Relief Therapeutics Announces $2 Million Milestone Under Royalty Sales Agreement

GENEVA (SEPT. 23, 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 it will receive a $2 million milestone payment from SWK Funding LLC (SWK) this month, following the U.S. Food and Drug Administration’s (FDA) approval of Zevra Therapeutics Inc.’s arimoclomol for the treatment of Niemann-Pick Disease Type C.

The payment is part of the previously announced royalty monetization agreement between Relief and SWK. Under this agreement, Relief received an initial $5.75 million in August 2024 and is eligible to receive up to an additional $5.25 million contingent on specific milestones. With the FDA’s approval of arimoclomol, the first $2 million milestone has now been successfully met. Relief remains eligible for $3.25 million if OLPRUVA’s quarterly net sales reach $1.5 million by the end of the third quarter of 2025. Further details about the agreement can be found in the press release issued on August 5, 2024.

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.

NOT FOR DISTRIBUTION OR DISSEMINATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR DISSEMINATION WOULD BE UNLAWFUL. OTHER RESTRICTIONS APPLY. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THIS ANNOUNCEMENT.

BRAIN Biotech AG concludes royalty monetization deal for up to EUR 128.88 million on investigational pharma compound deucrictibant with Royalty Pharma

Zwingenberg, Germany, 20 September 2024 – Today, BRAIN Biotech AG (ISIN DE0005203947; “Company”) concluded a royalty monetization deal on the royalty rights to investigational pharma compound deucrictibant with Royalty Pharma for up to EUR 128.88 million. The Company will receive an upfront payment of EUR 18.41 million, additional potential regulatory milestones of up to EUR 18.42 million and additional potential long-term sales related milestones of up to EUR 92.05 million. Pharma compound deucrictibant builds part of the Company’s BioIncubator pipeline and is currently in the phase of clinical development by Pharvaris NV (Nasdaq PHVS) for the target indication Hereditary Angioedema.

The Company intends to use the net proceeds of this transaction for future growth funding as well as loan repayments. This transaction remains subject to customary closing conditions.

Notifying person:

Martina Schuster

BRAIN Biotech AG

– Investor Relations –

Darmstädter Str. 34-36

64673 Zwingenberg

Deutschland

www.brain-biotech.com

Investor Relations Office

Tel.: +49-(0)-6251-9331-0

Fax: +49-(0)-6251-9331-11

E-Mail: ir@brain-biotech.com

IMPORTANT NOTICE

This announcement may not be published, distributed or released in the United States of America (including its territories and possessions, any state of the United States of America and the District of Columbia), Australia, Canada, Japan or any other jurisdiction in which the publication, distribution or release would be unlawful. This announcement does not constitute an offer of securities of the company for sale or a solicitation of an offer to purchase securities of the company. There will be no public offer of securities of the Company.

BRAIN Biotech AG concludes major pharma compound transaction valued up to EUR 128.88 million from its BioIncubator

• Total transaction value up to EUR 128.88 million significantly exceeding current market capitalization of BRAIN Biotech
• Immediate upfront payment of EUR 18.41 million
• Royalty monetization of an investigational compound, deucrictibant, with market leading Royalty Pharma
• Contractual milestone payments of up to EUR 9.0 million for the nearer-term clinical progress stay with BRAIN Biotech

Zwingenberg, Germany, 20 September 2024 – BRAIN Biotech AG (“Company”) concluded a royalty monetization deal on the royalty rights to an investigational compound, deucrictibant, with Royalty Pharma for up to EUR 128.88 million. The Company will receive an upfront payment of EUR 18.41 million, additional potential regulatory milestones of up to EUR 18.42 million and additional potential long-term sales related milestones of up to EUR 92.05 million.

Adriaan Moelker, CEO of BRAIN Biotech AG, states: “This is truly a milestone transaction in the history of BRAIN Biotech. We have always believed in the high value of our BioIncubator projects and are now starting to increasingly harvest the strong pipeline investments of the past. This transaction with market leader Royalty Pharma has not only confirmed our value assumptions of deucrictibant but also allowed us to significantly forward cash proceeds from this exciting project. With the proceeds we will accelerate the ongoing transformation of BRAIN Biotech to a global top ten player in the highly attractive market of industrial enzymes. We will continue to focus here on our core areas of Food, Beverage and Life Sciences with a very strong heritage in scientific excellence.”

A result of the Company’s BioIncubator pipeline of highly innovative projects, deucrictibant is currently in clinical development by Pharvaris Netherlands NV (Nasdaq PHVS) for the treatment of Hereditary Angioedema. This project was initiated by group subsidiary AnalytiCon Discovery, which has been merged into the Company but will continue to work as an independent commercial unit of BRAIN Biotech AG. All existing commitments and licenses associated with the investigational compound will be transferred from BRAIN Biotech to Royalty Pharma. BRAIN Biotech intends to commercialize and monetize additional projects with high value from its BioIncubator pipeline during the next years.

