Immunic, Inc. to Announce Financial Results for the Third Quarter Ended
September 30, 2024, and Provide Corporate Update

– Webcast to be Held at 8:00 am ET on November 7, 2024 –

NEW YORK, October 31, 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 company will release its financial results for the third quarter ended September 30, 2024, including a corporate update, on Thursday, November 7, 2024, before the opening of the U.S. financial markets. A webcast will follow at 8:00 am ET.

To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_v2_K1Ze-QKS34X6c9W9ywg 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 Immunic, Inc.

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

Cautionary Statement Regarding Forward-Looking Statements

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

News Release

Notice of the Revised Forecast of Consolidated Financials for FY2024 (IFRS)

OSAKA, Japan, October 31, 2024 – Takeda (TSE:4502/NYSE:TAK) today announced the revised forecast of the full year consolidated financials for the fiscal year ending March 31, 2025 (FY2024), as below.

1. Revised Forecast for Full Year Consolidated Financials for the Fiscal Year Ending March 31, 2025

(millions JPY)

^* Announced on May 9, 2024.

(millions JPY)

^* Announced on May 9, 2024.

(Note) For the definition of Core financial measures, please refer to the “Definition and Explanation of Non-IFRS Measures and U.S. Dollar Convenience Translations” in the Financial Appendix attached to the Earnings Report.

2. Reasons for Revision

Takeda expects FY2024 revenue to be JPY 4,480.0 billion, an increase of JPY 130.0 billion, or 3.0%, from the original forecast. This is primarily attributable to milder than anticipated generic erosion of VYVANSE after the loss of exclusivity in the U.S. and other business momentum as well as favorable overall changes in the assumptions of foreign exchange rates.

The Core Revenue forecast has been revised in the same way as the Revenue forecast.

Operating Profit is expected to increase by JPY 40.0 billion, or 17.8%, from the original forecast to JPY 265.0 billion, reflecting the positive impact from VYVANSE due to milder than anticipated generic erosion in the U.S. This increase is partially offset by unfavorable impacts from other products, incremental operating expenses and foreign currency exchanges.

Core Operating Profit, which excludes impacts unrelated to the underlying trends and business performance of Takeda’s core operations, is expected to be JPY 1,050.0 billion, an increase of JPY 50.0 billion, or 5.0%.

Net profit for the year (attributable to owners of the Company) is expected to be JPY 68.0 billion JPY, an increase of JPY 10.0 billion, or 17.2%, from the original forecast. Profit Before Tax is expected to increase by JPY 38.0 billion, or 69.1%, to JPY 93.0 billion, mainly reflecting the increase in Operating Profit. This increase in Profit Before Tax is expected to be partially offset by higher tax charges, mainly due to the write-down of deferred tax assets, resulting in an assumed effective tax rate of approximately 27%.

Reported EPS is expected to be JPY 43.03, an increase of JPY 6.33, or 17.2%, and Core EPS is expected to be JPY 456, an increase of JPY 26, or 5.9%.

3. Management Guidance for the Fiscal Year Ending March 31, 2025

Takeda uses change in Core Revenue, Core Operating Profit and Core EPS at Constant Exchange Rate (CER) basis as its Management Guidance. The full year management guidance for the fiscal year ending March 31, 2025 (FY2024) has been revised from the original management guidance announced on May 9, 2024, as follows:

CER % Change

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Contacts

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Financial Information and Non-IFRS Measures

Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”).

This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit for the year attributable to owners of the Company, Core EPS, Constant Exchange Rate (“CER”) change, Net Debt, Adjusted Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and Adjusted Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as “reported” measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS measures to their most directly comparable IFRS measures, which are in the Financial Appendix appearing at the end of our investor presentation of our Q2 FY2024 financial results (available at www.takeda.com/investors).

The usefulness of Core Financial Measures to investors has significant limitations including, but not limited to, (i) they are not necessarily identical to similarly titled measures used by other companies, including those in the pharmaceutical industry, (ii) they exclude financial information and events, such as the effects of non-cash expenses such as dispositions or amortization of intangible assets, that some may consider important in evaluating Takeda’s performance, value or prospects for the future, (iii) they exclude items or types of items that may continue to occur from period to period in the future (however, it is Takeda’s policy not to adjust out normal, recurring cash operating expenses necessary to operate our business) and (iv) they may not include all items which investors may consider important to an understanding of our results of operations, or exclude all items which investors may not consider to be so.

