Abivax presents first-half 2024 financial results

• Cash balance of EUR 222M at June 30, 2024; cash runway in to Q4 2025

PARIS, France, September 9, 2024, 10:00 p.m. CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the inflammatory response in patients with chronic inflammatory diseases, announces today its 2024 half-year financial results, as of June 30, 2024. The interim financial statements for the first half of 2024, approved by the Company’s Board of Directors on September 5, 2024, have been reviewed by the Company’s external auditors.

Abivax recently provided updates on its business and operational goals in press releases published on July 15, 2024 (“Abivax provides operational and key program update”) and August 6, 2024 (“Abivax Announces ABTECT Phase 3 Trial Achieves Key Enrollment Milestone”).

First-half 2024 financial highlights (IFRS figures)

• Operating loss increased by EUR 42.7M to EUR -80.0M compared to EUR -37.3M for the six months ending June 30, 2023. Operating income, consisting predominantly of Research Tax Credit and Subsidies, increased by EUR 4.5M to EUR 6.8M compared to EUR 2.3M for the six months ending June 30, 2023. The increase in operating loss was driven by operating expenses as described further below.

• Research and development (R&D) expenses increased by EUR 32.1M to EUR -64.7M in the first half of 2024 compared to EUR -32.6M in the same period 2023. This increase was predominantly driven by expenses related to:
  • A EUR 25.6M, or 98%, increase related to our Ulcerative Colitis (UC) clinical program, driven by the progression of Phase 3 clinical trials for obefazimod in UC (where Phase 3 clinical trial costs were significantly higher than in Phase 2);
  • EUR 0.9M in expenses related to our Crohn’s disease (CD) clinical program, compared to no expenses in first half of 2023, driven by planning costs incurred for the Phase 2b CD trial; and
  • A EUR 4.8M, or 113%, increase in transversal personnel expenses related to the overall expansion of the R&D headcount to support our organizational growth and the issuance of new equity awards to officers and employees in R&D.

• Sales and marketing (S&M) expenses increased to EUR -4.2M for the six-month period ending June 30, 2024 compared to EUR -0.2M for the same period 2023. These expenses consist primarily of consulting costs associated with market research in preparation for our future sales and commercialization efforts in the U.S.

• General and administrative (G&A) expenses increased to EUR -17.9M compared to EUR -6.8M for the first half of 2023. This increase was primarily due to:
  • An increase in personnel costs of EUR 7.9M, resulting from an increase in headcount to support the expansion of the Company along with the issuance of new equity awards to our officers and employees; and
  • Increased legal and professional fees and other costs associated with operating as a dual-listed public company.

• Total headcount at the end of June 2024 was 84 and increased compared to December 2023, due to the implementation of the U.S. and European operational infrastructure.

• For the six-months ended June 30, 2024, our EUR -1.6M net financial loss was driven primarily by the following items:
  • Interest expenses of EUR -4.2M in relation to borrowings and loans;
  • Non-cash expense of EUR -1.9M in relation in relation to our royalty certificates;
  • Non-cash expense of EUR -1.6M related to the amortization of prepaid expenses related to the transaction costs of the Kreos/Claret tranche C bond loans;
  • Non-cash expense of EUR -1.5M in relation to an increase in the fair value of warrant derivatives issued in relation to the Kreos/Claret financing; and
  • Mostly offset by interest income of EUR 4.8M in relation to the invested proceeds from our U.S. initial public offering and listing on Nasdaq and foreign exchange gains of EUR 2.3M.

• Cash position as of June 30, 2024, was EUR 222.3M compared to EUR 260.0M (including other financial assets of EUR 9.0M) as of December 31, 2023. The decrease was due to EUR -85.2M used in operations, offset by EUR 48.5 M in net proceeds from a drawdown of tranche B and tranche C of the Kreos/Claret Financing (see below).