Michael Schneiders, CFO of BRAIN Biotech AG, says: “Royalty monetization is a very interesting and innovative form of alternative non-dilutive financing for us in an environment of an ultra-low BRAIN Biotech share price. We have not only been able to raise significant immediate proceeds via the upfront payment but will also participate in the ongoing clinical success of the investigational compound by nearer term regulatory milestones and further long-term payments related to the potential sales development of deucrictibant. The value of this single transaction is more than four times the total market capitalization of BRAIN Biotech prior to the deal announcement.” Schneiders adds, “We are very confident that the strong operational and structural development which started in the last three years in conjunction with increasingly crystallizing value from our BioIncubator pipeline will bring BRAIN Biotech AG back to the agenda of equity investors. In this transaction we have only monetized the future royalties on deucrictibant. Additional contractual milestone payments of up to 9.0 million EUR for the nearer term clinical progress stay with BRAIN Biotech.”

The Company intends to use the net proceeds of this transaction to accelerate its ongoing transformation to a global top ten position in industrial enzymes, for future growth funding including potential M&A transactions and short-term loan repayments. This transaction remains subject to customary closing conditions.

+++

About BRAIN Biotech

BRAIN Biotech AG is a leading provider of integrated solutions and products in the field of industrial biotechnology. The company specializes in enzymes and proteins, microbial production strains and bioprocesses for biotechnological production methods. BRAIN Biotech focuses on the growth markets of nutrition and life sciences as well as on innovative solutions for environment issues. BRAIN Biotech AG is the parent company of the international BRAIN Biotech Group. Its business activities are divided into three segments: 1. BioProducts: Production and sale of specialty enzymes and proteins; 2. BioScience: Customized solutions based on enzyme engineering, production strain and bioprocess development, and screening for bioactive compounds; 3. BioIncubator: Pipeline of research-intensive development projects. For production, the Group operates fermentation plants in the UK and other production facilities in continental Europe and the USA. BRAIN Biotech has been listed on the Frankfurt Stock Exchange since February 9, 2016 (ticker: BNN; ISIN DE0005203947 / WKN 520394). The company employs around 310 people and generated revenues of EUR 55.3 million in the fiscal year 2022/23. For more information, please visit www.brain-biotech-group.com

About AnalytiCon Discovery

AnalytiCon Discovery is an independent commercial unit of BRAIN Biotech AG with many years of R&D expertise in natural product chemistry. The Potsdam-based operation site specializes in small molecule compounds and offers customers from the pharmaceutical, cosmetics, food and agricultural sectors the development of substance libraries, the identification of active ingredients and their synthetic optimization as well as the production of active ingredients on a commercial scale. AnalytiCon has been part of the BRAIN Biotech Group since 2013. Further information: www.ac-discovery.com

About Royalty Pharma plc

Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly – directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products. Further information: https://www.royaltypharma.com/

Contact Media BRAIN Biotech

Dr. Stephanie Konle

PR & Corporate Communications

Phone: +49 6251 9331-70

Email: stk@brain-biotech.com

Contact Investor Relations BRAIN Biotech

Martina Schuster

Investor Relations

Phone: +49 6251 9331-69

Email: ms@brain-biotech.com

Disclaimer

This press release contains forward-looking statements. These statements reflect the current views, expectations, and assumptions of the management of BRAIN Biotech AG, and are based on information currently available to the management.

Forward-looking statements are no guarantees of future performance, and entail both known and unknown risks as well as uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Numerous factors exist that could influence the future performance of and future developments at BRAIN Biotech AG and the BRAIN Biotech Group. Such factors include, but are not limited to, changes in the general economic and competitive environment, risks associated with capital markets, currency exchange rate fluctuations, changes in international and national laws and regulations, in particular with respect to tax laws and regulations, as well as other factors.

BRAIN Biotech AG does not undertake any obligation to update or revise any forward-looking statements.

Hamburg, Germany, and Toulouse, France, 20 September 2024:
Just – Evotec Biologics, the biologics segment of Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO), today celebrated the Grand Opening of its J.POD^® biologics development and manufacturing facility located on Evotec’s Campus Curie in Toulouse, France. The J.POD^® facility in Toulouse, the second of its kind and the first in Europe, utilizes Just – Evotec Biologics’ adaptable J.POD^® technology to provide essential clinical and commercial biologics manufacturing capacity.

During a ceremony on Campus Curie, Pierre-André Durand, Prefect of Haute-Garonne and Occitanie, Jean-Luc Moudenc, President of Toulouse Métropole and Mayor of Toulouse as well as Jalil Benabdillah, Vice-President, Economy, Employment, Innovation and Reindustrialisation of the Occitanie region, joined the Management of Evotec and Just – Evotec Biologics, to inaugurate the new facility.

