Newron and Myung In Pharm announce license agreement
for evenamide in South Korea

• Myung In Pharm to develop, manufacture and commercialize evenamide in South Korea
• Myung In Pharm to contribute 10% of patients to Newron’s pivotal Phase III trial for evenamide, and share global development costs
• Newron will receive upfront payment, development and regulatory milestones, and royalties on net sales
• Newron expects to begin pivotal Phase III trial in H1 2025

Milan, Italy; Morristown, NJ, USA; and Seoul, Republic of Korea – January 9, 2025 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for diseases of the central and peripheral nervous system, and Myung In Pharm Co. Ltd. (“Myung In Pharm”), South Korea’s leading CNS specialist pharmaceutical company, today announced that they have entered into a license agreement to develop, manufacture and commercialize Newron’s innovative modulator of the excessive release of glutamate, evenamide, an add-on therapy for treatment-resistant schizophrenia (TRS) and poorly responding patients with schizophrenia, in South Korea. 

Under the terms of the license agreement, Myung In Pharm will contribute 10% of the total patient population to be enrolled into Newron’s upcoming pivotal Phase III trial and cover the costs related to this population. Myung In Pharm’s involvement leverages its established clinical infrastructure and expertise in the central nervous system (CNS) field. Furthermore, the company will bear a percentage of eligible global development costs and will also be responsible for all regulatory, registration, marketing, and commercialization costs for evenamide in South Korea. In return, Newron will receive an upfront payment, milestone payments for development and regulatory achievements, and royalties on net sales. Further details were not disclosed by the parties. 

The Phase III randomized, double-blind, one-year trial is expected to begin in H1 2025 and will compare evenamide to placebo as an add-on treatment in at least 600 patients with TRS. It will be coordinated by Newron, who will oversee the trial design, execution, and data analysis. Myung In Pharm will be responsible for enrolling patients in South Korea through its extensive network of clinical sites, as well as providing support with monitoring and data collection. Newron continues to pursue further development opportunities for evenamide in other territories. On December 13, 2024, Newron and EA Pharma (a subsidiary of Eisai Co., Ltd.) announced a license agreement for evenamide in Japan and other Asian territories.

“We are thrilled to partner with Myung In Pharm in this important clinical trial and to grant them the rights to develop, manufacture and commercialize evenamide in South Korea,” said Stefan Weber, CEO of Newron. “Their strong expertise in CNS therapies and their clinical infrastructure will be instrumental in advancing the development of evenamide. This collaboration underscores our shared commitment to transforming the treatment landscape for patients with unmet needs.”

Hang Myung LEE, Chairman of Myung In Pharm, commented: “Newron’s innovative approach aligns with our commitment to improving patient outcomes in the CNS area, and we believe our participation will make a significant contribution to the success of the study. Furthermore, we are honored to have received the license to commercialize evenamide in South Korea. This partnership presents a valuable opportunity for us to bring a new treatment option to patients in South Korea, a key market for Myung In Pharm. We look forward to working closely with the Newron team to bring this promising therapeutic to the forefront of clinical development and expand its impact in South Korea.”

Jefferies International Limited (“Jefferies”) acted as the exclusive financial advisor to Newron. Orrick Herrington & Sutcliffe LLP advised as legal counsel to Newron.

Cosmo Group Inc. of USA acted as the advisor to Myung In Pharm.

About schizophrenia

Approximately 25 million people worldwide are affected by schizophrenia, including more than 210,000 in South Korea as reported in 2022 by HIRA (Health Insurance Review & Assessment Service, Government agency). Despite more than 60 different types of atypical and typical antipsychotics used for schizophrenia globally, a considerable number of patients remain severely ill or resistant to treatment. Overall, 30-50% of patients do not respond to the available medications and are defined treatment resistant. In addition to the patients with treatment-resistant schizophrenia (TRS), another 20-30% are described as “poor responders to anti-psychotic medication,” even if not meeting the criteria for TRS. New findings indicate that patients with TRS have abnormalities in the glutamatergic system, but not in dopaminergic transmission, so there is a huge unmet medical need for a glutamatergic mechanism of action, efficacious both in TRS patients and in those who are poor responders to the current treatments.