• As part of the structured debt financing transaction for a total amount of up to EUR 75M with Kreos Capital and Claret European Growth Capital entered into on August 21, 2023 (the “Kreos/Claret financing”), Abivax proceeded with the drawdown of the second and third tranches of the Kreos/Claret financing for EUR 25M each.
  • Both the second and third tranches consist of 25,000,000 senior secured non-convertible bonds with a par value of EUR 1.00 each, which will not be listed on any market;
  • The issuance of the second and third tranches of the Kreos/Claret non-convertible bonds occurred on March 28, 2024 and June 21, 2024, respectively;
  • A variable interest rate of 7.5% European Central Bank Base Rate (MRO) (with a floor at 2.5% and a cap at 4%) applies to both tranches. These non-convertible bonds will be repaid monthly through March 31, 2027, after a deferred repayment of the principal until February 1, 2025.

• Abivax and Bpifrance agreed on the termination of the RNP-VIR and Carena projects. In connection with such termination, Abivax is to repay respectively EUR 2.4M and EUR 0.2M to Bpifrance in accordance with the terms of the financing made available by Bpifrance to Abivax in connection with such projects.

• The drawdown period for Tranche B of the structured debt financing transaction with Heights entered into on August 20, 2023 expired on August 24, 2024. Abivax did not draw down Tranche B prior to such date.

• The Company is in the process of terminating the liquidity contract signed on February 4, 2019 with TRADITION SECURITIES AND FUTURE (TSAF SA). The termination is expected to be effective from September 30, 2024.

Based on the currently available funds, Abivax expects to be able to finance its operating cash flow requirements into the fourth quarter of 2025.

*****

About Abivax

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

Contact:

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

FORWARD-LOOKING STATEMENTS

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

Secarna Pharmaceuticals will present data at 6th Inflammasome Therapeutics Summit demonstrating the potential of ASOs to target the expression of NLRP3

• NLRP3 is a promising target with a well-validated role in various inflammatory disease
• Secarna has shown the potential of the company’s ASOs to effectively and specifically suppress NLRP3 and IL-1β release
• In a CAPS mouse model, Secarna demonstrated prolonged survival and a significant reduction in systemic inflammation

Munich/Martinsried, Germany, September 09, 2024 – Secarna Pharmaceuticals GmbH & Co. KG (“Secarna”), a company redefining the discovery and development of best-in-class oligonucleotide therapeutics, announced today the presentation of conclusive data showcasing the potential of Secarna’s third generation antisense oligonucleotides (ASOs) to specifically target NLR family pyrin domain containing 3 (NLRP3), a promising therapeutic target for the treatment of inflammatory diseases. The data will be presented at the 6^th Inflammasome Therapeutics Summit taking place September 10 – 12, 2024 in Boston, MA, USA. The conference brings together leading biopharma professionals with 30 expert speakers on cutting-edge discussions to troubleshoot the most pressing topics in inflammasome research.

The talk entitled “Leveraging the Power of ASOs to Target the Expression of NLRP3 for Enhanced Specificity of Inflammasome Inhibition” will be held by Julia Hinterdobler, PhD on September 11th, 2024, at 11:30 EDT. The data were generated in collaboration with Prof. Ariel Feldstein and Prof. Hal Hoffman from the University of California San Diego, who are world-leading specialists in NLRP3-mediated inflammation and Cryopyrin-associated periodic syndrome (CAPS), a group of rare inherited autoinflammatory diseases. These findings suggest that ASO therapy could be a potential treatment of CAPS or other NLRP3-mediated diseases (data published in The Journal of Immunology).

Julia Hinterdobler, PhD, Scientist at Secarna Pharmaceuticals commented: “NLRP3 is a promising target with a well-validated role in various inflammatory diseases, that is receiving strong interest from biotech and big pharma in identifying and developing potent as well as tolerated inhibitors. We have shown the significant potential of NLRP3-specific ASOs to effectively and specifically target and downregulate NLRP3 expression and IL-1β release, resulting in prolonged survival and reduced inflammation in CAPS models. We are eager to see the development of ASOs targeting inflammation and other indications, in particular for previously untreatable targets.”

