Dermapharm Holding SE posts strong results for Q3 2024,
Arkopharma (France) back above prior-year EBITDA levels for first time

• Consolidated revenue up 2.7% to EUR 890.1 million. Growth in high-margin “Branded pharmaceuticals” more than offsets declining revenue in “Other healthcare products” segment.
• Above-average increase in (unadjusted) consolidated EBITDA by 12.3% to EUR 234.1 million, unadjusted EBITDA margin improves by 2.3 percentage points to 26.3%. Adjusted EBITDA of EUR 240.3 million results in adjusted EBITDA margin of 27.0%.
• Taken in isolation, Q3 2024 revenue up 9.5% on prior-year quarter; unadjusted consolidated EBITDA up 22.0% and adjusted consolidated EBITDA up 15.2%. Trend fuelled by branded pharmaceuticals segment in general and improvement at Arkopharma.
• Board of Management confirms outlook for 2024 overall, continues to expect consolidated revenue of EUR 1,170–1,210 million and adjusted EBITDA of EUR 305–315 million.

Grünwald, 14 November 2024 – Dermapharm Holding SE (“Dermapharm”), a rapidly growing manufacturer of branded pharmaceuticals and other healthcare products, today publishes its results for the first nine months of 2024.

Dermapharm Holding SE performed in line with expectations in the first nine months of 2024. Consolidated revenue increased by 2.7% to EUR 890.1 million as compared to the prior-year period (prior-year period: EUR 866.6 million). This was due to the strong organic growth in the existing portfolio, which more than offset the decline in revenue at Arkopharma and the projected decrease in revenue from the vaccine business. In addition, the rise in revenue was also bolstered by the revenue from Montavit, which was consolidated from July 2023.

Adjusted for non-recurring effects, EBITDA amounted to EUR 240.3 million, on par with the figure for the prior-year period (EUR 243.8 million); the adjusted EBITDA margin fell by 1.1 percentage point to 27.0%. Wage increases and the inflation-related rise in other operating expenses were thus partially offset by an increase in the gross margin. Adjusted to account for the loss of revenue from vaccines, sustainable EBITDA for the first 9 months of 2024 rose by a considerable 12.4%, with the corresponding EBITDA margin up year on year by 1.4 percentage points. Unadjusted EBITDA increased substantially by 12.3% to EUR 234.1 million (prior-year period: EUR 208.4 million). There were markedly fewer items to adjust for in the first nine months of 2024 than in the same period of the previous year (EUR 6.2 million compared to EUR 35.5 million).

“We are immensely satisfied with the Company’s performance in the first nine months of 2024. We were able to offer further evidence of our M&A expertise by successfully acquiring and integrating Montavit in the wake of its insolvency. I am particularly pleased to report that our internationalisation efforts are gaining pace. We are therefore highly optimistic for the final quarter and confident that we will meet our forecasted targets for 2024”, said Dr Hans-Georg Feldmeier, Chairman of the Board of Management of Dermapharm Holding SE.

Branded pharmaceuticals

In the “Branded pharmaceuticals” segment, organic growth in the Group’s core business in Germany and at its international subsidiaries translated to a 9.1% rise in revenue from EUR 395.7 million in the previous year to EUR 431.6 million. Additionally, after having been consolidated for three months in the previous year, starting from July 2023, Montavit made a positive contribution to revenue growth. The projected decline in revenue from the vaccine business, which had last peaked in Q1 2023, was therefore more than offset by the Group’s strong existing business.

Adjusted EBITDA amounted to EUR 197.3 million, representing 45.7% of revenue (prior-year period: EUR 183.8 million, or 46.4%). Unadjusted EBITDA rose by 18.7% to EUR 192.3 million (prior-year period: EUR 162.0 million), resulting in an EBITDA margin of 44.6% (prior-year period: 40.9%).

Other healthcare products

In the “Other healthcare products” segment, Dermapharm generated EUR 271.7 million in revenue in the first nine months of 2024 (prior-year period: EUR 287.9 million). This decline in revenue was attributable primarily to the French company, Arkopharma. The first half of 2023 had seen unusually high sales in the French pharmacies market in the wake of a price hike at the beginning of the year as well as major product launches. Although sales to end customers via pharmacies remained at a high level, pharmacies had been reducing their sizeable inventories since the end of 2023, resulting in lower demand in the first few months of 2024. This trend was amplified by increasingly fierce competition and the associated pressure on prices and volumes. In the third quarter of 2024, Arkopharma increased its revenue to the previous year’s level for the first time, with EBITDA even exceeding the previous year’s figure.

Adjusted EBITDA for the segment amounted to EUR 45.8 million (prior-year period: EUR 63.3 million). This translates to an adjusted EBITDA margin of 16.9% (prior-year period: 22.0%). The decline is due to the effects described above, which resulted in a lower gross margin. However, cost-cutting measures at the beginning of the year made it possible to partially offset this development. Unadjusted EBITDA amounted to EUR 44.6 million (prior-year period: 49.6 million), and the EBITDA margin amounted to 16.4% (prior-year period: 17.2%).