About evenamide

Evenamide is the first new chemical entity that has demonstrated significant benefits in this difficult-to-treat patient population, as seen in the potentially pivotal Phase III study 008A trial, as an add-on treatment to second generation anti-psychotics including clozapine, in 291 poorly responding patients with chronic schizophrenia. The primary endpoint, the Positive and Negative Syndrome Scale (PANSS)¹, and the key secondary endpoint, the Clinical Global Impressions Scale – Severity (CGI-S), were met and showed statistical significance compared to placebo. Importantly, evenamide treatment was associated with statistically significant increase in proportion of patients who experienced “clinically meaningful benefit” on the outcome variables. Evenamide was extremely well tolerated, without any of the usual side effects of available anti-psychotics.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago^®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia. For more information, please visit: www.newron.com

About Myung In Pharm

Myung In Pharm is a fully integrated pharmaceutical company established in 1985, based in Seoul, Republic of Korea. The company specializes in the manufacturing, processing, and distribution of pharmaceutical drugs, with a strong focus on central nervous system (CNS) therapies. Ranked number one in South Korea in the CNS field, Myung-In Pharm operates state-of-the-art manufacturing facilities that meet cGMP standards. With a robust network of over 1,200 neurologists and relationships with 98% of domestic neurology hospital departments, Myung In Pharm is dedicated to improving patient care and advancing the field of neuroscience. http://myunginph.co.kr/main/en/

References:

[1] Positive and Negative Syndrome Scale (PANSS) is widely used in clinical trials of schizophrenia and is considered the “gold standard” for assessment of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788255/)

For more information, please contact:

Newron

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

UK/Europe

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

Switzerland

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

Germany/Europe

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

USA

Paul Sagan, LaVoieHealthScience, +1 617 374 8800, Ext. 112, psagan@lavoiehealthscience.com

Myung In Pharm:

Jung Uk Lee – Executive Director, +82 2 3465 9640, julee@myunginph.co.kr

Important Notices

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

Press Release // January 8, 2025

Formycon and Fresenius Kabi Canada receive Health Canada’s approval for FYB202/Otulfi^® (ustekinumab), a biosimilar to Stelara^®

• Otulfi^® approved by Health Canada for both subcutaneous and intravenous formulations to treat serious inflammatory diseases
• Health Canada joins the FDA and the European Commission in granting regulatory approval for FYB202
• The earliest date for commercialization of Otulfi^® in Canada is defined in a confidential settlement agreement between Formycon, Fresenius Kabi and Johnson & Johnson signed in March 2024

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its commercialization partner Fresenius Kabi announce that Health Canada has issued a “Notice of Compliance” (NOC) for FYB202/Otulfi^®1 (ustekinumab), a biosimilar to Stelara^®2. This approval applies to subcutaneous and intravenous formulations for the treatment of adult patients with moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. Both the U.S. Food and Drug Administration (FDA) and the European Commission had already granted marketing authorization for FYB202 in September 2024.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “We are extremely pleased to receive Health Canada’s approval for our ustekinumab biosimilar. Canada was one of the world’s highest per-capita spenders on biologics and has taken significant steps in recent years to promote biosimilar adoption. These initiatives have proven highly effective in driving biosimilar uptake³, supporting our mission to improve patient access to essential medicines while reducing healthcare costs. Together with our partner Fresenius Kabi, we look forward to making a meaningful contribution to Canada’s healthcare system.”

In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement granting Fresenius Kabi commercialization rights for FYB202 in key global markets, including Canada. In accordance with the confidential terms of the settlement agreement with Johnson & Johnson, Fresenius Kabi intends to launch the biosimilar in Canada at the agreed time.

Ustekinumab is a human monoclonal antibody targeting the cytokines interleukin-12 and interleukin-23, which play an important role in inflammatory and immune responses. Health Canada’s approval was based on comprehensive analytical, preclinical, clinical, and manufacturing data demonstrating that FYB202 is highly comparable to Stelara^® in efficacy, safety, and pharmacokinetics. The pivotal clinical study included patients with moderate to severe plaque psoriasis (psoriasis vulgaris).

