Marinomed Biotech AG reports positive clinical results for unique Carragelose eye drops

• Marinomeds new Carragelose eye drops improve dry eye-related symptoms in patients with mild to moderate dry eye syndrome by remarkable 54%
• Product was well tolerated by patients and ocular surface disease index (OSDI) was significantly reduced
• Eye drops hold valid Medical Device Directive (MDD) certificate and are in transition phase for the new Medical Device Regulation (MDR) – launch preparations for 2024

Korneuburg, Austria, 24. September 2024 – Marinomed Biotech AG (VSE:MARI) reports positive clinical data for the new moisturizing Carragelose-containing eye drops. The eye drops are part of the recent Carragelose portfolio expansion from viral respiratory infections to targeting allergy and dry eyes. The clinical study conducted in Spain investigated for the first time the lubricating and hydrating effectiveness of Carragelose eye drops in patients affected by mild to moderate dry eye syndrome. 28 Patients were exposed to adverse environmental conditions (23°C, 10% relative humidity and airflow) to challenge dry eye symptoms. Treatment was started after the first challenge and lasted 28 days with a dose of one drop per eye, three times daily. After this treatment period, the patients were again exposed to adverse conditions and the effectiveness of the eye drops were assessed compared to the first challenge. The primary endpoint of the study was the improvement of dry eye-related symptoms such as foreign body sensation, burning or stinging, itching, pain, sticky feeling, sensitivity to light or blurred vision.

The results of the study show that treatment with Carragelose eye drops for four weeks significantly improves dry eye-related symptoms by 54%. Next to excellent tolerability, patients also reported a significant improvement in Ocular Surface Disease Index (OSDI). Strongest effects were seen on pain and blurred vision.

Eva Prieschl-Grassauer, CSO of Marinomed, says: “The clinical data further confirm our knowledge of Carragelose. It adds a moisturizing and protective layer to epithelial surfaces such as eyes, nose or throat. After demonstrating the effectiveness of Carragelose in blocking viruses and allergens with extensive clinical and in-vitro data, this new study is the first clinical validation of the lubricating properties of Carragelose. The obtained results are quite impressive and confirm that this compound is applicable to a wide range of indications. Together with an outstanding safety profile and other key benefits, Carragelose is an ideal compound for providing relief for dry eyes. Introducing the Carragelose eye drops to our product range is a logical addition and complements our recent portfolio expansion together with the new allergy product.”

The patent-protected medical device product is certified under MDD and is already in the transition phase for the new MDR coming into effect in 2028. A first partnership for Austria is in place with the launch envisaged still for 2024. Marinomed has started a business development process to identify further partners, expecting first revenues in the near to medium term.

About Carragelose®

Carragelose® is a sulfated polymer from red seaweed and a unique, broadly active virus- and allergen-blocking compound. It is known as a gentle, effective, and safe prevention and treatment of various viral respiratory infections. Several clinical and preclinical studies have shown that Carragelose® forms a protective layer on the mucosa that prevents viruses from infecting cells. Laboratory and clinical data have demonstrated that Carragelose® can also inhibit the spreading of SARS-CoV-2.^[1],[2] Marinomed is the holder of the IP rights and has licensed Carragelose® for marketing in Europe, North America, Australia, and parts of Asia and Latin America. Marinomed’s portfolio of Carragelose®-containing nasal sprays and oral products can be accessed at https://www.carragelose.com/en/portfolio/launched-products, scientific publications on Carragelose® at https://www.carragelose.com/en/publications.

About Marinomed Biotech AG

Marinomed Biotech AG is an Austrian, science-based biotech company with a growing development pipeline and globally marketed therapeutics. The Company develops innovative patent-protected products in the therapeutic areas immunology and virology based on the platform Marinosolv® and the virus-blocking activity of Carragelose®. The Marinosolv® technology improves the solubility and bioavailability of hardly soluble compounds and is used to develop new therapeutics for autoreactive immune disorders. The virology segment includes Carragelose®-based over-the-counter (OTC) products to prevent and treat respiratory viral infections that are partnered in more than 40 countries. The Company is headquartered in Korneuburg, Austria, and is listed on the Vienna Stock Exchange (VSE:MARI). For further information, please visit: https://www.marinomed.com.

For further inquiries contact:

Disclaimer

This press release contains forward-looking statements, which are based on current views, expectations and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as “anticipate,” “believe”, “estimate”, “expect”, “intend”, “plan”, “project” and “target”. Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise. Marinomed, Marinosolv® and Carragelose® are registered trademarks of Marinomed Biotech AG. These trademarks may be owned or licensed in select locations only.

^[1]  https://www.dovepress.com/efficacy-of-a-nasal-spray-containing-iota-carrageenan-in-the-postexpos-peer-reviewed-fulltext-article-IJGM

^[2]  https://www.marinomed.com/en/news/marinomed-biotech-ag-shares-positive-clinical-trial-results-for-iota-carrageenan-nasal-spray-in-the-prevention-of-covid-19-1

PRESS RELEASE

Heidelberg Pharma Announces New Clinical Data on Lead ATAC Candidate HDP-101 to be Presented at International Myeloma Society Annual Meeting 2024

Ladenburg, Germany, 23 September 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage company developing innovative Antibody Drug Conjugates (ADCs), today announces that new data from its Phase I/IIa clinical study with lead Amanitin-based ADC candidate, HDP-101, will be presented at the 21^st International Myeloma Society (IMS) Annual Meeting, being held in Rio De Janeiro, Brazil on 25 to 28 September 2024.

HDP-101 is an Anti-BCMA antibody-Amanitin drug conjugate for the treatment of relapsed or refractory multiple myeloma, a bone marrow cancer with a high unmet medical need. Phase I of the trial is a dose escalation study to determine an optimal and safe dose level of HDP-101 in patients in preparation for Phase II clinical studies.

Professor Marc-Steffen Raab, Head of the Myeloma Center at the University Hospital Heidelberg and clinical investigator of the study will present new clinical findings from five patient cohorts of the ongoing open-label, multicenter Phase I/IIa trial evaluating HDP-101 in multiple myeloma.