Parallel import business

Revenue in the “Parallel import business” segment rose by 2.2% to EUR 186.9 million (prior-year period: EUR 182.9 million). This increase was attributable primarily to the high availability of products, attractive procurement prices and growing market volume. From an operational standpoint, the decision to increase stockpiles helped to improve product availability to an appropriate level. In addition, efficiency enhancements in production and successful product launches were realised. However, the increase in sales allowances resulting from higher health insurance discounts related to the portfolio eroded these positive effects, with EBITDA remaining at the same level as in the previous year (EUR 1.1 million in the current and prior-year period). Just as in the previous year, the EBITDA margin for the segment was also 0.6% for the first nine months.

Board of Management confirms outlook for 2024 overall

In light of the Company’s projected performance in the first nine months of financial year 2024 and the recently reinforced positive trend at Arkopharma, the Board of Management confirms that both consolidated revenue and adjusted EBITDA will be in line with the published forecast range of between EUR 1,170–1,210 million and EUR 305–315 million, respectively.

The full interim statement for Q3 2024 is available from today at https://ir.dermapharm.de/en.
 

IFRS figures for 9M 2024 and the prior-year period 

(excluding segment reconciliation/Group holding company)¹

*9M 2024 EBITDA was adjusted for non-recurring items amounting to EUR 6.2 million.
  9M 2023 EBITDA was adjusted for non-recurring items amounting to EUR 35.5 million.

Company profile

Dermapharm – Pharmaceutical Excellence “Made in Europe”

Dermapharm is an innovative and rapidly growing manufacturer of branded pharmaceuticals and other healthcare products. Founded in 1991, the Company is based in Grünwald near Munich. In addition to its main location in Brehna near Leipzig, Dermapharm also operates other production, development and distribution locations in Germany, the rest of Europe and the United States.

In the “Branded pharmaceuticals” segment, Dermapharm has more than 1,300 marketing authorisations with more than 390 active pharmaceutical ingredients. Dermapharm’s portfolio of pharmaceuticals is tailored to selected therapeutic areas in which the Company is a market leader, especially in Germany. The Company’s integrated business model extends from in-house product development and production through quality management and logistics to the distribution of branded pharmaceuticals by a trained pharmaceutical sales force.

Dermapharm bundles food supplements, herbal pharmaceuticals, cosmetics, medical devices, herbal extracts and medicinal cannabis in its “Other healthcare products” segment. In this segment, Dermapharm can tap the expertise of Arkopharma, the market leader for herbal food supplements in France, and the Spanish company Euromed S.A., a leading global manufacturer of herbal extracts and plant-based active ingredients for the pharmaceuticals, nutraceuticals, foodstuffs and cosmetics industries.

Dermapharm also operates the “Parallel import business” segment under the axicorp brand. axicorp imports originator pharmaceuticals from other EU Member States and resells them to pharmaceuticals wholesalers and pharmacies in Germany. This enables axicorp to benefit from the different pricing structures in the individual EU member states. Based on revenue, axicorp is currently the sixth largest parallel importer in Germany.

With a consistent R&D strategy and numerous successful product and company acquisitions and by stepping up its internationalisation efforts, the Group is continuously optimising its business activities and seeks external growth opportunities in addition to organic growth.

Contact

Investor Relations & Corporate Communications
Britta Hamberger
Tel.: +49 (0)89 – 64186-233
E-mail: ir@dermapharm.com

[1] Due to rounding differences, the figures presented for the segments may not entirely match the reported totals.

PharmaSGP with strong revenues growth in 9M 2024 – revenues forecast for FY 2024 raised 

Gräfelfing, November 14, 2024 – In the third quarter of 2024, the German OTC pharmaceutical company PharmaSGP Holding SE was able to continue the dynamic business development of the first half of the year, generating revenues of €88.6 million in the first nine months of 2024 based on preliminary, unaudited figures. This represents an increase of 17.0% over the same period of the previous year (€75.7 million). The high-performance level of the already strong quarters of the first half of the year was confirmed in Q3 2024 with revenues of €30.2 million. With an increase of 9.4% compared to the previous year, adjusted earnings before interest, taxes, depreciation and amortization (adjusted EBITDA) amounted to €27.0 million in the first nine months of 2024. Consequently, the adjusted EBITDA margin reached 30.5%.

CEO Natalie Weigand comments: “I am very pleased that we were able to build on the positive business development of the first half of the year in the third quarter despite a still difficult macroeconomic and geopolitical environment. This impressive growth trajectory underlines the effectiveness of our platform and the measures we have taken as part of our marketing strategy. Thanks to these measures, we have been able to launch new products on the market very successfully so far this year.”

CFO Michael Rudolf adds: “Both in terms of revenues and earnings, PharmaSGP has performed very well in the first nine months of the year. In particular, revenues growth has been dynamic, prompting us to raise our revenues guidance for the full year. Based on our strong structural and financial base, we are also very positive beyond the 2024 financial year and expect the company’s successful development to continue.”