Leveraging the Company’s unique AI-powered bioinformatics selection process, Secarna has designed ASOs to specifically suppress the expression of the NLR family pyrin domain containing 3 (NLRP3), the central component of the inflammasome pathway. Activation of NLRP3 results in the release of proinflammatory cytokines such as IL-1β, the major mediator of the proinflammatory response, and the overactivation of this pathway plays a pathological role in several inflammatory, such as arthritis, inflammatory bowel disease, acute and chronic kidney disease, as well as diseases of the central nervous system. In vitro, the administration of NLRP3-specific ASOs resulted in a potent reduction of Caspase-1 activity and complete blockade of the release of mature IL-1β. In a mouse model CAPS, Secarna demonstrated prolonged survival and a significant reduction in systemic inflammation.

Secarna is currently testing the potential of antisense oligonucleotides in inflammatory diseases with additional targets.

About Secarna Pharmaceuticals GmbH & Co. KG

Secarna Pharmaceuticals a biopharmaceutical company redefining the discovery and development of best-in-class oligonucleotides therapeuticsaddressing high unmet medical needs in immuno-oncology and immunology, as well as viral, neurodegenerative and cardiometabolic diseases. Secarna’s mission is to maximize the performance and output of its proprietary antisense oligonucleotide discovery and development platform to generate highly specific, safe, and efficacious best-in-class antisense therapies. With over 20 discovery and development programs, including both proprietary pipeline projects and partnered programs, Secarna focuses on targets in indications where antisense-based approaches have clear potential benefits over other therapeutic modalities. www.secarna.com

CureVac to Present First CVGBM Glioblastoma Cancer Vaccine Clinical Data
at ESMO 2024 Congress

TÜBINGEN, Germany/BOSTON, USA – September 9, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that the first clinical data from CureVac’s ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma will be presented at the European Society for Medical Oncology (ESMO) Congress (Barcelona, Spain, September 13-17, 2024). Clinical data will be presented as an oral presentation on Friday, September 13, along with a poster presentation of preclinical data supporting the program’s development.

“Cancer vaccines have tremendous potential to improve the outcome of cancer patients and particularly, mRNA technologies offer innovative and promising platforms that could enable us to finally make cancer vaccines a reality in clinical practice,” said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. “We are assessing a breakthrough approach to cancer vaccines that uses our distinctive mRNA technology in one of the most aggressive forms of brain cancer and are very excited to share the first-in-human results of our mRNA technology platform in the GBLM trial in glioblastoma at ESMO.”

The Phase 1 study includes a dose-escalation part (Part A) and dose-expansion part (Part B). Results for Part A will be covered in the oral presentation, with safety and tolerability as well as initial immunogenicity data provided for all evaluable patients at dose levels of 12-100 µg. A summary of treatment-emergent adverse events (TEAEs), which were mostly Grade 1-2 and yielded no dose-limiting toxicities as confirmed by a Data Safety Monitoring Board, will also be provided.

The Phase 1 study is evaluating the safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-promoter unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. CVGBM features a single unmodified mRNA encoding eight epitopes derived from known tumor-associated antigens, with demonstrated immunogenicity in glioblastoma. Enrollment began earlier this year for Part B of the study, which is expected to include up to an additional 20 patients at the recommended 100 µg dose.

Details on the presentations are below.

Abstract: 440O

Title: First in human study of the mRNA-based cancer vaccine CVGBM in patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma (GBM): First results from the dose escalation phase

Session type: Proffered Paper

Date and Time: September 13, 14:00-14:10 CEST

Location: Pamplona Auditorium (Hall 3)

Speaker: Prof. Dr. Dr. Ghazaleh Tabatabai

Abstract: 22P

Title: Pre-clinical development of CVGBM: A therapeutic mRNA-based multiepitope vaccine for glioblastoma

Session type: Basic Science Poster

Date and Time: September 15, 09:00-17:00 CEST

Location: Hall 6

Speaker: Dr. Ronja I. Mülfarth

About CureVac

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

CureVac Media and Investor Relations Contact

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations

CureVac, Tübingen, Germany

T: +49 7071 9883-1298

M: +49 160 90 496949

sarah.fakih@curevac.com

Forward-Looking Statements CureVac

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

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

MPH Health Care AG: Preliminary IFRS result for the first half of 2024

EBIT increases significantly to 75.7 million euros. Equity (net asset value) increases by EUR 74.5 million to EUR 325.5 million, which corresponds to EUR 76.02 per share. The equity ratio rises to 94.7%.