Details of the presentation are as follow:

Presentation title: The Anti-BCMA Antibody-Drug Conjugate HDP-101 with a Novel Amanitin Payload Shows Promising Initial First in Human Results in Relapsed Multiple Myeloma (OA – 60)

Previous data from cohort five have demonstrated biological activity in three out of five patients, and an objective improvement in disease was detected (“partial remission”). The trial is currently treating patients in its sixth cohort with further data to be presented at upcoming scientific conferences.

Following the presentation at IMS, Heidelberg Pharma will host a R&D Webinar on 15 October 2024 at 17:00 pm CEST/ 11:00 am ET, for investors, analysts and media. Further registration information will be announced in due course.

About Heidelberg Pharma

Heidelberg Pharma develops novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the high affinity and specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with various toxins, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kills the diseased cells.

Heidelberg Pharma is the first company to use the mushroom toxin Amanitin in cancer therapies by exploiting the toxin’s biological mechanism of action with its innovative ATAC technology as a new therapeutic modality. It offers the opportunity to not only overcome resistance of cancer cells against therapeutic agents currently used, but also has the ability to eliminate dormant tumor cells. This could lead to significant advances in cancer therapy – even for patients who no longer respond to any other treatment. The most advanced product candidate HDP-101 is an BCMA-ATAC for the indication multiple myeloma, which is currently in clinical development.

In addition to Amanitin, other payloads are expanding the ADC platform technologies of Heidelberg Pharma to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors.

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

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

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

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Press Release

Pentixapharm Holding AG Sets Price Range for Planned IPO

• Offering of up to 3.9 million new shares at a price range of EUR 4.70 to EUR 6.00 per share
• IPO proceeds to secure financing for further development of promising product pipeline in the rapidly growing field of radioligand therapies
• Subscription period for institutional and retail investors begins on September 24, 2024, and is expected to end on October 1, 2024
• First trading day on the Prime Standard of the Frankfurt Stock Exchange anticipated on October 3, 2024
• High free float of over 60% expected post-IPO

Berlin and Würzburg, Germany, September 23, 2024 – Pentixapharm Holding AG (“Pentixapharm”), a biopharmaceutical company focused on developing innovative first-in-class radiopharmaceuticals for the diagnosis and therapy (“theranostics”) of blood cancer and other widespread indications not yet treated with radiopharmaceuticals, announces details of its planned initial public offering (“IPO”) on the Prime Standard of the Frankfurt Stock Exchange. The German Federal Financial Supervisory Authority (BaFin) has today approved the prospectus for the public offering in Germany and the listing of Pentixapharm shares.

The IPO price range has been set at EUR 4.70 to EUR 6.00 per share. The final offer price will be determined based on a bookbuilding process at the end of the offering period, which begins on September 24, 2024, and is expected to end on October 1, 2024, at 12:00 p.m. CEST for retail investors and at 2:00 p.m. CEST for institutional investors.

The public offering comprises up to 3,900,000 registered shares. There is no over-allotment option (“greenshoe”). In addition to the offered shares, 50,000 nominal shares and 20,845,477 spin-off shares will be admitted to trading on the regulated market of the Frankfurt Stock Exchange (Prime Standard). The spin-off shares result from a capital increase in kind resolved by the extraordinary general meeting on June 26, 2024, consisting of all shares held by Eckert & Ziegler SE in Pentixapharm AG following the spin-off of Pentixapharm AG approved by Eckert & Ziegler SE’s general meeting on the same day. In total, up to 24,795,477 registered shares of Pentixapharm Holding AG will be admitted to trading. All shares have a notional value of EUR 1.00 per share in the company’s share capital and carry full dividend rights from March 25, 2024.

Proceeds from the Offering to Fund Further Development of the Product Pipeline

Assuming full placement of the shares, the IPO would result in a market capitalization of EUR 132.7 million at the midpoint of the bookbuilding range. The expected gross proceeds for Pentixapharm from the placement of new shares amount to between EUR 18.3 million and EUR 23.4 million, based on the bookbuilding range and the maximum number of 3.9 million offer shares. With an additional convertible bond of up to EUR 18.5 million subscribed by the listed Eckert & Ziegler SE, Pentixapharm would have over EUR 39 million in additional financial resources at the midpoint of the bookbuilding range to implement the first phase of its growth strategy.

The proceeds from the IPO are primarily intended for the further development of the company’s product pipeline. The growth strategy in the coming years is focused on the clinical development and approval of main candidates, Ga68-PentixaFor and Y90-PentixaTher, as well as on strategic partnerships and potential acquisitions in the field of radiopharmaceuticals. The IPO is thus a milestone on the planned path toward commercialization of well-validated programs. Lead candidate PentixaFor is already in Phase III clinical development in Europe.

Dr. Hakim Bouterfa, CEO of Pentixapharm Holding AG, commented: “We are now in the home stretch with our IPO plans and are pleased with the positive feedback from investors. Our goal is to make the stock attractive to investors who join early and to minimize the dilution of Eckert & Ziegler SE shareholders who become Pentixapharm shareholders as a result of the spin-off. Therefore, only a limited number of shares are being offered in the IPO. We are convinced of a positive development of Pentixapharm and aim to achieve further milestones in the coming months.”

Dr. Andreas Eckert, Chairman of the Supervisory Board of Pentixapharm Holding AG, stated: “Pentixapharm has an attractive product pipeline and is gaining access to capital market investors through the IPO. As previously announced, as part of the spin-off of Pentixapharm from Eckert & Ziegler SE, Eckert Wagniskapital und Frühphasenfinanzierung GmbH is also participating in the IPO, underscoring its confidence in Pentixapharm. For future investments, several options are available, including further capital measures or other financing possibilities such as collaborations with established pharmaceutical companies. The current valuations of companies in the field of radiopharmaceuticals with programs in clinical trials in the US underscore the potential that investors see in this field.”