In light of the positive business development in the first nine months of the year, the Management Board of PharmaSGP has raised its revenues forecast and now expects revenues for fiscal year 2024 to be in the range of €112.0 million to €117.0 million (previous forecast: €107.0 million to €112.0 million). With regard to adjusted EBITDA, the Management Board continues to expect a figure between €35.0 million and €38.0 million. This corresponds to an adjusted EBITDA margin of 31.3% to 32.5%.

PharmaSGP will publish its full nine-months report 2024 on November 28, 2024.

OVERVIEW OF PRELIMINARY YEAR-ON-YEAR FIGURES

CONTACT

cometis AG
Jakob Hafer
Phone: +49-611-20585522
Email: ir@pharmasgp.com

ABOUT PHARMASGP HOLDING SE

PharmaSGP is a leading consumer health company with a diversified portfolio of over-the-counter (OTC) pharmaceuticals and other healthcare products that are marketed with a focus on the pharmacy distribution channel. These products are mostly based on natural active pharmaceutical ingredients with documented efficacy and few known side effects. 

The Company’s core brands cover chronic indications, including rheumatic pain, nerve pain and other age-related ailments. In Germany, PharmaSGP is the market leader for systemic chemical-free pain remedies with its brand families RubaXX® for rheumatic pain and Restaxil® for neuralgic pain. Furthermore, PharmaSGP also offers leading products against sexual weakness and vertigo symptoms. Since introducing the first product from the current product portfolio in 2012, PharmaSGP has successfully established its business model in other European countries, including Austria, Italy, Belgium, Spain and France. In September 2021, the product portfolio was expanded by the brands Baldriparan®, Formigran®, Spalt® and Kamol®, thus also strengthening or developing the indications pain and sleep disorder. The sales territory was expanded to include Switzerland and Eastern Europe. In 2023, PharmaSGP generated revenues of €101.1 million at an adjusted EBITDA margin of 33.7%. 

In order to further expand its competitive position, PharmaSGP plans to increase the number of indications covered by PharmaSGP’s product offering, increase PharmaSGP’s European footprint, and accelerate its growth strategy especially by capitalizing on selected M&A opportunities. 

Berlin, November 14, 2024. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) increased its sales by 17% year-on-year to € 215.5 million in the first nine months of 2024. Recurring EBIT from continuing operations (adjusted EBIT) rose by 24% to € 46.7 million. Net income (from continuing and discontinued operations) grew by 15% and reached € 23.4 million or € 1.12 per share.

The Medical segment recorded sales of € 104.5 million in the first nine months of the year, around € 21.7 million or 26% higher than in the previous year. The main growth driver remains the pharmaceutical radioisotope business, while all other main product groups also increased compared to the previous year.

The Isotope Products segment generated sales of € 111.0 million, an increase of € 10.0 million or 10% compared to the first nine months of 2023. In comparison to the same period of the previous year, seasonal effects and shifts between product groups continued to move towards higher-margin products.

For the 2024 financial year, the Executive Board continues to expect revenues of around € 265 million and an EBIT (earnings before interest and taxes) before special items from continuing operations of around € 55 million.

The complete quarterly report can be viewed here: https://www.ezag.com/q32024en/

About Eckert & Ziegler.
Eckert & Ziegler SE with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

Your contact:
Eckert & Ziegler SE, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, karolin.riehle@ezag.de, www.ezag.com 

Abivax Announces Former Prometheus COO, Mark Stenhouse, Appointed as Board Observer & Advisor to Abivax

PARIS, France, November 13, 2024, 10:00 pm CET – Abivax SA (Euronext Paris and Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced the appointment of Mark Stenhouse as Board Observer and Advisor to Abivax.

Mr. Stenhouse brings more than 30 years of experience in the biopharma industry. Most recently, he served as Chief Operating Officer of Prometheus Biosciences, a biotechnology company focused on gastrointestinal diseases that was acquired by Merck for $10.8 billion in 2023. Prior to Prometheus, Mr. Stenhouse spent over 25 years at AbbVie, most recently serving as Vice President of U.S. Immunology. In this capacity, Mr. Stenhouse oversaw U.S. sales and marketing teams for HUMIRA®.

In addition to his positions at Prometheus and Abbvie, Mr. Stenhouse held an executive leadership role at Exact Sciences. He holds a Bachelor of Science in Business Administration from the College of Charleston.

Marc de Garidel, Chief Executive Officer of Abivax, said: “We are pleased to welcome Mark to the role of Board Observer and Advisor to Abivax. We expect his perspective and extensive experience in gastroenterology and immunology to undoubtedly support our continued progress as we head toward commercialization of obefazimod and strengthen our pipeline.” 

Mark Stenhouse, Board Observer & Advisor to Abivax, said: “I am impressed with the clinical profile of obefazimod and its potential to address unmet needs in the patient community. I look forward to working alongside the Abivax management team and Board of Directors as the company continues to advance toward key milestones.”