Berlin, 5. September 2024 – MPH Health Care AG (ISIN: DE000A289V03) announces the preliminary IFRS consolidated result for the first half of 2024. Accordingly, equity increased from EUR 251.0 million to EUR 325.5 million. The net asset value (NAV) per share rose by 58% from EUR 48.12 (30.06.2023) to EUR 76.02 as of 30^th June 2024.

In the first six months of 2024, EBIT amounted to EUR 75.7 million (HY1/2023: EUR -15.6 million). In the first half of 2024, the IFRS result for the period increased significantly to EUR 74.5 million (previous year: EUR -15.4 million).

As of 30^th June 2024, equity increased by over EUR 74 million to EUR 325.5 million (previous year: 31 December 2023: EUR 251.0 million). The equity ratio improved to 94.7% (previous year: 94.2%) and remains at a very high level.

MPH AG is an investment company whose investments are reported as financial assets under the balance sheet item “Financial assets” and are measured at fair value through profit or loss as at the balance sheet date. The net profit for the period is mainly the result of the fair value measurement of the listed investments held as at the balance sheet date, which result from the higher market prices of the investments compared to the previous year’s balance sheet date of 31 December 2023. 

The investments M1 Kliniken AG and CR Energy AG, which are listed on the Frankfurt Stock Exchange, operated successfully in the 2023 financial year and in the first half of 2024.

M1 Kliniken AG further expanded its market position in the field of beauty medicine in the first half of 2024 and opened four new specialist medical centres in Germany. According to the preliminary IFRS figures, the M1 Group’s consolidated sales increased by 11.2% to EUR 167.4 million. The operating result (EBIT) almost doubled, rising to EUR 14.5 million (previous year: EUR 7.3 million). Net profit (before minority interests) as of 30 June 2024 rose to EUR 10.56 million, an increase of around 150% compared to the previous year (EUR 4.14 million).

The share price of M1 Kliniken AG rose by 64% from EUR 11.20 on 31 December 2023 to EUR 18.40 on 30 June 2024.

Our second direct listed investment CR Energy AG has not yet published its half-year figures at the time of writing. CR continued on its successful path in the 2023 financial year and almost maintained the good earnings figures of the previous year.

EBIT of EUR 66.4 million was achieved in the 2023 financial year (previous year: EUR 76.3 million). CR Energy’s cash and cash equivalents increased significantly to around EUR 19.5 million as of 31 December 2023 (previous year: EUR 16.3 million) as a result of the positive development of the investments. The equity ratio remained high at 97.4%. CR Energy is increasingly involved in the areas of renewable energy supply and sustainable living, whose markets have a volume in the billions.

The CR Energy AG share price fell slightly from EUR 28.90 on 31 December 2023 to EUR 27.30 on 30 June 2024.

„We are confident about the developments in the second half of 2024 despite the ongoing conflict situations in Ukraine and the Middle East and the continued high energy costs. The M1 Group will continue to drive profitable sales growth at its domestic and foreign locations. The medium-term plan is to grow from the current 63 locations to 150-200 locations by the end of 2029. With its vertically integrated investment portfolio, CR Energy AG is very well positioned in the areas of “sustainable energy supply concepts” and “quality and cost-optimized living space”. MPH AG can also systematically benefit from the positive developments of the investments in the coming years,” says Patrick Brenske, CEO of MPH.

About MPH Health Care AG:

MPH Health Care AG is an investment company with a strategic focus on the acquisition, development and sale of companies and company shares, particularly in growth segments of the healthcare market. This includes both insurance-financed and privately financed segments. However, MPH also exploits potential outside the healthcare market in high-growth and profitable sectors.

Contact:
Patrick Brenske, Management Board
Corporate Communications
E-Mail: ir@mph-ag.de

Promotion for SCHOTT Pharma: Listed on the MDAX for the first time

• SCHOTT Pharma to join the 90 most important shares listed on the Frankfurt stock exchange as of September 23, 2024
• MDAX promotion proves confidence in the company’s business model, strategic focus and ideal market position

The shares of SCHOTT Pharma AG & Co. KGaA, a global market leader for drug containment solutions and delivery systems, will be included in the MDAX for the first time as of September 23, 2024. Andreas Reisse, CEO of SCHOTT Pharma, said: “We are delighted that less than one year after our IPO and nine months in the SDAX we are moving up to the next league. The MDAX entry is further proof of the continued confidence of our investors in our business model and our strategy. We look forward to building on this next milestone.”