IPO Targeted at Both Institutional and Retail Investors Interested in Pentixapharm’s Innovative Growth Model

The shares will be offered as part of a public offering in Germany and an international private placement. The offering is aimed at both institutional and retail investors. Retail investors in Germany can place purchase orders in the public offering one day after the start of the offer period, i.e., from September 25, 2024, exclusively via the DirectPlace© subscription functionality of the Frankfurt Stock Exchange or through their custodian bank. Qualified investors can place purchase orders directly with BankM AG, acting as sole global coordinator and sole bookrunner, during the offer period. The free float after the IPO is expected to be over 60%. The main shareholder of Pentixapharm is Eckert Wagniskapital und Frühphasenfinanzierung GmbH, which will hold 31.57% of the share capital after the completion of the spin-off.

Admission to trading is expected on October 2, 2024. On October 3, 2024, the listing of the existing shares and the spin-off shares of Pentixapharm Holding AG under the ticker symbol “PTP” and the International Securities Identification Number (ISIN) DE000A40AEG0 is scheduled to take place on the regulated market (Prime Standard) of the Frankfurt Stock Exchange. The offer shares are expected to be traded from October 10, 2024, following the registration of the capital increase in the commercial register and the admission decision by the Deutsche Börse AG.

The securities prospectus regarding the public offering and the admission of the shares to trading on the regulated market (Prime Standard) was approved today by the German Federal Financial Supervisory Authority (BaFin) and is available in the Investor Relations section of the company’s website at www.pentixapharm.com.

About Pentixapharm Holding AG

Pentixapharm Holding AG was founded in 2024 to incorporate all shares held by Eckert & Ziegler SE in Pentixapharm AG, based in Würzburg, following the spin-off resolved by the Annual General Meetings of Eckert & Ziegler SE and Pentixapharm Holding AG on June 26, 2024. It is intended to list Pentixapharm Holding AG on the Prime Standard of the Frankfurt Stock Exchange.

Pentixapharm AG is a clinical-stage radiopharmaceutical development company founded in 2019 with its headquarters in Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. 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. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a US-centric Phase III registration study with PentixaFor in PA that will start in 2025.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
phillip.eckert@pentixapharm.com
Tel. +49 30 94 10 84 227
www.pentixapharm.com

Media Contact:
MC Services AG
Anne Hennecke
Tel. +49 211 529252 22
anne.hennecke@mc-services.eu

Important Notice

This announcement is an advertisement for the purposes of the prospectus regulation EU 2017/1129, as amended (“Prospectus Regulation”): lt does not constitute an offer to purchase any shares in Pentixapharm Holding AG and does not replace the securities prospectus which will be available free of charge, together with the relevant translation of the summary, in the IR section of the Pentixapharm Group website at https://www.pentixapharm.com/. The approval of the securities prospectus by the German Federal Financial Supervisory Authority (“BaFin”) should not be understood as an endorsement of the investment in any shares in Pentixapharm Holding AG. Investors should purchase shares solely on the basis of the prospectus (including any supplements thereto, if any) relating to the shares and should read the prospectus which is yet to be published (including any supplements thereto, if any) before making an investment decision in order to fully understand the potential risks and rewards associated with the decision to invest in the shares. Investment in shares entails numerous risks, including a total loss of the initial investment.

This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States, Australia, Canada, South Africa, Japan or in any jurisdiction to whom or in which such offer or solicitation is unlawful.

Neither this announcement nor the publication in which it is contained is for publication or distribution, directly or indirectly, in whole or in part, in or into the United States of America, including its territories and possessions, any state of the United States and the District of Columbia (“United States”). The information in this announcement does not contain or constitute an offer to acquire, subscribe or otherwise trade in shares in Pentixapharm Holding AG in any jurisdiction. Any securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”), or the securities laws of any state or other jurisdiction of the United States, and may not be offered, subscribed, used, pledged, sold, resold, allotted, delivered or otherwise transferred, directly or indirectly, in or into the United States absent such registration, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements under the Securities Act, in each case in compliance with any applicable securities laws of any state or other jurisdiction of the United States. There will be no public offer of the securities in the United States.

Subject to certain exceptions under applicable law, the securities referred to in this announcement may not be offered or sold in Australia, Canada, South Africa or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada, South Africa or Japan. There will be no public offer of the securities in Australia, Canada, South Africa or Japan.

In member states of the European Economic Area (other than Germany), this announcement is only addressed to and directed at persons who are “qualified investors” within the meaning of Article 2(e) of the Prospectus Regulation.

In the United Kingdom, this announcement is only addressed to and directed at persons who are “qualified investors” within the meaning of Article 2 of the Prospectus Regulation (Regulation (EU) 2017/1129 and amendments thereto) as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 and who (i) have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (“Order”) or (ii) are high net worth entities falling within article 49(2)(a) to (d) of the Order (all such persons being referred to as “Relevant Persons”). In the United Kingdom, this announcement is directed only at Relevant Persons. Any person who is not a Relevant Person should not act or rely on this announcement or any of its contents. Any investment or investment activity to which this announcement relates is available only to Relevant Persons and will be engaged in only with Relevant Persons and it should not be relied on by anyone other than a relevant person.

This announcement does not purport to contain all information required to evaluate the Pentixapharm Holding AG and its future combined subsidiaries (i.e. Pentixapharm AG, Würzburg , and the 100 % subsidiary of Pentixapharm AG, Myelo Therapeutics GmbH, Berlin) upon the completion of the spin-off by absorption (Abspaltung zur Aufnahme) in accordance with the German Transformation Act (Umwandlungsgesetz) of all of the shares held by Eckert & Ziegler SE, Berlin in Pentixapharm AG to Pentixapharm Holding AG (“Spin-off” and such combined subsidiaries together with Pentixapharm Holding AG “Pentixapharm Group”) and/or their financial position and, in particular, is subject to amendment, revision, verification, correction, completion and updating in its entirety. Neither (i) Pentixapharm Holding AG nor (ii) BankM AG (“Bank“, and together with Pentixapharm Holding AG “Persons“), or any of the respective directors, officers, personally liable partners, employees, agents, affiliates, shareholders or advisers of such Persons may notify you of changes nor is under an obligation to update or keep current the announcement or to provide the recipient thereof with access to any additional information that may arise in connection with it, save for the making of such disclosures as are required by mandatory provisions of law. This announcement does not constitute investment, legal, accounting, regulatory, taxation or other advice.