About Obefazimod

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

About Abivax

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

Contact:

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

DISCLAIMER

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

“Abivax” and the Abivax logo and other trademarks or service marks of Abivax SA in this press release are the property of Abivax SA. All other trademarks, trade names and service marks appearing in this press release are the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.

 Immunic Announces Publication of Data From Phase 1/1b  
Clinical Trial of IMU-856 in the Peer Reviewed Journal,  
The Lancet Gastroenterology & Hepatology

 – Includes Phase 1 Data in Healthy Human Subjects and
Phase 1b Data in Celiac Disease Patients –

NEW YORK, November 13, 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 that the data from its phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), has been published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology. Lead authored by Dr. A. James Daveson, Gastroenterologist, Wesley Research Institute and Coral Sea Clinical Research Institute, Queensland, Australia, the paper is entitled, “Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial.” It can be accessed through the following link: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(24)00248-6/fulltext.

Dr. Daveson stated, “Celiac disease affects approximately 1.4% of the world’s population. The only current treatment option is a strict, lifelong gluten-free diet, which poses significant challenges due to dietary and social restrictions and the risk of cross-contamination, which leads to persistent intestinal inflammation with villous atrophy in many patients. IMU-856’s potential ability to improve the integrity and function of the intestinal barrier represents a promising, novel approach to treat this condition. Importantly, this phase 1b clinical trial is the first study to show that IMU-856 can mitigate the gluten-related effects in celiac disease patients. Based on this result, in conjunction with the drug’s favorable safety and tolerability profile, we have concluded that it warrants further clinical investigation.”

“The publication of our phase 1/1b clinical data in healthy human subjects and patients with celiac disease, in such a prestigious peer reviewed journal, confirms that IMU-856’s novel mechanism modulating SIRT6, a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, can represent an entirely new approach to treating gastrointestinal diseases,” added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “In our phase 1b clinical trial, IMU-856 showed the first clinical signals of its potential ability to restore a healthy gut by renewal of the gut wall, demonstrating meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. Together with a favorable safety and tolerability profile, it may set the stage for a potential first-in-class, oral celiac disease therapy. Additionally, we believe that this data provides initial clinical proof-of-concept for a potentially new, oral therapeutic approach to a range of gastrointestinal diseases with high unmet needs, beyond celiac disease.”

The first two portions of the phase 1 clinical trial, Parts A and B, were single ascending dose and multiple ascending dose, double-blind, placebo-controlled studies in a total of 71 healthy human subjects. Single and multiple ascending doses of IMU-856 were found to be safe and well-tolerated, with no investigational medicinal product (IMP)-related serious or severe treatment-emergent adverse events. No maximum tolerated dose was reached in either part.

Part C was structured as a double-blind, randomized, placebo-controlled trial, designed to assess the safety and tolerability of IMU-856 in patients with celiac disease during periods of gluten-free diet and a 15-day gluten challenge with 6 g of gluten given daily. Further objectives included pharmacokinetics and initial clinical activity assessments, including malabsorption parameters, biomarkers for enterocyte functional mass, such as citrulline, disease-related symptoms as well as histological changes. The trial was conducted at sites in Australia and New Zealand. A total of 43 patients were enrolled in two consecutive cohorts with 80 mg or 160 mg of IMU-856 or placebo given once-daily over 28 days. The data demonstrated positive effects for IMU-856 over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients’ symptoms, biomarker response, and enhancement of nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. There were no IMP-related serious or severe treatment-emergent adverse events, nor was there any dose-dependency in adverse events. Moreover, the rates of treatment-emergent adverse events in non-disease-related parameters were comparable between the active treatment groups and placebo.

About IMU-856

IMU-856 is an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Based on preclinical data, the compound may represent a unique treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal diseases such as celiac disease, inflammatory bowel disease and other intestinal barrier function associated diseases. Based on preclinical investigations demonstrating no suppression of immune cells, IMU-856 may have the potential to maintain immune surveillance for patients during therapy, which would be an important advantage versus immunosuppressive medications. IMU-856 demonstrated positive results in a phase 1b clinical trial in celiac disease patients in four key dimensions of the disease’s pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. Currently, the company is preparing for phase 2 clinical testing. IMU-856 is an investigational drug product that has not been approved in any jurisdiction.

 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 IMU-856 to safely and effectively target diseases; preclinical and clinical data for IMU-856; 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, including the ability to satisfy the minimum average price and trading volume conditions required to receive funding in tranche 2 and 3 of the January 2024 private placement, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

Contact Information

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

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

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

Berlin, 13 November 2024. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) today signed a collaboration and licence agreement with the Australian-headquartered Telix Pharmaceuticals Limited (Telix) for the use of EZAG’s cyclotron-based technology to produce Ac-225. The contract entitles Eckert & Ziegler to milestone payments from Telix totaling up to € 20 million within approximately two years, as well as access to a higher availability of Ac-225.

For Eckert & Ziegler the licence and collaboration agreement is an important step towards establishing the company as a major supplier of Ac-225 for the radiopharmaceutical industry. Eckert & Ziegler is already supplying Ac-225 and will be able to provide the market with significantly increased quantities of Ac-225 in GMP quality from 2025.