Dr Christian Wojczewski, Chief Executive Officer of Evotec, commented: “J.POD^® is a bioprocessing facility by Just – Evotec Biologics that uses advanced technology to fulfill its mission of making biotherapeutics more accessible worldwide. The opening of J.POD^® Toulouse, France (EU), our first J.POD^® on European ground, represents a proud moment and a significant milestone for our Company. We are very thankful for the support from the French government, the Occitanie Region, Bpifrance, the Haute-Garonne prefecture, and Toulouse Métropole for helping us achieve this milestone at our Campus Curie in Toulouse. We also want to give special credit to our dedicated team, whose hard work and commitment made this possible.”

J.POD^® Toulouse, France (EU) brings much-needed biologics manufacturing capacity to Europe. Biologics offer a potent therapeutic solution applicable to various indications. However, conventional fed-batch manufacturing poses significant hurdles, particularly during the transition from clinical to commercial scale. The J.POD^® technology, with its modular continuous manufacturing approach, enables highly intensified cGMP production of biologics at flexible quantities, effectively mitigating scale-up risks and reducing manufacturing costs.

Built in a short 18 months green field project, the approx. 15,000 sqm J.POD^® facility stands out in the industry due to its cutting-edge continuous manufacturing technologies in a small, simple facility design built in significantly shorter construction time compared to conventional biologics manufacturing that can deliver up to 2 metric tons of biotherapeutics. The site features dedicated quality control and process development labs for both clinical and commercial products, along with a warehouse and collaborative office spaces. The facility is designed with enhanced environmental sustainability, resulting in reduced water, electricity, and chemical usage compared to conventional facilities.

J.POD^® facilities are constructed at a fraction of the cost compared to similar large-scale DS manufacturing facilities in the industry. This significant cost advantage, with benchmark costs for comparable facilities around $ 600 m, underscores one of our key competitive strengths.

Dr Linda Zuckerman, EVP and Global Head of Biotherapeutics at Just – Evotec Biologics, commented: “J.POD^® is an innovative technology that not only scales biologics manufacturing but also ensures availability precisely where it’s needed. With this second facility, we extend our capacity to discover and develop groundbreaking biologics but also, with our partners, deliver them promptly to patients in need. Our Toulouse-based team at Just – Evotec Biologics deserves immense credit for bringing the J.POD facility and its capabilities to France and the EU.”

The construction of J.POD^® Toulouse, France (EU) benefits from French government funding as part of the Investments for the future Programme (programme d’investissements d’avenir in French) and is also supported economically by the Occitanie Region.

About Just – Evotec Biologics
Just – Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform company that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch. The Just – Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics. Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners. Learn more at www.just-evotecbiologics.com.

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

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

For further information, please contact:

Media

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

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

Joséphine Pröhl
Corporate Communications Associate (France)
Josephine.Proehl@evotec.com

Investor Relations

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

Newron presents H1 2024 results and provides business update 

Milan, Italy, September 19, 2024, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the half year ended June 30, 2024, and provided an update on its business activities.

Highlights H1 2024: 

Evenamide

• Reported positive final one-year results from study 014/015, a Phase II open label trial evaluating evenamide as an add-on therapy to a single antipsychotic in patients with treatment-resistant schizophrenia (TRS):
  • The study demonstrated significant, clinically important, progressive, sustained, and long-lasting improvement on Positive and Negative Syndrome Scale (PANSS) Total, Clinical Global Impression of Severity (CGI-S), the mean rating of change for the Clinical Global Impression of Change (CGI-C) and Level of Functioning (LOF)
  • More than 70% of patients experienced a clinically important reduction in disease severity
  • 25% of all patients achieved “remission,” never described before in TRS patients
     
• Reported compelling results from study 008A, a potentially pivotal, four-week randomized, double-blind and placebo-controlled study of evenamide as an add-on therapy in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic:
  • Study analysis revealed statistically significant multi-domain benefits in PANSS and Clinical Global Impression of Change (CGI-C) ratings
  • Benefit on efficacy measures increased over time, suggesting larger and enduring patient effects to be expected during long-term treatment
     
• Together, these studies:
  • Confirm evenamide’s favorable safety and tolerability profile
  • Demonstrate evenamide’s efficacy on multiple measures of psychopathology in TRS and chronic schizophrenia
  • Add to the growing evidence that the glutamatergic inhibition mechanism of action offers an innovative therapeutic option to schizophrenia patients not benefitting from current antipsychotic treatments
     
• Company is working towards the initiation of a potentially pivotal, multinational, randomized, double-blind, one-year, placebo-controlled study, assessing the efficacy, safety, and tolerability of evenamide as an add-on treatment in patients with TRS
   
• Company is currently running a structured process of securing the most attractive, value creating transaction around evenamide, and several indications of interest have been received. Board and Management are prioritizing and negotiating offers according to their potential to increase shareholder value, with the expectation of closing a transaction in the coming months

Corporate

• Company entered into an agreement for the subscription of up to 2.05 million newly issued shares, up to a value of EUR 15 million, with an institutional investor focused on investing in high-growth firms across sectors including biotech and healthcare
   
• An agreement was entered into with the European Investment Bank to extend the near-term tranche repayment dates of its 2018 financing agreement until the end of 2025 and into 2026, after potentially significant milestones
   