This approval underscores Formycon’s commitment to expanding access to high-quality biosimilars worldwide, reinforcing its position as a global leader in the development of biosimilar medicines.

————————————————————————————-

¹⁾ Otulfi^® is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
²⁾ Stelara^® is a registered trademark of Johnson & Johnson
³⁾ https://www.canada.ca/content/dam/pmprb-cepmb/documents/npduis/analytical-studies/posters/2023/biosimilars-policies-promote-switching.pdf

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe and Canada. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich and is listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and has been part of the selection index SDAX since December 2024. Further information can be found at: https://www.formycon.com/

About Fresenius Kabi:
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.

Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.

Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.

For more information visit the Fresenius Kabi’s website at www.fresenius-kabi.com. For more information about the company’s work in biosimilars, please visit https://biosimilars.fresenius-kabi.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

STRATEC TO PARTICIPATE IN THE 43RD ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

Birkenfeld, January 8, 2025

STRATEC SE, Birkenfeld, Germany, (Frankfurt: SBS; Prime Standard, SDAX) will participate in the 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2025, at the Westin St. Francis in San Francisco, CA, USA. Marcus Wolfinger, Chief Executive Officer of STRATEC SE, will represent the company in a session scheduled at 9:00 am PST (12:00 pm EST / 5:00 pm GMT / 6:00 pm CET).

The presentation will be webcast live and can be accessed on the company’s website at www.stratec.com in the Investors section under Events & Presentations. A replay of the webcast will be available after the presentation and will remain available for 30 days.

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

Media release

Doubling of production capacity at the manufacturing site in Malmö

Baar, 8 January 2025 – PolyPeptide Group AG (SIX: PPGN), a focused global CDMO for peptide-based active pharmaceutical ingredients, announces the planned doubling of solid-phase peptide synthesis (SPPS) capacity at its manufacturing site in Malmö, Sweden.

The construction work is already underway, along with the supporting infrastructure, including a tank farm. PolyPeptide uses its proprietary manufacturing technology with an integrated engineering design and advanced automation and process control to ensure high productivity, safety, and sustainability. A modular approach is intended to accelerate time to market, while enhancing flexibility to ensure high utilization. As part of its mid-term outlook communicated on 13 August 2024, PolyPeptide plans to invest around EUR 100 million at the site and to create approximately100 permanent new positions.

The additional production capacity will mainly serve to fulfill one of the large commercial agreements previously communicated by PolyPeptide. It relates to one of the growth initiatives reflected in the mid-term outlook, whereby PolyPeptide targets to double 2023 revenue by 2028 and to deploy capital expenditures of 15% to 20% of revenue to ensure capacity, also beyond 2028.

Juan José González, CEO of PolyPeptide: “The large-scale capacity expansion in Malmö allows us to further deepen the long-standing collaboration with an important GLP-1 customer. We are making good progress with the implementation of our growth strategy to meet our mid-term targets, benefiting from balanced, supportive partnerships with customers.”

Contact

PolyPeptide Group AG

Michael Stäheli

Head of Investor Relations & Corporate Communications

michael.staeheli@polypeptide.com

T: +41 43 502 0580

About PolyPeptide

PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a focused Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide offers products and services from pre-clinical through to commercial stages, including generics. Its active custom projects pipeline reflects the opportunities from novel drug therapies in development to fight both widespread and rare diseases. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.

For more information, please visit polypeptide.com.  

@PolyPeptide – follow us on LinkedIn

Disclaimer

This media release has been prepared by PolyPeptide Group AG and contains certain forward-looking statements that reflect the current views of management. Such statements are subject to known and unknown risks, uncertainties and other factors that may cause actual developments to differ materially from those expressed or implied in this release. In particular, the statements related to the guidance for 2024, and mid-term outlook constitute forward-looking statements and are not guarantees of future financial performance. The Group’s actual results of operations could deviate materially from those set forth in the guidance for 2024 and mid-term outlook. As such, investors should not place undue reliance on the statements related to the guidance for 2024 and mid-term outlook. PolyPeptide Group AG is providing the information in this release as of this date and, except as required by applicable laws or regulations, does not undertake any obligation to update any statements contained in it as a result of new information, future events or otherwise.