Currently, Ac-225-based radiopharmaceuticals are under clinical investigation for various cancers, including prostate tumors, colorectal cancer, and leukemia. A substantial increase in the demand for Ac-225 is projected over the next decade, driven by its expanding clinical applications and the promising results seen in ongoing trials. Despite its therapeutic promise, sufficient quantities of Ac-225 remain scarce.

Contact:
Eckert & Ziegler SE, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, karolin.riehle@ezag.de, www.ezag.com 

• Loss of Pentixapharm Holding AG for the reporting period: €49k
• No revenue realized during the stub fiscal year through the end of Q3
• Current liabilities of €487k, mainly from the purchase of Pentixapharm AG shares

Berlin and Würzburg, Germany, November 12, 2024 – Pentixapharm Holding AG (ISIN: DE000A40AEG0), listed in the Prime Standard of the Frankfurt Stock Exchange, today published its consolidated interim report for the stub fiscal year from March 18 to September 30, 2024. Since the spin-off from Eckert & Ziegler SE, through which Pentixapharm AG and Myelo Therapeutics GmbH will be integrated into the group financial statements, was entered into the commercial register on October 2, 2024, this consolidated report includes only the figures for Pentixapharm Holding AG and does not yet contain results for either company.

During the reporting period, Pentixapharm Holding AG reported a loss of €49k, attributed to other operating expenses, primarily fees and charges related to the company’s establishment, acquisition of financial assets, and the spin-off. The interim report also shows no revenue, as operational business activities will commence only after the formal spin-off of Pentixapharm AG and Myelo Therapeutics GmbH.

For the 2024 consolidated annual financial statements, management anticipates a significant increase in losses in the fourth quarter due to the inclusion of Pentixapharm AG and Myelo Therapeutics GmbH from October 2, 2024, with an expected total loss of approximately –€8 million for the fiscal year.

The full interim report is available on the Pentixapharm Holding AG Investor Relations website: www.pentixapharm.com/investors/reports.

About Pentixapharm

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

For more information, please contact:

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

Mainz Biomed and Thermo Fisher Scientific Sign a Collaboration Agreement for the Development of Next Generation Colorectal Cancer Screening Product for Global Markets

BERKELEY, US and MAINZ, Germany – November 12, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced a collaborative agreement with Thermo Fisher Scientific Inc. (NYSE: TMO), through its subsidiary Life Technologies Corporation (“Thermo Fisher”), a world leader in supplying life sciences solutions and services.

The collaboration agreement will enable Mainz Biomed and Thermo Fisher to jointly develop and potentially commercialize Mainz Biomed’s Next Generation colorectal cancer screening product. The collaboration will harness Thermo Fisher’s powerful technologies, instrumentation and information translation systems to enable Mainz Biomed to develop the proprietary assays for its mRNA-based next-generation CRC screening tests which are redefining standards in early cancer detection. Mainz Biomed’s flagship non-invasive test not only targets the early detection of colorectal cancer but also focuses on precancerous lesions, particularly advanced adenomas, demonstrating significant clinical success in both US and European trials.

The collaboration will leverage combined capabilities to deliver testing solutions being developed at Mainz Biomed’s laboratories in Mainz, Germany.

Guido Baechler, CEO of Mainz Biomed, said: “This collaboration with Thermo Fisher will be instrumental to our goal to bring to market a home collection colorectal screening tool with highly effective detection of adenomas. Our product development will be greatly enhanced by Thermo Fisher’s knowledge and scalable, class-leading technologies, providing both partners with a means to accelerate the availability of an innovative new test for colorectal cancer screening around the world.”

Peter Jacobs, Director, EMEA Clinical Business Development, Thermo Fisher Scientific, said: “We are excited at the prospect of working with Mainz Biomed on their next generation screening test and are confident that together we will be able to achieve rapid progress and deliver innovative new assays for the global clinical marketplace.”

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

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About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

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. 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.

CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2024
and Provides Business Update
 

Strengthened Cash, Strategic Refocus and Pipeline Progress Define Transformative Quarter

• €400 million upfront payment from restructured GSK collaboration reflected in financials, cash position increased to €551 million; expected cash runway re-affirmed into 2028
   
• CVGBM Phase 1 glioblastoma study showed 77% of patients with antigen-specific T-cell responses; data presented at ESMO, SITC and SNO
   
• New off-the-shelf program for squamous non-small cell lung cancer started, expected to enter Phase 1 in H2 2025
   
• New preclinical prophylactic vaccine program for urinary tract infections initiated, supported by positive preclinical data versus protein-based vaccines
   
• Positive Phase 2 data from seasonal influenza program licensed to GSK demonstrated strong immune responses against challenging influenza B as well as A strains; program progressing to Phase 3, which will be associated with significant milestone payment
   
• Corporate redesign on track with 30% workforce reduction, expected to yield significant annual cost savings from 2025 onwards and increase operational agility
   
• Appointment of seasoned industry executive Axel Malkomes as new CFO effective November 11, enhancing financial leadership and strategic execution
   
• CureVac to host conference call and webcast today at 9 a.m. EST / 3 p.m. CET; details below and under https://www.curevac.com/en/newsroom/events/
   

TÜBINGEN, Germany/BOSTON, USA – November 12, 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 financial results for the third quarter and first nine months of 2024 and provided a business update.