###

Management Board and Supervisory Board of APONTIS PHARMA AG recommend accepting Zentiva’s public tender offer
 

• Joint reasoned statement by Management Board and Supervisory Board published
• Offer price of EUR 10.00 per share represents an attractive premium of around 52.9% compared to the closing price on 15 October 2024 and a premium of 38.3% compared to the volume-weighted average stock exchange price (Xetra) in the last three months prior to and including 15 October 2024
• Management Board and Supervisory Board of APONTIS PHARMA consider the offer price to be fair, adequate and attractive from a financial point of view and recommend shareholders to accept the offer
• Management Board and Supervisory Board of APONTIS PHARMA welcome Zentiva’s intentions, in particular with a view to continuing APONTIS PHARMA’s growth strategy
• Acceptance period ends on 21 November 2024

Monheim / Rhein, 30 October 2024. Today, the Management Board and the Supervisory Board of APONTIS PHARMA AG (Ticker APPH / ISIN DE000A3CMGM5) (the “APONTIS PHARMA”), a leading pharmaceutical company specializing in Single Pill combinations in the German market, have issued their joint reasoned statement on the public purchase offer by Zentiva AG (the “Bidder”) to all APONTIS PHARMA shareholders for the acquisition of all no-par value bearer shares in APONTIS PHARMA (the “Offer”). The Bidder is a wholly-owned subsidiary of Zentiva Pharma GmbH with its registered office in Frankfurt am Main, Germany, and part of the Zentiva Group (“Zentiva”). After careful and thorough review of the offer document published by the Bidder on 24 October 2024, the Management Board and the Supervisory Board of APONTIS PHARMA recommend that APONTIS PHARMA shareholders accept the Offer. The members of the Management Board and the Supervisory Board of APONTIS PHARMA intend to tender all APONTIS PHARMA shares held by them.

The Management Board and the Supervisory Board of APONTIS PHARMA consider the offer price of EUR 10.00 per APONTIS PHARMA share to be fair, adequate and attractive from a financial point of view and see it as an attractive premium of approximately 52.9% compared to the closing price on 15 October 2024 and a premium of 38.3% compared to the volume-weighted average stock exchange price (Xetra) in the last three months prior to and including 15 October 2024.

The Management Board and the Supervisory Board of APONTIS PHARMA, taking into account the overall circumstances of the Offer as well as the objectives and intentions of the Bidder, are of the opinion – independently of each other – that the consideration offered by the Bidder is fair, adequate and attractive and that the consummation of the Offer is in the interest of APONTIS PHARMA and its shareholders, employees and other stakeholders. The Management Board and the Supervisory Board of APONTIS PHARMA support the Offer. The business combination will enable the Bidder and APONTIS PHARMA to combine its existing resources in order to achieve a higher availability of resources and a broader product range.

Furthermore, the Management Board and the Supervisory Board of APONTIS PHARMA welcome the economic and strategic objective of the Bidder and Zentiva to strengthen APONTIS PHARMA and to support its growth as set out in the offer document. The Management Board and the Supervisory Board of APONTIS PHARMA are of the opinion that the cooperation in the area of research and development as well as the access to Zentiva’s European network for the future commercialization of the pharmaceutical products developed by APONTIS PHARMA are of central importance for the long-term success of the Company.

There is no legal obligation for the Management Board and the Supervisory Board of APONTIS PHARMA to issue a reasoned statement as the German Securities Acquisition and Takeover Act (WpÜG) does not apply. The joint reasoned statement is published in German on the APONTIS PHARMA website in the Investor Relations section at Public voluntary purchase offer and is also available in a non-binding English translation.

The acceptance period for the Offer commenced with the publication of the offer document on 24 October 2024 and ends on 21 November 2024 at 24:00 hours (Frankfurt / Main local time). All relevant details regarding the terms and conditions and, in particular, the acceptance of the Offer are set out in the offer document, which is available on the Bidder’s website: www.zentiva-offer.com. In order to tender their shares into the purchase offer, shareholders are kindly requested to contact their custodian bank directly.

Important notice

The information in this publication does not constitute explanations or additions to the statements in the reasoned statement. Only the joint reasoned statement of the Management Board and Supervisory Board of APONTIS PHARMA is binding.