Press Release

QUANTRO Therapeutics achieves breakthrough in transcriptomic drug discovery with first successful simultaneous 10-target multiplex-screening

• QUANTRO’s proprietary time-resolved functional transcriptomic discovery platform accelerates target screening for complex indications in oncology and inflammation
• QUANTRO CEO Dr. Michael Bauer to attend Biotech Showcase and participate in the WuXi Global Forum in San Francisco, January 13-16, 2025

Vienna, Austria, 7 January 2025: QUANTRO Therapeutics (QUANTRO), a pioneer in the discovery of first-in-class transcription factor targeting cancer treatments, announced today that the company has successfully completed its first ten-target multiplex-screening campaign, which yielded validated hits and functional proof of on-target activity for multiple molecular targets. This milestone further expands the capability to establish QUANTRO’s innovative QUANTROseq^® platform as a pioneering technology in the fight against diseases driven by transcriptional dysregulation, such as cancer and inflammation indications.

After successfully establishing its technology for single- and dual-target screenings at a current capacity of approximately one million compounds per year, QUANTRO has now completed the first-ever simultaneous 10-target multiplexing high-throughput screening (HTS). This pilot project, which screened a 10,000-compound diversity library, met all quality control criteria and achieved a 100% hit rate for both positive and negative controls. Furthermore, the QUANTROseq^® platform identified high-quality hits across most of the selected targets, providing deep insights into transcriptional changes as well as on-target potency and selectivity, while minimizing off-target effects.

“This achievement represents a significant breakthrough for QUANTRO and more broadly for drug discovery, unlocking unprecedented opportunities for the discovery of novel targeted therapies,” said Dr. Michael Bauer, CEO of QUANTRO. “By advancing our capabilities from single and dual target screenings now up to currently 10-target multiplexed high-throughput screenings, we are effectively profiling entire compound libraries for multiple targets, redefining the possibilities in transcription factor drug discovery. The unparalleled precision and depth of information generated by our QUANTROseq® platform now enable us to rapidly create proprietary compound libraries for a wide range of targets, including those previously deemed ‘undruggable’.”

Meet QUANTRO at Biotech Showcase in San Francisco, USA, January 13-16, 2025

QUANTRO also confirms its attendance at Biotech Showcase, a premier investor conference for private and micro-mid-cap biotechnology companies. Dr. Michael Bauer, CEO of QUANTRO, will participate in this important industry event to discuss how QUANTRO’s innovative technology is pushing the boundaries of transcriptomic drug discovery. Dr. Bauer welcomes the opportunity to connect with industry leaders and potential investors to explore strategic partnerships and investment opportunities, including discussions about QUANTRO’s current financing round. To schedule a meeting, please use the conference partnering system or contact QUANTRO directly.

In addition, Dr. Bauer will participate in the WuXi Global Forum 2025 on January 14, where he will host an Executive Roundtable from 2:30 – 3:30 pm PST. This interactive session is designed to encourage personalized, in-depth discussions, reflecting the collaborative and innovative nature of the industry.

About QUANTRO:

QUANTRO Therapeutics is a transcriptomic Drug Discovery and R&D company focused on building a highly innovative pipeline of modulators, inhibitors or degraders of transcription factors, transcriptional regulators and cell signaling targets. QUANTRO’s transcriptomic discovery platform is using a novel and proprietary time-resolved gene expression profiling technology to target gene transcription factors, so far considered un-druggable.

The technology is uniquely positioned to quantify changes in gene expression over time with unprecedented precision and sensitivity, overcoming the deficiencies of traditional RT-qPCR based technologies like DRUG-seq, which are limited to only measure RNA abundance, without information on transcriptional activity and dynamics.