Commenting on the quarter Dr. Alexander Zehnder, Chief Executive Officer of CureVac said:

“The third quarter was truly transformative for CureVac. By restructuring our collaboration with GSK, we have embarked on a new chapter of growth and innovation, unveiling new programs that leverage our advanced mRNA technology to tackle critical health challenges. The strategic decisions we’ve made, combined with encouraging initial clinical results, have laid a solid foundation for our future success. We are now strategically aligned, more operationally efficient, and financially empowered to create shareholder value by advancing our portfolio of novel mRNA-based medicines.”

Selected Business Updates

Strategic Redesign

CureVac made meaningful progress in restructuring its operations during the third quarter by implementing significant cost-cutting measures. These include the previously announced 30% workforce reduction, which is on track to be completed by the end of 2024. The goal of the restructuring is to reorganize the company for flexibility in executing immediate priorities while maintaining a strong innovation focus and ensuring long-term value creation. Right-sizing CureVac for future growth allows for continued focused development of a prioritized portfolio, including high-value mRNA projects in oncology, infectious diseases and other areas.

“With funding secured into 2028, and our operational expenses increasingly streamlined by our ongoing redesign, we are in a strong position to expand our R&D efforts across several promising areas,” said Dr. Zehnder. “We will be launching new development programs in the coming quarters and will continue to execute our business and pipeline strategy well into the future.”

Strengthening the Leadership Team

As of November 11, 2024, CureVac welcomed a new Chief Financial Officer, Axel Sven Malkomes. Mr. Malkomes brings over three decades of senior corporate and investment banking experience within the biotech and pharmaceutical industries. Most recently, he served as CFO at Cardior Pharmaceuticals, a private clinical-stage company developing non-coding RNA-based therapeutics for heart disease. During his tenure, he played a crucial role in strategically and financially preparing the company for capital markets, co-leading financing rounds, and supporting potential M&A and partnering transactions, culminating in the successful acquisition of Cardior by Novo Nordisk in 2024.

Before Cardior, Mr. Malkomes was CFO and Chief Business Officer at Medigene AG, a publicly listed cell therapy company. His extensive experience also includes senior healthcare investment banking roles at Barclays and Société Générale, as well as co-heading European healthcare investments at 3i Group plc, a UK-listed private equity firm with over $20 billion in assets under management. Earlier in his career, he held senior leadership positions at Merck KGaA.

Oncology

Expanding oncology development pipeline

CureVac sees significant opportunities to apply precision immunotherapy using mRNA vaccines in large patient populations. The company aims to create earlier treatment options for multiple solid tumor types and is strengthening its clinical development pipeline following two complementary approaches: off-the-shelf cancer vaccines targeting tumor antigens shared across different patient populations and/or tumor types and fully personalized cancer vaccines based on a patient’s individual tumor genomic profile.

CureVac is extending its off-the-shelf cancer vaccine pipeline and has selected an additional clinical candidate for a shared-antigen cancer vaccine targeting squamous non-small cell lung cancer (sqNSCLC). Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions are being prepared for filing in the first half of 2025. Additional discovery work aims to deliver further off-the-shelf cancer vaccines and selection of a second clinical candidate is anticipated in 2026.

In parallel, the program for fully personalized cancer vaccines is progressing and on track with the planned start of a Phase 1 study expected in the second half of 2026.

Clinical off-the-shelf program in glioblastoma

CureVac presented the first clinical data from the Phase 1 study of CVGBM, its off-the-shelf mRNA cancer vaccine candidate, in patients with resected glioblastoma in September 2024 at the European Society for Medical Oncology (ESMO) Congress and in November at the Society for Immunotherapy of Cancer (SITC) and the Society for Neuro-Oncology (SNO) Congresses. Preliminary immunogenicity results in this highly aggressive and challenging cancer indication demonstrate the potential of CureVac’s proprietary second-generation mRNA backbone to enhance the immune system’s capacity for a coordinated defense against the disease.

“As our lead oncology program, CVGBM has demonstrated encouraging initial clinical results in patients with resected glioblastoma,” said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. “Data presented recently at the ESMO, SITC and SNO congresses showed that 77% of evaluable patients exhibited sustained immune response induction over a 99-day monitoring period. Importantly, we believe these data are very promising because the response was led by de novo T-cell generation, which likely plays a crucial role in the success of a cancer vaccine.”