• Chairman and CEO increased their holdings in Newron, underlining their commitment to the Company

Stefan Weber, CEO of Newron, commented:

“It has been a busy and exciting six months for Newron where we have delivered two positive clinical milestones in the development of our novel drug evenamide. We reported exceptional data demonstrating positive clinical results from both study 014/15 and study 008A, which evaluated evenamide as an add-on treatment for patients with treatment-resistant schizophrenia (TRS) and chronic schizophrenia, respectively. We were also delighted to host a successful Investor Day in June in New York City, featuring presentations from leading KOLs on the unmet medical needs for patients with schizophrenia, underscoring the potentially pivotal role of evenamide for these patients. We believe our new chemical entity has blockbuster potential and could bring enormous benefits to patients who are insufficiently served by the existing treatments available. Newron, with the help of a leading healthcare investment bank, is currently exploring potential partnership agreements and opportunities for collaboration that will enable us to progress evenamide into Phase III clinical development for the potential treatment of patients with TRS and create value for our shareholders.”

Evenamide (Schizophrenia)

During Q1 2024, Newron reported final one-year results from study 014/015, a Phase II open label trial evaluating evenamide as an add-on therapy to a single antipsychotic in treatment-resistant patients. The data demonstrated that evenamide as an add-on treatment for patients with TRS was associated with sustained, clinically significant benefits that increased throughout the one-year course of treatment, with more than 70% of patients experiencing a clinically important reduction in disease severity.

Overall, data from study 014 has demonstrated that evenamide was safe and well-tolerated at all doses, with 97% of patients completing six weeks of treatment. The incidence of treatment-emergent adverse events was very low, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015).

In Q2, the Company announced two sets of data from study 008A, a potentially pivotal four-week randomized, double-blind and placebo-controlled study of evenamide as an add-on therapy in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic. Topline data announced in April confirmed evenamide’s favorable safety and tolerability profile, followed by compelling data from additional analyses reported in May.  

The study met the primary endpoint (improvement of the Positive and Negative Syndrome Scale (PANSS) Total Score) and key secondary endpoint (improvement of the Clinical Global Impression of Severity (CGI-S)), with a high rate of study completion (96%). No new or specific concerns were raised in the study; only 25% of the patients in the study experienced at least one adverse event (evenamide 25% versus placebo 25.8%).

Newron will be presenting the results of study 008A at the upcoming 37th ECNP Congress (September 21-24, 2024) in Milan, Italy.

The totality of these results validated evenamide as the first glutamate modulator to demonstrate efficacy in inadequately responding patients with schizophrenia in a placebo-controlled study.

Following results from both study 008A and study 014/015, Newron’s key focus is now on initiating a Phase III randomized, double-blind, one-year clinical trial. The trial is expected to start in the first half of 2025 and will compare evenamide to placebo as an add-on treatment in at least 400 patients with TRS. Participants will be evaluated at three timepoints, 12 weeks, 26 weeks, and one year, to assess the long-term safety, tolerability, and efficacy of evenamide. The study design has received regulatory approval in all relevant territories, final discussion is ongoing with the US Food and Drug Administration (FDA) on the dosing regimen.

Several indications of interest were received in a structured process of securing the most attractive, value creating transaction for Newron’s shareholders, be it a regional or global license or an M&A transaction; with the process supported by one of the world’s leading full-service investment banking and capital markets firms. The Board and Management will prioritize and negotiate the offers according to their potential to increase shareholder value, with the expectation to close a transaction in the coming months, enabling progression of the Phase III clinical development of evenamide in TRS patients.

Xadago^®/safinamide (Parkinson’s disease)

In partnership with Zambon and Supernus, Newron continues to further develop and market its product, Xadago®/safinamide.

In reference to the receipt of several Paragraph IV Notice Letters in May 2021 regarding the submission by some generic manufacturers of an Abbreviated New Drug Application ANDA to the US FDA, seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the US before expiration of the three US patents listed in the FDA Orange Book for Xadago®, Newron and its partners Zambon and Supernus have reached settlement agreements with said generic manufacturers, thus resolving the legal action. All three patents remain valid and in force. Under the agreement, the generic manufacturers will be allowed to enter the US market with a safinamide mesylate drug product no earlier than December 1, 2027.

In the EU, Supplementary Protection Certificates (SPCs) have already been approved in most territories of relevance; Newron and Zambon are confident that upon completion of the still ongoing procedures and targeted activities, the SPCs will be granted in all key territories.

Corporate

In April, Margarita Chavez, US-based, was elected as a Non-Executive Director to the Board of Newron following the 2024 Annual General Meeting. Margarita Chavez has been an advisor to Newron’s Board since October 2023, and the Company continues to benefit from her more than 20 years of strategic transaction expertise in the US and internationally and her leadership in the pharmaceutical industry. She is heading the Business Development Committee of Newron’s Board of Directors.

During the first half of 2024, Newron announced an agreement with the European Investment Bank to extend the near-term tranche repayment dates of the 2018 financing agreement until the end of 2025 and into 2026, after potentially significant milestones.