As part of the 90 most important prime standard shares listed on the Frankfurt stock exchange, the MDAX index comprises the 50 largest and most liquid companies following the DAX in terms of market capitalization.

SCHOTT Pharma (WKN A3ENQ5, ISIN DE000A3ENQ51) has been listed on the Frankfurt Stock Exchange since September 2023 and part of the SDAX since December 2023. Dr. Almuth Steinkühler, CFO of SCHOTT Pharma, said: “Today is yet another special day for SCHOTT Pharma. We are excited about joining the MDAX and further strengthening our position and visibility in the capital market. The promotion to the MDAX is proof of our strong financial performance and offers SCHOTT Pharma the best conditions to further achieve its ambitious growth targets.”

The company announced its Q3 2024 results on August 29, 2024, and will publish its annual report for the fiscal year 2024 on December 12, 2024.

About SCHOTT Pharma

Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of over 4,600 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 16 manufacturing sites in Europe, North and South America, and Asia. With over 1,000 patents and technologies developed in-house and a state-of-the-art R&D center in Switzerland, the company is focused on developing innovations for the future. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the SDAX. It is part of SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment and has the strategic goal of becoming climate-neutral by 2030. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 899 million in the fiscal year 2023.

Press contact:

Lea Kaiser
Corporate Communications Manager
Tel.: +49 6131 66 2422
E-Mail: lea.kaiser@schott.com   

Tobias Erfurth
Head of Investor Relations
E-Mail: IR.Pharma@schott.com

Jasko Terzic, CFA
Senior Manager Investor Relations
E-Mail: IR.Pharma@schott.com

Simon Steiner
FGS Global
Tel.: +49 172/6411298
E-Mail: simon.steiner@fgsglobal.com

Christopher Raad
FGS Global
Tel.: +49 171/8657549
E-Mail: christopher.raad@fgsglobal.com

Bremen, September 4, 2024 – MeVis Medical Solutions AG [ISIN: DE000A0LBFE4], a leading provider of medical imaging software, is adjusting its annual forecast for the current fiscal year based on the preliminary business figures for the first eleven months.

• For fiscal year 2023/2024 (October 1, 2023 to September 30, 2024), sales are now expected to remain stable at between € 17.0 million and € 17.5 million (previous forecast for fiscal year 2023/2024: slight increase in sales from € 18.0 million to € 18.5 million).
• EBIT (earnings before interest and taxes) is now expected to fall to between € 3.0 million and € 3.5 million in fiscal year 2023/2024 (October 1, 2023 to September 30, 2024) (previous forecast for fiscal year 2023/2024: stability in the range of € 4.5 million to € 5.0 million).

The reasons for the decline in sales are an unexpected cautiousness in purchasing behavior due to global economic challenges. In addition, the result will be strongly impacted by the development of the US dollar/euro exchange rate since the beginning of the fiscal year.

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Contact:
Kirchhoff, Marcus / CEO

Secarna establishes Scientific Advisory Board with leading oncology experts
Prof. Dr. Eggermont and Prof. Dr. Zippelius

• Scientific Advisory Board (SAB) to offer expert guidance and direction for the development of lead compound SECN-15 and the Company’s oncology pipeline
• Prof. Dr. Alexander M.M. Eggermont convened SAB as of July 1, 2024 together with Prof. Dr. Alfred Zippelius, who has been an advisor to Secarna since 2016

Munich/Martinsried, September 4, 2024 – Secarna Pharmaceuticals GmbH & Co. KG (Secarna), a biopharmaceutical company redefining the discovery and development of best-in-class oligonucleotides therapeutics, announced today the formation of an oncology focused Scientific Advisory Board with the appointment of Prof. Dr. Alexander M. M. Eggermont and Prof. Dr. Alfred Zippelius.