In the fully enrolled dose-escalation Part A, CVGBM monotherapy induced cancer antigen-specific T-cell responses in 77% of 13 evaluable patients. Notably, 84% of these immune responses were generated de novo, inducing T-cell activity in patients without prior immunity to the encoded antigens. Among responding patients, 69% showed CD8⁺ responses, 31% had CD4⁺ responses, and 23% had both. 67% of responding patients showed immune responses against multiple antigens. At the recommended 100 µg dose for the expansion part of the study, responses were sustainable over a 99-day monitoring period. Induction of cellular responses was accompanied by systemic cytokine and chemokine activation, indicating innate immune response activation.

The treatment was well tolerated, with no dose-limiting toxicities up to the highest dose of 100 µg. 91% of treatment-related adverse events (TRAEs) were mild to moderate systemic reactions characteristic of mRNA-based therapeutics, resolving within 1-2 days post-injection. Seven patients reported nine severe TRAEs, including four serious adverse events; no grade 4 or 5 adverse events occurred.

The dose-expansion Part B of the study is ongoing at the recommended 100 µg dose. Initial data and a decision on advancing the program to Phase 2 are expected in the second half of 2025.

More information can be found at clinicaltrials.gov (NCT05938387).

Prophylactic Vaccines

Initiation of Urinary Tract Infections Program

CureVac has initiated a new program to address urinary tract infections (UTIs), which are among the most common bacterial infections. UTIs are most commonly caused by uropathogenic Escherichia coli (UPEC) bacteria, which can enter the urinary tract, invade and colonize bladder and kidney tissues. These infections can lead to complications such as kidney damage and urosepsis. UTIs lead to approximately 8-10 million doctor office visits and 1-3 million emergency department visits per year in the U.S. alone.

“Urinary tract infections are extremely common, affecting millions of people each year—often repeatedly—and are increasingly prone to antibiotic resistance,” said Dr. Mendila. “Our encouraging preclinical data show that our investigational vaccine candidates targeting uropathogenic Escherichia coli elicit strong antibody titers and robust T-cell responses, comparing very favorably to recombinant protein-based vaccines. Based on these promising results, we believe there is a significant commercial opportunity for an mRNA solution that offers meaningful benefits to individuals suffering from these infections.”

mRNA technology is ideally suited for developing prophylactic vaccines against bacterial targets like UPEC due to its ability to target specific disease antigens and flexibly combine multiple antigens.

CureVac has conducted preclinical studies with several UPEC vaccine candidates and selected a lead candidate for further preclinical testing. The promising data, which compares favorably to recombinant protein-based vaccines, is being presented at the 12th International mRNA Health Conference in Boston from November 11-14, 2024.

The studies assessed two mRNA vaccine candidates encoding FimH, an antigen facilitating UPEC adhesion to bladder epithelial cells, in mouse and rat models. Both candidates induced high levels of binding antibodies in serum and urine, correlating with high serum functional antibodies, and showed strong induction of antigen-specific CD8⁺ and CD4⁺ T-cells. Additionally, both vaccine candidates demonstrated superior immunogenicity compared to protein-based comparator vaccines.

Based on these encouraging preclinical results, CureVac expects to select a clinical candidate in the first half of 2025. An IND application filing is planned in the second half of 2025, aiming to initiate a Phase 1 study in the first half of 2026.

Seasonal Influenza Phase 2 Data – Program Licensed to GSK

In September 2024, GSK announced positive Phase 2 headline data from its seasonal influenza mRNA vaccine program based on CureVac’s second-generation mRNA backbone. According to GSK, the data demonstrated positive immune responses against both influenza A strains as well as historically challenging influenza B strains compared to the current standard of care.

“For many years, developing vaccines that elicit strong immune responses against influenza B strains has been a significant challenge,” said Dr. Mendila. “The recent data from our GSK-licensed seasonal influenza mRNA vaccine program are remarkable because they show we are overcoming one of the greatest hurdles in bringing this type of vaccine to market. This is a significant milestone in seasonal flu vaccine development.”

The interim data met all predefined success criteria in the tested age groups of older and younger adults and suggested an acceptable safety and reactogenicity profile. GSK confirmed that the program is progressing to Phase 3 in 2025, which will be associated with a significant milestone payment for CureVac.

More information can be found at clinicaltrials.gov (NCT06431607).

As previously announced in July 2024, CureVac and GSK restructured their collaboration into a new licensing agreement. Under the new agreement, GSK has assumed full control of the development, manufacturing and global commercialization of mRNA vaccine candidates against influenza and COVID-19, including combinations. All vaccine candidates currently in clinical development are based on CureVac’s proprietary second-generation mRNA backbone.

Financial Update for the Third Quarter and First Nine Months of 2024

Commenting on the financial results, Axel Sven Malkomes, CureVac’s new Chief Financial Officer, said:

“Joining CureVac at this pivotal time is incredibly exciting. Our strengthened cash position, supported by our strategic redesign—including a significant reduction in headcount—provides a solid foundation to execute our strategic objectives. By extending our cash runway into 2028, we can allocate more resources toward our promising R&D pipeline in oncology and infectious diseases. I am committed to ensuring that we maintain financial discipline as we drive forward our mission to develop transformative mRNA medicines and create long-term value for our shareholders.”

