CVGBM in patients with newly diagnosed MGMT-unmethylated glioblastoma
Session type: Poster Presentation
Date: November 8
Presenting Author: Sven Koch, Ph.D., Director Immuno-Monitoring, CureVac SE

Abstract:  380
Title: mRNA vaccination enhances TCRtg T cell therapy efficacy in solid tumors
Session type: Poster Presentation
Date: November 9
Presenting Author: Dr. Johannes Lutz, Director Pre-Clinical Development, CureVac SE

Abstract:  370
Title: Identification and validation of a T cell receptor recognizing shared HLA-A02:01 presented epitope from TP53 frameshift
Session type: Poster Presentation
Date: November 9
Presenting Author: Katka Franke, Ph.D., Pharm.D., Director Oncology Antigen Discovery and Validation, CureVac Netherlands B.V.

About CureVac

CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media and Investor Relations Contact

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

Forward-Looking Statements CureVac

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company’s vaccine and treatment candidates and the company’s strategies, financing plans, cash runway expectations, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, the effects of the COVID-19 pandemic on the company’s business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company’s reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

Berlin, Germany, October 25, 2024 – Following the receipt of various approvals, consents, and registrations, Pentixapharm Holding AG will implement, at the end of October 2024, a series of changes to the group’s management bodies.

As announced, Dr. Hakim Bouterfa, founder and CEO of Pentixapharm AG, will step down from his positions on the Management Boards of both Pentixapharm AG and Pentixapharm Holding AG, effective October 27, 2024. He will transition to the Supervisory Board of Pentixapharm Holding AG. This transition does not require a shareholder resolution, as the major shareholder, Eckert Wagniskapital und Frühphasenfinanzierung GmbH, exercised its nomination right, and Dr. Bouterfa accepted the appointment.

Simultaneously, with Dr. Bouterfa’s transition, nuclear medicine specialist Prof. Dr. Ken Herrmann will join the Supervisory Board of Pentixapharm Holding AG. He was appointed to this position at the Annual General Meeting in June 2024 and has now received the necessary consents. The physicist Paola Eckert-Palvarini, who temporarily held this role as an elected substitute, will step down at this time.

Until all changes are formally completed, including the execution of various supplementary agreements, Dr. Andreas Eckert will temporarily assume the role of Executive Chairman on the Management Board of Pentixapharm Holding AG. In the interim, Frank Perschmann will serve as Chairman of the Supervisory Board.

Dr. Dirk Pleimes has been appointed as CEO of Pentixapharm AG by the Supervisory Board, effective October 27, 2024. He will continue to serve as Chief Medical Officer, with no changes to the other operational management positions.

These restructuring measures represent the organizational completion of the spin-off from the former parent company, Eckert & Ziegler SE. A full list of the new management and supervisory board members is expected to be available on the company’s website starting Monday. Biographical information on Prof. Herrmann will be provided in a separate press release upon his assumption of office.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

STRATEC REPORTS RESULTS FOR FIRST NINE MONTHS OF 2024

• Measures to enhance earnings show effect; at 8.4%, adjusted EBIT margin for 9M/2024 almost matches previous year’s level (9M/2023: 8.6%) despite negative scale effects
• Sales on a constant-currency basis -6.0% to € 176.3 million in 9M/2024 (9M/2023: € 187.7 million)
• Significantly improved sales and earnings dynamics expected in fourth quarter of 2024 due to upcoming conclusion of additional orders
• 2024 guidance: Sales expected to remain stable or decrease slightly with adjusted EBIT margin of around 10.0% to 12.0%

Birkenfeld, October 25, 2024

STRATEC SE, Birkenfeld, Germany, (Frankfurt: SBS; Prime Standard, SDAX) today announced its financial results and major events for the period from January 1, 2024 to September 30, 2024 with the publication of its Quarterly Statement 9M|2024.

KEY FIGURES ¹

Adj. = adjusted / bps = basis points / cc = constant currency

¹ To facilitate comparison, figures have been adjusted to exclude amortization resulting from purchase price allocations in the context of acquisitions and other non-recurring items. These non-recurring items include advisory expenses relating to M&A activities and one-off personnel expenses of € 1.7 million in connection with the departure of a member of the Board of Management in the third quarter of 2024.

BUSINESS PERFORMANCE
STRATEC’s consolidated sales in the first nine months of 2024 fell year-on-year by 6.1% (constant currency: 6.0%; organic: 9.6%) to € 176.3 million (9M/2023: € 187.7 million). This subdued sales momentum is attributable to a lower volume of Systems sales. Here, the sales performance continued to be held back by the sharp expansion in molecular diagnostics laboratory capacities during the pandemic, as well as by the start-up curve for a product newly launched onto the market turning out less dynamic than expected. Despite deliveries originally expected for the third quarter of 2024 being postponed, sales in Service parts and Consumables rose significantly. Sales in this business area were positively influenced by the significant extension in the installed systems base in recent years, as well as by rising utilization levels for systems in the market. Sales with Development and Services also showed moderate year-on-year growth in the first nine months of 2024.