QUANTRO was founded in 2019 as a spin-out from the prestigious research institutes IMBA and IMP in Vienna, Austria. Since 2020, the company has been supported by Boehringer Ingelheim Venture Fund (BIVF) and Evotec as seed investors. In total, EUR 11 million was earned in milestone-driven tranches during 2020 and 2023, complemented by undisclosed proceeds from a strategic collaboration on selected oncology targets with Boehringer Ingelheim Oncology.

Please find more information on our website at www.quantro-tx.com.

Contact

QUANTRO Therapeutics GmbH

Dr. Michael Bauer, CEO
Email: Contact | QUANTRO
Phone: +43 122 66001

Media Contacts

MC Services AG
Dr. Cora Kaiser, Dr. Johanna Kobler (international and German-speaking media inquiries)
Shaun Brown (international trade press)
Phone: +49 89 210228 0
Email: quantro@mc-services.eu

Immunic Highlights 2024 Accomplishments and Upcoming Milestones

– Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April – 

– Reported Positive Outcome from Interim Analysis of Ongoing, Twin Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Both Trials on Track to Be Completed in 2026 – 

– Strengthened Management Team and Board of Directors with Key Hires – 

– Announced a Three-Tranche Private Placement Totaling Up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025, Based on Initial $80 Million Tranche – 

NEW YORK, January 7, 2025 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today highlighted its 2024 accomplishments and upcoming milestones.

“The past year was marked by substantial progress for our orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), as we continued to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS),” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “Looking ahead, we eagerly anticipate reporting top-line data from the CALLIPER trial in April. The previously reported interim results showed a clear reduction versus placebo in neurofilament light chain (NfL) levels across the PMS patient population, hinting to potential neuroprotective effects of the drug.”

“We also achieved a significant milestone for our phase 3 ENSURE program, having received a positive interim result from an unblinded Independent Data Monitoring Committee (IDMC), which concluded that the trials are not futile and recommended they should continue as planned, without any sample size increase. These favorable recommendations corroborated our initial assumptions about the design, powering and relapse rate of the trials and illustrate that they remain on track. The result makes us immensely confident and excited as we await the completion of the twin phase 3 trials: ENSURE-1 remains on track for completion in the second quarter of 2026, with ENSURE-2 expected to follow in the second half of 2026.”

Jason Tardio, President and Chief Operating Officer of Immunic, added, “Since joining Immunic in July 2024, we have ramped up our efforts preparing for the potential commercial launch of vidofludimus calcium. There continues to be a large unmet medical need for new therapeutic advancements in the treatment of MS that address both the neuroinflammatory and neurodegenerative aspects of the disease to better slow disability worsening. Vidofludimus calcium is the only medicine in development that targets activation of Nurr1 for neuroprotection and combines that with selective inhibition of DHODH for anti-inflammatory and antiviral effects. We believe our drug has the potential to become the first oral disease-modifying therapy approved to treat both relapsing and progressive MS to address the full spectrum of the disease.”

Dr. Vitt concluded, “In 2024, we were also honored to have had our previously reported results from the phase 1/1b clinical trial of IMU-856, our orally available and systemically acting small molecule modulator targeting Sirtuin 6 (SIRT6), a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology. Data from this study showed that, in patients with celiac disease during periods of gluten-free diet and gluten challenge, IMU-856 demonstrated positive effects over placebo in four key dimensions of celiac disease, including protection of the gut architecture, improvement of patients’ symptoms, biomarker response, and enhancement of nutrient absorption. We continue to believe that IMU-856 could offer a new therapeutic approach for various gastrointestinal disorders, also beyond celiac disease.”

2024 Corporate Highlights

• Strengthened the Board of Directors in July, with the appointment of Simona Skerjanec, M.Pharm, MBA, a thought-leader in brain health with decades of experience.
• In July, appointed seasoned biopharmaceutical executive, Jason Tardio, as President and Chief Operating Officer, to lead internal efforts in positioning the company for the potential launch of vidofludimus calcium and to work closely with Patrick Walsh, Chief Business Officer, to prepare the company for a range of potential partnership outcomes. Additionally, reported that Werner Gladdines, former Vice President, Program Management & Clinical Development Operations, was promoted to Chief Development Officer.
• Announced a three-tranche private placement totaling up to $240 million, with participation from select new and existing investors, in January. The initial tranche successfully closed on January 8, 2024, with Immunic securing $80 million in gross proceeds. 