Cash Position

Cash and cash equivalents amounted to €550.9 million at the end of September 2024, increasing from €402.5 million at the end of 2023. The company received the €400 million upfront payment from the new GSK licensing agreement in August 2024. In the first nine months of 2024, cash used in operations was mainly allocated to payments related to the termination of raw material commitments for the first-generation COVID-19 vaccine, CVnCoV, amounting to a total of €52 million and the payment of contract manufacturing organization (CMO)-related arbitration awards. All CMO-related arbitrations are closed, with the last payment made in the third quarter of 2024. Looking forward, there will be no further payments related to CVnCoV.

The remaining cash spend was mainly related to ongoing R&D activities. The company reaffirms its expected cash runway into 2028.

Revenues

Revenues amounted to €493.9 million and €520.7 million for the three and nine months ended September 30, 2024, respectively, representing an increase of €477.4 million and €489.5 million, or 2,897% and 1,569%, from €16.5 million and €31.2 million for the same periods in 2023.

The increase year-on-year was primarily driven by the new license agreement with GSK, which was closed in July 2024. CureVac received a non-refundable upfront payment of €400 million. Under the new license agreement, CureVac has no obligation to perform R&D work in connection with the newly granted licenses and GSK is provided with the right to use CureVac’s intellectual property. As such, the upfront payment was fully recognized in the third quarter of 2024 as revenue.

Under previous GSK agreements, upfront and milestone payments were related to R&D activities performed by CureVac over a period of time. Accordingly, related payments were recognized as contract liabilities and recognized as revenue on a pro rata basis over the period R&D activities were performed.

CureVac and GSK agreed in the new license agreement that all unfulfilled performance obligations from prior collaborations relating to R&D services had expired. As a result, the remaining €80.4 million of contract liabilities for prior collaborations were recognized as non-cash revenue in the third quarter of 2024.

€480.4 million of the revenue recognized in the third quarter of 2024 must therefore be seen as a positive one-time event that will not be repeated in the future.

Additionally, in the third quarter of 2024, CureVac reached a development milestone of €10.0 million under the previous GSK collaboration for the Phase 2 transition of the pre-pandemic avian influenza (H5N1) program, which is also fully recognized as revenue in the third quarter of 2024.

The remaining revenues relate to work on the GSK and CRISPR collaborations.

Operating Result

Operating profit amounted to €368.4 million and €221.4 million for the three and nine months ended September 30, 2024, respectively, representing an increase of €422.4 million and €407.6 million from an operating loss of €54.0 million and €186.2 million for the same periods in 2023.

The operating result was affected by several key drivers partially related to the new strategy and the closing of the first-generation vaccine effort in COVID-19:

• Cost of sales increased year-on-year mainly due to higher arbitration costs for CMO activities related to the first-generation COVID-19 vaccine as well as due to higher personnel expenses related to the restructuring of the organization.
   
• Research and development expenses increased primarily with increased activity in oncology R&D projects. Additionally, the first nine months of 2024 were impacted by increased expenses related to the litigation to enforce intellectual property rights.
   
• General and administrative expenses decreased compared to the prior year period mainly driven by lower personnel expenses.
   
• Other income increased year-on-year due to the sale of raw materials to GSK.
   
• Other operating expenses increased year-on-year due to a partial impairment of CureVac’s production facility.

  While the production facility was initially planned and set up for commercial (large scale) production, CureVac no longer has large scale production obligations in addition to the strategic re-focus on technology innovation, research and development. Most parts of the production process can be scaled down to provide products for clinical production. Parts of the production process that cannot be scaled down were partially impaired in an amount of €36.6 million.

Financial Result (Finance Income and Expenses)

Net financial result for the three and nine months ended September 30, 2024, amounted to €2.2 million and €8.0 million, or a decrease of €3.1 million and €4.7 million, from €5.3 million and €12.7 million, respectively, for the same periods in 2023. This decrease was mainly driven by lower interest income on cash investments.

Pre-Tax Results

Pre-tax profit was €370.6 million and €229.4 million for the three and nine months ended September 30, 2024, compared to a pre-tax loss of €48.7 million and €173.5 million in the same periods of 2023.

Conference call and webcast details

CureVac will host a conference call and webcast today at 3 p.m. CET / 9 a.m. EST.
Dial-in numbers to participate in the conference call:

U.S. Toll-Free:  +1-877-407-0989

International: +1-201-389-0921

Germany: 0800-182-0040 (landline access) / 0800-184-4713 (cell phone access)

The live webcast link can be accessed via the newsroom section of the CureVac website at https://www.curevac.com/en/newsroom/events/

Corresponding presentation slides will be posted shortly before the start of the webcast.
A replay will be made available at this website after the event.

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 of CureVac

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company’s vaccine and treatment candidates and the company’s strategies, financing plans, cash runway expectations, the timing and impact of restructuring, 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,” “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 (the “SEC”). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

Cash and Condensed Consolidated Profit and Loss Data