About APONTIS PHARMA:

APONTIS PHARMA AG is a leading pharmaceutical company specializing in Single Pill combinations in Germany. Single Pills combine two to three generic active ingredients in a single dosage form administered once a day. Single Pill therapies have been scientifically proven to significantly increase adherence and thus improve the treatment prognosis and quality of life of patients while reducing complications, mortality, and treatment costs. Consequently, Single Pill combinations are the preferred treatment option in numerous international treatment guidelines, including in the EU and Germany. APONTIS PHARMA has been developing, promoting, and distributing a broad portfolio of Single Pill combinations and other pharmaceutical products since 2013, with a special focus on cardiovascular diseases such as hypertension, hyperlipidemia, and secondary prevention. For additional information about APONTIS PHARMA, please visit www.apontis-pharma.de.

APONTIS PHARMA AG

Investor Relations
ir@apontis-pharma.de
T: +49 2173 89 55 4900
F: +49 2173 89 55 1521
Alfred-Nobel-Str. 10
40789 Monheim / Rhein
Germany
apontis-pharma.de

APONTIS PHARMA Press Contact

CROSS ALLIANCE communication GmbH
Sven Pauly
ir@apontis-pharma.de
T: +49 89 125 09 0330

Disclaimer – Legal notice

The information contained in this press release may include certain forward-looking statements that are based on current assumptions and forecasts made by the management of APONTIS PHARMA AG. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. Such factors include those discussed in APONTIS PHARMA AG’s public reports. These reports are available on www.apontis-pharma.de. The Company assumes no obligation to update such forward-looking statements or to adapt them to future events or developments.

Cinven to Acquire Elliott’s Stake in SYNLAB AG, Squeeze-Out to Follow

Elliott to remain indirect minority shareholder in SYNLAB

The Management Board of SYNLAB AG (“SYNLAB”) has been informed that international private equity firm Cinven has reached an agreement with funds advised by Elliott Advisors (UK) Limited (“Elliott”). Under this agreement, Cinven will acquire Elliott’s current direct minority stake of approximately 10% in SYNLAB. Elliott will become an indirect minority shareholder in SYNLAB, alongside existing shareholders Cinven, Labcorp (subject to regulatory approval), and Qatar Holding LLC. The transaction is subject to regulatory approvals and is expected to close in early 2025.

The acquiring entity of Elliott’s shareholding will be Ephios Bidco GmbH (“Ephios Bidco”), an entity controlled by funds managed and/or advised by Cinven and the majority shareholder of SYNLAB AG. Ephios Bidco currently holds approximately 86% of the SYNLAB share capital. Upon closing of the transaction with Elliott, Ephios Bidco will hold at least 96.09% of the share capital and at least 97.15% of the voting rights of SYNLAB AG.

In light of this development, Ephios Bidco today submitted a demand to the Management Board of SYNLAB to convene a general meeting of SYNLAB AG to resolve the transfer of the shares held by its remaining (minority) shareholders to Ephios Bidco as majority shareholder in return for appropriate cash compensation, in accordance with Sections 327a et seqq. AktG (squeeze-out under stock corporation law). Ephios Bidco will announce the amount of the appropriate cash compensation separately to the Management Board of SYNLAB once the required valuation work has been completed.

The Management Board of SYNLAB will inform about the date of the Annual General Meeting at which a corresponding transfer resolution will be adopted in accordance with statutory legal requirements. The squeeze-out will only become effective following approval by the general meeting of SYNLAB and registration with the commercial register.

Mathieu Floreani, CEO of SYNLAB Group, commented: “We see this development as a positive step for SYNLAB. Elliott’s decision to remain an indirect shareholder demonstrates their continued belief in our Group’s potential and future growth. We look forward to working closely with all our shareholders to drive SYNLAB’s success.”

– end –

For more information:

About SYNLAB

• SYNLAB Group is the leader in medical diagnostic services and specialty testing in Europe. The Group offers a full range of innovative and reliable medical diagnostics to patients, practising doctors, hospitals and clinics, governments and corporates.
• Providing the leading level of service within the industry, SYNLAB is the partner of choice for routine and specialty diagnostics in human medicine. The Group continuously innovates medical diagnostic services for the benefit of patients and customers.
• SYNLAB operates in more than 20 countries across four continents and holds leading positions in most markets. More than 27,000 employees, including over 2,000 medical experts, as well as a large number of other specialists such as biologists, chemists and laboratory technicians, contribute every day to the Group’s worldwide success.
• SYNLAB performed around 600 million laboratory tests and achieved revenues of €2.64 billion in 2023.
• More information can be found on www.synlab.com

About Cinven

Cinven is a leading international private equity firm focused on building world-class global and European companies. Its funds invest in six key sectors: Business Services, Consumer, Financial Services, Healthcare, Industrials and Technology, Media and Telecommunications (TMT). Cinven has offices in London, New York, Frankfurt, Paris, Milan, Madrid, Guernsey and Luxembourg.