Furthermore, the Company entered into an agreement for the subscription of up to 2.05 million newly issued shares with an institutional investor focused on investing in high-growth firms across sectors including biotech and healthcare. Under the agreement, the fund subscribed to an initial 750,000 newly issued shares at a subscription price of EUR 7.33 per share, which corresponds to gross proceeds of approximately EUR 5.5 million and had the right to subscribe to an additional up to 1,300,000 newly issued shares until no later than January 31, 2025. The funds raised enable Newron to focus its attention on progressing evenamide into Phase III clinical development in TRS patients and support activities beyond immediate inflection points. At the time of this report, 1,350,000 newly issued shares have been subscribed to by the investor, under the rules of the agreement, generating proceeds of EUR 9.9 million. For further detail, please refer to https://www.ser-ag.com/en/resources/notifications-market-participants/significant-shareholders.html#/.

In June 2024, Dr. Ulrich Köstlin, Chairman of Newron’s Board of Directors, and Stefan Weber, CEO demonstrated their commitment to Newron and its future by buying shares via the SIX Swiss Exchange and Xetra.

ESG commitment and reporting

The Company has worked diligently to further implement its Environment, Social and Governance (ESG) strategy and reporting framework as disclosed in the Annual Report 2023. The ESG goals and projects for 2024 are well on track and management hopes that this will ensure Newron operates as a sustainable and conscious employer, business, and provider of innovative therapeutics. The Company will provide a further update in our 2024 Annual Report.

Financial Summary (IFRS) H1 2024 and H1 2023

In thousand EUR (except per share information)

* Including one-time payments of EUR 2,284

Outlook

Following positive results from the pivotal study 008A and unprecedented results from study 014/015, Newron expects to enter into a value-creating transaction around evenamide in the coming months, enabling progression of the Phase III clinical development of the compound. The Company is convinced about the blockbuster potential of evenamide and the benefits it can bring to patients who are currently underserved by the current treatments on the market. Newron also continues to assess the market for opportunities to expand its CNS pipeline. The Company looks forward to providing an update on its evenamide partnership discussions and any pipeline developments as they may occur. Newron’s total available cash resources will fund the Company’s planned development programs and operations well into 2025.

Newron’s Half-Report 2024 is available for download on https://www.newron.com/investors/reports-and-presentation/year/2024 

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 

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 / Caroline Bergmann, MC Services, +49 211 52925222, newron@mc-services.eu 

USA

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

Important Notices

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

Ad hoc announcement pursuant to Art. 53 LR

Fribourg, 19 September 2024

AEVIS VICTORIA SA (AEVS.SW) – Publication of Half-Year Report 2024 – Revenue up 8.0% to CHF 527.6 million – Operating profit at EBITDAR level up 21.3% to CHF 87.7 million

AEVIS VICTORIA SA (AEVIS), a key player in the healthcare, hospitality, and real estate sectors, today released its 2024 Half-Year Report, showing strong results despite a complex economic environment. The Group re-iterates its strategic shift towards a diversified investment model, marked by the gradual opening of Swiss Medical Network’s capital over the next three years.

Fabrice Zumbrunnen, CEO of AEVIS, commented: « We are extremely pleased with the results achieved in the first half of 2024. Our progressive transformation towards a pure play investment company aligns perfectly with our mission Investing for a better life. This evolution will enhance our agility and ability to generate value for our shareholders while maintaining our commitment to the sectors where we have historical expertise. »

2024 Half-Year Financial Results

AEVIS recorded revenues of CHF 527.6 million in the first half of 2024, up 8.0% compared to the same period in 2023. This result was driven by organic growth of 7.0%, with significant contributions from Swiss Medical Network (+4.7%) and MRH Switzerland (+13.7%). EBITDAR reached CHF 87.7 million, up 21.3%, representing a strong margin of 18.9%. Thanks to rigorous cost management and improved operational processes, AEVIS successfully transformed a CHF 10.2 million loss in the first half of 2023 into a net profit of CHF 0.7 million in 2024.

MRH Switzerland: Record half-year and 39.0% increase in operating profit

MRH Switzerland delivered an exceptional performance, generating revenues of CHF 101.2 million with organic growth of 13.7%, despite the challenges posed by unusual spring weather, which impacted weekend tourism in May and June. MRH Switzerland’s EBITDAR surged by 39.0% to CHF 27.7 million, with a margin of 27.4%, a significant improvement from 22.6% in the previous year.  The winter season in Zermatt was very good, and the hotels in Davos and Interlaken achieved double-digit growth, significantly above the industry average. The AlpenGold Hotel in Davos benefited from very good results during and outside the WEF. In general, bookings for the second half of the year are encouraging, and MRH Switzerland expects full-year results to be higher than last year.