Prof. Eggermont, M.D., Ph.D., is an internationally recognized expert in oncology and cancer drug development. He currently holds roles as Prof Clinical & Translational Immunotherapy at the University Medical Center Utrecht in the Netherlands and as Board Member of the Comprehensive Cancer Center Munich of the Technical University Munich and the Ludwig Maximilians University, Munich, Germany. He is the Coordinator of Comprehensive Cancer Center Program at Deutsche Krebshilfe. He is the past Scientific Director of the Prinses Maxima Center for Pediatric Oncology in the Netherlands and the past Director General of the Institut Gustave Roussy and emeritus Professor of Oncology (Classe Exceptionelle) at Paris-Saclay University, Paris, France. Additionally, Prof. Eggermont has served as President of ECCO and President of the EORTC, he was a member of the Board of Directors of ASCO, served on the Editorial Board of the Journal of Clinical Oncology and is currently Editor-in-Chief of the European Journal of Cancer.

Prof. Eggermont will be joined by Prof. Alfred Zippelius, M.D., Ph.D., Professor of Translational Oncology at the Department of Biomedicine, University of Basel, and Co-Head Medical Oncology at the University Hospital Basel. He has been a scientific advisor to Secarna since 2016. Both will form the foundation of a Scientific Advisory Board (SAB) with more experts to be added in the near future.

The Scientific Advisory Board will provide scientific guidance and advice working in close collaboration with the Secarna management team, as the Company advances its lead oncology program, SECN-15, and its technology platform. The aim is to develop targeted, disease-specific antisense therapeutics progressing from preclinical to clinical stage development. SECN-15 is a potential first-in-class therapeutic ASO targeting Neuropilin 1 (NRP1), a protein involved in various tumor-promoting functions. Secarna aims to advance SECN-15 to IND-enabling studies and subsequent IND submission.

“We are thrilled to have Prof. Dr. Eggermont and Prof. Dr. Zippelius, both renowned international experts in oncology, joining our SAB”, said Alexander Gebauer, M.D., Ph.D., CEO of Secarna Pharmaceuticals. “Based on the encouraging results that our lead candidate, SECN-15, has shown so far, we are excited to advance the compound through further pre-clinical development. As we aim for IND submission as the next milestone in the drug development process, their expertise will be invaluable.”

“It is my pleasure to join Secarna’s Scientific Advisory Board and support their efforts in advancing the development of SECN-15, a first-in-class drug candidate in oncology”, said Alexander Eggermont, M.D., Ph.D. “SECN-15 targets NRP1, a promising protein involved in creating a tumor-promoting microenvironment through various mechanisms.  SECN-15 has shown to induce strong knockdown of NRP1, modulating all functions simultaneously. I am very much looking forward to supporting the exciting development of SECN-15.”

“I am honoured to serve as a member of Secarna’s newly established Scientific Advisory Board after years of service as a scientific advisor. I am convinced that our collaboration will be meaningful in advancing evidence-based decision-making when focusing on the development of novel, targeted cancer therapies, such as SECN-15. Secarna’s commitment to harnessing science and technology for the greater good is commendable,” commented Prof. Dr. Alfred Zippelius, M.D., Ph.D.

“Attracting these accomplished and internationally renowned experts in the (immuno-) oncology field as inaugural members of our Scientific Advisory Board is a validation of our innovative approach to utilize our oligonucleotide technology in the field of novel therapeutic options for conditions with high unmet medical needs, despite currently approved blockbuster PD1/PD-L1 antibody therapies,” adds Alexander Gebauer.

