BRAIN Biotech AG and Akribion Therapeutics GmbH sign exclusive pharma licensing agreement for G-dase E^® CRISPR-Cas technology

• Akribion Therapeutics GmbH financed by strong Venture Capital Consortium with pharma expertise
• BRAIN can receive up to EUR 92.3 million R&D and commercial milestone fees plus additional royalties in exchange for granting exclusive G-dase E rights for use in Pharma
• Non-pharma related proprietary CRISPR rights remain with BRAIN Biotech for use in its core business

Zwingenberg, Germany, 31.10.2024 – BRAIN Biotech AG signed an exclusive technology pharma licensing agreement with Akribion Therapeutics GmbH for its genome editing nuclease G-dase E^®. In exchange for granting exclusive pharma rights to Akribion, BRAIN Biotech can receive up to EUR 92.3 million R&D and commercial milestone fees. In addition, the company will be entitled to royalties on net sales. The payment structure is based on clinical development progress and market success.

Akribion is led by the two Co-CEOs Lukas Linnig and Dr. Michael Krohn, who will leave BRAIN Biotech in the next weeks to lead Akribion Therapeutics. Lukas and Michael will be joined by an experienced team of scientists and commercial developers. Akribion is financially backed by a venture capital consortium with a strong track record in early-stage pharma ventures.

Adriaan Moelker, CEO of BRAIN Biotech AG, states: “This transaction marks the next important milestone to commercialize and partner projects from our BioIncubator segment which contains highly value-added projects. To successfully develop pharma projects, we have always been looking for strong partners with deep expertise in the sector. This strong venture capital consortium will now help develop this very promising new therapy approach together with the management and scientific team of Akribion Therapeutics, giving the technology the best chance for success whilst allowing BRAIN Biotech to focus on its core business. BRAIN Biotech will continue to realize additional commercialization options for our CRISPR-Cas nucleases outside the exclusively licensed field.”

Lukas Linnig, Co-CEO Akribion Therapeutics GmbH says: “We are pleased to see this transaction unfold with a strong consortium, a committed team and supportive licensing partner in BRAIN Biotech. We look forward to building Akribion Therapeutics as a key player to develop urgently needed medication for patients with life threatening diseases.” Dr. Michael Krohn, Co-CEO Akribion Therapeutics GmbH adds: “This pioneering technology holds the potential to significantly expand the treatment landscape, not only in oncology but across various therapeutic areas but always driven by our commitment to deliver innovative, ethically grounded treatments that improve outcomes for patients facing serious diseases.”

The genome editing nuclease G-dase E^® is part of the proprietary CRISPR-Cas genome editing nuclease portfolio of BRAIN Biotech AG and has been developed within the company’s BioIncubator pipeline of highly innovative projects. BRAIN Biotech intends to commercialize and monetize additional projects with high value from its BioIncubator pipeline during the next years.

This transaction remains subject to customary closing conditions.

+++

About BRAIN Biotech

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

About Akribion Therapeutics

Akribion Therapeutics GmbH is an early stage biotech company developing precision oncology treatments. Using a groundbreaking new class of guided cytotoxic nucleases, Akribion aims to broaden the treatment landscape in critical therapeutic areas, with an initial focus in oncology through the use of highly selective cell depletion technology, enabled by specific targeting of RNA biomarkers. This unique technology platform is based on a proprietary family of nucleases termed G-dase® E.

Akribion is committed to using its technology to improve patient treatment in compliance with high ethical standards.

Akribion Therapeutics has been founded in 2024 by an expert team of scientists and Biotech executives, and is headquartered in Zwingenberg, Germany.

For more information, please see LinkedIn.