It is pleasing to note that, despite negative scale effects and the product mix still not being optimal, STRATEC managed to significantly improve its gross margin in the first nine months of 2024. In this respect, the margin particularly benefited from earnings enhancement measures already initiated at the beginning of last year and since extended, as well as from associated steps to adjust capacities in line with the current market situation. The adjusted EBIT margin for the first nine months amounted to 8.4% and thus virtually matched the previous year’s level (adjusted EBIT margin 9M/2023: 8.6%).

Adjusted consolidated net income amounted to € 8.1 million in the first nine months of 2024, as against € 9.7 million in the previous year. Adjusted earnings per share (basic) stood at € 0.67 (9M/2023: € 0.80).

For comparison purposes, the earnings figures for the first nine months of 2024 have been adjusted to exclude amortization resulting from purchase price allocations in the context of acquisitions and other non-recurring items (advisory expenses and restructuring expenses relating to M&A activities, as well as one-off personnel expenses). A reconciliation of the adjusted figures with those reported in the consolidated statement of comprehensive income can be found in the Quarterly Statement 9M|2024 also published today.

FINANCIAL GUIDANCE
STRATEC is shortly due to sign further additional orders with customers that are also expected to generate notable sales and earnings contributions in the remainder of the 2024 financial year. Furthermore, STRATEC expects that part of the deliveries postponed from the third quarter can now be realized in the fourth quarter of 2024. In view of this, sales and earnings are expected to improve significantly in the final quarter compared with the first nine months of 2024. STRATEC accordingly expects to be able to make up for most of the shortfall in sales by the end of the year. Overall, and in light of the ongoing volatility in the market climate, STRATEC expects its constant-currency sales to remain stable or decrease slightly compared with the previous year. The adjusted EBIT margin for 2024 is forecast at around 10.0% to 12.0%.

For the 2024 financial year, STRATEC has planned investments in property, plant, and equipment and intangible assets corresponding to a total of 6.0% to 8.0% of sales (FY/2023: 6.7%; 9M/2024: 7.0%).

PROJECTS AND OTHER DEVELOPMENTS
Together with its partners, STRATEC pressed ahead with numerous developments and projects in the first nine months of 2024, while also concluding new agreements for new cooperations. In the second quarter of 2024, for example, the final development milestone was reached for customer products in transfusion diagnostics.

Moreover, in recent months STRATEC has completed various initiatives and projects to boost its local presence in markets of particular strategic relevance and can already report its first major successes. Measures worth mentioning include the development of sales and production units in Asia. STRATEC is thus building an optimal position to continue benefiting in future as well from the wide variety of growth opportunities in the Asia-Pacific region. By successfully integrating the Natech Group and intensifying cooperation across the whole of the Group, STRATEC has also accessed new distribution channels and created significant potential for cross-selling activities in the US, the largest and most important market for laboratory solutions, and thus further significantly strengthened its market position. This is reflected in the successful conclusion of orders, for example to develop and subsequently manufacture a complex consumable in the US for an existing customer of the STRATEC Group.

Given promising negotiations concerning new cooperations and the well-filled development pipeline, which includes numerous projects in various stages of development, major market launches can be expected in future as well.

DEVELOPMENT IN PERSONNEL
Including personnel hired from employment agencies and trainees, the STRATEC Group had a total of 1,462 employees as of September 30, 2024 (previous year: 1,532 employees). This corresponds to a reduction of 4.6% compared with the previous year’s reporting date, a development mainly attributable to the earnings enhancement program initiated in March 2023 and the adjustment in capacities in line with subdued customer demand.

QUARTERLY STATEMENT 9M|2024
The Quarterly Statement 9M|2024 of STRATEC SE has been published on the company’s website at www.stratec.com/financial_reports.

CONFERENCE CALL AND AUDIO WEBCAST
To mark the publication of the final results for the first nine months of 2024, STRATEC will be holding a conference call in English at 2.00 p.m. (CEST) today, Friday, October 25, 2024.

You will receive the dial-in data (telephone number, password + individual PIN) following brief registration at the following link: www.stratec.com/registration

The conference call will also be available at the same time as an audio webcast at http://www.stratec.com/audiowebcast20241025 (brief registration required). Please note that no questions can be submitted via the audio webcast. Clicking this link also enables you to follow or download the slide presentation.