Swiss Medical Network: EBITDAR margin rises to 20.0%

Swiss Medical Network also demonstrated solid growth, with revenues increasing by 5.8% to CHF 417.5 million. Net revenues (excluding medical fees) increased by 5.6% to CHF 353.0 million. The EBITDAR margin rose to 20.0%, largely thanks to the completion of construction at the Genolier Innovation Hub, allowing Clinique de Genolier to return to normal operations. Additionally, cost optimization measures contributed significantly to the financial improvement of Swiss Medical Network.

Réseau de l’Arc, the first truly integrated care organization in Switzerland and a 35% subsidiary of Swiss Medical Network, also had a promising start with the successful launch of its health insurance product « VIVA », further strengthening AEVIS’s leadership position in integrated care in Switzerland.

Infrastructure investments benefit from strong tenant performance

The real estate investments in Swiss Hotel Properties, with a net asset value (NAV) of CHF 363.4 million, and the 30% stake in Infracore, with a NAV of CHF 566.3 million at the end of 2023, are benefiting from the strong operational performance of their tenants, namely MRH Switzerland and Swiss Medical Network. As such, the real estate assets provide both value and stability to the AEVIS portfolio.

A strategic shift towards a diversified investment profile

AEVIS continues its transformation into a diversified investment company, while keeping its focus on the healthcare, hospitality, and real estate sectors. As part of its strategic roadmap, AEVIS intends to welcome new strategic investors in the shareholder base of Swiss Medical Network, thereby gradually reducing its own stake in the hospital group. Over the next three years, AEVIS plans to successively place shares in Swiss Medical Network with institutional and strategic investors, further improving the positioning and increasing its value.

Outlook for 2024

For the full year, AEVIS anticipates positive results, driven by strong performances in its hotel and healthcare activities. The real estate holdings, both in the hotel and healthcare sectors, are expected to benefit from the positive momentum of its tenants. The Group remains cautious, however, in the face of current macroeconomic challenges and does not plan to set consolidated revenue or margin targets for the current year.

Detailed reporting

AEVIS VICTORIA SA’s Half-Year Report 2024 can be downloaded via this link: Half-Year Report 2024

For further information:
AEVIS VICTORIA SA Media and Investor Relations: c/o Dynamics Group, Zurich
Philippe R. Blangey, prb@dynamicsgroup.ch, +41 (0) 43 268 32 35 or +41 (0) 79 785 46 32
Séverine Van der Schueren, svanderschueren@aevis.com, +41 (0) 79 635 04 10

AEVIS VICTORIA SA – Investing for a better life
AEVIS VICTORIA SA invests in healthcare, hospitality & lifestyle and infrastructure. AEVIS′s main shareholdings are Swiss Medical Network SA (80%, directly and indirectly), the only Swiss private network of hospitals present in the country’s three main language regions, MRH Switzerland AG, a luxury hotel group managing eleven luxury hotels in Switzerland and abroad, Infracore SA (30%, directly and indirectly), a real estate company dedicated to healthcare-related infrastructure, Swiss Hotel Properties SA, a hospitality real estate division, and NESCENS SA, a brand dedicated to better aging. AEVIS is listed on the Swiss Reporting Standard of the SIX Swiss Exchange (AEVS.SW). www.aevis.com.

All 154,053 new shares have been subscribed at these issue terms and conditions by a total of eleven investors, including members of the Supervisory and Management Boards.

The Company is continuing to negotiate with another investor regarding a possible second capital increase of a further 154,053 new shares to be issued from the authorized capital 2024, which would be issued in accordance with the authorization to exclude the statutory subscription rights of existing shareholders. The actual implementation of this second capital increase is dependent on the outcome of the specific negotiations with the investor, the conclusion of the respective transaction documents and the adoption of a resolution by the Company’s Management Board and Supervisory Board. For the second capital increase, a report on the planned exclusion of statutory subscription rights must also be published at least two weeks before the required Supervisory Board resolution. In addition, the approval of the restructuring administrator (still pending for the second capital increase) is required due to the ongoing restructuring proceedings.

+++ End of ad-hoc announcement +++

Mainz Biomed Announces Petra Smeltzer Starke to Join Company as Brand Ambassador

Strategic Alliance with Former White House Senior Adviser to Focus on Awareness of Mainz Biomed’s Products and the Importance of Early Detection  

BERKELEY, US and MAINZ, Germany – September 18, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the addition of Petra Smeltzer Starke as a Brand Ambassador for the Company.  As Brand Ambassador she will help the Company in the development and dissemination of messaging focused on the importance of early detection of colorectal cancer.

“We are excited about Petra joining our team as Brand Ambassador.  Her broad and deep experience will be invaluable to us as we bring our next generation colorectal cancer screening product to market, with the intention to launch a pivotal PMA trial by the end of 2025,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. 

Petra Smeltzer Starke commented, “I am proud and excited to work with Mainz Biomed as they push the envelope on the early detection of colorectal cancer and importantly the detection of pre-cancerous polyps.”

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About Petra Smeltzer Starke

Petra Smeltzer Starke’s phenomenal career started from studying international business, trade, and diplomacy at the Prague School of Economics while supporting herself as a model. Petra’s passion for Fashion translates into her modeling successes notwithstanding, Starke finished both undergraduate and graduate degrees at the top of her class and moved to the United States to attend law school at Georgetown University.