Cinven takes a responsible approach towards its portfolio companies, their employees, suppliers, local communities, the environment and society.

Cinven Capital Management (V) General Partner Limited, Cinven Capital Management (VI) General Partner Limited, Cinven Capital Management (VII) General Partner Limited and Cinven Capital Management (SFF) General Partner Limited are each authorised and regulated by the Guernsey Financial Services Commission, and Cinven Limited is authorised and regulated by the Financial Conduct Authority.

In this press release ‘Cinven’ means, depending on the context, any of or collectively, Cinven Holdings Guernsey Limited, Cinven Partnership LLP, and their respective Associates (as defined in the Companies Act 2006) and/or funds managed or advised by any of the foregoing.

For additional information on Cinven please visit www.cinven.com and www.linkedin.com/company/cinven/.

About Elliott

Elliott Investment Management L.P. (together with its affiliates, “Elliott”) manages approximately $69.7 billion of assets as of June 30, 2024. Founded in 1977, it is one of the oldest funds under continuous management. The Elliott Funds’ investors include pension plans, sovereign wealth funds, endowments, foundations, funds-of-funds, high net worth individuals and families, and employees of the firm. Elliott Advisors (UK) Limited is an affiliate of Elliott Investment Management L.P.

More information can be found on www.elliottmgmt.com.

Hamburg, Germany, 30 October 2024:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) will announce its financial results for the first nine months of 2024 on Wednesday, 06 November 2024.

The Company is going to hold a conference call to discuss 9-months results as well as to provide an overview on the ongoing priority reset and the strategic review process. The conference call will be held in English.

Webcast details

Date:  Wednesday, 06 November 2024

Time:  2.00 pm CET (01.00 pm GMT, 08.00 am EST)

To join the audio webcast and to access the presentation slides, please register via this link.

The on-demand version of the webcast will be available on our website: www.evotec.com/en/investor-relations/financial-publications.

Conference call details

To join via phone, please pre-register via this link. You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

A simultaneous slide presentation for participants dialling in via phone is available under this link.

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.

IR Contact Evotec SE:
Volker Braun, EVP Head of Global Investor Relations & ESG, Volker.Braun@evotec.com

Immunic to Participate in Industry, Scientific and Investor Conferences in November

NEW YORK, October 29, 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 participation in the following industry, scientific and investor conferences in November:

• November 4-6: BIO-Europe. Members of Immunic’s management, business development and investor relations teams will participate in partnering activities at this conference in Stockholm, Sweden. To schedule a meeting, please use the BIO-Europe partneringONE portal.
• November 8-9: Symposium 238: Immuno-Mediated Diseases of the GI Tract: Where Do We Stand? Sara Elhag, Ph.D., Associate Manager Translational Pharmacology at Immunic, will present data from the company’s phase 1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator targeting SIRT6 (Sirtuin 6), in patients with celiac disease, in a poster presentation at this symposium in Florence, Italy. The poster will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.
• November 19-21: Immunic’s management, business development and investor relations teams will be hosting one-on-one meetings in London in connection with the Jefferies London Healthcare Conference 2024. To schedule a meeting, please contact Jessica Breu, Vice President Investor Relations and Communications, at: jessica.breu@imux.com.
• November 21: Virtual Investor Summit. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will present a company overview on Thursday, November 21, 2024 and participate in one-on-one investor meetings at this conference. To listen to the company presentation, register for the conference using this link. The presentation and presentation time will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations, once they are available. 

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 management’s and employee’s participation in industry, scientific and investor conferences. 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 and Würzburg, Germany, October 29, 2024 – The National Cancer Institute (NCI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), two highly respected research organizations belonging to the US government’s National Institutes of Health (NIH), have started a clinical trial involving 77 patients to see if Pentixapharm’s new radioactive tracer PentixaFor ([68Ga]Ga-PentixaFor) can make it easier to identify functional adrenal tumors through positron emission tomography (PET) scans.