About Secarna Pharmaceuticals GmbH & Co. KG

Secarna Pharmaceuticals a biopharmaceutical company redefining the discovery and development of best-in-class oligonucleotides therapeutics addressing high unmet medical needs in immuno-oncology and immunology, as well as viral, neurodegenerative and cardiometabolic diseases. Secarna’s mission is to maximize the performance and output of its proprietary antisense oligonucleotide discovery and development platform to generate highly specific, safe, and efficacious best-in-class antisense therapies. With over 20 discovery and development programs, including both proprietary pipeline projects and partnered programs, Secarna focuses on targets in indications where antisense-based approaches have clear potential benefits over other therapeutic modalities. www.secarna.com

Contact

Secarna Pharmaceuticals GmbH & Co. KG

Immunic Announces First Patient Enrolled in Investigator-Sponsored Phase 2 Clinical Trial of Vidofludimus Calcium in Patients with Post COVID Syndrome 

– Investigator Study Sponsored by Goethe University Frankfurt (Germany), Funded via a German Government Grant; Study Drug Vidofludimus Calcium Provided by Immunic –

– In Addition to Post COVID Readouts, Study Designed to Deliver Important Data on the Activity of Vidofludimus Calcium Suppressing Epstein-Barr Virus Reactivation and Related Fatigue Symptoms; Third-Party Research Identified Epstein-Barr Virus Reactivation as Potential Cause for Post COVID Fatigue –

– Severe Fatigue Also a Common and Debilitating Symptom for Multiple Sclerosis Patients
with No Effective Therapies Available; Potential Read-Through to Immunic’s Multiple Sclerosis Development Program – 

NEW YORK, September 4, 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 enrollment of the first patient in an investigator-sponsored phase 2 clinical trial of its lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), entitled, “Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE).”

“There remains an urgent need for the treatment of Post COVID Syndrome (PCS) and its related symptoms, including physical function and fatigue,” stated Prof. Dr. Maria J.G.T. Vehreschild, Head of the Department of Infectious Diseases at the University Hospital Frankfurt and Principal Investigator for the RAPID_REVIVE trial. “That said, vidofludimus calcium is an ideal candidate for our trial, due to its proven antiviral and anti-inflammatory effects, as well as its potential ability to prevent Epstein-Barr virus (EBV) reactivation and reduce fatigue. We look forward to further enrolling patients in this trial.”

“We are honored to have vidofludimus calcium chosen for this investigator-sponsored trial, run by such highly regarded investigators at esteemed institutions in Germany,” added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “We have seen convincing data supporting vidofludimus calcium’s antiviral effects in our preclinical and clinical studies and its ability to reduce fatigue in patients from our phase 2 CALVID-1 trial. Importantly, third-party research has identified EBV reactivation as a potential cause for fatigue, one of the most dominating symptoms for both PCS and multiple sclerosis (MS) patients, negatively impacting their quality of life and ability to participate in social activities. We aim to confirm the ability of vidofludimus calcium to influence fatigue and EBV reactivation in our ongoing MS trials and look forward to receiving additional data from the RAPID_REVIVE trial. It is our belief that this may create yet another differentiating feature for this product candidate.”

In patients with PCS, fatigue is by far the most prevalent symptom. Similarly, fatigue is frequently experienced by MS patients, often to such an extent that it interferes with quality of life. Recent third-party data in PCS patients have identified EBV reactivation as a leading risk factor and potential cause for fatigue in this patient group. Depending on the clinical study, EBV reactivation is observed in 55-95% of PCS patients. A recent study found detectable amounts of EBV DNA, a sign of lytic EBV reactivation, in throat washes of 50% of PCS patients experiencing fatigue compared to 20% of those without fatigue.

Vidofludimus calcium is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive MS, respectively. Preclinical experiments showed a dose-dependent reduction for vidofludimus calcium of lytic EBV reactivation in B cells as well as reduced lytic EBV production in Akata cells. A post-hoc analysis of Immunic’s previous phase 2 CALVID-1 trial in COVID-19 patients revealed a lower prevalence of Post COVID fatigue using a patient questionnaire. Notably, 80% of patients who received placebo reported fatigue, compared to 50% who received 45 mg vidofludimus calcium. Fatigue decreased in both treatment groups over the next 9-17 weeks to 33% for placebo and to 17% for vidofludimus calcium. Given the known suppression of EBV reactivation observed for vidofludimus calcium in in vitro experiments, lowering patient’s assessment of fatigue as observed in PCS patients may, potentially, also extend to MS patients. Signs of EBV reactivation and prevalence of patient-reported fatigue are also being investigated in the ongoing clinical trials of Immunic in relapsing and progressive MS patients.