Vidofludimus Calcium 2024 Highlights and Upcoming Milestones

• Completion of the ENSURE-1 trial of vidofludimus calcium in RMS is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026.
• Top-line data for the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April of this year.
• Announced a positive outcome of the interim analysis of the phase 3 ENSURE program, investigating vidofludimus calcium for the treatment of RMS, in October. An unblinded IDMC confirmed that the trials are not futile and recommended they should continue without changes, including no need for a potential increase of the sample size.
• Presented key data on vidofludimus calcium in four presentations at the 40^th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September. The data included the NfL interim data from the phase 2 CALLIPER trial, antiviral data suggesting an effect on reducing fatigue, Nurr1 target data supporting a neuroprotective profile, and pathogenic T cell data further supporting the drug’s anti-inflammatory effects.
• Announced enrollment of the first patient in the investigator-sponsored phase 2 RAPID_REVIVE trial of vidofludimus calcium in patients with post COVID syndrome in September.
• Hosted an MS R&D Day in New York City in September, focused on vidofludimus calcium’s potential to become the treatment of choice for both RMS and PMS patients. Presenting MS industry experts included Francesca Montarolo, Ph.D., Neuroscience Institute Cavalieri Ottolenghi (NICO) and University of Turin, Italy and Amit Bar-Or, M.D., FRCPC, Department of Neurology, Perelman School of Medicine, University of Pennsylvania.
• Published extended data from the phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting MS in the peer reviewed journal, Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology, in April.
• Hosted an MS R&D Day in San Francisco in April, during which management discussed the latest developments in the MS landscape, along with recent preclinical and clinical data supporting the neuroprotective potential of vidofludimus calcium.
• Received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) in March, for a patent covering the composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material. The company’s multilayered intellectual property strategy now provides protection into 2041 in the United States, unless extended further.
• Presented data from the company’s phase 2 CALLIPER and CALVID-1 trials of vidofludimus calcium, in two poster presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024 in February.

IMU-856 2024 Highlights and Upcoming Milestones 

• Announced the publication of data from the phase 1/1b clinical trial of IMU-856 in the peer reviewed journal, The Lancet Gastroenterology & Hepatology in November.
• Based on the positive data from the phase 1b clinical trial, the company continues preparing for clinical phase 2 testing of IMU-856, contingent on financing, licensing or partnering. 

Immunic’s management, business development and investor relations teams will be hosting one-on-one meetings in connection with the 43rd Annual J.P. Morgan Healthcare Conference taking place January 13-16, 2025, in San Francisco. To schedule a meeting, please contact: Jessica Breu at jessica.breu@imux.com. 

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com. 

Cautionary Statement Regarding Forward-Looking Statements 

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for Immunic’s development programs to safely and effectively target diseases; preclinical and clinical data for Immunic’s development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the company’s expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, including the ability to satisfy the minimum average price and trading volume conditions required to receive funding in tranche 2 and 3 of the January 2024 private placement, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information 
 
Immunic, Inc. 
Jessica Breu 
Vice President Investor Relations and Communications
+49 89 2080 477 09 
jessica.breu@imux.com 

US IR Contact                                                                                                                                Rx Communications Group                                                                                                         Paula Schwartz                                                                                                                               +1 917 633 7790                                                                                                     immunic@rxir.com 

US Media Contact                                                                                                                    KCSA Strategic Communications                                                                                               Caitlin Kasunich                                                                                                                               +1 212 896 1241                                                                                                    ckasunich@kcsa.com

Berlin, January 7^th, 2025 – Pentixapharm AG, a developer of innovative radiopharmaceuticals, receives 6.77 million Euro for intangible assets formerly developed by Glycotope from undisclosed Asian pharma and biotech companies. The transaction, which will be effective still in 2024, involves rights that had been transferred to Pentixapharm as part of the acquisition of Glycotope’s target discovery business in July 2024.