Starke was first in her class in law school & practiced law at the international law firm of O’Melveny & Myers, LLP representing many political nominees and appointees during the Bush Administration. Starke was subsequently recruited for the Obama Presidential Transition and later the Obama White House where she served as General Counsel to the White House Council of Economic Advisors and Senior Advisor to the President. Starke has Counseled American Presidents, and global Diplomatic Leaders around the world, and established a phenomenal international network. Starke’s expertise helped the Biden-Harris Transition Team – ethics and avoiding conflicts of interest.

About Mainz Biomed NV

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe and the United Arab Emirates. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Immunic Presents Key Vidofludimus Calcium Data at the 40^th Congress of ECTRIMS, Highlighting Its Therapeutic Potential in Multiple Sclerosis

– Vidofludimus Calcium Consistently Reduced Neurofilament Light Chain Levels, Compared to Placebo, in the Interim Analysis of the Phase 2 CALLIPER Trial, Across Age and Disability Levels at Baseline For All Progressive Multiple Sclerosis Subtypes – 

– Clinical Signal Shown for Vidofludimus Calcium on Post COVID Fatigue May Be Related to Epstein-Barr Virus Reactivation; Preventing This Reactivation May Contribute to Fatigue Reduction in Multiple Sclerosis Patients – 

– Preclinical Data Showed Improved Neuronal Survival, Likely Driven by Vidofludimus Calcium’s Induction of Nurr1 Activation, as Demonstrated by Primary Target Gene Regulation –

– In Preclinical Experiments, Vidofludimus Calcium Reduced or Prevented Development of Pathogenic Peripheral T Helper Cells, Which Could be One of the Treatment Pathways in Multiple Sclerosis –

NEW YORK, September 18, 2024 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the presentation of key data at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), highlighting Immunic’s lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium’s (IMU-838) therapeutic potential in multiple sclerosis (MS). The data will be presented in an oral poster presentation and three ePosters at this conference, being held September 18-20, 2024, in Copenhagen, Denmark. Additionally, members of Immunic will be available throughout the event at booth #60.

“Having four poster presentations on our lead asset, vidofludimus calcium, at the prestigious ECTRIMS Congress, illustrates the strength of the data generated for our drug candidate, to date, and its potential to become a new treatment option for MS,” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “We are particularly excited to have the opportunity to present data on various aspects of vidofludimus calcium’s profile, including the neurofilament light chain (NfL) interim data from our 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.”

Dr. Vitt added, “As previously reported, in the interim analysis of our CALLIPER trial, we observed a clear separation from placebo in serum NfL levels among all patients with progressive multiple sclerosis (PMS) as well as its subtypes. These observations support the potential effectiveness of vidofludimus calcium in slowing disease progression in PMS and further substantiate its neuroprotective capabilities through the activation of Nurr1. Our next major data readout for this asset is the CALLIPER top-line data, which we expect to release in April of next year. We believe that, if the CALLIPER trial is successful in showing a beneficial effect of vidofludimus calcium, this data, along with that from the ENSURE program and vidofludimus calcium’s already established, strong safety and tolerability profile, may allow for a meaningful clinical differentiation of vidofludimus calcium compared to other MS medications, providing potentially attractive commercial positioning.”

Dr. Vitt continued, “Fatigue is one of the most common and most debilitating symptoms for both post-Covid Syndrome (PCS) and MS. Third-party research has recognized Epstein-Barr virus (EBV) reactivation as a potential cause for PCS fatigue. Notably, data has demonstrated not only vidofludimus calcium’s antiviral effects, but also its potential ability to prevent reactivation of EBV. We aim to confirm vidofludimus calcium’s potential to reduce fatigue in MS patients in our ongoing CALLIPER and phase 3 ENSURE trials and in the recently initiated investigator-sponsored phase 2 RAPID_REVIVE trial in PCS patients. Additionally, results from an animal model suggest that vidofludimus calcium reduces or prevents the development of pathogenic peripheral T helper cells. Besides its effect on pathogenic immune cells, preclinical evidence further suggests a neuroprotective role of vidofludimus calcium via activation of Nurr1. Preclinical data support Nurr1-driven direct neuroprotective effects by vidofludimus calcium enhancing neuronal survival and indirect effects by reducing neurotoxic activation of microglia cells. The combination of neuroprotective and anti-inflammatory effects of vidofludimus calcium represents a potential beneficial profile for effective treatment of MS.”

