STRATEC REPORTS RESULTS FOR FIRST NINE MONTHS OF 2024

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

Birkenfeld, October 25, 2024

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

KEY FIGURES ¹

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

PRESS RELEASE

Heidelberg Pharma to Participate in Leading Scientific and Financial Conferences in November 2024

Ladenburg, Germany, 24 October 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage developer of innovative Antibody Drug Conjugates (ADCs), announces it will present its ADC candidates and ADC technology platforms at leading scientific and financial conferences throughout November.

The Company’s most advanced Amanitin-based ADC product candidate, HDP-101, is currently in a Phase I/IIa trial for the treatment of relapsed or refractory multiple myeloma. In late September, Heidelberg Pharma presented clinical data from the fifth patient cohort, demonstrating a case of complete remission in a patient who had been treated multiple times. This patient showed a partial response after the second treatment cycle, with a complete remission observed after 11 cycles. In addition, several patients exhibited promising biological activity and objective improvements, underscoring the potential of HDP-101 as a treatment option for patients with this disease.

HDP-201, Heidelberg Pharma’s first Exatecan-based ADC candidate, is a topoisomerase I inhibitor that has proven success in cancer therapy and is already used in two approved ADCs. Its distinct mode of action from Amanitin broadens the Company’s portfolio of active ingredients. HDP-201 targets guanylyl cyclase-C (GCC), a receptor expressed on the surface of intestinal cells and cancer cells in various gastrointestinal tumors. Preclinical data suggest that the tolerability and efficacy of HDP-201 is at least on a par with existing, approved Exatecan-based ADCs. Following extensive preclinical testing, the final development candidate for HDP-201 was determined in recent weeks, with colorectal cancer identified as the target indication for its clinical development.

World ADC San Diego 2024

Deutsches Eigenkapitalforum

Walter Miller will be available for one-on-one meetings, which can be arranged via the online conference system.

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma uses several compounds and has built up an ADC toolbox that overcomes tumor resistance via numerous pathways and addresses different types of cancer using various antibodies. The goal is to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors. Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology. It offers the opportunity to overcome therapy resistance and also eliminate dormant tumor cells, which could lead to significant progress in cancer therapy – even for patients who no longer respond to other treatment.

The most advanced product candidate HDP-101 is a BCMA-ATAC for the indication multiple myeloma, which is currently in clinical development.

The first candidate that Heidelberg Pharma is developing with a toxin other than Amanitin is HDP-201, an Exatecan-based ADC. Exatecan is a topoisomerase I inhibitor that has proven itself in cancer therapy and is used in two already approved ADCs. It differs in its mode of action from that of Amanitin and thus expands the company’s range of compounds.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com.

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH.

ITAC™, ETAC™ are pending trademark applications of Heidelberg Pharma Research GmbH.

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”, “should”, “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

Hamburg, Germany, 23 October 2024:
Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) today announced progress within the Company’s strategic partnership with Bristol Myers Squibb relating to building a molecular glue-based pipeline. Key scientific achievements drive the expansion of the pipeline of molecular glue degraders in fields beyond oncology, triggering a programme-based payment of US$ 50 m to Evotec. Based on potential programme-based milestones, the expansion contributes to the deal value.

Evotec and Bristol Myers Squibb entered their strategic protein degradation partnership in 2018 and expanded it in May of 2022, because of the highly productive initial collaboration generating a promising pipeline. Since the expansion, Evotec has significantly scaled up its activities to develop highly promising compounds from Bristol Myers Squibb’s industry-leading library of cereblon E3 ligase modulators (“CELMoDs™”). The partnership continues to deliver on its goal to maintain leadership in the field, adding a broad pipeline of novel molecular glue degraders for high-value targets, in this case for fields beyond oncology.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are delighted to expand our successful partnership with Bristol Myers Squibb into fields beyond oncology with a significant unmet medical need. The unique mode of action, combined with drug-likeness and oral administration make molecular glue degraders a promising and versatile therapeutic option. Our partnership with BMS continues to build an extraordinary pipeline of first-in-class product opportunities and we look forward to driving the joint portfolio of programmes towards clinical validation for the benefit of patients.”