No person is authorized to give any information or to make any representation not contained in and not consistent with this announcement and, if given or made, such information or representation must not be relied upon as having been authorized by or on behalf of Pentixapharm Holding AG or any Person.

Certain market positioning data about Pentixapharm Holding AG and Pentixapharm Group included in this announcement is sourced from or based on third-party sources. Third-party industry publications, studies and surveys generally state that the data contained therein have been obtained from sources believed to be reliable, but that there is no guarantee of the fairness, quality, accuracy, relevance, completeness or sufficiency of such data. Such research, estimates and forecasts, and their underlying methodology and assumptions, have not been verified by any independent source for accuracy or completeness and are subject to change without notice. Accordingly, Pentixapharm Holding AG expressly disclaims any responsibility for, or liability in respect of, such information and undue reliance should not be placed on such data.

This announcement may contain forward-looking statements which reflect Pentixapharm Holding AG’s and Pentixapharm Group’s current view on future events and financial and operational development. Forward-looking statements are sometimes, but not always, identified by their use of a date in the future or such words as “will”, “anticipates”, “aims”, “could”, “may”, “should”, “expects”, “believes”, “intends”, “plans”, “prepares” or “targets” (including in their negative form or other variations). By their nature, forward-looking statements are inherently predictive, speculative and involve risk and uncertainty because they relate to events and depend on circumstances that may or may not occur in the future. There are a number of factors that could cause actual results, performance and developments to differ materially from those expressed or implied by these forward-looking statements. All subsequent written or oral forward-looking statements attributable to Pentixapharm Holding AG or its affiliates, or any persons acting on their behalf are expressly qualified in their entirety by the factors referred to above. No assurances can be given that the forward-looking statements in this announcement will be realized. Any forward-looking statements are made of the date of this announcement.

Subject to compliance with applicable law and regulations, neither Pentixapharm Holding AG, nor the Bank nor their respective affiliates intend to update, review, revise or conform any forward-looking statement contained in this announcement to actual events or developments whether as a result of new information, future developments or otherwise, and do not undertake any obligation to do so.

The information contained in this announcement does not purport to be comprehensive and has not been subject to any independent audit or review.

Certain figures, including financial and market data, contained in this announcement have been rounded and the relevant sums may not add up to 100% due to rounding.

The Bank is acting exclusively for Pentixapharm Holding AG and no-one else in connection with the planned offering of shares of Pentixapharm Holding AG (“Offering“). It will not regard any other person as their respective clients in relation to the Offering and will not be responsible to anyone other than Pentixapharm Holding AG for providing the protections afforded to their respective clients, nor for providing advice in relation to the Offering, the contents of this announcement or any transaction, arrangement or other matter referred to in this announcement.

In connection with the Offering, the Bank and any of its affiliates, acting as investors for their own accounts, may subscribe for or purchase securities of Pentixapharm Holding AG and in that capacity may retain, purchase, sell, offer to sell or otherwise deal for their own accounts in such securities and other securities of Pentixapharm Holding AG or related investments in connection with the Offering or otherwise. Accordingly, references in the prospectus, once published, to the securities being issued, offered, subscribed, acquired, placed or otherwise dealt in should be read as including any issue or offer to, or subscription, acquisition, placing or dealing by the Bank and any of its affiliates acting as investors for their own accounts.

In addition, the Bank or its affiliates may enter into financing arrangements and swaps with investors in connection with which the Bank (or its affiliates) may from time to time acquire, hold or dispose of Pentixapharm Holding AG’s shares. The Bank does not intend to disclose the extent of any such investment or transactions otherwise than in accordance with any legal or regulatory obligations to do so.

None of the Bank or any of its affiliates, directors, officers, personally liable partners, employees, advisers or agents accepts any responsibility or liability whatsoever for or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to Pentixapharm Holding AG, its combined subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith.

The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed by any person for any purpose on the information contained in this announcement or its accuracy, fairness or completeness.

The dates of the admission(s) to trading of shares of Pentixapharm Holding AG on the regulated market segment (regulierter Markt) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) with simultaneous admission to the sub-segment of the regulated market with additional post-admission obligations (Prime Standard) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) (together “Admission”) may be influenced by things such as market conditions. There is no guarantee that Admission will occur and no financial decision should be based on the intentions of Pentixapharm Holding AG in relation to Admission at this stage. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing all of the amount invested. Persons considering making such investments should consult an authorized person specializing in advising on such investments. This announcement does not constitute a recommendation concerning the Offering. The value of shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of the Offering for the person concerned.

Relief Therapeutics Announces $2 Million Milestone Under Royalty Sales Agreement

GENEVA (SEPT. 23, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced it will receive a $2 million milestone payment from SWK Funding LLC (SWK) this month, following the U.S. Food and Drug Administration’s (FDA) approval of Zevra Therapeutics Inc.’s arimoclomol for the treatment of Niemann-Pick Disease Type C.

The payment is part of the previously announced royalty monetization agreement between Relief and SWK. Under this agreement, Relief received an initial $5.75 million in August 2024 and is eligible to receive up to an additional $5.25 million contingent on specific milestones. With the FDA’s approval of arimoclomol, the first $2 million milestone has now been successfully met. Relief remains eligible for $3.25 million if OLPRUVA’s quarterly net sales reach $1.5 million by the end of the third quarter of 2025. Further details about the agreement can be found in the press release issued on August 5, 2024.

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

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

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

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 concludes royalty monetization deal for up to EUR 128.88 million on investigational pharma compound deucrictibant with Royalty Pharma

Zwingenberg, Germany, 20 September 2024 – Today, BRAIN Biotech AG (ISIN DE0005203947; “Company”) concluded a royalty monetization deal on the royalty rights to investigational pharma compound deucrictibant with Royalty Pharma for up to EUR 128.88 million. The Company will receive an upfront payment of EUR 18.41 million, additional potential regulatory milestones of up to EUR 18.42 million and additional potential long-term sales related milestones of up to EUR 92.05 million. Pharma compound deucrictibant builds part of the Company’s BioIncubator pipeline and is currently in the phase of clinical development by Pharvaris NV (Nasdaq PHVS) for the target indication Hereditary Angioedema.