ABOUT STRATEC
STRATEC SE (www.stratec.com) designs and manufactures fully automated analyzer systems for its partners in the fields of clinical diagnostics and life sciences. Furthermore, the company offers complex consumables for diagnostic and medical applications. For its analyzer systems and consumables, STRATEC covers the entire value chain – from development to design and production through to quality assurance.

The partners market the systems, software, and consumables in general together with their own reagents, as system solutions to laboratories, blood banks and research institutes around the world. STRATEC develops its products on the basis of patented technologies.

Shares in the company (ISIN: DE000STRA555) are traded in the Prime Standard segment of the Frankfurt Stock Exchange and are listed in the SDAX select index of the German Stock Exchange.

FURTHER INFORMATION IS AVAILABLE FROM:
STRATEC SE
Jan Keppeler, CFA | Investor Relations, Sustainability & Corporate Communications
Tel: +49 7082 7916-6515
ir@stratec.com
www.stratec.com

Relief Therapeutics Reports New Study Results for RLF-OD032 and Files Provisional Patents

New Study Results Indicate Superior Absorption of RLF-OD032 in Fasted State Compared to KUVAN^®, Potentially Enabling Flexible Dosing Options

GENEVA (OCT. 25, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced new positive clinical study results for RLF-OD032 and the filing of provisional patent applications in the United States. The patents, based on these new findings, cover additional claims for Relief’s investigational drug RLF-OD032, a highly concentrated, novel liquid formulation of sapropterin dihydrochloride, for the treatment of phenylketonuria (PKU).

The patent filings follow the recently announced completion of a pilot, proof-of-concept, four-way crossover study that evaluated the pharmacokinetic profile of RLF-OD032 and its absorption in both fasted and fed conditions. The Company previously reported that RLF-OD032, when administered in fed conditions without water, achieved peak and total exposure of sapropterin dihydrochloride similar to those achieved by the reference product (KUVAN^® Powder) administered with water.

Today, Relief announced additional positive and unexpected results from the study that form the basis of these new patent applications. Specifically, the administration of RLF-OD032 in a fasted state without water resulted in greater absorption of sapropterin dihydrochloride compared to the reference product administered under fed conditions with water. In contrast, KUVAN shows poor absorption when taken with water in a fasted state, as reported in KUVAN’s Full Prescribing Information, which recommends that PKU patients take the product exclusively with meals with a large volume of water.

These findings indicate that RLF-OD032 could offer new administration options for PKU patients, providing greater flexibility for dosing without the need for food and water. This may improve patient convenience and compliance, allowing them to take their medication anytime, even while on the go.

The U.S. provisional patent applications strengthen the intellectual property around RLF-OD032 and complement the Company’s existing patent estate. Relief is evaluating the development and regulatory implications of these findings as it continues to advance RLF-OD032 through clinical development with the objective of filing a 505(b)(2) NDA in the U.S. by Q3/2025.

ABOUT RLF-OD032
RLF-OD032 is an innovative, ready-to-use, portable and highly concentrated formulation of sapropterin dihydrochloride in liquid suspension for oral administration, designed to lower blood phenylalanine levels in adult and pediatric PKU patients. It offers a more patient-friendly solution by significantly reducing the volume of medication required compared to current formulations. This advancement aims to enhance compliance, particularly among pediatric patients, who often struggle with the high volumes associated with existing sapropterin treatments. If approved, RLF-OD032 would be the first and only portable, ready-to-use liquid formulation of sapropterin dihydrochloride.

ABOUT PHENYLKETONURIA
Phenylketonuria (PKU) is a genetic disorder caused by a deficiency of the enzyme needed to break down phenylalanine (Phe), leading to a toxic buildup of Phe from the consumption of foods containing protein or aspartame. Individuals with PKU lack the ability to metabolize Phe, which is present in many foods. Without treatment, PKU can cause severe neurological and developmental issues. The standard treatment involves a lifelong phenylalanine-restricted diet supplemented with amino acid-based, phenylalanine-free medical foods to prevent protein deficiency and optimize metabolic control. However, this diet is highly restrictive and often creates barriers to social interaction, limiting compliance and increasing the risk of poor disease management. Sapropterin dihydrochloride is the first approved drug for PKU for reducing Phe blood levels and allowing patients to follow a less restrictive diet.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief’s filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.

KUVAN^® is a registered trademark of BioMarin Pharmaceutical Inc. The use of this trademark in this press release is for reference purposes only, and Relief has no affiliation, sponsorship, or endorsement from BioMarin Pharmaceutical Inc. All references to KUVAN are made solely for comparison of study results and do not imply any relationship between the companies.