About molecular glue degraders
Conventional small molecule therapeutics work via a drug-induced interference with a protein activity. This limitation to agonistic or antagonistic functions renders about 90% of proteins “undruggable”. Also, conventional small molecules only work while they are actively binding to the receptor, which typically requires a treatment regimen consisting of one or even several carefully dosed medications every day.

Molecular glue degraders are compounds that induce interactions between an E3 ubiquitin ligase and a molecular target. The induced interaction results in ubiquitination and subsequent degradation of the recruited protein. Through this mechanism of action molecular glues are not restricted to the agonistic/antagonistic features of a protein, thus massively expanding the range of the druggable proteome. Also, the molecular glue itself is not degraded in the process and can trigger the degradation process several times over, thus leading to longer-lasting therapeutic effects.

About Evotec’s strategic partnership with Bristol Myers Squibb in molecular glues
In 2018, Evotec entered a long-term strategic drug discovery and development partnership in the field of molecular glues with Celgene, now Bristol Myers Squibb. Bristol Myers Squibb is a leader in this field based on its unique library of cereblon E3 ligase modulators (CELMoDs™). The aim of this strategic alliance is to discover and develop a leading pipeline of molecular glue degraders for a range of therapeutic indications leveraging all of Evotec’s proprietary PanOmics and PanHunter platforms as well as A.I./M.L.-based drug discovery and development capabilities.

Evotec applies high-end proteomics and transcriptomics at industrial scale to profile and select promising drug candidates based on comprehensive cell biological profiles. Evotec’s leading PanOmics screening capabilities are delivering unmatched throughput. The selection of the most promising candidates for drug development is facilitated by Evotec’s PanOmics data analysis platform PanHunter, which was recently launched commercially as a software-as-a-service (“SAAS”) solution. PanHunter supports the integration and analysis of these data sets and thereby enables the selection of the most promising CELMoDs™ for further progression into lead optimisation.

Evotec announced in May of 2022 that the Company has further extended and expanded its partnership with Bristol Myers Squibb for another 8 years as the initial collaboration proved to be highly productive in generating a promising pipeline of molecular glue degraders. 

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

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

For further information, please contact:

Investor Relations

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

Media

Susanne Kreuter
VP Head of Strategic Marketing
Susanne.Kreuter@evotec.com

The Management Board of aap Implantate AG (“Company“) today resolved, with the approval of the Supervisory Board, to increase the Company’s share capital from currently EUR 10,979,625.00 by EUR 1,097,962.00 to EUR 12,077,587.00 by issuing 1,097.962 new no-par value bearer shares, each with a pro rata amount of the share capital of EUR 1.00 (“New Shares“), against cash contributions, making partial use of the authorized capital 2024/I and excluding shareholders’ subscription rights (“Cash Capital Increase“). The issue price per New Share is EUR 2.03. The Cash Capital Increase corresponds to around 10% of the existing share capital. The New Shares will be issued by way of a private placement to selected investors. The New Shares will carry dividend rights from January 1, 2024.

The cash capital increase serves to provide the necessary liquidity and strengthen the company’s equity base, thus securing its financing in the medium term, assuming normal business development. The gross issue proceeds from the cash capital increase will amount to around EUR 2.2 million.

In order to further strengthen the equity base, the Management Board of the company also intends, with the approval of the Supervisory Board, to increase the company’s share capital by up to EUR 400,000.00 (approx. 3.6% of the current share capital) against contributions in kind, excluding shareholders’ subscription rights, making further partial use of the authorized capital 2024/I. The object of the contribution in kind is to be shareholder loans granted to the company in the nominal amount of EUR 750,000.00 plus accrued interest, which are to be contributed to the company by way of a debt-to-equity swap in return for the granting of up to 400,000 new shares. The issue price of the New Shares therefore also corresponds to EUR 2.03. The implementation of the capital increase against contributions in kind requires a non-cash contribution audit by a court-appointed non-cash contribution auditor.