Study Details

The phase 2 RAPID_REVIVE trial (EudraCT number: 2024-511628-16-00) is a randomized, placebo-controlled, double-blind, parallel group trial led by Prof. Dr. Vehreschild and sponsored by the Goethe University Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research (BMBF).

The trial, for which Immunic is providing study medication, plans to enroll 376 patients at 11 clinical sites in Germany. Following a 7-day screening period during the initialization phase, patients will be randomized 1:1 to receive either vidofludimus calcium (22.5 mg initiation dose for 7 days, followed by 45 mg for 49 days) or placebo. Thereafter, a response-adaptive randomization procedure will be followed. The trial will also include a 28-day follow-up period. The primary endpoint of the trial is the intra-patient change in physical function as measured by the Short Form-36 Physical Function (SF-36-PF) from baseline to day 56. Secondary endpoints include mental and physical health, intensity of fatigue and incapacitation, severity of mental disorder symptoms, and cognitive function.

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, government grants to fund clinical trials, 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

 Mainz Biomed Partners with Liquid Biosciences to Leverage the Power of Artificial Intelligence for the Expansion and Optimization of Biomarker Selection for PancAlert

PancAlert is a Next-Generation Pancreatic Cancer Detection Test in Mainz Biomed’s Research and Development Pipeline – Promising Results of First Analysis 

BERKELEY, US and MAINZ, Germany – September 4, 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 expansion of its collaboration with Liquid Biosciences to Mainz Biomed’s next-generation detection test for pancreatic cancer. The companies will leverage Liquid Biosciences proprietary AI analysis technology platform (EMERGE) to expand and optimize the selection of novel biomarkers for PancAlert.

The recently completed first phase of the collaboration included the evaluation of biomarkers from the Company’s research program co-funded by the German Federal Ministry for Education and Research, and applied a single algorithm developed by Liquid Biosciences using its EMERGE platform. The results of this feasibility analysis were promising, leading the Company and Liquid Biosciences to believe that a PancAlert diagnostic test could, in the future, be combined with Mainz Biomed’s colorectal cancer screening product. The Company and Liquid Biosciences plan to continue with the second phase of the collaboration, for which the evaluation of biomarkers will be expanded to include the microbiome biomarkers that were analyzed in collaboration with Microba Life Sciences in 2023, as well as an extension of the AI algorithm. The companies plan to complete this analysis in the fourth quarter of 2024.

“We are excited about the collaboration with Liquid Biosciences on PancAlert, which is being developed for early-stage disease detection. A first-in-class screening test for pancreatic cancer would be a major achievement in the fight of this devastating disease,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Liquid Biosciences is already a key partner for our next generation colorectal cancer screening test. Expanding our partnership will allow us to leverage the power of AI also for the detection of this deadly form of cancer.”

Pancreatic cancer is a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. Each year, about 466,000 lives are taken globally, and it’s the seventh leading cause of cancer-related death worldwide.¹ It has one of the lowest survival rates of any cancer, with typically late detection and poor outcomes with standard of care treatment(s). The 5-year overall survival rate is approximately 11% in the U.S.² and 9% globally.³ However, if diagnosis occurs in the early stages of the disease, the survival rate is significantly higher.

References

1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338. The online GLOBOCAN 2020 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.
2. National Cancer Institute, Surveillance, Epidemiology and End Results Program (SEER). Cancer Stat Facts: Pancreatic Cancer. July 2021. https://seer.cancer.gov/statfacts/html/pancreas.html
3. Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019;10(1):10-27. doi:10.14740/wjon1166 

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

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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.

About Liquid Biosciences

Liquid Biosciences is the leader in quantitative AI for diagnostics and biopharma.  We radically reduce diagnostic and drug development risk, time, and cost. Our Emerge quantitative AI platform agnostically discovers and models the nonlinear dynamics of biology, behavior, and circumstances that drive patient outcomes. Emerge has produced superior accuracy, novel insights, and explainability in every head-to-head comparison with other AI methods. Liquid Biosciences has completed over 250 major analytic programs across 50 diseases, for major biopharma firms, diagnostic companies, and world-class research institutions. For more information about Liquid Biosciences, visit www.liquidbiosciences.com.

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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.