The Company intends to use the net proceeds of this transaction for future growth funding as well as loan repayments. 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.

BRAIN Biotech AG concludes major pharma compound transaction valued up to EUR 128.88 million from its BioIncubator

• Total transaction value up to EUR 128.88 million significantly exceeding current market capitalization of BRAIN Biotech
• Immediate upfront payment of EUR 18.41 million
• Royalty monetization of an investigational compound, deucrictibant, with market leading Royalty Pharma
• Contractual milestone payments of up to EUR 9.0 million for the nearer-term clinical progress stay with BRAIN Biotech

Zwingenberg, Germany, 20 September 2024 – BRAIN Biotech AG (“Company”) concluded a royalty monetization deal on the royalty rights to an investigational compound, deucrictibant, with Royalty Pharma for up to EUR 128.88 million. The Company will receive an upfront payment of EUR 18.41 million, additional potential regulatory milestones of up to EUR 18.42 million and additional potential long-term sales related milestones of up to EUR 92.05 million.

Adriaan Moelker, CEO of BRAIN Biotech AG, states: “This is truly a milestone transaction in the history of BRAIN Biotech. We have always believed in the high value of our BioIncubator projects and are now starting to increasingly harvest the strong pipeline investments of the past. This transaction with market leader Royalty Pharma has not only confirmed our value assumptions of deucrictibant but also allowed us to significantly forward cash proceeds from this exciting project. With the proceeds we will accelerate the ongoing transformation of BRAIN Biotech to a global top ten player in the highly attractive market of industrial enzymes. We will continue to focus here on our core areas of Food, Beverage and Life Sciences with a very strong heritage in scientific excellence.”

A result of the Company’s BioIncubator pipeline of highly innovative projects, deucrictibant is currently in clinical development by Pharvaris Netherlands NV (Nasdaq PHVS) for the treatment of Hereditary Angioedema. This project was initiated by group subsidiary AnalytiCon Discovery, which has been merged into the Company but will continue to work as an independent commercial unit of BRAIN Biotech AG. All existing commitments and licenses associated with the investigational compound will be transferred from BRAIN Biotech to Royalty Pharma. BRAIN Biotech intends to commercialize and monetize additional projects with high value from its BioIncubator pipeline during the next years.

Michael Schneiders, CFO of BRAIN Biotech AG, says: “Royalty monetization is a very interesting and innovative form of alternative non-dilutive financing for us in an environment of an ultra-low BRAIN Biotech share price. We have not only been able to raise significant immediate proceeds via the upfront payment but will also participate in the ongoing clinical success of the investigational compound by nearer term regulatory milestones and further long-term payments related to the potential sales development of deucrictibant. The value of this single transaction is more than four times the total market capitalization of BRAIN Biotech prior to the deal announcement.” Schneiders adds, “We are very confident that the strong operational and structural development which started in the last three years in conjunction with increasingly crystallizing value from our BioIncubator pipeline will bring BRAIN Biotech AG back to the agenda of equity investors. In this transaction we have only monetized the future royalties on deucrictibant. Additional contractual milestone payments of up to 9.0 million EUR for the nearer term clinical progress stay with BRAIN Biotech.”

The Company intends to use the net proceeds of this transaction to accelerate its ongoing transformation to a global top ten position in industrial enzymes, for future growth funding including potential M&A transactions and short-term loan repayments. This transaction remains subject to customary closing conditions.

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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 AnalytiCon Discovery

AnalytiCon Discovery is an independent commercial unit of BRAIN Biotech AG with many years of R&D expertise in natural product chemistry. The Potsdam-based operation site specializes in small molecule compounds and offers customers from the pharmaceutical, cosmetics, food and agricultural sectors the development of substance libraries, the identification of active ingredients and their synthetic optimization as well as the production of active ingredients on a commercial scale. AnalytiCon has been part of the BRAIN Biotech Group since 2013. Further information: www.ac-discovery.com

About Royalty Pharma plc

Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly – directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products. Further information: https://www.royaltypharma.com/

Contact Media BRAIN Biotech

Dr. Stephanie Konle

PR & Corporate Communications

Phone: +49 6251 9331-70

Email: stk@brain-biotech.com

Contact Investor Relations BRAIN Biotech

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.

Hamburg, Germany, and Toulouse, France, 20 September 2024:
Just – Evotec Biologics, the biologics segment of Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO), today celebrated the Grand Opening of its J.POD^® biologics development and manufacturing facility located on Evotec’s Campus Curie in Toulouse, France. The J.POD^® facility in Toulouse, the second of its kind and the first in Europe, utilizes Just – Evotec Biologics’ adaptable J.POD^® technology to provide essential clinical and commercial biologics manufacturing capacity.

During a ceremony on Campus Curie, Pierre-André Durand, Prefect of Haute-Garonne and Occitanie, Jean-Luc Moudenc, President of Toulouse Métropole and Mayor of Toulouse as well as Jalil Benabdillah, Vice-President, Economy, Employment, Innovation and Reindustrialisation of the Occitanie region, joined the Management of Evotec and Just – Evotec Biologics, to inaugurate the new facility.

Dr Christian Wojczewski, Chief Executive Officer of Evotec, commented: “J.POD^® is a bioprocessing facility by Just – Evotec Biologics that uses advanced technology to fulfill its mission of making biotherapeutics more accessible worldwide. The opening of J.POD^® Toulouse, France (EU), our first J.POD^® on European ground, represents a proud moment and a significant milestone for our Company. We are very thankful for the support from the French government, the Occitanie Region, Bpifrance, the Haute-Garonne prefecture, and Toulouse Métropole for helping us achieve this milestone at our Campus Curie in Toulouse. We also want to give special credit to our dedicated team, whose hard work and commitment made this possible.”