The capital increase against contributions in kind serves to strengthen the balance sheet structure by increasing equity while at the same time eliminating loan obligations and leads to a reduction in the interest burden associated with the granting of shareholder loans.

Contact:

If you have any questions, please contact:

aap Implantate AG; R. Di Girolamo; Chairman of the Management Board/CEO; Lorenzweg 5;

D-12099 Berlin

Tel.: +49/30/750 19 – 170; Fax: +49/30/750 19 – 290; r.digirolamo@aap.de

Immunic Announces Positive Outcome of Interim Analysis of Phase 3 ENSURE Program of Vidofludimus Calcium in Relapsing Multiple Sclerosis 

– Based on a Review of Unblinded Data, an Independent Data Monitoring Committee (IDMC) Confirmed that Predetermined Futility Criteria Have Not Been Met – 

– IDMC Also Recommended Continuing Trial without Changes, Including no Need for a
Potential Upsizing –

– ENSURE Program Remains on Track to be Completed in 2026 –

– Webcast to be Held Today, October 22, at 8:00 am ET – 

NEW YORK, October 22, 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 a positive outcome of the non-binding, interim futility analysis of its phase 3 ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned.

“While Immunic remains blinded to all data, the IDMC’s favorable recommendations in this interim analysis corroborate our initial assumptions for the design, powering and relapse rate of the twin phase 3 trials of vidofludimus calcium in RMS, and suggest that they are in line with the data observed so far,” stated Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic. “In particular, the planned sample size seems appropriate to address the primary endpoint of time to first relapse. As the IDMC recommends, we are continuing the ENSURE trials unchanged, with completion expected in 2026.”

“I am particularly excited about the positive outcome of the interim analysis of our phase 3 ENSURE trials, marking the successful achievement of a critical milestone for the program,” added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “We are confident in vidofludimus calcium’s potential to transform the oral MS market and continue to believe that the phase 3 program provides a clear and straightforward path towards seeking potential regulatory approval in RMS. Our next clinical milestone for vidofludimus calcium is the top-line readout of our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS), which we expect to release in April of next year. If this data set continues to show a neuroprotective effect for vidofludimus calcium, we believe our drug may be positioned as first-in-class oral treatment option for PMS, a form of MS with highest unmet medical needs.”

The interim futility analysis of the phase 3 ENSURE program was performed by an unblinded IDMC and based on a pre-specified assessment after approximately half of the planned first relapse events occurred in the double-blind treatment periods of each of the twin ENSURE-1 and ENSURE-2 trials. The analysis was intended to inform potential sample size adjustment and help prevent the final study readout from occurring before sufficient events have been achieved. The unblinded IDMC was asked to make two decisions: The first question, as to whether the trials are futile, was answered by the IDMC with “futility criteria have not been met.” The second question, as to whether the sample size in each trial should be increased, was answered by the IDMC with “continue as planned.” Both decisions were based on the conditional power of the trials at the time of the interim analysis. Immunic has remained blinded during the interim analysis and has not seen any of the data available to the IDMC to make their recommendations.

The ongoing ENSURE program comprises two identical multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, is expected to enroll approximately 1,050 adult patients with active RMS at more than 100 sites in more than 15 countries, including the United States, India and countries in Latin America, Central and Eastern Europe. Patients are being randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo and the primary endpoint for both trials is time to first relapse up to 72 weeks. Key secondary endpoints include time to confirmed disability worsening based on Expanded Disability Status Scale (EDSS) disability progression, volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and percentage of whole brain volume change, grey matter volume and white matter volume. As previously reported, completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026.

Webcast Information

Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_fSJNHWuxRMGRPaMl3hUlqg or on the “Events and Presentations” section of Immunic’s website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial-in access.

An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations.

About Vidofludimus Calcium (IMU-838)

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

About Immunic, Inc. 

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

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; announcements regarding the positive outcomes of the interim analysis of the phase 3 ENSURE trials; 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, 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@ksca.com