Oral Poster Presentation:

• Title: Serum Neurofilament Changes in Progressive MS: Exploring the Impact of Vidofludimus Calcium by Age and Disability in the CALLIPER Study Interim Analysis
• Presenting Author: Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio
• Poster Number: P753
• Session Title: Poster Session 2
• Date: Thursday, September 19, 2024
• Time: 4:45 pm – 6:45 pm CEST

In the phase 2 CALLIPER trial interim analysis of 203 patients, serum NfL levels were reduced by 22.4% (p=0.01, post hoc) after 24 weeks of vidofludimus calcium treatment compared to placebo, with consistent treatment effects across each progressive MS subtype, including primary progressive MS as well as active and non-active secondary progressive MS. The vidofludimus calcium group showed a 10% decrease in NfL versus a 20% increase for placebo among those with an Expanded Disability Status Scale (EDSS) score ≤ 5.5; and a 2% decrease for vidofludimus calcium versus a 12% increase for placebo among those with an EDSS score >5.5. Similarly, among patients aged ≤ 45 years, the reduction was 11.6% for vidofludimus calcium versus a 15% increase for placebo, while for those aged > 55 years, it was a 10% decrease versus a 13% increase, respectively. The data suggest that vidofludimus calcium treatment consistently reduces NfL levels compared to placebo across different patient subgroups based on age and disability scores at baseline. 

ePosters:

• Title: Exploring the Potential of Vidofludimus Calcium to Reduce Fatigue in Multiple Sclerosis by Preventing Epstein-Barr Virus Reactivation
• ePoster Number: P1119

Analysis of the antiviral activity of vidofludimus calcium in vitro revealed a dose-dependent reduction of lytic EBV reactivation in B cells and an anti-EBV effect in epithelial cells. Results of a post-hoc analysis of PCS symptoms in the phase 2 CALVID-1 trial indicated a potential contribution of vidofludimus calcium to the prevention of long-term fatigue. 80% of patients who received placebo reported fatigue compared to 50% who received 45 mg vidofludimus calcium. Fatigue decreased in both treatment groups in the next 9-17 weeks to 33% for placebo and 17% for vidofludimus calcium. A clinical signal for vidofludimus calcium on PCS fatigue was observed which might be related to EBV reactivation. By preventing this reactivation, vidofludimus calcium may contribute to fatigue reduction in MS patients as well. This hypothesis will be further assessed by determining effects on fatigue using patient questionnaires as well as analyses of the anti-EBV effect in the ongoing CALLIPER, ENSURE, and RAPID_REVIVE clinical trials.

• Title: Vidofludimus Calcium Activity on Nurr1 in Preclinical Models: A Potential Neuroprotective Function in Multiple Sclerosis
• ePoster Number: P1410

Vidofludimus calcium enhanced the expression of Nurr1 target genes important for neuronal survival, such as brain derived neurotrophic factor (BDNF) and superoxide dismutase 1 (SOD1), in a rat neuronal cell line. Additionally, it upregulated key Nurr1 target genes, such as tyrosine hydroxylase (TH) and vesicular monoamine transporter 2 (VMAT2), in human microglial and murine neuronal cell lines, which could contribute to neuronal protection. Vidofludimus calcium protected neurons under pro-apoptotic conditions, reduced gene expression of IL-6, TNF and IFN in human microglia stimulated with lipopolysaccharide (LPS), and increased BDNF levels in human peripheral blood mononuclear cells (PBMCs) stimulated with LPS. Vidofludimus calcium effectively attenuated disease severity in an experimental autoimmune encephalomyelitis (EAE) model. Treatment with vidofludimus calcium led to reduced immune cell infiltration, including decreased numbers of pathogenic T cells producing IL-17A, GM-CSF, and IFNγ. Preliminary data showed that mice receiving vidofludimus calcium exhibit elevated levels of BDNF in the blood and enhanced expression of Nurr1 and its target gene TH in the central nervous system. 

• Title: Vidofludimus Calcium Shows T Helper Cell Modulatory Effects in Murine Experimental Autoimmune Encephalomyelitis: One of the Potential Mode of Action Pathways for MS Treatment
• ePoster Number: P1390

Vidofludimus calcium given prophylactically reduced disease severity and prevented disease development (63% and 15% symptom free in vidofludimus calcium and vehicle, respectively). This was reflected in the strong reduction of infiltrating T helper (Th) cells in the spinal cord as well as reduced numbers of proinflammatory Th cells in the periphery (draining lymph nodes, dLN). Vidofludimus calcium treatment, given after symptom onset, reduced disease progression compared to vehicle. This was supported by lower numbers of infiltrating proinflammatory Th cells into the spinal cord, while no significant difference was seen in the periphery compared to vehicle. The effect of vidofludimus calcium was assessed on myelin oligodendrocyte glycoprotein (MOG) antigen-specific Th cells (2D2) on day 7 after disease induction. Although vidofludimus calcium seems to increase MOG-specific follicular T helper (Tfh) cells in the periphery (dLN), the progression to develop into pathogenic Th cells was inhibited and the development of regulatory T cells was increased. Overall, vidofludimus calcium reduces or prevents development of pathogenic peripheral Th cells.

All poster presentations will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.

About Vidofludimus Calcium (IMU-838)

Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, vidofludimus calcium is a known inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been tested in more than 1,800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country. 

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 vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; 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; and the development and commercial potential of any product candidates of the company. 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, 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 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@ksca.com