J.POD^® Toulouse, France (EU) brings much-needed biologics manufacturing capacity to Europe. Biologics offer a potent therapeutic solution applicable to various indications. However, conventional fed-batch manufacturing poses significant hurdles, particularly during the transition from clinical to commercial scale. The J.POD^® technology, with its modular continuous manufacturing approach, enables highly intensified cGMP production of biologics at flexible quantities, effectively mitigating scale-up risks and reducing manufacturing costs.

Built in a short 18 months green field project, the approx. 15,000 sqm J.POD^® facility stands out in the industry due to its cutting-edge continuous manufacturing technologies in a small, simple facility design built in significantly shorter construction time compared to conventional biologics manufacturing that can deliver up to 2 metric tons of biotherapeutics. The site features dedicated quality control and process development labs for both clinical and commercial products, along with a warehouse and collaborative office spaces. The facility is designed with enhanced environmental sustainability, resulting in reduced water, electricity, and chemical usage compared to conventional facilities.

J.POD^® facilities are constructed at a fraction of the cost compared to similar large-scale DS manufacturing facilities in the industry. This significant cost advantage, with benchmark costs for comparable facilities around $ 600 m, underscores one of our key competitive strengths.

Dr Linda Zuckerman, EVP and Global Head of Biotherapeutics at Just – Evotec Biologics, commented: “J.POD^® is an innovative technology that not only scales biologics manufacturing but also ensures availability precisely where it’s needed. With this second facility, we extend our capacity to discover and develop groundbreaking biologics but also, with our partners, deliver them promptly to patients in need. Our Toulouse-based team at Just – Evotec Biologics deserves immense credit for bringing the J.POD facility and its capabilities to France and the EU.”

The construction of J.POD^® Toulouse, France (EU) benefits from French government funding as part of the Investments for the future Programme (programme d’investissements d’avenir in French) and is also supported economically by the Occitanie Region.

About Just – Evotec Biologics
Just – Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform company that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch. The Just – Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics. Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners. Learn more at www.just-evotecbiologics.com.

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

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

For further information, please contact:

Media

Gabriele Hansen
SVP Head of Global Corporate Communications
Gabriele.Hansen@evotec.com

Hinnerk Rohwedder
Director of Global Corporate Communications
Hinnerk.Rohwedder@evotec.com

Joséphine Pröhl
Corporate Communications Associate (France)
Josephine.Proehl@evotec.com

Investor Relations

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

Newron presents H1 2024 results and provides business update 

Milan, Italy, September 19, 2024, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the half year ended June 30, 2024, and provided an update on its business activities.

Highlights H1 2024: 

Evenamide

• Reported positive final one-year results from study 014/015, a Phase II open label trial evaluating evenamide as an add-on therapy to a single antipsychotic in patients with treatment-resistant schizophrenia (TRS):
  • The study demonstrated significant, clinically important, progressive, sustained, and long-lasting improvement on Positive and Negative Syndrome Scale (PANSS) Total, Clinical Global Impression of Severity (CGI-S), the mean rating of change for the Clinical Global Impression of Change (CGI-C) and Level of Functioning (LOF)
  • More than 70% of patients experienced a clinically important reduction in disease severity
  • 25% of all patients achieved “remission,” never described before in TRS patients
     
• Reported compelling results from study 008A, a potentially pivotal, four-week randomized, double-blind and placebo-controlled study of evenamide as an add-on therapy in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic:
  • Study analysis revealed statistically significant multi-domain benefits in PANSS and Clinical Global Impression of Change (CGI-C) ratings
  • Benefit on efficacy measures increased over time, suggesting larger and enduring patient effects to be expected during long-term treatment
     
• Together, these studies:
  • Confirm evenamide’s favorable safety and tolerability profile
  • Demonstrate evenamide’s efficacy on multiple measures of psychopathology in TRS and chronic schizophrenia
  • Add to the growing evidence that the glutamatergic inhibition mechanism of action offers an innovative therapeutic option to schizophrenia patients not benefitting from current antipsychotic treatments
     
• Company is working towards the initiation of a potentially pivotal, multinational, randomized, double-blind, one-year, placebo-controlled study, assessing the efficacy, safety, and tolerability of evenamide as an add-on treatment in patients with TRS
   
• Company is currently running a structured process of securing the most attractive, value creating transaction around evenamide, and several indications of interest have been received. Board and Management are prioritizing and negotiating offers according to their potential to increase shareholder value, with the expectation of closing a transaction in the coming months

Corporate

• Company entered into an agreement for the subscription of up to 2.05 million newly issued shares, up to a value of EUR 15 million, with an institutional investor focused on investing in high-growth firms across sectors including biotech and healthcare
   
• An agreement was entered into with the European Investment Bank to extend the near-term tranche repayment dates of its 2018 financing agreement until the end of 2025 and into 2026, after potentially significant milestones
   
• Chairman and CEO increased their holdings in Newron, underlining their commitment to the Company

Stefan Weber, CEO of Newron, commented:

“It has been a busy and exciting six months for Newron where we have delivered two positive clinical milestones in the development of our novel drug evenamide. We reported exceptional data demonstrating positive clinical results from both study 014/15 and study 008A, which evaluated evenamide as an add-on treatment for patients with treatment-resistant schizophrenia (TRS) and chronic schizophrenia, respectively. We were also delighted to host a successful Investor Day in June in New York City, featuring presentations from leading KOLs on the unmet medical needs for patients with schizophrenia, underscoring the potentially pivotal role of evenamide for these patients. We believe our new chemical entity has blockbuster potential and could bring enormous benefits to patients who are insufficiently served by the existing treatments available. Newron, with the help of a leading healthcare investment bank, is currently exploring potential partnership agreements and opportunities for collaboration that will enable us to progress evenamide into Phase III clinical development for the potential treatment of patients with TRS and create value for our shareholders.”

Evenamide (Schizophrenia)

During Q1 2024, Newron reported final one-year results from study 014/015, a Phase II open label trial evaluating evenamide as an add-on therapy to a single antipsychotic in treatment-resistant patients. The data demonstrated that evenamide as an add-on treatment for patients with TRS was associated with sustained, clinically significant benefits that increased throughout the one-year course of treatment, with more than 70% of patients experiencing a clinically important reduction in disease severity.