The FDA-endorsed and US-located investigator-initiated phase II study, conducted by Dr. Liza Lindenberg and Prof. Dr. Peter Choyke (Clinical Trial number: NCT06246357) investigates the performance of PentixaFor in subtyping hormone-secreting adenomas in people suffering from primary aldosteronism (PA) or hypercortisolism (Cushing´s syndrome). The first patient was recently examined.

Primary aldosteronism is among the most common causes of secondary hypertension, a disorder affecting tens of millions of people in the United States alone. In some subtypes PA can be cured completely through a short surgical intervention, so finding a reliable tool for accurate subtyping is important and potentially beneficial to a large segment of the population. In contrast, Cushing’s syndrome, also described as hypercortisolism, is a rare endocrine disorder designated as an orphan disease that is caused by chronic exposure of the body’s tissues to excess levels of cortisol.

Pentixapharm itself is currently preparing a US-centric Phase III pivotal study to obtain marketing authorization for PentixaFor in PA. The work of the NCI/NIDDK will add to the global clinical evidence about the compound and make it easier to compile the necessary data.

“We are pleased that the NIH investigate the clinical value of PentixaFor at its own initiative and see this as a token of confidence in the potential of CXCR4 targeting imaging in unexplored indications expanding market opportunities for PET/CT diagnostics. In our opinion, PentixaFor has broad potential as a novel imaging modality for adrenal diseases and could be particularly helpful for individuals grappling with primary aldosteronism-induced resistant hypertension or Cushing’s disease,” stated Dr. Dirk Pleimes, Group CEO and Chief Medical Officer at Pentixapharm. 

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.

PentixaFor (Gallium (⁶⁸Ga) boclatixafortide) is an innovative PET tracer that specifically targets the chemokine-4 receptor (CXCR4), with broad applications in oncological, cardiovascular, and inflammatory diseases. Particularly in hypertension, PentixaFor has the potential to significantly improve patient management by identifying the presence of hormone-secreting adenomas through non-invasive and broadly available PET/CT imaging.

Apart from PentixaFor, the clinical pipeline also encompasses PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL). Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Recently, the EMA granted PRIME status to PentixaFor in the indication PA.

For more information, please contact:

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

PRESS RELEASE

Biotest and SteinCares partner to improve access to plasma-derived products in Latin America

• Financial and strategic reliability is key driver of partnership to start to penetrate Latin American markets with plasma-derived Factor VIII products
• Agreement will be the first step to its expand our commercial footprint in the area

Dreieich, Germany, October 29, 2024. Biotest announced today, that it has signed a new distribution agreement with SteinCares, a leading specialty healthcare company in Latin America, for the commercialization and distribution of Haemoctin^® in selected Latin American countries (Chile, Colombia, Costa Rica, Ecuador, Mexico and Peru).

The plasma-derived factor VIII product Haemoctin^®, indicated for the treatment and prophylaxis of bleeding in patients with hemophilia A, offers an accessible alternative compared to other available treatments. As a plasma-derived product, it ensures fast and reliable efficacy, high purity and a favorable safety profile and thus reduces the risk of long-term complications of hemophilia.

Hemophilia therapies are essential for the management of this disease, which affects approximately 56,000 people in Latin America. However, according to the World Federation of Hemophilia, only 57% of these patients are diagnosed and approximately 40% have access to prophylactic treatment. With the introduction of Haemoctin^®, Biotest reaffirms its commitment to improving patient access to high-quality, cost-effective specialty care treatments.

“We are pleased to partner with SteinCares, whose financial and strategic reliability is a key driver for us to begin penetrating the Latin American markets with our products, where economic and political challenges have historically presented opportunities for resilient and innovative growth,” indicates Enrico D’Aiuto, Senior Vice President Commercial Operations at Biotest AG. “With this first agreement we are making our Factor VIII product available to hemophilia patients in Latin America. SteinCares’ deep-rooted presence and established operations throughout the region, gives us confidence that this agreement will be a success and will be the first step in expanding our commercial footprint in the LATAM region” highlights Carolin Shah, Vice President responsible for the Business Unit Distribution Partners at Biotest.

“The addition of the Factor VIII to our portfolio underscores our commitment to making a meaningful impact on the well-being of hemophilia patients in Latin America. By offering a high-quality treatment alternative, we not only improve the economics of healthcare systems through budget balancing and cost-effectiveness, but also expand access to safe and effective therapies for patients with rare diseases,” said Sebastian Katz, Chief Strategy Officer at SteinCares.