“The deal eliminates almost all of the remaining obligations from an earn-out that Pentixapharm had accepted with the purchase of the target discovery business”, comments Henner Kollenberg, Chief Business Officer. “While it will not significantly reduce the losses of Pentixapharm in 2024, it paves the way for the monetization other Glycotope assets acquired by Pentixapharm. The transaction also confirms the ongoing interest of major industry players in the know-how maintained and now furthered by Pentixapharm”.

The acquisition of Glycotope’s target discovery business in July 2024 included a portfolio of preclinical antibodies against multiple oncology targets, a unique tumor target database, the equipment needed to exploit a discovery platform, and the related IP. Transferred to Pentixapharm as part of the deal were also a range of patents, licenses and license agreements.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with offices in Berlin and Würzburg, Germany. It is committed to developing ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs. Its pipeline features CXCR4-targeted compounds as well as early-stage radionuclide-antibody conjugates addressing 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

CHEPLAPHARM EXPANDS MANAGEMENT WITH TAMAS SZOGA AS VP COMMERCIAL

Greifswald, January 2, 2025
 

The globally active CHEPLAPHARM Group, headquartered in Greifswald, is continuing to position itself for the future and is expanding its management team. Tamás Szóga started as Vice President (VP) Commercial on 1 January 2025. The position was newly created. Tamás Szóga comes from Recordati Spa and takes over the Commercial division for the entire CHEPLAPHARM Group. 

As VP Commercial, Tamás Szóga is responsible for the strategic planning and management of the Global Sales division of the entire CHEPLAPHARM Group. This includes developing and implementing strategies to optimise the existing sales organisation and ensuring targeted distributor management. Tamás Szóga is also responsible for the management and development of the CHEPLAPHARM affiliates. 

‘Maximisation of growth through strategic brand development and implementation of innovative commercial strategies will be the main tasks for Tamás Szóga. The newly created position of VP Commercial demonstrates the importance of this function within the company. I am therefore delighted that we have been able to recruit Tamás Szóga, a leader with two decades of expertise in the development of markets and product portfolios in the pharmaceutical industry,’ says Edeltraud Lafer, CEO of the CHEPLAPHARM Group. 

About Tamás Szóga

Tamás Szóga joins from Recordati Spa, where he has been responsible for portfolio development in 30 markets and Managing Director for the international business since the beginning of 2022. Prior to this, he was Director, Strategic Projects at EGIS focusing on global initiatives. He spent the longest part of his career at GlaxoSmithKline for 18 years across various geographies, where he held positions with increasing responsibility in portfolio development, commercial operations, market access and business development. Tamás Szóga started his career at management consultancies such as KPMG and Ernst & Young. Tamás Szóga holds an economist degree with finance and accountancy specification from Budapest Business University.

About CHEPLAPHARM

CHEPLAPHARM is a family-owned company with headquarters in Greifswald. For over 20 years, the company has been very successful in taking over well-known and well-established medicines from the research-based pharmaceutical industry and transferring them to an existing global network of partners for production and distribution. In this way, CHEPLAPHARM ensures the continuous supply of these medicines to patients worldwide. In addition to its headquarters in Greifswald, CHEPLAPHARM operates further sites in France, Japan, Russia and Switzerland. The company employs around 780 people worldwide.

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

Press office:

CHEPLAPHARM ǀ Ziegelhof 24 ǀ 17489 Greifswald ǀ press(at)cheplapharm.com

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

Change in Evolva’s shareholder structure

Reinach, Switzerland, 30 December 2024 — Evolva Holding SA (SIX: EVE) (“Evolva”) was informed by its largest shareholder Nice & Green SA, Nyon, that it had sold all its Evolva shares to an unnamed third party.

Nice & Green SA, Nyon, Evolva’s largest shareholder with a latest reported shareholding of 19.344%, informed Evolva that it had sold all its Evolva shares to a third party. The identity of the third party is currently unknown to Evolva. Under applicable shareholding disclosure rules, the new investor is required to notify Evolva and the Disclosure Office of SIX Exchange Regulation AG within four trading days of the transaction. Evolva has the obligation to publish the disclosure within two trading days as of its receipt on the electronic publishing platform of the Disclosure Office.

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.