Overall, data from study 014 has demonstrated that evenamide was safe and well-tolerated at all doses, with 97% of patients completing six weeks of treatment. The incidence of treatment-emergent adverse events was very low, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015).

In Q2, the Company announced two sets of data from study 008A, a potentially pivotal four-week randomized, double-blind and placebo-controlled study of evenamide as an add-on therapy in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic. Topline data announced in April confirmed evenamide’s favorable safety and tolerability profile, followed by compelling data from additional analyses reported in May.  

The study met the primary endpoint (improvement of the Positive and Negative Syndrome Scale (PANSS) Total Score) and key secondary endpoint (improvement of the Clinical Global Impression of Severity (CGI-S)), with a high rate of study completion (96%). No new or specific concerns were raised in the study; only 25% of the patients in the study experienced at least one adverse event (evenamide 25% versus placebo 25.8%).

Newron will be presenting the results of study 008A at the upcoming 37th ECNP Congress (September 21-24, 2024) in Milan, Italy.

The totality of these results validated evenamide as the first glutamate modulator to demonstrate efficacy in inadequately responding patients with schizophrenia in a placebo-controlled study.

Following results from both study 008A and study 014/015, Newron’s key focus is now on initiating a Phase III randomized, double-blind, one-year clinical trial. The trial is expected to start in the first half of 2025 and will compare evenamide to placebo as an add-on treatment in at least 400 patients with TRS. Participants will be evaluated at three timepoints, 12 weeks, 26 weeks, and one year, to assess the long-term safety, tolerability, and efficacy of evenamide. The study design has received regulatory approval in all relevant territories, final discussion is ongoing with the US Food and Drug Administration (FDA) on the dosing regimen.

Several indications of interest were received in a structured process of securing the most attractive, value creating transaction for Newron’s shareholders, be it a regional or global license or an M&A transaction; with the process supported by one of the world’s leading full-service investment banking and capital markets firms. The Board and Management will prioritize and negotiate the offers according to their potential to increase shareholder value, with the expectation to close a transaction in the coming months, enabling progression of the Phase III clinical development of evenamide in TRS patients.

Xadago^®/safinamide (Parkinson’s disease)

In partnership with Zambon and Supernus, Newron continues to further develop and market its product, Xadago®/safinamide.

In reference to the receipt of several Paragraph IV Notice Letters in May 2021 regarding the submission by some generic manufacturers of an Abbreviated New Drug Application ANDA to the US FDA, seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the US before expiration of the three US patents listed in the FDA Orange Book for Xadago®, Newron and its partners Zambon and Supernus have reached settlement agreements with said generic manufacturers, thus resolving the legal action. All three patents remain valid and in force. Under the agreement, the generic manufacturers will be allowed to enter the US market with a safinamide mesylate drug product no earlier than December 1, 2027.

In the EU, Supplementary Protection Certificates (SPCs) have already been approved in most territories of relevance; Newron and Zambon are confident that upon completion of the still ongoing procedures and targeted activities, the SPCs will be granted in all key territories.

Corporate

In April, Margarita Chavez, US-based, was elected as a Non-Executive Director to the Board of Newron following the 2024 Annual General Meeting. Margarita Chavez has been an advisor to Newron’s Board since October 2023, and the Company continues to benefit from her more than 20 years of strategic transaction expertise in the US and internationally and her leadership in the pharmaceutical industry. She is heading the Business Development Committee of Newron’s Board of Directors.

During the first half of 2024, Newron announced an agreement with the European Investment Bank to extend the near-term tranche repayment dates of the 2018 financing agreement until the end of 2025 and into 2026, after potentially significant milestones.

Furthermore, the Company entered into an agreement for the subscription of up to 2.05 million newly issued shares with an institutional investor focused on investing in high-growth firms across sectors including biotech and healthcare. Under the agreement, the fund subscribed to an initial 750,000 newly issued shares at a subscription price of EUR 7.33 per share, which corresponds to gross proceeds of approximately EUR 5.5 million and had the right to subscribe to an additional up to 1,300,000 newly issued shares until no later than January 31, 2025. The funds raised enable Newron to focus its attention on progressing evenamide into Phase III clinical development in TRS patients and support activities beyond immediate inflection points. At the time of this report, 1,350,000 newly issued shares have been subscribed to by the investor, under the rules of the agreement, generating proceeds of EUR 9.9 million. For further detail, please refer to https://www.ser-ag.com/en/resources/notifications-market-participants/significant-shareholders.html#/.

In June 2024, Dr. Ulrich Köstlin, Chairman of Newron’s Board of Directors, and Stefan Weber, CEO demonstrated their commitment to Newron and its future by buying shares via the SIX Swiss Exchange and Xetra.

ESG commitment and reporting

The Company has worked diligently to further implement its Environment, Social and Governance (ESG) strategy and reporting framework as disclosed in the Annual Report 2023. The ESG goals and projects for 2024 are well on track and management hopes that this will ensure Newron operates as a sustainable and conscious employer, business, and provider of innovative therapeutics. The Company will provide a further update in our 2024 Annual Report.

Financial Summary (IFRS) H1 2024 and H1 2023

In thousand EUR (except per share information)

* Including one-time payments of EUR 2,284

Outlook

Following positive results from the pivotal study 008A and unprecedented results from study 014/015, Newron expects to enter into a value-creating transaction around evenamide in the coming months, enabling progression of the Phase III clinical development of the compound. The Company is convinced about the blockbuster potential of evenamide and the benefits it can bring to patients who are currently underserved by the current treatments on the market. Newron also continues to assess the market for opportunities to expand its CNS pipeline. The Company looks forward to providing an update on its evenamide partnership discussions and any pipeline developments as they may occur. Newron’s total available cash resources will fund the Company’s planned development programs and operations well into 2025.