Contact Media

Dr. Stephanie Konle
PR & Corporate Communications
Phone: +49 6251 9331-70
Email: stk@brain-biotech.com
 

Contact Investor Relations

Martina Schuster
Investor Relations
Phone: +49 6251 9331-69
Email: ms@brain-biotech.com

Disclaimer

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

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

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

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

BRAIN Biotech AG signs exclusive pharma licensing agreement for G-dase E® CRISPR-Cas technology with Akribion Therapeutics GmbH for up to EUR 92.3 million milestone fees plus royalties

Zwingenberg, Germany, 31 October 2024 – BRAIN Biotech AG (ISIN DE0005203947; “BRAIN” or “Company”) signed an exclusive technology pharma licensing agreement with Akribion Therapeutics GmbH (“Akribion”) for its genome editing uclease G-dase E®. In exchange for granting exclusivity for pharma applications to Akribion, BRAIN can receive up to EUR 92.3 million R&D and commercial milestone fees. In addition, the company will be entitled to royalties on net sales. The payment structure is based on clinical development progress and market success of Akribion. Akribion is independently owned from the Company and seed financed by venture capital. Non-Pharma related proprietary CRISPR rights remain with BRAIN for commercialization in its core business.

This transaction remains subject to customary closing conditions.

Notifying person:

Martina Schuster

BRAIN Biotech AG

– Investor Relations –

Darmstädter Str. 34-36

64673 Zwingenberg

Deutschland

www.brain-biotech.com

Investor Relations Office

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

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

E-Mail: ir@brain-biotech.com

IMPORTANT NOTICE

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

Martinsried (Munich), Germany, October 31, 2024 – Secarna Pharmaceuticals GmbH & Co. KG, a company redefining the discovery and development of best-in-class oligonucleotide therapeutics today announced the promotion of Konstantin Petropoulos, PhD, MBA, to Chief Executive Officer.  He has served as the Company’s Chief Business Officer since June 2023.  Alexander Gebauer, MD, PhD, is stepping down with immediate effect to focus his efforts on another company, Galimedix Therapeutics, that he has co-founded and is leading. He will continue to support Dr. Petropoulos in his new role to ensure a smooth transition.

“I am excited to take on this new role at Secarna,” said Konstantin Petropoulos. “I joined Secarna because of my strong belief in the Company’s oligonucleotide technology platform and its potential to bring groundbreaking therapies to patients.  My enthusiasm has grown as I’ve seen our partnered programs advance into the clinic and as we produce highly differentiated proprietary preclinical projects. I want to express my deep gratitude for Alexander’s success in growing our platform and progressing our lead program SECN-15, as well as his dedication and tireless energy in helping us to grow and bringing us to where we are today.  I very much look forward to leading Secarna in its next stage, as we deliver best-in-class oligonucleotide therapeutics that offer the possibility of transforming untreatable conditions into treatable ones and profoundly changing the future of medicine.”

“I have worked very closely with Konstantin since he joined Secarna, and he has been highly successful in helping to drive the business,” said Alexander Gebauer. “With my responsibilities increasing elsewhere, it is the right time to hand over the reins.  Konstantin is highly respected by our partners, customers and the Secarna team, and I am convinced Konstantin has the ability to grow Secarna’s business and advance the pipeline. I look forward to continuing to serve as an advisor and am enthusiastic about the Company’s future.”

Konstantin Petropoulos joined Secarna as CBO in June 2023. He previously served as CEO of AMW GmbH. Prior to that, he held senior management positions in business development as well as commercialization at several biotech and pharma companies, including Leukocare AG, Bayer AG and MorphoSys AG. Konstantin has strong industry experience and a solid track record of growing and expanding businesses. He has been responsible for major business development deals, including licensing/co-development agreements and strategic alliances, and brings extensive knowledge of portfolio strategy development, marketing and sales.

Konstantin has a PhD in oncology from the Ludwig-Maximilians-University, Munich, Germany and an MBA from the University of Applied Sciences for Economics and Management.

About Secarna Pharmaceuticals

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

Contact
Secarna Pharmaceuticals GmbH & Co. KG

Am Klopferspitz 19
82152 Planegg/Martinsried · Germany
Tel.: +49 (0)89 215 46 375

Konstantin Petropoulos, PhD, MBA
Chief Executive Officer
info@secarna.com

For media inquiries contact
MC Services AG

Anne Hennecke/Vera Lang
secarna@mc-services.eu
Tel.: +49.211.52 92 52 15

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