About Haemoctin^®

Haemoctin^® is a von Willebrand factor containing coagulation factor VIII preparation obtained from blood plasma from qualified voluntary donors. It is manufactured from a pool of up to 20,000 plasma donations using state-of-the-art concentration and purification techniques. The injection solution consisting of powder and solvent has been successfully used for more than 25 years for the treatment and prophylaxis of bleeding in patients with congenital factor VIII deficiency (Haemophilia A) and is appreciated for its good tolerability and low immunogenicity. Haemoctin^® is storable for two years at room temperature and available in three different strengths. Dosage and duration of treatment with Haemoctin^® depend on the indication and the severity of the disease.

About Hemophilia

As a lifelong inherited bleeding disorder, hemophilia affects about 1 in 10,000 people worldwide. Hemophilia is one of a number of such disorders that prevent blood from clotting properly. People with hemophilia experience prolonged internal bleeding that can result from a seemingly minor injury. Bleeding into joints and muscles causes severe pain and disability while bleeding into major organs, such as the brain, can cause death. Treating the bleeding episodes involves the prompt and proper use of clotting factor concentrates. Hemophilia A is caused by a deficiency of clotting factor VIII. Therefore, intravenously administered therapeutic factor VIII is often recognized as a foreign protein (antigen) by the patient’s immune system. As a consequence up to 30% of patients with severe hemophilia develop antibodies against the therapeutic factor VIII. These antibodies are called inhibitors because they reduce or eliminate the therapeutic effect of factor VIII. Most inhibitors develop during early childhood and compromise the ability to effectively prevent or manage hemorrhages, resulting in a greater rate of disability, morbidity, complications and costs of therapy. The formation of inhibitors is the most serious complication of today’s hemophilia treatment. Avoiding the risk of inhibitor development would be the most effective prerequisite for a continuous therapy enabling hemophilia patients to live an almost normal life without irreversible joint damage. For more information on hemophilia and FVIII, please visit the World Federation of Hemophilia website at https://www.wfh.org/en/home.

About SteinCares

SteinCares is a leader in commercializing and distributing specialty healthcare products in Latin America, including innovative pharmaceuticals, biosimilars and complex generics. With over 40 years of progressive healthcare experience and operations in over 30 countries in Latin America and the Caribbean, SteinCares serves as a bridge between global pharmaceutical companies and the region’s healthcare providers. The company is deeply committed to creating healthcare opportunities that positively impact the lives of patients and their families in Latin America, with a vision of increasing access to innovative and cost-effective healthcare for patients in the region.

For more information, visit http://www.steincares.com/ or follow the company on LinkedIn.

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com).

IR contact

Dr Monika Baumann (Buttkereit)
Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

Dräger with good demand, robust net sales development and higher earnings in the first nine months of 2024

• Order intake exceeds high prior-year level
• Net sales almost reach the strong prior-year figure
• EBIT up around four percent
• Annual forecast confirmed

Lübeck – Drägerwerk AG & Co. KGaA increased its order intake in the first nine months of 2024 thanks to good overall demand. At around EUR 2,421 million, order intake was around EUR 17 million above the high prior-year figure. Net sales decreased by 0.4 percent (net of currency effects) to EUR 2,295.1 million (9 months 2023: EUR 2,320.9 million) after Dräger had benefited from strong catch-up effects in the prior-year period as a result of the noticeable improvement in delivery capacity and a surge in demand for ventilators in China. Earnings before interest and taxes (EBIT) rose by 4.2 percent to EUR 80.1 million (9 months 2023: EUR 76.9 million). The EBIT margin increased to 3.5 percent (9 months 2023: 3.3 percent). In addition to the operating business performance, several one-off effects with an impact on earnings contributed around EUR 32 million to EBIT.

“Our order intake increased in the first nine months of 2024 thanks to good demand for our ‘Technology for Life’ – and was thus able to exceed the high level of the prior year,” says Stefan Dräger, Chairman of the Executive Board of Drägerwerk Verwaltungs AG. “Net sales saw robust development and almost reached the high prior-year level despite the challenging comparative figures. Our earnings increased. This was due not only to the operating business but also to measures to improve profitability which included the sale of a non-core local business activity in the Netherlands.”