Newron’s Half-Report 2024 is available for download on https://www.newron.com/investors/reports-and-presentation/year/2024 

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago^®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia. For more information, please visit: www.newron.com 

For more information, please contact:

Newron

Stefan Weber – CEO, +39 02 6103 46 26, pr@newron.com 

UK/Europe

Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting, +44 20 3727 1000, SCnewron@fticonsulting.com 

Switzerland

Valentin Handschin, IRF, +41 43 244 81 54, handschin@irf-reputation.ch 

Germany/Europe

Anne Hennecke / Caroline Bergmann, MC Services, +49 211 52925222, newron@mc-services.eu 

USA

Paul Sagan, LaVoieHealthScience, +1 617 374 8800, Ext. 112, psagan@lavoiehealthscience.com

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

Ad hoc announcement pursuant to Art. 53 LR

Fribourg, 19 September 2024

AEVIS VICTORIA SA (AEVS.SW) – Publication of Half-Year Report 2024 – Revenue up 8.0% to CHF 527.6 million – Operating profit at EBITDAR level up 21.3% to CHF 87.7 million

AEVIS VICTORIA SA (AEVIS), a key player in the healthcare, hospitality, and real estate sectors, today released its 2024 Half-Year Report, showing strong results despite a complex economic environment. The Group re-iterates its strategic shift towards a diversified investment model, marked by the gradual opening of Swiss Medical Network’s capital over the next three years.

Fabrice Zumbrunnen, CEO of AEVIS, commented: « We are extremely pleased with the results achieved in the first half of 2024. Our progressive transformation towards a pure play investment company aligns perfectly with our mission Investing for a better life. This evolution will enhance our agility and ability to generate value for our shareholders while maintaining our commitment to the sectors where we have historical expertise. »

2024 Half-Year Financial Results

AEVIS recorded revenues of CHF 527.6 million in the first half of 2024, up 8.0% compared to the same period in 2023. This result was driven by organic growth of 7.0%, with significant contributions from Swiss Medical Network (+4.7%) and MRH Switzerland (+13.7%). EBITDAR reached CHF 87.7 million, up 21.3%, representing a strong margin of 18.9%. Thanks to rigorous cost management and improved operational processes, AEVIS successfully transformed a CHF 10.2 million loss in the first half of 2023 into a net profit of CHF 0.7 million in 2024.

MRH Switzerland: Record half-year and 39.0% increase in operating profit

MRH Switzerland delivered an exceptional performance, generating revenues of CHF 101.2 million with organic growth of 13.7%, despite the challenges posed by unusual spring weather, which impacted weekend tourism in May and June. MRH Switzerland’s EBITDAR surged by 39.0% to CHF 27.7 million, with a margin of 27.4%, a significant improvement from 22.6% in the previous year.  The winter season in Zermatt was very good, and the hotels in Davos and Interlaken achieved double-digit growth, significantly above the industry average. The AlpenGold Hotel in Davos benefited from very good results during and outside the WEF. In general, bookings for the second half of the year are encouraging, and MRH Switzerland expects full-year results to be higher than last year.

Swiss Medical Network: EBITDAR margin rises to 20.0%

Swiss Medical Network also demonstrated solid growth, with revenues increasing by 5.8% to CHF 417.5 million. Net revenues (excluding medical fees) increased by 5.6% to CHF 353.0 million. The EBITDAR margin rose to 20.0%, largely thanks to the completion of construction at the Genolier Innovation Hub, allowing Clinique de Genolier to return to normal operations. Additionally, cost optimization measures contributed significantly to the financial improvement of Swiss Medical Network.

Réseau de l’Arc, the first truly integrated care organization in Switzerland and a 35% subsidiary of Swiss Medical Network, also had a promising start with the successful launch of its health insurance product « VIVA », further strengthening AEVIS’s leadership position in integrated care in Switzerland.

Infrastructure investments benefit from strong tenant performance

The real estate investments in Swiss Hotel Properties, with a net asset value (NAV) of CHF 363.4 million, and the 30% stake in Infracore, with a NAV of CHF 566.3 million at the end of 2023, are benefiting from the strong operational performance of their tenants, namely MRH Switzerland and Swiss Medical Network. As such, the real estate assets provide both value and stability to the AEVIS portfolio.

A strategic shift towards a diversified investment profile

AEVIS continues its transformation into a diversified investment company, while keeping its focus on the healthcare, hospitality, and real estate sectors. As part of its strategic roadmap, AEVIS intends to welcome new strategic investors in the shareholder base of Swiss Medical Network, thereby gradually reducing its own stake in the hospital group. Over the next three years, AEVIS plans to successively place shares in Swiss Medical Network with institutional and strategic investors, further improving the positioning and increasing its value.

Outlook for 2024

For the full year, AEVIS anticipates positive results, driven by strong performances in its hotel and healthcare activities. The real estate holdings, both in the hotel and healthcare sectors, are expected to benefit from the positive momentum of its tenants. The Group remains cautious, however, in the face of current macroeconomic challenges and does not plan to set consolidated revenue or margin targets for the current year.

Detailed reporting

AEVIS VICTORIA SA’s Half-Year Report 2024 can be downloaded via this link: Half-Year Report 2024

For further information:
AEVIS VICTORIA SA Media and Investor Relations: c/o Dynamics Group, Zurich
Philippe R. Blangey, prb@dynamicsgroup.ch, +41 (0) 43 268 32 35 or +41 (0) 79 785 46 32
Séverine Van der Schueren, svanderschueren@aevis.com, +41 (0) 79 635 04 10

AEVIS VICTORIA SA – Investing for a better life
AEVIS VICTORIA SA invests in healthcare, hospitality & lifestyle and infrastructure. AEVIS′s main shareholdings are Swiss Medical Network SA (80%, directly and indirectly), the only Swiss private network of hospitals present in the country’s three main language regions, MRH Switzerland AG, a luxury hotel group managing eleven luxury hotels in Switzerland and abroad, Infracore SA (30%, directly and indirectly), a real estate company dedicated to healthcare-related infrastructure, Swiss Hotel Properties SA, a hospitality real estate division, and NESCENS SA, a brand dedicated to better aging. AEVIS is listed on the Swiss Reporting Standard of the SIX Swiss Exchange (AEVS.SW). www.aevis.com.