Rising demand for safety technology
In the first nine months of 2024, the Group’s order intake increased by 1.4 percent (net of currency effects) to EUR 2,420.5 million (9 months 2023: EUR 2,403.3 million). This was due in particular to growth in Germany and the positive development in the regions Europe, Middle East, and Africa and the Americas.

In the safety division, order intake rose by 6.5 percent (net of currency effects) to EUR 1,052.1 million (9 months 2023: EUR 992.7 million). Almost all product areas recorded higher demand. Growth was driven in particular by our occupational health and safety equipment as well as respiratory and personal protection products.

In the medical division, order intake fell by 2.1 percent (net of currency effects) to EUR 1,368.5 million (9 months 2023: EUR 1,410.7 million). This is due in particular to the significantly lower demand for ventilators, which had been supported by an extraordinary surge in demand from China in the same period of the prior year. The significant increase in order volumes in thermoregulation in particular had a positive effect.

Safety division continues to grow – base effects weigh on medical division
The safety division recorded an increase in net sales of 5.5 percent (net of currency effects) to EUR 1,009.7 million in the first nine months of 2024 (9 months 2023: EUR 961.7 million), due in particular to the good order situation.

In the medical division, net sales fell by 4.6 percent (net of currency effects) to EUR 1,285.3 million (9 months 2023: EUR 1,359.2 million). This was due in particular to the significant decline in net sales in the Asia-Pacific region, which, as expected, is primarily attributable to the China effect described above. In the same period of the prior year, the segment also benefited from catch-up effects as a result of the noticeable improvement in delivery capacity.

One-off effects drive earnings growth
In the second quarter of 2024, we sold our fire alarm systems business in the Netherlands. In the 2023 fiscal year, net sales in this business area amounted to around EUR 20 million. However, there were only a few synergies with the core business of Dräger. We have therefore exited this business. In addition, we sold an unneeded plot of land in the USA in the second quarter. Together, these two one-off effects contributed around EUR 20 million to EBIT. In the third quarter, a further EUR 10 million was recognized in earnings from the sale of an unneeded building in Spain. Overall, these one-off effects contributed around EUR 30 million to EBIT of EUR 80.1 million (9 months 2023: EUR 76.9 million).

The gross margin rose to 44.4 percent (9 months 2023: 44.0 percent) as a result of the increased share of net sales and the improved gross margin of the safety division. Our functional costs increased by 0.4 percent (net of currency effects). Earnings after taxes amounted to EUR 49.4 million (9 months 2023: EUR 47.1 million).

Business development in the third quarter
In the third quarter, order intake increased by 2.6 percent (net of currency effects) to EUR 816.2 million (Q3 2023: EUR 806.7 million). In the safety division, it increased significantly by 11.9 percent (net of currency effects) to EUR 347.8 million (Q3 2023: EUR 313.5 million). In the medical division, it decreased by 3.4 percent (net of currency effects) to EUR 468.4 million (Q3 2023: EUR 493.1 million).

Dräger’s net sales in the third quarter decreased by 0.7 percent (net of currency effects) to EUR 774.6 million (Q3 2023: EUR 788.5 million). The gross margin fell to 43.5 percent (Q3 2023: 44.0 percent). EBIT amounted to EUR 24.4 million (Q3 2023: EUR 29.2 million). The EBIT margin came to 3.1 percent (Q3 2023: 3.7 percent).

Annual forecast confirmed
Dräger confirms its outlook for the current fiscal year and expects net sales growth of 1.0 to 5.0 percent (net of currency effects) and an EBIT margin of 2.5 to 5.5 percent. We continue to expect net sales growth in the lower half and an EBIT margin in the upper half of the forecast range.

Further information is available in the financial report at www.draeger.com.

Disclaimer
This press release contains statements on the future development of Dräger Group. These forward-looking statements are based on the current expectations, presumptions, and forecasts of the Executive Board as well as the information available to date. They were compiled to the best of the company’s knowledge. Dräger does not provide any warranty nor assume any responsibility for the future developments and results described above. These are dependent on a number of factors. They entail various risks and contingencies outside of the company’s influence and are based on assumptions which could prove to be incorrect. Dräger does not assume any responsibility for updating the forward-looking statements contained in this report. This does not infringe any legal stipulations on the adjustment of forecasts. Information on the financial indicators used (incl. alternative performance measures) can be found on our corporate website www.draeger.com in our Investor Relations section.